Elekta

Veronique Audet

Regulatory Design Practitioner

During my 20 years of experience in the medical device (MD) industry, product development has faced unique challenges in adapting to meet the increasing demands of users and regulatory bodies. Amidst this dynamic landscape, I’ve witnessed two seemingly contradictory approaches that have gained traction: ‘failing fast’ and ‘slowing down to move faster.’

The fundamental question around product development revolves around timing – when can we provide this value to our customers? This consideration is essential for business success, yet it presents a formidable challenge in MD product development. Finding the right balance between speed and thoroughness is vital for securing deadlines.

Detecting issues during the later stages of product development can be expensive and lead to delays in product releases. However, employing these two approaches allows for early problem identification, alignment between design output with input, and ultimately contributing to a successful clinical deployment.

Similar to the concept of fail-fast in upfront innovation, development also employs a controlled approach to failing fast, which is crucial for achieving value during productification. ‘Failing fast’ aims to identify critical aspects early in the process, ensuring that designers and developers deliver the optimal solution corresponding to the clinical need, verifying compliance with all necessary regulations, as well as identifying technical flaws that could impede successful deployment and adoption at customer sites.

Detecting issues early and maintaining vigilance throughout the process involves adopting a stepwise approach. The development is broken down into subreleases that represent a specific set of features. These are installed in a clinical representative environment that mimics real-world conditions and allows testing deployability and upgradeability. Reviewing the product in sub-releases during development – with a multi-disciplinary team of users and tech leads – not only ensures that the right solution is being built, but also that it complies with various regulatory standards such as usability, interoperability and cybersecurity.

These environments, often hosted in the cloud, enable easy demonstration to users of the device under development. Rapid creation and recreation of these environments for testing purposes are optimized and potentially automated. By leveraging cloud platforms, one can easily scale resources as development grows and developers can swiftly provision and configure environments, even as teams are geographically dispersed.

"Automation Plays A Central Role In Enhancing Efficiency And Maintaining Quality Throughout The Entire Process, Ensuring Product Stability And Reliable Environments."

Automation plays a central role in enhancing efficiency and maintaining quality throughout the entire process, ensuring product stability and reliable environments. As software evolves, the number of test cases grows, and manual testing struggles to keep up. Whether you’re testing a single feature or the entire application(s), automation guarantees reproducible results. Furthermore, automating deployment processes significantly reduces the time spent configuring these environments. Additionally, automating the traceability matrices and documentation ensures up-to-date formal documentation accompanies the product’s development, minimizing the burden of regulatory paperwork at the time of product release. Consequently, a sub-release becomes ‘ready for release,’ positioning it as a potential final candidate for regulatory submission or clinical release. However, properly setting up these automations demands dedicated time and effort, and their success hinges on effective cross-functional collaboration.

The ‘slowing down to move faster’ approach emphasizes the importance of thoroughly understanding requirements and ensuring that the design undergoes comprehensive discovery phases. This ensures that teams have a clear grasp of all inputs in the design. This proactive approach aims to avoid future problems that may increase considerably in complexity further down the development cycle.

The discovery phase serves as a crucial precursor to ‘formal’ product development, understanding the ‘how’ of the ‘what’ to deliver. During this phase, the focus is on concretizing objectives and requirements to refine the technical goals and describing the boundary conditions and the device’s technical feasibility. Investing in this phase pays dividends by minimizing avoidable risks and maximizing overall success.

MDs directly impact patients’ lives, so it is paramount for teams to understand the clinical context. For individual contributors, gaining a holistic understanding of the patient treatment journey and their role within it adds considerable value to the end solution provided. This implies that early in the design process, they have direct engagement with users to understand how users intend to treat their patients. On-site observations of patient care in clinical settings also provide first-hand insights into use cases, successes, and areas that require improvement.

Similarly, engineers should be well-versed in ISO 13485, FDA regulations, and other relevant standards. When designers and developers receive consistent training on these regulations, they can incorporate the requirements into the design and verify compliance early.

Both approaches contribute to successful product development by ensuring alignment, minimizing risks, and fostering a proactive mindset. They demand unwavering dedication and discipline from designers, developers, and manufacturers. They must allocate time, resources, and tools to safeguard success throughout the entire development process.

In summary, by establishing efficient environments with iterative sub-releases, teams can learn from mistakes and adapt swiftly (“failing fast”). Investing time upfront in training and discovery can significantly enhance the success and impact of an MD in the long term (“slowing down to move faster”). These approaches accelerate development cycles and shorten time-to-market to deliver real value to those who matter most – the patients.