Every successful business builds on a well-considered and intelligently mapped-out strategy. While you likely know you need a robust commercial or marketing strategy, your regulatory strategy is the true starting point when developing any health technology.
Whether you intend to pursue medical device classification or not, your regulatory strategy heavily influences your commercial approach, expansion options, and product development. Having clear oversight of the direction of your product from day one supports future investment and long-term viability. We believe that good governance is great business, and this begins long before you supply a device.
Naturally, a regulatory strategy is also a mandatory requirement within EU MDR 2017/745 and EU IVDR 2017/746, which mandate a strategy for regulatory compliance and conformity assessment procedures. However, beyond the minimum requirements, deep value lies in thoroughly evaluating your product within the regulatory landscape.
Setting the Foundation for Compliance
A strong regulatory strategy provides a succinct summary of everything you need to understand to design, build, and register your product safely and compliantly. For each planned territory or market, your strategy should include:
- A justification for device qualification as a Medical Device
- A justification for your device risk classification
- Your chosen (if you can choose) conformity assessment pathway and how you will meet that
- An analysis of all relevant international standards, regulations, guidance documents and other relevant requirements that may apply.
Each of the above should be carefully considered and documented, but most importantly, maintained over time. Regulatory requirements and business decisions may change, and it’s vital to keep your regulatory strategy document up-to-date to account for any such changes.
A strategy for regulatory compliance will form part of your product submission for approval, so starting one before you even think about registering your product is a great way to get ahead and maintain a focus on the regulatory aspects which are most important to you.
Securing Market Access
A well-crafted regulatory strategy also acts as a primary tool to review broader market access. For example, when you enter the UK healthcare market, you need to plan for legal requirements and the purchasing frameworks your customers use. Your regulatory strategy should outline your approach to critical areas like the Digital Technology Assessment Criteria (DTAC), the Data Security and Protection Toolkit (DSPT), or clinical safety standards such as DCB0129.
Reviewing your current market access needs alongside your future plans creates a comprehensive accompaniment to specific medical device considerations. This holistic approach provides a single document that you can share with internal and external stakeholders, improving organisational focus and cohesion.
Future Planning and Feature Changes
Your regulatory strategy gives you a solid understanding of your current market position while offering a mechanism to document and analyse potential product improvements.
When you consider adding new features, it is highly beneficial to evaluate the regulatory oversight those changes require. Depending on your business plans and your readiness to engage with higher-risk classification devices, a regulatory review helps you make calculated decisions. You can choose to consolidate plans to expand medical device functionality or deliberately limit product features to reduce your regulatory exposure.
To ensure long-term alignment, you should thoroughly assess both existing functionality and aspirational roadmap features. Evaluating proposed changes alongside current capabilities allows you to anticipate shifts in risk classification early, helping you design a clear, future-proof path.
Driving Expansion and Investment
Finally, performing a regulatory review establishes a straightforward position from which your business can grow. External investors and grant funding bodies expect to see clear plans and anticipated costs for your product position. A regulatory review outlines the processes and certifications you need to implement, helping you define realistic financial needs and funding requirements to achieve your goals.
Understanding the costs and timelines related to certification allows you to be transparent and forward-looking as you expand into new markets. Furthermore, a defined regulatory strategy helps you evaluate which target markets offer lower barriers to entry. This insight allows your regulatory planning to directly inform your broader commercial and expansion strategies, ensuring you direct resources toward the most efficient growth opportunities.
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Ready to map out your regulatory path?
Navigating compliance requirements doesn’t have to slow your innovation down. Whether you need support shaping your initial regulatory strategy or preparing for market access, we’re here to keep you on the right path.
