Choosing a Facility for your Human Cadaver Study

After identifying the need to conduct a human cadaver study for medical device testing or physician bioskills training (review our recent blog post detailing when human cadaver labs provide value over animal studies), the next step is vetting possible locations and ideal partners for your project. This decision should not be taken lightly as the benefits or …

The Benefits of Human Cadaver Labs for Medical Device Development

Studies involving human cadaver tissues can be a valuable resource for companies developing new medical devices. Human cadaver labs allow an entrepreneur to gather integral information about a medical device or procedure including:  Dimensional compatibility of a device with the human anatomy; Spatial interactions between adjacent anatomical structures a…

Considerations for Preclinical Wound Healing Models

Wound healing is a fundamental process to every living organism. Humans have been tending to each others wounds since the day of our creation. The complexity of human wound care has evolved through history from homemade magical potions, incantations, charms, and ointments to institutionally trained physicians, surgeons, and nurses and an ever increasing indu…

Rationale for Conducting a Pilot Study Prior to a GLP Preclinical Study

Many companies setting out to perform Good Laboratory Practice (GLP) studies want to proceed directly into their GLP preclinical study without conducting a preclinical pilot study first. While, this may make sense in some situations, many times it can introduce more challenges that can be mitigated if a small efficient preclinical pilot study is conducted fi…

Planning a Successful Drug Coated Balloon Preclinical Study

With the recent approval of the first drug coated balloon (DCB) in the US, and accepted use worldwide, more and more medical device companies are developing drug coated balloons. With the help from partners such as Alizée Pathology and BASi®, below are some key considerations around the Test Article, In Vivo Study Design, Analytical Testing and Histopatholog…