At Automa8, we have wide experience of medical devices, diagnostics and products. Our medical automation consultants have more than 17 years industry experience and know that a well thought-out product, designed for manufacture and automation, can make a hugely positive impact on budgets and timescales.
Using standard ‘tools’ such as Design for Automation [DFA], Design for Manufacture [DFM] and Design Failure Mode Effect Analysis [dFMEA], we work closely with our clients’ design teams and consider changes that could markedly improve their products for assembly and automation.
Extensive experience involving pressurised metered dose inhalers, dry powder inhalers and diagnostic devices, means that our medical automation experience is significant. As such, we have worked flexibly with clients, design houses and consultancies, on many notable devices.
Within medical automation, the need for early involvement cannot be over-stressed. As projects develop they gain their own momentum and can limit or prohibit necessary changes when they are best (and most cost-effectively) implemented. Ownership of design and the mentality that says ‘it’s too late to change it now’ can often lead to significant additional costs and time delays as each element becomes ever more entrenched.
Some useful points for consideration:
- Design should be considered in relation to assembly and automation and its impact on the robustness of your device. This is best undertaken at the earliest possible opportunity
- Simplify parts as early as possible, make the design intrinsically cost-effective at the design stage and save exponentially later on in the project
- To ensure the project runs to plan and budget, involve experienced medical automation consultants to help ensure necessary decisions are made sooner rather than later
- Automated checking; what is your philosophy and how is it best applied?
- dFMEA should be undertaken with knowledge of the product functionality along with shortcomings on the processing of the device
- Validation and 21CFR part 11: this process must be undertaken in a progressive and appropriate manner, using automation suppliers to their best effect with involvement from both parties
For further insight into our widespread experience in medical automation consulting or to find out more about our the services that we provide, please contact us