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Medical Device

Novel Approaches

In addition to our wide-ranging capabilities in aerosols, barrier pressurized packs, tubes, liquids and semi-solids, we also support the development of medical devices — products that are used to treat medical conditions but that do not contain any formally recognized pharmaceutical actives. Medical devices are one of the more unique, novel approaches to delivering therapeutic value, which means they’re right in our wheelhouse.

We have extensive experience supporting customers through 510(k) submissions for FDA marketing clearance and are well-versed in the process of creating formulations based off of predicate devices. From anti-inflammation sprays and artificial saliva to treatment of scars and radiation burns, we’ve helped to develop a broad range of medical devices for both consumer self-care and professional care applications. If you have an idea for a medical device, we want to hear it — and then we want to help execute.

SILICONE-BASED
FORMULA

Case Study  | Medical Device

In-Field Failures Resolved, Paving The Way For Global Growth

The Challenge

The owner of a branded medical device had a serious issue. The company had been contracting the manufacturing of a novel silicone-based medical device formula and was seeing in-field package failure rates in excess of 30%. Not only was the product failing in the field, but the consistency was highly variable and incredibly difficult to manufacture.

Create_MD_CS_applicator_tube
The 'Formulated' Solution

As soon as we got the call, the team dug in with vigor. Internally, we got to work creating a stable blending process — one that would provide a highly consistent product within a narrow viscosity range. In parallel, our engineering team flew to Europe to work directly with machinery experts to create a custom solution to alleviate seal integrity failures. The blending issue was resolved, two pieces of custom machinery were built and shipped to the U.S., patents were issued and the product, along with the resulting global line extensions, is still being manufactured by Formulated Solutions today. 

Formulated Solutions fosters a problem-solving culture.

Project Manager, Global Consumer Healthcare Company