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

Key Component PoC Prototypes

A Proof-of-Concept (PoC) prototype of the key modules which demonstrates that the key functions can be achieved
The need for a prototype that demonstrates the key functions of the proposed solution is pretty well understood. But, don’t let the best be the enemy of the good. Try to develop this prototype as quickly and cost effectively as you can rather than trying to make it perfect from the start
These PoC for components, which are Works-Like prototypes, just need to show that the key functions of the anticipated solution can work on the intended platform.

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A guide to talking with healthcare providers
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...
Previous Impact data can be found here.
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...
Terms of Service for all CIMIT sites
GAITS and CoLab Security and Privacy Policy
Google research on how hospital admins make purchasing decisions
THE ULTIMATE GUIDE TO ISO 13485:2016 QUALITY MANAGEMENT SYSTEM FOR MEDICAL DEVICES - Greenlight Guru
IVD Specific Resources
Greenlight Guru guide to design controls for medical devices

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