Having the right project process can be key in developing products in as short time as possible and at a low cost as possible while still meeting regulatory requirements.
It can allow you to exercise control over projects, especially in a multi-project environment. A well-recognized project process will facilitate the introduction of new employees or new project team members, and both the new team members and medical device auditors will feel at home.
Phases in a project process
Unfortunately, there is no universal naming convention for the different steps the medical device product development project process should contain. But there are some names, more common than others, often borrowed from the regulatory world, where some concepts have been defined clearly in regulations or standards.
Being in a regulated industry also leads to processes that, in some cases, are very focused on the regulatory process. This may be unfortunate because reaching the market on time may be equally important to regulatory compliance. If the project process does not support project management and efficient product development, it may cost a lot. Luckily, efficient product development and regulatory compliance can be combined.
The alternative phase/stage names shown below are based on extensive research of multiple project models and their processes. The top row represents the names that we commonly use in our design control training courses. The rows below represent some of the most commonly used names (together with the top row).
Please note that product maintenance phase is normally not considered part of a project process, but it is rather part of the product life-cycle. However, it is very commonly described in relation to product development.
The typical project process phases have received their names from different areas, such as:
- Project management (initiation, planning)
- Regulations and standards (design planning, design input, design output, design transfer, design validation)
- Manufacturing (pilot production, production ramp-up)
Regulations and standards are particularly influential in the medical device industry, for good and bad. There are project process examples that are almost entirely made up from design control terminology and principles.
Where does design transfer belong?
Design transfer is a regulatory term, defined as the translation of design results to manufacturing specifications. During this phase, the manufacturers of medical devices have the hardest time to agree in terms of what the design transfer should consist, and when it should occur.
Design transfer can be seen as the summary task that comprises tasks relating to setting up the production of a medical device. This should include at least process validation, finding and evaluating suppliers, process design, manufacturing tools, authoring assembly instructions, and defining final product testing.
But when should design transfer occur in relation to design validation?
Some argue that design transfer should occur after design validation, yet one should keep in mind that design validation (during which the manufacturer demonstrates that the product meets its intended use and user needs) should be done on production units or equivalents. In most cases, it is very hard, if not impossible, to create production products or equivalents without having gone through and completed or partially completed the design transfer.
Is anything exempt from Design Control?
Design control does not apply to all the phases mentioned; the pre-study, initiation and the closeout phases. It could be argued that the initiation phase is also not under design control, but design control most certainly applies at the end of the planning phase when the design and development inputs have or can been defined.
Can phases happen in parallel?
There is a widespread misconception in the medical device industry that one phase needs to be completed before the next one starts. But there is nothing requiring that in the standards or regulations. The concepts of design input, design output, design verification, design transfer, and design validation are more principles or concepts than they are phases. The FDA guidance document on design control (page 5) contains an excellent discussion on how to work with concurrent engineering as opposed to a more traditional waterfall model.
Would you like to know more about Project Management?
Take a look at our online Project Management for Product Development of Medical Devices course that provides a high-level overview as well as hands-on tools and techniques for developing a medical device within budget and schedule constraints. R&D engineers wanting to become project managers, consultants working with medical device projects, project managers within the medical device industry, and managers working directly or indirectly with projects and product development
We recommend that you take the Introduction to Design Control for Medical Devices online course prior to taking this course.
Peter Sebelius is a highly esteemed trainer, consultant and entrepreneur in the medical device industry. He is a member of the Joint Working Group that is revising the ISO 13485 and ISO 14971 standards.
He has vast ‘hands on’ experience, having developed, amongst other things, a mechanical chest compression device and an ex vivo perfusion machine for lungs. He has received numerous awards including the Great Design Award and the title “This year’s specialist” by Veckans affärer.