Live Medical Device Development Immersion

Gain insight into the fast-moving world of device innovation, from market evaluation to design, regulatory approval, and manufacturing with Medical Device Development Immersion. Learn proven strategies for success through real-world insights and an interactive prototype-building activity.
- Learn the lifecycle of medical device development to better evaluate investment opportunities
- Gain insight into the regulatory, design, and quality requirements that impact time-to-market and commercial success
- Discover the strategies that align product development with user needs, regulatory demands, and business goals to drive market adoption
Rapid learning for results-driven professionals
- Designed for non-scientists in the life science industry
- Taught by experts with real-world industry experience
- Focused on practical, applicable knowledge
- Ideal for individual learners or company teams
- Trusted by top biotech and pharmaceutical companies

- Overview
- Agenda
- Logistics
- FAQ
What You'll Learn
- Medical Device Overview
Explores the FDA’s regulatory history, mission, and what defines a medical device, including software, diagnostics, mobile devices, and wellness products. - Medical Device Regulations
Highlights regulatory compliance, including GMP, GLP, GCP, and FDA enforcement actions. Examines device classifications and approval pathways, including 510(k), de novo, Class III exemptions, and combination products. - Device Development Phase I – Market Opportunity Evaluation
Explores development timelines, design regulations, and market evaluation strategies through a practical customer needs assessment for a Bionic Walker. - Device Development Phase II – Concept Evaluation
Discusses risk analysis planning, risk matrix development, and risk quantification using a real-world concept evaluation of the Bionic Walker. - Device Development Phase III – Engineering Design
Teaches core engineering design principles, including software development and design documentation, with application to the Bionic Walker prototype. - Device Development Phase IV – Verification and Validation
Showcases strategies for product testing, labeling verification, biocompatibility, and human factors, all applied to the Bionic Walker design. - Device Development Phase V: Manufacturing
Examines key manufacturing factors, technology transfer, and scale-up strategies essential to optimizing device production. - Medical Device Approval
Explores the FDA approval process, including pre-submission meetings, submission types, expanded access, and MDUFA timelines. - Commercialization
Highlights medical device commercialization strategies, covering the roles of the FDA and CMS, as well as reimbursement.
Logistics
Customized Training, Delivered Your Way
Biotech Primer designs and delivers customized courses tailored to your organization’s specific needs. Whether live onsite at your location or live online, our expert-led programs range from half-day sessions to three-day deep dives—ensuring the right fit for your team’s schedule and goals.
Deliverables
- Expert-Led Course Content: Customized training developed and delivered by seasoned industry professionals.
- Comprehensive Course Materials: Electronic PDF of all presentation slides provided for reference and continued learning.
- Interactive Course Activities: All required lab materials, case studies, and supporting documents supplied to facilitate hands-on engagement.
- Certificates of Completion: Formal recognition for participants who complete the course.
FAQ
Our Executive
Certifications
Cannot make our live class? Consider one of our Executive Certifications.

Drug Development Executive Certification
- Level:Beginner
- CPE:13.50 Credits
- Time:10.5 Hours
- Total:12 Courses

Biotechnology Executive Certification
- Level:Beginner
- CPE:14.50 Credits
- Time:12 Hours
- Total:12 Courses

Drug Manufacturing Executive Certification
- Level:Beginner
- CPE:14.50 Credits
- Time:10 Hours
- Total:11 Courses

Medical Device Executive Certification
- Level:Beginner
- CPE:12.00 Credits
- Time:8 Hours
- Total:9 Courses