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Allyson Hein Interviewed on Medical Device Manufacturing Trends

July 3, 2019 | Durham, NC
Medical device industry lead Allyson Hein was interviewed by Geoff Giordano SME’s Manufacturing Engineering magazine on emerging medical device manufacturing trends. An excerpt of the interview is included below. 

Growth areas for manufacturers include at-home patient diagnosis and customized patient care, fueled by 3D printed custom implants and surgical guides; digitally connected monitoring devices; and more sophisticated gene analytics. Developments in these areas are creating new opportunities and partnerships.

“We’re seeing a lot of integration between the medical device and the pharmaceutical industries,” noted Allyson Hein, medical device industry lead for Clarkston Consulting, Durham, N.C. The firm is fielding more requests for “combination” products and seeing pharma companies adding medical devices to their portfolios.

Given the disparate regulations governing pharmaceutical or biotech products and medical devices, refining quality management systems for manufacturers becomes crucial.

Clarkston reviews “every corner” of its customers’ QM systems to determine if they have the appropriate measures in place “that an inspector for a medical device regulation is going to look at that may not have been as much of a priority for someone coming out of the pharmaceutical industry,” Hein explained. “How you design a medical device is different than how you are going to market a new pharmaceutical or biotechnology product.”

These evolving combination devices will require manufacturers to expand their control systems to address regulations specific to the ISO or CFR standards or FDA Corrective and Preventive Actions board review. Harnessing enterprise resource planning (ERP) software is essential, for instance, to measure and monitor your supply chain, from acquisition of raw materials to storage, testing and eventually shipping. Makers of combination devices also must reconcile which regulations take the lead and where required unique device identifiers or serialization numbers will be marked.

In short, accounting for every step of the medical manufacturing process, from vendor to end user, not only ensures patient safety but also protects manufacturers by codifying the integrity of their processes. This even applies to mobile apps or other software that might originate as entertainment but evolve into something patients and even doctors might rely on to make decisions. In such cases, “you’re becoming a de facto medical device. Just because it’s digital doesn’t mean it’s not a medical device,” Hein cautioned.

Consumer-based health care will drive far more personalized devices, she concluded. “As consumers, we have a greater demand for something that’s specific for us,” she said. “People are asking, ‘Why do I have to go to the doctor’s office when there can be telemedicine, or I can have a device in my home that can communicate data and results to my physician?’”

Read the full article here