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Reaching 15% Freedom to Innovate in the Medical Device Industry

Updated: Apr 14, 2021

Frank Gehry is perhaps best known as the architect behind the Guggenheim Museum in Bilbao and the Walt Disney Concert Hall in Los Angeles. He finds that after all the constraints are dealt with (gravity, budgets, expectations from client, etc.) he has around 15% of freedom to make his art - this he estimated after a discussion with the late director Sidney Pollack who also found that after constraints, he had around 15% of artistic freedom while making films.

Similarly, in the automotive industry, where for example the VW Group uses a small amount of product platforms over a large range of brands and cars, there is a 67% part commonality between the parts in a Skoda Octavia and an Audi TT (both brands owned by the VW Group), suggesting that there is a similar amount of design freedom in this industry, after considering brand specific constrains.

Constraints in the Medical Device Industry

The constraints when it comes to developing a medical device are numerous - e.g. the physiology of a human being, user needs, resources, materials, manufacturability, lifetime of the product, budget and timeline. These are all factors that need to be considered - but the freedom to design and innovate can still be pretty high.

However, once constraints that are proclaimed in regulations (e.g. FDA regulations in the US and MDD (soon MDR) in the EU - where companies themselves declare conformity with the help of harmonised standards and Notified bodies) are added, the freedom to design and innovate drops substantially - probably now below the freedom an architect or movie director have to make art, and below that of the fine engineers at the VW group.

Arguably, most startups in the space start with an idea, some clever people and a drive to make the world a better place with a brilliant device. The rain however starts pouring on the parade, often after months or even years of development - it dawns on the development team that minutes from design meetings should have been kept, a risk analysis plan made, hazard traceability matrix updated, formative usability assessments performed, etc. Here is when panic sets in and expensive consultants are hired to try to fix the damage - unfortunately in many cases this is also where the journey ends.

For the medical device industry to remain innovative with the current constraints, it is important to spend significant time in the beginning on both defining and understanding the consequences of the intended purpose, user needs, and specific requirements - which affect the classification of a device and the overall scope of the work that needs to be performed during and after development. In an earlier blog post, product platforms and modularisation are mentioned as ways to shorten this step.

Xybel offers seminars and workshops on how to successfully start a medical device development journey - defining the intended purpose, user needs, classification, and setting up the development plan and milestones. Please click here for more information.

Xybel is looking for champions in medical device companies that are interested in giving feedback on an online SaaS tool we are developing. The tools aim is to improve the overall understanding of which, and at what point, regulations are needed during the development of a medical device. Please contact us for more information at

We welcome feedback and thoughts on this topic.

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