Increasingly, device makers are discovering what pharmaceutical companies have known for many years – that using CROs to support regulatory testing can speed up development efforts and, ultimately, save money.
The medical device CRO market worldwide is poised to grow by over 12% a year, reaching $7.4 billion in sales by 2018 (source: FierceCRO). Device makers can tap into this growth and the opportunities it offers to gain several benefits: use of streamlined processes, increased capacity, and experience in device development.
A CRO set up to support medical device development will almost assuredly have systems put in place to move a device through the testing and report processes as quickly as possible. Device makers routinely push for short turnaround times, forcing competing CROs to minimize dead time in the testing process. For example, parallel testing can be performed on a device undergoing biocompatibility testing: cytotoxicity testing may be done at the same time as irritation testing. This means that once your device arrives for testing, results can often be delivered rapidly. If a change or new iteration of a device is necessary, this ability to rapidly generate new data can reduce a device's time to market.
Companies performing testing in-house may come upon internal capacity limits. Even medium-sized CROs, because of their specialization for testing, are set up to accommodate much larger volumes of testing than in-house facilities can handle. Additionally, if one CRO is at capacity or backlogged, it is usually possible to find another CRO that performs the same type of testing.
Experience in Testing Similar Devices
Most importantly, CROs specializing in medical device testing will have experience testing many different types of devices. Because of this experience, they can often recommend strategies for testing that may save time, or minimize the total number of devices that need to be tested. At Pacific BioLabs, we work with clients to combine extracts, or recommend places where there may be unnecessary redundancy in testing.
Of course, it is always prudent and recommended to contact the FDA to discuss any testing program that you are considering for your device. There can be differences in recommended testing programs from one CRO to another, and sometimes a testing program that looks to be inexpensive can become very costly in the long run if the FDA rejects the testing performed due to insufficient regulatory data.
All of the factors listed above are important when choosing a CRO and determining if working with a CRO is right for you. We do believe that there are significant benefits, and if you are considering CROs, we encourage you to contact us here at Pacific BioLabs to discuss a recommended testing program.
Visit PacificBioLabs.com to learn more about PBL and our medical device testing capabilities.