![]() Overall goals for quality are provided in 21 CFR part 820 and in ISO 13485 – from providing adequate resources and proper work environment, to controlling and documenting design, to managing measurement processes, to following procedures to correct or prevent product flaws. Written in plain language, it describes key Agile practices and how they each compare with traditional practices to cover safety and quality concerns.Īfter stating their development process and how they’ll show their adherence to it, medical product companies must then demonstrate that their development work occurs within the framework of a Quality Management System (QMS), and that they have adequately addressed potential hazards to the patient/user, caregiver, or bystander.Ī QMS needs to support product development and maintenance – to outline the activities and outputs which ensure quality of the company’s products and services. In 2012 a group from industry, standards organizations, and regulatory bodies collaborated to provide just such an explanation bridge: AAMI TIR45 (an advisory document available for purchase from the Association for the Advancement of Medical Instrumentation: Guidance on the use of AGILE practices in the development of medical device software). Businesses did not want to explain a very different approach like Agile, especially if they had had a rocky relationship with regulators. When Agile was a new concept, the traditional approach had the advantage of familiarity auditors and QA / RA were accustomed to the stage-gate idea, and development processes typically involved only minor variations on that theme. ![]() Hazard analysis and risk management must be incorporated, not added afterwardĪlthough the regulatory rules allow companies to choose their own development process, the companies must provide evidence that they are in fact following their stated process.Documentation shall provide evidence of following a quality process.Every company must have a Quality Management System.Each company is to choose its own development process.Regulatory bodies have four key concerns for medical product companies: How Agile Fits into the Medical Regulatory World While no company or group should merely copy another’s approach, these case studies offer insights into how readers might implement Agile principles in their own company. By valid, we mean a sincere effort by both management and technical contributors to move the company through genuine change. We chose our cases based on several factors, chief of them being that we knew enough about the situation to say that it’s a valid use of Agile. Attend in-person or online at QCon New York (June 13-15, 2023). Uncover emerging trends and practices from domain experts. Specific companies and products are examined, and the actions their Agile change leaders took. This article is based on case studies from our new book Agile Methods for Safety-Critical Systems: Case Studies of Medical Product Companies. The FDA’s own Design Control Guidance, immediately after depicting development in a waterfall-like diagram, notes that “In practice, feedback paths would be required between each phase of the process and previous phases, representing the iterative nature of product development.” This has been refuted by regulators and by industry people multiple times. One belief is that regulators (both FDA and in the EU) prefer stage-gate, waterfall-like product development. The question is no longer whether, but how Agile can work in medical product development - for our mix of technical, market, and regulatory constraints?ĭoubts persist, based on misinformation about Agile practices, regulations, or merely on a deep suspicion that work completed quickly must be taking unsafe shortcuts. The rise of home-use medical products has spurred use of Agile continuous delivery for mobile hardware platforms. Practices vary with the types of development work, from cloud-based continuous flow for data-intensive services (clinical trial data management) to a sprint-based flow for physical devices with embedded software. We’ve noticed adoption of Agile methods steadily growing in medical product companies over the past ten years.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |