Avoiding surprises in transitioning wellness products to software as a medical device

After successfully building a wellness product, healthtech leaders may want to take the next step and transition their product to software as a medical device (SaMD). But this isn’t as simple as making a few adjustments and flipping a marketing switch. It’s a dramatic mindset shift.

Because SaMD products have a medical purpose, they are subject to many more regulatory requirements than a wellness product. These requirements can include clearance from regulatory bodies—such as the U.S. Food and Drug Administration (FDA)—as well as demanding a specific, mandated SaMD development process, which is more challenging, expensive and lengthy than traditional software development processes.

Beyond regulatory challenges, the transition process from wellness to SaMD product includes hundreds of opportunities for missteps that could lead to negative patient outcomes, losses of time and money, poor adoption by clinicians and legal pitfalls. While a “move fast and break things” ethos can work when building a consumer-based product, it isn’t an option when developing a SaMD solution.

Is your company preparing to work on a SaMD product? These three actions can help position you for success, avoid unpleasant surprises and speed up time to launch. 

Regulations require a quality management system (QMS) and a quality team to ensure that certain standard operating procedures (SOPs) are used to guide the process from early user research activities to design and development, all the way through to post-launch surveillance activities. New product development under a QMS means documenting all critical product decisions, exploring and mitigating any potential patient risks, validating that each product feature matches the original documented plan and, of course, not making product adjustments that require going through the entire process again.

Because a QMS is so critical and the design and build process for these products is so complex and nuanced, quality team members should have experience launching SaMDs. Not surprisingly, talent with this background is hard to find. It can take years and cost millions of dollars to stand up an internal quality team properly, establish and audit the QMS, and develop the necessary capabilities and infrastructure from scratch.

A contract manufacturer can shave quarters—if not years—off your SaMD launch: Proactive companies that prioritize rapid time to market often use an outside firm with SaMD expertise. These outside firms, known as contract manufacturers or CMs, can help a healthtech company hit the ground faster while minimizing long-term regulatory risk. And even if a healthtech company is building SaMD expertise in-house, a CM can augment areas where the internal team is less experienced, which will accelerate the capability-building process. Most CMs have already built an ecosystem of third-party and pre-validated vendors that can start work immediately, speeding up time to value.

The time-saving potential of a CM goes beyond using their team’s experience. CMs can help with the considerable preparatory work that needs to be done before starting design and development work. This includes setting up the QMS and going through audits from accredited third parties, while also preparing for unscheduled audits by regulators. The SaMD software development life cycle (SDLC) process needs to be well documented and designed to meet both regulatory and QMS requirements. And third-party software tools must be vetted, tracked and validated prior to their use. Using a CM’s QMS, SDLC and pre-validated tools can minimize this preparatory work, allowing you to immediately focus on the strategic work of defining and building a great SaMD product.

Other ways to “borrow” expertise: While the easiest approach may be to outsource the QMS and related preparatory work to a CM, there are other strategies that can accelerate your internal capability building. Some CMs and other firms offer advisory services or will serve as subcontractors in a niche role. CMs may also offer a QMS accelerator featuring SaMD-specific SOPs that have been audited to comply with ISO 13485, as well as an SDLC that is IEC 62304 compliant and a set of pre-vetted tools.

While there are different ways to borrow or leverage these SaMD-ready foundational capabilities, each with its pros and cons, they all allow you to benefit from third-party investments and expertise. The result: less time and less risk. 

It’s important to think about the entire product life cycle early in the SaMD strategic planning process, because building a SaMD product gives you less flexibility than other types of wellness and consumer products.

Who you work with matters: It typically takes a village to design, develop, validate and deploy a SaMD. Regardless of how ambitious your strategic plan is, you will likely need some vendors for near-term tactical purposes, others to handle ongoing tasks that aren’t core to your strategy and possibly a few that rise to the level of strategic partner. QMS regulations require a substantial amount of work to qualify and onboard your first set of vendors, and other regulatory issues can make it even harder to change certain vendors after launch. To control your own destiny, it’s important to create a savvy make, buy and partner strategy that includes both short- and long-term perspectives.  

Plan the last mile from the start: Most healthtech companies are accustomed to working with consumer apps and nonclinical IT systems. Once again, SaMDs are different, as integrating with hospital EHRs, radiology information systems and other healthcare systems may be necessary for a SaMD to function—and are often essential to a product’s clinical adoption. These last-mile needs shouldn’t be an afterthought. Instead, they should be included in a SaMD’s product definition, anticipated by its technical architecture and considered when qualifying vendors. If you fail to do this, you will run the risk of having to adjust features late in the process because of QMS design control, adding time-consuming rework.

When you’ll need to think big: You should keep the big picture in mind when architecting a SaMD solution. It’s vital to anticipate a number of items: current and future features, including separating SaMD and non-SaMD components; localization requirements for various geographic markets; cultural and regulatory differences between regions and countries; and the possible roadmap for an expanded intended use and features (IUF).

Where the details of code quality assurance matter: Tech companies often use patch releases to resolve quality assurance issues after a product launches. For SaMD, though, this is a recipe for disaster. Because the health of a patient is at stake, it’s critical that quality assurance processes and tools be systematic and best in class when coding a SaMD product. This also helps avoid the risk of a product recall or a relaunch, which is much more costly for a SaMD than a consumer app.

How to best communicate with regulators: Regulatory bodies like the FDA play such a significant role in a SaMD’s product journey that regulatory experts should be embedded in your product team. There are many benefits that can result from this, but an important one is to ensure strategically proactive communications with regulators. Given that the digital product and regulatory landscapes are constantly evolving, early stage discussions can provide insights on possible regulatory paths and evidence requirements for a potential solution. This information is helpful as you develop your product strategy. While regulator communications may be new to healthtech companies, this is an issue that veteran medical device firms carefully consider early and often.

SaMD study designs are far more clinically rigorous, lengthy and expensive than those for wellness solutions. Failing to prepare sufficient clinical evidence can result in regulatory approval delays, waste of critical resources and poor commercial adoption by clinicians and health systems. There are several critical factors to keep in mind to help you limit mistakes on your path to clinical validation.

Clinical-grade evidence: Healthtech companies must prove, through a multi-staged process, that their SaMD products are safe and meet their intended clinical use. The vast majority of SaMDs will require human factors testing prior to FDA submission. And an increasing percentage of SaMD products demand rigorously designed clinical studies for approval. It is far less often that observational studies will meet the FDA’s and clinicians’ expectations, even for low-risk SaMDs. Instead, healthtech companies should be prepared to conduct high-quality clinical studies that can take significant time to design, plan and execute.

No (easy) second chances: A SaMD product is defined by its clinical intended use (IU) and indications for use (IFU). And after you’ve submitted a SaMD product for regulatory approval, the IU and IFU can’t easily be modified. Evidence strategy and study design are integral elements that need to be anticipated even before finalizing the product design. The implications go beyond today’s FDA submission because once your IU and IFU are validated and approved, you have effectively set the boundaries for any claims you make in future marketing efforts.

The sooner you start thinking about clinical validation and dovetail it with your product strategy, the better.

SaMD products can offer tremendous rewards for healthtech companies. Clinically sound SaMDs can justify significant profit margins, and more importantly, improve patient care in a scalable manner. SaMDs can also place companies in a position between the two realms of digital health and digital medicine—an intersection of strategic importance for the future.

If you are part of a healthtech company entering the SaMD space, some of your prior capabilities and successes in digital health can help as you transition your wellness product to SaMD, but you’ll still need a new set of SaMD capabilities. Building these new capabilities, while avoiding mistakes, makes it challenging to deliver your first SaMD to market quickly. Thankfully, working with a CM allows healthtech companies to minimize the risks and time associated with establishing a SaMD-specific QMS and SDLC, learning new specialized product management issues and navigating new evidence and regulatory hurdles.

The opportunity for SaMDs is significant, but the key to commercial success is accelerating the various capabilities that can help avoid both the expense of unnecessary rework and, more importantly, the opportunity costs of launch delays.

ZS SaMD Factory, an affiliate of ZS.