Some might point to FDA as an obstacle to achieving true device innovation to provide enhanced healthcare. Others view the agency as a necessary element to help ensure patient safety and provide regulated oversight. In this month’s Perspectives feature, industry leaders shared their viewpoint explaining which side of the debate they fell and why.
Are current FDA regulations inhibiting medical device innovation or requiring companies to work more effectively within the established parameters? Would FDA/regulation reform aid the situation?

Gabe Gurman
VP of Research and Development, Sparta Systems

The question of whether or not current FDA regulations are inhibiting medical device innovation is somewhat irrelevant at this point. These regulations are necessary and are implemented, whether companies like it or not. For as long as the FDA has existed, companies have complained that its regulations and directives have hindered innovation, and, subsequently, business growth. Further, with new regulations, like eMDR, looming on the horizon, this isn’t likely to change any time soon.

So how can companies work within this framework to continue innovating despite intense regulatory scrutiny? By finding ways to streamline and automate processes and improve quality and compliance. Medical device organizations today are riddled with quality and process management issues that serve to create headaches when it comes time to report to the FDA and some of these process issues even have to do with the act of reporting itself.

There are many areas that companies can improve to ease the burden of FDA compliance issues. These can include supplier quality management (risk- and performance-based analysis of suppliers), Corrective and Preventative Action (CAPA) management, document management, complaint management, medical device reporting, escalation procedures—the list goes on.

By streamlining these processes down to the point where FDA compliance is automatic and accurate, companies devote less time to making sure every facet of their organization is compliant and more resources to research, development, and product innovation.

The answers to FDA scrutiny are simple: better processes, more efficient reporting, and streamlined management of quality initiatives. FDA regulations may take the chains off innovation in the short term, but force manufactures to deploy creative technology solutions that eventually reduce the complexity of their processes. By addressing these issues at a process level, companies can be prepared to confront them and continue their innovation regardless.

Steve Kennelly
Medical Products Group Manager, Microchip Technology Inc.

Of course current FDA regulations inhibit medical device innovation; that’s just what they are supposed to do. The reason for the regulations is to prevent the introduction of devices until they have been sufficiently evaluated to be proven safe and effective. After observing the development of new medical devices at a number of different companies, the impact of meeting the FDA’s requirements for safety and effectiveness becomes clear. It can be measured in the cost of generating test data, in the manpower required to manage regulatory affairs, and in the time to bring new products to market. All that time and money could be spent on additional new product development, as in more innovation.

Any discussion of reforming current regulations needs to include the benefits that medical device companies get in return for feeding the regulatory machine. While any human system carries the potential for abuse, when everything works right, FDA regulations result in a lower probability that someone will be injured by a device. The U.S. Supreme Court recently increased the tangibility of this benefit by limiting the legal liability of device companies who obtain pre-market approval from the FDA. Additionally, some companies who make Class III devices enjoy the entry barrier presented to new competitors by pre-market approval.

Bound by their duty to consumer protection, the FDA is unlikely to reform their regulations in any way that has the potential to compromise safety; yet they recognize the need for more innovation. They have pointed out that regulations could be more effective and less burdensome if innovation in applied science kept pace with basic science. As the regulatory environment evolves, the FDA and companies will each have opportunities to apply their innovative muscle to finding new ways of making sure that new devices do what they are supposed to.

Pedro Gonzalez
Application Engineer, Roland DGA

The U.S. government has strict material standards for everything from food processing equipment to medical prosthetics and implants. While these FDA regulations keep millions of people safe from poisoning, they do pose a problem for those looking to design new devices for any of these applications. It all starts with prototyping.

The fact is that today’s 3D printers cannot produce prototypes out of approved materials, such as NSF (National Sanitation Foundation) food-safe plastic. The exact 3D printer material properties are totally unknown, making functional testing of these parts impossible. Expensive and time-consuming virtual testing is getting better; but for the most part designers are still spinning their wheels.

To achieve models made from the desired material, a popular work-around is to build a form and fit model layer by layer. Then, use it to create a molded part with known material properties. This two-step process works nicely, but the secondary molding process of creating hard or soft mold tooling adds time and cost to the development process.

All of the hassle is completely unnecessary. From actual human bones to FDA-approved plastics, you can mill prototypes out of the same material as actual medical devices. Rather than building a prototype layer by layer using a mystery material, or a two-step labor intensive process, desktop mills start with a homogeneous block and cut away unwanted material to reveal the desired part in the desired material.

The process is so easy and so inexpensive. Yet, it produces low-cost prototypes that are structurally, thermally, and electrically nearly identical to the final production part/product. The part typically performs just like the manufactured product. As a result, products get to market faster with less effort and money.

A good prototyping process should help, not hinder the innovation of medical devices.

Bob Andrews
Medical Division Manager, Foster-Miller

The FDA plays a critical role in the development of safe, efficacious medical devices. Some might view FDA regulations as burdensome or a hindrance to innovation. However, it has been Foster-Miller’s experience that it’s not the regulations or the FDA itself that are stifling innovation, but the frequent practice of not assessing the regulatory environment until too late in the device design process. Once requirement specifications are established and product development is underway, it can be costly and time consuming to make design changes to meet regulatory standards. Unfortunately, when the regulatory issues are not considered up front in the product development process, the product launch will likely be delayed.

Companies that design and develop products with existing regulations in mind can avoid needless costs and accelerate the product launch timeframe. Surveying the regulatory environment and creating a regulatory strategy should be considered as early as the ideation and concept generation phases, so that regulatory findings can be woven into the design process. Companies that understand the regulatory environment are able to more quickly obtain necessary approvals and bring truly innovative and useful devices to market.

In addition, practical innovation is essential. Great ideas must be directed toward solving an unmet market need. Unique devices will not be a commercial success if they do not meet a clinical need in the marketplace. Conversely, practical innovation results in a differentiated product that enhances a firm’s market position and distinguishes the company from the competition.

Hern Kim
Principal Designer,

Here’s a pretty radical view to the issues of regulations or factors “inhibiting” design innovation. Regulations and constraints are needed for innovation. First off, the very definition of innovation is the advancement derived from critical and incremental thinking translated into design. Regulations should not be seen as hindrances, but as challenges for us to define our boundaries for innovative design solutions.

If we as designers didn’t have sets of constraints, whether related to mechanics, manufacturing, cost, ergonomics, or regulations, how “innovative” will our designs be? Will critical and incremental thinking be necessary? Will the need to push further for an innovative solution be there? What will categorize design as being innovative without the need to overcome these constraints? The argument is to not embrace regulations, but to use them as benefits in orienting and planning your design and manufacturing discoveries.

Design and manufacture of medical devices should always be user centric. Design-for-user should be the paramount goal in all of design, especially in medical device design. Doing so, within the guidelines and constraints of real world feasibility, including regulations, will truly yield innovative design solutions. FDA/regulation reform is not inherently necessary to help enable more creative thinking. Instead, recognizing the need to understand and decipher the boundaries will help enable more critical thinking and innovative design.

S. Michael Sharp
Ph.D.Senior Vice President, Regulatory and Clinical Affairs, ConforMIS Inc.

The effect of FDA regulation on innovation has been positive. Having been a part of the industry since the implementation of the MDA, I can clearly recall the overwrought reaction it received. But history has proven the doomsday predictors wrong and the U.S. medical device industry has flourished. Public financing of medical device companies has surged. Cutting-edge new technologies have come to market and are now enormously successful. The U.S. medical device industry is respected throughout the world for its quality and innovation. This has not happened in spite of the FDA; conversely, it was aided in a substantial way because of the role of the FDA.

In turn, innovation and creative thinking are far from being stifled by regulation. Partnering between industry and academic institutions has blossomed. FDA regulation actually helped the industry mature and brought a number of advantages, among them:

• A consistent approach to quality which has lead to high consumer confidence in our products

• A risk-based approval process that ensures that new technology is carefully tested and evaluated

• Additional protection, in the form of PMA requirements, for innovators

• A business model that is attractive to investors

The challenges facing the industry, however, derive from limits in the FDA’s capabilities. Congress must ensure that the FDA has adequate resources to carry out its mission, including prompt and efficient product reviews. Subsequently, the FDA must act in a manner that is based on clear and well-communicated regulations that are applied in fair and transparent ways.

The medical device industry should view regulators as essential partners in bringing the benefits of innovation to physicians and patients. Under the right conditions, the U.S. medical device industry will continue to flourish.