Marcus Evans, Medical Device Summits Release: Adapting to a New Reality: the Impact of the Health Care Reform on Medical Device Manufacturing
Published: Sep 26, 2012
What are some of the upcoming changes that medical device manufacturers should be prepared for?
Thomas Novelli: In the next few years, medical device manufacturing executives will have to adapt to the changes made in the new healthcare laws. One issue that will directly impact them is the 2.3 percent excise tax, therefore they will need to find ways to minimize this effect.
Looking forward, executives have to find much leaner production methods, cutting costs where possible. For example, they can look at their supply chain management systems. They should be finding more efficient approaches, minimizing distribution delays and executing high-quality manufacturing practices, such as six-sigma.
What long-term strategies would you suggest?
Thomas Novelli: In supply chain management systems, mid-sized companies are not as efficient as they could be. It is essential for them to look at the best practices in the industry – this could be industry leaders, or small companies like themselves. By looking at these practices, they can learn what they need to do to improve their Just-in-Time strategies and make sure that the product lifecycle process is being implemented and utilized to its fullest potential.
Medical device manufacturers should also be aware of new disclosure requirements. The law provisions require device manufacturers to disclose the payments that they make. In addition, they need to be prepared for the research division of the litigation, as a private public entity called The Patient’s Centre of Malcolm’s Research Institute will start to guide pairs within the healthcare system, such as Medicare and Medicate, and provide them with evidence on medical interventions, drugs, devices, and more. My advice is: target equipment gain, as technology is always moving forward, and the appropriate evidence is going to help you not only secure regulatory purpose problems, but reimbursement as well.
How can innovation in medical device manufacturing be enhanced?
Thomas Novelli: In order for innovation to take place, there has to be a favorable environment. The medical device industry is different from the pharmaceutical industry, in the sense that most of the innovation takes place in small or mid-sized companies. These smaller companies are developing innovative technologies and commercializing them themselves, or being acquired by larger corporations.
To have a favorable regulatory and legislative environment, there must be a clearly proven medical technology. In recent years, the Food and Drug Administration (FDA) has become less predictable and timely for device application approval with the agency. This has led to a back-up of applications and venture capitalists who have invested in these companies and are choosing to stop due to problems they are seeing in the FDA. In order for investors to continue to invest and promote innovation, this situation must be resolved.
marcus evans, Summits Division
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