Operations

Companies Shifting Focus to Better
COVID-19 Testing

By Adam Khan, KHAN Semiconductor

In order to meet the worldwide need for faster and affordable testing processes, companies must shift goals and apply resources to ending this pandemic.

Ameing for Asia

Asian Governments, Private Sector Response to Pandemic Shows Opportunity, Challenge

By Ames Gross, Pacific Bridge Medical

In general, the Asian markets have controlled the COVID-19 virus successfully outside of China, but its effect has still led to new developments and trends.

Product Development

How the Internet of Things Will Revolutionize
Medical Research

By Alyssa Rapp, Surgical Solutions

Across our industry, IoMT will enable us to conduct research in ways that would never previously have been possible.

Featured Quote

In light of the ongoing pandemic, the healthcare industry, which has historically been slow to change, is being forced into fast innovation and adoption of virtual care. Health systems, providers and patients are not only seeing that virtual care is possible across new clinical specialties—but that it [also] works.

— Catherine Murphy, Zipnosis

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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Business Analysis

Playing by the Rules: A Lever for Doing Better Business?

By Xavier Duburcq, Ph.D.

Investments in new processes and systems must satisfy the needs of the authorities and ensure patient safety and public confidence. Getting it right is likely to be expensive. but regulatory compliance shouldn’t be viewed purely as a cost center.

Quality/Regulatory

Patent and Regulatory Challenges
in AI’s Use in Life Sciences

By Emily Rapalino, Cindy Chang and Nicholas Mitrokostas,
Goodwin Procter, LLP

With the rapid growth of life tech discoveries, there is a need to adapt the patent and regulatory frameworks governing the approval, use, and protection of such discoveries.

Quality/Regulatory

Postmarket Surveillance:
The Urgent Need for a Holistic Approach

By Carl Ning, Veeva Systems

Simplifying the PMS process globally from end to end, can help medtech companies realize significant improvements across the board while keeping operating costs under control.

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