High five

Daniel Benze, Forefront Medical Technology explains the five ways your injection moulding supplier can take time and cost out of product development

Medical device manufacturers are under continuing pressure to cut cost while delivering superior quality. A well-organised product development process that taps contract manufacturer resources can reduce both upfront cost and time, plus reduce overall manufacturing cost. Involvement of the injection moulding supplier is key, because this manufacturing ‘expert’ is well positioned to reduce a number of major cost drivers. Not surprisingly, the injection moulding supplier business model has evolved to include many of the services more broadly defined as ‘contract manufacturing’.

The product development team at Forefront Medical Technology, a specialty contract manufacturer with a focus in disposable diagnostic, drug delivery and medical device systems, has average product development cycles of eight to nine months. The team attributes its success in regularly shortening product development cycles and reducing overall cost to focus in five key areas: Materials selection; design process; tooling design and fabrication; prototyping; validation infrastructure.

Materials selection

Using materials that have previously been tested and approved within the regulatory environments associated with the product can cut months from a product development cycle. Some validation tests take six months to one year and the process may have to re-start if the material fails testing. This contract manufacturer  often eliminates eight months to one year of development time, when materials from its database that have been previously approved such as DEHP-free PVC, Peek or Kevlar are utilized.

Design process

Standardised product development processes that are aligned with regulatory and validation testing requirements make it easier for the device manufacturer’s product development team and the moulding supplier’s team to understand what resource gaps need to be addressed at the beginning of the process.

For example, in this contract manufacturer’s process, customer requirements are assessed and a Design Development Plan (DDP) is created. A customer specification is then developed and market inputs are collected. Once the customer specification is approved, 3D CAD models are developed and analysed. Design reviews which include functional analysis and risk evaluation are completed. After the customer’s team approves the design, prototyping and verification began. 

Tooling design and fabrication

A primary benefit of using a tooling development team that is part of a moulding supplier rather than a standalone tooling firm, is that it ensures the design process aligns well with production processes. Tool complexity tradeoffs can be analysed to develop the best tool for projected volumes, minimisation of secondary processes and cost targets. The earlier manufacturability issues are analyzed in tooling development, the less expensive the tooling design modifications will be. Working with a design team that is analysing the design for manufacturability early in the product development process eliminates added design spins, enhances quality and minimises non-value added processing. Additionally, vertically integrated tooling capability can also cut time from the design cycle.

This contract manufacturer utilizes a gated design process to enable tooling development to begin as early in the design process as possible. Taking a vertically integrated approach to tooling fabrication and use of in-house resources often cuts another 2-3 months off of product development time. The tooling design process includes a design for manufacturability (DFM) phase, followed by development of the mold specification.  Mould-flow analysis tools are used to ensure efficient moulding with minimal scrap and minimization of secondary finishing processes. Computer analysis minimizes design iterations on tooling.

The mould fabrication process includes a testing and debugging phase which incorporates a dry run and analysis of product (FOT) first off the tool. Design assumptions related to target labour utilisation and run rate are evaluated during the validation process. All data is shared with the customer, for their approval.  Changes are made if that analysis indicates assumptions were flawed. Production processes undergo a similar development and validation phase.

Prototyping

Taking an integrated approach to rapid prototyping also contributes to reduced product development time.  For example, this contract manufacturer’s use of Selective Laser Sintering (SLS) and Multi-Jet Modeling (MJM) systems in rapid prototyping cuts lead-time in the product validation process.  In-house resources are used to scale up moulds and tools, and perform pilot runs and validations.

Validation infrastructure

One of the most challenging aspects of the medical device market is meeting the regulatory requirements of different markets. The high level of automation associated with many disposable medical products makes sourcing regionally less cost competitive. Working with an injection moulding supplier capable of supporting a global device marketing strategy in terms of validation testing and quality infrastructure saves time and improves economies of scale.

For example, this contract manufacturer has a dedicated Regulatory Affairs team whose responsibilities include product registration and CE marking; maintenance of the Device History Record (DHR) and technical file; biocompatibility testing; validation and support sterilization; updates on regulations and communication of new/revised regulations; and intellectual property protection.

Conclusion

Cutting time and cost from the product development process requires focused expertise and robust systems. That investment typically provides dividends in terms of cost competitiveness and superior quality that continue over the full product lifecycle.