Small batch manufacture of a medical device

Challenge

We managed the manufacture of controlled short run batches during the development cycle of the Tympa System, a smartphone-enabled otoscope device, to support testing and trials.

Approach

Team Consulting managed a network of approved suppliers and assembly partners to provide qualified devices for our client, TympaHealth.

Outcome

We created two versions of production equivalent devices, ready for verification testing.

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Producing small batches
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Small batch manufacture of a medical device

As part of the development process of the smartphone enabled otoscope, we needed to produce short run batches of devices to complete both verification testing and in-use trials. Our client, TympaHealth, was a start-up company with limited manufacturing capability. With extensive experience at all stages of development, Team Consulting took on the responsibility to manage the production of short runs of the device that would meet the technical and regulatory requirements of a CE Marked Class I medical device.

For the batch manufacture of the Tympa System, we worked very closely with a contract manufacturing partner and several sub-suppliers for the provision of a range of components. These components included plastic injection moulding, aluminium casting, machined parts, optical elements and printed circuit board assemblies.

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Batch released product for DVT - Design Verification Testing

Team’s ISO 13485:2016 certified Quality Management System covered all aspects of the manufacturing process including appropriate approval of suppliers, control of the design, manufacturing processes, test procedures, inventory control and product release.

As part of the manufacturing plan, Team specified components, sub-assembly inspection and approval requirements in addition to the 100% end of line essential performance test.

The device contained four separate PCB assemblies. Each one was tested against a test specification that Team developed before release to the assembly process.

Team Consulting was able to take responsibility for all aspects of manufacturing the short run batches that we needed in order to complete the development process and get the product to market.

Dr. Krishan Ramdoo, Founder and CEO, TympaHealth

Clean room assembly

The device included sensitive optical components used to allow inspection of the external ear canal and tympanic membrane under magnification. These parts needed to be assembled in a controlled and clean environment to ensure that the system was dust free.

Team had a clear understanding of when controlled manufacturing environments were needed and how that could be included in the manufacturing process.

Mark Di Cioccio, Head of Quality Engineering, Team Consulting

Production equivalent devices for Design Verification Testing

By working with our proven network of suppliers and contract manufacturers, we were able to produce devices for verification that were production equivalent.  Any differences to the final product, such as surface finishes on some components, were fully assessed to ensure that the device tested would be acceptable for regulatory purposes.

Batch assembly of pcb for smart ear otoscope

Outcome

PCB assembly, clean room assembly and co-ordination of supply chain was all combined into one supplier. Working with a dedicated contract manufacturing partner reduces error and is thus an effective route to produce small batches in advance of commercial production.

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