To help small and medium medical device manufacturers benefit from access to the skills of freelance scientific experts, Kolabtree has released "The complete guide to freelancers in MedTech". The white paper explores the benefits of collaborating with experts at every stage of the medical device lifecycle and explains the factors to consider when working with a freelancer.
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Medical device companies can outsource almost all parts of the process of bringing a device to market, from research and development, to design, to manufacture, to regulatory writing. When doing so, it is vital to outsource the right tasks, to the right person, to make sure the project is a success. For many small businesses, working with a consultancy or agency is a big commitment, as well as a large financial investment.
The white paper is built on contributions from Kolabtree scientists, who shared their expertise on how to streamline the process of bringing a medical device to market in a cost-effective way. From product design, to manufacture, to medical writing, this white paper highlights the role of the freelancer in getting the best for products, processes and patients. In response to the tightening of global regulatory restrictions, the whitepaper offers some guidance of building an effective regulatory strategy. It offers advice for both the US Food and Drug Administration and the EU Medical Device Regulations (MDR), that becomes enforceable from May 2021.
“Bringing a medical device to market is a notoriously challenging task,” explained Ashmita Das, CEO of Kolabtree. “While large global players have hefty teams in-house for everything from research to regulatory writing, we recognise that start-ups and small and medium enterprises (SMEs) may find it difficult to know when, where and how to outsource — and how to make the right decision when they do.
“The rise of the gig economy has introduced a new resource to medical device manufacturers — freelancers,” added Das. “Investing in expertise reduces risk of product recall, financial losses and harm to patients. According to data that we have collected, hiring a freelance consultant can save up to 40%.”