Industrialisation

At Team Consulting, we think about manufacture from day one of your development. Our dedicated industrialisation group and production specialists can support you across the whole process: detailed design, pilot manufacture, scale-up and completion of design transfer.

From complex, high value electro-mechanical systems to high-volume, disposable medical devices, our engineers can help with manufacture. We collaborate closely with world-class contract manufacturers and specialist equipment suppliers. This ensures your products are robust and reliable, manufactured on fully capable production systems to be delivered at the right cost and the right scale.

Our involvement doesn’t end at device design and transfer. Our medical device manufacturing consultants can support your product’s journey right through to commercial launch.

Designing for manufacture and assembly

Designing medical devices for manufacture and assembly is integral to our development philosophy and design process. Our manufacturing consultants ensure your devices are engineered for production to meet your commercial needs, operational requirements, applicable quality standards and are fully compliant with medical regulations.

Design for manufacture starts from requirements capture and concept generation. From this point onwards, our engineers and designers focus on helping you develop viable and robust solutions for commercial production, using tools such as statistical tolerance and sensitivity analysis, formal DFM/DFA analysis and process-based risk assessments.

We have our own global network of approved suppliers to support the early stages of your device development, including specialist prototypers, cost-effective rapid toolmakers and equipment manufacturers. This enables us to rapidly turn your concept designs into production representative solutions.

As your project progresses into pilot production and scale-up, our expert team can support you to ensure that the design intent is translated into achievable and verifiable manufacturing specifications.

We have a long history of collaborating with the world’s best Contract Manufacturing Organisations (CMO’s), and can help you select the right partners for your needs. Alternatively, we can also work in partnership with your existing manufacturers. Our aim is to provide the necessary experience and expertise to bring your product vision to commercial reality.

Electronic and electro-mechanical systems

Industrialisation of electronic and electro-mechanical systems can bring unique production, supply-chain and quality challenges which need to be understood and addressed. Such challenges include the optimisation of the Bill of Materials for cost, availability and identification, and mitigation of obsolescence risks. Another key aspect is the need to implement semi- or fully-automated PCB test systems, in-line programming and self-testing.

Our electronics and software teams have a wealth of production experience across various medical systems but also from other highly demanding industries. Our medical device manufacturing consultants can scope out, manage and deliver your project, ensuring that the electronic development timelines converge with other aspects of your programme.

Production assembly and test equipment

As your project scales up from pilot and commercial manufacture to final design verification and validation, our production engineers can fully support the specification, development and qualification of assembly, inspection and test equipment.

Medical device development frequently entails the parallel development of bespoke test and assembly jigs and fixtures to support the characterisation of performance parameters. Working closely with our device testing team, we ensure that these systems are suitably developed, qualified and documented for use during design verification programmes.

The designs of fixtures can inform the input requirements and development of commercial assembly and test systems (semi- or fully-automated). Our production engineers have experience in all aspects of equipment specification, development, commissioning and qualification. Our manufacturing consultants can support you from the initial exploration of equipment requirements to sourcing, procurement and final validation steps including installation qualification, operational qualification and performance qualification.

Design transfer

Design transfer is a critical final phase of medical device development, led by design controls aspects of both ISO 13485 and 21 CFR 820.30. It entails far more than merely handing over technical files and CAD databases. We can support you with the entire process: verifying that your design and development outputs are suitable for manufacture, translating device designs into production specifications and ensuring the production capability can meet your product requirements.