Miranda Conary, product specialist at Web Industries, discusses how device makers and contract manufacturers collaborate for success in development of medical diagnostic devices.
In today’s fast-moving medical device industry, original equipment manufacturers (OEMs) are increasingly turning to resources outside of their four walls to bring products to market. The reasons why they choose to collaborate with contract manufacturers vs. go it alone are as varied as the businesses themselves, but a few drivers include:
- Bridging capability gaps. Perhaps a start-up has strong new product ideas but little experience with product development and the path to commercialisation. Or a device maker lacks a biochemistry lab or quality control team experienced in lateral flow immunoassay (LFI) devices.
- Optimising high-speed, high-volume automation. A contract manufacturer may have machinery to handle very wide material rolls or robotic assembly lines to eliminate manual labour.
- Qualifying a secondary supply source to mitigate risk in case a primary supplier reaches capacity or has a production interruption.
- Accessing a more extensive supplier network, presenting the chance to use novel and different materials supplied in diverse formats.
Device maker-contract manufacturer relationship: step by step
Every contract manufacturing relationship is different. In some situations, a device developer may turn to a converter to perform a single but specialised process, such as supplying a pad material with a deposition on it. In other cases, a contract manufacturer may be engaged with the device developer from the very earliest design phases all the way through to commercial-scale production and packaging. Regardless, there are some common steps in the collaborative process.
Project definition phase
During this step the device developer and contract manufacturer typically conduct a technical meeting to review the product, its status in the development process, documentation, studies that are completed or underway, the desired timeline and any forecasts for anticipated volume. There are advantages to involving a contract manufacturing partner as early as possible in the development process. The contractor can weigh in regarding design or raw material changes that could be made to significantly enhance manufacturing efficiency and speed. For example, if the device developer’s pad material supplier only provides 50-meter rolls, and the converter’s operations can support 100-metre rolls, it makes sense for the device developer to take advantage of the larger batch sizes possible with using larger rolls. Such issues often rise to the surface during the project definition phase. From this phase, the OEM usually receives a full report from the contract manufacturer outlining an estimated project timeline, preliminary pricing, risk assessment and point-by-point review of how the project will flow through its operations.
Technical transfer phase
During this phase the contract manufacturer presents the device OEM with a more formalised project plan and starts conducting activities such as raw material supplier assessments, engineering studies and equivalency testing. Equipment is calibrated to deliver products within precise specifications, and the partners continually verify and validate results every step of the way. As with the other two phases of development, this should be a stage-gated process in which the partners pause at each gate to evaluate how things are going and are free to walk away if the relationship is not satisfactory.
Commercialisation phase
During this stage, the OEM and contractor enter into formal supply agreements, nail down quality requirements for the commercial-scale production and start manufacturing devices for sale to the market.
In conclusion, throughout the device development process there must be communication, trust and transparency between a device OEM and its contract manufacturing partner. These qualities and a strong spirit of adaptive engineering go a long way toward ultimate product success.
