Three unique challenges for medical device startups

During five years developing a device to help patients with neuromuscular disorders, such as multiple sclerosis and Parkinson’s disease, Dr. Zeb Kimmel overcame several challenges to getting a medical device startup off the ground.

Kimmel, MBA ’07, is the founder of Atlas5D, the maker of the Echo5D sensor, an “ambient measurement system.” Echo5D measures how a patient moves at home, then quantifies metrics related to the patient’s speed, strength, and dexterity over time. Echo5D emphasizes privacy and ease-of-use, and does not require worn devices.

Here are Kimmel’s three lessons for entrepreneurs launching a medical device.

Focus on a scalable market

Kimmel considered a variety of markets to place Echo5D, such as aging-in-place, or helping older adults to live safely in their own homes. He selected an early focus on the enterprise market.

“In health care, you need scale because of the regulatory requirements,” Kimmel said, “Serving enterprise customers helps to reach that scale earlier.”

Partner with an industry leader

“I think many startups follow the same process we did,” Kimmel said. “At the earliest stage, you are bouncing around like a molecule, working to meet with the decision-maker who’s struggling with a customer need that you solve.”

An adviser to Atlas5D realized that Cambridge biotech Biogen, a global manufacturer of multiple sclerosis treatments, offered a potential alliance. His introduction of Kimmel to senior executives blossomed into a partnership and the publication of joint research.

“The data from our development work could provide information about the patient’s walking in a real-world setting in the moment,” said Glenn Phillips, director of Health Economics and Outcomes Research at Biogen. “This could allow for the detection of changes in patients walking much more quickly than waiting for routine visits that generally only occur once every six to twelve months. This kind of early detection could provide the opportunity to intervene when a patient initially experiences a change and reduce the long-term impact of the disease.”

Settle in for the long haul 

The pace for startups in health care is different than in almost any other industry. Regulatory requirements impose a variety of needs, including: peer-reviewed research studies; specialized review by institutional review boards; and enhanced protection of data integrity and patient privacy.

The founding of new medical technology companies in the United States has dropped nearly 70 percent over the past 30 years. Dr. Isaac Kohane, chair of the Department for Biomedical Informatics at Harvard Medical School, cited the difficulty in demonstrating value in an ever-tougher environment.

“Real business and health value propositions have been harder to come by. Demonstrating the value is tricky and often requires broad product adoption, thereby creating a Catch-22-like loop,” Kohane said. 

Kimmel said startups in other industries often employ a “fail fast strategy” to see whether something gains traction, then pivot if it doesn’t.

“In health care, though, you don’t have the luxury of fast experimentation,” Kimmel said. “No one can fail fast in health care. You have to build the clinical evidence base before you can move forward, and the evidence you have to assemble is rigorous and takes a lot of time and care. So in health care you have to be mentally steeled for a journey of many years. You have to be motivated by a desire to help people and to make a positive impact, not by a desire for a quick win.”