Having experienced several corporate take-overs, mergers and general restructuring initiatives as part of working in medical device departments of large global pharmaceutical companies, we have been intimately involved with many different ways of running a medical device project and the many different activities which take place.
Experiences of Device Developers
Over the years we have been involved with or even carried many of the various roles required to develop combination products and medical devices.
Our experience covers;
- Device & Packaging Evaluation, Device Design; Usability Testing,
- Risk Management, both ISO 14971 and of projects,
- Formulation Scale-Up; Pilot and Process Development and Manufacturing; Product Filling and Packaging; Clinical Manufacturing,
- Quality Management (ISO 13475, ISO 9001); Quality Assurance; Quality Control; Customer Complaints; Internal and External Auditing of Departments and Suppliers; Supplier Management,
- Regulatory Audit Fronting and Backroom; Technical Support; DHF compilation,
- Software Development, Design Controls, Human Factors Engineering,
- Sarbanes-Oxley, 21CFR11, 21CFR210, 21CFR211, MDD, MDR, IVD, IVDR, Orange Guide
- Equipment, Process and Cleaning Qualification and Validation; Analytical Chemistry (Sample Prep & HPLC).
This experience provides us with a deep appreciation of what goes on in a development project, what needs to happen when, and the difficulties encountered with juggling all of the diverse tasks.
Projects Come in All Shapes & Sizes
We have been involved in both “fast track” projects lasting a couple of years and long-term, shifting goal-post projects, including one that lived for over 18 years! In that time we have seen both good and bad ways of developing a medical device.
Some of the most commonly encountered frustrations we have experienced have come from the huge losses in time, material and budget caused by teams skipping through the early stages of development or not phasing activities appropriately.
Activities which are intricate and involved, such as developing the formulation alongside the device, or developing the device assembly process based on shifting device designs, need to follow a clear strategy and progress at an even pace. Often there is an almost unstoppable drive to finalise a device design before most of the early stage or process interactions have been tested. In our experience this often means discovering at a late stage that fundamental issues exist with the product design; usability issues or mechanical failures; the manufacturing process is not sufficiently robust to hold tight tolerances; or there is poor device/drug interaction which causes unacceptable performance.
Development Route Map
To make sense of, and explain how the disciplines and activities need to progress alongside each other, we created a Development Route Map.
We know that device development isn’t easy, but often times it can be made a lot easier with clear strategy setting and good communication.
We created Three Circles to help people and companies benefit from our expertise, because we know there are easier paths through development.
Matthew and Fiona, the directors of Three Circles, are supported by a team of specialists in their fields, all used to working in regulated environments.