MedTech Intelligence Volume 8 Issue 42

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	Volume 8 Issue No. 42

Business Analysis Combination Products Market Access Operations Product Development Quality/Regulatory

Featured Articles

Maria Fontanazza, Editor-in-Chief Transformation of New Healthcare Model Demands More Medtech Partnerships

By Maria Fontanazza, Editor-in-Chief

Device companies will need to assess their business model in order to compete in an outcomes-based reimbursement environment.

Soapbox

Joachim Schäfer, Messe Düsseldorf Medtech Trends: Digitization, Smart Technologies and 3-D in the Operating Room

By Joachim Schäfer, Messe Düsseldorf

The healthcare landscape is changing, and technologies are racing to meet new demands.

Devine Guidance

Christopher Devine, Ph.D., Devine Guidance International Pins and Needles

By Christopher Devine, Ph.D.,
Devine Guidance International

Penetrating the skin introduces a different set of unavoidable safety and efficacy questions.

Featured Quote

To get a design right and minimize use error consequences, you need to understand who the user actually is—what their day is like and the other demands, conscious and unconscious, that they are under while operating the device.

— John Walmsley, Starfish Medical

Global Revenue Drops, MedTech Struggle for Growth Signals Industry Shift Global Revenue Drops, MedTech Struggle for Growth Signals Industry Shift

By Maria Fontanazza

Ernst & Young’s annual Pulse of the Industry report reveals decreasing global revenue and financing in the medtech industry.

FDA Software as a Medical Device Draft Guidance Aims for Global Harmonization

By MedTech Intelligence Staff

FDA offers help on when and what type of clinical evaluation is appropriate for SaMD.

MedFlix

Blunders in Risk Management Blunders in Risk Management

By MedTech Intelligence Staff

Some common mistakes medical device companies make when approaching risk.

UL - How to meet FDA guidance for 3D Printed Medical Devices

Compamed - Trade Fair with Forums - November 14-17, 2016 - Dusseldorf Germany

3M Freedom of design. Freedom of movement.

Advanced Design Control Conference - October 26-27, 2016 - Washington, DC

Resource Centers

Resource Centers are single topic focused micro-sites within MedTechIntelligence.com that are portals of information on medical device components and quality systems offering news, articles, white papers, case histories and videos.

Medical Device Audits, Certification & Verification
sponsored by SGS
Quality & Regulatory Market Access Solutions
sponsored by UL
Medical Device Component
sponsored by 3M

Sponsored Resources

Quality Management for Medical Products in China Quality Management for Medical Products in China

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Axendia Navigating the Complexities of Med Tech Innovation

Learn to create market opportunities by truly designing quality into your products and not merely chasing defects.

Webinar: Thursday, November 3, 2016 1 PM to 2:00 PM (Eastern)

Complex - accurately describes the current Med Tech environment which keeps executives up at night thinking about Connectivity, Supply Chain and Regulatory Requirements, as well as higher risk. As a result, effective Change and Configuration Management (C&CM) strategies are becoming critical to product quality.

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Upcoming Events & Webinars

October 26-27, 2016 - Advanced Design Control