Preventing catheter caused infections

Challenge

The client, a start-up, needed a cost-effective way to prevent catheter-acquired infections of the bladder and came to Team to help them find a solution.

Approach

Efficiency was key to deliver this grant funded project. We combined a small team with key skills in human factors, mechanical and electronics engineering and industrial design to take the initial concept from petri-dish experiments to a functional prototype. The group re-designed the fundamental technology and carried out testing to prove functionality.

Outcome

Within 8 months, we developed a functional prototype which allowed our client to apply for extra funding to develop the device.

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At glance

Client
Clean Blue

Sector
MedTech

Services
Electronics
Mechanical
Industrial design
Human factors
Regulatory
Quality

 

Project background

Artboard 2

Over 100,000 patients in the UK and 1 million in Europe acquire a urinary tract infection every year linked to catheter fitting. This costs over £1 billion to the UK healthcare system. Clean Blue had an idea for a novel way to reduce catheter-acquired infections without the use of antibiotics. The company received an SBRI award to develop the idea into a prototype medical device and contacted Team to help develop the product while they supervised in vitro testing in parallel.

 

More

Understanding the technology

We started the project by ensuring the team understood the client’s concept, this included learning about the early biological in vitro testing carried out as well as the clinical area and user needs.

Testing the concept

We undertook desk-based research and developed experiments to test the concept, ensuring all requirements could be met.

Develop and prototype

From 3D printing initial space models to electronics development and rapid plastic prototyping, a functional prototype was developed.

Engineering testing

We carried out prototype testing to inform future development, performed early HF studies with clinicians and completed tissue testing that should help optimise the design in the future.

Rapid prototyping of small electronics

Specialist technicians created electronics prototypes in-house to fit within the small footprint required for the product, including selecting appropriate battery technology.

Electronics-V3

In addition to considering the main functional requirements, we had to ensure the device had low power consumption to allow it to be battery powered. To achieve this, early representative prototypes were key.

Peter Money, Consultant Hardware Engineer, Team Consulting

Ethnographic research in hospitals and clinics

Many patients who are catheterised in the long term are elderly so ensuring the product would meet their needs was key to the development of the device. Early visits to clinical and nursing advisors, as well as nursing homes, gave us some key insights. Following this, we performed a small formative study in a hospital to gather focused feedback for future development.

Preventing catheter caused infections

Seeing how the existing kit is managed in hospitals and nursing homes was fundamental in shaping the device, it also connected us with the potential users and informed us on how they might benefit from the device. It made the need for Clean Blue very real.

Jonathan Bainbridge, Senior Human Factors Consultant, Team Consulting

Developing novel testing approaches

Many aspects of the concept needed engineering testing to determine feasibility and to subsequently optimise the design. We developed custom jigs and fixtures to allow novel tests to be carried out. Outcomes from testing allowed us to have informed design choices and product requirements. Testing also provided additional evidence for grant monitoring reports.

We 3D printed prototypes in-house to allow testing to be carried out quickly. In this way, updates to the fixtures could be made efficiently and cost-effectively as the testing protocols evolved.

Testing V2

We reviewed several firms and I have no regrets in choosing Team Consulting; they are experts across a wide range of disciplines and helped us achieve a very ambitious deadline while simultaneously increasing our own understanding of the development of medical devices. Clean Blue was highly impressed by Team’s design, prototyping, testing and documentation work.

Daniel Taylor, CEO, Founder and Owner, Clean Blue

Outcome

Our ISO13485 approved processes allowed us to develop the device within a regulatory framework, with all engineering development and data controlled through certified platforms. Sharing our expertise on medical device development and technical file submissions helped Clean Blue really understand the documentation requirements and the next steps to take in the technical development.

The device now has a patent pending and our client is in the process of applying for funding to carry out more advanced testing.

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