Maneuvering through a world of regulation: advice from a seasoned medtech innovator

Now more than ever, physician innovators are entering into a highly regulated and cost constrained environment. “This industry is not for the faint of heart,” says Rafael Andino, Vice President of Engineering and Manufacturing for Clearside Biomedical, Inc. Andino is part of a team of innovators that built a biopharmaceutical company from concept to clinical development. GCMI was initially part of the company’s early stage development activities. Andino offers the following guidance to aspiring medtech innovators.

From IP to product

Rafael Andino, Vice President of Engineering and Manufacturing for Clearside Biomedical, Inc
Rafael Andino, Vice President of Engineering and Manufacturing for Clearside Biomedical, Inc

Emory University investigators found that the suprachoroidal space in the eye can be accessed with a microneedle, and with the help of graduate students at Georgia Tech, they created an approach to access the suprachoroidal space (SCS) of the eye. Clearside licensed the intellectual property for the use of microneedles in the eye from Emory and GeorgiaTech.

Clearside Biomedical is a biopharmaceutical company that is developing a series of combination product candidates to treat blinding diseases of the eye. They primarily develop product candidates for this particular part of the eye called the suprachoroidal space. Their product portfolio is targeting blinding diseases like uveitis, retinal vein occlusion (RVO), diabetic macular edema (DME) and age related macular degeneration (AMD). Their first candidate, Zuprata™, is a steroid that is designed to treat macular edema associated with noninfectious uveitis, an inflammatory disease of the eye that if not treated, will produce poor vision leading to blindness. Clearside is currently enrolling patients in a phase 3 clinical trial of Zuprata. The second focus is on treating macular edema associated with RVO. Clearside completed its IPO in June 2016 (NASDAQ: CLSD). The company looks to expand their product line in the hopes of providing therapy to more debilitating diseases of the eye.

The product candidates produced by Clearside paired with their novel, proprietary microinjector have the potential to provide therapy to millions of people worldwide. Here’s how they are making it happen and what innovators can learn from their experience.

Leveraging connections to commercialize medtech innovations

“GCMI was instrumental in our early development including prototyping that led to a product candidate we could take into clinical trials,” he says. “We used their space, cleanrooms, equipment and personnel to help develop and validate our product candidate and its value.”

He illustrates that medtech innovation is not simply about wanting to create a piece of technology, rather it is a commitment that requires a great deal of early evaluation and research in order to complete the path from concept to commercialization.

Step one: Know your market

“Before you even start developing the specs, you have to really think. You shouldn’t be enamored by the technology alone,” he says.

“Talk to customers, physicians, hospital purchasers and ask them, ‘What’s your standard to treat disease x? What needs improvement? The current technology, price, or clinical outcomes?’After you talk to them, engage industry experts that understand CMS (Centers for Medicare and Medicaid Services) reimbursement requirements and ultimately the pathway you are going to need to follow. You must paint the landscape with these discussions.”

After you talk to them, engage industry experts that understand CMS (Centers for Medicare and Medicaid Services) reimbursement requirements and ultimately the pathway you are going to need to follow. You must paint the landscape with these discussions.”

Step two: Ask yourself, “Is my product really better than the gold standard?”

The next step is understanding the clinical value proposition of your product. “You must ask ‘Clinically, how would my solution be better than the standard of care?’ That is easier said than done,” Andino stresses. “It is critical to solve the unmet problem in light of other products existing in the market. You must effectively answer the question, ‘What differentiating benefit am I bringing to patients and physicians with this new technology?’”

Step three: Develop a strong economic rationale

The last step in evaluating creation of a new medical product or device is evaluating the financial value proposition of your product, Andino advises. “What financial value will your innovation bring? How is this product going to save the healthcare industry money while improving outcomes? If it’s not saving money, you’re going to have a hard time marketing the product. There are solutions for diseases out there. Yours must be both financially and clinically more attractive.”With GCMI’s supporting resources and relationships, Clearside Bio is navigating the complex medtech regulatory development path.

With GCMI’s supporting resources and relationships, Clearside Bio is navigating the complex medtech regulatory development path.

Are you a physician, engineer or startup with an idea for a new piece of medical technology? Contact GCMI today to connect with experts across the medical device ecosystem who can provide the guidance you need to advance your product’s journey from concept through commercialization. Or simply email info@devices.net.