Columns

Cardiovascular

The TAVR Plot Thickens

Transcatheter aortic valve replacement (TAVR) surgery has typically targeted patients considered too risky to undergo open-heart surgery.

Sam Brusco, Associate Editor 09.06.19

Update on Integrated Delivery Networks and Physician Employment

The top five IDNs employ 135,913 MDs and DOs in the U.S., approximately 15 percent of all active physicians in the country.

Maria Shepherd, President and Founder, Medi-Vantage 09.06.19

U.S. May Offer a Safe Harbor from the Impending MDR Storm

U.S. may represent the preferred route to market with regulatory changes elsewhere in the world, like the EU's MDR.

Dawn A. Lissy, President & Founder, Empirical 09.06.19

Innovating for the Clinical Space: An Interview with Clinical Innovations' President/CEO Ken Reali

Ken Reali of Clinical Innovations speaks with Sean Fenske about current issues impacting medical device manufacturing and emerging trends influencing care.

Sean Fenske, Editor-in-Chief 09.06.19

Globalization: Will Your 2019 Regulatory Strategy Help You Win in 2020?

Successful medtech leaders have ongoing regulatory strategies for their respective businesses.

Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 09.06.19

First Come, First Served: Class I Manufacturers Stand in Line for EU MDR Certification

The days remaining to attain EU Medical Device Regulation (MDR) compliance are numbered.

Peter Rose, Managing Director—Europe, Maetrics 09.06.19

Contract Manufacturing

J&J-Jabil Deal Truly Is Transformative for the Medtech Supply Chain

On Aug. 2, 2018 Johnson & Johnson announced a reorganization of its Medical Devices division.

Tony Freeman, President, A.S. Freeman Advisors LLC 09.06.19

Healthcare, Breakthrough Technology, and the 2020 Election: A Summer Update

With only a year and two months until the 2020 presidential election, Washington is buckled down and ready for yet another busy season of campaigning.

Jeffrey J. Kimbell, David C. Rudloff and Caroline P. Tucker, Jeffrey J. Kimbell & Associates Inc. 09.06.19

R&D & Design

Three Crucial Elements of Conducting International Usability Research

It is important to conduct usability research throughout the product development cycle.

Joe Pratt, CHFP, Lead Human Factors Engineer, BlackHägen Design 09.06.19

Trends, Opportunities, and Drivers in Early-Stage Life Sciences Investing

Despite trade wars and economic shifts in China and the EU, early-stage investing in life sciences remained strong in Q1 2019.

Byron S. Kalogerou, Partner, McDermott Will & Emery 09.06.19

Contract Manufacturing | Digital Health | Software & IT

Connecting the Dots in Medical Device Outsourcing

San Francisco is globally renowned for many things: The Golden Gate Bridge (its color, international orange, was actually a primer used to protect the steel during transit), Ghirardelli chocolate, the TransAmerica pyramid building, and the “Pai…

MPO Staff 07.30.19

What Keeps Hospital CEOs Awake at Night and How Can Medtech Help?

With commanding new players like Apple and Google entering the healthcare space, the continued surge of mergers and acquisitions, vertical integrations, and no clear U.S. healthcare policy and reform direction for our $3.6 trillion annual healthcare…

Maria Shepherd, President and Founder, Medi-Vantage 07.30.19

Mayday: How the Upcoming MDR Implementation Forecasts Disaster for Our Industry

I’m generally an optimistic person. My outgoing voicemail greeting encourages every caller to “keep smiling!” My wardrobe is about 40 percent “Life is Good” apparel and I keep a daily gratitude journal. Despite this s…

Dawn A. Lissy, President & Founder, Empirical 07.30.19

The OEM’s Roadmap to Navigating MDR

With recent updates to ISO 10993-1 and the Medical Device Regulation (MDR) on track to replace Europe’s current Medical Device Directive (MDD) next year, European medical device requirements present greater regulatory hurdles. The impending upd…

Sandi Schaible, Senior Director, Analytical Chemistry and Regulatory Toxicology, WuXi AppTec 07.30.19

Materials | Packaging & Sterilization | R&D & Design

Case in Point: Robust Sintered PTFE Material Helps to Reduce Risk of HAIs

In China, concerns are mounting over the life-threatening issue of healthcare-associated infections (HAIs) and how to prevent future incidents from occurring. Recently, researchers investigated increased hospitalization costs due to HAIs,1 which not…

Jack Chan, Global Marketing Director—Medical, Porex 07.30.19

Innovation in Medtech: Choosing an Execution Strategy

Innovation is an easy topic to discuss strategically among intelligent people (at all levels of the organization) in the medtech industry. We all enjoy having conversations about the latest trends, future technology, and global innovation models driv…

Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 07.30.19

Software & IT

Five Strategies to Navigate Regulatory Challenges in Medical Device Development

Medical device products are rapidly evolving to become more personalized and connected, leveraging artificial intelligence (AI), robotics, and mobile technology. Against this backdrop of continual innovation, medical device manufacturers face uniq…

Seth J. Goldenberg, Ph.D., Vice President, Vault Medical Device & Diagnostics, Veeva Systems 07.30.19

Three Key Takeaways from Four International Medtech Clusters

The United States is widely considered to have developed the world’s leading medtech industry, consistently ranking among the highest in R&D spending, registration of international patents, and sales. Much of this success owes to the strate…

Mihir Torsekar, Analyst, U.S. International Trade Commission 07.30.19

R&D & Design

What Is Human Factors Engineering and Why Is It Important?

It is becoming common knowledge Human Factors Engineering (HFE), also known as Usability Engineering (UE), is required as part of most medical device development. But what exactly does that entail and how does it affect product development? A rece…

Rich Newman, Usability Engineering Manager, BlackHägen Design 07.30.19

Funding Tips to Help Medtech Startups Cross the ‘Valley of Death’

Bringing innovative medical technology to market today is as complex and competitive as it’s ever been for entrepreneurs and startups. One of the major hurdles for any early-stage medtech company is funding product development, and the venture…

David J. Dykeman, Co-chair, Global Life Sciences & Medical Technology Group, Greenberg Traurig LLP 07.30.19