Software as a Medical Device: What is SaMD?
Software as a Medical Device (SaMD) requires healthcare companies to act differently to succeed. The old models of healthcare product development just don't work.
What is Software as a Medical Device?
Healthcare regulators use the term, “software as a medical device,” to refer to software that is not part of a hardware medical device and is intended for a medical purpose, such as:
- diagnosing, monitoring, treating, or alleviating health conditions
- preventing diseases or injury
- monitoring patient outcomes
- supporting or evaluating physiological processes
Software that is and what is not SaMD
A SaMD must perform its medical purpose(s) without being a part of a hardware medical device and target individual patients (i.e., a specific disease or condition).
Let’s look at three examples in the sleep apps market. A mobile app that:
Software as a Medical Device: Why innovate with SaMD?
Market demand and readiness for SaMD are growing as companies launch viable new products to the market: year-over-year market size growth is outpacing that of even telemedicine.
Between 2020 and 2027, the compound annual growth rate is estimated to be
Current trends in the healthcare industry revolve around digital solutions. Pharmaceutical and medical companies must compete with startups that are disrupting the healthcare industry.
Patient readiness enables mainstream adoption opportunity
The next wave of opportunity in healthcare will be in SaMD. Patients’ expectations are changing: every other aspect of their lives is digitally enabled, data-driven, and available at their fingertips.
This paradigm shift in patient behaviour requires that the healthcare industry create new digital solutions that:
- address the current challenges in customer experiences
- bridge innovation gaps in preventative solutions, wellness, and wellbeing
- deliver seamless, high-quality and convenient patient-centric care
A growing number of patients are ready and willing to share their data and pay out-of-pocket for digital solutions. SaMD represents a tremendous opportunity for evolvable, high-impact, and value-added digital products that will reach mainstream adoption quickly.
Technology readiness enables faster time-to-market
We’re experiencing exponential advances in technology that enable us to create any data-driven, digital, and personalised SaMD that we can imagine. Each iteration of mobile and wearable devices is smarter and packed with more sensors than their predecessor. Software products represent an opportunity to move away from specialised hardware and toward adaptable and evolvable software solutions.
Competing in the digital era requires you to innovate and deliver in weeks, not years. Innovators can enter and disrupt the software market with lower starting costs. Patient-centricity, business agility, and the ability to operationalize disruptive innovation quickly are the ultimate differentiators.
SaMD is suited for both continuous and disruptive innovation
In addition to the digitalization of currently existing processes and improvement of broken experiences, SaMD has the potential for serving many medical purposes and unmet patient and healthcare provider needs through truly disruptive innovation. For example, how can you improve drug compliance by gamifying chronic disease management, or use large population-based data to monitor and prevent illnesses?
A few better-known examples of SaMD applications:
Software as a Medical Device: Regulations & compliance
Medical devices are highly regulated; how you design, build, test, validate, and implement SaMD will vary across geo-political boundaries, medical specialities, market segments, and patient populations.
Regulators classify SaMD according to the level of risk posed to patients. A SaMD has a medical device classification and a software safety/risk classification. How regulators determine and define medical device classifications varies across governing bodies.
Medical device classifications
Software safety/risk classifications
The classification of your SaMD determines the level of rigor regulators expect in:
- software documentation and development
- the quality management system
- risk management processes
- the clinical evidence supporting its safety and effectiveness before you can market your product
- post-market surveillance and support
The IEC 62304 is an internationally recognized standard that provides requirements for designing, developing, and maintaining SaMD (and SiMD) across the software life cycle.
European regulators require an independent conformity assessment by a notified body ensuring IEC 62304 compliance to achieve CE marking as well as market a SaMD in Europe.
SaMD must be developed and maintained within a quality management system (QMS).
- A QMS refers to processes that an organization should establish, implement, and maintain to consistently adhere to customer and regulatory requirements.
- Manufacturers must document and maintain the effectiveness of a QMS compliant with ISO 13485 or a national standard.
- Manufacturers must also have an ongoing process for identifying potential sources of harm, estimating and controlling the associated risks, and monitoring the effectiveness of risk control measures across the product life cycle (including in post-market surveillance).
- The ISO 14971 requires that manufacturers systematically apply management policies, procedures, and practices to plan, perform, and document risk management activities (e.g., as part of a risk management system).
Examples of the regulations, systems, and standards that we operate within frequently in Europe and the US:
Software as a Medical Device: Compliance by Design
With Compliance by Design, organizations can launch SaMD products on average 60% faster with all the necessary regulatory compliance
Why Compliance by Design?
In our experience, regulatory compliance is much more of a process challenge than a tooling issue. Long lead times are often the result of a siloed approach to risk and compliance. Product teams, for example, often find themselves at the mercy of several subject matter experts who enforce stringent requirements without understanding the context and risks involved.
Other common challenges relating to regulatory compliance include:
- Siloed product, engineering, design, and compliance and risk management teams
- Complicated internal auditing and governance procedures
- Absence of executive sponsors
- Inadequate stakeholder engagement or alignment
- Lack or inadequate customer validation
- Different regulatory requirements across countries and, in some cases, medical specialities
- Talent gaps
- Changing regulatory requirements (e.g., new laws)
Organizations tend to believe their governance, risk management, and compliance (GRC) processes and standards are carved in stone. However, the reality is that GRC processes can be integrated as part of an end-to-end, transdisciplinary process. Highly regulated companies can strike the right balance between speed and control.
Compliance by Design has helped our clients:
✓ Manage regulatory and internal process challenges
✓ Create evolvable products reliably and efficiently
✓ Accelerate time-to-market
✓ Protect your business from disruptors and outsiders
✓ Evolve the product at the pace of patient needs
What is Compliance by Design?
Our approach leverages agile software development values and principles to build regulatory compliant SaMD in weeks, not years.
Software as a Medical Device: Organizational capabilities to build & evolve SaMD
To succeed in bringing SaMD to market, you need to be a digital-first organization with high business agility and strong digital capabilities that can evolve over time.
Becoming or growing as a high performing digital organization is difficult. Whether you’re currently a big established medical organization or a small startup with big dreams, you’ll face much of the same organizational challenges, in addition to size- and healthcare-specific challenges.
But to meet your customers’ and your investors’ needs effectively and efficiently, you need to know what good looks like to outline a blueprint for your digital transformation journey.
Based on our experience, these principles can help your organization to successfully develop and manage SaMD:
Use micro-transformations to anchor digital transformation capability
Digital transformation is a continuous, iterative process: an organizational capability that will differentiate your organization from the competition, long-term. This organizational capability is not unique to the healthcare market; however, changing a well-established, traditional medical hardware company might present more challenges and need more time than would a tech or digital-first company entering the healthcare market.
What worked for our clients is a pragmatic, micro-transformation model, where hands-on management divides the work into a series of micro-goals designed to deliver real customer value and allow cross-functional teams to simultaneously test the values, principles and practices of the end goal state in a real-world context.
Digital transformation should be part of every company culture that is competing on digital experiences. Download our book
Shift from project to ongoing product development
Many organizations fail to build a Minimum Viable Product (MVP) because of antipatterns in their organizational behaviour. One antipattern is to approach building a SaMD as the sum of loosely connected projects. In today’s world, organizations need stable, incrementally adjusted and integrated cross-functional teams. You need product managers, developers, designers, quality assurance, and regulatory specialists owning and evolving a SaMD product throughout the product life cycle to be successful.
But building and launching an MVP is not enough. Digital products need to continuously evolve to match the fast-changing needs of the end users. Therefore, organizations need to shift away from funding initiatives based on an annual budget, and instead incrementally allocate and reallocate funding to product streams based on results. It requires clear leading and lagging indicators and a metric of success based on tangible outcomes that end users value. Good product management prioritises delivering business value by roadmapping and hypothesis testing, rather than following a project plan.
Lean-agile organizational processes are non-negotiable
In modern software development, building and maintaining new products in a lean-agile manner is table stakes. Engineering must incorporate elements of both continuous delivery and continuous improvement, optimized across the entire value stream, in order to reduce wasteful activities like handovers and wait time and to improve the overall work quality.
But lean-agile processes don’t end with engineering; it should scale to the entire organization. People closest to the work should be empowered to make decisions, teams should own products and outcomes, feedback loops should be built in all processes, approvals, escalations and governance should be made as lean and as fast as possible. How your organization funds and prioritises value, resources, your product teams with talents or reinforces any other organization level processes should be all done in an lean-agile way in order to drive high business agility culture and cross-functional behaviour across departments to successfully meet any unpredictable change in market.
Increase your proximity to users
A key differentiator in successful new product development is your proximity to your users. Understanding the burning needs and desires of your end users and solving these problems is key to making your product sticky. We always say “fall in love with the problem and not the solution.”
To set your product development up for success, you ought to build a feedback mechanism and a solid pool of innovators and early adopters who will continuously test your ideas and make them better. This process is even more important to SaMD than to any other market, as you might be potentially creating products that save lives. Therefore, receiving both qualitative and quantitative feedback will be crucial and highly regulated. You will need to work with not only patients and HCPs, but medical advisors and boards who are subject matter experts in the medical field you are designing your products for.
We always advise to first test the problem space with a focus group before you even start building anything to gain a deeper understanding of the needs and desires of patients. Then build a POC in 2-3 weeks to test the problem-solution fit by understanding the patient's and HCPs’ interest and first thoughts of your solution idea. If your POC is gaining enough traction, you integrate the feedback and build it out into an MVP in 12-16 weeks to test your product-market fit.
Short-cycled iterations and continuous user feedback is therefore absolutely crucial to minimize your risks and time-to-market and maximize value delivery and competitive strength. Furthermore, you need to make sure you are defining your product success the right way, focusing on your patient-centric north star metric and all the leading and lagging indicators around that to mitigate risk and inform your SaMD product roadmap.
Humanize your digital products by prioritizing accessibility and experience
Building a superior digital end-to-end experience is always your unique value proposition when you are building a human-centric product. When you are building a SaMD, you are building an experience for real patients. Humanize your digital product and make it safe, comfortable, and effective for persons with different capabilities, limitations, and characteristics. For example, think of how you would present information for elderly patients with cognitive impairment and young adults with a learning disability.
Beyond accessibility considerations, design products that can accommodate for all the variation that you’ll see in different customer bases.
It’s important to design the user interface to enhance patients’ experience and engagement. For example, animations are more effective in educating patients how to use a medical device than are lengthy written guides. In the end, SaMD is about solving a problem in the built environment with a digital solution–you cannot ignore the human element of interacting with patients.
Actually launch and iteratively grow in multiple markets
Here are the two most common ways companies fail when building and marketing a SaMD: they fail to reach customers who would actually benefit from using their product, or they see product launch as the final step and fail to evolve and respond to changes in user needs.
Most health organizations that successfully build a regulatory compliant SaMD get stuck at the go-to-market stage. Large organizations face a lot of complexity, e.g. who owns the go-to-market strategy and success of a globally developed application? How to optimize for local markets? How to localise? How to drive adoption? How to drive local ownership of the app? Small organizations face different challenges at this stage, mostly related to reaching customers, brand recognition and trust, driving engagement, and handling financial pressure from investors. Very rarely do organizations look beyond the product building phase; having a strategic plan around how to drive adoption and make your product ‘sticky’ is critical to successfully launching your product.
Similarly, after launching an MVP in one or more markets, most organizations begin to lose touch with their customers. They focus on solely maintaining the product or becoming a ‘feature building factory’ without user-tested strategic intent. We believe that before augmenting MVP scope with new features, organizations should wait for users to start using the SaMD product and measure their engagement and interactions and collect market specific data. Product managers should design and run appropriate experiments to optimize the MVP based on user analytic data and find the right product-user fit before expanding to new markets or adding new features. We strongly believe that systematic growth comes from elevating constraints and optimizing the weakest links in your user engagement and experience. This way, we believe you will scale a product that has a stable foundation, good fit with user needs.
Deal with regulatory compliance in an agile way
Compliance by Design is our methodology to accelerate digital products’ time-to-market amidst regulations & internal process challenges.
Most organizations treat compliance as a penultimate step near the end of the product building phase. When product and regulatory teams are siloed, products are built without regulatory constraints in mind.
When you bring compliance requirements into the software development process, digital teams that are building SaMD will understand the landscape better and be empowered to create software with regulatory compliance built-in. Engage compliance stakeholders and prioritise regulatory tasks in every sprint. To learn more about how to build compliant SaMD the agile way, read our
Develop your own tech, data and product capabilities in house
In the era of software, not having your own internal capabilities to evolve your own products in the long run might be a fatal strategic decision. Want to accelerate digital transformation at your organization? Want to shorten the runway to product launch? It’s okay to strategically partner with companies that have experience in developing and launching successful SaMD–but make sure that you partner and work with them as an integrated team. You need to learn everything from these partners and build up your own technical, data, and product capabilities. SaMD is not a project, but a product that must evolve over time; you need to develop these capabilities in-house.
You can also insource by using existing APIs and headless architecture. Focus on the work that makes your SaMD product truly unique. Not sure how you can use APIs or tools to enable product development? Check out our hub on Headless technology.
Never outsource work that is integral to your unique value proposition. The foundation of your business cannot be dependent on another firm.
Focusing on ROI for your medical mobile app? You’re searching for value in the wrong place.
Software as a Medical Device: Our experience
In this critical market, speed isn't just good for business—it improves lives.
Here are some real world examples of how we've help leading organizations bring SaMD to market and evolve them based on patient feeback. All while ensuring regulatory compliance and high-quality software.
Improving lives with the first React Native app with CE marking for patients in the European Union
Rebuild of native Dysport dosing guide app to a Progressive Web Application to drive adoption and scalability
Software as a Medical Device: Practitioner content for experts
We've years of experience building and launching SaMD.
Eager to learn more? Here is more content to help you.
Software as a Medical Device: Community events
Participate in community events
Join us on Tues Nov 29 at 11 am EST.
Speaker: Danielle Dorfman Faruq, Regulatory & Quality Director at Kintsugi.
➡ Danielle led Apple’s Digital Mental Health Study and the development, testing, and deliverables for de novo submissions of Apple’s first FDA-regulated features on the Apple Watch. Now, she’s on a mission to make mental healthcare access available for everyone, with a novel AI-based digital health product to detect signs of depression and anxiety from speech.
Strategies to get your product into the hands of real users in the US
Clinically validate and launch digital products in highly regulated markets
Insider’s tips and learnings from developing, testing, and getting FDA clearances for digital health products
Our in-person and online events will feature live speakers, open discussions, and opportunities for networking. We cover a range of topics related to SaMD and digital therapeutics.
We created this meetup to invite, inspire, and illuminate creativity and ingenuity in the SaMD space. Since we began as an Angular meetup in 2013, we’ve learned so much about agile software and product development.
Supporting the tech community and advocating for innovators are part of our DNA—and we’re here to give back and support innovators in this nascent space.
Whether you have something to share or just want to be a part of the SaMD community, you’ll be in good company.
We can’t wait to meet you!
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