I’ve spent much of my professional life assessing regulatory compliance in the life sciences industry. In the past, there was always a clear difference between compliance and continuous improvement, but times have changed. The old (i.e., out of date) concept of compliance is no longer effective, especially with regard to the quality management system and its ability to support innovative new medical device design and manufacturing technologies. 

In the July/August issue of MPO, I advocated the notion of selling regulatory compliance, so I obviously am not declaring compliance totally dead (yet). However, I do believe the concept of compliance is changing, especially within regulatory agencies, and the change is forcing medtech companies to take a new approach to compliance. The U.S. Food and Drug Administration and its supervisory sisters worldwide have adopted a new paradigm for the 21st century, and this new standard represents a significant change from traditional concepts. Some changes currently shaping the global regulatory environment include:

• The Medical Device Single Audit Program—just one element of the global harmonization effort
• A transition to the new Medical Device Regulations for Medical Devices and IVD devices
• ISO 13485:2016—the latest version of this key medical device quality management system standard
• The revision of ISO 14971—a key risk management standard for medical devices. The first draft document for the revision should be out later this year.
• New guidance documents for complex medical devices and manufacturing processes, such as:
  • Software as a Medical Device
  • Technical Considerations for Additive Manufactured Devices
  • Manufacturers Sharing Patient-Specific Information with Patients Upon Request
  • Deciding When to Submit a 510(k) for Software Changes to an Existing Device

Regulatory changes have become an inevitable part of medtech product development in recent years due to growth in complex devices and advanced manufacturing processes, as well as the ability to more efficiently generate, collect, and analyze data.

Lean manufacturing and Six Sigma methodologies have affected compliance, too. During my tenure as a medtech employee and consultant, Lean and compliance responsibilities were often at odds within design and manufacturing operations. But now Lean and Six Sigma concepts are more accepted within the regulatory function. 

Medtech’s shrinking product lifecycle has impacted compliance as well. Many new medical devices have shorter lifespans than their predecessors due to fast-changing technology, oftentimes incorporating advanced design, development, and manufacturing processes that require new assessment methodologies from regulatory bodies.

The new regulatory compliance paradigm is tailor-made for today’s digital world. Post-market communication such as advertising and complaint reporting is almost instant and accessible through multiple avenues (internet, email, social media, etc.). The new regulatory paradigm takes the Electronic Age into consideration.
 
Electronic quality management systems are becoming more common, even in startups and very small medtech companies. Often, multiple information technology systems interact with the quality management system. This increased connectivity and efficiency drives an increase in compliance expectations.

Risk management for product safety has become a key component of the industry’s quality management systems. Risk-based decisions are now considered in assessing regulatory compliance.

The merger of medical devices with pharmaceuticals and biologics (combination products) is one of the key reasons for the paradigm shift. The silos between these life sciences sectors are beginning to fall, and the quality system standards are aligning. Expectations for quality management system performance in these different sectors are also becoming more similar.

Advancements in state-of-the-art medtech products, design, and development require teams that include people from multiple disciplines; likewise, today’s more complex manufacturing processes must involve people with specific expertise. Companies’ regulatory and quality teams must include members who can provide valuable input into the development and oversight of these complex processes. Improvements in device design and manufacturing often raise regulatory compliance issues, which requires collaboration among everyone involved in product development (even top management) to ensure regulatory compliance.

Today, when I think of compliance, my thoughts are much different then they were just a few years ago. My paradigm has shifted, too. I now think for the better. 

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James A. “Jim” Dunning’s consulting career began in 2001. He has provided quality and regulatory consulting services for various companies ranging from Fortune 500 medical device firms to startups. Dunning’s passion, however, lies with startups and small companies, especially those in regulatory distress. He has amassed significant experience in preparing 510(k) applications, developing complete Quality Management Systems, providing Quality System Training, and advising on quality, business, and leadership issues. Dunning is a senior member of the American Society for Quality (ASQ) and a member of the Regulatory Affairs Professional Society (RAPS). He can be reached at jdunning@qpcservices.com.