With increasing market pressure in the highly regulated MedTech industry, developers are doing their best to accelerate time to market while staying compliant with regulatory requirements. Despite widespread concerns, we argue that Agile is in fact suitable for developing medical device software. Learn more in our Agile in MedTech guide!
Like most facets of healthcare, the medical device development industry is regulated by strict requirements, compliance with which is often a necessary prerequisite of being able to bring products to the market. Yet despite regulatory requirements, market competition is pushing developers to accelerate the delivery of their medical technology products. Agile is one methodology that developers can apply to ensure speedy development.
Marrying Agile and compliance
Some believe, however, that there is a conflict between Agile practices and being able to satisfy strict regulations. According to Agile process expert Dr. Andreas Birk (and evidenced by a multitude of use case descriptions, case studies, experience reports, etc), this couldn’t be further from the truth.
Find out how this global MedTech leader was able to scale Agile without jeopardizing compliance:
With adequate planning and using the right practices, MedTech development can greatly benefit from Agile without jeopardizing compliance. Agile can enable companies to create groundbreaking medical devices while still complying with regulatory statutes.
In this post, we’re going to discuss bringing regulatory compliance and medical device development together. We'll introduce you to some Agile best practices that allow MedTech development to thrive while still making auditors happy!
Learn more about Dr. Birk's insights in this 3-part webinar & white paper series:
MedTech Regulatory Issues
As technology develops, MedTech regulations are being updated continuously. Medical device development companies can expect more scrutiny thanks to new legislation globally.
Let's outline some of the changes below.
FDA Regulatory Changes
The FDA is overhauling the pathway MedTech products must take before they are brought to market.
One of the biggest changes is the Software Precertification Pilot Program. This program is focusing on the FDA's regulation of software as a medical device. The Pre-Cert pathway intends to emphasize a medical software's real-world performance.
The FDA will look further into a company's previous performance and reputation. If a software developer passes this test, it may help them bring products to market more quickly. The FDA will not have to approve future updates and iterations of the same software.
This will cause software companies to really "tighten their ship". There's no room for error. Companies might have to spend more money on regulatory compliance and work harder to ensure the maturity of their development processes.
The FDA will change laws on Artificial Intelligence (AI) and Machine Learning (ML). One of the biggest changes is the distinction of "locked" vs "adaptive" algorithms. The FDA intends to advance the use of these concepts in their approval of any new MedTech. But, the agency may be slow to do so. Companies that leverage this technology may want to consider crafting specific proposals for the use of change protocols.
Federal Healthcare Programs
The Department of Health and Human Services is redefining "value-based care". The sections of legislation that make changes to the Office of the Inspector General and the Center for Medicare and Medicaid Services are particularly important to MedTech companies.
A lot of these laws will pertain to value-based care and the Anti-Kickback Statute. These changes will affect how products are purchased. Also, how they're used as part of a larger value-based care program.
Agile For Medical Device Development
Although there are a lot of changes in the regulatory landscape for MedTech companies, these don’t change the fact that the Agile development of innovative medical devices is still possible. Agile can help your team to build high-quality medical devices faster, while also remaining compliant with regulations.
Step 1: Find out how to start your journey to Agile in MedTech development:
Let’s see a few of the key Agile practices that help you get there:
Definition of Done
Development teams can set their own definitions of done. The definition of when a particular project or task is done stays in place for each iteration of the product. As teams are working towards aligned goals, using DoD right can greatly support MedTech teams in achieving quality standards.
The definition of done doesn’t just set criteria for the product, but also the creation process. This makes the Definition of Done a crucial tool for controlling compliance.
Step 2: Interested in learning more about using DoD to ensure regulatory compliance? Download this informative white paper:
Agile and NFRs
NFR stands for Non-Functional Requirements, aspects of the product like performance and safety. NFRs need as much monitoring and are just as important as Functional Requirements.
One effective practice is to apply User Stories to express non-functional aspects. NFR may also be used to establish backlog constraints that apply to multiple functional requirements at the same time.
Agile software development allows for MedTech teams to develop compliance incrementally.
Most companies' development process doesn't address compliance until later stages of the development lifecycle. In Agile, development teams can conduct compliance testing for each backlog item or product iteration, enabling them to monitor compliance at every step.
Over time, Agile will help integrate compliance activities into development activities. This means compliance and development happen simultaneously, ideally resulting in a system of continuous compliance.
Another important aspect is establishing an Agile Quality Management System (QMS). The Agile QMS should be rooted in development teams, but should be integrated throughout the organization. The QMS is built on Agile processes rather than process control.
Step 3: Gain insights from multiple case studies to find out how MedTech companies have been able to successfully implement Agile!
Making Medical Device Development Possible
Agile is changing the way (as well as the pace) medical device development is carried out. Teams can now innovate and create faster without fearing the subsequent audit preparation work, due to the continuous application and enforcement of mature and documented processes. The result is that their medical devices will hit the market faster, while their development becomes more cost-efficient.
Interested in learning more about using Agile in medical device development? Download our 3-part series of webinars and white papers on the subject, developed by Agile process expert Dr. Andreas Birk!