- Since medical devices have so many different geometries and applications, rarely is there an “off-the-shelf” test for each device. Instead, we often need to modify existing tests, or develop new ones to demonstrate efficacy applicable to the device and its use environment.
- The most important part of testing is defining what the test is meant to address. We define the test objectives and scope of the testing project before starting testing.
- Once we know what the test is supposed to demonstrate, we go about designing the test to support the desired claims. We consider the need for sample size, statistical power, and the regulatory path to ensure testing will support the sponsors intended use of the data.
- Compiling the final report and summarizing the data in succinct tables and graphics is the final stage in testing. We are adept at summarizing reams of data into simple to follow charts and graphs that convey the outcome of the study for presentation and regulatory submission purposes.
- This is where Lupine sits down with the client and makes sure that the testing being performed is appropriate for the claims and intent of the sponsor. We leverage our years of experience to ensure the test method chosen will meet the desired objectives of the sponsor. We ask questions like:
- Is this a proof-of concept test for internal R&D?
- Is this a test to select among competing technologies or formulations?
- Is this test going to part of a regulatory submission?
- Once we understand how the data will be used, we draft a scope statement that describes the desired outcome of the test in detail, e.g.:
- To demonstrate long-term durability of a coating and sustained release of drug X in the bloodstream for a 7 day period.
- To show that device “A” is better than or equivalent to existing device “B” in the number of platelets activated when blood is exposed to the surface of the device.
- To establish antimicrobial efficacy on the surface of the device in a sub-cutaneous pocket environment for the first 14 days following implantation.
- Another other application of drug release kinetics, hemocompatibility, or antimicrobial efficacy?
- The final step in scoping out the study is defining the size of the study, duration, and sample requirements. We can perform testing under GLP conditions for regulatory submissions.
- For tests already in our library, testing is straight-forward. For test methods that are new, there is usually a series of steps which involve proof of concept, development and optimization, fixing the test parameters, validation, and finally, test execution. A typical test may include all or several of the steps below:
- Proof of concept entails using smaller, targeted studies to establish that each portion of the test is capable of producing the desired outcomes.
- Development and optimization can including ranging studies for a single variable, to full-blown designs of experiments looking at a multitude of variables. This step is critical to knowing what parameters require control and validation.
- Once optimized, the test parameters are frozen and a formal test method validation protocol is drafted and signed by the sponsor.
- The test method validation is conducted, analyzed, and kept on file for support of further studies.
- A test protocol is drafted and signed by the sponsor. Training to the protocol is carried out for all parties involved in performing the testing.
- The test is performed per the protocol, data collected and checked by quality assurance.
- We communicate with the sponsor during this stage to provide preliminary data summaries.
- Once the data has been verified, we crunch numbers and prepare statistical summaries of the data. While the report will include all the raw data collected, we believe that well designed summary tables and charts are critical to communicating the outcome of the test.
- We write and organize a final report that will stand up the required level of scrutiny depending on the intended use of the results.
- For GLP studies, a final quality assurance audit is performed on all the data included in the report.
- The sponsor receives a final report in electronic and hard-copies for the design history file.