BrainTrust #7: Medtech's Agile Transformation: Accelerating Patient-Centered Innovation

A Regulated and Measured Industry Adapts to Agile Innovation.

The healthcare sector is constantly striving for better patient outcomes. Yet, the development of medical technology, often lifesaving, can be slow. These traditional linear development approaches, while meticulous in terms of safety and regulatory compliance, can take years to bring new devices to market, leaving a lag for potential impact options for patients.

Enter Agile methodologies - a project management philosophy that emphasizes iterative development, rapid prototyping, and continuous feedback loops. These principles, widely adopted in software development, are now transforming the medtech innovation paradigm. By embracing Agile, companies can accelerate innovation, improve device usability, and ultimately deliver more personalized and impactful patient care.

Lessons from the Tech Titans: How Speed Can Breed Innovation

The typical discussion on the pace of iteration revolves around healthcare being a regulated space.? Illustrative is the impact the experiment-heavy, iterative approach has used to redefine the similarly regulated spacetech industry. SpaceX results have shown the ability to exponentially drop the cost of low-orbiting satellites, paving pathways for affordable and widely available communications. McKinsey & Co. previously highlighted a similar culture in F1 racing, with next year's step-up innovations being developed in parallel with this year's focus.

Imagine applying this concept judiciously to aspects of medtech, such as user interfaces, cross-platform interoperability, or delivery systems. Agile methodologies could revolutionize these areas and offer more adoptable, personalized, and integrated solutions. For example:

• A medication adherence app, for instance, could receive real-time user feedback and iterate based on data to improve engagement.
• Similarly, a wearable health monitor could be quickly updated with new features for remote patient monitoring, thanks to a more agile development process?

Legacy: A Linear Path to Innovation

Traditionally, medtech development has followed a linear path. Each stage, from identifying user needs to product launch, is documented, reviewed, and built upon. This ensures safety and regulatory compliance, but it can hinder responsiveness to evolving and changing needs and requires considerable resources for iterations, customizations, and workflow integrations—real-world necessities for any broadly adopted consumer-facing product.?

While there are countless real-world examples that could benefit from the ability to use the market to drive product feedback and prioritize pipelines versus linearly advancing the value proposition, some notable examples from both medtech players and technology entrants include:

• Philips' Digital Pathology Solution aimed to streamline diagnostics but faced delays due to its rigid development approach, preventing it from quickly adapting to changing market and user needs.??
• Verily’s StudyWatch, which envisioned generating longitudinal data (Project Baseline, Aurora studies), was limited in its ability to iterate features and adapt to user feedback.
• IBM Watson Health encountered setbacks with its AI-powered healthcare solutions due to the slow pace of traditional development.?
• Apple Health Kit aimed to be a cross-platform repository of biometrics and biomarkers integrating into a patient's healthcare journey, but limitations in data privacy and security hindered adoption.

These examples highlight a growing need for agility, as companies that have started to adopt novel methodologies have achieved:

• Faster Time-to-Market: significantly reduce the time it takes to bring new medical devices to market, potentially leading to a 15–25% decrease based on insights from adjacent industries.
• Improved User Experience: continuous feedback allows for user-centric design, resulting in devices that are more intuitive and effective for patients.
• Enhanced Regulatory Compliance: focus on risk management and documentation can streamline the regulatory approval process .

Bridging the Gap: Innovating with Agile and Critical Chain Methodologies in a Regulated Environment

Agile methodologies, however, offer a compelling solution by prioritizing flexibility and iterative development, allowing for quicker adaptation to user feedback and changing market demands. This translates to a faster time-to-market for innovative medical devices, potentially improving patient outcomes.

To meet the needs of the regulated medtech industry, the Association for the Advancement of Medical Instrumentation (AAMI) published AAMI TIR-45, a set of guidelines specifically for incorporating Agile practices into medical device software development.? These guidelines promote a risk-based approach. Critical activities, like design control and verification & validation, are still meticulously addressed within the Agile framework. The approach also emphasizes robust documentation practices and change management processes. This ensures all changes are tracked and documented, maintaining compliance with regulations like IEC 62304.

Furthermore, Critical Chain Project Management (CCPM) can improve Agile. CCPM complements Agile by focusing on planning based on success with buffers for risk. By prioritizing features based on risk profile, CCPM helps streamline development and mitigate potential delays caused by unforeseen technical hurdles by focusing on critical task management and buffer management, thereby mitigating variability. Together, Agile and CCPM allow medtech development to leverage the advantages of both methodologies, achieving faster development cycles while adhering to strict regulatory requirements.

Early Wins in the use of these methodologies?

• Reduced Cycle Time: Philips Healthcare has embraced a Scaled Agile Framework (SAFe) for development within their IT operations. Early results show reduction in the average release cycle time from 18 months to just 6 months and shrinking feature cycle time of 58%, from over 240 days to under 100 days, now allowing for "release on demand.” Philips has scaled this to five major releases per train per year on demand, indicating a maturing capability. Additionally, quality improvements have been noted, indicating fewer issues with new software releases. which highlights their improved capability to meet market demands efficiently.??
• Real-world Data:? Intuitive Surgical's approach melds their Agile methodology with validation, continuous improvement, and real-world clinical outcomes data, leading to a culture of continuous improvement. Additionally, the company provides surgeons with the My Intuitive app, which captures detailed surgical data. This allows the company to evaluate innovations based on not only traditional workflow benefits but also clinical metrics such as reduced recovery time, pain, and complications as they innovate. This can be seen as surgeons transitioned from the da Vinci “Si” to “Xi” and now the “5” surgical systems. It will be worthwhile to monitor this approach as innovation shifts to the power of big data and AI.??
• User centric design:? Siemens Image Recognition Software: implemented a Kanban framework through cross-functional teams. This resulted in a reduction in the development time for their new heart monitoring system. The faster development cycle allowed them to incorporate real-time user feedback from physicians, leading to a more user-friendly design and ultimately improving patient care.?

Key Considerations for Successful Agile Implementation in Medtech

Implementing Agile in medtech requires a strategic shift from traditional, linear processes to a dynamic, iterative approach: where these methodologies are most beneficial, assesses industry readiness, and identifies best practices for implementation.

Where it makes sense: ?Digital health and data-driven decision-making, critical aspects across therapeutic areas, are prime examples of where Agile methodologies excel. These approaches thrive in environments requiring ongoing engagement, tracking, monitoring, personalization, and integration – all hallmarks of these fields.

Readiness: ?McKinsey conducted an Agile360 survey for the MedTech industry that found partial readiness for transformation, with strengths in shared vision (67%), dynamic resource allocation (78%), and culture (78%). However, it also reveals significant gaps, particularly in leadership (43%), IT infrastructure (25%), and customer-centric practices (45%). These gaps suggest that while the foundational elements for agile methodologies are present, the MedTech industry's journey towards comprehensive agile adoption is more extensive and will require a multi-faceted, long-term approach. The readiness level overall stands at 54%, reflecting a need for balanced improvements across all areas. Strategic leadership and IT infrastructure are immediate areas for action, requiring investment and attention to ensure the infrastructure can support agile practices effectively. The readiness for agility is an ongoing process, not a one-time goal, demanding continuous adaptation and evolution of practices alongside a company-wide commitment to holistic change.

Best Practices to Implement:? Success hinges on several pillars by which medtech can navigate the complexities of Agile adoption:

• Leadership Commitment: Endorsement from top leadership is crucial, along with awareness, interest in details, and understanding of both the successes and challenges associated with implementation.
• Cultivating an Agile Mindset: Shift from simply questioning the value proposition to actively discovering the optimal one. This involves directly involving end-users in the feedback loop, expanding beyond traditional Key Opinion Leaders (see BrainTrust #4).
• Focused Training and Skill Development: Equip teams with the knowledge, mentorship, and feedback they need to utilize the tools they likely already have access to.
• Integrated Risk Management: Embed Agile methodologies seamlessly within the existing risk management framework, ensuring continued focus on safety and effectiveness throughout the entire product lifecycle.
• Modular Architecture: Design with modularity in mind. Separate non-regulated aspects (e.g., UI changes, API integrations) from core, regulated components (e.g., therapeutic functions). This approach facilitates rapid updates in non-critical areas without requiring complete system overhauls. This paves the way for smoother regulatory processes and more agile responses to market or clinical needs.

The Future of Medtech: An Agile Landscape

By embracing Agile methodologies, medtech companies can unlock a future of faster, more impactful, and more adoptable innovation that will be part of a broader vision for optimized patient care and a more responsive healthcare system. A tailored combination of program management methodologies, such as Agile and Critical Chain Project Management (CCPM), can be implemented as catalysts for change. Agile, with its roots in software development, champions iterative cycles, rapid prototyping, and continuous feedback. CCPM focuses on critical task management and buffer management, which can help teams mitigate variability.? These frameworks work together to create a dynamic environment free from conventional bottlenecks, where innovation can flourish.

Sources:

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16. Synergio adapted from FDA Guidance documents for 21 CFR Part 820
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As we observe the ever-changing landscape of healthcare, this reflects Netra Health's ( Puneet Gupta and Manan Atit ) current understanding of the topic. We believe in fostering ongoing dialogue and welcome insights to refine our perspective in light of emerging developments.? Visit us at www.netrahealth.com to learn more about Netra’s mission to drive innovation by guiding and connecting startup companies with investors, advisors, and experts who share our passion for transformative impact.

Netra Health had the opportunity to co-author this article with Vivek Kulkarni ( Vivek Kulkarni ), who possesses decades of experience as a medical device leader across research and development, manufacturing, and program management and within cultures large or early-stage.?

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