Controlling bleeds during surgery

Challenge

Supporting a start-up in the development of a device that could deliver a fine, sticky powder precisely to control bleeds during a variety of surgical procedures.

Approach

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

Outcome

We developed a groundbreaking surgical device which received regulatory approval in Europe and the United States, leading to the company being fully acquired for $240M.

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At a glance

Client
ProFibrix

Sector
Surgical

Services
Industrial design
Human factors
Mechanical
Design for manufacture
Project management
Manufacturer management

 

Intro

Project background

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.

Team Consulting helped ProFibrix to create a device to deliver this sticky powder during a variety of surgical procedures.

Human factors studies

A thorough understanding of the context of use would be essential throughout product development if we were to meet the needs of the users, surgeons and operating room 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 early user research took place in the United Kingdom, Netherlands, Switzerland and the United States to inform how and when the device would be used. 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.

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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-centered design

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.

Paul Greenhalgh, User Experience and Innovation Director, Team Consulting
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We optimized the ergonomics of the handle to meet the needs of a broader range of surgical procedures while still achieving a quick and easy setup.

Perfecting complex powder delivery

In conjunction with the design work, our engineers developed a novel technology to fluidize and propel the powder in a controlled, accurate manner. It is common for some surgical devices to be disposed of after a single use, so we needed to focus on minimizing waste and manufacturing cost.

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

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Developing an innovative powder delivery 'engine'

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.

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The concept was designed to be highly tunable 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.

Taking a concept to manufacture

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

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Outcome

Following successful outcomes from the clinical program, 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.

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Getting approval in both Europe and the United States 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.

Paul Greenhalgh, User Experience and Innovation Director, Team Consulting

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