How MedTech Leaders Are Rethinking Compliance, AI, and R&D Efficiency

Bringing a novel medical device to market is a complex process that requires more than technological innovation. Companies must optimize internal processes and make strategic decisions early in development to avoid costly delays. Too often, these obstacles are approached in isolation, missing opportunities to accelerate progress and improve efficiency by leveraging industry insights and best practices. 

To foster collaboration and address common R&D challenges, MDIC and Deloitte launched the Research & Development Leaders Circle, a forum for MedTech professionals working in R&D to share insights, benchmark best practices, and explore solutions to some of the biggest hurdles in product development, including process inefficiencies, cost constraints, and regulatory navigation. Douglas Billings, Managing Director at Deloitte, described it as a community built for action, where R&D pioneers “can share insights in a way that helps us all grow as MedTech innovators.” 

At the inaugural meeting, industry leaders dug into the realities of accelerating innovation without compromising compliance, explored AI’s role in streamlining development, and examined how benchmarking data can shape more effective R&D strategies. The discussions revealed both challenges and opportunities for MedTech companies looking to stay ahead. 

Navigating the Tension Between Speed and Compliance 

R&D teams in MedTech must balance the urgency of innovation with the realities of regulatory approval. Compliance is essential, but many delays stem from internal decision-making, process inefficiencies, and unnecessary bottlenecks long before regulators are involved. 

Overly complex approval chains, redundant documentation steps, and risk-averse cultures can slow progress. Tom Savard, senior program director of R&D at Medtronic, noted that “speed of innovation, process burden, and team structure all factor into how we move forward.” 

Francisco Vicenty, director of continuous improvement at Getinge, added that regulatory submission delays often come from inefficiencies built into company processes. Streamlining documentation and approval steps allows teams navigate compliance more efficiently while maintaining safety and quality standards. 

The challenge grows as new technologies blur the lines between regulated and unregulated spaces. Kapil Parakh, MD, MPH, PhD, senior medical lead at Google, explained that companies must determine when regulatory approval is necessary. “Where it makes sense, like detecting atrial fibrillation, we chase the approvals,” he said. “In gray areas, we assess what makes sense.” By refining internal processes, engaging with regulators early, and taking a more strategic approach to compliance, companies can improve efficiency while maintaining high safety standards. 

From Compliance to Innovation: The Expanding Role of AI in MedTech 

AI is reshaping industries by improving efficiency and automating complex processes, but MedTech has been more cautious about integrating AI into workflows subject to regulatory compliance review. Leaders explored how AI could reduce administrative burdens, enhance documentation accuracy, and help teams focus on high-value work rather than manual processes, prioritizing business efficiencies without implications for product integrity or patient outcomes. 

Lucas Fernandez, director of product safety and compliance at Reality Labs via Meta, shared how AI is already improving compliance documentation. “I’ve already played with AI writing the 50 essential requirements for an insulin injector,” he said. “It pulls the best-known information from the industry, creating a strong starting point.” Instead of automating compliance entirely, AI helps generate an initial draft, allowing teams to refine, verify, and finalize submission materials more efficiently. This reduces the time spent on manual document creation and enables experts to focus on accuracy and regulatory alignment. 

AI is also advancing how MedTech companies monitor device performance and patient outcomes. Fernandez highlighted that improvements in telemetry now allow companies to collect and analyze real-world data at scale. “We’re finally getting to critical mass on telemetry—collecting data from devices in the field and bringing it back to understand what’s happening with them.” This shift is enabling better post-market surveillance, product refinement, and data-driven decision-making. 

AI holds significant promise in MedTech, but adoption remains cautious due to regulatory constraints. Parakh noted the tension between innovation and compliance, stating, “There’s a lot of hype, but also a lot of potential. We’re just scratching the surface of where these tools can be applied in MedTech. Because the field is regulated, it will take time before these solutions reach patients and providers.”​ 

As AI technologies evolve, human oversight remains essential. Compliance frameworks for AI are still developing, making collaboration between industry and regulators critical to ensuring responsible implementation. By working together to establish regulatory structures that align with AI’s rapid advancement, stakeholders can ensure AI becomes a tool for efficiency without introducing unnecessary risk. 

Using Benchmarking Data to Improve R&D Strategy 

Without industry-wide benchmarks specific to the R&D phase, MedTech companies may struggle to assess their performance and identify areas for improvement. Key aspects of research and development, such as efficiency in clinical testing, regulatory submission timelines, and resource allocation, can be difficult to evaluate without reliable data for comparison. 

The MedTech Product Development Benchmarking Program, led by Deloitte, provides companies with data on factors including R&D spending, regulatory approval timelines, and development efficiency. Billings explained that benchmarking allows organizations to see beyond their own internal metrics, stating, “It’s a unique set of information for the industry. The goal is to gather insights that drive meaningful improvements and innovation around MedTech in general.” 

One of the most significant findings from the program’s 2021-2022 study was that top-performing companies invest more in early-stage innovation and market insights. Billings emphasized the value of early investment, stating, “This is the most consistent data I’ve seen over 30 years of doing this. Companies that make smarter early investments achieve better results downstream,” including faster approvals and fewer costly redesigns. 

The next phase of the study, planned for 2025, will explore digital transformation, AI applications, and process improvements, with findings expected to provide critical insights for companies looking to stay ahead of industry evolutions.  

The Future of the R&D Leaders Circle 

The February 2025 R&D Leaders Circle meeting reinforced the value of bringing MedTech professionals together to tackle shared challenges in product development. Discussions focused on streamlining regulatory processes, integrating AI into R&D responsibly, and leveraging benchmarking insights to improve efficiency.  

Through initiatives like the MedTech Product Development Benchmarking Program and ongoing industry dialogues, MDIC and Deloitte are working together to provide data-driven insights and foster collaboration that supports more effective R&D strategies. As AI adoption evolves and new efficiencies emerge, continued engagement from industry leaders will be key to driving sustainable medical device innovation.

Interested in participating? Fill out our R&D Leaders Circle Interest Form to get updates on future meetings.