INCUBATORS: Eight experts discuss the myriad factors affecting the outsourced medtech research and development industry.

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Author: Sam Brusco
Date: Jan-Feb 2021
From: Medical Product Outsourcing(Vol. 19, Issue 1)
Publisher: Rodman Publishing
Document Type: Article
Length: 3,943 words
Lexile Measure: 1340L

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Research & development (R&D) activities don't offer an immediate return on investment, so there can often be uncertainty about how much funding to invest in R&D, and where exactly to invest it. Many stress the importance of the earliest design stages, so perhaps more funding should be allocated there. But a product can't hit the market without validation and testing, so perhaps those phases should receive more funding.

Thanks to demand for quicker turnaround on new devices, there is a time crunch for medical device R&D activities. Move too slowly, and the product risks obsolescence. Move too quickly, and it may not achieve U.S. Food and Drug Administration approval. Or worse, it may contain a design flaw that risks a recall or endangers patients.

For that reason, OEMs turn to firms that provide R&D services when they lack the internal resources to develop a product or using their resources would be cost prohibitive. These companies provide the expertise necessary when the OEM doesn't have the bandwidth or monetary resources, and they can be quite valuable because of their specialized knowledge and dedicated teams.

To get more insight on the trends and challenges impacting R&D services for medical device manufacturers, MPO spoke to eight industry experts over the past few weeks:

Alex Beaumont, VP of Beaumont Technologies, an Erie, Pa.-based full-service partner for companies involved in development and/or manufacture of plastic injection molded products.

Justin Bushko, principal at Concise Engineering, a Clearwater, Fla.-based provider of full product lifecycle development from eliciting requirements through to design transfer, manufacturing, service, and process improvement.

Dan Kline, CEO of Novo Engineering, a San Diego, Calif.-based provider of product development engineering services from concept through pilot manufacturing.

Jim Kelley, VP of research & development, Cardio & Vascular at Integer Holdings Corp., a Plano, Texas-based medical device outsource manufacturer.

Jim Medsker, president of Keystone Solutions, a Kalamazoo, Mich.-based product development and medical device contract manufacturing company.

David Schechter, president of Meddux Development Corp., a Boulder, Colo.-based partner for the design, development, and manufacture of complex medical devices.

Mark Turner, president and managing director of Medical Engineering Technologies Ltd., a Dover, U.K.-based provider of medical and combination device batch release and design validation testing.

Raghu Vadlamudi, chief research and technology director at Donatelle, a New Brighton, Minn.-based firm providing medical device design, development, and contract manufacturing services.

Sam Brusco: What are the biggest drivers of outsourcing medtech R&D?

Alex Beaumont: Medical OEMs may have a clear vision of the component(s) they need to make their potentially life-saving devices a reality, but may lack the specific knowledge regarding optimal design/DFM for an injection molded plastic part. They recognize finding a company with significant expertise in that area is critical to success while avoiding wasting time and money on acquiring skills and assets that may not be value-added to their overall organizational goals. These outsourcing partnerships make sense when both parties involved recognize each other's areas of expertise and can trust each other appropriately.

Justin Bushko: At many firms, we...

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Gale Document Number: GALE|A652003859