Surgical Bleeding Control Device Development

Developing a novel, regulatory-approved surgical device

Dutch biotech start-up, ProFibrix, had developed the technology to manufacture a vial of powder derived from a mixture of fibrinogen and thrombin, a protein and enzyme which occur naturally in human blood and cause blood to clot. They needed a partner to help them develop a surgical device to precisely deliver this fine, sticky powder during a variety of surgical procedures.

Following extensive research with leading surgeons in Europe and the United States, we developed a highly intuitive device with effective usability, helping ProFibrix take this from concept to high-volume manufacture. The result was a groundbreaking surgical device which received regulatory approval in Europe and the United States, leading to ProFibrix being fully acquired for $240M.

Working with surgeons to understand user needs

Our human factors experts worked closely with surgeons and nurses throughout the product development to build a thorough understanding of the context of use, allowing us to create a solution that met real user needs.

This involved examining access requirements, the powder flow characteristics required for different types of bleeds, as well as how the set-up and application of this new product would compare with competitors. Our early user research took place in the United Kingdom, Netherlands, Switzerland and the United States, providing key insights into how and when the device would be used.

Throughout the project we gained regular feedback from surgeons and nurses who role-played procedures with early prototypes. This allowed us to gain direct feedback on usability and rapidly iterate the design.
Rob Fernall, Senior Human Factors Consultant, Team Consulting

Man looking at human factors usability study at viewing facility

Human factors validation studies

Later in the project, with a final prototype developed, we undertook a full human factors engineering program, culminating in validation studies conducted within a surgical simulation center in the United States. This data was used in the ProFibrix documentation for the FDA and EMA application, where approval was granted.

User-centred design

We optimised the ergonomics of the handle to meet the needs of a broader range of surgical procedures while still achieving a quick and easy setup.

The device needed a range of detachable nozzles, a feature to allow multiple vials to be used within a procedure and the requirement for intuitive fingertip control. We developed several options, carrying out iterative testing with users to ensure they met their needs.

Developing an innovative powder delivery 'engine'

In conjunction with the design work, our engineers developed a novel technology to fluidise and propel the powder in a controlled, accurate manner. The innovative ‘engine’ we developed uses pressurized gas which spins a ball bearing to create vibration – removing the need for electronics or an onboard energy supply.

The concept was designed to be highly tuneable during the development process. This was essential in the early stages of the project to allow us to work with physicians to find the right powder flow characteristics.

Preparing for clinical studies

After rigorous testing and characterisation of the powder plume, we advanced from rapid prototypes to injection mould tooling. Following this, we created clean room manufactured pilot units suitable for testing in both phase II and III clinical studies, which the client successfully progressed through.

Taking a concept to manufacture

From our global network of experienced manufacturing organisations, we established a partnership of firms who could meet both the tight timelines and high-quality standards demanded for the manufacture of a Class II medical device.

Outcome

Following successful outcomes from the clinical program, we supported ProFibrix through the final leg of their journey, which culminated in a full acquisition by The Medicines Company for a deal worth $240M.