Building links between Engineering and Manufacturing for product success
Did you know that having geographically separated engineering and manufacturing can have a detrimental effect on your project’s success?
The more complex, or high-volume your device is, the more important it is to design with manufacturing in mind. Working with a partner that provides both in-house design and manufacturing services will significantly reduce the risk of project failure.
There are many data inputs and outputs generated throughout the life-cycle of a new product that need to strictly reflect and meet the requirements of current medical device legislation including the European Medical Device Directive. There should be a cohesive and comprehensive development and manufacturing process that follows a Quality Management System capable of seamlessly managing a device from concept through to volume manufacture, servicing and support, and in the longer term, obsolescence mitigation. To guarantee the success of your device, it’s best to keep it all under the same roof, within the same company. Divide and conquer will not work under these circumstances.
By working with ITL you’ll have access to all services, including:
- Product development
- Product design
- Regulatory and product development consultancy
This enables you to gain more control over specifications, planning, development, manufacturing, quality, turnaround time and the overall costs for your project. It provides reassurance that we are able to identify and mitigate risks associated with product development and optimise design for manufacturability as part of this phase. The result being preservation of your confidence and accelerated market acceptance of your medical or diagnostic device.
Advantages of in-house R&D and Production
You need a controlled, but flexible process incorporating;
- Design for manufacture as an intrinsic part of development
- Production Engineering involvement at the earliest stage
- Efficient monitored progress throughout the whole development life-cycle
- Quality built into the design
- Accountability within one organisation
Design for manufacture
A DFM approach can produce significant benefits even from the smallest details. It’s very easy to design an instrument or disposable for one-off use but designing for manufacturability requires a greater attention to detail, especially materials. Consistently applying DFM principles and best practices will allow for a successful product that may be mass-produced cost-effectively and speed up time-to-market.
Production Engineers act as a bridge between R&D and production, ensuring a smooth, integrated process from start to finish. By having a team of Production Engineers in-house we’re not only able to implement risk mitigation at an earlier stage but we gain immediate feedback on the design, helping to avoid costly rework further down the line. The earlier they’re involved, the better.
Having all the required services under one roof means that all of the design and manufacturing processes can be aligned, tracked and managed throughout the life-cycle. This continuity means that the plans can mesh together seamlessly giving rise to a much more time and cost-efficient process.
Choosing a partner with a strong QMS ensures that the appropriate quality gates are in place throughout the entire product development life-cycle. Quality cannot be overlooked when it comes to medical device development. Your product won’t ever reach commercialisation if it doesn’t fully comply with industry regulations.
No hiding, no pointing fingers, all the accountability is on us. Working with one partner that understands the complete product development process is central to ensuring a seamless transition from design to manufacturing.
Design and Engineering specialists
Our flexibility, commitment and quality, whether handling small projects or designing projects from concept to completion, has deservedly earned us a first-class reputation in the MedTech industry. It has also helped to establish us as leaders in providing innovative and cost-effective engineering solutions on a commercial and practical basis.
We are an ISO 9001, ISO 13485:2016 and FDA GMP certified full-service contract design and manufacturing partner with an exclusive focus on medical, diagnostic and analytical instruments. No matter where your device is in its life-cycle, we’d love to hear from you. Get in touch with a member of our team to discuss your project and how we could help you. Please call us +44 (0)1233 638383, email us firstname.lastname@example.org or simply start a conversation with our team on LiveChat.
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