Releasing Regulatory Restraints: Agile Methods at HSD
Agile Methodologies truly suit a wide range of tasks and, when aptly applied, can stoke the fires of innovation in a highly effective and efficient manner. In medical device development, allowing room for Agile methods can be difficult. It’s a heavily regulated world and in some instances, they may seem entirely at odds. However, it is possible to maintain a flexible agile approach, that is typically associated with software, in the development of complex medical devices.
As we continue the process of integrating our practices with our manufacturing arm, SteriPack, a most important priority is continuing to offer our team the latitude to freely explore, shift, and experiment to create medical devices that not only fill needs, but truly improve clinical practices and ultimately impact their patients’ quality of life.
So, how are we managing to balance that Agile approach with the stringent requirements of regulatory approval? How can team leaders adjust their SOPs to allow more flexibility in the development process?
Agile Development & Regulatory Guidance
For those unfamiliar with the methodology as a formal concept, Agile development practices are based on a combined iterative and incremental approach and are designed for adaptability, collaboration, and efficiency. HSD employs these methods in all processes, from initial concept design through product design to commercialization. They champion four core values defined by their founders: collaboration with customers, teamwork across disciplines, prompt response to change, and holding results over record-keeping.
It is this last point, of course, that is cause for concern when dealing in healthcare technology, where each step of development is subject to a prescribed process and requirements set forth by regulatory agencies such as the FDA, MHRA, NB’s and WHO, wherein each device approval submission must demonstrate exhaustive proof of safety along with disclosure of the entire planning and documentation of all development activities. While these regulations are absolutely necessary, designers and engineers can feel bogged down by the heavy documentation burden that results from a quality system based on checking a box rather than a flexible system enabling an agile approach by design.
The Balancing Act
With a continuously expanding team and evolving clientele, we want to ensure that our systems, while maintaining compliance, preserve the flexibility allowing our team to take full advantage of the new resources at our disposal. To achieve this, our quality system targets critical regulatory activities while remaining lean on prescribed actions. Fortunately, most regulations, including ISO-13485, do not dictate specific processes but rather provide a framework that enforces best practices while leaving the specifics to developers.
At HSD, we understand that quality and excellence are not the same as compliance. Our processes are based on teamwork wherein our user centered design dovetails with our client partnerships with a focus on helping physicians, helping nurses who help patients improve their lives. Our passion is people helping people.
We take steps to simplify and, where possible, reduce the burden of documentation on our staff by teaching them efficient record-keeping, making composition, access, and circulation as simple as possible, limiting leadership check-offs to only those truly necessary.
We also plan the programs to make the most of each development phase. For example, we embrace the uncertainty in the early development phases and exploit it to explore multiple design concepts, architectures while the documentation and change control burdens are lightest. In a similar light, the requirements that are “put on paper” tend to stay high level so that we can target the needs, and not get bogged down in technical details that would either be difficult to comply with when the full device is known, or need to be obsoleted with a detailed rationale. As designs progress through the development phases the details are added at the appropriate points.
While our integration continues with our broader manufacturing teams, our goal is to not only execute on these principles but to do so in a way that makes the absolute most of each part of our organization’s best practices to create a quality system that promotes innovation throughout. Meanwhile, we are pushing several products through late development and constructing new SOPs to support them. As we perform these processes, our utmost aim is to bring safe medical devices to the market that make true differences in the lives of those who need them.