The concept of 'cost of compliance', i.e. the cost of complying with laws, regulations and industry standards, including legal, process, training and technology, becomes particularly evident when companies are forced to backtrack in the development process after missing critical regulatory requirements. For example, a medtech company may need to replace the battery in a product if it is found to lack the right certification. This increases costs, requires reworking the design or scrapping the project.
Cybersecurity is another growing area of compliance. The NIS2 directive means that medical devices connected to hospital systems and cloud services must meet high security requirements. A failure here could make the product a security risk and force the company to redesign the entire solution.
Compliance as a strategic advantage
How do medtech companies balance innovation with the risk of having to reverse product development due to missed regulatory requirements? As compliance professionals, we don't see ourselves as brakes, but as enablers. Regulations such as Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR) and harmonized standards are part of the game plan where companies that integrate them early in their product development win in the long run.
AI makes the issue even more complex. To gain regulatory approval, the manufacturer must be able to demonstrate how the AI model was trained and validated. A model that has only been tested on Swedish patients may not work on an American population. If the AI is self-learning, the requirements are almost impossible: how do we validate an AI-driven validation process?
Another issue in the industry is that of making or being acquired. In the case of an acquisition, the valuation is affected by how far the company has come in its compliance work. If the company has a certified quality system or has built up its technical documentation in something similar to a technical file, this is a great advantage.
Viewing compliance as a burden is an outdated view. In fact, regulations can become a competitive advantage. A product developed in line with regulations builds market trust, reduces the risk of product recalls and strengthens business.
3 tips to balance innovation & compliance:
1. bring in compliance expertise early.
An hour with an expert at the start can save months of rework later on.
2. integrate compliance into the entire development process.
Compliance is not an afterthought, it needs to permeate design, testing and documentation from day one.
3. leverage digital tools.
Automated systems for documentation and traceability can both streamline innovation and ensure regulatory compliance.
Medtech regulations are comprehensive and designed to ensure the safety and well-being of end users. Companies that master them run a smarter and better business.
By: Cecilia Fällman, Business Area Manager for Compliance at Plantvision
*Syno International Plantvision a qualitative survey of 31 life science companies in the Skåne region on behalf of Plantvision . The interviews were conducted over a two-week period in November 2024.
