The phrase “Minimum Viable Product”, or MVP, is now standard language when speaking with start-up companies about their market strategies. An MVP is a cut down version of a dream product that provides customers with only those features they find critical in your product. To some MVP may mean a demonstration version of your product used to obtain valuable feedback from customers or investors for your new development project. However, to me this is more of a mock up or a prototype, not an MVP, and obtaining this sort of feedback with minimum resources (time and cost) is integral to the success of any project.

In IDE’s opinion, the MVP is the minimum product we can take to market successfully, allowing a start-up or new business within a large organisation to generate positive cash flow and fund further development work. Even more importantly, the right MVP will validate the product or business concept by proving its value to the customer. No matter what feedback is generated during a demonstration or clinical trial, nothing validates the value of a new product like a customer revenue stream.

“Designers always want to design the perfect product. Instead, they need to be controlled and directed to give me my MVP.” We have heard this often from our clients. But is it true? To us this problem occurs when a designer loses focus on what they are designing. Design is a quest to meet all stakeholder requirements however, the focus is often only on users, clinicians and patients. We believe other stakeholders such as suppliers, manufacturers and distributors must be consulted as well, to ensure a project’s success. Unquestionably, the person holding the project purse strings is a critical stakeholder, as no product will get to market without the required budget. So understanding your budget and what you can achieve with the available resources is an important step in preparing a development plan that allows you to succeed by finishing with a product that generates positive cash flow.

Minimum viable medical device

The MVP vernacular comes from the same place many start-up catch phrases start – the world of IT and the Internet. We all know from experience that software is often released as a beta version with the attitude – ‘let’s test it out to see what happens, and we can always release a patch to fix problems later’. This “wait and see” strategy cannot apply to a medical device where lives are at stake, however, the principle of developing and executing a plan that will provide a Minimum Viable Product still hold true. You just need to re-define the meaning of “minimum”.

Our experience demonstrates that by engaging all stakeholders early to address priorities such as regulatory, manufacturing, safety, clinical, and end user needs early in the development process, you can establish a path that will reduce your time to market, and determine a reasonable set of minimum viable product requirements. 

How do you define your MVP?

Nothing can replace early stakeholder consultation. You must gather information to understand your product offering by answering questions such as:

• What is the core problem or unmet need you are trying to address?
• What is the value proposition that a customer will see in your new idea?
• What are the critical characteristics and features of your concept or idea?
• When evaluating existing products, what features are unnecessary or must be replaced?

We all know that bringing a medical device to market can be a long and complicated process. What we are attempting to achieve is a shorter, lower cost project – a Minimum Viable Project. We can also achieve this by efficiently managing our timeline and path to market. Once again, this is where early consultation with stakeholders will help us by answering questions such as:

• What usability or clinical trials are required?
• What quality levels must be achieved?
• Which regulatory authorities must be consulted?
• What biocompatibility level must be established?
• What are the risks and how will we manage them?

The earlier we answer these questions, the more effectively we can plot our path to market. In conclusion, we believe the combination of early stakeholder involvement, an understanding of your budget and budgeting process, and a thorough risk analysis, are invaluable in determining your MVP and will help you establish a successful development plan for your medical device.