Entrepreneurship I. Our Solution

The Problem

Parkinson's disease (PD) is a neurodegenerative disorder that predominantly affects the dopamine-producing neurons in a specific area of the brain called the substantia nigra. Symptoms can be divided into two main categories: motor and non-motor. As the disease progresses, these symptoms intensify. Motor symptoms include tremors, bradykinesia (slow movement), stiffness in limbs, and balance issues. Non-motor symptoms include sleep disorders, mental health challenges, cognitive impairments, constipation, and urinary dysfunction.

Table 1: Motor and non-motor symptoms in the early and later stages of Parkinson’s Disease.

Parkinson’s disease is the second most common neurodegenerative disorder, following Alzheimer's disease. Globally, over 10 million individuals live with PD, and this number is expected to double by 2040. Based on US data, the combined direct and indirect costs of PD amount to nearly 52 billion USD annually. Moreover, the average annual cost of medication for a patient is around 2,500 USD. In recent times, the WHO has characterized Parkinson’s as the fastest-growing neurological disorder and one of the leading causes of disability worldwide.

There are currently no specific tests that can be used to diagnose Parkinson's disease. The diagnosis of Parkinson's disease is mainly based on clinical appearance, which is not always clear in the early stages of the disease. This can lead to delays in both diagnosis and treatment, which can severely affect the patient's prognosis. There are also significant error rates in clinical diagnosis, with some studies measuring it from 15% to 24%. Another difficulty that is presented in clinical practice is differentiation of Parkinson’s disease from atypical parkinsonian disorders, particularly in the early stages. These delays in diagnosis ultimately also lead to increased healthcare costs.

There is general agreement that the development of clinically diagnosed Parkinson's disease occurs considerably earlier than current diagnostic criteria can detect. The prognosis of those who exhibit one or more characteristics linked to a higher chance of developing clinically diagnosed Parkinson's disease is a particular challenge that cannot be addressed with current standards. This is the issue SCENTIPD attempts to address, focusing on two key points:

>50% of dopaminergic neurons lost at diagnosis [5]

No reliable biomarkers for early detection

The criticality of an early diagnosis (The need)

As with many medical conditions, early diagnosis of PD can make a world of difference not only in the quality of life of the affected individual but also from an economic standpoint [7]. Below we list some compelling reasons why early diagnosis of PD is imperative:

1. >50% of dopaminergic neurons lost at diagnosis: This stat is self-explanatory. With the current methods of diagnosing, the results come too late. Managing the disease and mitigating its effects becomes exponentially harder, because the damage already done is irreversible.

Image 2: In the image above, we have the DaTscan of a healthy person on the left and the one of a PD patient on the right. Using today’s methods, the diagnosis is extracted when the patient has reached the state on the right. The damage is irreversible. The diagnosis in such advanced stages hinders the management of the disease in an emotional, social and economic standpoint. [8]

2. Improved Patient Outcomes: Early detection of Parkinson's allows for the initiation of treatments that can slow the progression of the disease, thereby prolonging the period during which a patient can maintain independence and a high quality of life. This translates to fewer hospitalizations and reduced healthcare expenses in the long run.

3. Cost-Effective Treatment Planning: Early intervention can steer patients towards more cost-effective treatments and management strategies. Over time, delaying the progression of PD can translate to considerable savings, both for the individual and the healthcare system.

4. Indirect Economic Benefits: Early diagnosis and management can reduce the indirect costs associated with Parkinson's, such as lost productivity, early retirement, and caregiver burden. This has broader economic implications as it retains skilled professionals in the workforce for longer and reduces the strain on social support systems.

5. Facilitates Research & Innovation: Early diagnosis can aid in research by identifying patients who can participate in clinical trials. This can lead to faster and more efficient development of new treatments and interventions, which businesses can capitalize on, fostering innovation in the field.

6. Emotional and Social Benefits: From a human-centric perspective, early diagnosis can mitigate the emotional and social toll on patients and their families. This not only uplifts the community spirit but also indirectly impacts workforce productivity and societal harmony. From a different perspective, an earlier diagnosis and monitoring of PD symptoms, help reduce drastically the number of misdiagnoses, relieving many people from a huge unnecessary emotional burden.

The criticality of an early diagnosis (The need)

Let us now fit in a little story among all this business stuff. A small break in all of this. Our inspiration. Meet Joy Milne.

Joy Milne, is a 73 year old retired nurse from Perth in Scotland. For most of her life, Joy Milne had a superpower that she was totally oblivious to. She simply had no idea she possessed an utterly amazing, slightly terrifying biological gift that scientists would itch to study. In fact, Joy probably would have stayed oblivious if it hadn't been for her husband, Les Milne.

Turns out Joy is a supersmeller! She has hereditary hyperosmia, a rare condition that gives her a heightened sense of smell, which she first noticed when her husband, Les, developed a different musky aroma before being diagnosed with Parkinson's. She had noticed his body smell change 14 years before it was diagnosed! It wasn’t until she escorted her husband to a Parkinson’s Disease support group after his diagnosis, that she noticed that this smell was, well… Everywhere! Then, she went on to prove the correlation between smell and PD detection under clinical settings.

Joy Milne was the inspiration behind SCENTIPD, our endeavor to construct an ‘artificial nose’ to uncover a potential patient’s scent signature and ‘smell’ Parkinson’s Disease years in advance.

So, now let us examine the criticality of an early diagnosis from a human-centric perspective, forgetting all the business-y stuff. Let’s examine the emotional toll on the patient and their family’s lives, through Joy’s story:

“Unfortunately, as the years peeled on, Joy began to feel that it wasn't just her husband's smell that was changing. "It was his personality, his character. He began to change. He was more moody. He wasn't as tolerant," she says. They fought more and more. So many of the qualities Joy valued in her husband — his thoughtfulness, his patience, his quiet dignity — began to bleed away until eventually, by his early 40s, she began to see Les as a totally different person”. [10]

In a different interview, Joy Milne herself told BBC Scotland that not knowing Les had Parkinson's put her family in a "negative spiral". [9]

"What if we did know?," she said.

"It would have changed things dramatically."

"The fact that he became withdrawn, reserved, he had bouts of depression and mood swings, if I had understood what was happening it would have changed our total outlook on life."

Finding out about Joy and Les’ story, in addition to the struggle of relatives of some members of ours, we are inspired and fueled with the determination to make a change to all people’s lives affected by Parkinson’s Disease.

Our Solution

The problem that our business idea aims to solve is this lack of an early and accurate diagnosis of Parkinson's disease.

The goal of our project is the creation of a portable self-testing diagnostic kit for the detection and quantification of specific Volatile Organic Compounds (VOCs) from skin sebum. Those compounds have been associated with PD, with evidence pointing to their change in concentration occurring long before the evident onset of the disease.

Our proposed way for this detection is by using the M13 Bacteriophage as a colorimetric biosensor. This technique utilizes the phage’s capsid proteins, which can obtain affinity for the target compounds by genetic engineering. After the VOC-protein binding has occurred, the phages “swell”, changing the way they interact with light, and finally giving off a different color. This color is structural, that is, not dependent on dyes and non-iridescent, not affected by the viewing angle, which can in turn be captured and quantified by a camera.

Once captured, the image is processed by our app. In the first step, it is processed by an advanced image processing pipeline. The lanes of the kit, which are designed to bind the phage to different VOCs and help cross validate the diagnosis, are cropped and merged into a single image. Next, a correction pipeline standardizes the images and manages any anomalies. After these steps, the images are given as input to a deep learning model which deduces a diagnostic prediction.

To ensure that users do not have adverse reactions to direct results, the app provides a suggestion instead of a conclusive diagnosis. For positive results, it strongly encourages the user to consult a neurologist (message: "Visiting a neurologist is strongly recommended"). For ambiguous results, it advises precautionary consultation (message: "Consider visiting a neurologist as a precaution"). For negative results, no action is suggested (message: "No precautions suggested").

Our product can be used to potentially help with other VOC related diagnoses. Volatolomics-based diagnosis has been emerging as a fast, non-invasive and inexpensive alternative to many different diseases. The structural affinity of the capsid proteins can be modified to interact with different VOCs and potentially serve as multi-disease diagnosis platform.

Finally, there is a crucial expansion to our solution that adds new dimensions to our vision. Using our app for diagnostic extraction allows us to monitor Parkinson's Disease (PD) cases in real-time worldwide, capturing an invaluable wealth of information that would otherwise go undocumented. In contrast, other biomarker techniques currently under exploration are restricted to limited testing in clinical settings. A mass scale testing of Parkinson’s Disease in the early stages is simply not possible at the moment and so the demographics and the nuances of the disease cannot be extracted, studied and thus understood.

So, we propose an enhanced data analysis platform that can be used to serve as an invaluable research tool for:

1) Analyzing Parkinson's Disease (PD) demographics and offering country-specific statistics.

2) Evaluating the current economic impact of PD by country and forecasting its future financial burden.

3) Tracking real-time data on PD cases and projecting potential increases in prevalence.

4) Offering real-time estimates of the direct and indirect costs associated with PD, both at the country level and for individual hospitals.

5) Serving as a clinical decision support system for neurologists, aggregating a comprehensive pool of PD cases.

Additional potential benefits of our proposed kit-app-platform solution include:

1) Contributing to the refinement of the different PD subtypes and thus lead to better and more personalized treatment regimens.

2) Helping differentiate PD with PD plus syndromes.

3) Gaining insights into the early stages of PD, as well as its progression, predispositions, and prognosis.

Conclusion

In conclusion, our self-testing diagnostic kit coupled with our app’s image processing and deep learning techniques, in synchronous collaboration with our data analytics platform, aim to combat this disease, helping alleviate the patient's and their family's struggle and ameliorate their lives, while also relieving economic burdens related to the disease.

Entrepreneurship II. Products & Implementation

Implementation stage:

The kit’s case has already been designed and 3D printed. The optimal way to conduct the test is still being evaluated. We explore many options, but the front runner for the optimal functionality of the kit is the following:

The kit consists of five gold-coated silicon wafers positioned in the bottom of a small box (3 cm * 5.5 cm * 2 cm). Its proposed method of application is the positioning of the box on the patient’s upper back for a few minutes, until the Volatile Organic Compounds have sufficiently evaporated and diffused into the testing chamber. To ensure airtight conditions, a sliding transparent cap will be implemented, and moved to the side before the kit is placed on the patient’s skin. Also, a soft padding will be added on top of the box, where the kit comes into contact with the skin. After the testing time has expired, the sliding cap is moved back into position sealing the kit, which is then removed from the patient’s upper back, and the colorimetric output is scanned using the smartphone application. In order to have a common point of reference for image taking, the user must place their smartphone on top of the glass and take a picture of the lanes within the boundaries of a predefined rectangle within the camera app.

The diagnostic pipeline visualized:

The prototype:

The 3D printed design of the kit was re-engineered for optimal results and deviates from the simplistic approach conceptualized in our early stages. First of all, the color of the kit must be white/gray/black in order to better extract the colorimetric results. The indentation is used for a sliding lid, on which the smartphone will be placed for a better point of reference for image capturing. The kit’s design is the following:

Images 7a, b: The kit re-engineered for optimal diagnostic results

SCENTIPD App

The app’s functionality is to process the images and feed the final processed standardized image to the AI models, our Da Vinci AI model pipeline.

The app’s design was designed very carefully to be robust, visually appealing, and simple enough so anyone can use it. It just consists of the Home Page and the functionalities to take a picture, upload a picture, see the results and get help on how to perform the self-test.

Development stage:

Prototype’s development has been completed. Pending state: Real world data needed.

Implementation stage:

Pending State: Real world implementation and deployment

Prototype status:

Functional. Ready. Dark theme. The image processing pipeline is general enough to process both the concept kit and the re-engineered implementation. Here is a demonstration of the prototype:

Future functionalities:

Pending. Light theme.

The App’s Image Processing Pipeline & the Da Vinci AI Models Pipeline

The App’s Image Processing Pipeline:

As we described before, the initial functionality of the kit is to process the images in order to make them suitable for input in our AI models. As we mentioned before, the image processing pipeline is general enough to process both the concept kit and the re-engineered implementation. It is presented in the entrepreneurial section because the image processing and the AI models alone can serve as a pivot point product, being versatile enough to be applied in different computer vision applications. Besides, they comprise a crucial part of our product.

Development stage:

Finished. Ready for case testing.

Implementation stage:

Let’s examine the implementation visually. The experiments were conducted on the initial kit’s concept design but the pipeline is generalizable and scalable to other kind of structures like our 3D designed case, thanks to color masking techniques:

Image 16: Kit color extraction. It is presented in the entrepreneurial section because the image processing and the AI models alone can serve as a pivot point product, being versatile enough to be applied in different computer vision applications. The image processing pipeline is general enough to process both the concept kit and the re-engineered implementation.

The App’s Da Vinci AI models Pipeline:

The SCENTIPS’s Da Vinci AI models comprises an ensemble of models carefully tuned to be selected when the right task for them arrives (bagging technique, ensemble learning). Various architectures have been explored and perform differently on synthetic data. We opted to avoid sharing the code yet, because it is potentially a pivotal point for our start-up. For simplicity we provide a trained CNN on synthetic data, for the totality of the pipeline. Yet, without real world data tuning, both the Da Vinci models and the simple CNN model are of no use, until we are able to train them on clinical study scenarios.

Development stage:

Pending. Architectures are developed, waiting for real world data.

Implementation stage:

Pending. Waiting for real world data to continue with the pipeline’s deployment.

SCENTIPD’s Data Analysis Platform

Using our app, we can track PD cases in real time globally. Without it, we'd miss out on this critical information. Currently, other methods for detecting PD are limited and can only be done in specific clinical settings. This means large-scale early testing for Parkinson’s Disease isn't possible, making it hard to understand the full scope of the disease by region. Given this, we suggest a refined data analysis platform, beneficial for:

1. Reviewing PD trends and offering country-specific statistics.

2. Measuring the current economic impact of PD in each country and estimating future costs.

3. Providing up-to-date data on PD cases and estimating potential growth.

4. Offering real-time cost estimates of PD cases for each hospital and country, along with projections for future economic impacts.

5. Using the platform's data to assist neurologists in making informed decisions.

Development stage:

Design completed. Development pending

Implementation stage:

Pending. The kit’s and app’s development must come first

Prototype’s Design:

Real Time PD Demographics

Image 17: In this image we present the design of the data analytics platform, visualizing real time demographic data of PD cases and PD costs per country onto a 3D globe.

Clinical and research support via a pool of databases and patient cases

Image 20: A pool of patient data can be provided to work as a clinical decision support systems for neurologists. This entails the EHR data sharing of the patients via the app. This pool of cases can be provided in the form of databases or individua cases. Also, this pool of data can serve as an interoperability point of study between different research institutions.

News and Biomarkers

Image 21: The kit in collaboration with the platform might also give us the opportunity to verify biomarkers and their concentration in PD patients. Moreover, news about advancements in combating PD can also be gathered in one spot, concluding a unique point of study for Parkinson’s Disease.

Future Product Strategy

Let’s now explore our futures strategies regarding both the expansion and the optimization of our diagnostic tools:

1) Personalized medicine: Expanding the ML pipeline, so that timeseries data can be exploited along with the patient’s genotype, giving a personalised result.

2) Via Volatolomics, we aim to a possible diagnosis differentiation from disorders often mistaken for Parkinson's, like Parkinson-plus syndromes.

3) Ideally, we would want to perform multi—disease diagnosis with our kit, leveraging additional VOCs.

Failsafes: Potential Pivots/Alternatives

Phage centered pivot:

If our phage-based method fails, there are some biological circuit alternatives that can detect our target VOCs.

Photonic Nose centered pivot:

Let’s now explore potential pivots in the case everything just doesn’t go our way:
1) Our technology is easily transferable to every project related to photonic noses and artificial olfactory systems in general. In these cases it can be used to detect a wide variety of chemical substances, unrelated to diseases. Two new use cases can be:

a) Environmental Monitoring: Detecting and monitoring pollutants, hazardous chemicals, or pathogens in the air, water, or soil. They can serve as early warning systems for harmful chemical leaks or spills.

b) Food and Agriculture: Photonic noses can be utilized for quality control in the food industry by detecting spoilage or contamination. They can also be used to determine the ripeness of fruits, the freshness of fish, or the presence of contaminants in dairy products.

Medical Diagnostics centered pivot:

A less deviating pivot would be to remain in the field of Volatolomics-based diagnostics using a photonic nose, just for a different disease. [12]

Software centered pivot:

For a pivot we could also leverage the AI and image processing pipeline for similar colorimetric result extraction projects, in one of the many use cases of photonic noses or even broader use cases of computer vision. Also, all the novel modeling in the bioinformatics section of our project in the dry lab constitutes a valuable piece of expertise.

Entrepreneurship III. Business Model & Plan

SCENTIPD: Key Parts

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Business Model

B2C

Our target group includes researchers, primary care physicians, neurologists, and other healthcare professionals who are involved in the diagnosis and treatment of Parkinson's disease. We also aim to approach individuals directly in the consumer market who have a high risk of Parkinson’s disease such as genetic predisposition or family history of PD.

B2B

We also plan to target companies such as pharmaceutical companies and diagnostic centers.

B2G

Our company will also aim at connecting with government agencies such as the public health sectors or public research centers. A typical end-user of the device would be a healthcare professional who is looking to screen patients for Parkinson's disease or diagnose the disease in its early stages. Additionally, researchers that study Parkinson’s disease could use this device as a part of their experiments or clinical trials. Finally, we are optimistic that the kit might also facilitate self-testing.

Key Partners

Some of our Key Partners include our respective universities namely the School of Medicine and the Department of Biology at the National and Kapodistrian University of Athens, the Department of Chemical Engineering and the Department of Electrical and Computer Engineering at the National and Technical University of Athens, the Department of Biomedical Sciences at the University of Western Attica and the Department of Digital Systems at the University of Piraeus. We have also developed connections with other research institutions such as the Biomedical Research Foundation of the Academy of Athens through our professors and mentors. Additionally, we have established communication with industry experts and members of the pharmaceutical industry, such as Pfizer Greece which has also provided us with funding. Lastly, through various networking opportunities we have approached and been approached by private investors as well as representatives of venture capital firms.

Motivations for Partnerships

As a startup composed mainly by students, we are eager to construct new partnerships in order to holistically develop our product and our business. These include, first of all, obtaining guidance from Parkinson's Disease experts, both researchers and clinicians to ensure the effectiveness and the accuracy of our diagnostic test. We also plan to partner with Parkinson's Disease research organizations to gain access to their expertise and resources. With the experience of research foundations we aim to conduct thorough testing and validation of the diagnostic kit to minimize the risk of inaccurate or unreliable results. Additionally, we plan to collaborate with design and engineering service providers to optimize our manufacturing process, to reduce costs and improve efficiency, as well as partner with contract manufacturers to scale up production and ensure high quality standards that our product will adhere to. It is also part of our plan to work with regulatory consultants to ensure that the diagnostic kit complies with all relevant regulations and standards for medical devices.

Key Activities

SCENTIPD, as a groundbreaking solution for early Parkinson's Disease (PD) diagnosis, has several pivotal activities that underpin its operation, ensuring that patients, healthcare providers, and researchers receive accurate, reliable, and timely diagnostic results.

1. Research and Development (R&D): Central to SCENTIPD's mission is the continuous R&D for refining the diagnostic kit. The utilization of M13 bacteriophages to detect specific VOCs associated with PD is revolutionary. It requires extensive laboratory testing, experimentation, and iterative design. As the field of volatolomics grows, adapting to new discoveries and ensuring that the kit remains at the forefront of technology is imperative.

2. Production and Quality Control: SCENTIPD's diagnostic kits are produced under stringent standards to ensure every kit's reliability. The production involves cultivating the bacteriophages, integrating them into the photonic nose, and packaging the kits for distribution. Each stage demands meticulous attention to detail. After production, quality control processes, involving rigorous testing of the kits, ensure that they meet the established benchmarks of accuracy.

3. Digital Solutions and AI Integration: SCENTIPD isn't merely about physical diagnostic kits; it's an amalgamation of biotechnology and digital innovation. The SCENTIPD App processes colorimetric outputs and leverages the Da Vinci AI model pipeline for diagnosis. Constantly updating the app, refining its deep learning algorithms, and ensuring compatibility with various smartphones and devices is a continual process.

4. Regulatory Compliance: Navigating the regulatory landscape of medical diagnostics is a key activity. This involves liaising with government health agencies, ensuring the diagnostic kit adheres to safety and efficacy standards, and staying updated on any changes in medical device regulations.

5. Collaborative Research: SCENTIPD doesn't operate in a vacuum. Collaborating with research institutions, tapping into clinical studies, and gathering invaluable patient data are activities that enhance the product's accuracy. Partnerships with universities, like NTUA and UOA, ensure that SCENTIPD remains rooted in rigorous academic research.

6. Marketing and Distribution: Once the diagnostic kit is ready, it must reach the people who need it. Strategic marketing campaigns, both online and offline, and establishing distribution channels ensure that SCENTIPD kits are accessible globally.

7. Training and Support: It's essential that healthcare providers understand how to use SCENTIPD's kits. Offering training sessions, creating instructional content, and providing customer support ensure that the kits are used correctly, and any concerns or queries from users are addressed promptly.

8. Data Analytics and Global PD Monitoring: One of SCENTIPD's unique propositions is its ability to provide real-time global monitoring of PD cases. Setting up data servers, ensuring patient data privacy, and regularly analyzing this data to provide insights into PD demographics are ongoing activities.

9. Continuous Feedback Loop: Every business must adapt to feedback, and SCENTIPD is no exception. Regularly gathering feedback from patients, doctors, and researchers, and then iterating on the product based on this feedback, ensures that SCENTIPD remains the gold standard in early PD diagnosis.

Value Propositions

Early Diagnosis/Self-testing

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• Prolonged and ameliorated patient’s life

• Saving billions in direct and indirect costs

• Competitive price (selling at a low price en masse, estimated 150€ per unit)

• Accessibility, portability: Reaching third world countries

App/Platform

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• Understanding PD demographics and its cost

• Clinical decision support system (Interoperability of PD studies)

• Connecting doctors with their patients for studies and monitoring

• Biomarker Discovery

In a world where medical diagnosis is steadily converging with technological advancement, SCENTIPD stands as a beacon of innovation for Parkinson's Disease (PD) diagnosis. The profound value propositions it brings to the table are set to reshape the landscape of early PD detection and patient care.

1.Early and Accurate Diagnosis: At the heart of SCENTIPD's mission is the promise of early detection. With its groundbreaking use of genetically engineered M13 bacteriophages to detect specific VOCs linked to PD, SCENTIPD offers a diagnostic tool that could potentially identify the disease at its very nascent stages. Early diagnosis translates to earlier interventions, potentially slowing the disease's progression and enhancing the patient's quality of life.

2. Non-Invasive Testing: SCENTIPD's diagnostic kit is designed to be non-invasive. By simply positioning the kit on a patient's upper back for a few minutes, the necessary data is captured without any discomfort or invasive procedures. This ease of testing can lead to higher patient compliance and more frequent screenings.

3. Integration of AI and Digital Solutions: Beyond the physical diagnosis, SCENTIPD seamlessly marries biotechnology with digital sophistication. The accompanying app, equipped with advanced image processing and deep learning algorithms, interprets the colorimetric results, ensuring that diagnoses are not just accurate but also delivered promptly. This synergy of biology and technology provides a cutting-edge solution unparalleled in the diagnostic arena.

4. Real-time Global Monitoring: SCENTIPD is not just about individual diagnosis; it offers a macro perspective. With its data analytics platform, there's potential for real-time global monitoring of PD cases. Such insights can be invaluable for healthcare policymakers, researchers, and pharmaceutical companies, offering a bird's eye view of PD prevalence, trends, and potential hotspots.

5. Patient Empowerment: In the modern healthcare paradigm, patients seek active involvement in their health journeys. SCENTIPD's self-testing capability and the app-based solution offer patients autonomy in monitoring their health, fostering a sense of empowerment and proactive health management.

6. Cost-Effective Solution: While SCENTIPD is a beacon of advanced medical technology, it also presents a potentially cost-effective solution for PD diagnosis. By streamlining the diagnostic process and offering a self-administered kit, the associated costs of frequent clinic visits, and specialized tests can be significantly reduced.

7. Continuous Improvement and Adaptability: The world of medical research is dynamic, with new discoveries made regularly. SCENTIPD's commitment to continuous R&D ensures that the diagnostic kit evolves with the latest scientific findings, always offering the most up-to-date solution for PD diagnosis.

8. Educational and Supportive Infrastructure: SCENTIPD values its users, be it patients or healthcare providers. Through training sessions, instructional content, and responsive customer support, it ensures that every user feels confident in utilizing the diagnostic kit to its full potential.

In essence, SCENTIPD isn't just a product; it's a promise. A promise of early, accurate, and efficient PD diagnosis that empowers individuals, supports healthcare professionals, and offers invaluable insights to the global medical community. As the boundaries between medicine and technology continue to blur, SCENTIPD proudly leads the charge in redefining diagnostic excellence.

Value Chain

Customer Analysis

Understanding the Landscape: The world after the COVID-19 pandemic has irrevocably changed, especially in the realm of healthcare. Patients and healthcare providers are now more receptive to digital, non-invasive, and preventive diagnostic solutions. Amidst this backdrop, SCENTIPD's innovative diagnostic approach for Parkinson’s Disease (PD) is not just timely but essential.

Segmenting the Market:

Patients with Parkinson's Disease Symptoms:

• Demographics: These are individuals spanning a wide age range but primarily middle-aged and elderly, both male and female, who may be experiencing initial symptoms of PD.

• Behavioral Traits: They seek early, accurate, and non-invasive diagnostic solutions, often after initial consultations with general physicians. The potential progression of their condition makes them keen on preventive and proactive healthcare solutions.

• Needs & Preferences: A seamless, easy-to-use diagnostic kit, clarity in results, and a support system for any queries or concerns. They also value discretion and privacy in their diagnostic journey.

Healthcare Providers and Clinics:

• Demographics: Ranges from individual practicing neurologists to large hospital chains with neurology departments.

• Behavioral Traits: Prioritize accuracy, reliability, and ease-of-use in diagnostic tools. They seek solutions that can be integrated into their existing diagnostic framework with minimal disruption.

• Needs & Preferences: Comprehensive training on the product, clarity on regulatory compliances, and continuous support from SCENTIPD. They'd also value any data analytics that can help in longitudinal patient monitoring.

Research Institutions:

• Demographics: Academic and private research institutions focusing on neurodegenerative diseases, primarily Parkinson’s.

• Behavioral Traits: Interest in novel, cutting-edge diagnostic solutions that can aid in their research. They're often on the lookout for collaborations and partnerships.

• Needs & Preferences: Detailed insights into SCENTIPD's technology, potential for collaboration on studies, and flexibility in terms of bulk orders or tailored solutions for research purposes.

Addressing Pain Points and Challenges: Each customer segment, while seeing value in SCENTIPD, will undoubtedly have reservations. Patients might be concerned about the accuracy, cost, or potential side effects. Healthcare providers might wonder about the product's scalability, integration into existing systems, and patient acceptance. Research institutions might seek deeper data, potential for customization, and collaborative opportunities. Addressing these concerns head-on, with transparency and data, will be key.

Feedback and Iteration: Understanding customers doesn’t stop after initial analysis. Continuous feedback loops with all customer segments ensure that SCENTIPD evolves according to their changing needs. This could range from app updates for better user experience for patients to additional training modules for healthcare providers.

Future Expansion: With the foundational understanding of its primary customer segments, SCENTIPD is poised to explore secondary segments in the future. This could include caregivers of PD patients, allied healthcare professionals, or even educational institutions focusing on neurology.

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In conclusion, SCENTIPD stands at a unique intersection in the healthcare market, with its innovative diagnostic tool resonating with diverse customer segments. A deep understanding of these segments ensures that the product not only meets existing needs but continually evolves in its pursuit of revolutionizing Parkinson’s Disease diagnostics.

Customer Relationships

The Underlying Philosophy: In the realm of healthcare, the importance of fostering trust cannot be overemphasized. For SCENTIPD, customer relationships aren't merely transactional; they are transformative. The very essence of SCENTIPD’s innovative diagnostic solution revolves around a compassionate understanding of the individuals and entities it seeks to serve.

Patients with Parkinson's Disease Symptoms:

• Empathy First: Recognizing that many of these individuals are grappling with the possibility of a life-altering diagnosis, SCENTIPD’s approach is rooted in empathy. The company seeks to provide not just a diagnostic tool, but a holistic support system.

• Accessible Support: A dedicated customer support team ensures that patients have a channel to voice concerns, seek clarifications, or simply learn more. This could involve both digital platforms and helplines.

• Continued Engagement: Regular updates about product enhancements, new research findings, or even general information about Parkinson's can help patients feel connected and informed.

Healthcare Providers and Clinics:

• Collaborative Partnership: Healthcare providers aren't just customers; they are collaborators. SCENTIPD envisions a relationship where feedback from these professionals drives product refinement.

• Training and Onboarding: To ensure seamless integration of the SCENTIPD diagnostic tool into clinical settings, comprehensive training modules would be provided. This not only enhances product usage but also fortifies trust.

• Open Channels of Communication: Regular check-ins, webinars, and feedback sessions will help in gauging the product's efficacy in real-world settings and addressing any challenges faced by healthcare providers.

Research Institutions:

• A Shared Vision of Innovation: Recognizing that research institutions operate at the frontier of medical science, SCENTIPD seeks to establish a relationship of shared learning and innovation.

• Customized Collaborations: Understanding that research needs can be diverse, SCENTIPD is open to customizing its offerings, whether it's in terms of data access, product variations, or collaborative studies.

• Engagement Beyond Transactions: Whether it's participating in academic seminars, co-publishing research, or even sponsoring events, SCENTIPD aims for a multi-faceted engagement with research entities.

Cost Structure

It would be unwise to provide a detailed cost structure of the kit. We have a lot of in-house expertise and lab space and equipment that significantly lower our costs. Our future infrastructure for developing the project is unclear at the moment, but in the next paragraphs we will analyze the cost structure from a broad perspective.

The Foundational Overview:

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At the intersection of groundbreaking scientific endeavor and transformative healthcare, SCENTIPD is meticulously charting its path. Every financial commitment is not just an expenditure, but a testament to the vision of revolutionizing Parkinson’s diagnosis.

Key Resources:

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Bacteriophages & Materials: Integral to SCENTIPD's offerings. The sourcing and quality assurance of bacteriophages and associated materials will be a recurring priority. The consistency and quality in this realm are non-negotiable, and as such, partnerships with leading biotech firms are anticipated.

Specialized Equipment: The laboratories and development spaces of SCENTIPD will undoubtedly demand state-of-the-art equipment, both for the progression of their diagnostic kit and for stringent testing processes. Such sophisticated machinery not only requires an upfront investment but will entail periodic maintenance, calibration, and eventual upgrades.

Key Activities:

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Product Development & Optimization:The realm of scientific innovation is never stagnant. SCENTIPD will continually embark on research to refine and improve its diagnostic kit. This iterative process of research, testing, feedback, and prototyping ensures that the product remains at the pinnacle of its capabilities.

Regulatory Compliance & Navigation: In the domain of healthcare, adherence to standards and regulations is paramount. SCENTIPD, to ensure its global adaptability and acceptance, will invest in expert consultation and continuous engagement to stay abreast of international medical device regulations.

Value-Driven Approach:

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Patient-Centric Outreach: Beyond the tangible product, SCENTIPD's mission emphasizes the invaluable human touchpoint. Investments in patient education, engagement campaigns, support systems, and community building efforts will play a crucial role in bridging the gap between groundbreaking technology and its end-users.

Fixed and Variable Overheads:

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Salaries & Operations: A multidisciplinary team, encompassing researchers, operations staff, customer support, regulatory experts, and business development professionals, will be the backbone of SCENTIPD's daily functions.

Facilities: Premium locations in bio-tech hubs offer not just operational advantages but also foster collaborations, partnerships, and networking. Thus, SCENTIPD's choice of location, alongside the upkeep of its facilities, will be strategic.

Marketing & Patient Outreach: For a solution as novel as SCENTIPD's, awareness, and outreach are paramount. Engaging healthcare providers, patients, and the larger medical community will necessitate both digital and offline campaigns, events, workshops, and collaborative efforts.

Economies of Scale and Scope:

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Bulk Purchasing: As SCENTIPD scales, bulk purchasing strategies will be instrumental in optimizing resource allocations.

Diversification: SCENTIPD's foundational technology holds promise beyond just Parkinson's diagnosis. Exploring its adaptability to detect other conditions can bring about diversification in both product offerings and revenue streams, although it would require recalibration of initial investments.

Pricing Strategy

The ever-evolving landscape of healthcare, with its intricate interplay of innovation, demands, and affordability, renders pricing strategy not just a commercial decision but a defining aspect of a product's identity. SCENTIPD, with its pioneering diagnostic kit and digital platform, strides confidently into this landscape, balancing the scales of patient care and business sustainability.

SCENTIPD's Diagnostic Kit Pricing: At the heart of SCENTIPD's diagnostic solution is its revolutionary kit, a culmination of cutting-edge research, biotechnological advancements, and patient-centric design. The pricing for this kit is crafted keeping multiple facets in mind. Firstly, the uniqueness of the product – there's an intrinsic value associated with the early, non-invasive diagnosis of Parkinson's Disease, a value that has both tangible and intangible dimensions. Tangibly, early diagnosis could translate to potential healthcare savings for patients, by initiating treatments earlier and possibly slowing disease progression. Intangibly, the peace of mind and clarity such early diagnosis provides to patients and their families is invaluable. Yet, SCENTIPD acknowledges the diverse economic landscapes it operates within. The goal is to ensure broad accessibility, striving to make the kit affordable to a wide array of users while retaining its premium positioning. Collaborative endeavors with healthcare institutions, potential subsidies, or tiered pricing models based on geographies or purchasing volumes might be explored to strike this balance.

Pricing for the Digital Platform: The digital platform, which seamlessly integrates advanced image processing and deep learning algorithms, stands as an epitome of tech-driven healthcare. While the kit provides the initial diagnosis, it's the platform that offers longitudinal insights, patient tracking, and potentially even global Parkinson's disease trend analyses. The pricing strategy for the platform will lean towards a subscription model. Recognizing that different users might have varying needs, there could be tiered subscriptions. For instance, individual users seeking basic monitoring might opt for a standard package, while research institutions or healthcare providers wanting in-depth analytics and trend analyses might gravitate towards a premium offering. Moreover, as SCENTIPD expands its diagnostic repertoire, leveraging its technology for potential other disease markers, the platform could evolve into a comprehensive health monitoring tool. This would not just justify the subscription model but also offer users consolidated health insights under one digital roof. Collaborations with pharmaceutical companies, through sponsored content or targeted advertising, could further subsidize costs for users, making the platform more accessible while offering relevant product insights to patients.

Revenue Streams

Asset Sale - The Diagnostic Kit: At the heart of SCENTIPD's offerings is the revolutionary diagnostic kit. Designed with precision and backed by rigorous research, the kit presents an unprecedented solution for early Parkinson's disease detection. Recognizing its intrinsic value, SCENTIPD has opted for an asset sale model, offering the diagnostic kit for a fixed price to healthcare providers and institutions. This direct sale approach ensures that the groundbreaking tool reaches its intended users seamlessly, from clinics and hospitals to research institutions aiming for in-depth Parkinson's studies.

Subscription Fees - The Digital Ecosystem: While the diagnostic kit offers tangible value, SCENTIPD's digital platform elevates the patient experience by providing continuous monitoring and in-depth analysis of longitudinal data. To harness this digital prowess, a subscription-based revenue model has been envisioned. Patients seeking ongoing health insights can subscribe for individual access, while healthcare institutions aiming for a holistic patient monitoring solution might opt for a more comprehensive subscription package. This recurring revenue stream not only ensures steady financial inflow but also fosters a continuous relationship with users, enhancing their trust and loyalty.

Licensing - Technological Prowess to the World: Beyond direct sales and subscriptions, SCENTIPD's innovative technology holds immense promise for broader applications. Recognizing its potential, SCENTIPD offers licensing opportunities, allowing other companies or research institutions to integrate its groundbreaking technology into their own platforms or tools. This not only amplifies SCENTIPD's impact across the healthcare sector but also generates revenue from its intellectual property, fortifying its position as a tech leader in the diagnostic realm.

Advertising - Strategic Collaborations: The digital platform of SCENTIPD is not just a conduit for health insights but also a hub of user engagement. Leveraging this, SCENTIPD has opened avenues for strategic advertising partnerships, particularly with pharmaceutical companies or businesses operating in the healthcare domain. Through targeted advertising or sponsored content, these entities can reach SCENTIPD's user base, offering them relevant products, services, or information. This advertising model, while generating additional revenue for SCENTIPD, also enhances the platform's value proposition for its users by providing them with pertinent health-related content.

Key Suppliers

Our future startup's success in developing an early diagnostic test kit for Parkinson's disease depends heavily on our key suppliers who will be of key importance during of the production process, as they will determine the final cost of the product:

• Genetic Material Suppliers: For the genetic modification of bacteriophages that change color upon contact with Volatile Organic Compounds (VOCs), we will rely on our own laboratory at first to prepare the genetically modified viruses. At a later stage, we will collaborate with more external laboratories to supply us with the genetic material needed. The quality and purity of these genetic components are of utmost importance to ensure the accuracy of our diagnostic results.

• Raw Material Suppliers: To construct our diagnostic kit, we require a range of raw materials, including the glass plates, titanium nanoparticles, and gold nanoparticles, as outlined in our hardware development process.

The glass plates can be purchased in large quantities by glass manufacturers and distributors, or even local glass suppliers.

The titanium nanoparticles can be found by chemical companies specialized in providing nanoparticles. The same applies to gold nanoparticles that could be bought by nanotechnology companies too. In both cases, we could cooperate even with university research labs. Dependable suppliers of these materials are essential to maintaining the consistency and integrity of our product.

• Specialized Equipment Providers: Our diagnostic kit's creation involves unique processes, such as coating glass plates with nanoparticles. Providers of the specialized equipment needed for these procedures, such as diamond cutters that can be found by industrial tool suppliers. Immersion solutions are also needed. These solutions can be supplied by chemical companies, laboratory and scientific equipment companies.

The precision and reliability of these tools and materials directly impact the quality and effectiveness of our diagnostic kits.

• Manufacturing Partners: These partners will be at the core of our supply chain, responsible for the large-scale production of our diagnostic kits. Their role will involve the assembly of various components, quality control, and the packaging of the final product. The efficiency, quality, and reliability of these manufacturing partners are crucial to ensuring our kits meet the highest standards.

Our startup's ability to produce an effective early diagnostic test kit for Parkinson's disease depends on the reliability, quality, and collaboration with these key suppliers. They play an essential role in ensuring that our product meets the necessary standards, is consistent, and provides accurate and reliable results for potential patients.

Key Resources

To create our early diagnostic test kit for Parkinson's disease we rely on a set of key resources. At its core, we employ genetically modified bacteriophages to serve as the primary sensors for detecting disease-related Volatile Organic Compounds (VOCs). These bacteriophages are meticulously developed and tested to ensure their sensitivity.

The availability of essential kit materials such as the substrates for bacteriophages, necessary reagents, and appropriate packaging elements, are of equal importance, so they must all be chosen with care to guarantee the diagnostic kit's reliability.

Our team's diverse expertise spans biology, material science, microfabrication, and biochemistry, so funding is crucial, supporting every research in all, and fabrication from development of the materials to the kit’s distribution.

Regulatory expertise is of course indispensable, facilitating cooperation with evolving medical device standards. Collaborations and partnerships with key suppliers, manufacturers, and experts in Parkinson's disease research and clinical practice are our bedrock.

All of these factors equally contribute to create a powerful synergy, driving the development of an innovative diagnostic kit with the potential to transform early Parkinson's disease diagnosis.

Channels

1. Online Platforms: The digital age provides SCENTIPD with a vast platform to introduce and sell its product to a global audience. The manufacturer's website can serve as the primary source of product information, testimonials, demonstrations, and direct sales. Partnering with online retailers broadens the reach, making it accessible to diverse customer segments. Social media platforms, on the other hand, offer a dual advantage: they serve as both marketing and engagement tools. Through targeted ads, interactive posts, and customer engagement activities, SCENTIPD can both educate the public and generate interest in its diagnostic kit.

2. Healthcare Providers: This channel is instrumental, especially considering the nature of the product. By presenting the diagnostic kit's advantages and efficacy to healthcare providers, SCENTIPD can ensure a built-in customer base. Doctors and healthcare professionals can act as influencers, prescribing or recommending the kit to patients showing early signs of Parkinson's disease. This direct-to-provider approach also establishes credibility, ensuring that the kit becomes an integral part of the diagnostic routine.

3. Direct Mail: A targeted approach, direct mailings can be especially impactful for specific segments. By identifying potential healthcare providers, institutions, or even patient groups, SCENTIPD can send detailed promotional materials, brochures, or sample kits. This tactile approach often leaves a lasting impression, making the recipient more inclined to explore the product further.

4. Events: Medical conferences and events are the crossroads of innovation, research, and practical healthcare. By showcasing the diagnostic kit at such venues, SCENTIPD ensures it's presenting its innovation to an audience that understands and values its potential. Live demonstrations, interactive Q&A sessions, and networking at these events can lead to fruitful collaborations, bulk purchase agreements, and even potential research partnerships.

6. Data-Driven Channel Optimization: To ensure the effectiveness of these channels, SCENTIPD's data analytics department plays a pivotal role. By analyzing sales statistics, website traffic, engagement metrics on social media, and feedback from events, the department can offer insights into which channels are yielding the best ROI. This data-driven approach ensures that marketing budgets are allocated efficiently and that strategies are constantly refined based on real-world feedback.

Stakeholders

Business Model Canvas

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Business Plan

Executive Summary (also see section I and II: Products and Solution)

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Background & Problem Identification:

Parkinson's disease (PD) represents a significant global health challenge, affecting over 10 million individuals. A neurodegenerative disorder with both motor and non-motor symptoms, its societal and economic implications are vast. Standing as the second most prevalent neurodegenerative disorder after Alzheimer's, the economic toll of PD, based on US metrics, escalates to nearly 52 billion USD annually. A pivotal issue compounding this challenge is the current diagnostic landscape. Without definitive diagnostic tests, reliance on clinical appearance in early stages often culminates in misdiagnoses, triggering cascading delays in treatment initiation and amplifying healthcare costs.

The SCENTIPD Solution:

Addressing this diagnostic void, SCENTIPD introduces a revolutionary solution: a self-testing diagnostic kit designed to detect specific Volatile Organic Compounds (VOCs) indicative of PD. By leveraging the capabilities of genetically engineered M13 bacteriophages, this kit aims to provide an early PD diagnostic window, significantly ahead of traditional clinical symptom manifestations. This kit operates seamlessly with our proprietary smartphone application, utilizing state-of-the-art image processing and deep learning algorithms to derive diagnostic predictions. Beyond individual diagnosis, the app extends its capabilities into real-time global PD monitoring, offering a holistic view of disease prevalence and demographic trends.

Market Differentiator:

Our inspiration stems from a unique human narrative - Joy Milne's unparalleled ability to detect Parkinson's through scent. This human-centric narrative, combined with our cutting-edge technological solution, positions SCENTIPD uniquely in the market. Our commitment is twofold: ensuring early, accurate PD diagnoses and offering an accessible and affordable diagnostic tool with broader adaptability potential for other diseases, solidifying SCENTIPD's role as a multifaceted diagnostic platform.

Product Development & Future Trajectory:

The SCENTIPD kit, while still in its developmental phase, is designed to provide user-centricity. Our app, currently operational as a prototype, guides users meticulously through the diagnostic process, from image capture to result interpretation. Our vision transcends Parkinson's. The foundational technology harbors the potential for adaptability to other conditions, positioning SCENTIPD as a potential leader in the diagnostic space.

To conclude, SCENTIPD embodies the future of diagnostic excellence, strategically integrating cutting-edge technology, medical innovation, and market-driven solutions. As we venture forward, our goal remains clear: to reshape the early diagnosis and management paradigm for Parkinson's disease, delivering tangible value to healthcare providers, stakeholders, and patients worldwide.

Product overview: see Products & Implementation section.

SWOT Analysis

STRENGTHS

Affordability: One of the key advantages of our product is its affordability. Current diagnostic methods for Parkinson's disease, such as clinical evaluations and brain imaging techniques, can be significantly costly. By offering a cheaper alternative, our product would be more accessible to patients and healthcare professionals in both developed and developing countries.

Ease of Use: Current diagnostic methods for Parkinson's disease can be time-consuming and require specialized training. By offering a simple and user-friendly diagnostic test, we are making it easier for healthcare professionals to screen patients for Parkinson's disease and diagnose the disease in its early stages.

Early Diagnosis: Early diagnosis of Parkinson's disease is crucial for effective treatment and management. Our product's ability to possibly detect Parkinson's disease in its early stages can help healthcare professionals intervene earlier and provide more effective treatment.

Non-invasive: Skin sebum samples can be collected with simple gauzes or other membranes, a painless and acceptable method for most patients.

WEAKNESSES

Lack of Clinical Trials: We do not have any real-life clinical data supporting the efficacy of our kit.

Small team composed of students: Although we have received the support of various experts, our core team still is comprised by only ten students.

OPPORTUNITIES

High investment interest in Point-of-Care test: Especially after the coronavirus pandemic, investment in accessible point-of-care diagnostic test has been incredibly high

Connections to the biotech startup environment: Through some of our members trips abroad we have established connections to professor, investors and entrepreneurs involved in the biotech industry.

THREATS

Potential alternative diagnostic techniques: PD related research is extremely active and the potential of new biomarker discovery as well as alternative early diagnostic techniques is not negligible.

Tough approval procedure: As with all diagnostic tests, approval procedures can be lengthy.

Growth and Exit

Our next steps in our growth strategy include the participation and the presentation of our company to potential investors in the iGEM Jamboree and the completion of a working prototype by the end of November. At the start of the new year we plan to use our partnerships with the research facilities of our universities in order to obtain permission to start the clinical trials. By July 2024 we will have obtained a CE mark and we will have a patent approval in the EU and by the end of year 1 we will start Series A funding and our scentiPD platform will be online. Lastly, we plan to officially launch our company in March 2025, when the support from the clinical results as well as the legal protection of the company will be such that will allow us to enter the market.

Competitors Analysis

Our diagnostic test kit for Parkinson's disease does not have any direct competitors as it offers a unique and innovative diagnostic method. However, it may have several indirect competitors. Firstly, there are alternative approaches to VOC detection. SebOMIX Ltd, a company founded by a research team at the University of Manchester also does sebum VOC analysis related to a possible Parkinson’s diagnosis. This company, however, is using the standard method of Gas Chromatography-Mass Spectrometry (GC-MS) for their analysis, which is completely unrelated to our own innovative technique. GC-MS analysis requires expensive equipment, which is also not widely available and specialized personnel to use this equipment, thus making their services not as accessible or as affordable as the test kit our company plans to create. Current diagnostic methods for Parkinson's disease can also be hypothesized to be our indirect competitors. These include clinical evaluations performed by neurologists, or other supporting tests, such as brain imaging techniques (e.g. MRI or PET scans). These tests are also really costly, time-consuming, and require specialized personnel. Clinical diagnosis will remain the ‘gold standard’, as our test kit does not aim to replace the clinical practitioner but it will bridge the huge gap between early-stage patients who do not have immediate access or in some cases the financial ability to get examined by specialized medical personnel or to undergo specific imaging tests.

Market Research

Market overview: Target Markets and Market Sizes

The size of our product's target market depends on the prevalence of Parkinson's disease. According to the Parkinson's Foundation, around 10 million people worldwide are affected by the disease and the target market could be further expanded to include individuals who are at risk of developing Parkinson's disease due to family history or exposure to environmental toxins. Additionally, more than $254 million were spent this year by the American National Institute of Health in Parkinson’s disease research. Finally, if we extract data from the US market there are over 16,400 neurologists, 25,505 Diagnostic & Medical Laboratories and 44,900 Pharmacies that are part of our target group.

PAM: Potential Addressable Market

• 10 mil current patients + 90,000 new diagnosis (US only)

• 16,400 neurologists

• 25,505 Diagnostic & Medical Laboratories

• 44,900 Pharmacies

SAM: Serviceable Addressable Market

• 1 mil people tested

• 14,760 neurologists

• 20,404 Diagnostic & Medical Laboratories

• 35,920 Pharmacies

SOM: Serviceable Obtainable Market

• 50,000 total kits by 2028 (see Financial Projections for more info)

Market Trends and Drivers

In the aftermath of the COVID-19 pandemic, the healthcare industry has witnessed transformative shifts, establishing a ripe environment for SCENTIPD's innovative Parkinson's disease diagnosis approach. Bolstered by significant investments in diagnostic technologies during the pandemic, there's a prevailing emphasis on data integration, digital solutions, and wide-scale health monitoring. The growing trend towards collaboration encourages SCENTIPD's potential partnerships with key industry stakeholders. Additionally, the rapid digitalization of healthcare workflows and an emphasis on patient engagement underline the value of SCENTIPD's app-based solutions and self-testing capabilities. As healthcare continues its trajectory towards data-driven planning and consistent innovation, SCENTIPD's pioneering diagnostic methods, particularly its use of the M13 Bacteriophage as a biosensor, position it advantageously in the evolving market landscape.

For more see: The change of the diagnosis landscape after covid in Entrepreneurship IV. Ventures & Opportunities

Market Entry Strategy

SCENTIPD's market entry strategy capitalizes on its innovative diagnostic solution, targeting initial introductions to leading healthcare institutions and Parkinson's research centers. By collaborating with these institutions, we aim to establish credibility and gather essential feedback to refine our offering. Parallelly, a robust online presence, through our website and social media platforms, will cater to direct consumers, fostering awareness and driving early adoption. Collaborations with pharmaceutical firms and attendance at medical conferences will further enhance visibility, ensuring a holistic approach to effectively penetrate the market and set the foundation for sustainable growth.

Regulatory Environment

We are excited to share with you that we are in the talks with regulatory bodies on how we should navigate the regulatory environment in Greece! We are also being guided by industry experts and attorneys, as you will see in the Team section.

Sales Strategy

We will meticulously identify and approach healthcare institutions, leading clinics, research entities, and potential individual end-users. This segmented approach ensures that our messaging is tailored, resonating with the specific needs and pain points of each category. On-the-ground sales teams, trained extensively on the nuances of SCENTIPD's offerings, will be dispatched to major health conferences, symposia, and industry events. Their objective? To conduct live demonstrations, engage in B2B discussions, and initiate bulk order negotiations. To bolster these efforts, we'll implement a robust CRM system to track leads, manage customer interactions, and schedule follow-ups, ensuring no potential sale slips through the cracks. Digital platforms will complement our physical outreach. Webinars, virtual product demonstrations, and online workshops will be organized to reach a global audience, ensuring SCENTIPD's revolutionary diagnostic approach is showcased far and wide. A dedicated support team will handle online queries, book virtual appointments, and offer technical guidance, ensuring seamless customer experience. Collaboration remains central to our sales ethos. We are actively seeking strategic partnerships with renowned healthcare providers, research institutions, and pharmaceutical companies. These alliances will not only amplify SCENTIPD's brand presence but also open doors to exclusive markets, bulk purchase deals, and collaborative research projects. Feedback loops will be integral to our sales approach, too. Regularly scheduled interactions with our clients will help us gather insights, understand market shifts, and adapt our sales tactics accordingly. Whether it's refining our pitch, launching limited-time promotions, or exploring new markets, SCENTIPD will remain agile, ensuring our sales strategy remains in lockstep with the evolving healthcare landscape.

Marketing Strategy

Content Creation: At the forefront will be insightful and engaging content. Blog posts, whitepapers, and video content detailing the science behind SCENTIPD, its benefits, and its potential impact on Parkinson's disease diagnosis will be regularly published. These materials won't just serve to inform but will also position SCENTIPD as a thought leader in the field.

Interactive Platforms: The website will feature interactive sections, such as Q&A forums, chatbots for instant queries, and virtual product demos. This ensures that potential users can get real-time insights and assistance, enhancing the overall user experience.

Social Media Engagement: Leveraging platforms like LinkedIn, Twitter, and Facebook, we will run targeted ad campaigns and organic posts to reach healthcare professionals and potential end-users. Engaging infographics, patient testimonials, and snippets of our product in action will be regularly shared.

Event Participation: SCENTIPD will have a strong presence in key healthcare and biotech conferences, symposia, and workshops. Beyond just stalls and presentations, we'll host panel discussions, live demonstrations, and interactive sessions to directly engage with attendees.

Collaborative Campaigns: Partnering with renowned institutions, research entities, and even influencers in the healthcare space, we'll launch joint marketing campaigns. This could be in the form of co-authored research, joint webinars, or collaborative content on social platforms.

Supply Chain Outline

1. Raw Material Acquisition:

• Sourcing of bacteriophages and associated materials integral to the diagnostic kit.

• Acquisition of other essential components for the kit like substrates, reagents, and packaging materials.

2. Manufacturing & Assembly:

• Laboratories where the bacteriophages are cultured, modified, and integrated into the diagnostic system.

• Assembly units where the diagnostic kits are compiled, integrating both the biological and technological components.

• Quality control labs where each kit undergoes rigorous testing to ensure consistency, reliability, and efficacy.

3. Storage & Warehousing:

• Storage facilities maintaining optimal conditions to ensure the shelf life of the diagnostic kits.

• Inventory management systems to track and manage stock levels and to predict future production needs.

4. Distribution:

• Partnerships with logistics providers to facilitate the shipping and distribution of kits globally.

• Direct distribution to healthcare providers and institutions, ensuring that the kits reach their intended users in a timely and efficient manner.

• Potential for specialized distribution to research institutions for further studies and advancements.

5. Customer Interface & Feedback Loop:

• Channels (like helplines, web portals) where healthcare providers and users can provide feedback, report any issues, or ask questions regarding the kit's usage.

• Mechanisms to funnel this feedback back into the product development and manufacturing process for continuous improvement.

6. Regulatory & Compliance Management:

• Continuous engagement with regulatory bodies to ensure that every kit meets global medical device standards.

• Periodic review and updating of compliance protocols in line with evolving regulations and findings.

7. Post-sale Support & Service:

• Dedicated support teams to guide users on the effective use of the kits.

• Mechanisms for kit servicing, replacement, or upgrading as the technology and methodology evolve.

8. Research & Development Inputs:

• Continuous input from the R&D team based on latest research findings, ensuring the diagnostic kit remains at the forefront of PD detection technology.

• This influences the raw material acquisition and manufacturing processes, ensuring SCENTIPD remains a leader in the field.

9. Recycling & Waste Management:

• Processes to handle used or expired diagnostic kits, ensuring eco-friendly disposal or recycling measures.

• Partnerships with environmental agencies or firms to minimize the ecological footprint

Risk Analysis

Risk Mitigation

We can classify our risks into three main categories; advances in science, financing obstacles and legal hurdles.

The prospect of the development of new VOC detection techniques or new biomarkers that are potentially easier to analyze is beyond our controllability. Specifically, the scenario of an alternative biomarker will have a negligible effect on our company, as our platform is able to be modified in order to cater to different VOCs. Although through our calculations our product seems to be a significantly cheaper detection method of VOCs, there is always the possibility of newer and more competitive methods to be developed. This could be disastrous but after thorough literature research, we could not identify cheaper alternative VOC techniques currently under development.

Regarding the potential financial obstacles, our approach to decrease the related risks will be through networking opportunities. We have already developed substantial communication with investors and venture capital firms and we plan to broaden our connections to investors in the iGEM Jamboree as well as to future networking events and entrepreneurship competitions.

Lastly, our most important risks are associated with attaining regulatory approval. As our team does not have any members with a law background, we intend to branch out to outside help. We have started to mitigate these risks by partnering with legal representatives specialized in health policy, patents and intellectual property protection. Furthermore, we aim to obtain help from the legal departments of partner research institutions or pharmaceutical companies.

Financial Plan

At our MVP's current maturity level, constructing a comprehensive financial plan poses significant challenges due to the inherent volatility and uncertainties we face. Firstly, our access duration to NKUA’s lab spaces remains ambiguous, which directly impacts our cost and development forecasts. Without established partnerships with manufacturers and suppliers, accurately predicting production, distribution, and operational costs becomes exceedingly difficult. Moreover, economies of scale play a crucial role in our financial structure. As we aim for mass production of the kit, the unit cost can vary substantially based on production volume. Given these variables, creating a precise and reliable financial plan at this juncture is not feasible. We are against trying to produce fake numbers just for show. So, below we present only some aspects of a financial plan for SCENTIPD.

Financial Status

We are very excited to share with you that our estimations about the costs of creating the prototype have been amassed thanks to our fundraising members. Good job guys!

Prototype’s budget

Initial Funding Plan

• Non-dilutive funds (EU, ERC)

• GoFundMe

• Angel Investors

Note: We were approached by a VC but we don’t think that a VC would be a great fit for us in such an early phase of SCENTIPD.

Financial Projections

We estimate to achieve a penetration rate of at least 0.01% around the world by 2028 which corresponds to around 50.000 kits sold including: 50 research institutions and hospitals and 3 government agencies. The graph below represents the different revenues produced by 2028 for a profit margin of 150 per kit and 50 Euros per kit accordingly.

Broader Financial Implications: A Study

US Statistics: New Parkinson’s Disease cases every year: 90.000 [3] Total Annual Cost: $51.9 billion [4] Direct Medical Costs: $25.4 billion [4] Indirect Costs: $26.5 billion [4] (Parkinson’s wellness projects, caregiver burden, disability income, etc.)

For 20.000 positive results (22% success): 0.22 * $51.9 billion = $11.5 billion Through treatments to delay cognitive impairment and advanced PD stages, by having the opportunity for preventative measures and intervention, we estimate a total reduction of the total costs of PD around: $2 billion

Development and Implementation

The development of our business ventures started when one of our members, Nicolas visited Boston. There, he had the opportunity to present our project idea to various biotech startup founders, venture capitalists as well as members of the Greek diaspora in academia and in the embassy. He also received valuable advice and mentorship which we used to further develop and analyze our business plan.

We used this framework to compete in a famous entrepreneurship competition in Greece, called Mindspace University. With the submission of our business model canvas and a meticulous presentation of our company, we managed to advance to the next stage of the competition. We, then, acquired the ability to receive mentorship on a one on one basis with various members of the biotech environment and namely, we received guidance from Dr Alexia Pollisidis, co-founder and CEO of Anacalypsis Therapeutics, Professor Nadeem Kasmani of Harvard University and industry expert Ms. Katerina Papathoma. The final presentation in front of the judging committee comprised by KEMEL members (Center of Volunteer Managers of Greece) led us to win first place in this contest and acquire funding of 10,000€, as well as free accountant services, in order to properly found our company in Greece, which we will proceed to do after the iGEM competition.

For details about the implementation of our products in real world scenarios, see Products & Implementation section.

For details about our endeavors and wins, see Ventures & Opportunities section.

Intellectual Property

Our efforts haven’t yielded a prototype ready for patent application, but it is definitely in our plans considering the novelty of our diagnosis extraction pipeline and our kit.

Closest Comparables

The field of neuroscience related companies includes companies with valuations of hundreds of millions of dollars. Although we cannot directly compare our startup to other biotechnology companies focused on neurodegenerative diseases, some of the closest comparables would be the following.

Alector Inc is a biotechnology company focused on developing therapies for neurodegenerative diseases, including Alzheimer's disease and Parkinson's disease. While Alector's primary focus is on therapeutic drug development, it still is a part of the broader field of neurodegenerative diseases. It is a publicly traded company on NASDAQ and their current market cap as of September 2023 is 473,64 million USD.

Quanterix Corporation is a biotechnology company known for its approach to ultra-sensitive biomarker detection and measurement. They have been actively involved in research for the detection of specific biomarkers associated with Parkinson’s. Quanterix Corporation is a publicly traded company, listed on the NASDAQ stock exchange with a current market cap of 1,01 billion USD.

Entrepreneurship IV. Team

Hello iGemers, nice to meet you!

Our team consists of graduates and undergraduates of various schools. There are doctors, biologists and engineers of various disciplines (chemical, electrical, computer and software engineers). We are all very different in our academic backgrounds, but we share a common passion in Synthetic Biology. It excites us with its potential in solving serious problems with relatively simple logic. This seems counter-intuitive; Synthetic Biology combines principles of so many fields, being the intersection of so many disciplines, namely: Biology, Chemistry, Physics, Engineering and so on. And yet, every solution proposed feels simple and elegant.

Our strength lies in our multidisciplinary composition, as different fields of expertise are brought together. Our diverse skill sets allow us to approach the development of the diagnostic test kit for Parkinson's disease from multiple perspectives.

The collaboration between our biologists and our doctors enables us to deeply understand the biological mechanisms underlying Parkinson's disease and the specific diagnostic needs. Their experience in clinical practice and patient care ensures that our solution addresses the practical requirements and enhances patient outcomes. Concurrently, the involvement of our chemical engineer brings a profound understanding of chemical processes, materials, and quality control, which is crucial for the development and manufacturing of accurate and reliable diagnostic tests. She contributes valuable insights into optimizing assay components and ensuring consistent performance.

On the other hand, the expertise of our electrical, computer and software engineers complements our team's capabilities by enabling the integration of advanced technologies into our diagnostic test kit. This includes innovative sensor systems, data analysis algorithms, deep learning techniques and device connectivity solutions, enhancing the functionality and usability of our product. Moreover, our engineers play a significant role in the development of the app, the software platform and our site.

In collaboration with some of our doctors that have also been involved with programming, they leverage computational tools and bioinformatics techniques to create our model and analyze complex datasets, extracting meaningful insights.

Our diverse disciplines enable us to consider various technical, clinical, and practical factors, resulting in a well-rounded solution that meets the needs of both healthcare professionals and patients. To sum up, the key to our successful run so far lies on the interdisciplinarity of our team members, each one equipped with a skillset to tackle every problem that arises. Though, we should mention that our ‘secret ingredient’ was our unity; everyone was eager to help each other during both tough and easier times during this crazy year. Well, there is another secret ingredient. A secret secret ingredient. Persistence. Not taking no as an answer. This year every member was new. No one had the experience. The project started from scratch. And yet, here we are! How? No matter how many doors were closed on us we never gave up. We knocked on another 100. And as you will see below, many brilliant people answered. And we want to thank them for that.

Our Mentors

Our Universities

At this point we would like to thank our Universities that support us every year in our endeavors, either through financial aid or via providing us with equipment and workspaces.

Our Mission

We believe that early detection and comprehensive care are the cornerstones of our mission to transform the Parkinson's disease landscape and bring relief to countless families.

Our Vision

Together, we strive to bring hope, empathy, and scientific innovation to the forefront of Parkinson's disease care, ushering in a brighter future for all those touched by this condition.

Entrepreneurship V. Ventures & Opportunities

The change of the diagnosis landscape after COVID-19

SCENTIPD is poised to make a significant impact on the healthcare landscape, given the company's innovative approach to early Parkinson's disease diagnosis. Here's why the timing is perfect for SCENTIPD to enter the market [1]:

1. Investment and Innovation: The recent wave of innovation and investment in diagnostic technologies, exemplified by the response to the COVID-19 pandemic, has created a receptive environment for novel diagnostic solutions. SCENTIPD's groundbreaking approach to Parkinson's disease diagnosis aligns perfectly with this spirit of innovation.

2. Data and Digital Solutions: The healthcare industry is increasingly focused on integrating data and digital solutions into the testing and diagnostic process. SCENTIPD's utilization of advanced image processing, deep learning, and a data analytics platform positions the company at the forefront of this trend, showcasing the company's alignment with the evolving healthcare landscape.

3. Partnerships and Collaborative Models: Collaboration and partnerships played a pivotal role in the successful response to the pandemic. SCENTIPD can leverage this collaborative spirit to form strategic partnerships with healthcare institutions, testing laboratories, and other stakeholders. Such partnerships will be instrumental in introducing SCENTIPD's diagnostic kit and app-based solution for Parkinson's disease detection.

4. Wider Screening and Monitoring: The pandemic demonstrated the feasibility of wider screening and monitoring for various health conditions, including through self-testing. SCENTIPD's approach, which involves self-testing for Parkinson's disease, aligns perfectly with this trend and opens the door to broader applications beyond the pandemic context.

5. Digitalization of Diagnostic Workflow: The acceleration of digitalization in healthcare workflows, including diagnostics, is a notable trend. SCENTIPD's integration of digital technologies and app-based solutions for data processing and patient engagement aligns seamlessly with the ongoing digital transformation in healthcare.

6. Data-Driven Healthcare Planning: Data-driven healthcare planning and decision-making are increasingly essential. SCENTIPD's data analytics platform not only provides diagnostic information but also offers valuable insights into Parkinson's disease demographics and economic impacts. This aligns with the growing emphasis on data utilization in healthcare strategies.

7. Patient Engagement and Ownership: Empowering patients to take ownership of their healthcare data and engage in the diagnostic process is a key aspect of modern healthcare. SCENTIPD's approach allows patients to participate actively in their health by providing self-testing capabilities and potential long-term health monitoring.

8. Continued Innovation: The healthcare industry continues to prioritize innovation in diagnostics. SCENTIPD's use of M13 Bacteriophage as a colorimetric biosensor represents a cutting-edge approach to disease detection that distinguishes the company in the market.

Ventures & Networking

Boston

In our quest to find the most suitable ecosystem to found our start-up, Boston stood out. Being one of the biggest bio and biotech hubs in the world, it combines the brainpower of top US universities with the financial power of companies and investors; and all of that in a matter of some miles in radius! Of course, we had to explore such an ecosystem fast to plan our next moves and get insights on Boston. For this reason, we decided one of us, Nicolas, to participate in an entrepreneurial trip to ‘The Hub’, exploring our options and representing SCENTIPD. Here are the highlights of the trip:

Link

Day 1, 19/04/2023:

Product Management: From research to industrial settings

Day 2, 20/04/2023:

Harvard Business School Visit

Boston’s Ecosystem, Legalities, Success Stories

Day 3, 21/04/2023:

No photos here, but still a very important day. We met with faculty of TUFTS’s Tech Transfer Department and examined how the department works aiding many research projects reach industrial maturity and become start-ups. It was very interesting comparing other projects’ trajectories with SCENTIPD’s.

Also, that day we visited a venture café and casually run up to a MIT lecturer and some investors. Gotta love venture cafes and Boston!

Day 4, 24/04/2023:

How to develop and refine your AI product in a start-up by the CEO of voda.ai

Day 5, 25/04/2023:

A decades-long effort to combat ovarian cancer by the CEO of Mersana Therapeutics

Solving simple problems using out of the box solutions

Day 6, 26/04/2023:

The meeting with a Benchling’s product manager gave us many ideas on how to build software tailored to the needs of different customers (+ pricing strategies) and on the iterative process required to build software of great quality.

Finally, we met and discussed with the wonderful and brilliant Jules Pieri, whose entrepreneurial journey is really amazing.

Entrepreneurial trip to Boston: The Participants

Well, a part of the network were the participants themselves. In our group there were consultants, co-founders and engineers of 2 very successful greek start-ups (TPL IKE, Promilist), a PhD student, a manager and an engineer. Also, we had an entrepreneurship & start-up mentor and a greek VC associate. As Nicolas was the youngest and the least experienced of the group, everybody was eager to help with SCENTIPD by providing meaningful insights and invaluable experiential advice. A big part of SCENTIPD is influenced by those kind and experienced people.

Finally, the first day of the trip Nicolas had the chance to meet the Co-Founder and CBO of Anodyne Nanotech, Inc., Mr. Konstantinos Tzortzakis. Having a similar start as Nicolas, the path and career choices of Mr. Tzortzakis paved the way for many of SCENTIPD’s planned future endeavors.

New York

Nicolas even got the chance to visit New York during the weekend of his trip, meeting expatriates and getting the chance to discuss with them and the rest of the Greek participants about the start-up ecosystems of New York and Greece. Those were informal discussions.

Conclusion:

All in all, the entrepreneurship trip to Boston was a great success for SCENTIPD.

Strasburg

Well, a part of the network were the participants themselves. In our group there were consultants, co-founders and engineers of 2 very successful greek start-ups (TPL IKE, Promilist), a PhD student, a manager and an engineer. Also, we had an entrepreneurship & start-up mentor and a greek VC associate. As Nicolas was the youngest and the least experienced of the group, everybody was eager to help with SCENTIPD by providing meaningful insights and invaluable experiential advice. A big part of SCENTIPD is influenced by those kind and experienced people.

Meeting co-founders in Greece

Apart from the co-founders we met in Boston, we also came in contact with many Greek co-founders in Greece. Let’s meet them

Opportunities

Throughout our journey, many opportunities have emerged. Here are some of our defining moments:
1) For our Mindspace win (see Milestones below) we won a considerable amount to cover for vital procedures of SCENTIPD. Just as importantly, we won 3-month free accounting services by Indima and thus a valuable partner. Through our talks, we have gained all the necessary knowledge about founding a company and handling vital finances. Another perk of our win was that People’s Trust -the institution that will award us the Mindspace’s monetary prize-, also gives us access to a big network of fellow co-founders.
2) We are also in the talks with a trusted private attorney, regarding legality issues of founding a start-up and navigating through the regulations of constructing our diagnostics tool. Of course, we also examine our patent application options.
3) After witnessing all the pros of participating in (and winning) entrepreneurial competitions, such us mentoring, networking and financial boosts, we have opened our radar and spotted some interesting competitions we would like to compete in. We won’t disclose any information yet, but we will keep you updated!
4) We were invited to speak on the biggest radio station in Greece and in the entrepreneurial event “Panorama of Entrepreneurship”. Both opportunities gave us lots of exposure as a team.
5) We have been approached by an undisclosed VC, but we didn’t think it was a good fit for us at the moment.
6) We were given the opportunity to take part in a start-up acceleration program, which might be our next step as a team!

Milestones

In June 2023, our team achieved a remarkable victory at the Mindspace Entrepreneurship Competition organized by Mindspace University of Life Sciences. Out of a pool of 100 competitors with outstanding ideas and incredible projects, we emerged triumphant with our groundbreaking venture, SCENTIPD. Winning the competition not only brought us a sense of accomplishment but also provided us with valuable resources to propel our project forward. After weeks of intense preparation, we left no stone unturned. We seized the opportunity to meet renowned entrepreneurs from both Greece and Boston, as one of our team mates traveled there to become acquainted with important CEOs and CFOs, who graciously shared their expertise and insights. We would like to especially thank Ms. Papathoma and Dr. Polissidis, who provided significant support through countless web meetings, sharing their knowledge and experiences. They guided us on constructing a comprehensive business plan, identifying potential revenue streams, analyzing our target market and competitors, and perfecting our presentation techniques to impress the judges. Their advice proved invaluable in refining our strategies. During the finals, we delivered a compelling five-minute presentation that showcased the inspiration behind our project, the underlying technology and biology, the test kit and its accompanying application and platform, our meticulous business plan, the project timeline, and the exceptional capabilities of our team. Eminent scientists and entrepreneurs from America and Greece posed challenging questions regarding the feasibility of our idea and its potential expansion to detect other related diseases or even cancer. Their positive feedback and numerous congratulations filled us with pride. As winners, we were awarded a generous prize of 10,000 euros and three months of free logistic advice, which will significantly support our journey ahead. The recognition and validation we received from such esteemed individuals have energized us to strive further and make a lasting impact in the field of medical diagnostics. With gratitude and determination, we are excited to continue our mission of developing SCENTIPD and revolutionizing the early detection of Parkinson's Disease and potentially other conditions. This triumph has reinforced our belief in the power of innovation, collaboration, and the transformative potential of entrepreneurship.

https://www.youtube.com/watch?v=aExVPAnVcC8

SKAI Radio

We were invited twice to discuss about our project on one of the biggest radio stations in Greece, SKAI radio. We discussed about our team, our project, the iGem competition and much more. Fun fact: the first time we appeared was 30’ minutes after Greece’s Prime Minister appearance on the SKAI radio! So, the ratings were up and we got a lot of exposure!

Founding a Company

You have reached that far! Wow. This is a good checkpoint. For all the dedicated readers that reached this far, we want to share with you our immediate next goal after iGem, our exciting news! Having read so much, we consider you, the reader, a part of SCENTIPD’s journey at this point. So, we know that you will get as excited as us! We aim to found our start-up, SCENTIPD, right after iGem!

Entrepreneurship VI. Social Responsibility

Social Responsibility

Our test was designed to be as accessible and portable as possible, always keeping in mind the unique geography of Greek society. The incidence of PD increases with age and the most remote areas of Greece, both island and mountainous, have the highest density of people over the age of 60. This demographic, who is most likely to develop PD, lives far from specialized medical professionals who can clinically diagnose them and even further away from diagnostic centers with the appropriate imaging tools, such as a Dat-Scan.

Another approach we took regarding social responsibility was social awareness via human practices. Parkinson’s Disease might be a famous condition, but its complex symptoms are not truly known and understood. We made it our goal to emphasize the emotional toll on the patient, as well as the change in their character. We emphasize that knowing and preparing for the disease can make a world of difference in both the patient’s life and their family members’.

As Joy Milne put it:
What if we did know?," she said
"It would have changed things dramatically."
"The fact that he became withdrawn, reserved, he had bouts of depression and mood swings, if I had understood what was happening it would have changed our total outlook on life."

Future Plans on Social Responsibility

At this point we should note that all the extended functionalities of our products aim to combat PD in a societal level. The app will include calls for study participants. The data analytics platform, gathering PD diagnoses around the world, will serve as a common point of reference for everyone affected by or affiliated with PD. Our ultimate goal is to have an impact on societies on a global scale.

Sustainability

Our diagnostic pipeline is environmentally friendly. The manufacturing and supply chains haven’t been established yet. We are also exploring options for reusability to make our kit even more cost-effective and sustainable.

Inclusivity

Our diagnostic test kit for Parkinson's disease is designed to be inclusive and user-friendly, addressing the valuable input we received from elderly people, like the ones we met in ‘’Sivilla’’, home for the elderly, or the Parkinsons’ patients. We have taken their preferences and expectations into account to create a kit that caters to a wide range of individuals, ensuring accessibility, affordability, and ease of use.

Regarding its user-friendly design, our kit will come with a set of clear and simple instructions, translated into multiple languages, including English, Albanian, Bulgarian, Turkish, and others commonly spoken by migrants from neighboring countries. Users will only need to place the kit on their upper back, where sebum containing the relevant Volatile Organic Compounds (VOCs) accumulates. The kit will automatically absorb the sample as gas, requiring no further action from the user. The user will then download the accompanying application to their phone and scan the result with their phone camera. We will provide very clear instructions on that part too. In case they face difficulties in the download and usage of the app, we will also give them the option of contacting an assisting phone line. It will be a complementary service, in order to offer further help and guidance on the user via the phone.

Also, we certainly aim to make our kit widely available by partnering with pharmacies across Greece. We would like to transcend the Greek borders too, by distributing our kit all over the globe, especially to countries where specialized exams and medical equipment are scarce or terribly difficult to find. This approach ensures that individuals, regardless of their location, can easily purchase and use the kit, even in remote areas with limited access to healthcare resources. We are committed to addressing healthcare disparities and making our kit accessible to as many people as possible.

Furthermore, we understand the financial challenges faced by many, especially the elderly, since the cost of life everywhere is on the rise. While the price of our kit will be kept as low as possible, it is important to note that early detection through our kit can ultimately reduce overall healthcare costs. Parkinson's disease is associated with expensive treatments, and by catching it early, the financial burden on individuals can be significantly reduced.

It is worthy to mention that we are exploring the possibility of designing the kit to be reusable, allowing users to conduct multiple tests without the need for frequent repurchase. This potential feature not only saves money but also encourages individuals to monitor their health regularly.

Our commitment to inclusivity and the incorporation of the elderly residents' feedback ensures that our diagnostic test kit for Parkinson's disease is not only effective but also accessible, affordable, and user-friendly. We aim to make early detection and disease management more attainable for everyone, transcending borders and helping individuals globally, including those in less privileged regions.

To conclude, our vision extends from local communities to entire nations and the global stage. We firmly believe that our diagnostic kit has the potential to make a meaningful impact in the fight against Parkinson's Disease in any given scenario.