When the FDA’s Center for Devices and Radiological Health (CDRH) recognized that a new systematic approach to device regulation was needed, it began to focus on “smart” regulation, moving away from the traditional misperception that safety and effectiveness are incompatible with innovation. The CDRH has recently acknowledged that it must work together with industry to assure that the Center receives high-quality submissions which contain the information CDRH needs to make well-informed, timely decisions.
With this new goal of accelerating innovation without compromising safety or efficacy, the FDA and medical device industry are moving together toward a much more transparent and collaborative process. This is a positive step in the right direction, but in order for this initiative to fully succeed, there is a critical need for device manufacturers to have open, robust compliance management systems. We could even go so far as to call these “innovation” management systems.
To understand why such systems are necessary, let’s look at some concrete examples. Suppose you are a medical device manufacturer who has created a sophisticated implantable medical device. The medical world will take action to validate this new device on its own merits; however, when the validation process is fully analyzed, it may be discovered that nobody took the initiative to look just one step upstream or downstream—for example, the accuracy of the device readings and resultant error rates in their transcription and export to electronic health records. To achieve a genuinely innovative and streamlined approach, a more holistic view is required to manage technological innovation in the medical device industry.
Manufacturers Must Consider Impact of New Medical Devices on Entire Health System Spectrum
Consider how a new blood sugar monitor would interface with people taking measurements from it, when data must be taken from the monitor and put into an electronic health record and displayed in real time. In many cases that information must be transcribed by a person, possibly go through a speech recognition system or automatically interface with some other device.
You could have the best new medical device in the world in a controlled test environment (even during clinical trials), but if real-world results tend to trigger transcription errors, you have defeated the original purpose of the device.
Today, FDA approval must involve consideration of the overall end-to-end process of what a new medical device touches, what its impact will be on other areas of the health system spectrum, and how compliance comes into the picture. The entire upstream and downstream flow of information connected to the new device within the health system as a whole must be considered by both the manufacturer and the FDA.
As a provider of web-based information, training and compliance management services and custom solutions that conform to regulatory agency requirements, we have seen clients enjoy the benefits of developing within a more transparent regulatory framework. It can not only speed the ultimate approval, but provide strategic benefit by better understanding how the device will feed upstream and downstream information from itself into the health system. It is a much broader view – in fact, a macro view – of the entire device development and FDA-approval process.
Perhaps someone has a diagnosis of “x, y, z,” and your new device must be accurately prescribed for this particular patient population and no other. Let’s say you have invented a medical device to deliver bronchial thermoplasty to reduce the excess airway smooth muscle present in the airway walls of a specific asthma patient population. This population comprises patients 18 years and older with severe persistent asthma that is not well controlled with inhaled corticosteroids and long-acting beta2-agonists. How do physicians know your medical device is not considered an option for other patient populations, say those with underlying emphysema, COPD or other conditions such as Alpha-1 Antitrypsin deficiency? Can the device itself and the way it displays or provides upstream and downstream information help physicians prevent indication errors from happening, or prevent a physician from using it the wrong way?
Robust Compliance Management Systems Promote Transparency and Collaboration with FDA
A robust compliance management system helps a manufacturer look beyond the device itself, beyond the FDA-approved intended purpose, to consider a broader level that is not only aimed at preventing errors from occurring with the new device, but also how it will feed information to other elements of the electronic health record. If enough precaution and information systems are in place on the device before it goes onto the market, unintended use can be mitigated, and ultimately the accuracy of electronic health records will improve.
Another good example is the Risk Evaluation and Mitigation Strategies (REMS) program enabled by the Food and Drug Administration Amendments Act of 2007. Under REMS, certain drug (generally narcotics) manufacturers are now required to establish risk mitigation and training programs for healthcare providers in order to ultimately ensure that the benefits of a drug or biological product outweigh its risks. This trend of expanding the regulatory oversight to healthcare providers will only increase, and the medical device community should expect similar programs in short order.
Today’s usual scenario is that a manufacturer designs a new medical device, and the FDA does not become involved until the very last stages. Traditional FDA scrutiny happens within a tense period where everybody gets worked up, mostly because there has not been a continuous stream of communication prior to the inspection. If a device manufacturer has done something wrong, or overlooked some element, it can set the product launch back a year and a half.
However, if you show the FDA early results, and do it remotely via a robust compliance management system, the process can help the FDA in assisting you to create a better product. Such a system can show the FDA you are looking at upstream and downstream health care information, and that you are being more global and more macro in looking at overall safety.
In addition, by providing FDA inspectors remote access to the data long before an actual audit through a robust compliance management system, the FDA becomes your friend and collaborator rather than an adversary. The device manufacturer gets a better end result, and the FDA does a much better job of inspecting.
One example of a company doing things this way is PRIDE Industries, a major employer serving Fortune 500, state, federal and military agencies in areas including medical device manufacturing, supply chain, logistics and facility services. PRIDE recently launched an integrated compliance management system in its medical device manufacturing environment and results to date have been strong. Management can spend more time focusing on helping their medical device clients be more innovative, rather than focusing on compliance of the single device.
A compliance management system promotes an open, transparent process, and a much more cooperative relationship between medical device manufacturers and regulators. Medical device manufacturers should strongly consider adopting such a system so that their innovative device can have far more strategic benefit.
About the Author
Dr. Frank Gozzo is president and CEO of Noverant, Inc., a global leader providing web-based information, training and compliance management services and custom solutions that conform to regulatory agency requirements for public, private, profit and nonprofit organizations. For more information, call (919) 825-5613 or visit http://www.noverant.com
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