Healthcare Innovation Cycle for "MedTech" Solutions

MedTech is broad term for electro/mechanical medical devices. Tracking data has been added to show an example of an early stage team at risk due to a focus on technology. Select any Maturity Level to see the core Requirements or select the Requirements themselves to see a description of what is involved in completing a requirement and curated resources.

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Milestone

Requirement

Target Outcomes

Describe the measurable outcomes that you expect will be used to support any claims that are intended to be made
It is critically important to know what parameters must be measured and achieved in planning the technical work
Convert the envisioned benefits into quantifiable parameters

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Talking to HCPs - Laura Johnson via LinkedIn.pdf

A guide to talking with healthcare providers

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Rimsys-Ultimate-Guide-to-EU-MDR-IVDR-GSPR-2ED.pdf

With the initial rollout of the European Medical Device Regulation (MDR) complete, medical device companies
are shifting focus to the sister In Vitro Diagnostic Regulation (IVDR) that became...

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Clear Product Requirements Document (PRD) - Guide and Checklist

https://www.greenlight.guru/blog/product-requirements-medical-devices

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Legacy Impact

Previous Impact data can be found here.

CRAASH Schedule - BCN 2021

BCN CRAASH 2021 Schedule Date & Page Link Topic Time (CET) 27 July Orientation and Kick-Off Assignments 14:00 to 15:30 6-7 September In Person...

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how-hospital-administrators-make-purchase-decisions_research-studies.pdf

Google research on how hospital admins make purchasing decisions

Filing a US patent application on your own

Link

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ISO-13485_Ultimate_Guide_Greenlight_Guru.pdf

THE ULTIMATE GUIDE TO ISO 13485:2016 QUALITY MANAGEMENT SYSTEM FOR MEDICAL DEVICES - Greenlight Guru

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Which Type of IP Protection Is Right for Your Medical Device?

Link

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Clinical-Evidence-IVD-Framework-MDC.pdf

Developing Clinical Evidence for Regulatory and Coverage Assessments in In Vitro Diagnostics (IVDs)

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IVD

IVD Specific Resources

HOW TO PLAN AND CONTROL THE DESIGN OF YOUR MEDICAL DEVICE WHILE MEETING REGULATORY EXPECTATIONS

Link

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Ultimate Guide to Design Controls.pdf

Greenlight Guru guide to design controls for medical devices

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