Navigating Medical Device Development: Preclinical Study Insights for Success

Bringing a medical device from concept to commercialization is a complex journey filled with potential challenges and significant investment. At BioBoston Consulting, we often see innovators pursuing in-vivo preclinical studies prematurely. Addressing key questions early in the process can save thousands of dollars and set the stage for more effective, regulatory-compliant testing when the time is right. 

 

Key Considerations Before Preclinical Testing 

Before moving forward with costly preclinical studies, it is critical to evaluate: 

• Has the technology demonstrated success in bench tests or in vitro experiments? 

• Has a pilot study been completed to verify functionality and initial biological responses prior to GLP testing? 

• Are there outstanding design refinements that could improve outcomes? 

 

Three Essential Types of Preclinical Studies to Advance Your Device 

Understanding the purpose of different preclinical study types helps streamline your development pipeline and regulatory readiness. 

1. Proof of Concept Studies

Begin by completing bench and in-vitro testing followed by a proof-of-concept preclinical study. This stage identifies the most suitable animal model, confirms basic device functionality, and validates smooth device use in vivo. 

2. Feasibility Studies

Once proof of concept is established, a small-scale, non-GLP feasibility study further verifies design refinements, uncovers potential risks, and establishes robust workflows and data collection methods — all crucial before embarking on GLP studies. 

3. Safety and Efficacy Studies

Finally, conduct comprehensive GLP studies designed to demonstrate your device’s safety and efficacy in clinically relevant models. These studies provide the detailed reports required by regulatory bodies such as the FDA to support device approval. 

 

The Preclinical Study Process: Collaboration and Customization 

Our business development team works closely with sponsors to tailor each preclinical program to their unique needs. Key decisions include: 

• Selection of the optimal in-vivo animal model, considering species-specific anatomy, physiology, and clinical relevance. 

• Defining regulatory requirements, including target endpoints, sample sizes, and anatomical considerations. 

• Structuring the project into multiple studies if needed to generate clear, timely data supporting regulatory submissions. 

Early agreements on confidentiality, scope of work, and intellectual property protection are also established to safeguard all parties. 

 

Developing Your Preclinical Study Protocol 

A detailed preclinical protocol, including species selection, study design, objectives, and in-life observations, is developed collaboratively between the sponsor and study director or principal investigator. Securing Institutional Animal Care and Use Committee (IACUC) approval is a critical regulatory step before study execution. 

 

Execution, Data Delivery, and Compliance 

Following protocol approval, the study is conducted with rigorous quality assurance and auditing processes. For GLP studies, data generated become the backbone for regulatory submissions and the subsequent stages of device development. 

 

Setting Realistic Expectations for Study Duration and Costs 

Preclinical study timelines vary widely. While some GLP studies can be completed in as little as eight days, others—especially translational studies assessing long-term device effects—may span several years. Medical device developers should budget and plan accordingly, understanding that study duration depends on device novelty, predicate comparisons, and regulatory requirements. 

 

Partner with BioBoston Consulting to Overcome Preclinical Challenges 

At BioBoston Consulting, we recognize the complexities of medical device innovation across every phase. Beyond preclinical expertise, we provide end-to-end support covering market assessment, human factors, design, regulatory submission, quality control, manufacturing, and market access. Wherever you are in your development journey, our integrated approach ensures you will not face downstream challenges alone. 

Ready to optimize your preclinical strategy and accelerate your path to market? Contact BioBoston Consulting today to learn how our expert guidance can save you time, reduce costs, and enhance your regulatory success.