SaMD development: 6 Steps for acceleration while decreasing costs

Unlike traditional software, SaMD development faces additional layers of complexity. Developers must ensure patient safety and comply with regulatory standards from the very beginning. Key challenges include regulatory requirements, cybersecurity concerns, interoperability with other healthcare systems, and user adoption.

• Regulatory complexity: Navigating frameworks like the FDA’s regulations in the U.S. or the EU Medical Device Regulation (MDR) in Europe can be time-consuming and costly if tackled too late in development.
• Cybersecurity and data privacy: SaMD solutions handle sensitive healthcare data, so they must prioritize security to prevent data breaches and meet privacy regulations like HIPAA or GDPR.
• Interoperability: Integrating with systems such as Electronic Health Records (EHRs) ensures SaMD products can be used in real clinical settings, but this often presents technical challenges.
• Patient engagement and usability: A technically sound product can still fail if the user experience is too complicated, making adoption by patients and clinicians less likely.

Agile development methodologies, known for their iterative and flexible approach, are particularly useful in SaMD development. With Agile, teams can break down the project into smaller cycles called “sprints,” focusing on continuous testing, feedback, and adjustment. This helps catch potential problems early, preventing costly rework and ensuring compliance as you go.

• Faster iterations: By working in short, focused sprints, the team can address problems as they arise, reducing the overall development time.
• Early testing and feedback: Agile encourages frequent feedback from stakeholders—patients, healthcare providers, and regulators—to ensure that the solution meets real-world needs and expectations.
• Built-in compliance: Adopting Agile allows teams to integrate regulatory requirements early and throughout the process, reducing the risk of encountering compliance issues later.

Building everything from scratch is resource-intensive and can lead to inflated costs. Many MedTech companies find value in partnering with established platforms that provide ready-made infrastructure, pre-configured compliance features, and security protocols.

For instance, at HTD Health, we collaborated with Galen Data, a secure cloud platform, to develop a Class II medical device. By utilizing Galen Data’s existing infrastructure, we were able to create a patient-facing app within three months—a process that would have otherwise taken much longer and been significantly more expensive had we built the infrastructure ourselves.

• Built-in compliance: Platforms like Galen Data come equipped with FDA, HIPAA, and GDPR compliance, allowing teams to focus on developing core features rather than regulatory setups.
• Faster time to market: Leveraging pre-built platforms helps you avoid months of backend work, accelerating product release.
• Focus on core features: By delegating infrastructure and regulatory matters to the platform, your team can dedicate more time to refining the product’s user experience and functionality.

Even the most advanced SaMD solution will struggle if it’s difficult to use. A user-friendly design can improve the chances of the software being adopted by end users, be they patients or clinicians. Human-Centered Design (HCD) is a principle that focuses on creating intuitive, user-friendly interfaces based on user needs and feedback.

• Early user testing: Involve patients and healthcare providers in the testing process from the start to ensure the software is easy to navigate and meets practical needs.
• Behavior change design: Features like reminders or progress tracking can engage users and encourage healthy habits, which in turn boosts the effectiveness and adoption rate of the software.
• Iterative design: Continuously testing and refining the software based on user feedback reduces the risk of major redesigns down the line, saving time and money.

With the high stakes of healthcare data, cybersecurity cannot be an afterthought in SaMD development. Embedding cybersecurity early on helps prevent potential breaches, avoids costly fixes, and ensures regulatory compliance.

• Data encryption: Encrypt patient data during transmission and storage to protect sensitive information.
• Secure software development: Follow secure coding practices and conduct regular vulnerability assessments to identify and address potential risks.
• Regular security audits: Schedule ongoing security audits to ensure your software remains secure as new threats arise.

Ignoring regulatory requirements until later stages of development can lead to significant delays, rework, and added costs. Planning for compliance from the start allows companies to address regulatory needs proactively.

• Engage regulatory experts early: Bringing in regulatory experts at the beginning of your project helps guide your compliance strategy, reducing surprises and minimizing rework.
• Continuous documentation: Maintaining comprehensive documentation as you develop the product keeps you aligned with FDA, MDR, and other regulatory guidelines.
• Use proven frameworks: Leverage frameworks that provide templates and tools for meeting regulatory requirements efficiently, making the approval process smoother and faster.

Accelerating SaMD development without driving up costs is achievable with a strategic approach. Agile methodologies, established platforms, user-centered design, and built-in cybersecurity help MedTech companies bring innovative solutions to market faster and more affordably.

By building key partnerships, utilizing proven tools, and focusing on the needs of users and regulatory bodies alike, MedTech companies can navigate the challenges of SaMD development, delivering high-quality products on time and within budget.

Developing software as a medical device (SaMD) involves more than just technology—it requires an in-depth understanding of regulatory landscapes, cybersecurity, user experience, and agile methodologies. At HTD, we blend healthcare expertise with cutting-edge technology to help you navigate these complexities efficiently.

Whether you need support in meeting compliance requirements, integrating secure platforms, or optimizing design for patient engagement, HTD is here to provide customized solutions that fit your unique goals. Let’s work together to accelerate your SaMD development, streamline your costs, and bring high-quality medical devices to market that enhance patient care. Reach out to HTD today to explore how we can support your journey in healthcare technology.