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Industrialisation for medical devices – the basics

When designing complex medical products, experience tells us that manufacturing needs to be considered right from the early stages of a new development to help avoid costly project delays later on. In our work, we must design products that can be produced reliably and consistently, using capable processes. We do this by using our expertise and background in production methods and by working closely with manufacturing partners from early on in the design process.

We have developed tools and techniques which have been proven on numerous projects to help ensure a smooth transition from the development phase into industrialisation and production scale-up and to meet the particular needs of medical device development. These include; analytical tolerance analyses methods, templates for managing and tracking Design for Manufacture and Assembly (DFMA) actions and bespoke process risk assessment and FMEA’s.

 
But, what exactly do we mean by medical device industrialisation?

This is a general term given to the activities involved with scale-up of the manufacturing equipment and procedures for a product to meet the market volumes at a target production cost.

Here at Team, we get involved in a high number of drug delivery development programmes that ultimately need to be manufactured on a mass scale. So, for an inhaler or injection device, activities may include; the design, manufacture and validation of multi-cavity injection mould tooling and automated assembly and test machines, for example.

The term ‘industrialisation’ is also used broadly to cover any aspect of translating a design or prototype into a product that can be manufactured.

 

 
What is the difference between industrialisation and ‘pilot’ manufacturing?

As we’ve identified, industrialisation is a term used describe the phase of scaling up to manufacture to a large scale. In contrast, pilot manufacturing is a term typically used to describe early or short-term manufacturing methods.

Introducing a pilot manufacturing process that is representative of the final manufacturing process, but at a lower capacity level, can be the most cost and time efficient way of progressing a product development project. It is a practical route for building small batches of products for essential activities such as; clinical trials, real-time aging studies and other verification activities to prove the device safety and effectiveness.

 
When is the best time in the development process to start work on industrialisation?

The strategy and approach to industrialisation should be driven by the predicted production or sales estimates gathered in the early ‘direction setting’ and ‘market research’ phases.

Suitable manufacturing and assembly methods can then be explored by the design team from the very start of the concept selection and development process. It stands to reason that the process of industrialisation will take a different approach for a device with expected sales in the multiple millions, compared to a device expected to only sell a few thousand units per year.

 

 
How do you balance product innovation with manufacturing requirements?

Innovation and manufacturing should not be thought of as being mutually exclusive. If you think about industrialisation in the concept stages of your product, there will be time to identify the aspects that may be tricky – or novel – to manufacture and focus more effort on these from the outset. An experienced development team will do this intelligently throughout the development process by continually reviewing the design and tracking the actions.

We also know from experience that early collaboration between manufacturing experts and designers leads to faster development timescales and lower costs.

 
Who is responsible for industrialisation?

The responsibility is ultimately with the product ‘owner’ – or in our case the client – but in the development phases the responsibility to deliver a robust product that meets the manufacturing requirements lies with the design authority.

The simple truth is that good medical development is all about experienced development teams working in collaboration with expert partners and manufacturers; we absolutely do not believe in an ‘over-the-fence’ approach to passing complex designs on to manufacturing partners to ‘fix’ or find solutions to.

 

 
Is the industrialisation process for medical devices covered by any specific regulations or guidance?

It is driven by both FDA’s QSR (Quality System Regulation) 820.75 and ISO: 13485.7.5.2. There are some other specific guidance documents on design techniques for industrialisation and production validation, which we will cover at another time.

 
These questions and answers begin to illustrate how for product developers, good design and ingenious engineering count for nothing if the final product cannot be made in the required volumes, to the right quality level and at the right cost. Thinking about industrialisation is a way of thinking ahead, and to ensure a smooth transition from concept through to scale-up.

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