On a daily basis, we are approached by medical device manufacturers (sponsors in GLP speak) regarding new testing programs they wish to initiate.  These manufacturers range from Silicon Valley startups through multi-national corporations, and the sponsor contacts at these companies have biocompatibility experience ranging from zero through sitting on ISO technical committee 194.  The biggest difference between sponsors when we’re first contacted is the amount of background information and organization that is brought to the table to help the lab work with the manufacturer on designing their evaluation programs.  FYI, learn to love ISO 10993-1 and the 2016 FDA Use of 10993-1 documents!

Testing labs don’t expect everyone to have all of the necessary information to set up their programs, but it is too often clear that certain sponsors have not engaged the necessary internal or external consultation prior to initiating their testing.  Prior to initiating any biocompatibility testing, there are a series of assessments that need to be performed including chemical characterization, technical risk assessment and biological risk evaluations.  These evaluations will help the sponsor identify what biocompatibility testing, if any, is required to be performed as well as work through the process of identifying comparative products for 510(K) purposes if this regulatory path is being followed.

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When you have reached the point when testing is to be started, there are a number of key pieces needed, especially if you haven’t performed all of the aforementioned evaluations.  This information will be necessary so the testing lab can help guide you in setting up the test plan and getting your projects logged in for testing.

  1. What is your device, including any special technologies to be considered, what components are patient contacting, and where in the body it’s going and for how long it will be there.  The length of patient contact is cumulative so even if a patient sees a product for 1 hour a day, they may be exposed daily for 12 months.
  2. The device’s physical properties including surface area, as well as a list of materials that may be incompatible with certain test systems such as antimicrobials, latex, rubbers etc.. While most devices are extracted for biocompatibility tests, there are certain others such as vascular occlusion gels or wound cleansing solutions which should be tested directly and not extracted.  Also, if any materials are degradable it is critical to let the lab know ahead of time so they don’t reach the end of a 13 week implant and wonder why they couldn’t locate the implant sites for histopathological evaluation.  Absorbable implant studies will be covered in another document.
  3. Ask for a sample requirement assessment by the lab before sending samples as to avoid testing delays related to requests for additional sample units.
  4. Any prior FDA or consultant related information related to the request for testing.  There are cases where FDA has directed testing to be performed a certain way during the pre-sub process and the lab needs to make sure they follow these specific directives.  
  5. A conference call with the technical group at a lab is most often not the best first step.  While a call is useful and helps establish a relationship with the lab, there are many times where the call is not as productive as it should be because of a lack of information.  We have found historically that email at first helps keep everyone on the same page and makes sure that information isn’t misinterpreted and can always be referenced again at a later date.  Once the details have been hashed out via email, the call can be used to help settle final details and “close the deal” per se.
  6. Lastly, if there are any questions about filling out paperwork or how to generally get the ball rolling, start the dialogue with your lab as early as possible in the process since they’ll be your partner in the process and are equally vested in your success.

The biggest takeaway from everything here is the more information you bring to the table, the more smoothly the testing process will be and the greater chance at success you’ll have.  Do your best to educate yourself about the testing and evaluation process and you’ll be sure to have a better path towards a successful testing experience.

Remember your knowledge of the process is power so keep up with us at Biocompatibility Hub and feel free to reach out to us if you need any help.