Looking for Quality Content to Build Medical Device Curriculum - Concept to Commercialization

spazeinvader

Principal Consultant
#1
Hello, I am looking for content for a curriculum designed to help equip medical device startups with foundational knowledge related to taking a concept from ideation to commercialization.

Does anyone have any go-to sources they trust for building medical device related curriculum content? Instead of re-inventing the wheel, I'm looking to leverage the wealth of information that is already available, but would appreciate if people could recommend some pre-vetted, high quality sources. I'm open to looking at articles, white papers, online learning websites (such as coursera, linkedin learning and the likes), youtube videos, webinars, etc. I'm also willing to connect with guest lecturers or folks and organizations that regularly speak on these topics (preferably webinars due to COVID):

Here are some of the modules I'm looking for content on:

- Unmet Clinical Need and Market (customer discovery, stakeholder analysis, market assessment, competitive assessment, value proposition)
- Intellectual Property / Patents (IP evaluation and strategy, licensing, royalties, and negotiation)
- Quality Systems Regulations (Quality management systems - both US and international, FDA approval for specific use, Design Control Regs, Device Classification & Reg Pathways, Reg Submissions, Human Factors & Usability, Nuances of Drug, therapeutics, biologics and combo devices, electronic records practices, risk management, staying ahead of reg changes)
- Clinical Trials and Good Clinical Practice Regulations (Designing and planning a clinical trial -Phases 0-IV, review process and review boards, financial controls, GCPs, post market support studies)
- HIPAA & HITECH Compliance (the need for compliance, penalties, physical & technical safeguards and policies, case studies, best practices)
- Product Development / Design Controls (design control process, killer experiment, testing - Verification & Validation, V&V design, process validation, software validation, risk management procedures, pros/cons of outsourcing R&D, external and joint R&D, CROs, CDMOs, CMOs)
- Manufacturing Strategy (overview of manufacturing processes & materials, DFX methodology, overview of prototyping processes & technologies, design requirements and material specifications, current good manufacturing practices, Pros/cons of outsourcing, component & system level reliability, design transfer best practices)
- Pricing & Reimbursement Strategy (money flow, reimbursement codes, competitor costs, main purchasers, factors influencing decision making, cost caps)
- Hospital Procurement & Sales Strategy (value analysis teams & committees, the hospital procurement process)

I would appreciate people's advice and feedback.
 
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yodon

Staff member
Super Moderator
#2
Not completely sure if this is what you're after, but Emergo, BSI, TUV, etc. all maintain libraries of some of the material you mention. FDA has CDHR Learn where they maintain materials.
 

yodon

Staff member
Super Moderator
#5
Generally speaking, I know a few content providers that may have material: Intertek, Oriel Stat-a-Matrix, Compliance Online, LearnAboutGMP, Plianced, 247 Compliance. Not endorsing, just these are ones I know about that provide training. I think they're all webinar-based, though; I doubt you could review actual content (only titles).
 
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