Bridging the Gap: SaMD Strategy for Teams Built on Hardware

Randy Horton

Published on: April 9th, 2025

Executive Summary

As medical technology rapidly evolves, Software as a Medical Device (SaMD) is becoming increasingly integral to innovation. However, teams accustomed to traditional hardware devices often encounter significant hurdles when adapting their regulatory and quality strategies to software-centric products.

In Orthogonal’s recent webinar, industry experts Ashley Miller (Hologic), Carl Washburn (Eli Lilly), and Bernhard Kappe (Orthogonal) shared insights into successfully navigating these challenges, moderated by Randy Horton (Orthogonal). This article distills the core themes from the webinar, offering practical guidance to facilitate a smoother transition which is typically very challenging when shifting from hardware-oriented practices to a robust SaMD strategy.

Common Ground: What Hardware and SaMD Share

Fundamentally, hardware and SaMD share regulatory pillars, including design controls, risk management, validation, and compliance with standards such as ISO 14971. Both rely on documentation, traceability, and verification. However, for SaMD, this demands deeper consideration due to the complexity and variability of software interactions.

“Both must comply with ISO 14971 application of risk management to medical devices.” – Carl Washburn, Director, Digital Quality, Eli Lilly

SaMD’s Unique Challenges

Despite shared foundations, SaMD introduces nuances demanding a shift in thinking and processes:

Dynamic Change Management:

Unlike the fixed nature of hardware after manufacturing, software requires agile change processes that can manage frequent updates, which may occur daily. Effective change control demands proactive planning and adaptable regulatory frameworks.

“You have to have a change control process so agile that you can make changes literally in a matter of hours if needed.” – Carl Washburn, Director, Digital Quality, Eli Lilly

Continuous Cybersecurity Vigilance:

Cybersecurity isn’t a static checklist but an ongoing commitment. Software deployed on connected platforms requires regular updates and adherence to standards such as ISO 27001.

Redefining ‘The Device’:

Cloud-based platforms and external services integral to software functionality challenge traditional definitions of device boundaries, complicating regulatory and quality oversight.

Complex User Interfaces as Labels:

Software may have hundreds of interactive screens, each constituting labeling, which complicates regulatory submissions and demands precise documentation and usability validation.

Reevaluating Human Factors in Software

With SaMD, user interaction errors are as impactful as hardware failures, highlighting the necessity for detailed human factors analysis. Usability must extend beyond technical functionality to ensure intuitive, error-resistant interactions. Communicated digital instructions and accessible user interfaces have become regulatory essentials.

“You have to consider what if the user presses the wrong button? What happens if the user doesn’t see the outcome that they’re hoping for? How do you mitigate that sort of risk?” – Ashley Miller, Director, Regulatory Affairs, Hologic

Navigating Complex Software Ecosystems

SaMD rarely operates in isolation. Interoperability with third-party hardware and external software systems introduces shared risks. Managing these requires a holistic, “system of systems” approach, including integrated risk assessment and end-to-end testing. Additionally, software architecture must anticipate and accommodate external changes, such as smartphone platform updates from Apple or Android.

“You need to have a larger perspective… a system of systems development plan or approach to making all of these interoperable systems interoperate correctly.” – Carl Washburn, Director, Digital Quality, Eli Lilly

Organizational Integration: Breaking Silos

One significant cultural shift required by SaMD is integrating software and hardware teams. Treating them as separate entities can lead to disconnected systems and regulatory complications. Instead, a unified, cross-functional approach, backed by clear quality agreements and shared accountability, ensures alignment and successful product development.

Scaling for Organizational Maturity

Companies differ significantly in their readiness for SaMD adoption:

Startups: Benefit from early engagement with external consultants and targeted training, focusing on high-value regulatory activities.
Larger Firms: Require established internal knowledge-sharing platforms or centers of excellence to leverage insights and scale effectively across teams.

Proactive evaluations of internal capabilities help determine whether to build, partner with, or outsource software development activities.

Data as a Strategic Asset

Intentional, compliant data management is central to the SaMD strategy. Operational data serves a purpose beyond regulatory compliance, providing strategic insights for product refinement, proactive monitoring, and innovative business models, including subscription or service-oriented approaches.

“Think about data as an asset rather than exhaust.” – Bernhard Kappe, Founder and CEO, Orthogonal

Preparing for AI Integration

The growing presence of AI in SaMD necessitates careful regulatory and quality considerations. The dynamic nature of AI models requires ongoing validation of real-world effectiveness. Ensuring clarity and strong documentation around AI integration helps maintain compliance and boosts market confidence.

“Regulators are going to expect you to use that same data to monitor for post-market surveillance complaints and for things that are going wrong.” – Ashley Miller, Director, Regulatory Affairs, Hologic

Strategic Recommendations for Leaders

Successfully transitioning from hardware to SaMD involves strategic clarity:

Assess the internal maturity of your R&D organization realistically before initiating SaMD projects.
Clearly define intended use and risk profiles early to streamline regulatory pathways.
Embed quality, cybersecurity, and usability into the initial design, avoiding costly post-development reworks.

Conclusion: Embracing the SaMD Paradigm

For teams with a solid foundation in hardware expertise, embracing SaMD presents a challenge and an essential evolution. Orthogonal’s webinar highlights the necessity of agile, integrated processes, proactive risk management, and strategic foresight. The transition from hardware to SaMD is not about reinventing the wheel; it’s about recalibrating your approach, fostering internal collaboration, and leveraging digital innovation to enhance patient care effectively.

Traditional hardware teams can confidently transition to successful Software as a Medical Device (SaMD) development with careful planning, clear communication, and strategic adaptability.

Watch Webinar Recording

Bernhard Kappe orthogonal software as medical device

Randy Horton, VP of Solutions and Partnerships, Orthogonal