Reasons to outsource to a CDMO for Assay Development

November 27, 2024

Reasons to outsource to a CDMO for Assay Development

Outsourcing to an external Contract Development and Manufacturing Organisation (CDMO) for assay development can be a tricky decision to make. Often projects are a labour of love, and a reluctance to collaborate with an external developer can result in delays with bringing medical devices and in vitro diagnostics to market.

 

Maybe it’s the worry of relinquishing control to somebody else to translate an idea into a market-ready product. Perhaps there are pre-existing misconceptions that a CDMO will cut corners to monetise an idea, without the due care and attention that it deserves. All of these are valid concerns when choosing who to work with to bring a medical device or IVD to market. However, enlisting the help of a CDMO, either for full life-cycle, or for milestone projects can streamline and accelerate your route to market.

7 reasons to outsource to a CDMO

for assay development and manufacturing

  1. Expertise in development and manufacturing

An established CDMO will have worked on many projects with similar technologies required for your assay development. Outsourcing to a CDMO with experience in assay developments similar to yours will mean they are better prepared to deal with any unforeseen hurdles along the route to market.

  1. Capabilities

A commercial laboratory is likely to be better suited to carry out the relevant testing. The Health Tech industry, and diagnostics in particular, is an area that requires cutting-edge technologies and innovations. Better still, a world-class lab is likely to offer more robust, sensitive, and accurate assays.

  1. Compliance and regulatory requirements

There are so many aspects to consider when bringing a medical device to market. It can’t simply work; it has to be compliant. Choosing a highly-skilled, ISO 13485 accredited CDMO who has developed many IVDs and medical devices means they will have a deep understanding of what is needed throughout every stage of the manufacturing process.

  1. Quality Control (QC)

In addition to being compliant, your device has to be of the highest quality. A great Health Tech CDMO will be ISO13485 accredited, integrating a Quality Management System (QMS) into every stage of product development. This reduces risk and ensures consistent and reliable results.

  1. Reputation

Investors like to know that there is a reduced (or an absence of) risk for their investment. De-risking your technology by partnering with a CDMO that puts compliance and quality at the heart of everything it does will satisfy even the most reluctant of fundraisers.

  1. Speed to market

Bringing a medical diagnostic product to market sooner means more lives can be changed. By partnering with a CDMO, projects can be completed quickly, with less risk.

  1. Cost saving

Collaborating with an experienced CDMO team brings all aspects of product development under one roof. This means traditional barriers to market, or unforeseen circumstances are dramatically reduced, and your medical diagnostics production process becomes seamless, cutting down on unnecessary waiting times and communication delays.

Benefits to outsourcing to a CDMO

In conclusion, it is understandable why there may be a reason you choose to bring a medical device to market without the help of a CDMO. But as we have found time and time again, the benefits of outsourcing assay development to a CDMO, and working with a skilled and experienced team in world-class facilities really do help to bring med tech to market.

 

We provide a cost-effective and time-efficient outsourcing solution for the development of fully accredited medical diagnostics within a seamless, end-to-end process to help our clients achieve market success efficiently, confidently, and with reduced risk.

 

Want to know more about how we can help? Contact us today.