Moving a product from idea to industry can be an intimidating process. The Small Business Development Center (SBDC) @ UCI Applied Innovation recently held their “From Concept to Commercialization” event at the Cove @ UCI to help companies better determine a course of action.
Photo: Marissa Koo
In partnership with the Orange County Regulatory Affairs Discussion Group, a non-profit organization that provides regulatory services, this event delved into the knowledge necessary to move a product from idea to industry. Prominent members of the medical technology industry shared experiences and discussed various topics, including regulatory considerations, FDA device classifications, pathways to revenue and reimbursement strategies.
One presenter, John W. Sheets Jr., former director of FDA’s Office of Device Evaluation, Center for Devices and Radiological Health, highlighted the importance of preliminary clinical studies and their impact on risk reduction. He also discussed the value of submitting quality data to the FDA, and how to design a product that will produce high returns on investment.
“Data is the product, and the product is the data,” said Sheets. “You have to have data to prove the value of your product.”
Photo: Marissa Koo
The presentations concluded with a personal anecdote by Paul Strasma, president and CEO, Capillary Biomedical on his journey through the commercialization process. As a former Cove tenant and current SBDC client, Strasma shared insight into the clinical, regulatory, funding, and reimbursement stages of developing a biomedical device.
“We incubated here at the Cove for about two years where we actually, in the lab, built all our prototypes that were used in animals,” said Strasma. “We’re now preparing for our first clinical trial in support of regulatory clearance and, hopefully, by end of next year, have a product to market.”
To learn more about the SBDC @ UCI Applied Innovation, click here.