Do you trust me? 🤔
What establishes trust in a professional context? Is it created through an endorsement or experience? Does it come from having an advanced degree or certification? 👩🎓
What about trust in a product, specifically a medical device?
Trust is rooted in the process of certification, documenting how it was designed and develop, testing and performance, and that it does what it was intended to do. We extend our trust to these products because we indirectly trust the regulatory process.
The regulatory process, while daunting and tedious, was designed to vet products, ensuring that they are safe and achieve their intended purpose.
Despite its flaws—and ignoring the current EU capacity issues with notified bodies—the process functions. Medical devices that enter the market, after going through the regulatory approval process, can most often be trusted.
Embracing the regulatory process can become a super-power for your venture. 👍
Within many digital health ventures, and other med tech startups, regulatory challenges are viewed as a burden or a risk.
I am of the opinion that this attitude is false. Regulatory requirements can help point a venture in the right direction, a catalyst for innovative ideas, features, and functions within a product that make it more competitive and effective.
Regulatory obligations should be viewed as an opportunity to make a better product and a stronger company. 🦸♀️
Good companies understand this, and double down on doing things right from the start.
Regulatory considerations should be included in the planning phase of product development—a venture needs a strategy.
Once underway with product development, sufficient resources and time should be allocated towards the regulatory effort, in parallel to design and engineering. This can and should be done in-house (take a look at Oliver Eidel’s OpenRegulatory to see how).
Part of the strategy should be to understand what is sufficient to meet the expectations of an auditor. Documentation should be well written without being overly verbose. Content should concentrate on the product, exercising restraint on including superfluous items that may be tangential to the core solution. A certain degree of minimalism can be effective.
The goal: establish levels of transparency that foster trust.
Good documentation, like solid research and appropriate validation, provides a window into your product, and by extension, your company. 🪟
Being appropriately open about the process, the easier it will be to create trust with your patients and health care providers.
Embrace this and you can turn regulatory obligations into an opportunity to excel. 🏃