Regulatory and Quality knowledge speeds up medical device projects

The regulations on CE marking and FDA approval are often blamed for slowing projects down, but they can have the opposite effect, argues Bert Degens, trainer for InSciTe. ‘If you take account of the regulations and related standards early on in your project, the process is more efficient and you get your product onto the market faster.’ This experience is echoed by participant Alicia Damen, who completed the entire educational programme at InSciTe. ‘The courses run by InSciTe give you the knowledge you need.’

Bert Degens spent many years at Medtronic in various quality-related roles. In 2003, he started out as an independent consultant and auditor and, since 2015, has been running two training courses for InSciTe. Bert: ‘During the Medical Devices CE Marking & FDA Approval training, we spend 2 1/2 days looking at what you have to do to get a medical device with CE marking or FDA approval onto the market. What are the implications for the device and for the way the parties who are marketing the device organize things? The follow-up course, Design Control & Risk Management, is really more of a ‘how to’ training, during which participants put forward their own cases and explore the development process. Alicia adds: ‘As participants, you learn a lot from each other here, because the projects are in different phases of this process and you look at them all in the practical cases.’

Broad picture

Naturally, Bert doesn't cover all the regulations during the training sessions. ‘There's a pile of paperwork involved, particularly since, in May 2021, the EU Medical Device Regulation will be incorporating the bulk of the relevant previous EU directives. It will be ballooning from around 60 to 180 pages. My aim is for participants to grasp the broad picture and learn to navigate the documentation. For me, the most important thing is that participants recognize the underlying importance of the rules. There's a widely held belief that you save time by leaving the documentation and regulations for another day, but the reverse is true. There are questions and challenges that crop up that you will inevitably have to deal with at some point. The regulations and, in particular, various supplementary standards are conducive to having a clear structure and logical sequence, and help ensure good communication. The earlier you delve into the regulations and take them into account, the more efficient your process will be, leaving you with more time to focus on quality.’

Different approach

Alicia Damen attended the training sessions run by Bert a few years ago. During her graduation project at TU/e, she was involved in InSciTe's SyCaP project and she now works as a PhD candidate on the MimiCart project. Both projects are focused on knee implants. Says Alicia: ‘I did the training when my project was still in its infancy and, to be honest, I didn't really think the knowledge was relevant to me at the time. I’ve since changed my mind. I totally agree with Bert that it's important to get a general grasp of the regulations and applicable standards early on and keep them in mind. It altered my approach to doing research. Now, for instance, I check straightaway the forces and speeds at which I have to run certain tests, to avoid having to redo them a year or two down the line when they fail the approval procedure.’

Communication

For the InSciTe projects, Alicia works in multidisciplinary teams with experts from various universities, clinics, and companies. Taking account of the regulations and documentation early on also helps when communicating with other disciplines in the project, Alicia has noticed. ‘Now, I discuss questions sooner with the surgeon, DSM, and Fujifilm and find out what they need, so that I can take this into account in the lab. It’s so much more efficient when everyone involved in the project from the different disciplines is speaking the same language from the very beginning and pursuing the same approach. It moves the process along faster towards the end user: the patient.’

Move forward

Bert nods in agreement with Alicia: ‘I’m pleased to hear that the underlying idea has hit home; that's my aim. The regulations help tie in with the other disciplines in the project, encourage communication, and save time. I wouldn't keep banging on about this added value if I hadn’t experienced it first hand in my work and got feedback from my trainees. Knowing and applying regulations and standards isn't just a box you have to tick; it can really help move your product and project forward.’

Bert Degens

Bert Degens has a background in Technical Physics. After working for 5 years in different R&D positions with Océ, he started in 1991 with Medtronic. During his 13 years with Medtronic he held increasingly responsible positions in quality engineering, project management, operational management and quality management. Bert Degens founded Degens Quality Solutions in 2003. Since then he served many different customers in the medical device industry, provided numerous trainings and was a speaker at international conferences and auditor for a major notified body.

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Alicia Damen

Alicia Damen started her academic studies with a BSc in Biomedical Engineering at the TU/e. Given her interest in engineering and medical science, she subsequently studied Medical Engineering at the TU/e (with an internship at the University of Auckland, New Zealand) where she received her MSc degree in 2018. In her final master project, Alicia was involved in research for the InSciTe SyCaP project. Having started her PhD project in the Orthopaedic Biomechanics group of Prof. dr. Keita Ito, she will be involved in the MimiCart project of InSciTe.

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