A whopping 77% of the cost to develop a 510(k) medical device to market is spent on clinical research and the regulatory submission. This figure goes up to 80% for a device requiring a PMA.1

Much of that cost is a result of sponsors and medical device manufactures inadequately handling the required data.1

The medical device regulatory world is finally (yay!) moving into the 21st century with regards to electronic data transmission. Moving yes, albeit slowly.

The US FDA, way back in 20132, recognized and actually promoted the opinion that capturing data electronically would:

  • Eliminate unnecessary duplication of data
  • Reduce the possibility for transcription errors
  • Eliminate transcription of source data
  • Facilitate remote monitoring of data
  • Promote real-time access for data review
  • Facilitate the collection of accurate and complete data

Granted this particular guidance was focused on the transmission of clinical investigation data, the concept of efficient electronic data capture translates to all required regulatory submission data.

Effective, integrated, electronic Regulatory Information Management (RIM) remains in its infancy for most small and midsized medical device companies.

According to Gens & Associates latest survey3 of 76 organizations, (data comparison to 2020) RIM efficiency increased by only 17%. Health authority interactions secured the largest efficiency increase at 25%. The number of companies achieving real-time regulatory information increased from 37% to 43% in 2022, with a significant jump in affiliate access to global RIM systems moving up to 57%. Unfortunately, the survey uncovered a severe perceived lack of internal data confidence, with only 38% of the surveyed firms acknowledging a high confidence level.

The Drug Information Association (DIA) recently published version 2.0 of their Regulatory Information Management Whitepaper. The Reference Model4, as described in the 45-page document, is intended to “aid organizations in structuring the complex organizational, data, process, information, and workflow issues as they implement or upgrade their RIM systems.”

The DIA working group espouses the harmonization of definitions, processes and concepts as the ideal approach with which to produce a quantifiable increase in regulatory affairs efficiencies for the maximum impact.

Software vendors such as Instem, are developing electronic solutions in line with the evolving regulatory requirements and dynamic integration models. Successful RIM implementation will allow you and your team to:

  • Increase confidence in data quality
  • Access your data in real time
  • Increase operational performance
  • Improve decision making and strategy implementation activities
  • Decrease inefficiencies such as data revalidation
  • Increase speed and accuracy when responding to a regulation change

As described in the paragraphs above, many collaborative initiatives are on-going and more data is being generated to confirm multiple organizational benefits for industry, vendors, suppliers, health authorities and end-users when electronic RIM integration is implemented.

Get involved. Let’s work together to ensure the evolution of our regulatory affairs profession. You do not want your team and company to fall behind the RIM curve.

K Young


  1. https://medicaldeviceevents.com/medical-device-conferences/save-costs-510k-pma/
  2. https://www.fda.gov/media/85183/download
  3. http://gens-associates.com/2022/07/11/are-rim-investments-resulting-in-better-operating-performance-and-business-value/
  4. https://www.diaglobal.org/en/resources/tools-and-downloads#RIM
  5. Photo by Alp Duran on Unsplash