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Poll: Regulatory Affairs Weakest Function of Medtech Firms

Qmed Staff

September 25, 2013

2 Min Read
Poll: Regulatory Affairs Weakest Function of Medtech Firms

The LinkedIn group Medical Device Opportunity recently sponsored a poll asking members to choose the organizational structure that was the most problematic. More than 230 people participated in the poll, with the majority selecting regulatory affairs, combined with quality assurance, as the "weakest function." Not far behind was marketing. The other choices included manufacturing, sales, and R&D. The poll, while informal in format, provides an interesting window into the views of medical device professionals.

Regulatory functioning can be especially challenging for small- to mid-size firms, explains Larry Petersen, a medical device consultant at Medical Products International. Such firms may have difficulty affording to have sufficient professional staff manage 510(k) submissions and other work related to regulatory affairs.

Marketing can be difficult for medical device firms to manage because of the complexity of the industry, explains Jim Gustafson, executive/consultant in clinical and regulatory affairs. "It is hard to apply conventional marketing concepts (e.g., the Marketing P's of product, price, promotion, position, etc.), in a setting where the product is bought by one entity (the hospital) with money ultimately from another (the third-party payors) on the order of a third (the physician) for the benefit of a fourth (the patient)," he explains.

Other comments pointed out the need for a deeper analysis into the subject matter. The weakest function depends on the company's size and management team. One commenter recommended looking beyond the weakest function to identify the root cause of the problem. "Budget limitations, timelines, lack of applied experience (and training), and the general lack of alignment (conflicting multiple agendas) are often the challenges to successful projects," explains George J. Marcel, a quality professional with experience in the medical device, biotech, and automotive industries.

We'd love to hear your feedback! Below is a live poll that is unrelated to the one mentioned above that includes more responses. If you'd like to weigh in via email, please contact us at MPMN Editorial.

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