Agile Development Methods for Regulated Medical Software
In industries outside regulated medical products, adopting Agile methods (with appropriate discipline) has resulted in substantial improvements in both quality and productivity - precisely the pair we have always thought were inversely related.
Major improvements are badly needed in software development for regulated medical businesses - medical devices, clinical trial software, or custom production/quality software for pharmaceuticals, biologics or medical devices. Quality/safety issues are embarrassingly common, costs are high, and development times commonly run well beyond initial plans. Some firms, hoping to solve the quality/productivity crisis, have embraced Agile methods, at least in name and with varying results from case to case. Other firms are investigating the possibilities, while others are simply curious.
Naturally, many ask the valid question - whether Agile can deliver on its promise. Beyond that, however, many firms struggle with whether the method can be used while still complying with design control requirements. Agile has, after all, been used as an excuse for sloppy non-structure in too many development teams - no planning, no documentation, no clear definition of goals, and no completion criteria. AAMI, with input from industry, from Agile experts, and from regulatory bodies, has published TIR 45, its guidance on use of Agile methods for medical device software, but for many the discomfort remains.
Overcoming this negative impression, to help introduce Agile methods with the necessary discipline and attention to regulatory compliance, is a vital area of interest for ShoeBar Associates.
Through a special collaboration, ShoeBar Associates and Lean-Agile Partners now offer consulting and assistance for regulated medical companies interested in introducing Agile development methods. This assistance is tailored to each company's needs and their current level of Agile comprehension; elements can include:
We recognize that the transition to Agile can require challenging mindset changes not only in the software group, but also among management, quality, regulatory and marketing. Changes of this scale are best accomplished in small steps - therefore a coaching model, with guidance for a seasoned Agile expert, has always worked best.
If you are interested in exploring how Agile could work in your organization, or in planning steps for your Agile transformation, click here.
NEW! We've developed one-day courses on the business and regulatory impacts of an Agile transitions, and how to avoid the "land mines." Take a look at the description on our Agile Courses page!
Major improvements are badly needed in software development for regulated medical businesses - medical devices, clinical trial software, or custom production/quality software for pharmaceuticals, biologics or medical devices. Quality/safety issues are embarrassingly common, costs are high, and development times commonly run well beyond initial plans. Some firms, hoping to solve the quality/productivity crisis, have embraced Agile methods, at least in name and with varying results from case to case. Other firms are investigating the possibilities, while others are simply curious.
Naturally, many ask the valid question - whether Agile can deliver on its promise. Beyond that, however, many firms struggle with whether the method can be used while still complying with design control requirements. Agile has, after all, been used as an excuse for sloppy non-structure in too many development teams - no planning, no documentation, no clear definition of goals, and no completion criteria. AAMI, with input from industry, from Agile experts, and from regulatory bodies, has published TIR 45, its guidance on use of Agile methods for medical device software, but for many the discomfort remains.
Overcoming this negative impression, to help introduce Agile methods with the necessary discipline and attention to regulatory compliance, is a vital area of interest for ShoeBar Associates.
Through a special collaboration, ShoeBar Associates and Lean-Agile Partners now offer consulting and assistance for regulated medical companies interested in introducing Agile development methods. This assistance is tailored to each company's needs and their current level of Agile comprehension; elements can include:
- Introductory training for the software team
- Awareness training for other stakeholders (quality, regulatory, marketing, service)
- Evaluation of SOPs and other procedures, to recommend edits which will allow Agile methods
- Demonstration of supporting tools which help Agile teams work more efficiently and produce compliant documentation (NOTE: Our views on methods and tools are completely independent; we have no sales obligations to any vendors.)
- Onsite coaching of software teams to help them adjust to the Agile mindset and working style
We recognize that the transition to Agile can require challenging mindset changes not only in the software group, but also among management, quality, regulatory and marketing. Changes of this scale are best accomplished in small steps - therefore a coaching model, with guidance for a seasoned Agile expert, has always worked best.
If you are interested in exploring how Agile could work in your organization, or in planning steps for your Agile transformation, click here.
NEW! We've developed one-day courses on the business and regulatory impacts of an Agile transitions, and how to avoid the "land mines." Take a look at the description on our Agile Courses page!
A collaboration with: