How will the new health care legislation impact the medical device market?

Part of the new health care legislation imposes a tax on medical device manufacturers in order to help finance the bill, and questions arise as to how this will impact the medical device industry. We turned to our panel of Zintro experts and asked them to share their knowledge. Here’s what they had to say:

Nancy Mize, a PhD scientist with expertise in preclinical development for devices, biologics, and combination products, explains that there are both advantages and disadvantage to the new regulations, because while “the FDA does an excellent job of protecting patients,” it does so “at the cost of stifling innovation.” Mize understands that there is a delicate balance within the medical device industry, and although the new legislation tips the balance towards safety and decreased risk, innovation in the medical device market will be severely effected. Similarly, Dr. John Muraski, owner and principal consultant for Catalyst Biomedical, believes that not only will the new health care legislation impact the medical device industry, but that in some ways it already has changed. Referencing companies like Medtronic, Zimmer and St. Jude, Muraski explains that they are anticipating decreased demand due to the changes outlined in the bill. Therefore, they have begun planning their R&D efforts around the changes in reimbursement under the new health care reform.

Allan Brack, owner of Graduate Schools International LLC, has doubts that the recently passed healthcare legislation will pass the judicial review, pointing to cases in Florida and Virginia as examples. He feels that the bigger issue facing device manufacturers is the myriad of international standards, each with their own prejudices and demands. Brack grasps that companies today face the need for hiring and maintaining strong regulatory groups in-house that constantly monitor changes to existing legislation in their respective export countries, as well as local changes and mandates such as the FDA’s need to remain relevant. Further, Brack describes how “international countries all mandate safety with testing to prove that safety, whereas the United States mandates that the paperwork is correct and leaves safety testing to the manufacturer.” In short, most manufacturers that sell medical devices will face a rift in logic between international and domestic standards. This shift will force even small manufacturers to place emphasis in-house on a strong regulatory department, with significant powers in all levels of the manufacturing and marketing process.

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