How to tackle complex health technology regulations using existing resources

As demand for new technologies increases, the supply of medical devices and diagnostics is expected to increase through 2030, at a compound annual growth rate of 10%.¹ This growth is further accelerated by the explosion of enabling technologies such as artificial intelligence, robotics and 3D printing, as well as new requirements for sustainability and net zero. All of these factors influence the way devices and diagnostics are manufactured and regulated.

In response, health authorities around the world are issuing new regulations at an exponentially fast pace. Between 2015 and 2022, there was a 64% increase in regulation of medical device manufacturers, reaching over 13,000 regulations in 2022.² As Figure 1 shows, the FDA has published more guidance in the last six years than in the previous 40-plus years.³

The numbers in the EU tell a similar story. As Figure 2 shows, only 30 regulatory guidelines were issued between 1994 and 2017, when the MDD and IVD were in force. However, this number increased to 124 between 2017 and 2023 with the advent of MDR and IVDR.^4,5

Increased regulatory activity means greater challenges

This surge in regulatory activity creates a very challenging environment for health technology organizations as they strive to bring new products to market while maintaining compliance with their existing portfolio of devices and diagnostics. The brunt of this burden falls on regulatory professionals, who struggle with many competing priorities:

1. Managing ambiguity: As shown in Figures 1 and 2, regulatory guidance is issued over many years, leaving RA teams to make decisions based on partial information. This ambiguity can be extremely frustrating and result in delays and lost revenue opportunities when plans have to change unexpectedly. It is therefore critical that industry stakeholders monitor and contribute to the draft guidance by presenting issues and real-life examples so that regulators can understand the implications.
2. Dealing with bottlenecks: When it comes to new product development, RA is inundated with data, including product information, registration information, application documentation and marketing plans. In most cases, this information is isolated across systems, subject to duplication errors, and assembled manually in slow and outdated processes. In Veeva’s recent regulatory benchmarking study, just 14% of survey participants said they had a single-source-of-truth platform for sharing strategic plans across functions. This creates countless bottlenecks and slows down the time-to-market.
3. Re-uploading information multiple times: Once you submit your application, there is no guarantee that it will be accepted. In fact, 20% of 510,000 submissions are not accepted for initial review by the FDA, and two-thirds require additional information.⁶ In the EU, approximately 25% of MDR applications are rejected.⁷ The reasons can range from incompleteness to incorrect classifications or qualifications, creating a vicious cycle of review and resubmission. RA teams will often need to reallocate resources and put other projects on hold until the submission is approved.

Dealing with higher costs with limited resources

The costs associated with obtaining market approval are also at an all-time high. The company’s total funding for the development of a Class II 510(k) medical device is approximately $30 million, of which $24 million is for FDA-related activities.⁸ If your company is working on a high-risk Class III device, that total skyrockets to $75 million.

RA teams are also struggling to find new talent, and the situation is only set to get worse as forecasts estimate that 70,000 regulated jobs will enter the workforce over the next decade.⁹ This means that RA teams must learn to handle higher volumes with the same number of employees.

Using technology to keep up with new regulations

Despite all these negative factors, RA is in an ideal position to help drive innovation and enable teams to bring new products to market faster. However, to fulfill this strategic role, RA specialists need more technology to scale their efforts and keep pace with regulatory requirements. Many companies are now turning to regulatory information management (RIM) systems to centralize information, streamline operations and accelerate deadlines while maintaining compliance. These solutions can support the full regulatory lifecycle and help answer questions such as where to register products and when to renew them. For a comprehensive overview of the scope and selection of a RIM solution, read this guide.

By using a single source of truth to store, validate and access information, RA teams can save time while increasing visibility and control over global registrations. For example, GE Healthcare saved over 200 hours per year by centralizing product approval and renewal reporting in Veeva Vault RIM. The company also reduced the time it took to update country data by 95%, reducing the two-hour process to just five minutes.¹⁰

Vault RIM not only helps companies manage product registrations, but also provides a unified platform for creating, publishing and archiving tickets. Thanks to this solution, the world leader in diagnostics has shortened the deadlines for sending technical documentation to new markets to just two days. This level of efficiency allows health technology companies to function as truly global regulatory organizations, providing visibility across teams and regions.¹¹

Learn more and connect

To learn more about how leading health technology companies are navigating the growing number of new regulations, save your date for the Veeva MedTech Summit in Amsterdam November 5-7 and Austin April 28-30, 2025.

Bibliography

^{1. Grandview Research, Medical Device Regulatory Report, Market Size, Share and Trend Analysis Report, 2022↩}

^{2. Compliance and Risk, Medical Device Regulatory Trends, 2023↩}

^{3. FDA, Guidance (Medical Devices and Radiation Emitting Products), 2024↩}

^{4. European Commission, MEDDEVs Guidelines, 2022↩}

^{5. European Commission, Guidelines – documents endorsed by the MDCG and other guidelines, 2024↩}

^{6. FDA, MDUFA V Fourth Quarter 2023 Results Report, 2023↩}

^{7. European Commission, Notified Body Survey on Certificates and Applications (MDR/IVDR), 2023↩}

^{8. StarFish Medical, how much does it cost to develop a medical device?, 2023↩}

^{9. Research Articles, Regulatory Talent Shortage is a Cause for Concern, 2021↩}

^{10. Veeva Systems, GE Healthcare streamlines global regulatory processes with Veeva Vault RIM, 2020↩}

^{11. Veeva Systems, Roche Diagnostics and Veeva MedTech, 2021↩}