Columns

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…

ODT Staff 08.14.19

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

With the continued surge of mergers and acquisitions, vertical integrations, and no clear U.S. policy or reform direction for our $3.6 trillion annual healthcare spend,1 the healthcare ecosystem remains in a phase of dramatic disruption. What Is K…

Maria Shepherd, President and Founder, Medi-Vantage 08.14.19

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 08.14.19

Successful Strategies for Health Plan Medical Policy Outreach

Getting approval from the FDA can be a significant achievement for a company but a bigger challenge awaits for novel technologies: health payor acceptance and coverage. Adopting a novel technology does not occur easily due to complex commercial insur…

Chelsey Jaworski and Anabel Tapia, MCRA 08.14.19

Design

Why and How Good Design Matters to the Bottom Line

There should be no confusion: good design pays dividends. Literally. Many highly successful medical products that substantively improve the delivery of healthcare also significantly increase market share and revenue. But just what is the elusive good…

Bryce G. Rutter, Ph.D., Founder and CEO, Metaphase Design Group Inc. 08.14.19

Contract Manufacturing | Supply Chain

Contract Service Providers: Forward Thinking in Supplier Management

Virtual manufacturing is common among startups and entrepreneurs building a new company or project with a prudent fiscal approach. Intellectual property and an experienced contract manufacturer can make it a reality. Harnessing a contract manufacture…

Bryan Brosseau, Founder and Principal Consultant, Brosseau Consulting LLC 08.14.19

Large Joint

AJRR Struggling to Find PROM Dates

Timothy Mojonnier owes his sanity to a walk around the block. The greater Chicago-area management consultant had been inching closer to the breaking point for years prior to that walk, courtesy of his steadily deteriorating knee. But each time Mojonn…

Michael Barbella, Managing Editor 05.23.19

U.S. Healthcare Spending in Orthopedics

While total 2017 U.S. healthcare spending grew by 3.9 percent to $3.5 trillion,1 it was at a lower rate than the 4.8 percent increase reported by the U.S. Department of Health and Human Services in 2016. The 2017 growth rate correlates to the lower i…

Maria Shepherd, President and Founder, Medi-Vantage 05.23.19

3-D Printing/Additive Mfg. | Assembly & Automation | Machining & Tooling | Materials

What’s ‘In’ for Manufacturing? (Hint: It’s Not Neon)

It seems the only time I catch up on the latest clothing fashions is when I seek inspiration online for columns I write pertaining to trends. Each time I do, I’m reminded why I read magazines like MPO and ODT instead of something in the checkou…

Dawn A. Lissy, President & Founder, Empirical 05.23.19

Developing Market Access Strategies

Clearly, innovation is one of the keys to success for medtech OEMs and their suppliers. But it’s not the only key—market access is equally as important to long-term growth, as it helps drive immediate sales and generate a return on invest…

Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 05.23.19

Medicare for All: Choice and Affordability for None

The term “Medicare for All” has increasingly become a rallying cry in the Democratic Party. The motto has become even more resounding as Republicans struggle to reach a consensus on what free-market healthcare reforms may look like. While…

Jeffrey J. Kimbell, David C. Rudloff, Caroline P. Tucker, Jeffrey J. Kimbell & Associates Inc. 05.23.19

Design | Software & Quality

Dominating the Competition with Digitization

Companies developing cutting-edge orthopedic devices need cutting-edge technology for their business processes. Whether a company focuses on finding new materials for implants, manufacturing better surgical instruments, or getting a new device throug…

Bryant Headley, Customer Success Executive, MasterControl 05.23.19

MIS/Robotics

Justifying the Hype of Robotic Orthopedic Surgery

The robots are coming. But they’re not yet seeking subjugation of the human race. Instead, they want to perform surgery on our joints and spine. Last year’s “Top 10 Global Orthopedic Device Firms” reports made it clear roboti…

Sam Brusco, Associate Editor 03.29.19

Spine/Neurology

2019 Update on Surgical Management of Vertebral Compression Fracture: The Comeback Kid

Ten years ago—2009—was a controversial time for spine surgeons. This was the year the outcomes of two randomized controlled trials were published in The New England Journal of Medicine (NEJM).1,2 The results? The outcomes for vertebral co…

Maria Shepherd, President and Founder, Medi-Vantage 03.29.19

Biocompatibility & Testing

Why Big Companies With Internal Labs Should Outsource Testing

Most of us know when we’ve hit that line signaling we’ve left our cutting edge and officially spread ourselves too thin. Pushing to do and be more is often a half-step from maxing out and dropping all those balls we’re juggling.…

Dawn A. Lissy, President & Founder, Empirical 03.29.19

ISO 14971 Update: What Changes Can Medical Device Manufacturers Expect?

ISO 14971 for medical device risk management is in the final stages of an important update slated for publication this year. While ISO has specifically said the intent of the revision isn’t to rework the risk management process, subtle changes…

Tony Parise, Product Strategist—Life Sciences, ETQ 03.29.19

7 Steps Toward a Successful Orthopedic Product Launch

We have a common goal in the medical device industry to implement innovative, fast, and cost-effective designs and solutions. Design engineers also know that being proactive by focusing on the upfront work prior to freezing the design will save time…

Arley Perez, Senior Product Development Engineer, Orchid Design 03.29.19

Design

Regulatory Perspectives: Anatomy of a Medical Policy

Health insurance is a contract between a third party payer (insurer) and an individual to help cover medical and surgical expenses. The insured party pays a premium to the health insurer for this benefit. The rights and obligations of the insured and…

Bonnie Clothier and Simran Madhani, MCRA 03.29.19

An Industry on the Defensive

It’s been a rough six months for the medtech industry. Nearly 200 days after it was first blindsided by a one-two punch of bad publicity from the damning Netflix documentary “The Bleeding Edge,” the sector remains firmly immersed…

Michael Barbella, Managing Editor 02.13.19

Medtech and The Management Top 250

Developed by the Drucker Institute and publicized by The Wall Street Journal, The Management Top 250 Ranking measures and ranks corporate competencies from 1-250 by scrutinizing operations in five areas: customer satisfaction, employee engagement and…

Maria Shepherd, President and Founder, Medi-Vantage 02.13.19