Introducing a Different Approach to Developing Compliant Software as a Medical Device (SaMD) with Coauthor
Alan Parkinson
Technical Director
Coauthor is a new, innovative software compliance tool being introduced this week at the Med-Tech Innovation Expo that helps with the development of compliant Software as a Medical Device. Coauthor has been developed by Hindsight Software, a leading provider of software development tools and a company who are determined to bring innovative solutions to complex regulatory environments. Hindsight Software are committed to merging compliance with modern software development practices, and Coauthor exemplifies this well.
A Developer-First Approach to Compliance
It is easy for software developers to rely on tools like AI for policy creation when developing their new products, but Alan Parkinson, the founder of Coauthor comments “There is a lot of hype about AI helping to create policies and plans for medical device manufacturers’ QMSs. Even if the generated documents were compliant, it doesn’t take into account how software developers prefer to work or help with configuring development tooling and software applications to support the process and policies.”
Coauthor’s strategy for this challenge is to provide a set of pre-built IEC 62304-compatible policies, SOPs, and plans aligned with modern software practices. It goes beyond just policy generation by configuring development tools to enforce these policies and plans. Due to Coauthor's collaboration with regulatory compliance and medical standards experts (Fieldfare Consulting) to develop these policies, it is certain that the product meets regulatory requirements.
Coauthor recognises the historical divide between compliance and software developers, often likened to oil and water. To bridge this gap, Coauthor takes a developer-first approach, fully integrating with GitHub. Through comments and Pull Request checks, it highlights policy violations to developers in real-time, ensuring immediate compliance feedback.
Early Adoption Produces Better Results
Traditionally, compliance processes have been carried out at the end of the development lifecycle, leading to increased costs, delays, and more work for the developer. But in an attempt to improve their software development, finance companies have recently taken a different approach. These developers have begun incorporating compliance into the early stages of development and it has proven to be a game-changer - resulting in faster product releases and enhanced developer productivity.
Dr. Heather Carre-Skinner, Director of Fieldfare Consulting commented “it is absolute paramount that compliance teams and the development teams work together to ensure success with getting their SaMD to market, and Coauthor helps with this. It was important to me that Coauthor was designed so that all compliance housekeeping tasks were taken care of, so teams could focus on the higher level tasks such as product launch”.
Embracing Shift-Left Compliance
From the very inception of a SaMD project, the Coauthor tool can ensure its compliance and maintain that compliance throughout the development lifecycle. This significantly reduces the time required by regulatory affairs teams to prepare submissions for notified bodies, cutting down from months to mere days or weeks. Additionally, Coauthor aids in submission preparations by automatically gathering evidence from software development tools.
Richard Koch, SaMD IEC62304 Consultant at Koch SaMD GmbH said “The future of Agile software development will be a closer merging of project management and code management tools. Alan's product is the only one I am aware of which is pursuing this product strategy. He has already successfully launched a BDD requirements management tool that brings clarity and efficiency to software development, and we are looking forward greatly to his latest product"
Coauthor’s Presentation at the Med-Tech Innovation Expo
The Med-Tech Innovation Expo is an exclusive event for medical technology professionals, showcasing the latest advancements and innovations in the sector. Held annually at the NEC in Birmingham, the Expo brings together industry leaders, innovators, and thought leaders to share knowledge, explore new technologies, and discuss the future of medical technology.
To learn more about developing compliant Software as a Medical Device (SaMD), hear Alan Parkinson, Founder of Coauthor, and Dr. Heather Carre-Skinner, Director of Fieldfare Consulting present “Shift Left: Redefining Software Development and Compliance” on the 6th of June, 12:00 - 12:20, at the Med-Tech Innovation Expo.
Coauthor’s presentation will provide valuable insights into how this strategy can redefine SaMD development and compliance in the medical technology sector. Attendees will learn about real-world case studies and best practices for implementing compliance as well as gain a deeper understanding of how Coauthor's approach can drive efficiency and innovation in their organisations.