Controlling bleeds during surgery

ProFibrix - Dutch start-up

Challenge
Delivering a fine, sticky powder precisely during a variety of surgical procedures.

Approach
Following extensive research with leading surgeons in Europe and the US, we developed a highly intuitive device for delivering a novel powder. Our remit included selection and management of a contract manufacturing organisation for high-volume manufacture.

Outcome
A ground-breaking product which received regulatory approval in Europe and the US, leading to the company being fully acquired for $240M.

Dutch biotech firm, 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 Team to create a device to deliver this sticky powder during a variety of surgical procedures.

 
Understanding the needs

A thorough understanding of the context of use would be essential if we were to meet the needs of the users, surgeons and theatre nurses. We examined access requirements, the powder flow characteristics required for different types of bleeds, and how the set up and application of this new product would compare with competitors.

Our user research took place in the UK, Netherlands, Switzerland and the US to inform how and when the device would be used. The device would need 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 gained input from surgeons and nurses during role-playing procedures with early prototypes and throughout the project, which enabled us to rapidly iterate the design. We optimised the ergonomics of the handle to meet the needs of a broader range of surgical procedures whilst still achieving a quick and easy set-up.

Development of handheld surgical haemostatDevelopment of handheld surgical haemostat

 
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. It is common surgical practice for devices to be disposed of after a single use and so we needed to focus on minimising waste and manufacturing cost.

The innovative ‘engine’ we developed uses pressurised gas which spins a ball bearing to create vibration – removing the need for electronics or an on-board 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 surgeons to find the right powder flow characteristics.

After rigorous testing and characterisation of the powder plume, we advanced from rapid prototypes to injection mould tooling. We created clean-room manufactured pilot units suitable for testing in both phase II and III clinical studies.

 
Taking a concept to manufacture

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

In parallel with supporting ProFibrix through industrialisation scale-up, we undertook a full human factors engineering programme, culminating in validation studies conducted within a surgical simulation centre in the US.

This data was used in the ProFibrix documentation for the FDA and EMEA application, where approval was granted.

Observing surgery for development of handheld surgical haemostatOne of our human factors consultants, Rob Fernall observing surgery

 
The outcome

Following successful outcomes from the clinical programme, we supported ProFibrix through the final leg of their journey which culminated in full acquisition by The Medicines Company for a deal worth $240M in 2013.

Handheld surgical haemostat

Paul Greenhalgh, Director of Design at Team and who managed the project, said: “Getting approval in both Europe and the US in 2015 was an incredible milestone for this device.”

“We’re enormously proud of what we’ve achieved together on the development of what is now RaplixaSpray™ – we believe it was our ability to work flexibly and draw on our broad network of experienced staff and suppliers which helped meet the timelines required of a young start-up.”