Key Concepts for Medical Device Testing
Recorded: July 2023
The journey from concept to clinic is rarely linear for a new medical device. Behind each regulatory approval is a complex cycle of design, refinement and testing. This phase—especially in vivo preclinical testing—is where many promising innovations face the “valley of death.” At Pharmaron, we recognize the complexity of this challenge and provide comprehensive solutions that streamline the path to market, without compromising on scientific rigor or animal welfare.
Agenda
- Introduction
- Development of innovative Medical Devices
- Challenges of in vivo testing
- How to succeed in the in vivo testing phase
- Capabilities and expertise
Overcoming the Challenges of In Vivo Testing for Medical Devices
Biological Complexity and Model Variability
In vivo testing for medical devices introduces biological variability that can’t be replicated in vitro. Living organisms produce unpredictable responses that impact study reproducibility. Differences in anatomy and physiology between animals and humans mean model selection must be deliberate and evidence-based. Large animals, especially swine models, are often essential to mimic human conditions—especially for cardiovascular or surgical applications.
Human and Technical Factors
Human skill affects test outcomes. Device familiarity, operator training and procedural complexity directly influence study reliability. Designing and executing a robust protocol requires coordinated expertise from veterinary surgeons, engineers and interventionalists.
Regulatory and Anatomical Barriers
Devices designed for human anatomy must often be modified for animal testing. Custom surgical approaches, imaging guidance and novel deployment techniques are required. FDA’s evolving requirements—especially for Class III cardiovascular devices—place additional demands on sponsors. Programs like the FDA’s TAP (Total Product Lifecycle Advisory Program) now aim to improve predictability and reduce time to commercialization.