Our credentials

Medical Devices come in all shapes and sizes

Established in 2006, our consulting expertise has
evolved to cover several of the key aspects of developing and launching successful medical devices. For more than 12 years, we have helped clients successfully develop and launch a wide range of medical devices and combination products.

Our team has enjoyed working with a diverse group of clients; broadening our appreciation of the nuances of developing different types of medical device. The team help a wide range of clients, from medical devices, through pharmaceuticals (generic and innovator), design developers, to start-ups and spin-outs.

Our expertise and capabilities have been recognised by accreditation as a provider of regulatory and product development support for healthcare products, through the Business Bridge programme.

 

Companies we work with encompass small, regional and global medical device and pharmaceutical businesses; they come to us from many countries.

 

 

Assuring the quality of our work with you

Every aspect of Three Circles work, both with clients, and internally, is managed by a Quality Management System that has been awarded ISO 13485:2016 certification

Experts in Medical Devices and Drug/Device Combination Products

Our team hold a range of qualifications relevant top the work we undertake with clients. Combined with each of our experts having a minimum of 20 years experience in their fields, we’re a powerful knowledge bank for you to access.

Our team members have worked for many of the top 5 global Pharmaceutical and Medical Device companies, generic Pharmaceutical companies, regional Medical Device companies and niche device development agencies. Thanks to the breadth and depth of roles we’ve undertaken, you can be confident that we’ve the knowledge and practical experience that you need.

Publications

We’ve authored many publications, including:

“How humans factor (in medical device development)”

Two of our team authored this book that introduces and navigates the path for Human Factors (or usability) aspects of developing medical devices and combination products.

Medical Device Development Route Map

[dropcap]A[/dropcap] well received picture of medical device development that portrays the key disciplines, activities and their complex interactions, from project definition through to product launch.

“Remember the Patient”

Examining the human factors impacts of medical device use moving outside hospitals and clinics, with new risks and challenges coming into view as devices are placed in the hands of people who aren’t medical professionals.

“How To Build An Ark: Project Leadership for the 21st Century”

One of our team is a co-author of this book, introducing the Ark approach to leading projects. 83% of projects fail; not because of methodologies, not because of documentation, not because of processes. 83% of projects fail because of people; how they behave, how they communicate, the relationships they build (or don’t).