MVP and MMP: a winning strategy for medical device development
It goes without saying (or you’d think so anyway) that strategic planning goes hand in hand with medical device development for regulatory approval and market success. However, it is often overlooked.
To achieve market success, it’s important to consider and integrate market needs and viability, health technology assessments, and health economics into your product development strategy. However, we cannot underestimate the key role both a Minimally Viable Product (MVP) and a Minimally Marketable Product (MMP) has in market success. Believe it or not, understanding your target market should happen before starting your regulatory journey. Allow us to explain why…
MVP vs MMP: what is the difference?
The MVP focuses on achieving the minimum features necessary for regulatory certification. This confirms the product meets safety, effectiveness, and cybersecurity regulatory requirements, which is needed for gaining initial market approval. Whilst passing regulatory scrutiny and receiving approval is crucial, this does not guarantee market success.
The MMP, on the other hand, builds on the MVP by incorporating features that meet specific market requirements. This is how you make sure your idea becomes a medical device success. But, as with everything, developing an MMP requires a lot of work, going beyond basic regulatory standards to make the product attractive to buyers and have a clear value to both users and investors.
Before you start to develop a medical device, it’s important to know the difference between the two. Understanding these concepts can help you navigate the regulatory landscape more effectively and ensures your product meets both compliance standards and market demands. This can save time, resources, and increase the chances of market success.
It is also important to understand that we use the terms MVP and MMP a little bit differently than they are used outside of our view of medical devices, for instance by the Agile Alliance, but with complementary expected benefits:
Developing the MVP to gain an understanding of customers' interest in a product that will gain regulatory approval;
The MVP contains the smallest amount of functionality that can gain regulatory approval.
Adapting the Agile Alliance’s point about Potential Costs in the cited article:
Proper use of an MVP means that a medical device manufacturer may dramatically change a product that they deliver to their customers or abandon the product together based on feedback they receive from their customers and the regulators. The minimum aspect of MVP encourages teams to do the least amount of work possible to get useful feedback (Eric Ries refers to this as validated learning) which helps them avoid working on a product that no one wants and/ or that cannot win regulatory approval.
By implementing both concepts thoughtfully, you can navigate the caveats of medical device development and move beyond just having a great idea, ultimately achieving both regulatory approval and market success.
Assess the market needs, then start the health technology assessment
Understanding the target market's specific requirements is the best place to start developing a product that actually meets real-world needs. It is only from there that market-specific certifications and standards, such as the Digital Technology Assessment Criteria (DTAC) for the NHS or DiGA criteria in Germany, should be considered. By meeting these requirements, you confirm your product is not only compliant with applicable regulations but also positioned for success in your target market.
Health Technology Assessments (HTAs) play a critical role in demonstrating a product's value to healthcare providers. It assesses both the technical and economic aspects of the product, confirming it meets the necessary standards. The NICE Evidence Standards Framework (ESF) is a valuable tool in this process, offering criteria to evaluate both the immediate and long-term benefits of the product. This comprehensive evaluation assures that the product meets clinical and economic standards, which is needed for market acceptance.
Health economics further strengthens your product's market position by analysing its cost-effectiveness and value proposition. This involves evaluating the potential savings and return on investment healthcare systems can achieve by adopting your new technology. Convincing healthcare providers and payers of the economic benefits of your device is where widespread adoption occurs. By demonstrating cost savings and improved outcomes, you make a compelling case for the integration of your product into existing healthcare systems.
When is the right time to start MVP and MMP evaluations?
The Technology Readiness Level (TRL) framework, developed at NASA during the 1970s, helps assess a technology's maturity by assigning a level from 1 to 9. While it's common to start MVP and MMP evaluations around TRL 4, when research transitions to development, beginning these considerations even earlier can be extremely beneficial. Early evaluations show that technical feasibility aligns with market needs from the outset.
Starting evaluations during TRL 1-3 involves incorporating market research, feasibility studies, and prototyping from the very beginning. Being this proactive helps identify potential regulatory and market challenges early on, allowing time for adjustments before significant resources are invested.
There are various TRL or RRL (Regulatory Readiness Level) frameworks in the public domain, all modifying the original NASA one. Below is Hardian’s version:
How to make the most out of early planning
Early and thorough planning is crucial for a product’s marketability and regulatory compliance. While you may feel unprepared, involving expert advisers and consultants in the early stages of development can provide valuable insights and guidance. Not only can it help shape your product strategy, regulatory pathway, and market entry plan, engaging with the experts early on in the process ensures that your development process aligns with market needs and regulatory requirements.
Proactive steps include detailed market research, understanding the competitive landscape, and preparing for potential regulatory hurdles well in advance. You can then integrate market feedback, using multidisciplinary teams, and assess your product's market fit. Meaning your product not only meets regulatory standards but also becomes a success in your target market.
A successful transition from MVP to MMP
At the end of the day, it’s always about balance. Balancing regulatory requirements with market needs is ultimately what will be the most helpful for a successful transition from MVP to MMP. Whilst it’s easy to get carried away, not thinking about the market fundamentals alongside regulatory approval can lead to issues down the line.
At Hardian Health, our expertise spans clinical strategy, scientific validation, regulation, health economics, and intellectual property. We work collaboratively and transparently to provide comprehensive support, ensuring that your medical device is not only regulatory-compliant but also market-ready.
Hardian Health clinical digital consultancy focused on leveraging technology into healthcare markets through clinical strategy, scientific validation, regulation, health economics, and intellectual property.
