As we discussed in our last post, it’s been a challenge for some med-device companies to leverage antimicrobials to protect the surfaces of their devices. With several antimicrobial solutions providers offering many different types of technologies, combined with confusing FDA guidelines around antimicrobial additives for 510(k) submissions, this is a complex issue for manufacturers.
In Lise Moloney’s article, “A Guide to Leveraging Antimicrobials to Protect the Surfaces of Medical Devices”, she addresses some of the most pressing challenges for med-device companies. In a two-part blog series, we’ll briefly explore some of these topics. Let’s jump into the first three:
Defining Product Requirements
While some med-device companies think they need to start the antimicrobial additive process by finding an antimicrobial technology, they would be wrong. It’s imperative that they first define product requirements, which will make finding the right antimicrobial technology all the more clear. Lise recommends that companies define their products’ end-user environments, clinically relevant organisms, durations of efficacy and ideal antimicrobial performances.
Picking an Antimicrobial Supplier
The antimicrobial space is crowded, so when looking for the right partner, there are some critical things to consider. Lise advises readers to find a company with deep experience in FDA-regulated products, U.S. and EU technical files and clinical data to prove its technology’s efficacy.
Considering Manufacturing Requirements
Many med-device companies overlook the fact that they need to understand the current manufacturing processes and the capabilities of manufacturing partners and facilities. To do this, they need to know, upfront, how they want to incorporate antimicrobials.
To learn more about these best practices and more, you can download Lise’s article below: