In this episode, our hosts are joined by APS’s Senior Director of Biocompatibility Services, Dr. Yan Chen, to discuss NAMSA’s acquisition of APS and the importance of preclinical studies in the biological evaluation of medical devices.

This podcast discussion revolves around the many synergies of the combined companies, as well as a technical discussion regarding preclinical studies, preclinical study biocompatibility endpoints, and of course, an energetic game of ‘2 Truths and a Lie’ that will surely bring you a laugh.

“We have expanded the possibilities of people who can join us now.”-Sheri Krajewski

“We are very excited. We firmly believe that both companies share the same goals to provide high-quality, comprehensive services for medical device development.” – Dr. Chen

“Companies are beginning to think about biocompatibility when they should early-on with studies like these. These [preclinical] studies can be so powerful in so many ways.” – Don Pohl

“The local tissue response is the most commonly used (biocomp endpoint) in the preclinical study. Sometimes you want a clinically relevant implant site. That is something to keep in mind to combine (preclinical and biocomp) studies.” – Dr. Chen

Discussion points include:

• The importance of preclinical testing to the biological

evaluation

• Early-stage preclinical studies vs. GLP studies and the value

they bring to medical device regulatory submissions

• The challenges of combining preclinical and biocomp studies