Medical research organization NAMSA has released its 2018 Medical Device Landscape Report that shows the trends and challenges in clinical research outsourcing.
The report was conducted on behalf of NAMSA by the Avoca Group. Over 200 responses were received from global medical device sponsors that have a responsibility for clinical research outsourcing. The data shows outsourcing behaviors and the most significant drivers, barriers and opportunities for medical device development.
“We are extremely pleased to provide new information to the medical device market place surrounding the unique challenges and opportunities for clinical research and outsourcing. In comparison to the pharmaceutical industry, little data existed previously regarding medical device outsourcing obstacles and how they might be addressed to achieve stronger CRO/Sponsor partnerships,” Christopher Rupp, NAMSA’s director of global marketing and sales operations, said in a press release. “With significant medical device growth expected globally – $619B by 2022 – it is imperative that we find strategies to work together to efficiently bring novel technologies to market and to quickly deliver them to patients who need them most.
Some of the findings show there are increasing prices, profitability pressures with access to funding that continue to drive decision making in clinical research outsourcing. The report also shows there is a growing cost of clinical trials, which is a contributing factor to sponsors needing to outsource clinical research.
More regulatory requirements from EU’s Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR) and International Standards of ISO 10993-1:2018 and ISO 13485:2016 also take away resources from companies looking to participate in clinical trials. Sponsors have to use internal resources and need updated expertise to meet these standards and participate in clinical research.
Sponsors are also using and relying more on IT solutions like electronic data capture (EDC) tools and clinical trial management systems (CTMS). These types of IT solutions are required to conduct effective clinical trials, according to NAMSA.
NAMSA also reported that outsourcing spending from sponsors has grown 55% over the last three years. Budgets for outsourcing services are expected to by 30% within the next few years.
The full report can be downloaded from NAMSA’s website.