Columns

Diagnostics

From Genome Sequencing to the World’s First Portable MRI

Dr. Jonathan Rothberg has risen about as high as a scientist can, save for the Nobel Prize.

Sam Brusco, Associate Editor 11.04.19

Digital Health

An Update on Digital Health

Sure, most are startups—but not all. There were some brilliant ideas presented at The MedTech Conference (AdvaMed’s annual meeting) on Sept. 23-25 in Boston and the Connected Health Conference, also in Boston, put on by Partners Health…

Maria Shepherd, President and Founder, Medi-Vantage 11.04.19

‘If You’re Reading This, You Need to Be at This Meeting’

The AAOS/FDA/Industry Townhall is taking place March 24, 2020, at the AAOS annual meeting in Orlando.

Dawn A. Lissy, President & Founder, Empirical 11.04.19

Five Steps for Succeeding Globally in Medtech

World views can differ considerably, so it is important to understand, appreciate, and respect cultural realities and differences.

Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 11.04.19

Software & IT

Unlocking Market Doors with Real-World Evidence

Real-world evidence is becoming increasingly important for manufacturers to demonstrate value beyond efficacy and safety standards.

Seth Goldenberg, Ph.D., Vice President, Vault Medical Device & Diagnostics, Veeva Systems 11.04.19

Contract Manufacturing

Sales Tips for Contract Manufacturers of Finished Devices

Evolving trends in the supply chain may require companies to consider a strategy of selling devices of their own design.

Tony Freeman, President, A.S. Freeman Advisors LLC 11.04.19

Impeachment, Executive Orders, and Must-Pass Congressional Legislation: A Fall Update

The final quarter of 2019 has begun, which means Congress and the Trump Administration are hard at work finalizing healthcare initiatives before year's end.

Jeffrey J. Kimbell, David C. Rudloff and Caroline P. Tucker, Jeffrey J. Kimbell & Associates Inc. 11.04.19

R&D & Design

Perfecting Drug Delivery Device Design

Unlike medical products that just need to work, drug delivery devices must also consider intuitiveness, usability, and how it makes the user feel when operated.

Bryce G. Rutter, Ph.D., Founder & CEO, Metaphase Design Group Inc. 11.04.19

Diagnostics

Elizabeth Holmes: The Making of a Pop Culture Icon

Despite keeping a relatively low profile this year (not by choice), Elizabeth Holmes’ celebrity status has continued to grow.

Michael Barbella, Managing Editor 10.08.19

A Look at Physician/Surgeon Salary and Employment Statistics

No more call for physicians? Not really, but schedule predictability is in for physicians.

Maria Shepherd, President and Founder, Medi-Vantage 10.08.19

Bridging Generation Gaps to Build Better Teams and Business

I’ve learned the hard way that building teams of motivated, productive employees is equal parts science and art.

Dawn A. Lissy, President & Founder, Empirical 10.08.19

Testing

Managing Risks for Medical Devices: A Guide to Understanding ISO 14971

The intent of ISO 14971 is to provide a general “bird’s-eye view” approach to designing and implementing a risk management plan for medical devices.

Helin Räägel, Ph.D., Biocompatibility Expert, Nelson Labs 10.08.19

Testing

Preparing for MDR: Test In-House or Outsource?

As the EU MDR deadline draws near, manufacturers are under pressure to bring products into compliance and get submissions in front of regulators ASAP.

Sandi Schaible, Senior Director, Analytical Chemistry and Regulatory Toxicology, WuXi Medical Device Testing 10.08.19

Think Chinese Tariffs Are the Only Industry Job Killers? Think Again

One of the latest concerns—arising from an old issue—is the medical device tax, which could return next year without legislative intervention before then.

Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 10.08.19

Contract Manufacturing | Software & IT