Building links between engineering and manufacturing for product success

21 January 2021 Resources

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 needs 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
  • Manufacturing
  • Regulatory and product development consultancy
  • Aftersales

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 optimize design for manufacturability as part of this phase. The result is the 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 device 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 organization
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 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 engineering

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 commercialization 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.

Trusted 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.