Product Development

How a Requirements Management Solution Helps Keep the Pace with Innovation

By Josh Turpen, Jama Software

During product development, collaboration between software, hardware and quality teams must be tracked and seamless to meet the increasing pace of market demand.

Market Access

Life-like Patient Simulators Used for Healthcare Training During the Pandemic and Beyond

By James Archetto, Gaumard Scientific

During the current operating environment there has been an increased need for healthcare training using patient simulators for students and practicing healthcare professionals.

Business Analysis

House Introduces Legislation to Give Tax Relief to Medtech Manufacturers

By MedTech Intelligence Staff

The IGNITE American Innovation Act aims to help small- and mid-sized businesses affected by the COVID-19 pandemic.

Trends in Medical Device Purchasing, Evaluation of Value, and Advice for Manufacturers

Sponsored By Evidera

Gone are the days of selling med tech products to surgeons and physicians based on relationships alone. Today, surgeons must convince hospitals that a new product provides clinical and economic value, and manufacturers must arm surgeons with evidence to facilitate successful discussions with hospital value-analysis teams (VAT).

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The Growing Need for Real-World Evidence in Medical Devices

Sponsored By Evidera

Derived from a wide range of data sources, real-world evidence (RWE) is used to complement clinical trial data to create a robust evidence base showing both safety and efficacy in defined populations (clinical trials), as well as outcomes in the general populations.

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Product Development

Herding Health Data to Provide Clearer Medical Guidance

By Huei-Sin, Keysight Technologies

New health-related data is arriving almost daily. Making sense of it all is a huge challenge.

Quality/Regulatory

EU MDR 101: Preparing Technical Documentation

By Archana Nagajaran, Ph.D., Kolabtree

Although medical device manufacturers have more time to prepare due to the delayed EU MDR deadline, this shouldn’t distract from the extensive documentation they must compile in the meantime to prove their devices are compliant.

Quality/Regulatory

GS1 Updates Global Model Number Identifier
For Use as a Basic UDI-DI to Meet EU MDR Requirements

By Terry Burton, Terry Burton Consulting, Ltd. and
George Wright IV, Product Identification & Processing Systems, Inc.

A recap of a recent effort involving a small group of AIDC experts in devising a data integrity scheme suitable for protecting a new device identifier used in modern healthcare applications against mis-keying. It presents the group’s undertakings in researching solutions to ensure identifier integrity, the challenges encountered, and how a more complete understanding of the constraints of the intended application led to a departure from the initial design and resulted in the elegant solution that exists today.

Quality/Regulatory

What Patients Expect Out of Their Wearable
Medical Devices

By Del R. Lawson, Ph.D., 3M, Medical Solutions Division

User needs and expectations continue to advance. Medical device technology needs to keep pace. For a successful design, take the following requirements into consideration.

Operations

Post-COVID Era of Product Safety:
Recall Risks During and After a Pandemic

By Chris Harvey, Stericycle

The medical device industry is pressured to aid those stricken by the pandemic, while at the same time working to mitigate increased risks usually associated with hurried manufacturing and quality control procedures.

Featured Quote

As the proliferation of connected and complex medical devices grows, healthcare providers are more susceptible to cyberattacks.

— Mo Madinejad, Irdeto

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