Growth Manufacturers Case Study
Interscope Takes Medical Device Innovation from Concept to Launch
By Kathie Mahoney, Marketing and Administration Director, MassMEP
"The successful commercial launch of the EndoRotor® System is a testament to the strength of collaboration between both public and private resources providing the optimal solutions for high value projects, such as the Interscope project. We could not have gotten to commercialization as quickly as we did without MassMEP." – Jeff Ryan, President, Interscope
Five years ago, Interscope would never have imagined having a globally approved product that’s ready for market. Five years ago, they had an idea on a piece of paper. Today, they have product with a CE Mark (received October 2015), ISO 143845 certification, 7 patents, $7 million raised in funding, 4 employees, and a pending FDA clearance.
Interscope developed a technique for accessing and removing polyps through an endoscope instrument channel without changing and re-inserting the endoscope or multiple interventional instruments. The Interscope EndoRotor® is a novel method of removing diseased GI tract mucosa. It improves the procedure’s precision by reducing incomplete resection and saves time by reducing the demands of the current technique.
During Interscope’s nascent stages, Jeff Ryan, President, walked through the doors of MassMEP and announced, "I have some drawings and an idea. I don’t know where to go or what to do to have the product manufactured."
Unlike many early start-up companies, Jeff was not looking for funding assistance, but was looking for the means to develop proof of concept components built to his specifications. So began a partnership between Jeff and MassMEP to commercialize his idea.
"Opportunities for partnership and mentoring can be difficult to obtain," said Ryan. "Now, having created a globally commercialized, innovative product, I recognize the impact these relationships can have on development."
Matchmaking: From Concept to Commercialization
MassMEP Project Manager, Greg King, worked with Ryan to develop partnerships and bring his idea from a concept to prototype. To start the process, Greg found suppliers in the areas that Jeff needed. The first match was with an existing MassMEP client with expertise in manufacturability, Algonquin Industries, Bellingham, MA. After a few subtle changes to the drawings to accommodate manufacturing, prototype parts were created that enabled Interscope to test and validate the viability of their original concept.
With nascent proof of concept, Interscope then needed to find someone in the medical device industry to manufacturer the product that would meet the strict requirements of the medical device industry. Greg connected Jeff with Boston Engineering, also a MassMEP client and a designated Innovation Center by MassDevelopment. The partnership with Boston Engineering allowed Interscope to expedite their R&D efforts through the matchmaking relationship. Once the development project was underway, it became clear that additional resources would be necessary to navigate the regulatory environment. Vention Medical was enlisted as a contract manufacturer, as well as Icon, plc (formerly Aptiv Solutions, Marlboro, MA) for supporting regulatory needs.
The collaboration benefited Boston Engineering in the form of critical experience in medical device engineering and manufacturing. This reinforced their internal quality system and led to their earning of an ISO 13485 certification. The collaboration continues and is expected to grow and expand.
These collaborations resulted in Interscope achieving a CE Mark and a pending 510K. (CE Mark designation enables product sales within the European Union. The 510K designation is U.S. premarket approval for the medical device industry.)
Further to the matchmaking process, Boston Healthcare provided market research including unbiased physician input in on the future viability of the product. The research showed that the majority of physicians agreed with the value proposition and provided insight into where Interscope would fit in the marketplace.
All of these matchmaking referrals by MassMEP were an integral part of the growth of Interscope at critical junctions. The partnerships also allowed Interscope to garner seed capital as the partnerships provided them with deliverables to seek new investors.
Milestones
Key milestones were set and met along the way:
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Proof of Concept – Boston Engineering proved the concept from where it is now. They took Interscope’s nascent proof of concept and developed a viable medical device, ready proof of concept. This enabled another round of funding. The proof of concept allowed Jeff to make Interscope his primary career focus, including the hiring of additional employees.
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Design for Manufacturing – Conversion of a proof of concept into a manufacturing product.
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Manufacturing Design – Interscope is verified and validated under ISO 13485.
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Expansion of Markets – Through the MassMEP Business-2-Business network and its partnership with RTI and the EEN (Enterprise European Market), Greg was able to connect Interscope with a distributor in the United Kingdom and France. Interscope pursued direct employees in Germany, driving a 20% increase in gross margin therein.
Impacts
Interscope is an example of how American ingenuity and entrepreneurship can grow manufacturing in the United States.
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