Medical Device News and Insights

Making a Dent in the Established Insurer - Practioner Order

Wednesday, May 5th, 2010 | FDA Medical Device Regulations, Medical Device Market

Small medical device innovators are often surprised to find out that clinical trial data used to support a successful FDA clearance or approval is not always the driving force behind the acceptance of a treatment amongst both insurers and practitioners.  This disconnect is easy enough to understand.  The vast majority of companies developing new medical devices are staffed by dedicated scientists who have devoted their lives to seeking out accurate data and then using that information to reach conclusions that ultimately support the effectiveness of the course of treatment they have studied.

While this is an excellent practice within the realm of medical science - and indeed, one of the key tenets of achieving FDA approval to market a device - it represents only part of the overall package required to achieve the level of acceptance in the medical industry that most device manufacturers are seeking.

At MDCI, we often come across companies that  have invested time and financial resources into clinical trials which have produced reams of data but which have failed to help a device make a dent in the complex world of actual practice.  This problem is actually endemic across the entire medical industry, and is not just limited to medical devices but also affects almost every new treatment that seeks to muscle aside the current order that has been established by years of insurer reimbursement and practitioner habits.

It is critical for medical device companies to embrace the concept that doctors and insurance companies represent the biggest hands on the steering wheel when it comes to guiding the industry to the adoption of new treatments.  Clinical data is definitely a part of breaking through to a targeted community of practitioners, but it must be paired with an effective strategy that goes beyond mere journal publication and deals with the realities of changing the attitudes and reimbursement preferences of doctors and insurance companies.

When gathering outcomes data, it is important to assemble an initial investigatory team that is composed not only of competent scientists but also of medical leaders and early adopters.  Plainly speaking, involving men and women of influence within the treatment sphere of a device plays a huge role in attracting attention to outcomes data once it has been gathered and analyzed.  Furthermore, early adopters who are willing to help make the case to insurers that reimbursement for the new treatment not only fits within their financial model, but may in fact provide them with additional benefits, is critical to gaining a toehold in the market.

Site and investigator selection for new medical devices is often more political than many scientists are initially prepared to acknowledge.  MDCI regularly assists medical device companies through the process of identifying and qualifying clinical investigators, with the goal of connecting promising new devices and diagnostics with respected practitioners who are more likely to become their potential future champions.  This is a sensitive aspect of study planning, but one which requires absolute attention on the part of a company looking to make meaningful inroads with a new device.  It is far easier to establish an effective investigator team from day one than it is to attempt to go back and start from scratch to produce the type of results and involve the right personnel who can influence future adoption of the device in question.

Tags: FDA, FDA device approval, insurance companies, Medical Device Clinical Trials, medical device development

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