This is the start of our series about developing an MVP.
MVP stands for Minimum Viable Product. Its goal is to get valuable user feedback as early as possible during the implementation phase, and it needs to be developed fast. An MVP is the version of a new product that allows a team to collect the maximum amount of validated learning about customers with the least effort. An easy example from the finance sector could be a banking app where you can already make a bank transfer but cannot change the settings.
MVPs are often developed using Agile techniques, which means that features can be added over time as needed. Often, a low-code or no-code solution can be proposed as well. MVPs should always provide first value to the user for them to be successful. But how can the fine line of providing just as much as needed with the least amount possible be met while still being compliant?
Challenges with regulation
In regulated industries, such as digital health, MVPs can be especially difficult to develop. User research and market knowledge are paramount in ensuring the MVP meets the needs and complies with regulations. It's essential to ensure that the MVP provides enough features to meet user needs without going overboard and creating something that isn't necessary or practical.
When considering what features should be included in an MVP for digital health applications, it's essential to assess the impact of user experience on patient safety and satisfaction. An MVP should have a solid foundation that includes all the necessary regulatory requirements, such as authentication/authorization measures, data privacy and security protocols, usability testing, etc. before any additional features are added.
Meeting all these requirements at once before launching an MVP can be a burden for innovative product ideas and slow down development tremendously. Principles like MoSCoW or user story mapping can help to provide the crucial components and not follow the Hippo approach. Additionally, familiarizing stakeholders and control functions with the product idea and vision while outlining a roadmap can help to remain flexible and agile.
The importance of data protection
An essential thing to keep in mind while developing an MVP for healthcare is that it needs to meet a wide range of regulations. First of all, it needs to comply with the Protected Health Information list that comprises but is not limited to the following:
Patient and physician’s names
Geographical data (like addresses)
Social security numbers
Medical record numbers
Health plan beneficiary numbers
The collected data must be protected from unauthorized access while maintaining easy access for authorized parties. Data exchange, copying and storage must be evaluated in terms of risk management and regulated accordingly. Furthermore, all authorized users should have access to role-based control and data management option within a user-friendly interface.
The products in the European Union area must comply with the GDPR directive. The only exceptions to the rule are products that don't collect or process sensitive data. Choosing the right partner for developing the MVP in a highly regulated environment like healthcare is important.
More than only data protection
There are also other regulations that we need to take into account when developing a medical device, be it a minimum viable product or a complete one:
Medical Device Regulation (MDR): a set of EU regulations to ensure that registered medical devices meet the required standards and compliance.
Software as a Medical Device (SaMD): regulations imposed by medical experts (of International Medical Device Regulators Forum) on what counts as a medical device. For software to classify as a medical device, it needs to serve as such, supporting the diagnostics or treatment process.
In Vitro Diagnostic Medical Devices Regulation (IVDR): a regulatory basis for placing on the market, making available and putting into service in vitro diagnostic medical devices on the European market.
ISO 13485: a certification asserting that a product classed as a medical device meets the proper regulatory compliance laws and customer needs. It’s not a mandatory certification. However, it can bring a range of benefits when acquired.
It is important to team up with a regulatory affairs expert who knows the right regulations for your target market even before starting the MVP design phase.
Patient-centricity – develop an MVP for who it matters
When developing MVPs in healthcare, it is essential to consider feedback from doctors and patients to ensure patient-centricity. Doing so can help ensure that MVPs are tailored to the specific needs and preferences of the patient population. Patient feedback can be obtained through surveys, interviews, focus groups, or other UX Design methods. This feedback must be considered throughout the agile process when developing MVPs in healthcare.
Surveys and interviews can provide qualitative data about the needs of a particular patient population. For instance, surveys can ask what features they want to see in an MVP product and why. Focus groups can also dive deeper into patient preferences and gain insights that may not have been revealed in one-on-one conversations with individual patients. This qualitative data can be beneficial for determining what features should be included in an MVP for healthcare applications.
Customer needs assessment is also essential in MVP development for healthcare products. By understanding customers' needs before MVP development begins, developers can create Minimum Viable Products tailored to those needs from the beginning. This type of pre-planning helps ensure that MVPs provide enough value to users quickly and effectively, making them more likely to succeed in the long run.
Most prominent areas of the MedTech industry that encourage MVP approach
Let's have a look at those areas in digital healthcare in which starting off with the MVP might be a good idea:
When is it best to refrain from developing a Minimum Viable Product?
In such a complex industry as healthcare, MVP can prove to be an excellent way to showcase a new product and answer essential questions about its use and market readiness. However, in some cases, developing a full-featured product might be a better decision, even if it requires considerably more time and resources.
Not all health conditions can be approached with an MVP. Acute conditions and those that require urgent support provided in a professional facility with reliable equipment that needs to be tested in clinical conditions might not be a good choice for developing an MVP product. In such cases, product-market fit is often better tested with marketing experiments and methods grounded in the lean startup methodology.
Continuous planning and learning
A practical MVP roadmap includes the features to be developed and tested, with specific timelines for each stage and regular check-ins with control functions. This will ensure that your MVP is created fast and provides enough user value but can also outline when e.g. non-functional requirements can be expected. Additionally, it's important to collect both feedback from users and analytical insights throughout the Minimum Viable Product development and testing process to ensure that it meets their needs.
Get feedback even earlier
Prototyping is another critical component when developing MVPs. They allow rapid iterations and experiments with different features even before releasing an MVP to a broader audience. Including prototyping in analysis and sprint, preparation enables the development of things that were already tested, keeping the overall development cost-efficient.
When a Minimum Viable Product is launched, e.g. for a Beta-Testing phase, the user behaviour can be monitored and measured before increasing the customer base. Once an MVP has gathered enough user feedback and met all customer requirements, it can be enhanced with additional functionalities to turn it into a complete product that can be launched. After launching the MVP and developing based on metrics and user feedback, agile development starts and enters the next level on the way to a product.
In conclusion, patient feedback is essential when developing MVPs in healthcare applications. Using surveys, interviews, focus groups, customer needs assessments, and prototyping techniques, developers can create MVPs that provide sufficient value to users quickly and effectively while allowing room for future iterations based on user feedback over time.