Many medical device companies develop software using a traditional waterfall methodology, which means, they have to document, review and approve every implementation they want to make. Although this has been an approach that has been widely accepted, many organizations are seeking approaches that produce value quicker and are able to adapt to business needs as they are changing.
According to Dr. Marion Lepmets, our Partner and CEO of SoftComply, mentions that when combined with empowered product development teams, agile methods can address common problems which include:
Initial Recommendations by TIR45
This TIR provides recommendations for ways to effectively apply agility to medical device software. Here are some of the initial recommendations:
Agile is driven by the value statements written in the Manifesto for Agile Software Development. These value statements can seem to be contradictory to the values of the regulated world of medical device software, but they need not be interpreted that way. Instead, they can be aligned to enhance the effectiveness of the quality management system.
- Apply the values of agile in a way that enhances a robust quality management system.
Agile emphasizes the need for the team to own its practices, inspect them, adapt them, and optimize them to their context. Regulatory requirements emphasize the need to establish a robust quality management system. Within the context of an established quality management system, agile practices can be applied without disrupting the quality system and without raising undue concern among regulators.
- Apply the practices of agile within the context of an established quality management system.
Agile embraces a highly incrementally/evolutionary lifecycle for software development. Although regulations and standards do not mandate a particular lifecycle model if stakeholders have expectations for linear lifecycle models, an incrementally/evolutionary lifecycle might bring challenges.
- Set the correct expectations by defining the software development lifecycle model.
- Demonstrate how an incrementally/evolutionary lifecycle satisfies regulatory requirements.
As part of its incrementally/evolutionary lifecycle, agile emphasizes the ability to respond quickly to change. Because rapid change can increase risks to product quality, effective change management systems are essential to align the desire to change quickly and the need to manage risk.
- Establish robust change management systems to manage changes and mitigate risks associated with rapid change.
PEDCO strongly recommends this paper if you are interested in an unbiased view on agile and to truly establish scaled agility in a medical device development environment.