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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 production of medical devices — products that are used to treat medical conditions but do not contain any formally recognized pharmaceutical actives. Medical devices represent one of the more unique and novel approaches to delivering therapeutic value, aligning perfectly with our expertise.

We hold ISO 13485 certifications and possess extensive experience in supporting customers with 510(k) submissions for FDA marketing clearance. Our team is proficient in creating formulations based on predicate devices. Our portfolio includes developing a broad range of medical devices, from topical anesthetics, cryosurgery, and anti-inflammation sprays to sterile saline sprays, artificial saliva, and treatments for scars and radiation burns. These devices cater to both consumer self-care and professional care applications. If you have an idea for a medical device, we are eager to hear it — and then assist in bringing it to fruition.


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.

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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