What constitutes a good design package for medical device manufacturing?

Tom Ackrill: A good design package should be complete, suitably detailed and well structured. Of course, if a product has been developed following the Medical Device Directive, you would expect the design package to be suitably equipped for any prospective manufacturer to pick it up and run with it.

A manufacturer should then be issued a device master record with an accurate bill of materials, including full part details and suppliers, together with any information on parts or components that are either critical or technically challenging. It may be that your device relies on a particular supply chain or key vendors, and this must be understood at the earliest stage.

What makes certain medical devices more difficult to manufacture?

All devices have their complexities, but more often than not, the larger the device, the more complex it is to manufacture, as they tend to require more components, subassemblies and testing; however, smaller devices can present their own challenges. Intricate parts and small components can prove difficult for production teams to build; therefore, providing a pilot instrument during the design phase can help standardise processes for when the device is implemented into full-scale manufacturing. Products should be designed with manufacturability in mind, to ensure the build is as easy to repeat as possible.

When during the design process should a manufacturer get involved?

As early as possible. The earlier a manufacturer is involved, the easier it is to establish manufacturing volume expectations, cost parameters and regulatory requirements. It’s one thing having a product or device designed to perfection, but ensuring it gets to market on time and within budget is highly dependent on the transition period between design and manufacture. Early collaboration leads to faster development timescales and lower costs.

When during the design for manufacturing phase have you seen potential stumbling blocks occur?

Lack of detail in the design package can often be an issue; for example, an insufficient bill of materials can trigger delays in the quotation process, ultimately causing setbacks in a product reaching manufacturing.

Another common stumbling block appears during the review of a supply chain. We always advise our clients to select components that are widely available and have numerous substitutes; this reduces exposure to the volatility of the component markets and also prevents complex supply chains from getting out of control.

What critical steps must medical device startups take to get the most value out of their design and manufacturing partner?

Select a partner that has relevant experience and a proven track record in manufacturing. Don’t get distracted by big buzzwords and flashy diagrams, because, ultimately, you want a manufacturer that can produce a device that works first time, every time.

Good communication at all levels of a business is crucial. It’s important to meet everyone involved on a project, from the CEO to the individuals building the product. Not only does it keep the dialogue flowing, avoiding confusion or misunderstandings, but it’s reassuring to know you are in safe hands.

Finally, don’t be afraid to accept change or admit mistakes. A manufacturing partner may suggest minor changes in a product’s design simply to make it more suitable for high-volume manufacture. Most of the time, they’ll work to improve your product because it’s better for all parties involved.

What important question or consideration is often overlooked by medical device start-ups in their selection process of a contract manufacturing partner?

‘What are your long-term plans?’ It’s important to ask your prospective manufacturer where they picture themselves in five, ten or even 20 years. When multiple tenders are on the table, and one manufacturer is offering a more competitive bid, it’s important to ask where they view themselves in the future. Putting it simply: if the price is too good to be true, it probably is.