Client Spotlight: Sydney Robinson and Oleksiy Zaika, co-founders of Vessl Prosthetics

An estimated 38 million people in the U.S. and 3.7 million people in Canada live with diabetes, a family of diseases where the body has trouble controlling the amount of sugar in the blood. While many people living with diabetes can manage the disease with diet or medication, thousands suffer serious diabetes-related medical conditions that can require leg amputations due to poor circulation and nerve damage in the lower extremities.

Diabetes is the cause of 80% of non-traumatic lower limb amputations in the U.S. and 70% in Canada. In the U.S. alone, more than 150,000 people in the U.S. with diabetes undergo an amputation each year. For many of these patients, post-operation recovery involves being fitted with a prosthetic limb. Unfortunately, many of the existing socket solutions cause irritation and pain for the patient due to the eventual misfit to a changing residual limb size.

Vessl Prosthetics co-founders Sydney Robinson and Oleksiy Zaika saw this problem first-hand after meeting at an entrepreneurship program. The co-founders recognized their backgrounds in biomedical engineering and clinical anatomy, which gave them the tools they needed to develop a solution that put the patient’s comfort and mobility front and centre.

Combining a passion for engineering and patient care

Robinson’s path to entrepreneurship started while studying mechanical engineering at Queen’s University. She jokes that car engines never interested her, so she decided to study the human body and biomechanics instead. It was during her undergraduate degree program that she was first exposed to prosthetics.

“I had the opportunity to design an ankle foot orthosis for a five-year-old girl as my capstone project. I decided I didn't want to be a prosthetist myself, but I was moved by medical device design. That inspired me to do my Master's in Biomedical Engineering at Western University,” Robinson says.

Entrepreneurship had always interested her, but she wasn’t sure where to start. After finishing her Master’s degree, Robinson had the opportunity to participate in the Western Medical Innovation Fellowship, a ten-and-a-half-month entrepreneurial program. The fellowship program brings engineers, doctors, and scientists together, and it was there that she met Vessl co-founder and CTO Oleksiy Zaika.

Zaika earned his Master’s in Clinical Anatomy and PhD in Anatomy and Cell Biology at Western University. Like Robinson, Zaika was always interested in entrepreneurship. It was the same interest that brought him to the Medical Innovation Fellowship.

“I had some ideas of my own on different businesses that I wanted to start and got connected to the Innovation Fellowship, where I met Sydney. We hit it off and found that we work really well together because our skills complement each other,” Zaika says.

During the fellowship program, Zaika and Robinson had the opportunity to find a problem they could build a business around solving.

“The easiest way to learn about entrepreneurship is to do it yourself. So we went out and scoured the medical space for different problems to solve—and there’s no shortage of problems in medicine. But what we discovered, and what really spoke to us, we discovered by going to a diabetes clinic,” Robinson says.

The co-founders visited and spoke with diabetes patients who had leg amputations. Robinson says they were all struggling with the same problem: their residual limb changing size inside their prosthetic socket. That misfit causes pain and discomfort for the patient, and Zaika and Robinson set out to create a solution using user-centred design principles.

Building a better prosthetic socket

Prosthetic devices can change patients’ lives but also have unique issues. In addition to fit, comfort, and mobility, Robinson says prosthetic wearers also face mental health challenges.

“It's really tough. Patients can feel shame, even though it’s not their fault. There are so many confounding factors in how these things happen. The mental health challenges around prosthetics are something that's not talked about still, although we’re getting better at it,” Robinson says.

Speaking with prosthetic users helped Zaika and Robinson develop a deep understanding and empathy for the daily challenges of wearing a prosthetic leg. Zaika says their outsider perspective gave them the freedom to ask many “why” questions that others assume have already been answered.

“This seems like a pretty straightforward problem every amputee experiences, so why has it not been solved? We started exploring the regulatory side of things, insurance workflows, how sockets are made and maintained, and the typical day for an amputee. Combining all these things together, we understood that whatever solution we would come up with had to be fairly mechanically simple and straightforward,” Zaika says.

From the start, Zaika and Robinson knew that actuators, batteries, and sensors would not work for their solution. The socket needed to work well and wouldn’t need to be charged every night.

“These patients need a solution they can put on and it will just work with their lifestyle,” he says.

The solution is Isoform, an adjustable volume management system that uses kinetic energy to constrict panels around the residual limb until a pressure limit. Throughout the day, the socket will always try to stay at that pressure limit, even if the limb shrinks. A manual dial provides amputees with the ability to override the pressure setting, and a release mechanism gives them the option to release pressure without having to take the socket off.

“When the patient first gets this system fitted, the socket is adjusted to set a pressure threshold. Throughout the day, their limb volume changes and the socket uses the kinetic energy to adjust its fit without the patient having to think about it,” he says.

While much of their research focused on diabetic amputee patients, the Isoform socket can be used by virtually any amputee. Robinson says the pain and discomfort from traditional sockets affect every patient differently.

“We learned that it was felt especially by patients who recently had an amputation and are adjusting to using a prosthetic. On average, people with an amputation have two or three other comorbidities, so there are many different reasons why their residual limb could be changing size. Little things affect limb volume so much, so this is a solution for everybody,” Robinson says.

From idea to market-ready with the Accelerator Centre

Robinson and Zaika incorporated Vessl in June 2022 and quickly applied to the Accelerator Centre’s AC:Studio program. Robinson says the program provided them with much of the foundational business knowledge they needed to go from co-founders with an idea to a viable startup.

“The Accelerator Centre was the first incubator studio venture program that we did. We got help developing our pricing strategy, and we worked with mentors on creating the mission, vision, and values for our company. We found that to be extremely valuable guidance,” she says.

Beyond building the basics, the company hired its first employee during the AC:Studio program. Hiring an employee is more than posting a job description, and Robinson and Zaika worked with HR mentor Andrea Houle to ensure they were set up for success.

“We didn't know what interview questions to ask or what the process should be. Andrea helped us on that front we had. We've gotten so much strategic help,” Robinson says.

In addition to Accelerator Centre mentors and staff, the AC:Studio program offers additional support services through a partnership with the Conestoga Entrepreneurship Collective (CEC)’s Gig Lab. The Gig Lab program participants spend 15 weeks developing a freelance business around their industry skills, including PR, social media, and design.

“The Gig Lab services helped us to develop our website and gain insight into developing our branding. Another surprise was the types of services offered. Typically they’re digital services, but there was a machinist who was instrumental in helping us figure out some of the more nuanced things about how to manufacture our product. That support through the Gig Lab team has been incredibly helpful,” says Zaika.

Creating a more comfortable future for amputees

Vessl is currently in the first phases of its clinical testing in the U.S. The Vessl team's user-centred design approach involves iterating the product based on patient feedback to bring the best final version of Isoform to market.

“We're going to be expanding that into the next phases, and bringing in the feedback that we received to make changes to the product. This is gearing up for a release of the product in the new year. We've done a lot of patient-driven, data-driven testing, and I'm just really excited to put all of these pieces together to get to the point where we can do a big release of the product,” Zaika says.

Vessl’s Isoform system is a class one medical device in the U.S. with lower testing requirements than other medical products. Robinson says this classification does not require as rigorous of testing as other classifications, but that the testing is important regardless.

“All of that testing is not actually needed because of the low regulatory requirements. But as a good business, Oleksiy and I want to make sure that we are protecting these patients and delivering on our values and vision,” Robinson says.

Visit vessl.ca to learn more about Vessl and the Isoform socket.