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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Requirement

Preliminary Regulatory Pathway

The regulatory pathway you expect will be used to approve your solution.
The regulatory pathway that your solution must follow will have a tremendous impact on the development cost and time it takes to reach patients. Understanding that pathway early may allow you to adjust the solution or application to find an easier path to the initial product. It also helps you understand the type of information you will need to collect as your development effort proceeds.
Web sites of regulatory agencies, discussions with regulatory experts, observations/discussions with companies/managers who have successfully gotten regulatory approvals for similar solutions. The process will also typically involve a consideration of reduced product claims that may provide an expedited pathway to market. If US focused, follow the FDA’s guidance to determine the most appropriate pathway. Consider if market introduction is best through a different regulatory body – but only those such as EU and Australia that are recognized as having robust systems.

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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

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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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