Breaking Down Silos: How Engineering-Regulatory Collaboration Accelerates Medical Device Innovation

The medical device industry stands at a crossroads where technical innovation must seamlessly integrate with regulatory compliance to bring life-changing technologies to market. At a recent RAPS San Francisco Chapter event hosted by Triple Ring Technologies, industry leaders shared compelling insights on how early collaboration between engineering teams and regulatory professionals can dramatically accelerate time to market while maintaining safety and efficacy standards.

The Foundation: Building Bridges, Not Walls

Vrad Levering, Director of Systems Engineering at Triple Ring Technologies, opened the discussion by addressing a fundamental challenge: many clinicians and engineers are intimidated by regulatory requirements. "It's not that scary," Levering emphasized. "There are clear paths ahead, and you can get this done."

This sentiment was echoed throughout the panel, with speakers consistently reinforcing that regulatory professionals and engineering teams share the same ultimate goal: bringing innovative technologies to patients who need them.

Angela Frederickson, founder of SPRAQ Compliance, framed the relationship perfectly: "I like to consider the engineering team my best friends, even if they don't know it yet." She emphasized her role as a service provider and translator, bridging the gap between regulatory requirements and technical innovation.

Case Studies in Success: From Concept to Clearance

Triple Ring's presentation showcased several compelling examples of successful engineering-regulatory integration:

HeartBeam: Credit Card-Sized ECG Innovation

One standout example was HeartBeam, which received 510(k) clearance in December 2024 for a revolutionary 12-lead ECG device the size of a credit card. This technology enables suspected heart attack patients to perform ECGs anywhere and communicate results via telemedicine, with AI assistance for arrhythmia detection.

The key to success? Early regulatory engagement. "We engaged with them very early on, at the very beginning, and tried to structure everything thinking about their regulatory process," Levering explained. While HeartBeam eventually brought on specialized regulatory consultants, the early foundation made the approval process significantly smoother.

Bioptics: Decade-Long Partnership Success

Cameron Casale, Systems Engineer at Triple Ring, detailed their long-term partnership with Bioptics, demonstrating how sustained collaboration can drive multiple successful products to market. Their work on the Intraox (Intraoperative Tissue Oximeter) exemplified efficient development, moving from early ideation to FDA submission in just 18 months.

A particularly innovative aspect was Triple Ring's development of an in vitro bench test platform that established substantial equivalence to predicate devices while reducing animal testing requirements—a win for both regulatory efficiency and ethical considerations.

The AI Revolution: New Challenges, New Opportunities

The discussion highlighted how artificial intelligence is reshaping both innovation and regulatory strategy. Levering introduced two critical FDA concepts that engineering teams must now consider:

Predetermined Control Change Plans (PCCPs)

These represent a paradigm shift from traditional one-time submissions to forward-looking regulatory strategies. "It's almost like here's my 510(k) and here's what my next five 510(k)s are going to be like," Levering explained. This approach enables continuous learning and model improvement within pre-approved guardrails.

Model Cards

Borrowed from the AI industry, model cards provide a "layman's way to understand what your AI is doing", documenting training datasets, current performance, monitoring plans, and other critical information for regulatory review.

Innovation in Regulatory Strategy: The Melcova Approach

Peymon Ghazi, CEO of Melcova, presented a particularly innovative approach to regulatory challenges through digital and physical twins. Facing a PMA pathway for their breast imaging solution, Melcova developed a strategy that could revolutionize clinical trial design:

• Digital twins: Computer simulations of breast anatomy and imaging devices enable virtual clinical trials, providing sensitivity and specificity data at a fraction of traditional costs
• Physical twins: Physical models with human-like complexity allow real-world testing of positioning, scan times, and potential failure modes
• Combined approach: Supplementing smaller patient cohorts (200-300 patients) with thousands of physical twins, potentially reducing clinical trial requirements while maintaining scientific rigor

This approach has garnered significant FDA interest, with Ghazi noting that regulators are "crazy about this" and "really excited about this" innovative methodology.

Key Success Factors: The Three Pillars

The panel identified three critical elements for successful innovation-compliance integration:

1. Early and Continuous Collaboration

Dr. Roger Tang, CTO of Triple Ring, emphasized that regulatory strategy must be established before entering product development: "We can't almost walk into the true product development part of our process without having some idea what the regulatory strategy is."

2. Thoughtful Infrastructure

Frederickson stressed the importance of quality management system (QMS) infrastructure that enables speed rather than creating obstacles: "The things that you're creating should allow the innovative creative teams to move quickly."

3. Cross-Functional Understanding

Rather than maintaining silos, successful teams foster mutual understanding. Levering suggested having team members role-play opposite functions: "You make the engineers pretend to be regulatory and the regulatory folks pretend to be engineers."

Beyond FDA: The Reimbursement Reality

The discussion highlighted an often-overlooked aspect of market access: reimbursement strategy. Levering noted that while regulatory pathways have become more predictable, reimbursement considerations require even longer-term planning, sometimes seven years ahead.

Frederickson emphasized the growing intersection between regulatory and reimbursement strategies: "To leave it to chance is just crazy." Early engagement with reimbursement specialists, alongside regulatory professionals, has become essential for commercial success.

Practical Takeaways for Industry

The event yielded several actionable insights for medical device companies:

Do's:

• Engage regulatory early: Include regulatory considerations from day one, not as an afterthought
• Foster collaboration: Create processes that require cross-functional interaction
• Leverage FDA resources: Pre-submission meetings are free and can significantly mitigate risks
• Network actively: Build relationships with FDA scientists and reviewers through conferences and professional events

Don'ts:

• Avoid silos: Never treat regulatory as gatekeepers to be circumvented
• Don't wait: Late regulatory engagement consistently leads to "catastrophic failure"
• Don't ignore draft guidance: Even draft FDA guidance provides valuable insight into regulatory thinking

The Future of Medical Device Innovation

The discussion painted an optimistic picture of an industry where innovation and compliance work in harmony rather than opposition. As Frederickson noted: "We all have the same goal to bring innovative technologies to the market that are going to improve patient lives."

The key insight from this RAPS event is that the most successful companies don't view regulatory compliance as a hurdle to overcome, but as a strategic advantage when properly integrated into the innovation process. By breaking down silos, fostering early collaboration, and embracing new regulatory paradigms like PCCPs and innovative trial designs, medical device companies can accelerate their path to market while ensuring patient safety remains paramount.

As the industry continues to evolve with AI, gene editing, and other transformative technologies, the lessons shared at this event provide a roadmap for navigating complexity while maintaining the innovation pace that patients desperately need.