For the past two years, medical device manufacturers and suppliers have been facing more challenges in product development to bring their devices faster and easier to the market. The complexity in the regulatory aspect of clinical trials for medical devices has been increasing constantly, which has resulted in more manufacturers considering outsourcing to lower costs, increase agility, reduce time-to-market, and boost their return on investment.
However, in the US, the medical device industry hub has been booming in Minnesota. With organisations like the Medical Alley Association, that has more than 6 billion dollars invested between the big multinationals and the small start-up companies. In addition to this, there are more than 2,000 clinicians working here.
Since the regulatory landscape of the medical device sector has changed with the FDA new regulations approved last year, the global market for medical device outsourcing is predicted to grow over the next years. Brand owners are now increasing manufacturing to third-party companies in other countries to streamline production costs and improve access to emerging markets. Service providers are also meeting the demands by changing models from functional to full-service models instead.
There is a growing interest when it comes to outsourcing; therefore, the FDA recently published a new rule for the medical device trials performed outside the USA. The new regulation indicates the obligation of the sponsors and applicants to provide information about how the studies conform to the good clinical practices - “This change is intended to provide consistency across different submission or application types” FDA said. The Food and Drug Administration has published a guide that examines the new modifications - “Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions”. (FDA U.S. Food and Drug Administration, 2018)
From the suppliers’ point of view, CRO’s should invest in ensuring the delivery of clinical trials services for the medical device companies. In February of 2017, Grand View Research (Grand View Research, 2017) published a report where the global medical device outsourcing market is expected to reach USD 88.2 billion by 2025 and the contract manufacturing services is projected to be contributing by a 19% of the revenue share. Nonetheless, while there is a pretty diverse CRO’s market for pharmaceutical clinical trials; there are still not many specialised suppliers for the medical devices, leaving a big opportunity for new service providers to enter the market. Some of the market players mentioned in the Grand View Research report are Daiichi Jitsugyo Co. Ltd., Mitutoyo Corp., Hamilton Company, Cirtec Medical Systems LLC, Kinetic Climax Inc., CregannaTactx Medical Inc. and Omnica Corp. among others.
