MVP in Healthcare: How to Launch Fast Without Risking

In the case of healthcare minimum viable products, you do not have a choice of launching when you are still ashamed. Even though the speed to market is very much essential in this very competitive market, the safety, security and the regulatory compliance of the healthcare product is even more important. Then, what would an ideal healthcare MVP look like, and how can healthcare innovators be fast and not cut corners either in clinical or security? We have been able to accumulate experiences of more than 300 projects to outline how to launch a healthcare MVP as fast as possible and not leave anything behind.

In general, an MVP, which is also known as a minimum viable product is the prototype version of your product that you are obliged to launch so as to determine whether your product concept meets the precise problem that the user is experiencing. The fundamental concept behind MVP development stage is that it should be created in a form of a product that has only the basic features that are considered to be sufficient to enable that product to be functional. Once released, the developers compile feedback of the user so that they can incorporate further integrations depending upon target market demand. Nevertheless, a healthcare minimum viable product is very different compared to the regular consumer-oriented MVPs:

Key Differences Between Standard and Healthcare MVPs

Contrary to popular belief, a minimum viable product in healthcare requires different strategies. In short, where you begin is dictated by where your greatest risk is:

When to Use Each Approach

Proof of Concept (PoC) - When you are in the "Can we even build this safely?" phase, then your healthcare project requires a proof of concept to determine whether your high-risk technology idea can be successfully implemented technically. A PoC is typically meant to be internally focused. Prototype - The answer to "Will clinicians and patients use this correctly?" is to respond with a prototype. A prototype is an illustrated, interactable model of a product idea that illustrates the appearance and actions of the product. MVP - The first real milestone that provides the answer to "Does this work and comply?" is an MVP. As opposed to PoCs and prototypes, MVPs are facing and can also undergo real-world testing in controlled conditions.

Healthcare MVPs are not minimum. The process of creating one has more to do with developing a Minimum Viable and Validated Product that the users can trust, both clinically and ethically. Speed is important, though, to achieve momentum, the innovators have to tackle industry-specific development issues.

Going at Speed with a Regulatory Playbook

In the case of a company that is developing an application to be used in clinical practice, the regulatory bar is considerable - and quite reasonably so. These software products, because of their capability to influence the healthcare outcomes, bias clinical decisions, and even result in health-related damage, are subject to the FDA, EU MDR, and other regulatory frameworks in the world. Medical regulations usually imply that the development teams are required to have:

• Organized processes (ISO 13485 Quality Management System)
• Records of the design and risk controls (IEC 62304 Software Lifecycle and ISO 14971 Risk Management)
• Validated systems present even though it is only an MVP

Unlike other field-based MVPs, healthcare MVPs do not merely get user engagement. They primarily aim to prove their safety and efficacy in the real patient care settings and clinical workflow. This may involve:

• Professional reviews with product
• Usability testing
• Pilot programs approved by an IRB

Not every healthcare MVP needs to go through extensive clinical trials; however, all of them need to be based on plausible science because the border between wellness and medicine is fine.

High-Stakes User Trust

Healthcare software is not introduced to a group with high stakes (patients) and low stakes (healthcare providers) users whom the software must not fail to satisfy without seeking any alternative solution. To build this degree of trust when developing MVP, the development team will need to:

• Co-design with frontline staff to map clinical features to existing clinical pathways
• Understand and base features on medical guidelines or evidence
• Build the UX according to the best practices of accessibility (WCAG, ADA)
• Be transparent about the limitations of the application

Nailing Data Security and Interoperability

An MVP in healthcare is not even going to hit pilot or partnership conversations with a minimum level of data security. That is why encryption, role-based access, audit logs, and other existing industry standards of data security are a non-negotiable of a healthcare app on the first day. In addition to the data security, the teams of healthcare developers must consider interoperability at the initial stage in case the product has to be a part of a bigger healthcare technology environment. Interoperability involves creating an app that will share data with EHRs, hospital systems, and wearables. On the technical side, interoperability is ensured with the help of:

• Data standards, including HL7 or FHIR
• Standard vocabularies, including SNOMED CT, LOINC or ICD-10

The creation of an MVP in the healthcare industry will require between 2 and 6 months on average. The schedule mostly hinges on the complexity of the product, the regulations, and the features that have been incorporated in the MVP.

Product Discovery

The process of product development commences with an in-depth product discovery, which facilitates project stakeholders to get a very fine sense of the product purpose, users, and regulatory environment. Deliverables: Healthcare quality product specifications, wireframes, a working prototype, and an approved product business model.

Development Planning

Although at the product discovery stage, a list of must have features is defined, when the team refines the features and ranks them later, it is based on:

• Clinical necessity - What's needed to guarantee patient safety and usability?
• Regulatory risk - What characteristics might lead to increased compliance demandingness?
• Budget and timeline - How can we strike a balance between scope and feasibility?

Deliverables: Technology stack definition, team make-up and schedule, solution architecture blueprint, preliminary cost estimate.

MVP Development and Testing

Although healthcare MVP has unique characteristics in implementation, the design and development phases follow the same models of agile or iterative development as other projects, albeit with a stronger organization and a higher-level of documentation. In case the team creates apps intended to collect clinical outcomes or submit them to the authorities (FDA/CE Mark), the developers comply with the ISO 13485 and IEC 62304 standards. Deliverables: Final UI/UX design system, functional MVP, source code and technical documentation, testing reports.

MVP Validation and Release

This means that a healthcare MVP must be tested in the real world, such as through clinical and regulatory testing, by the time the MVP is nearly complete. Rather than a general release, it is initiated in controlled settings initially which can comprise:

• Pilot programs with healthcare providers
• IRB-approved studies
• Internal use deployments with collaboration with clinical advisors
• Sandbox environments coupled with test instances of EHRs or third-party systems

The prices of MVP development in the healthcare market depend on the project and the specifics of the app, the regulation process, and technologies. It is the reason why we always suggest that a person should receive a free estimation of the development company to form a realistic view of the amount of money beforehand.

Sample Cost Breakdown

Based on our remote patient monitoring platform project, here's a detailed breakdown of the costs (estimated at $50/hour):

If there is anything we have learned during 15 years in the market, it is that healthcare software development projects are a very complicated story, the one that involves numerous variables.

Begin with the Specific, Right Issue (and Not the Cool Tech)

Companies can not attempt to turn the whole care in v1 into a flip. Beginning with a small (as small as possible) wedge, such as the digitalization of a manual workflow or a specific clinical pain focus area, will assist the product in gaining first traction and credibility. Example: Teladoc did not begin as a comprehensive virtual care model. Initially, the product was a lean solution, which would provide patients with 24/7 access to licensed physicians, in the non-emergency cases.

Invest in Documentation as Part of the Product

Although the companies that intend to follow a regulatory route often have theirs in place, the companies that are developing an initially unregulated solution will often omit this step.

Design with Regulatory Constraints

In most innovation cases, healthcare innovators believe that compliance or user-friendly healthcare UX are the two options. However, it does not necessarily need to come at such a cost provided that regulatory compliance is utilized by the design team as creative restraints.

Be Familiar with Your SaMD Classification

In case your healthcare solution has one or more medical uses, which conduct those medical uses without qualifying as a hardware medical device, it is likely to fall under the category of Software as a Medical Device.

It is Not Enough to Say That Their AI is 99% Accurate, Demonstrate It

In healthcare, a company cannot go around with the claims that its algorithms are the best. The regulators such as FDA (and clinicians, at that) want concrete, real-life demonstration of your tool meeting the promise.

Speed is Never Cheap in Healthcare Innovation

You can only go so far with speed-building critical features at the expense of security, compliance and user trust. MVP in healthcare does not involve the creation of the smallest product. It is about creating safest iteration of your vision that still carves it in terms of impact on the real world. When you begin with regulatory-first thinking, parallelize clinical validation, and structure in a modular way to expand in the future, you can get into the market more quickly - without having to make cuts that end up coming back to haunt you.