How to Thrive Amid the Shifting Sands of Medical Device Regulations

By Emily Newton
January 3, 2024


• Categories: 05-Quality/Regulatory, AI/ML, Regulatory, Supply Chain

Emerging issues around artificial intelligence (AI), telehealth and data privacy have triggered a surge in regulatory action. This trend is both a challenge and an opportunity. Companies that can adapt quickly to meet regulatory shifts could surge ahead of the competition. Here’s how organizations can meet the challenge of shifting MedTech regulations.

Maximize Transparency

Ensuring visibility is the first step in thriving amid changes in medical device regulations. Enterprises can’t conform to new laws and regulations if they don’t know where they conflict with their current operations.

Supply chain management often requires the most improvement regarding transparency. A stunning 45% of brands today lack visibility beyond their first-tier suppliers. Medical device manufacturers must increase data sharing with partners through real-time tracking solutions and digital twins of the supply chain to reverse that trend.

Maximizing transparency is largely an issue of data collection and organization. Internet of Things (IoT) devices can generate relevant real-time data companies organize into a single point of view through cloud computing. This digitization will make it easier to get a full picture of operations, streamlining regulatory compliance.

Anticipate New Needs and Concerns

Given how quickly regulations shift, waiting until new laws emerge to adapt is no longer sufficient. Medical device businesses must prepare before rules take effect to reduce disruption.

New laws emerge in response to widespread concerns. If medical organizations adapt to these underlying concerns before they become a legislative or regulatory issue, they’ll be better positioned to comply. Further adaptation may still be necessary when rules are finalized, but companies that work ahead of the curve will need to make only minor adjustments in line with the new rules.

If enterprises stay up to date on emerging technologies, trends and their impact on the industry—especially concerning patient well-being and privacy—they can notice these issues early. As concerns arise, brands should find and embrace best practices to protect patients above all else before the law lays out specifics.

Embrace Automated Compliance

Even with early adaptations, changes in medical device regulations happen too often for manual compliance to be sufficient. Consequently, MedTech companies must automate their compliance workflows wherever possible to enable faster responses.

Documentation is a common pain point to address. Most workers spend one to three hours a day on data entry and 73% spend the same amount searching for specific information. These repetitive, data-heavy tasks are crucial to compliance but too time consuming to do manually. Automating them through robotic process automation (RPA) and AI makes compliance much less tedious.

Newer AI solutions can automate even more of the compliance process. Some tools can scan legal documents to find relevant regulations and compare them to current workflows, revealing any areas of noncompliance. These quick, accurate audits lead to faster adjustments in the face of shifting legislation.

Streamline R&D

Research and development (R&D) is another area that can be streamlined to enable compliance agility. The FDA only offers general guidance on how to meet its standards, and many other regulators take a similar approach. Consequently, device manufacturers must spend time during R&D to determine how to meet new regulations, often creating bottlenecks and delays.

Automation and AI are key to higher R&D productivity. Digital twins can reveal where production line inefficiencies lie. AI-powered RPA can automate data entry during clinical trials to minimize errors and reduce timelines. Similarly, AI can highlight ideal populations for these trials and reach out to them automatically.

Some regulations may require complete product redesigns, while others only need small adjustments. In either case, a heavily manual, inflexible R&D process will make adaptation more time consuming than it needs to be.

Build an Adaptive Supply Chain

Changes in medical device regulations often affect manufacturers’ supply chain partners, in addition to production itself. Consequently, organizations must be ready to adjust their supply networks with minimal notice. Conventional, lean supply chain approaches don’t facilitate this adaptability, so businesses must embrace an agile philosophy instead.

Agile supply chain management emphasizes flexibility and resilience over sheer efficiency. To do that, it utilizes distributed sourcing, IoT tracking and digital twins. These systems may raise supply chain costs, but they prevent disruption and allow for faster adaptation of sourcing strategies.

Generally, agile management is best for high-volatility products, which includes many medical devices. Frequently changing landscapes create demand volatility and shift supplier needs, so agility offers more long-term value than lean alternatives.

Emphasize Collaboration

Finally, medical device manufacturers must recognize they can’t get through these changes alone. Thriving in this environment means maintaining communication to grasp incoming changes sooner and connecting with multiple partners to access new resources as necessary.

Trade associations are a great resource. These groups make it easier for businesses facing the same challenges to help each other through sharing of information and resources. Working more closely with logistics partners and multiple suppliers provides similar benefits.

Medical device brands must also collaborate with government regulators. Maintaining good relationships with the bodies making and enforcing these rules ensures that companies understand the regulatory requirements and how to comply. These relationships also allow manufacturers to help shape specific legal guidelines by offering an inside perspective on relevant issues.

The pace of innovation is increasing at a rapid rate and regulators are working diligently to keep up. In light of these disruptions, device manufacturers must embrace a business model that can withstand change and readily adapt. If organizations can anticipate these shifts and develop more agile working models, they will stand out as leaders amid competitors who struggle to keep up.