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 that are more common than others. They are 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, which may be unfortunate sometimes because reaching the market on time may be equally important to regulatory compliance. And if the project process does not support project management and efficient product development, you may pay dearly for it. Luckily, efficient product development and regulatory compliance can be combined.
Based on extensive research of multiple project models and their processes, I have compiled some typical and commonly used names and phases as shown in the picture below. The top row represents the names that I usually advocate when working with project processes for medical device product development. The row below represents 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 top process represents one of the more common project processes together with alternative names that are also often used. White phases are not under design control. Italic names are showing phase names that have been taken directly from regulatory concepts.
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) and 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. Design transfer is perhaps the phase that manufacturers of medical devices have the hardest time to agree on in terms of what it should comprise and when it should occur. Design transfer can be seen as the work package that comprises tasks relating to setting up the production of a medical device. This should include for example process validation, finding and evaluating suppliers, process design, manufacturing tools, authoring assembly instructions, and defining final product testing. But when should this phase occur in relation to design validation? Some argue that it should occur after design validation, however 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 products or equivalents. It is very hard, if not impossible, to create production products or equivalents without having gone through and completed the areas mentioned previously. Nevertheless, you will most likely find the design transfer phase either before design validation or after. If after, design transfer usually refers to a ramp up or scaling up the production to large volumes.
Is anything exempt from Design Control?
Not everything in the project process above is under design control, in this case the pre-study and the close out 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 been defined.
Can phases run 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.
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A pre-requisite for this course is that you have taken the Introduction to Design Control for Medical Devices online course.
Peter Sebelius (PMP) 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 too, having developed, amongst other things, a mechanical chest compression 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.