The regulation of medical devices is a vast and rapidly evolving field that is often complicated by legal technicalities and bureaucratese. FDA has been accused of going overboard when it comes to clearing or approving medical devices for use in the U.S., and because of the invasive concept of “marketing and selling in a global marketplace,” companies are finding that they can do business in other countries without red tape and inconsistent regulations. For example, FDA-related legal terms and their meanings are sometimes non-uniform, even within the U.S. regulatory system.
Yes, the U.S. remains the largest orthopaedic device market. But my observation is that not all companies are interested in running the FDA regulatory gauntlet—a disturbing trend.
The president of a mid-sized medical device company in Europe recently told me that it wasn’t worth the agita to submit a premarket notification for his Class II devices. So, we didn’t. His company has decided to market in Asia and Europe before they entertain a U.S. clearance. Another medical device client in China is only conducting business in China and Southeast Asia to avoid “unnecessary regulations” and the probability of executing a clinical study on a product that has been in use for 20-plus years.
Ex-U.S. markets are spending money on ex-U.S. medical devices because the world economy is not just made up of the U.S. and Europe. Recognizing this environment, FDA continues to choose strategic priorities to streamline the U.S. regulatory process.
Laying the Groundwork
FDA updates its strategic priorities about every four years to ensure that its plan aligns with its annual performance reporting in congressional budget justifications. It sets forth the agency’s intentions to streamline and improve its operations.
Worldwide, FDA has one of the most laborious regulatory standards for protecting public health. Counter to that, the agency has been historically under-funded, which causes inconsistency when it comes to making changes and addressing the challenges of products manufactured overseas. Because of both high regulatory standards and lack of sufficient funding and program-centric challenges, U.S. citizens have waited up to four or more years for access to lifesaving devices.
Of deceptive importance, there must be robust scientific evidence that a device is safe and effective before approving that product for the U.S. market. Maybe it’s too robust. Maybe FDA has gone overboard. The world marketplace is not viewing the so-called allure of selling products in the U.S. as a necessity to be successful.
FDA chose its strategic priorities over the past five years and for the next four to address this problem. The agency has tried to reduce the time and cost required to bring a product to the U.S. market and support it throughout its life cycle, while not compromising the reasonable assurance of a stringent safety and effectiveness standard.
By advancing a Total Product Life Cycle Approach (TPLC), the user fee program has supported and advanced the agency’s efforts. In doing so, the aim is now toward helping innovators choose the U.S. marketplace, rather than be stymied by a complex and cumbersome regulatory process.Personally, based on my perspective of submitting market clearance documentation, the results are off-center. At the same time, FDA has tried to preserve a top-shelf safety and efficacy standard with the need for rigorous science, upon which American patients rely for quality healthcare. Using flexible, patient-centered benefit/risk models, collaborating more with customers, streamlining internal processes and applying a least-burdensome approach, FDA hopes to be more successful in coming years.
We’ll see. Promises from 35,000 feet are one thing; feet-on-the-ground reality is a different scene when there is confusion at the top echelon level.
To support speedier time to market for medical devices, FDA’s 2018-2022 priorities include a focus on people, simplistic processes and risk-based decisions:
People (FDA Employees)
- FDA challenges its employees to question the status quo. Maintaining public trust and holding themselves accountable for actions taken has been an FDA edict so that industry and consumers can see what is happening and how decisions are made on their behalf.
- CDRH is reorganizing from seven offices into four, aligning employees into teams based on product type and technology. For example, individuals from the evaluation and compliance groups for orthopaedics will become one team.
- By instituting this TPLC approach to core activities, there will be new opportunities created and a certain predictability to career growth (both personally and professionally) without having to seek different jobs, meaning that employees can grow in place rather than having to leave an FDA job to advance. I have seen a mass exodus of seasoned FDA employees over the past 10 or 12 years. Some were ready to retire; some retired early to avoid the “craziness” at CDRH over the past three administrations and some simply found better jobs with more pay and less aggravation.
- An additional key factor for the transformation of employee careers and involvement is to continually ensure that barriers and silos become a thing of the past. The new teams that will be formed as part of FDA’s infrastructure model will depend upon progressive modernization that will engage colleagues across offices within and people outside of CDRH.
- Over the next three years, FDA’s goal is to complete these proactive efforts and make CDRH a workplace of trust, mutual respect and accountability, ongoing and open dialogue and personal and professional growth. FDA’s metric is that by December 31, 2020, it will achieve at least an 80% employee engagement level.
Keeping Things Simple
- FDA has indicated that the issues it faces are often complex. The solutions and the processes used to address them don’t necessarily have to be difficult. Over the next few years, FDA wants to streamline all policies, processes, programs and approaches, as appropriate, to more effectively, efficiently and quickly achieve FDA’s mission and vision.
- This sounds a lot like compliance to ISO 13485:2016. It simply means that FDA seeks to stop moving forward in an inefficient manner and streamline what is determined to be not sufficiently “value added” to the regulatory process thus freeing the CDRH team to spend more time on what matters most to patients and staff.
- An example is adoption of the Medical Device Single Audit Program, which allows a single regulatory audit to satisfy relevant requirements in Australia, Brazil, Canada, Japan and the U.S.
- It also means that policies should be as straightforward as possible, removing unnecessary burdens imposed on processes and employees. The use of cumbersome processes, vague policies and out-of-date information technology systems will be addressed in a timely manner over the next three years or so. It does not mean changing the regulatory standard of reasonable assurance of safety and effectiveness, the reliance on robust, valid scientific evidence, nor unabashed dedication to our public health.
- FDA’s focus on continuous improvement includes working to reduce burden and improve the efficiency of CDRH core processes, in part through the implementation of a modern Quality Management System and further advancing a culture of quality.
- All of us, including FDA, encounter uncertainty when making decisions, particularly regarding the benefits and risks of a device before it has been in widespread use.
- Here is the dilemma: this approach cannot be a reason for delay or the imposition of unnecessary or not sufficiently value-added requirements on the agency or on industry. For example, FDA does not typically know the full benefit/risk profile of a device before it is widely used in or on patients in routine clinical practice. Even large premarket clinical trials generally do not reflect the true spectrum of benefits and risks, but may impose unreasonable costs and time delays that ultimately adversely affect patients.
Proposed Approaches for Old Issues
- Develop flexible regulatory process directions or pathways tailored to specific technologies. Instead of trying to push devices down a one-size-fits-all regulatory pathway, FDA will continue to fine-tune approaches based on the technology type and its unique evidence generation, innovation cycle and patient access needs. For example, making regulatory decisions concerning devices driven by software versus devices not using software—same intended use, but a different method of getting results.
- Stop expending human resources in areas determined not necessary to protect public health. For example, in 2013, FDA issued the Mobile Medical Apps Guidance. Through that guidance, FDA exercised enforcement discretion for dozens of medical device functions that had previously been regulated. FDA determined that patients could benefit from the innovation in digital health technologies if they de-regulated lower risk technologies with a good safety track record.
Conclusions Moving Forward
Simplicity requires that FDA remain limber. For industry to be innovative, the federal government must be innovative as well. FDA must be well-positioned to try new things.
The simplistic approach must become embedded in FDA’s day-to-day operations as modernization and quality improvement become enabled. The medical device infrastructure has become increasingly varied and complex, and it must rebuild cumbersome processes into an efficient and effective quality management system, like 21 CFR, Part 820 and ISO 13485:2016. By applying the simplicity approach, FDA should be able to free up and better use resources to focus on high-risk areas that have the biggest impact, for instance, continue to expand the application of simplicity and incorporate it into a viable Quality Management System for a service-based company.
The issuance of new and revised documentation should complete the transition from a risk-based framework for medical device regulation to a benefit/risk framework to offer several regulatory options instead of one outdated pathway. The agency will continue to explore international merging of some regulatory and quality systems’ pathways, for example, creating a Medical Device Single Audit Program.
Of additional note, as European Union regulations become more stringent with the adoption of Medical Device Regulation, device companies may look to expand their presence in the U.S.
This is a prime moment for FDA as it executes on its priorities. Again, FDA’s metric is that by December 31, 2020, it will enable leaner and more efficient processes. CDRH’s leadership team will oversee the implementation of this strategic priority.. Tasks will include the development of principles for applying the simplicity approach.
John Gagliardi has had success over the past 45+ years in the medical device and pharmaceutical industries because of his practical approach to process-orientation and business. He has been actively involved in research and development, quality assurance, training, operations, process architecture, FDA inspections and regulatory affairs. Mr. Gagliardi specializes in building systems in a compliant and business-ready manner. Mr. Gagliardi can be reached by email.
MidWest Process Innovation, LLC