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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Stakeholder Map

A map that describes the relationships between the key stakeholders
For your solution to be adopted, it must be accepted by many stakeholders. Drawing a map ensures that you and others understand who the stakeholders are and how they related to each other.
The map is a visual representation of the relationship between the stakeholders - such as users, buyers, regulators, payers, suppliers, etc. The most common map connects the stakeholders by lines of different colors/dashes to show the flow of money, hardware and information.

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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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