A startup is a newly emerged, fast-growing business that aims to meet a marketplace need by developing a viable business model around innovation. Yet when the market is our medical demands, the road to getting your product there can seem long and dreadful.
That’s why this previous Wednesday at our third event of the season, the Student Executive Team (SET) President of the McGill Dobson Centre, Nicolas Briner, invited two McGill startups, Dialysave and MYOVUE, who were nurtured by the Centre, to share their experiences and insights as successful medical startups.
Anya Pogharian started Dialysave when she was just 16 years old. Anya developed a passion for dialysis and understanding their patients’ needs when she volunteered in a clinic and noticed that a lot of patients were unhappy with the treatment they were getting.
Dialysis is a solution to kidney failures which results in impaired ability to filter blood. Only about 3% of kidney failure patients get transplants, which are the most efficient long term solution, the rest of the 97% are mostly on some form of dialysis.
What is the accessibility problem with Dialysis machines?
Dialysis machines cost around $30k-$35k. They are very high cost machine with complimentarily costly infrastructure required to make the machine run. A single dialysis center uses over 100-200L of water a day, a very resource heavy treatment, and in part why it is so expensive. But an even greater problem, 90% of the people who need dialysis in the world do not have access to dialysis. Anya wanted to solve this. She wanted to create a dialysis machine that was tremendously less expensive and more financially and physically accessible—and with hours of work, a $30,000 machine became a $500 one.
Testing her Innovation
Anya was able to test her device at Héma-Québec with a blood pouch. Not only did it work, but the results were very successful. An insignificant damaging of the red blood cells proved her innovation worked and made the project seem very promising, and people were quick to catch on. Due to the success of the device and her unconventionally young age, media outlets really quickly took an interest and wrote about Anya’s story.
While Anya’s device was successful, everything was not on the road to success. The reality of it was that her innovation had no direction, and more importantly, no team! People were very quick to catch onto Anya’s innovation, too quick for her to even respond. In just the span of a night she woke up to over 80 articles about Dialysave and a denumerable amount of interview requests. Her success in her product quickly began to consume her time.
She kept getting swamped with everything between school and Dialysave. She had no way to create a business out of her successful invention.
How the McGill Dobson Centre Kickstarted Their Journey
She still had such a passion but just didn’t know what to do – her innovation seemed in vain. Anya figured she would stay in University and study nursing and just stick with that.
But last January her friend, and now co-founder Vivian decided to enter the McGill Dobson Cup with her.
The McGill Dobson Cup allowed for Anya and Vivian to organize their strategy. They were also able to meet their CTO (Shawana Habib) through McGill Dobson Match and get a solid foundation as a group before continuing the project. Vivian said that by creating a focused timeline while doing the McGill Dobson Cup really enabled them to get both their school work done and still continue to work on Dialysave. Having won 3rd place in the McGill Dobson Cup, the team felt validated that they had a good idea and business plan and decided they wanted to go on to participate in the McGill X-1 Accelerator.
Through the X-1, they were really encouraged to think about entrepreneurship and their business a lot and differently. It helped them realize the importance of building a team. And since earlier this year they have stretched their board of mentors to outside of just McGill – they’re now a member of the District 3 Innovation Centre at Concordia University. Over the course of the summer, they realized that their problem of making dialysis more accessible may have not been solved by their first machine, and they were ready to start moving forward from there.
Before the X-1, they wanted to make machine less expensive, but there are also dialysers and other recurring costs which in the long-run would still add up to make their solution expensive. Dialysave is now trying to make an affordable and wearable dialysis machine that makes dialysis both more affordable and portable. Their solution is through the use of a nanobiomaterial with a high absorbent tolerance that they are working on in conjunction with Dr. Thomas Chang and his lab.
Typical ultrafiltration dialysis passes blood through small membranes and dialysis fluids takes up toxins in the blood and cleans it. Instead of two circuits for blood and dialysis fluid, Dialysave’s nano material will have a high surface area and absorbent material that will capture toxins instead of filtering them. This nano piece will then be able to be thrown out and replaced. This innovative shift in their design production was representative of their values as a social start up– their changes in their product better align with their vision of democratizing dialysis.
What to Expect:
Be ready to tackle on a few years of development, production, and testing. Don’t fixate too much on the regulatory process, it’s better to develop a product and improve it rather than focus on micro-regulations.
What to Take Away
Dialysave has developed a lot since Anya was doing it alone. No matter where you are if you have an idea or concept developed for something and you want to go to the market and make a business and there is a market to profit off it, you should just go out there and find people to help you create a clear direction of where you are going. And you’d also be surprised at the amount of support you would get and the people who will help you in the way.
If you have a vision and a plan that you really believe in, but seemingly nowhere to go, don’t let yourself give up. Along the way you’ll meet the right people. Anya had no way of imagining that she would meet the right people to help turn her innovation into an industry breakthrough, yet she is now the inventor and founder of a medical startup on the road to success.
Jesse Ehrlick – Regulatory Finance Manager at MYOVUE
When you go to get a checkup you probably don’t suspect that you will undergo an amputation; yet this is the reality of around 5,000 people a year because of the diagnosis inefficiency of Acute Compartment Syndrome.
Acute Compartment Syndrome (ACS) is typically a consequence of high-impact trauma, most commonly bone fractures. It results when the tissue pressure within a closed muscle compartment exceeds the pressure of fluid passage causing the muscles and nerves to not receive enough blood. The damage of untreated ACS is usually amputation or immobility of the body part in question.
ACS is a major limb threatening complication and it can develop unpredictably up to 48 hours after trauma, and the damage it induces becomes irreversible afterwards. However, because of the uncertainty in diagnosis, doctors end up either missing the symptoms or operating on too many people just to avoid possibility of both medical and legal risk.
The main problem in ACS however is not treating it, but rather confidently diagnosing it. MYOVUE is the solution to the lack of adequate diagnosis procedures available to trauma surgeons looking to test for ACS in people with fractures or people who have sustained traumatic injuries.
ACS mostly occurs in bone fractures from high trauma and heroin overdose. There are almost 2.5M Long Bone fractures every year, 500k of which are from high energy injuries, and 50k of which will develop ACS, leading to muscle damage when diagnosed late. While diagnosing early to perform surgery is highly effective, 5,000 diagnoses are still too late resulting in amputation or loss of function.
MYOVUE as a Solution
MYOVUE is a single use, highly accurate, continuous remote monitoring device. MYOVUE works with diffusion pressure: it applies a small amount of continuous pressure to muscles to provide real-time, accurate muscle pressure measurement which allows doctors to decide if patients need surgery.
In these cases, elevated pressure is critical and must be monitored. There is currently no efficient and easy way to do it. We are about to solve this problem.” – Chief founder, Dr. Ed. Harvey.
The information from the device gets uploaded to an app where it can be live streamed and monitored. This not only gives physicians a constant and reliable stream of information, but also cuts down on time and staff that would have previously performed more lengthy and less effective measures repeatedly.
How they started
MYOVUE started off from a $350k Canadian Institute of Health Research (CIHR) Grant to Chief Medical Officer Ed. Harvey, leader of the Injury Repair and Recovery Program at the McGill University Health Center Research Institute.
Through networking within the biotech field and orthopedic surgeon community, he was able to start a young team along with a recruitment of senior external advisors who were successful in the field of medical technology. Currently the team has medical and biological technology entrepreneurs as well as also a scientific team working in conjunction through the Harvey lab
Setting up a team and having advisors was critical to turn the innovation from a device to a product. With the research from their grant they were able to produce a functional prototype and in 2016 they were ready to start bench testing. After that they were able to start animal testing in 2017 and have since then become patent pending.
Next in Line
MYOVUE enrolled in the McGill X-1 Accelerator in 2016. During this time, they met with mentors in their field and developed a more nuanced understanding for how to address market related inquiries about their product.
They’re now trying to get the remaining $500k in their $2M goal in investment for research and testing. Before they can enter the market, they need more clinical and regulatory testing, as well as the approval of regulatory organizations such as Health Canada, the FDA, and the EU.
Clinical Validations have been performed in Canada to test usability of device and that it functions. The commercial testing and FDA Approval are to come and then after testing to prove the clinical and economic value of their device.
In terms of taking a new approach to medical technology as a startup, quality approval for risk management is incorporated into every part of their product design and production. In addition, MYOVUE uses specialized paperless software in their production, a high energy and cost saving technique most long standing medical companies haven’t been able to do.
The only other competitor is Stryker – a highly inaccurate device to use in ACS diagnosis. Stryker is a fluid filled syringe that is injected into the injury site to check the diffusion rate. However, it gives different pressure readings based on a long list of factors such as: speed of injection, angle, location, etc., it also is mostly used after doctors already think that patients have ACS.
MYOVUE is more efficient and effective at screening for ACS. While it is also more expensive continuous measurement is far more effective compared to doing multiple injections at different times like Stryker, and the financial cost of purchasing MYOVUE is lowering the opportunity cost of misdiagnosis leading to amputation.
What is the market outlook?
Stryker has essentially a monopoly on ACS but they only act as a confirmation tool; MYOVUE wants to act as a screening device to prevent late diagnosis. Its results have proven economically successful in the lab resulting in: 40% reduction in measurement error, 40% reduction in operating room time, and a 60% reduction in ACS Related Costs. As an early screening device, it will also save on long-term costs associated with lawsuits that occur in misdiagnosis of ACS.
Due to the success and necessity of MYOVUE, institutions are coming on for the support of this program. Yet they’re not quite ready to hit the market soon, the hardest part they said is getting investments before your product becomes market ready. Most Investors only want to buy in when the development stage is over, but by attending conferences and tech fairs, you open your product to investment.
MYOVUE to Other Medical Start Ups
MYOVUE is an innovation that was created in a field that was lacking a specific device for a specific demand. In order for to create a well-defined product you must identify a need that isn’t well serviced in the medical market.
Likewise through the process of a medical startup, it is important to have plans for how you will test, regulate, quality control, and then market your device. In addition, networking, researching, and inquiring key leaders’ opinions in one’s product will spread the success of your device.
Interested in the stories of other successful medical startups out of McGill? Take your pick: