MEDdesign

Is Your Wearable Technology a Low-Risk Device?

By Kristyn Berry

…radiation exposure, or implants), raises new questions about usability, or raises questions of biocompatibility, the device is not low risk. To illustrate this, the guidance uses as an example of…

…radiation exposure, or implants), raises new questions about usability, or raises questions of biocompatibility, the device is not low risk. To illustrate this, the guidance uses as an example of…

Continue reading

Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Total Recall and This is Not the Movie

By Dr. Christopher Joseph Devine

competitors to design, develop and release the next wonder device to commercialization. Did Dr. D mention investors? Seriously, when project timelines become compressed and the proverbial heat has been turned…

competitors to design, develop and release the next wonder device to commercialization. Did Dr. D mention investors? Seriously, when project timelines become compressed and the proverbial heat has been turned…

Continue reading

Developing Adhesives for Oh-So-Delicate Areas

By MedTech Intelligence Staff

…delicate parts of the skin need to carefully select materials that provide effective adhesion and wear time while providing comfort to the patient and preventing skin damage upon removal. “Your…

…delicate parts of the skin need to carefully select materials that provide effective adhesion and wear time while providing comfort to the patient and preventing skin damage upon removal. “Your…

Continue reading

Reimbursement Report

Six Concepts to Navigate Manufacturer-Sponsored Clinical Trials

By Kristofer C. Munroe

Seeking reimbursement from Medicare for items or services provided during a manufacturer-sponsored clinical trial requires the navigation of a complex web of regulations. It requires assistance from legal, regulatory and…

Seeking reimbursement from Medicare for items or services provided during a manufacturer-sponsored clinical trial requires the navigation of a complex web of regulations. It requires assistance from legal, regulatory and…

Continue reading

How to Gather Clinical Evidence for Combination Products

By MedTech Intelligence Staff

combination product, the manufacturer needs to think about chemistry, materials, and compatibility. Susan Alpert, principal of SFA Consulting, explains the complexity involved and how manufacturers of combination products should approach…

combination product, the manufacturer needs to think about chemistry, materials, and compatibility. Susan Alpert, principal of SFA Consulting, explains the complexity involved and how manufacturers of combination products should approach…

Continue reading

Editorial Submissions

…of your article: Suitable title 2-3 sentence intro/executive summary of the article References Author bio: First and last name, job title, company name and email contact information. Company names, email…

…of your article: Suitable title 2-3 sentence intro/executive summary of the article References Author bio: First and last name, job title, company name and email contact information. Company names, email…

Continue reading

Maria Fontanazza, Editor-in-Chief, MedTechIntelligence.com
From The Editor's Desk

What’s in a Name? A Lot.

By Maria Fontanazza

Our content and conferences are stronger than ever, and our new name, MedTech Intelligence, reflects a continued commitment to the medical device industry….

Our content and conferences are stronger than ever, and our new name, MedTech Intelligence, reflects a continued commitment to the medical device industry….

Continue reading

Rick Biros, Publisher, MedTech Intelligence
Soapbox

MedTech Intelligence: Better Representing Our Business

By Rick Biros

…very successful Combination Products conference, and you’ll see us leverage content from the conference into the digital publication, including a new section appropriately called Combination Products. Our team has worked…

…very successful Combination Products conference, and you’ll see us leverage content from the conference into the digital publication, including a new section appropriately called Combination Products. Our team has worked…

Continue reading

Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Heigh-Ho, Heigh-Ho, It’s Off to Jail You Go

By Dr. Christopher Joseph Devine

…Part 820 Compliance. Charleston, SC: Amazon. OtisMed Corporation former CEO sentenced for shipping adulterated knee replacement cutting guides. (June 2016). FDA News Release. Accessed June 30, 2015. Retrieved from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm452987.htm…

…Part 820 Compliance. Charleston, SC: Amazon. OtisMed Corporation former CEO sentenced for shipping adulterated knee replacement cutting guides. (June 2016). FDA News Release. Accessed June 30, 2015. Retrieved from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm452987.htm…

Continue reading

Gain More Control over Your Supply Chain

By Maria Fontanazza

The demands on medical device manufacturers to reduce costs, comply with additional regulations, and ensure product security are putting increased pressure on the supply chain. As companies try to conserve…

The demands on medical device manufacturers to reduce costs, comply with additional regulations, and ensure product security are putting increased pressure on the supply chain. As companies try to conserve…

Continue reading