It’s easy to turn money into technology; it’s not so easy to turn technology into money

Developing medical products to prepare them for commercial production is commonly known as industrialisation. Officially, regulators call this either ‘Design Transfer’ (US Food and Drug Administration [FDA]) or ‘Design and Development Transfer’ (ISO 13485). These meanings are essentially the same, which is to ensure that ‘the design and development outputs are verified as suitable for manufacturing¹’ and that the ‘device design is correctly translated into production specifications²’.

Industrialisation of medical products is a complex part of the overall development process. It usually involves a lot of preparation and coordination among multiple groups and, as such, the resources and time needed to complete this phase are often underestimated. Even the most capable of medical companies can, and do, experience difficulties in turning prototype technology into a commercial product.

In the early stages of product development, the responsibility lies with the design team. Progress at this stage can be very tangible and exciting: product concepts are created rapidly, evaluated and then reiterated; prototyping methods are often used to quickly produce early models for mechanical and user evaluations. As the design develops, functional models are necessary to demonstrate and prove the robustness of the technology. These are called ‘proof-of-principle’ prototypes and closely resemble the final product solution. A typical prototype may include realistic electronics modules and even genuine components produced in the correct materials. These prototypes are very convincing and can easily lead to a false sense of the development process being almost complete. However, it’s worth remembering that these samples are still “prototypes” and, in reality, a lot of work is still required to produce actual medical products.

As the process moves towards the industrialisation stage, the rate of perceived progress seems to slow down significantly, which can be less exciting for those who have been involved from the beginning. This occurs because the manufacturing methods and processes need to be developed, which involves everything from the design and build of the production and assembly equipment to validation of the manufacturing processes. The objective is to have systems and processes that are predictable, consistent, and controllable to ensure that the end product reaches the required level of quality to safeguard patient/user safety.

To gain some insight into the industrialisation process, we have put together a few rules of thumb to consider when developing a new medical product:

This is perhaps the most obvious rule because adhering to your QMS is critical to obtaining regulatory approval from both the FDA and/or the ISO; without a QMS it is not possible to design or manufacture medical products. However, sometimes short-cuts are taken, especially during development when milestones can make or break whether a product continues. If this happens, these short-cuts will need to be remedied before Design Transfer can be completed. In the worst-case scenario, this can mean significant re-working. It’s worth remembering that any issues that are deferred will need to be resolved during this phase and that the cost of correcting errors increases exponentially during development, so gaps should be filled as soon as possible.

At Team we call this a Manufacturing Strategy Plan (MSP). The purpose of an MSP is to build on the commercial production requirements that are usually decided at the very beginning of the new product programme. It should contain information that may influence the design detail, such as the expected production volume, target product and investment costs, information on where the production sites will be located, and how/where the final product inspection and distribution will take place.

This plan should be created as early as possible and updated throughout the development phases. It should be made available to the development teams so there are no surprises regarding the production scale-up requirements. Having the basics well defined can help drive good decision making later in the plan.

As we have already mentioned, industrialisation really starts in earnest after the development and design verification work has been completed. But its worth remembering that the preparation for manufacturing needs to overlap the design activities from an early stage to make sure that the transfer process runs smoothly. A good technical development team will find a balance between design creativity whilst also de-risking potential future production difficulties. For example, a detailed review of production transfer trays will probably not be helpful at the design concept stage, but flagging components that have vulnerable design features should trigger further activities to identify product-handling solutions earlier in the program.

The design team should understand the technical strengths and weaknesses of the selected production partners. This will help to guide the product design towards areas of manufacturing strength, making for a smoother transition during industrialisation, and to identify whether new skills/processes will be needed. Questions should be asked, such as: is the manufacturing equipment already available? Have similar assembly processes been proven in the past? What is the expected process capability?

It is human nature to be drawn to the simpler aspects of the design detail to ‘get them out of the way’. However, during industrialisation it is much more efficient to focus efforts/resources on the most complex product components, sub-assemblies or production processes to ensure that the design solutions can be manufactured (and controlled) as planned. Ultimately, the difficult parts will determine whether the product can be manufactured successfully.

This can be one of the more complex aspects of the industrialisation process. For some product functions, it is possible to perform a direct check during manufacture; for example, the position of a component during assembly can be inspected using a camera to compare images of good and bad parts for Quality Control.

For other product functions, a secondary or inferred check may be required; for example, if the counter on an inhaler rotates by one digit in a test actuation this means that the internal mechanism is functioning correctly. These types of tests can be very difficult
to establish and validate, so detailed analysis and preparation are to be expected. Where no functional tests can be carried out in production to ensure – directly or indirectly – that input requirements will be met, a detailed understanding of the design space becomes essential e.g. through tolerance analysis. This will allow detailed discussions with commercial manufacturing partners to take place to ensure that production design specifications describe a device that will meet its functional requirements.

Processes such as component inspection, sub-assembly handling, labelling and packaging may seem less important during the concept development stages of a new product, but they soon become essential for validation of the manufacturing systems.

Metrology can often be the bottleneck in a validation process, so having fixtures and methods qualified as early as possible can avoid delays and the need to repeat work later on. Prototype moulded parts manufactured during detailed design can often prove very useful in support of such activities.

At Team we know that pioneering medical devices change people’s lives for the better so we understand the importance of efficiently transferring a design into commercial product. The principles that we have listed here are by no means exhaustive, but we hope that they give some useful insight into the planning and expertise needed to successfully make it ‘off the drawing board’ and into production in the most successful way.

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References

1. FDA – Design Control Guidance for Medical Device Manufacturers
2. ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes