Jon Speer, Greenlight.guruManaging your medical device product development project can be a daunting task. There are regulations and paperwork to manage, along with expectations such as deadlines or goals for getting the device to market.
I sat down recently to chat with Peter Sebelius about our thoughts on project management best practices for medical device product development. Sebelius is the founder of Gantus.com, where he helps medical device companies with quality assurance, risk management and project management. He is a certified project manager and member of joint working groups on ISO 13485 and ISO 14971. He has vast industry experience and extensive knowledge of medical device standards.
Here are some of the common traps that Sebelius has often found medical device companies falling into:
1. Thinking that regulation prevents lean development
There often seems to be a perceived conflict between using lean or agile development methodology and complying with FDA and ISO regulations.
The answer from Sebelius is that you definitely can operate this way, but many companies are struggling with it.
Companies have a perception that they need to have as many documents as possible, and this simply isn’t true. They have challenges with the “monster” that they consider the (FDA 21 CFR 820 and ISO 13485) regulations to be.
In my years in the industry, I’ve witnessed a number of changes. Back when I first started, design controls were new and it quickly became apparent that development was far from a “straight line” process, which the waterfall diagram might imply. The question is always, “What can I take from start to finish as quickly as possible, especially when I’ve been given deadlines already?”
You obviously have to work with the regulations, and there are some good tips for doing so.