Advanced CAPA & Root Cause Analysis Conference - March 26-27, 2019 - A Virtual Event

MedTech Intelligence

Volume 11 Issue No. 12


Scott Hensley, ivWatchProduct Myths Put Patient Safety at Risk

By Scott Hensley, ivWatch

Infusion pump companies are perpetuating misconceptions.

Featured Articles

FDACDRH Reorganizes In Effort to Stay Ahead,
Creates Super Office

By MedTech Intelligence Staff

The center began phasing in efficiencies on March 18.

Kolaleh Eskandanian, Ph.D., MBA, PMP, vice president and chief innovation officer at Children’s National Health System.Innovation in Orthopedic
and Spinal Devices for Kids Still Lacking

By Maria Fontanazza, Editor-in-Chief

Developing medical devices in general is costly, but there is funding available for companies that are willing to create products specifically for pediatrics.

Sean Otto, Ph.D., CyientIntegrating Data Science into Medical Device Development

By Sean Otto, Ph.D., Cyient

Successful integration requires a rethinking around the role of data science in product design and lifecycle management.

Sponsored Content

Accumold5 Things Everyone
Needs to Know About
Micro Molding

With the pressure on design engineers to deliver smaller, lighter, and more cost-effective components many are turning to micro injection molding for support. Challenges often arise when designing for micro molding that can present unforeseen road blocks. Questions like - What is micro molding? How is it different from standard molding? – are commonly asked by engineers. This whitepaper will explore the answers to these and other pertinent questions.

3M - Learn the science of sticking to skin

Medical Device Recalls Conference - June 24 - 25, 2019 - Washington, DC

Global Regulatory Strategy - October 22-23, 2019 - Washington, DC

Contact Marc Spector about MTI advertising programs.

EU MDR Workshop Series

Sponsored Resources

SiemensRegister Now to our Live Webinar

The use of additive manufacturing (AM) in the medical device industry has gone from being exotic and “next gen” to routine. Join us on April 2nd for a webinar on the current AM landscape, capabilities, and the Siemens digital solutions that support them.


3MWhitepaper - The impact of regulatory requirements on bringing medical devices to market.

There are many steps involved in the process of bringing a device to market, especially examining the regulatory environment in which medical device customers operate. Depending on your device, its indications or the presence of drug or biologic components, submissions to the U.S. FDA, EU Notified Bodies or Competent Authorities, and other regulatory bodies might be considered, but if you're using a component as a layer between other components of your medical device, or if you're using a component to adhere a device to skin, more may be expected from you by the FDA or other regulatory agency reviewers. When adhering a device to skin special attention should be given to the final, finished device composition and biocompatibility, inclusive of all component(s).

Access this white paper here.

Resource Centers

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

Medical Device Cybersecurity Conference - June 4 - 5, 2019 - Boston, MA

Upcoming Events & Webinars

March 2019March 26-27, 2019 - Advanced CAPA & Root Cause Analysis
A Virtual Event

May 20-21, 2019 - EU MDR Supply Chain & Economic Operators
Washington, DC

May 21-22, 2019 - EU MDR Clinical & Postmarket Surveillance Strategies
Washington, DC

May 23-24, 2019 - EU MDR Labeling, IFU, UDI, & Eudamed
Washington, DC

June 4-5, 2019 - Medical Device Cybersecurity: Legacy Device Remediation, Compensating Controls, & End-of-Life
Boston, MA

June 24-25, 2019 - Medical Device Recalls: Current Topics & New Initiatives
Washington, DC

OctoberOctober 22-23, 2019 - Global Regulatory Strategy
Washington, DC

OctoberOctober 23-24, 2019 - MedTech M&A: Regulatory & Quality Due Diligence
Washington, DC

NovemberNovember 13-14, 2019 - India - the MedTech Market: Strategic Planning & Practical Considerations
Washington, DC

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