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How to Vet Your Medical Manufacturer

How to Vet Medical Manufacturer

What needs to be asked when sourcing and vetting a potential medical manufacture?

To get a more thorough understanding of the medical device manufacturing landscape and having a head-start when it comes to choosing who you’d like to work with to get your product created and distributed, you’re going to need to ask some pointed questions. 

If you’re going into partnership with someone, you’re going to want to know that you can get along with them. You’re also going to want to know that they’re competent, trustworthy, and qualified. While this general understanding is easy enough to have, what specifically should you look for in a medical manufacturing partner?

Qualification

These are medical devices that have direct contact and a major influence on the wearer’s health and wellbeing. Like any provider of medical supplies from devices to services to medication, there are going to be some understandably detailed legal and ethical guidelines that a manufacturer must follow. Having an ISO 13485 qualification and being registered with the Food and Drug Administration is a must, as well as having registered production sites and staff with the proper education and qualifications. When vetting a potential partner, simply asking for proof of these qualifications should be enough, but they can also be acquired through a remote audit or a supplier questionnaire.

Production Environment

Products must be sterile and up to rigid specifications, and that means that the place where they are produced must also meet a high standard of cleanliness. Asking the following about the production facilities should give you some important information about your partner: do their sites focus entirely on medical manufacturing? What are their procedures in cleanroom manufacturing operations? How do they handle raw materials? How often do they do inspections on the status of their facilities? What kind of protective gear do workers wear in the cleanrooms? Stringent protocols for a sanitary production environment are standard operating procedure for these places – so they should have lots of information for you.

Process

What exactly does your manufacturer do themselves? This question, as opposed to the other ones above, may be a little less common. While some producers only focus on the assembly of the device and prefer to outsource elements like sourcing (the irony…) or distribution, more trustworthy companies offer a complete process – following the product from conception all the way to delivery to the client. That way there is total control over the process from start to finish, eliminating the potential for costly errors down the line.

Risk

Assessing the risk of a potential partner isn’t unique to the medical industry – it’s just common sense. If you’re about to rely on this company to make your product, you should know the potential pitfalls of doing business with them – do they have a plan B, C, or D should things go awry? How did their company handle the COVID-19 pandemic and the economic fallout? Are there additional production sites? Do they have a cohesive business plan? Drawing up a risk assessment questionnaire will be helpful in getting these answers.

The above questions may seem intrusive, but your future product shouldn’t be manufactured in half-measures. Finding the right partner to help you on this journey is one of the most important steps you can take, and knowing what to ask is the best way to start. 

For the previous blog in this mini-series, which looks into the future of medical manufacturing, please CLICK HERE.

For the next blog in this mini-series, which looks into the difference between local and global medical manufacturing partners, please click here.