Business Weekly - Cambridge, UK

Biotech and medtech companies are facing the increasing need to work together as, for example, new formulations need a device for delivery, or device companies find themselves faced with the development challenges of a combination product.

As specialists in medical product design and development, Team are accustomed to managing the marriage of these two very different industries.

We help clients who need to turn their science into a successful product, ensuring that their device development project meets the needs of all quality and regulatory requirements, while providing users with a product they are happy and safe to use.

After the significant time-scales and costs involved in drug discovery and manufacture, surely delivering the final results should be easy?

This depends on your definition of ‘easy’. It’s rather like The Hitchhikers’ Guide to the Galaxy claim that flying is easy – the knack lies in learning how to throw yourself at the ground and miss. 

Fortunately developing a successful delivery device is a little more achievable, and here we cover just a few of the basic principles. So how can you make sure you’re on the right development path?

First – plan. Do it before the project starts and accept that it will evolve. Make sure you’ve laid out clearly what’s expected of the people and the processes.

Start with standards such as FDA 21CFR820.30 and ISO 13485, which provide clear guidance on what is needed working forwards.
A Design History File, which provides a documented record of the development process, is required – and knowing at the outset what will be needed will help you work backwards.

To ensure that risk is understood and mitigated as early as possible, a risk management plan must be at the heart of your development.

Understanding what doesn’t need to be in the design and development plan is just as helpful. Early development work by its very nature requires flexibility, with space to understand the landscape and accommodate the many variables.

Then create your specification. These will cover the user requirements – what users will get from the product; functional requirements – what the product will and will not do, and the design specification – what the product is.

As you create these specifications, consider those that will need to be verified/validated and how you will do that. 
Devote time, attention and intellect to understanding in all areas. Be prepared to invest heavily here, as it will yield the highest return on investment of the entire project.

Understand the user’s perspective, perceptions and problems.

Understand the fundamental operating principles of the device design and reveal any weak points so they can be improved.

Understand the manufacturing issues – both moulding and assembly – involving the manufacturer from an early stage.

Understand the relationship between the formulation and the device, and insist on the early interaction between formulation and device development teams. 

Put the user at the heart of the project. Users, be they patients, carers or clinicians, are often the Cinderellas of the development process, with their needs considered as an afterthought.

Consider them from the very beginning of the development process, when it’s simpler to get it right. Investigate the context of use, carry out observational user trials, consult prescribers, and if at all possible, have a ‘user champion’ on the team, whose job it is to keep user needs at the top of the agenda.

Whatever you do, don’t leave it to Phase III clinical trials to discover that patients can’t use your device.
Some key design problems can be avoided if you beware of the traditional ‘monkey trap’ – where a team member refuses to let go of a doomed design route.

Perhaps most importantly, deal with company politics from the beginning and keep the lines of communication open, particularly between marketing and design teams. 

There are too many design and manufacturing issues to be covered in a brief overview, but Team are always happy to discuss in more detail how companies can best manage their medtech marriages.
• Please contact Matthew Young, senior consultant, on 01799 532 700.

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