Behind the scenes: R&D in medical device design

Posted on 31 Oct 2015 by The Manufacturer

Design team leader at Owen Mumford, Myles Whiting lifts the curtain and provides an exclusive backstage view of how the R&D department within a successful medical device manufacturer works.

Have you ever wondered what’s involved in the development and manufacture of medical devices?

It involves expertise in design capabilities, the latest in technological assets, thorough testing facilities and a profound understanding of the end-user and the market.

With this, when working so closely to end-user needs and healthcare concerns, the collaboration of teamwork and technology are key.

Built up of product designers, engineers, and human factors specialists, the R&D department at Owen Mumford designs life saving devices, each of which follows a thorough design journey, from concept through to creation.

Owen Mumford: Behind the scenes: R&D in medical device design 1
Cross-functional teams come together to build the starting blocks for new product development.

Teamwork and research

Initially, product designers work with the marketing team to establish unmet market and customer needs. The marketing team can then interpret and deliver market context and customer needs to the engineers, who then have the ability to process this into measurable design inputs.

While considering our available technologies and intellectual property (IP), we then review the research results and all the information gathered. This then accumulates into a brief, which the designer uses to address the market or customer need.

Gradually as the inputs are defined, the scope of work is developed, drawing on the broader team, which includes project management, industrialisation, quality, regulatory and our customers to deliver the project.

Rapid prototyping technologies

Owen Mumford: Behind the scenes: R&D in medical device design 2
3D printing allows us to rapidly iterate prototypes.

3D printing is a standard tool used in the initial product design stages, which allows us to produce multiple iterations of designs for rapid evaluation.

This gives the designer better visualisation of the product that up to then, only exists on a computer screen.

Designers and engineers can then foresee any potential issues with components and assemblies, prior to committing to a design.

At this stage, limited testing is performed which enables the team to check whether mechanisms work and how they look and feel, before committing to expensive tooling.

Concept generation 

We like to capture our ideas in their purest form and embed the design intent based on the research and inputs.

Owen Mumford: Behind the scenes: R&D in medical device design 3
Initial design stages are sketched out using the latest in digital input technology.

Initial concept generation is performed using traditional sketch methods directly into digital sketch software.

We then leverage this digital workflow to explore concepts fully and quickly work up ideas using CAD to create fully functioning prototypes.

The ability to hold a device within hours of it being conceived allows us to challenge designs and offer the best solutions.

We utilise a combination of bespoke and industry standard software to specify our designs.

Complex geometrical and tolerance analysis is handled to lower the risk profile of the devices and manufacturability.

In order to remain compliant to the design directives we have a streamlined procedure to scrutinise every product detail.

Device design and engineering

Owen Mumford: Behind the scenes: R&D in medical device design 4
Every aspect of a design is developed until it meets our rigorous standards.

During the development of a device, ergonomics – commonly referred to as human factors engineering – are intertwined in our processes and risk assessment.

Outcomes from studies to assess the human interface are fed back into the overarching design process, so the designer never loses sight of the end user, capturing their interactions and understanding.

Testing facilities

Testing is a natural proving ground for even the subtlest of changes, every iteration is checked until all geometry and functions are verified as safe and effective.

Within our testing facilities, we ensure both the prototypes of our products and the drugs sometimes contained within them, perform as they should and are completely accurate.

When working on a device in partnership with a pharmaceutical company, we will test the drug that they have created to ensure it works accurately with our device.

Owen Mumford: Behind the scenes: R&D in medical device design 4
Working with our partners we test their drugs, which utilise our devices to ensure accuracy.

Different drugs have different requirements, for example, higher viscosity drugs will require more force when being injected. Accuracy is crucial, as end-users will be completely dependent on the device injecting the correct dosage.

When it comes to testing a prototype, we are verifying its function at normal use conditions and often beyond the extremes of use.

Here we are testing to check that we meet the rigorous standards to ensure our products are safe and reliable.

Testing tends to involve shocking, freezing, heating, cycling controls, vibrating and dropping devices to simulate the multitude of use environments.

We then operate them multiple times, beyond the useful life of the product to ensure they still perform as intended.

Owen Mumford: Behind the scenes: R&D in medical device design 6
Our state of the test lab analyses our prototypes to ensure new innovations perform as expected.

In parallel we will be setting up to perform our validation activities which subject devices to realistic simulated use with actual users. This is the ultimate test and where all of the hard work pays off.

With the market ever evolving, and the rise of home use devices, the team are always thinking ahead to innovate.

Each stage of the development process, from concept through to delivery consistently looks to make devices meet the needs of the end-user, looking to improve patient outcomes.