This month, we wanted to elaborate a bit more on biocompatibility testing, and build a stronger foundation around what it was and its impact on a development project in terms of costs and timelines. We talked with Jake Wakley, our VP Quality and Regulatory, to explain a bit more in terms of what to expect.
In many cases, understanding costs of development for a medical device project can be what makes or breaks a project and how it progresses through a particular process. It is critical to understand the implications and costs associated with biocompatibility in the overall project development process. Developers need to understand biocompatibility requirements to budget adequately and make sure resources are available as biocompatibility testing often has a significant impact on development costs and timelines.
Before we begin, let’s ensure we are all on the same page with the meaning of biocompatibility testing. IUPAC defines biocompatibility as the ability to be in contact with a living system without producing an adverse effect. The term biocompatibility reflects the ongoing development into how biomaterials interact with the human body and how those interactions determine the clinical success of a medical device (Wikipedia). A medical device or biomaterial must be able to perform its desired function without adverse biological effects in the recipient or beneficiary of the procedure.
What is the first thing a customer should be aware of when considering biocompatibility?
Customers should become familiar with the ISO 10993 series of standards in general. The ISO 10993-1 standard is the framework for biocompatibility testing and gives guidance for the biological evaluation of devices within a risk management process. ISO 10993-1 provides a context in which to plan a biological assessment for a medical device, including in-vitro and in-vivo models as necessary to ensure the safety of the invention. In addition to ISO 10993-1, there are following 10993 standards that contain the details for a variety of specific biocompatibility testing.
What are the expected timelines for appropriate biocompatibility testing?
Cytotoxicity, irritation, and sensitization testing are required for most devices and take around 5-8 weeks. If additional testing like systemic/subchronic toxicity and implantation are necessary, turnaround time can grow to 26-28 weeks or longer Industry experts are working with regulatory bodies to implement additional in-vitro testing to replace current animal testing, which will simplify and shorten biocompatibility testing.
How much could these types of services cost as part of a project budget?
Depending on the type of device and testing required, biocompatibility can be the most expensive part of the development of a medical device. Costs can range anywhere from $25,000 to $100,000 and beyond. Biocompatibility testing is a significant amount in a program’s development process and budget. Knowing these pieces of the puzzle provide a developer more information into how much it would cost to get a product through the design process and ready to market.
What more should customers understand about as part of this overall discussion?
It’s essential that device developers know that even before the development process begins, they need to start considering what materials they are going to use in their device and the impact on biocompatibility. Even though many materials have a long history of use in medical devices, developers may need to be able to provide new biocompatibility data on the completed device using these materials. FDA is unusually strict in requiring data on production-equivalent, finished devices. Depending on the device application and data available, the EU may accept biocompatibility from previous products using the same materials, or even material biocompatibility testing rather than complete device data.
Ultimately, a completed and functioning device needs to be presented to the FDA or another regulatory body, with all of the appropriate documentation and testing reports proving that the device is safe, meets regulatory requirements and is ready for manufacturing.
What are some options moving forward, if maybe someone doesn’t want to take this on as part of their process?
We are more than happy to offer our services to customers and take on the biocompatibility side of the project and manage it on their behalf. Biomerics has extensive experience managing biocompatibility testing on all kinds of products from short-term, single-use devices to long-term implants. It is simpler for customers to turn the project over to us because we can get the appropriate tests and certifications in place as part of the overall design and development process. We make it a priority to create and maintain excellent relationships with industry-leading biocompatibility labs. These labs are not only experts at working with us to develop a biocompatibility plan and execute the testing, but they also provide support with FDA and other regulatory bodies to ensure questions are answered and biocompatibility testing is accepted.