Jim Swick, Chief Scientific Officer at LifeSciencePLUS http://www.lifescienceplus.com, gave a talk on Pre-clinical Medical Device Development at http://www.bio2devicegroup.org. He advised that it is important to ask some questions before taking the first step. These include, what is procedure or application for the device, who are the potential end users, and what might be anatomical challenges. Also market aspects should be considered like will the device reduce cost, significantly improve medical care, and would it satisfy or further complicate the existing mode of therapy. Study should begin with in-vitro testing to examine mechanical and ergonomic aspects of the device including if the device does what it is supposed to do, inside the blood or tissue. In-vivo testing should focus very strongly on satisfying safety requirements and examining anatomical compatibility.
For selecting the appropriate animal model, it is important to do review to identify precedents. Pitfalls of animal testing should be carefully considered. Translating data from animal to human is challenging. Despite many anatomical similarities, there are also many anatomical differences. There is no animal model that very closely mimics human anatomy and physiology completely. But certain animal models are good for certain regions of the anatomy. For instance, sheep is often a better animal model for spine devices. For challenging devices, it is absolutely important to also work on human cadavers. It is also important to remember that while some device work well in animals, these animals are often young and healthy, whereas, humans who might get these devices may be very sick or old. There are examples where some devices worked very well in young, healthy animals but failed in humans in first clinical trials. FDA’s primary concern in pre-clinical studies is with safety of the devices and that these devices would not kill an animal. Efficacy becomes a greater focus during human clinical trials. Swick discussed the importance of selecting a good SAB (scientific advisory board). Some advisory boards exclusively are formed with clinicians and that would be a problem. He suggested that SAB have a good mix of clinicians as well as scientists.