Solid Footing During Shaky Times: Current Compliance Considerations

The changes and challenges wrought by COVID-19 have significantly impacted the medtech industry—through product portfolios, work habits, and processes. Only time will tell what practices will become permanent after the pandemic, but surely a new cast of players, changing work practices, and heightened regulatory urgency are not likely to disappear with the virus.

Many outside companies that helped the healthcare industry battle the coronavirus through FDA emergency use authorizations (EUAs) are planning to remain in the medical device industry once the pandemic ends. Existing medtech organizations, meanwhile, are evaluating opportunities in new therapy areas.

While numerous operations personnel have remained on-site out of necessity, many supporting roles in quality assurance, regulatory affairs, and some technical roles are now performed remotely. Although resourceful, remote workers with critical functions present an opportunity for errors and oversight not previously identified. The shift to remote work has forced the adoption of new processes, and it has had a significant impact on both staff management and visibility.

Many organizations are finding that shifting marketing priorities and changing work habits are further complicating efforts to comply with recent regulatory changes. The medtech industry is at the intersection of drastic changes in regulation and significant and unforeseen changes in project and staff management. On the heels of Regulation (EU) 2017/745 (the new European Union medical device regulations), a world-wide shift in work habits presented itself through COVID-19.

Medtech Newcomers
Individuals and companies are scrambling to bring products to market under EUAs during the COVID-19 pandemic. For many, it’s been too easy to succumb to the temptation to quickly bring a product to market without the proper diligence. Industry outsiders do not quite comprehend medtech’s regulations or why they must be so stringent.

I’ve assisted many organizations in the last six months that received EUA authorization or marketed under an EUA for medical products used to treat and prevent COVID-19—ranging from face masks to active respiratory devices. In conducting research and creating regulatory strategies for these new players, I have observed numerous compliance issues for competing products. Medical devices are currently being imported without meeting regulatory requirements. Numerous Class II and unclassified devices are being imported with sham FDA certificates and listed with the FDA as irrelevant Class I FDA Product Codes to circumvent the 510(k) process (or not listed with the FDA at all).

Companies that are considering establishing a distribution or import relationship with a manufacturer should exercise proper due diligence to ensure the products are appropriately cleared, approved, and/or registered. A cogent regulatory strategy will be much easier to execute and less costly than a recall and compliance action. And, in some cases, minor changes to registration details may be all that is required for compliance. By contracting outside expertise to quickly confirm regulatory compliance, companies can ensure that EUAs or new operations will not violate existing mandates, which ultimately could hamper future operations and revenue.

Existing medtech organizations should consider their knowledge and practice of regulatory compliance as a competitive advantage over new (outside industry) competition. Portfolio reductions in Europe due to added EU MDR expenses can be offset with portfolio additions in other geographies. Established medtech firms might want to emulate the often nimble and efficient mentality of startup competitors in their own operations.

Balancing Resources
Despite the measures put in place to ensure long term financial security in the pandemic’s wake, many healthcare organizations have cut back on resources. Fiscal responsibility during these times is essential; however, companies must be mindful of the impact of human resource constraints on safety and compliance. While organizations must be cognizant of shareholder value and maintaining adequate financial reserve, they also must be mindful of the cost of non-compliance to the business and to shareholders. By scaling down resources for quality and regulatory functions, the strength of those spokes in the wheel of the organization are weakened. When a failure occurs, it is the shareholders and patients who ultimately bear the weight of noncompliance and safety issues.

This balance is the responsibility of executive management, thanks to a regulatory shift. As budgets are defined, projects are planned, and employees depart (I have witnessed an unusually high mobility for regulatory and quality personnel in the last six months), executive management must ensure the company has the appropriate balance of employees, contractors, consultants, and tools for the specific nature, risk, and volume of its products and services. Notified Bodies and MDSAP Auditing Organizations are increasingly focusing on executive management’s commitment to this resource allocation and FDA inspectors are increasingly scrutinizing the outputs of functional areas that are subject to these resource constraints.

Working Remotely
I am amazed at the productivity and efficiency with which the medtech community has adapted to remote work. With only several months of adjustment, Zoom meetings are proceeding smoothly, projects are progressing well, and regulatory submissions are being launched. Unfortunately, it took a pandemic for many organizations to realize that remote work is not only possible but creates a much better work-life balance for employees. The ability (and desire) to work remotely will last well beyond the pandemic’s eventual demise, creating another staffing challenge for medtech firms that are competing with other companies for talented employees. With so many new organizations entering medtech, the already limited pool of expertise in compliant manufacturing, importing, and distribution has been stretched even thinner. As such, competition for human resources is now an increased challenge for medtech companies.

Changes in organizational resources and tools will also drive employee efficiency and fulfilment. The continued adoption of technology by medtech organizations—electronic document and record control, electronic QMS processes, and software solutions—allow employees to focus less on administrative tasks and more on organizational goals. The initial outlay for these solutions will be balanced with a reduction in future resource costs and reduced employee frustration.

Auditing
Having recently resumed on-site audits, I have enjoyed the reduction in traffic, more spacious airplane accommodations, and quieter hotel rooms. However, such luxuries are not indicative that society is gradually returning to a pre-pandemic normality (a new normal is here to stay). Conversely, there are many audits I will continue conducting remotely because there is no advantage over in-person audits that warrants the added effort, time, and expense for the client.

Companies should take this opportunity to evaluate its requirements for internal and supplier audits. There are many considerations to contemplate: Is there a risk-based approach to supplier management? Is the nature and duration of audits commensurate with the supplier’s products and services? Has the company exceeded regulatory requirements without adding value or risk mitigation? How does an on-site assessment add value in verifying supplier conformance? Has the company delayed audits or transitioned to all remote audits due to COVID-19?

The risks of coronavirus do not warrant an outright pause in supplier oversight but rather a change in how they are managed. With less on-site presence from customers, some suppliers may not maintain the same level of diligence. Thus, manufacturers must ascertain whether their suppliers adopted any preventive actions to mitigate COVID-19-associated risks and reduced on-site presence of their employees. These firms might want to consider reassigning or contracting audits to employees or consultants who are amenable to travelling during this time. Suppliers should consider contracting with a third party that can conduct a single on-site assessment to supplement remote supplier audits for multiple customers.

When conducting internal audits, focus on a process approach, evaluate each process against current and future work practices, and ask the following questions: Are processes suitable for increasingly electronic systems? Are processes prone to mistakes or oversights based on a more remote workforce? Is there reduced visibility of operations for quality due to changing work practices? How do these changes impact compliance to new and revised regulatory requirements?

Conclusion
Confronted with multiple challenges, the medtech industry is re-examining long-established practices to find solutions with lasting benefits. How these challenges are addressed and leveraged to improve organizations will define a new set of competitive advantages for many companies. 

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Bryan Brosseau’s experience has been forged in 20 years in the medical device and biologics industries. With a varied and in-depth knowledge of quality and regulatory requirements, he hones in on the necessary requirements of a project to ensure quality and compliance without impeding progress. Bryan implements, manages, and improves quality management systems for numerous companies and has obtained regulatory approvals for products across a wide range of therapy areas. Bryan received his bachelor’s degree in biology from the University of Georgia, maintains a Regulatory Affairs Certification (U.S.) from the Regulatory Affairs Professionals Society, and is a certified ISO 13485:2016 and MDSAP Lead Auditor.