Empowering professionals for over 24 years

Empowering professionals for over 24 years

Live Medical Device Development Immersion

Live Medical Device Development Immersion
Bring InHouse

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.

  1. Learn the lifecycle of medical device development to better evaluate investment opportunities
  2. Gain insight into the regulatory, design, and quality requirements that impact time-to-market and commercial success
  3. 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

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

What options are there for live training?
Who are the instructors?
Are training materials provided?
Do I receive a certificate?
Who attends your open enrollments?
Where can I find a list of all the upcoming open enrollments?
Do open enrollments sell out? Are they ever canceled?
What should I wear and bring to an open enrollment?
What is your refund policy?
What discounts are available for live, open enrollments?
What can Biotech Primer’s in-house training offer my team?
How many people typically attend your customized in-house training sessions? What is the minimum number of participants? What is the maximum number of participants?
What sort of training materials do you provide?
Can you hold the training at our company facility?
What kind of room setup is needed?
Do you provide in-house training internationally?
I’m looking for training on a topic not listed on your website. Can you help?
Do you offer half-day training sessions?
How far in advance do I need to book in-house training?
What is the cost of the on-site customized training?
How do I contact Biotech Primer for questions about customized training options for my team?
Do you offer services beyond training?

WHAT PEOPLE ARE SAYING

I’ve been involved with med tech companies, so I had picked up on the development path in general, but the Medical Device Development Immersion course was really helpful in providing a full context and clarifying the details. All your [Biotech Primer] courses are really solid...

Elayne Wandler

Director, Programs​, Canada’s Digital Supercluster

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