You Are Developing an Innovative Product and Need to Understand the Regulatory Steps, Plan Your Resources and Assess the Impact of a Partnership: Where Do You Start?

Do you recognise this situation?

You are developing an innovative medical device perhaps incorporating artificial intelligence or an emerging technology. You have a clear product vision, but the regulatory questions remain unclear:

• What risk class does your product fall into?
• What are the steps to access the European market and the US market?
• And if you are considering an industrial or technology partnership, how do you anticipate the regulatory impact of that choice on your roadmap and resources?

This is a frequent situation for startups and companies in development and the answers to these questions directly determine investment, partnership and planning decisions.

What was at stake

In this type of project, three challenges converge:

• Product classification and qualification: a fundamental step that determines the applicable requirements, the conformity assessment procedure, and therefore the entire regulatory pathway. For an innovative medical device, particularly one incorporating software functions or artificial intelligence, this step is often complex and requires in-depth analysis of the applicable regulatory texts and guidance.
• Regulatory impact analysis of a partnership: the choice of an industrial or technology partner is not neutral from a regulatory standpoint. Depending on the nature of the partnership and the responsibilities of each party, the manufacturer’s obligations, assessment procedures and timelines can vary significantly. Anticipating these impacts upfront is essential for negotiating a partnership on solid foundations.
• The regulatory roadmap and resource impact: understanding the steps, their sequence and their duration makes it possible to plan human and financial resources realistically, identify critical milestones and anticipate the risk of delays. A challenge directly linked to business objectives and discussions with investors or partners.

What was done

I supported a startup in defining its regulatory strategy for an innovative medical device incorporating artificial intelligence, intended for use in dermatology. The mission covered several complementary areas:

• Classification and qualification: in-depth analysis of European regulatory texts and guidance applicable to software and AI-enabled devices, to determine the risk class and associated requirements.
• Regulatory impact analysis of the partnership: study of several technology partnership options, with for each one an analysis of the regulatory implications: qualification of the parties, responsibilities, impact on the conformity assessment procedure and on CE marking.
• CE regulatory roadmap: identification of the steps, timelines and resources required to obtain CE marking, with an analysis of manufacturer obligations and watchpoints to anticipate.
• US regulatory strategy (FDA): definition of the regulatory pathway to access the US market, including product qualification under FDA requirements, identification of the applicable submission procedure and an estimate of the associated costs.

What changed

The startup had a clear and documented picture of its regulatory pathway in Europe and the United States. The different partnership options had been assessed from a regulatory standpoint, with their advantages, disadvantages and planning impacts. These elements directly fed into discussions with potential partners and investors.

One lesson from this experience: the richness of the content produced must be calibrated to the real needs of the teams. Concise, decision-oriented deliverables, accompanied by interactive restitution sessions, are often more effective than an exhaustive report and this is the approach I favour today.

→ Are you developing an innovative medical device and need to understand your regulatory pathway, assess the impact of a partnership or plan your resources? A One Health Compliance Technical Day allows you to explore these questions in a targeted way, in one day with your team  to move forward with clarity and make your decisions on solid foundations.

Sandra Dejean, PharmD –  Founder of One Health Compliance

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