19.05.2023

A Medical Device Development Journey

 

  • Collaborated with a major brand (over £690 million turnover) on a Class 2B medical device project.
  • Conducted successful pilot manufacturing and extensive testing, enhancing shelf life and proving efficacy.
  • Currently finalising product registration and CE marking, poised for full-scale manufacturing.

 

In a significant venture, we joined forces with a leading company with a turnover exceeding £690 million. Our challenge was to transform a pioneering ingredient, developed in partnership with a team of scientists at a leading University research division, into a viable medical device aimed at addressing a top health issue related to obesity. 

This case study highlights our journey through the intricate process of medical device development, showcasing our expertise and capabilities.

 

Our Role

The client had already achieved a remarkable milestone by patenting an innovative material designed to tackle a major health concern linked to obesity. Our role was to translate this invention into a practical dosage form while ensuring a positive user experience.

Initial testing phases, including both in vitro and in vivo studies, were expertly conducted by the university with multiple groups. These tests were crucial in establishing the basic efficacy and safety of the raw material. Building on this foundational work, we undertook the challenge of pilot manufacturing the ingredient in its dosage form.

 

Our Tests

A key achievement in our development process was conducting stability and shelf life tests, which successfully extended the product’s shelf life from 12 to 24 months. This extension not only signified an improvement in the product’s usability but also its commercial viability.

Furthermore, we carried out rigorous first-stage double-blind placebo trials. These trials were pivotal in establishing the product’s efficacy in a controlled, unbiased manner. Alongside this, we conducted thorough contaminant testing to ensure the highest standards of product safety.

 

The Current Situation

Currently, we are in the process of registering this innovative product as a medical device and obtaining the CE mark. This step is essential for transforming the product into a fully commercialised medical solution.

As we move forward, we have been designated as the full-scale manufacturer for this product. This responsibility underlines the trust and confidence the client has in our capabilities, and we are excited to transition into full-scale manufacturing soon.

Are you looking to bring your medical device from concept to commercial reality? At Supplement Factory, our Research and Development team specialises in turning innovative ideas into market-ready solutions.

Contact us to learn more.

Supplement Factory

Written by Supplement Factory

Our team of industry experts not only work towards producing the highest standards of sports and health nutrition products, but also lend their knowledge towards educating the industry on the latest advances in products, ingredients and formulations.

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