Sep. 2019 - Jul. 2020, MedInnovate Graduate Programm, Visual Testing Device and Software
designed by Yiran Ren, Magomed Abdulaev, Anna Zapaishchykova, Leonardo Sepúlveda
MedInnovation Clinical Project
As the main designer, leading with Bio Design principles, I conducted numerous interviews and observed over 20 clinical procedures. Throughout the comprehensive bio design process, we developed a VR solution for patients with Multiple Sclerosis. This solution aims to improve their hospital experience and provide more accurate treatment options.
Observations
The team visited the neuroradiology department at Klinikum rechts der Isar, led by Prof. Dr. Claus Zimmer. Over a period of nearly two weeks, we conducted detailed observations to identify the needs of the neuroradiology department. During this time, the team actively engaged in diagnostic processes, participated in procedures, and interacted with patients. We identified numerous challenges and issues. For each identified problem, we outlined several corresponding needs that required solutions.
The team began by meticulously documenting all observations, noting each with the date, name, and a detailed description. In the initial phase, we collected 170 observations and identified corresponding needs.
Part of the observation documents
Part of the observation documents
User journey in the clinic from the observation and research
User journey in the clinic from the observation and research
First, the team formulated the needs statements consistently with three components: solutions, helps, targets, and clinical problems. We then eliminated duplicates and applied two filters: the magnitude of the problem and its feasibility. Through group voting, we narrowed the list down to 30 high-priority and 40 medium-priority needs. In the next step, the team voted on these 70 needs using two additional filters—market size and interest. After thorough discussion and group voting, we identified the six most critical needs. For easier reference, each need was assigned a name: Blind Needle, Chair Problem, Freshman, 90s Calendar, UX, and Bullet Coins.
How we filtered the 170 needs down to 6 needs
Part of the filtering process: how we filter and narrow down the problems and needs
Needs
Here are six refined needs statements:
1. Blind Needle: A way for doctors to avoid complications during epidural injections by addressing weak guidance.
2. 90s Calendar: A way to enhance the workflow for technical assistants by addressing complex scheduling issues.
3. Chair Problem: A way to alleviate symptoms of long workdays for doctors in a quiet work environment.
4. Bullet Coins: A way for technical assistants to check for dangerous objects before an MRI scan, addressing potential safety risks.
5. Freshman: A way to expedite diagnosis in complex cases for doctors, addressing the challenges posed by inexperience.
6. UX: A way to enhance the patient experience during radiology scans, aimed at reducing stress in highly tense situations.
Subsequently, to refine the list from six needs to a single, primary need, the team conducted extensive secondary research, held seven interviews in the neuroradiology department, sent 15 emails to experts and doctors, and convened seven additional group meetings.
Interview questions
6 Needs
Secondary needs filtering
The team evaluated each need against six criteria: potential solutions, cost, competitor analysis, market size, affected population, and concept ideas. Initially, multiple solutions such as research papers and products were identified for all needs. However, specific insights emerged:
Chair Problem and Bullet Coin had numerous competitors (15-20 and 20+, respectively).
90s Calendar faced three direct and 15 indirect competitors.
Bullet Coin incidents affecting MRI machines were rare, occurring 2-3 times a year with minimal damage or casualties.
Blind Needle already had effective existing solutions, making it challenging to develop a superior alternative.
UX involved complexities in collaboration with large corporations developing MRI or CT machines, which did not align with the team’s objectives.
Consequently, the focus shifted to the Freshman need, aimed at reducing diagnosis times in complex cases due to inexperience. This need had several supporting research papers and FDA approvals (limited to Mammography), with 3-5 competitors indicating a viable market entry. With 40 million MRI scans annually in the U.S., the impact potential was significant. Possible concepts included diagnostic recommendation tools and interactive learning aids. Further research led to the identification of two more specific needs to refine the concept.
Me writing down the criteria for filtering secondary needs
Secondary needs filtering
Needs statements
Need 1
The first need is A way to identify brain tumors in early stages for doctors to address the problem of late diagnosis.
There are different possible noticeable symptoms for brain tumors: severe, recurring headaches, vision loss or seeing double, difficulty remembering, seizures, nausea, and vomiting, difficulty hearing or speaking, trouble swallowing or controlling facial muscles, and prolonged, unexplained fatigue.
Patient journey Brain and spinal cord tumors are usually found because of signs or symptoms a person is having. If a tumor is suspected, tests will be needed to confirm the diagnosis. There are four diagnose for brain and spinal cord tumors today. Medical history and physical exam which are eye, hearing and reflex test, sense of touch and smell test, mental status and memory checking; Imaging test such as MRI, CT, PET; Biopsy and lumbar puncture; Blood and urine tests; genetic testing; laboratory tests; pathology reports; Biomarkers. Enable to see the exact problem of the process of the diagnosis, and the team evaluated all diagnosis for a brain tumor.
Patient journey for the case of brain tumor diagnosis and its problems
Concept
The first concept addresses brain tumor diagnosis by using inhaled contrast media to enhance early-stage detection. Traditional contrast agents, used in MRIs and X-rays, increase radiodensity or alter relaxation times to improve imaging contrast. However, these agents, typically injected intravenously, can cause discomfort and allergic reactions. Our alternative proposes the use of non-invasive inhaled gases, already utilized in brain CTs, which can increase O2 levels to improve vein contrast. Given that cancer cells metabolize differently from healthy cells—consuming more glucose and oxygen—this method could leverage gas inhalation to measure and compare O2 levels before and after inhalation, offering a simple and fast diagnostic approach.
Needs-Solution Fit
This non-invasive technique not only supports early detection but could also precede MRI scans, reducing procedural time for both patients and doctors. It provides quantifiable and reliable results, potentially lowering the risk of misdiagnosis associated with traditional imaging.
Concept 1
Concept 2
Market Potential
The incidence of brain tumors is significant, with estimates suggesting up to 320,000 new cases globally each year. Considering the high cost of existing biomarker solutions in the U.S. ($1,000-$3,000), our approach could tap into a market worth between $320 million to $960 million annually. This substantial market size underpins the feasibility of developing these concepts into viable business cases.
Competition and Collaboration
While several entities are exploring similar avenues, none have exactly replicated our proposed methods. Organizations like The Brain Tumor Charity and Our Brain Bank document disease progression, aiding in better patient assessment. Companies like Bio-Rad and Bodhimaya focus on biomarker tests for tumor identification, indicating potential for collaboration or differentiation in our approach.
Market potential
Competitors
Need 2
The second need focuses on standardizing the pre-assessment for MRI scans to address iatrogenesis in Multiple Sclerosis (MS).
MS is a chronic condition where inflammation in the central nervous system disrupts nerve fiber connections, causing signal transmission delays throughout the body.
Symptoms of MS are highly variable but commonly include fatigue, difficulty walking, blurred vision, bladder control issues, numbness, muscle stiffness, balance and coordination problems, and cognitive challenges. Symptoms may fluctuate or progressively worsen depending on the MS type.
Given the complexity and variability of MS, there is no single diagnostic test, making standardized pre-assessment protocols crucial for accurate MRI evaluations.
Possible noticeable symptoms for multiple sclerosis
Patient Journey for MS Diagnosis
Patients with suspected Multiple Sclerosis (MS) initially undergo a series of physical tests and provide relevant medical history at the clinic. Based on these preliminary assessments, doctors decide whether an MRI is necessary for further investigation.
Diagnosing MS is challenging as there are no specific tests for the condition. Diagnosis typically involves a differential process to exclude other diseases with similar symptoms. This can lead to subjective decisions and potential misdiagnoses, particularly with inexperienced physicians.
Current diagnostic tools include blood tests (to rule out other conditions), spinal taps (to detect markers like elevated IgG antibodies, oligoclonal bands, and high white blood cells, though 5-10% of cases show no abnormalities in cerebrospinal fluid), evoked potential tests (measuring brain activity in response to stimuli, while ensuring no other ocular issues are present), and MRI scans.
Given these complexities, the team is considering shifting towards more quantitative, objective testing methods to reduce the reliance on subjective judgment in diagnosing MS.
Patient journey for MS patient in clinic
Change the current solution to the quantitive objective tests
Concepts
We have developed two concepts to address this need.
The first concept is called "All-in-One Set." Typically, doctors conduct various functional tests on MS patients, such as walking and eye tests, but these lack a uniform evaluation scale and do not provide comparative data across different tests. To improve this, we propose the "All-in-One Set," which integrates all essential functional tests into a single, comprehensive evaluation tool. This tool is based on the Multiple Sclerosis Functional Composite (MSFC), a combined measure of three separate assessments for leg, hand, and cognitive functions—specifically confirmed disability progression (CDP), walking speed (T25-FW), and hand function (9-HPT). The MSFC, introduced in the late 1990s, offers a standardized way to measure the functional abilities of patients.
The second concept is a "Computer-Aided System" that assists doctors in distinguishing MS-related changes from artifacts in MRI scans. MS lesions can be unpredictable, appearing and disappearing in different brain areas, which complicates diagnosis. This system would help doctors more accurately identify MS by distinguishing these lesions from other artifacts in MRI images, enhancing diagnostic accuracy.
Concept 1
Concept 2
Need-solution fit
With the two concepts, the team wanted to make the MS diagnosis more standardized, faster, and reliable. Because the misdiagnosis rate in the early stage of MS is high, so it will cause many patients to miss the treatment on time and cause damage to the immune system.
Market
The team estimated the market potential of 2.5 Million people suffering from MS worldwide, and 75.847 dollars average cost of MS treatment per year. 18% of MS patient is misdiagnosed, so it is a vast number of the mistreatment targeting group. Because of the mistreatment, the insurance companies have to pay for unnecessary treatment 23 million dollars. Moreover, the team found four competitors for this need. The advantis, ClinSpec Dx, Smart reporting, and inform AI. They are all working on the smart reporting system of brain imaging to help distinguish MS or brain disease.
Market potential
Competitors
Concepts
We narrowed our focus to two concepts: a breathalyzer for measuring brain tumor or cancer markers, and a medical device equipped with a projector for visual testing in MS diagnosis. However, due to insufficient research, evidence, and experimental support for the brain tumor breathalyzer concept, we decided to proceed with the medical device for MS diagnosis.
Sketch concept of MS visual test device
Sketch concept of the brain tumor measuring breathalyzer
First design concept
Multiple sclerosis and disease monitoring
Multiple sclerosis (MS) is a chronic condition that inflames the central nervous system, disrupting nerve fibers and slowing signal transmission. Symptoms include cognitive dysfunction, vision loss, muscle weakness, and disorientation.
Treatment focuses on improving life quality since MS is incurable. Patients undergo regular check-ups every 6-12 months, involving functional tests, MRI scans, and consultations with specialists like ophthalmologists or psychiatrists. Despite rigorous monitoring, there is an 18% misdiagnosis and mistreatment rate, leading to significant insurance costs — €700 million in Germany and $7.7 billion in the US—and severe side effects including depression, heart problems, and kidney failure.
Challenges include the lack of objectivity in functional tests and the high cost of frequent MRI scans. To address these issues, our team is prioritizing enhancements in specialist consultations and patient self-management strategies.
Optic neuritis
During our research and interviews with experts, we learned that 40% of MS Patients have optic neuritis. Multiple sclerosis can cause inflammation and damage to the myelin sheath in the optic nerve, which results in blurred vision. This pathology is medicated with high-dose medication, and patients have to do regular vision tests in order to classify the current status of the inflammation. There is a statistic that shows that patients prefer visual tests over functional tests, and over 90% of patients with MS have delayed patterns.
Patient journey
The neurology department typically lacks the equipment for vision tests, necessitating referrals to an ophthalmologist. This process involves three separate appointments: an initial neurologist visit, vision testing with an ophthalmologist, and a follow-up with the neurologist to discuss results before proceeding to further EDSS tests or MRI scans. Scheduling these appointments can be time-consuming, with new patients waiting 30-40 days to see a neurologist, leading to delays, decreased patient compliance, and capacity issues.
Additionally, the cost of a Humphrey visual field analyzer, essential for these tests, ranges from €6,000 to €20,000—a prohibitive expense for neurologists. To streamline this process and reduce costs, our team proposes introducing an affordable, efficient vision testing device that quickly and accurately monitors changes in patients’ vision.
First design Product
There are some comparable companies in the market, such as Viewmind, Mirco medical devices, Essilor, oculus, and Zeiss. Viewmind is working on measuring biocognitive and functional performance through eye-tracking, but they do not available products. Micromedical devices is providing portable devices, but their scientific validation is not clear.
Essilor, oculus, Zeiss are the big players for the Humphrey visual field analyzer, the price range is 3000 – 6000 euros, they have sophisticated features and functionalities.
According to the research and analyzing the current solutions are not designed for the neurologist. So the team located the need statement as an easy way to use visual field test devices for the neurologist.
First design concept statement
How did we get there
Physical products
Market
There are two business models.
The model A is a subscription. This model combines the device and monthly subscription. The device costs 499 dollars, and the monthly subscription is 40 dollars. The team deduces the subscription price through a calculating process. According to the research and interview with doctors, the cost of the visual field test is 15 dollars, and at the same time, the new model charges the fee per patient for 5 dollars. Additionally, the MS patient needs to visit the doctors six times per year, and the amount of MS patients in the US is 1 million; in the EU, it is 700 thousand. So the total addressable market (TAM) in the US will be 30 million dollars, in the EU 21 million dollars.
VizCare only sells the device to neurologists with model B. The price of the device is 1.500 dollars. There are 18.000 neurologists in the US and 25.000 in the EU. So the team addressed the TAM as 27 million dollars in the US and 37 million in the EU.
Feedback and research
After that, the team got some feedback about the medical market, that the device as the selling point is not beneficial, and the cost is also high compared to the current solution. So the team went further research and did more interviews with different specialists for getting new ideas and feedback. So in summary of the process until 10th, February, the team spent 36 hours of clinical immersion, read more than 79 research papers, got support from 10 mentors with expertise in entrepreneurship, more than 15 interviews with medical experts and one interview with MS patient, and 100 more hours of group meetings, in order to deliver the need to the final concept and turned to be the products.
Competitors
Business model
Final concept
In order to solve the current shortcomings, VizCare has been created. With the new solution, VizCare uses Virtual Reality in combination with Visual Tests to track the progression of patient health and MS disease.
Features
VizCare has two core features.
VizCare focuses on vision tests because right now, they are already used in diagnosing MS in the clinic, but much time is wasted, sending the patient to different specialists. Additionally, VizCare uses VR. VR is the use of computer technology to create a simulated environment and places the user inside this world. Users are immersed and able to interact with 3D worlds with a VR device.
Right now, for a visual test, doctors use specific rooms with no light and with expensive devices in order to have comparable test conditions. VizCare uses VR because, with this, the patient can easily control and maintain the environment for the visual tests. Furthermore, they do not need a particular room for this, the patient can just put on the glasses, and they are good to go. Additionally, it is easy to implement new tests later on. Such as the test for neuromyelitis optica IIH (idiopathic and hypertension), Glaucoma, Macula, Diabetic retinopathy, and Cataract.
Visual Tests and intelligent report generating system
In Vizcare, we provide five different visual tests for low contrast, visual acuity, color vision, visual field, and depth perception.
Low-contrast letter acuity chart (low-contrast Sloan letter chart, Precision Vision, LaSalle, IL). These charts have a standardized format based on Early Treatment Diabetic RetinopathyStudy visual acuity charts, the standard used in ophthalmology clinical trials. They have several advantages over standard Snellen charts or near vision testing cards as traditionally used in MS trials:
The color vision test (Ishihara test) is a color perception test for red-green color deficiencies, the first in a class of successful color vision tests called pseudo-isochromatic plates („PIP”).
The visual field is the entire area (field of vision) that can be seen when the eyes are focused on a single point. In addition to what can be seen straight ahead, the visual field includes what can be seen above, below, and to either side of the point the eyes are focused on. Vision is typically the sharpest in the middle of the visual field.
Depth perception(Stereopsis) is a term that is most often used to refer to the perception of depth and 3-dimensional structure obtained based on visual information deriving from two eyes by individuals with usually developed binocular vision.
Additionally, VizCare comes with an Intelligent report generating System, that on its own can create test reports and will send it the neurologist if the patient chooses to.
Visual example of low contrast, visual acuity, color vision, visual field, and depth perception
Design and Demonstration
In the demonstration of VizCare product, there is a dark 3D model as the background. The dark background can highlight the tests graphics, and it can reduce the influence of the background for the tests, make the tests’ result have accurate data. Furthermore, the 3D model is a forest scene, which can bring the patients more joyful testing experience. Moreover, the tests primary graphic colors are white, yellow, and grey or dark, except the color vision tests pictures. This color combination has high contrast, and it is more visible and friendly for eye testing.
However, until now the team did not go further with the design for the testing screen, so the current design elements need to be more researched and proved, the team will work on the design later on.
In the demonstration, after choosing the test, a short introduction will tell patients how to do it.
In the low contrast test, the patients should choose the direction of the E-opening. During the low contrast test, the symbol is getting smaller together with the low contrast. It is harder to see E-opening. It is the same in the visual acuity test, but the latter changing is without getting low contrast.
In the color vision test, the patients see the pattern with dots which form a number or shape, and then they have to choose the number or shape which they saw.
The visual field mapping test is a vertical meridian map. There is a arrange central fixation point in the middle which the patients need to keep looking at. Then the several white light spots will randomly appear, and when the patient sees the white light, they need to press the controller.
The stereopsis(depth perception) test will show two cubes at different distances at the same time, and repeat it with a different place. The patients have to choose nearer cubes.
After completing every single test, the result is displayed and can automatically be sent to the doctor. These tests can be performed at any time. Using VizCare is comfortable for users as without any need to go to the doctor, neither writing down any of the information.
Eye tests VR program
Different screens and tests design for the VR demonstration
Different screens and tests design for the VR demonstration
3D model for the VR visual test background. The form is based on the nigh in the forest
The demonstration screens of the low contrast test
The demonstration screens of the low contrast test
The demonstration screens of the low contrast test
VR solution
Vizcare uses Oculus VR glasses and incorporating visual test into Oculus. Patients can directly use VR glasses and do vision tests without the need to do anything extra. Moreover, the test environment condition is very stable.
By using VizCare, the patient can always get the correct medication for his current health state. It helps reduce the chance of having adverse effects by continually keeping track of the patient’s health. Besides the amount of time waiting for appointments can be reduced, and VizCare also helps with the psychological effects of MS Patients.
Furthermore, at the same time, the treating doctor gets more accurate data on the disease progression automatically by using VizCare’s intelligent report Generation; the doctor does not need to create reports anymore. So it brings more capacity for other patients comparing the current situation.
Benefits
First, because VizCare provides data for the neurologist at a higher frequency, this will help with the time to diagnosis and the available data on the patient’s health. It will be easier to track changes in the disease progression, to adjust the medication and to prevent misdiagnosis and mistreatment. It results in more capacity because of fewer appointments and providing the best therapy for the patient. With the prevention of potential mistreatment, VizCare also saves millions of Euros/Dollars for insurance companies.
Second, with VizCare, the neurologist and the patients can quickly do visual tests on their own without the need for an ophthalmologist. The results are cost and time-saving in doctor visits and tests. Also, with the use of VR instead of notebooks and paper, the tracking system is more pleasant, more accessible and always available. This results in a better psychological and physical state because of reduced stress and adverse effects.
MS Patients with visual problems have a better quality of life with VizCare. They can at any given time put on the glasses, start the software and perform visual tests to get the current status of their visual capabilities. Simultaneously, they can always send their tracking report to their neurologist to make sure they receive the correct treatment. Moreover, by having VizCare prescribed to them, they are not paying anything. Without the constant stress of not knowing how much their disease has progressed, of waiting a long time to get a doctor’s appointment or of suffering from adverse effects because of incorrect medication, they can solely focus on the fascinating aspects of their life.
Business model
With the latest approval of the digital care act, doctors can now prescribe health apps starting 2020. The team is going to use this new regulation for the business model to ensure that everyone benefits at the end.
Subscription
It is effortless. First, the doctor will prescribe our solution. The patient will buy it but will get the costs reimbursed by the insurance company. The cost of the product is 40€ per patient per month, and that includes the access to the visual tests, the usage of our report generation system, the communication system for the doctor and the rent costs of the VR Device. The team estimated this price according to estimated costs for the operation in the first five years (including the pilots and clinical trials).
Market size
As for the market, in Germany alone, there are already 240 thousand patients suffering from MS. The rest of the EU, combined with the US, has 1,7 million MS patients. By only looking at the 40% that have visual problems, a total addressable market of 46 million euros in Germany is estimated. The rest of the EU, combined with the US, are totalling to 320 million euros.
Business plan
Calculation of insurance costs
Competitors
VizCare is providing a combination of benefits that do not exist right now (until 2021). Looking at the competitors and alternative solutions, Comparing to the current competitiors and alternative solutionsonly, VizCare provides a simple and accessible solution to tracks the patient health and disease progression in a controlled and comparable environment.
Reliability is the most crucial part of healthcare devices. Currently, more than 200 Health apps are published every day, but according to a study of Nature, only one of these seems to be reliable.
Evaluation
Under the new law, reimbursement coverage will be granted for digital health solutions that are medical devices of a low-risk class (Class I or IIa) with the main functionality based on digital technologies (apps or mainly software-based solutions). The solution’s purpose of usage has to be the diagnosis, monitoring or treatment of diseases or improvement of related healthcare provision. Now the insurance must refund the costs of digital health products. So the doctors are going to prescribe VizCare, the patients are going to pay for the product, and then the insurance must refund those costs.
In the medical device regulation (MDR), Annex VII-classification rules, rule 11, „Software intended to provide information which is used to make decisions with diagnosis or therapeutic purposes is classified as class IIa [...].” According to MDR, VizCare will be a class IIa medical device.
For a software update, it is heavily dependent on Notified Body. When there is a minor bug to fix, then it is no need for resubmission. However, functional enhancements or design changes need to have resubmission.
Logo Design
The logo concept is the combination of the abstract form of VR glasses and the beginning letter of VizCare – „V”. in order to present that our product is for medical caring, the medical cross is in the middle of the logo. Moreover, the color definition is also according to the medical color, which is white and blue.
Concept presentation video
Flyer design
Flyer design
Flyer design
Website design on different devices
