Nobody writes a regulatory strategy that commits them to doing the bare minimum  required by regulation to get a product to market and leave compliance activity to the last moment, but in practice this happens far too often. Unfortunately, a sad truth appears to be that when faced with competing pressures to bring a device to market, many innovators will focus on the technology and potential reimbursement without timely regard to compliance.

Demonstrating an appropriate understanding of your regulatory requirements in your early-stage business plan and pitch deck, will differentiate you from competitors, set an appropriate tone and increase your value proposition. 

A regulatory and compliance strategy should set the tone for your stakeholders to take you seriously.  We think it should show that you understand the regulatory and compliance challenges associated with your product  and product families in your chosen markets and it should set out how you plan to address these. So, in short we recommend even a one-page strategy evidences: 

• an appropriate understanding of your chosen market pathways and regulatory considerations. 
• confirm your approach to regulation and compliance, and 
• includes a credible roadmap for execution.

Where there is a potential for ambiguity as to whether the intended use of your products and claims fall within the remit of medical device regulations or not, we think it is important to show adequate consideration and a defensible position, especially for well-being software.  

It is also important to be mindful of other compliance activities needed to satisfy potential customers not just of the regulatory activity required to place a product on the market. In the UK this includes compliance with additional NHS standards for patient safety, data privacy, and digital technology. It may include registration with the Care Quality Commission for treatments. Across most jurisdictions data privacy and quality management governance will be required.

Once these parameters are established, a strategy should include credible resourcing and if possible costed plan for execution. Timescales may be difficult to articulate in early stages, but a sensibly staged and prioritised roadmap for execution should be included.

We’ve set out an example of a one-page regulatory and compliance strategy statement for a software as a medical device manufacturer seeking to enter the UK and additional markets with an uncertified quality management system already in place, and an example pathway for a class 2 device, but feel free to reach out if you’d like a more detailed regulatory and compliance strategy or some helpful advice.