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Ed Park, Decision Resources Group
December 13, 2019
Ed Park, Decision Resources Group
Soapbox

Evolve Your Commercial Approach to Meet Needs of a Changing Customer Base

By Ed Park

Medtech companies must account for a more complex web of influencers on purchasing.

Continue reading →

Jon Speer, Greenlight Guru
November 8, 2019
Jon Speer, Greenlight Guru
Soapbox

Top 3 Mistakes You Can Make When Adopting ISO 13485

By Jon Speer

Drop the checkbox mentality and embrace accountability and understanding.

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Healthcare Technology
October 7, 2019
Healthcare Technology

FDA Issues Warning about 11 Cybersecurity Vulnerabilities in IPnet Software Component

By MedTech Intelligence Staff

URGENT/11 introduces risks to medical device and hospital networks, and could allow a remote attacker to take control of a medical device such as an anesthesia machine of insulin pump.

Continue reading →

Nicholas Zampa
September 23, 2019
Nicholas Zampa
MEDdesign

Making Way for Probability in Human Factors (Part I)

By Nicholas Zampa

This series makes the argument for probability assessments in HFE/UE for medical devices and how to incorporate it into the paradigm.

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Sandi Schiable, WuXi AppTec
September 3, 2019
Sandi Schiable, WuXi AppTec
Soapbox

Preparing for MDR: Partner Up

By Sandi Schaible

There are several critical questions that your internal team should be ready to address when preparing product portfolios and seeking out a CRO.

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Jagger Esch, Medicare FAQ
August 26, 2019
Jagger Esch, Medicare FAQ
MEDdesign

Implanted Medical Devices and Vulnerabilities to Hackers

By Jagger Esch

How to improve medical device security and the importance of security updates.

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Sudeep Goswani, Tempo Automation
August 21, 2019
Sudeep Goswani, Tempo Automation
MEDdesign

Why Software-Powered Electronics Manufacturing is Advancing the Medtech Industry

By Sudeep Goswami

Software-powered PCBAs can help medical device engineers generate high-quality prototypes for complex electronics products in record speed.

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Data protection, intelliectual property, medtech
August 12, 2019
Data protection, intelliectual property, medtech

Protecting Data in the MedTech Industry

By Molly Grammel, Rachel Walsh, Robert Crawford

The revolution in data and technology should be pushing companies to focus on safeguarding intellectual property.

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FDA
July 15, 2019
FDA

FDA Announces Innovation Challenges to Find New Methods of Device Sterilization

By MedTech Intelligence Staff

The agency is encouraging the industry to develop sterilization approaches that either don’t rely on ethylene oxide or reduce emissions from this method.

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Checkbox
June 11, 2019
Checkbox

Anticipating Threats: How Prepared Is Your Business?

By Endrita Muhaxheri

Having an effective business continuity management system based on ISO 22301 can help medtech companies remain resilient.

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Columns

May 14, 2024

FDA Issues Final Guidance on Remanufacturing of Medical Devices

By MedTech Intelligence Staff
FDA Logo

The guidance defines remanufacturing, includes relevant considerations to determine if activities are remanufacturing, and provides recommended labeling information to ensure serviced devices are returned to their established performance and safety specification.

May 1, 2024

FDA Releases Laboratory Developed Tests Final Rule

By MedTech Intelligence Staff
FDA Logo

“The final rule announced today aims to provide crucial oversight of these tests to help ensure that important healthcare decisions are made based on test results that patients and health care providers can trust.”

April 10, 2024

Federal Court Enters Consent Decree Against Philips Respironics Following Recall of CPAP Machines

By MedTech Intelligence Staff
Gavel

The consent decree restricts the production and sale of new continuous positive airway pressure (CPAP) machines, bi-level positive airway pressure (BiPAP) machines and other devices at several Philips Respironics facilities in the U.S. until certain requirements are met.

April 3, 2024

FDA to Host Virtual Workshop on ASCA Program Expansion

By MedTech Intelligence Staff
FDA Logo

On April 17, the FDA is hosting a Virtual Public Workshop on approaches to Accreditation Scheme for Conformity Assessment Expansion.

March 25, 2024

FDA Proposes Ban on Electrical Stimulation Devices

By MedTech Intelligence Staff
FDA Logo

“These devices present a number of psychological risks including depression, anxiety, worsening of underlying symptoms, development of post-traumatic stress disorder, and physical risks such as pain, burns, and tissue damage.”

March 17, 2024

FDA Outlines its Approach to Artificial Intelligence Regulation

By MedTech Intelligence Staff

“Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together” outlines how FDA’s medical product centers plan to address regulation of AI used in medical products and their development.

February 20, 2024

FDA Urges Medical Device Manufacturers to Scrutinize Third Party-Generated Data

By MedTech Intelligence Staff
FDA Logo

Following a “alarming” increase in medical device submissions containing unreliable data, the FDA is reminding manufacturers and study sponsors that they are responsible for qualifying third-party test labs and closely scrutinizing all testing data.

January 31, 2024

FDA Elevates Office of Strategic Partnerships and Technology Innovation to CDRH Super Office

By MedTech Intelligence Staff
FDA Logo

As part of its reorganization of the CDRH, the FDA has elevated the Office of Strategic Partnerships and Technology Innovation (OST) to a Super Office that will include the Office of Supply Chain Resilience (OSCR), Digital Health Center of Excellence (DHCoE), Office of Technology and Data Services (OTDS), Office of Readiness and Response (ORR) and Office of Equity and Innovative Development (OEID).

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  • MedTech Economics
  • Manufacturing Execution
  • Product Design & Development
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