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Top-Down and Bottom-Up Modes in Medtech clinical strategy market driven innovation regulatory strategy Aug 31, 2022

Written by Eric Sugalski

Consider this analogy..  You are driving across the US, planning for a week to travel from coast to coast. With elevated gas prices you want...

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Quality - The Secret Weapon to Accelerate Time-to-Market in Medtech product development quality management regulatory strategy Jul 06, 2022

Most of the time, quality (as in “quality management”) is only considered after a design concept is mature, if not finalized. Design control, document control, risk management –...

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FDA's Early Payor Feedback Program (EPFP) payor strategy regulatory strategy May 04, 2022

The prospect of obtaining a new reimbursement code and corresponding coverage for a new medical device is daunting. So much so that many investors simply refuse to pursue medical device...

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3 Secrets to Capturing Reliable Clinical Data at Home clinical strategy market driven innovation regulatory strategy Apr 06, 2022

Written by Eric Sugalski and Ulrich Herken

True story.

A medical device manufacturer developed an at-home wearable defibrillator for populations at high risk of sudden cardiac death. This device...

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The Paper 510(k) Strategy regulatory strategy Mar 02, 2022

Written by Eric Sugalski

Many medtech leaders are pressured by investors and others to rapidly achieve regulatory clearance with a product design that is not intended for the market. This...

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5 Secrets to Actionable User Needs in Medtech market driven innovation regulatory strategy Feb 02, 2022

User Needs (UNs) are the foundational component of your Design History File (DHF). This single document should be the one that feeds design requirements, risk management, and the V&V process....

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Why the Endpoint is actually the Starting Point in Medtech market driven innovation regulatory strategy Jan 19, 2022

When you are developing a new medical device, it is tempting to start by brainstorming, developing prototypes, and running demos for investors and others. But this approach will often lead you to a...

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