JTremor3D

Parkinson’s Disease is a neurodegenerative disease manifested through tremors, which start with a limb and then gradually spreads across entire body. Globally, there are about 7-to-10 million patients of Parkinson's Disease. While this disease has no permanent cure, medication and surgery are two means employed to keep tremors in check. However, the overall dosage management involves a lot of “trial-and-error” approach. I have observed that at times, in spite of medication, the tremors still show up in patients at different times of the day and dosage needs fine tuning. This delays getting the tremor-controlled life to patients, which is a problem. 

Another problem that I have observed is regarding re-tuning of brain pacemaker of patients of Deep Brain Stimulation (DBS) surgery. Based of the changing tremor profile, the brain pacemaker needs to be retuned. This retuning is done by patient's caregiver purely based on gut feeling (unscientifically). This is another problem.

JTremor3D, the wearable tremor profiler for patients with Parkinson’s Disease, is the solution.

The device is made in the form of a glove or a strap that can be worn by any of the limbs. A controller communicates with each of the device to capture tremor data at a pre-configured interval of  1/10th of a second. I have also come up with JTremor Index, a single objective measure of tremor level (like say glucose level or cholesterol level) that represents all the parameters - intensity, duration and frequency of the tremor. Finally, since controller communicates with the cloud database in real time when networked, it can provide the insights to doctors on demand. 

 JTremor3D can assist neurologists during dosage planning by providing on demand tremor profile analysis of the patient. It can also provide recommendations to caregivers of patients who have undergone Deep Brain Stimulation surgery about re-tuning of brain pacemakers. 

This may get the patients a tremor-free life sooner. 

Following is the link to the presentation about details of device:

Presentation slides for the device details

Someday I want to try to use JTremor3D to auto-tune the brain pacemaker in real time.

Following is link to the product demo (unedited - to retain authenticity):

Product demo - unedited

JTremor3D can provide insights (like the one shown in the attached images). Using this, doctors can can do analysis like: 1) how the medication is reducing the overall tremor level of patients 2) How are the average tremor levels during different times of the day. This can assists doctors during dosage planning process. This may result in a tremor-controlled life for patients sooner.

The patent-pending invention has been my creation, hence I am best suited to take it forward. Two patents are filed on the device. While it has not been tried on any patient yet (since I still need to apply for safety certification), it is very useful for patients based on my observation about the challenges faced by my uncle who got Parkinson's Disease at an early age of 42. Hence, I have observed his disease progression very closely for 9 years. It provided me a deeper understanding of the problems faced the patient of PD.

It has been recognized as a useful invention by several organizations:

1) It has been demonstrated to a few neurologists and Parkinson's patient support group and received positive feedback from them.

Appreciation letter from Parkinson's Disease and Movement Disorder Society of India (one of the large patient support groups in India)

2) United Nations Development Program (UNDP) has added this invention to their Grass root innovation database.

Link to UNDP GRID page

3) The invention received Grand award (3rd place) at the Regeneron Internationals Science and Engineering Fair (ISEF) organized by Society of Science, US

Scaling the solution:

This solution is easily scalable since:

• It uses standard open source components. 
• The components are inexpensive (even the device and controller together is costing me less than $70 to make). At large scale the cost per piece will be even lesser since there will be economies of scale.
• We can get a compact chip designed that can be manufactured at a large scale. This will not only reduce the size of the chip, but also will make it less expensive
• Both the glove (and its circuit) and controller can be made available at a large scale fairly easily
• One can easily make 1,000 pieces of each of the glove and controller on a daily basis. To reduce risk to the supply chain, components that need to be procured externally can be ordered in bulk ahead of time. 

Who does the solution serve:

My solution (JTremor3D) serves two types of users:

1. The patients of Parkinson's Disease, especially those who are visiting the doctors during initial period of dosage planning or those who needs dosage replanning since the tremor profile of the body has changed. 
2. The patients who have undergone Deep Brain Stimulation (DBS) Surgery: Once fed with the current settings, this device can provide recommendations to the caregiver of the DBS surgery patient regarding retuning of the brain pacemaker based on the changing tremor profile of the body.

I have observed that at times, in spite of medication, the tremors still show up in patients at different times of the day and dosage needs fine tuning. This delays in getting the tremor-controlled life for patients. 

This device can potentially help get tremor-controlled life to the patients sooner.

Aspects of solution and ecosystem that can impact lives:

Human-centric Design:

The arrangement has been made to ensure that only real tremors are captured. Any movement of hand which is happening because the patient is walking around is ignored. The device records movements with respect to the rest of the body where controller is tied up, while ignoring non-tremor movements.

As for the device design, while glove is good, one can not wear a glove all the time. Hence, I am working on a half-glove design which will be more like a extended wrist band. 

Engaging and Serving the Underserved population:

While there are cases where Parkinson's Disease has been diagnosed in the younger population as well, but,  usually it is more often detected among people who are senior in age.  A lot of such senior patients don't know or don't opt for effective treatments, there by remaining underserved and get isolated from the society. Through my 'beat-the-tremor' foundation initiative (www.beatthetremor.org), I am getting connected with such patients and suggesting them good doctors in the areas. I am also providing them with monthly newsletters covering summary of curated information regarding new research, lifestyle tips (diet, exercise), etc.

Diversity, equity and inclusion:

Diversity, equity and inclusion are extremely important aspects for me since I have seen this to be lacking in several walks of life in India. Hence, I have got Mr. Anurag Keskar as my advisor. Mr. Anurag is himself a patient of Parkinson's Disease and DBS Surgery. While he is not able to perform activities that involves, mobility, he has been an amazing advisor about patient's pain points. While this also helps me get information straight from "horses-mouth", it also is satisfying that I am able to include and involve him in discussions, which he has is also liking. 

There also is a need for "inclusion" of patients in towns and villages in India. These are mostly native speakers who have limited understanding of the disease and less awareness about good hospitals / doctors. To specifically include them and bring them to the main stream, I send out monthly newsletter to them in native languages (Hindi, Marathi). In my community of 55 patients, almost half of them are native speakers and have opted for newsletters in native language. There also are a few patients who don't even use cell phones. I send out physical copies of newsletter for them via post. 

My ability to reach out to people of all genders and demographics from cities, towns and villages helps me maintain diversity and inclusion.

And finally, regarding the equity. People with tremor are most often get isolated from the society due to limited mobility or sheer embarrassment due to tremors. My goal in building this device is to help in managing the tremors so that patients can lead a normal life despite the disease. This is likely to bring equality in the minds of patients.

Beat-the-tremor foundation initiative - Building community relationship and their engagement:

While I am building the device, I also need to remain connected with the patient community so that I can listen to them and also keep them well-informed. 

To achieve this, I lead an initiative called Beat-the-tremor foundation (www.beatthetremor.org). Through this, I keep the patients informed about the happenings in the Parkinson's world (latest developments, Dietary tips, exercise tips, etc.). I do literature research every month and provide a summarized view in monthly newsletter (in English, Hindi and Marathi languages) to the patients who have subscribed to the newsletter. I built a small community of 55 patients of Parkinson's Disease. The community is growing each month. This connection with  the community is important from business standpoint as well.

I also seek feedback (input) from community on various topics ranging from their challenges, utility of the device, its design to the newsletter content as well. This indeed helps in refining the design and making it more human centric. 

The patent-pending invention has been my creation, hence I am best suited to take it forward. Two patents are filed on the device. While it has not been tried on any patient yet (since I still need to apply for safety certification), it is very useful for patients based on my observation about the challenges faced by my uncle who got Parkinson's Disease at an early age of 42. Hence, I have observed his disease progression very closely for 9 years. It provided me a deeper understanding of the problems faced the patient of PD.

It has been recognized as a useful invention by several organizations:

1) It has been demonstrated to a few neurologists and Parkinson's patient support group and received positive feedback from them.

Appreciation letter from Parkinson's Disease and Movement Disorder Society of India (one of the large patient support groups in India)

2) United Nations Development Program (UNDP) has added this invention to their Grass root innovation database.

Link to UNDP GRID page

3) The invention received Grand award (3rd place) at the Regeneron Internationals Science and Engineering Fair (ISEF) organized by Society of Science, US

4) It received Science Seed Award from Shanghai Youth Science Education Society

5) A few national level awards as well (like the recent one from Prime Minister of India)

Throughout the design and implementation, I have been mentored by my mentors. While the working prototype is ready, it will need to be tested on real patients once the safety certification is received. In the meantime, I am keeping the patients engaged through my initiative called Beat-the-tremor foundation. This initiative is a virtual patient information aid through which I send out monthly newsletters to patient and families regarding the latest developments in the PD world, Lifestyle tips (diet, exercise, etc.) from the experts. You can get more details on:

www.beatthetremor.org

 Through this initiative, I have built a community of over 50 patients of Parkinson's Disease. This also is a means to keep in touch with patients and their families.

Last but not the least, my advisor (Mr. Anurag Keskar) is himself a patient of Parkinson's Disease and DBS surgery. He provides me the information and advice about all the challenges that are faced by a PD patient, DBS Surgery patient, caregiver, etc. This is invaluable. 

I am looking for following support through this challenge:

1) Feedback and guidance from mentors and scientists

2) Guidance about regulatory norms for device launch in the US

3)Explore synergies with other "Solve" participants

4) Funding to support the development of the product into a world class offering (tremor profiling device) and research regarding body stiffness profiling technique.

The solution is unique because:

1. There are not much solutions being currently used for data-to-day tremor analysis. There are solutions available for suppressing tremors, but no solution that can provide tremor profile on demand. 2 patents have been filed for this device to protect the IP. The 2 international and 3 National level awards that I received is testimony to device's potential and innovation.
2. JTremor Index (the quantitative measure for overall tremor level of a patient for a given period) can be useful in tracking, comparing and better controlling the tremors (One can not control what one can not measure).
3. This device captures tremors of limbs with respect to the body. Also, the device can be programmed to detect and differentiate tremulous movements of limbs from non-tremulous movements. This makes it innovative.
4. The device can be extended to integrate other med devices like blood pressure monitor, and etc, so that data from those devices can also be made available to doctors on demand. This can be made into a complete solution for Parkinson's Disease.
5. This device is compact and affordable (the cost of building the prototype is less than $100 (both glove and controller).
6. This device can generate a lot of data that can help in knowing the disease better. If patient permits, the anonymized data can potentially help in training AI models that can help in classifying new cases based on the tremor pattern. It may also potentially predict the progression of disease for a patient. Use of this device can potentially be extended to other disorders that involve tremors (e.g. Epilepsy). It may help in understanding those disorders better.
7. This device may potentially be integrated some day to auto-tune the brain pacemaker of DBS surgery patients in real time based on the changing tremor profile of the patient. 
8. The solution is scalable and quite inexpensive

Following are my goals for the upcoming years:

Year 1: Make the device further compact, develop web app, mobile app

Year 2:  Safety certification, partner with clinics for tests, conduct tests and receive feedback, other regulatory compliances

Year 3: Finetune the device based on feedback. Mass produce and launch in India and the US. Also conduct research based on the gathered data

Year 4: Grow in India and the US. Explore partnerships with device company / pharma company for taking it to market. Continue research

Year 5: Explore other geographies and grow. Continue the research as well

Year 0  being the year of ideation, it included all of the following:

•  Defining the problem statement clearly (Done)
•  Exploring all existing solutions if any (Done)
•  Detailing the solution that includes:

         1. what to include, (Done) 

         2. what to exclude, (Done)

         3. how to go about doing it, (Done)

         4. what value it can bring to table, (Done) 

         5. get opinion from experts (Done)

• Filing the patent to protect the IP (Done)
• Building the working model (Done)

My uncle is a patient of Parkinson's Disease, who underwent Deep Brain Stimulation Surgery. I have seen the challenges faced by patients and their families due to tremors and frequent visits to the doctor. Several patients eventually get isolated from the society. Thus their is a huge cost of tremors.

JTremor3D can do thorough analysis of tremor and can make the tremor profile of the patients available to the doctor to assist in dosage planning. This can result in patient getting tremor-controlled life sooner there by lead a good life despite of the disease. 

No tremor means patient can continue to work and earn livelihood or at least remain independent to perform daily activities. This itself can be a huge achievement for the patient of PD.

The underlying technology involved includes:

- Hardware: Glove includes compact hardware that perform the functions of capturing the tremors (movement with respect to the controller) and sending the data to controller. Controller as well has an hardware to receive the data. Controller can be attached to the belt of patient. It has been configured to receive data at a frequency as low as every 1/10 sec. In case a patient is using multiple devices for capturing tremors (say one for hand, another for a leg), both the devices can be wirelessly connected to the same controller.

- Software: Controller has been programmed to process the received tremor data, store it locally on the controller. It also has programs that push the data to the cloud database whenever network is available.

- Cloud: Cloud is used to store the individual device specific tremor data of patients.  Cloud also has programs to build the tremor profile of the patient. It also will have APIs that will cater to the needs of the webapp and mobile app. Web UI would also be hosted on the cloud. 

Diversity, equity and inclusion are extremely important aspects for me since I have seen this to be lacking in several walks of life in India. Hence, I have got Mr. Anurag Keskar as my advisor. Mr. Anurag is himself a patient of Parkinson's Disease and DBS Surgery. While he is not able to perform activities that involves, mobility, he has been an amazing advisor about patient's pain points. While this also helps me get information straight from "horses-mouth", it also is satisfying that I am able to include and involve him in discussions, which he has is also liking. 

There also is a need for "inclusion" of patients in towns and villages in India. These are mostly native speakers who have limited understanding of the disease and less awareness about good hospitals / doctors. To specifically include them and bring them to the main stream, I send out monthly newsletter to them in native languages (Hindi, Marathi). In my community of 55 patients, almost half of them are native speakers and have opted for newsletters in native language. There also are a few patients who don't even use cell phones. I send out physical copies of newsletter for them via post. 

My ability to reach out to people of all genders and demographics from cities, towns and villages helps me maintain diversity and inclusion.

And finally, regarding the equity. People with tremor are most often get isolated from the society due to limited mobility or sheer embarrassment due to tremors. My goal in building this device is to help in managing the tremors so that patients can lead a normal life despite the disease. This is likely to bring equality in the minds of patients.

There are two business models possible:

1) Model 1: This device can be acquired by patient who can use it whenever there are tremors so that it can be captured. Tremor profile and other analysis will be made available on the mobile app / webapp. Patients can invite doctors to the webapp / mobile app to view the tremor profile. This may assist in dosage planning. Patients who have undergone Deep Brain Stimulation (DBS)  Surgery can use this device and get recommendations on their mobile appabout retuning of brain pacemaker. 

2) Model 2: Doctors / Clinics can acquire the device and lease it to the patient whenever patient visits the doctor for the first time or when ever there are changes to tremor profile. Patient goes back home and uses the device till the next visit to doctor. During next visit, this device can be returned to the doctor, who can access the tremor analysis of the patient. This may assist doctors in dosage planning.

This device got good coverage from various media houses (close to million views all together). Received comments from several patients about their willingness to acquire this device. This helped me decide that Model 1 will surely fly!

Partnership:

Another business model is to partner with devices company that are involved in making devices for the senior patients. We can license the device to them and reach the market through them and receive the royalty. This way we will be able to focus on the innovation and IP, while partner would be able to cross-sell our products through their channels.

We would like to connect with the right partners as well!

The first priority is make the device ready to use (affordable). Then get it safety certified. Also complete any other regulatory step as required by law. Then give the devices to a few clinics to try it on a few patients and get their feedback. 

There two aspects I am / will working on to make it financially sustainable:

• Ensure that the solution add high value to the patients, doctors and caregivers. 
• Keep the cost of manufacturing as low as possible
• Sell the devices to various geographies. Business Model 1 (above) is the easiest one.  This is because several patients have shown interest to acquire such a device if and when it becomes available.

So far the device has not been launched commercially. Hence, financial sustainability has not been tested. 

However, keep the cost as low as possible will make it easy to sustain it financially. Also, once the operations are scaled, the per piece cost will be even lower.

Since I am a student, I don't have any source of earning to fund my work. So far I have funded my work through my savings. 

For the upcoming work, like building the web app, mobile app, making the device compact, getting it certified, making 20 devices, launching it commercially, doing research on stiffness measurement, will need fund. Hence apart from guidance (specifically on regulatory requirements and business model), I am looking for funds that will support my work till it can be launched commercially.