As technology advances, the lines between mobile applications and medical devices are blurring in ways that have healthcare leaders, software developers, and regulators alike facing new and unprecedented challenges.
Just over ten years ago, the FDA began regulating mobile applications and software under similar legal frameworks as medical devices. Over the ensuing decade, as mobile devices changed the way that people access information and make transactions, widely cited studies now show that current trends in mobile technologies stand to transform how healthcare is delivered, how much it costs, and its impact on patient experiences going into the future.
Emerj Senior Editor Matthew DeMello recently spoke with Urvashi Tyagi, Advisor and former Chief Technology Officer at ResMed, on the ‘AI in Business’ podcast to discuss strategies to monetize digital solutions, collaborate proactively with regulators, and simplify software architecture to drive growth and innovation in healthcare. After recording the podcast, the pair were joined by Pieces Technical Co-founder and CEO Tsavo Knott to open a broader conversation on what these challenges look like from a software development perspective.
Pieces is an AI-driven software company that builds a platform to enable software developers to work more efficiently. ResMed is a medical equipment company that specializes in cloud-connected devices for treating sleep apnea and chronic obstructive pulmonary disease (COPD). The company develops solutions such as CPAP machines and ventilators, which the company claims enhance the quality of life for individuals with respiratory conditions.
Together, their conversation sheds light on actionable insights in two key areas for healthcare leaders:
- Streamlining development for highly regulated software products: Helping developers adjust to new roles in regulated industries and working environments by decoupling codebases, enabling agility by making development roles interchangeable, and minimizing context switching.
- Embracing modernization in Med- and HealthTech: Adopting an “80/20” rule for modularizing code to enable rapid changes while maintaining smaller regulated portions, allowing larger legacy enterprises to achieve startup-like agility.
Guest: Urvashi Tyagi, Advisor and former Chief Technology Officer, ResMed
Expertise: Business Development, Innovation, Software Development
Brief Recognition: As CTO, Tyagi lead ResMed’s Digital Health Technology team for the last two years, driving the innovation and adoption of its cloud-based digital health platforms, as well as investments in AI and machine learning. She has since moved to an advisory role on ResMed’s board. Tyagi has over 25 years of experience in IT and mechanical engineering, user experience, finance, business development, and executive leadership. Before joining ResMed, she served as chief technology officer and senior vice president at ADP.
Guest: Tsavo Knott, Technical Co-founder & CEO of Pieces
Expertise: Coding, Software Development, Entrepreneurship, Interactive Media, Computer Science
Brief Recognition: Tsavo graduated from Miami University in 2018 with a Bachelor’s Degree in Game and Interactive Media Design as well as Computer Science. Before co-founding Pieces in 2020, he served as vice president and co-founder of Accent.ai, a language learning platform.
Streamlining Development for Highly Regulated Software Products
Amid their opening discussion on mitigating software rework for medical software, Tsavo Knott asks about the experience of developers on the front lines, particularly in building products and using reusable modules. He seeks insights into their frustrations and what they wish to improve, referencing the challenges of long and delayed timelines when making changes.
Urvashi responds by noting that developers in both regulated and non-regulated industries face similar issues, especially in legacy environments. Many Fortune 500 companies are transforming from non-technology sectors to becoming tech-driven, often dealing with monolithic systems. She notes that these trends are particularly acute in the Med- and HealthTech sectors, mirroring a familiar dynamic business leaders have seen play out in the financial services space:
“Most of the big healthcare companies will need to go through this journey, and many of them have started this process. It will be about time when they will prioritize this, because there will be significant threats coming to the ecosystem from very agile, very innovative startups that will actually put pressure on the rest of the industry. Just like how the big banks in the financial sector got a lot of pressure from the FinTech world over the past decade, and they accelerated their investment in the pace of financial sector innovation.”
– Urvashi Tyagi, Advisor and former Chief Technology Officer, ResMed
Developers frequently experience frustration due to limited visibility in the deployment process and the need to address issues repeatedly after handing off their work to fellow developers. Both speakers agree that driving efficiency and flexibility through interchangeable roles is crucial to overcoming these challenges.
Tsavo emphasizes the importance of tools that enable developers to seamlessly pick up where others left off. These tools increase velocity and reduce reliance on individual developers, allowing teams to either lower the number of developers needed for a project or use the same team to ship more features. Even with regulated code as a bottleneck, efficient development practices help mitigate the challenges of long production timelines.
Urvashi builds on Tsavo’s points, stressing the need to avoid dependency on individual developers to mitigate risks and ensure continuity if someone leaves the organization or moves to another project. She also emphasizes making the smallest possible changes to reduce risks and suggests decoupling medical and non-medical codebases. By decoupling, approximately 80% of the code can be non-regulated, enabling more efficient development. She further notes that change advisory noards (CAB) are often established to manage production risks, further enhancing efficiency.
Among the advantages of a decoupling approach that Urvashi mentions:
- Allows internal regulators to focus on critical patient safety aspects rather than being overwhelmed by the entire software stack, leading to a more efficient regulatory process.
- Minimizes the number of issues and bugs that need to be reported to external regulatory bodies, as 80% of the codebase no longer falls under strict regulatory requirements.
Urvashi then discusses incremental modernization as essential, though sometimes inefficient, for enabling developers to focus on building features and delivering code to production. Continuous delivery pipelines ensure quality while transforming the system architecture incrementally, allowing for faster deployment and increased developer engagement.
Both speakers also address context switching as a major challenge for software developers working on medical applications. Tsavo notes that developers moving between projects can feel like they are re-onboarding each time, creating a productivity bottleneck. Urvashi agrees, pointing out that context switching affects all sectors, not just regulated industries:
“[Context switching] is the real problem, and that’s the problem we want to avoid. And there are pretty reasonable incentives to make sure, to minimize the technical debt, make sure to follow the DevOps and the development TechOps practices so that you have a developer that is responsible for end-to-end. They wrote the code, the unit test, that the integration test, and hence in this case, you don’t need a manual scheme – doing QA testing from a regulation standpoint and documenting it for this 80% of the code base. You can now release that code into production, and now you can move on to your other tasks and see a pretty big incentive, both from a business standpoint as well as from a development standpoint.”
– Urvashi Tyagi, Advisor and former Chief Technology Officer, ResMed
Embracing Modernization in Med- and HealthTech
Tsavo and Urvashi then turn to the benefits of applying an “80/20” rule by modularizing code into regulated and non-regulated segments. In the context of medical devices, Urvashi notes that about 80% of the software is non-medical and, therefore, does not require the same level of regulatory scrutiny.
Urvashi highlights that the approach enhances scalability and reduces development costs, allowing developers to iterate more quickly, introduce new features, and address issues without unnecessary delays. Adopting the 80/20 model can make teams more agile, helping companies keep pace with rapid technological advancements seen in other sectors.
For legacy enterprises to achieve agility similar to startups, Urvashi emphasizes the need for large companies to undergo cultural and architectural transformations. Legacy healthcare enterprises must shift from regional and business-specific products to developing global platforms that can be deployed across different markets. Achieving such a shift requires breaking down silos, fostering a collaborative culture, and encouraging seamless workflows.
From an architectural perspective, she notes that decoupling medical and non-medical software is also essential to:
- Create modular and scalable systems that also simplify device and digital architecture.
- Reduce regulatory complexity and shorten time-to-market, allowing developers to focus on adding value.
Regarding timelines for achieving such agility, Urvashi explains that transformation depends on a company’s commitment and urgency. According to Urvashi, there are generally two types of companies engaged in a transformation journey:
- Companies that recognize the critical need for agility and initiate incremental modernization efforts proactively
- Others that only begin these transformations when market pressures and competition threaten their business
However, modernization is a continuous journey with no endpoint, as companies must consistently adapt and innovate. Urvashi argues that taking an incremental approach to modernization allows businesses to improve their capabilities and address needs effectively without the drawbacks of long-term, large-scale projects. By adopting modernization patterns like the triangular pattern, companies can gradually transform their architecture while maintaining efficiency and competitiveness.
Tsavo adds that the rapid pace of innovation is outpacing the ability of regulatory bodies to adapt, creating a unique challenge for companies seeking total agility. Despite ongoing modernization efforts helping reduce friction in development, the lag in regulatory compliance requirements can lead to an imbalance between innovation and regulation.
Tsavo emphasizes that aligning software advancements with regulatory frameworks in advance will be crucial for companies striving to achieve true agility in the future.
