Is this you? As a journalist, you can create a free Muck Rack account to customize your profile, list your contact preferences, and upload a portfolio of your best work.
Claim your profile
Articles by Chris Rush
How medical device CROs build a sustainable growth engine
The medical device contract research organization (CRO) market is growing at close to 8% annually and is on track to reach $43.6 billion by 2035, up from $22 billion in 2026, according to Roots Analysis. For a CRO that specializes in device studies, the headline sounds like good news.
What you give up when your device study runs on a pharma EDC
A device manufacturer preparing a 45-patient feasibility study asks three vendors to quote an electronic data capture (EDC) system. Two of the quotes come back with implementation timelines measured in months, a required data management services package, and pricing modeled on patient volumes the study will never reach. The platforms are capable. They were also built for a different kind of trial. A pharma EDC can technically run a medical device study.
Why medtech manufacturers must own their clinical evidence
Every medical device manufacturer understands that clinical evidence is a regulatory requirement. Fewer think carefully about who actually controls it. The distinction matters more than most teams realize until a study ends, a CRO relationship changes, or a regulatory submission is due and the data is somewhere else. Clinical evidence is not just documentation.
Spreadsheets vs EDC: Real Cost Comparison for MedTech Clinical Studies
Spreadsheets look harmless. You already own Excel, your team knows how to use it, and you can build a tracker in an afternoon, add a few tabs, and send it out to your sites. Paper feels similar: print the case report forms, collect the data, scan the pages, and key everything in later. For a lean medtech team trying to move quickly, that practicality is appealing. Why pay for an electronic data capture (EDC) system when the tools on hand seem to do the job?
eCRF design best practices for medical device clinical investigations
An electronic case report form (eCRF) is the structured digital instrument used to collect, record, and transmit clinical trial data from study sites to the sponsor. In a medical device investigation, your eCRF is the primary evidence layer between what happens at the clinical site and what ends up in your regulatory submission. A well-designed eCRF produces clean data with minimal queries. A poorly designed one generates months of remediation work before you can lock the database and file.
How to work with a medtech CRO and stay in control
Most medtech manufacturers approach a clinical study the same way: find a contract research organization (CRO), hand over the protocol, and wait for data. The appeal is obvious. Clinical operations are complex, heavily regulated, and far outside the day-to-day work of a device company. Outsourcing feels like the rational solution. The problem is that outsourcing execution does not transfer accountability.
The clinical evidence investors actually care about
Unpopular opinion in MedTech: statistical significance is NOT the most important kind of success for your clinical evidence. That statement can feel uncomfortable. Many founders and clinical leaders are trained to focus on p-values, confidence intervals, and publication-ready results. Statistical rigor is essential. Without it, nothing else stands. But statistical significance alone does not determine whether a device will be adopted, reimbursed, or funded.
Turn your PMCF activities into a competitive advantage
To comply with the Post-Market Clinical Follow-up (PMCF) requirements laid out in EU MDR, MedTech companies must proactively collect clinical data on their products throughout the entire device lifecycle. And while these requirements have been in writing since MDR was first published in 2017, many companies with devices in Europe are still hesitant to perform proactive PMCF activities as the regulation requires. In a lot of cases, this is because management views PMCF activities only as a cost.
The future of EU MDR: insights and strategies for 2025 (free eBook)
When the European Union Medical Device Regulation (EU MDR) was first published in 2017, it kicked off an enormous amount of conversation, concern, and even frustration in the medical device industry. Eight years later, and the conversation is going. While the basic principles of EU MDR are not changing, there has been some evolution in the regulation, along with extensions for some companies, and it’s always a good idea to be up to date on the latest.
The 5 most common clinical data pitfalls in 2025 (and how to avoid them)
The methods and practices you use for collecting and managing clinical data will ultimately make or break the success of any clinical trial. A study may have an excellent design that’s executed flawlessly by each clinical site, but if there are errors in data collection, or the collection methods are not compliant with regulations, the sponsor may not be able to use that data in their regulatory submissions.
What’s New in Greenlight Guru Clinical 2025.1: Smarter Show Rules and Easier File Vault Access
Greenlight Guru Clinical 2025.1 is here, and it brings exciting new features to help MedTech teams move faster, stay compliant, and streamline study workflows. This release focuses on three core improvements: A more flexible Process Show Rules and a new builder Simplified, self-serve File Vault access and management New non-blocking amendment functionality for clinical studies Let’s walk through what’s new and how it improves your day-to-day work.
Community Voices: Protect our critically important public federal lands
Having served in the infantry in Vietnam in 1968, I returned home to spend the next eight months in and out of an Army hospital having been severely wounded in battle with wounds that included a traumatic brain injury. After being given a medical retirement, I planned to attend college. Before college, however, I needed to get my head straight. I ended up hiking the 200-plus-mile John Muir Trail through our wonderful federal park and forest lands in California’s Sierra Nevada Mountains.
Bishop blessing
...A SEVERE THUNDERSTORM WARNING REMAINS IN EFFECT UNTIL 630 AM CST FOR WESTERN MCINTOSH...NORTHWESTERN PITTSBURG...SOUTHERN OKMULGEE AND SOUTHEASTERN OKFUSKEE COUNTIES... At 601 AM CST, severe thunderstorms were located along a line extending from 4 miles north of Pharoah to 4 miles northwest of Hanna to 3 miles west of Haywood, moving northeast at 55 mph. HAZARD...70 mph wind gusts and quarter size hail. SOURCE...Radar indicated. IMPACT...Hail damage to vehicles is expected.
Navigating FDA Guidance on Electronic Systems, Records, and Signatures in Clinical Investigations: A Comprehensive Overview for Medical Device Companies
Study sponsors now have more options for electronic data capture (EDC) systems than ever. Though paper is still used in some cases, the accuracy, efficiency, and security of electronic systems make them an objectively better option in clinical trials.
Real-World Data and Real-World Evidence: When and How to Use Them
While clinical trials are the gold standard for generating clinical data to use as evidence of your medical device’s safety and effectiveness, they aren’t by any means the only way to gather clinical evidence. Real-world data (RWD), which typically comes from routine healthcare delivery or non-interventional studies like registries, is another potential source of clinical evidence.
How to Set Up Clinical Studies to Comply with US FDA Regulations
For manufacturers of high-risk medical devices, obtaining data from clinical investigations will be essential to a successful regulatory submission in the US. The Food and Drug Administration (FDA) requires all Class III medical devices to go through Premarket Approval (PMA) prior to being placed on the market in the US.
Designing a Medical Device for a Global User
In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Dr. Matthew Wettergreen, Director of the Global Medical Innovation Master of Bioengineering program at Rice University. Dr. Wettergreen shares his extensive experience in developing client-based engineering design courses and discusses the importance of global and contextual perspectives in medical device innovation.
Is China the next key driver of global portfolio performance?
Chinese equities is an area that has struggled relative to the rest of the world and valuation figures may still push many investors away. However, we believe the medium-term outlook has somewhat improved and they could soon be the next key driver of performance. Current market drivers The conflict in Ukraine has increased the volatility of global markets since February of this year and, for better or worse, we know that markets don't have hearts or minds.
[Memoir] Love and Acid, by Chris Rush
It’s forest fire season in Oregon. Yellow smoke fills the valley. I can’t see the mountains, can’t see across the street. My neighbor says, Don’t worry, the fire’s still thirty miles away. For weeks, my small town has been blighted by a thick, toxic smog. There’s a government advisory to remain indoors. Like everyone else, I’m going a little crazy. I decide to risk a walk. On Main Street, people are window-shopping in particle masks.
On Being Young, Gay and Addicted in the 1970s
NonFiction May 2, 2019 The Light Years By Chris Rush So much happens in the first 40 pages of the artist Chris Rush’s memoir of adolescence, “The Light Years,” that I doubted the pace could be maintained for the ensuing 300 pages — and worried that it would be. Before it’s done, the book crosses the continent from wealthy, suburban New Jersey to the countercultures and wildernesses of Arizona and California no fewer than four times and folds in at least three dozen significant characters.
A Remembrance of Painful Things Past
Chris Rush, author of the daring new memoir The Light Years, first got Tucson's attention more 20 years ago, when he painted a comical mural of a baby's fat-cheeked face on a downtown wall. It was adorned with three happy words: Eat. Fly. Cake. But Rush revealed his serious side in 2000 in one of the most extraordinary art exhibitions Tucson has ever seen. In his solo show The Lost Portraits at the Tucson Museum of Art, Rush unveiled masterly conte crayon drawings of disabled children.
Chris Rush on Confronting the Ghosts of His Past
Writing a book was never part of the plan. My whole life I’ve been a painter. By three or four, I had a brush in my hand. Childhood was a wave of watercolors, tempera, and ink. For decades, without interruption, I made art. Then, at 50, out of nowhere, I started to write. My collectors, my galleries—like jealous lovers—told me to stop fooling around. But the words wouldn’t stop. For ten years I filled notebooks with what would eventually become a memoir.
The Best Reviewed Books of the Week
A harrowing tale of abuse in a Bolivian Mennonite community, a murder mystery set in Blitz era London, and a true crime story forty years in the making all feature among the week’s best reviewed titles. Fiction Article continues after advertisement 1.
The Light Years: A Memoir
The Light Years is a joyous and defiant coming-of-age memoir set during one of the most turbulent times in American history "This stunningly beautiful, original memoir is driven by a search for the divine, a quest that leads Rush into some dangerous places . . .
Tips To Ease Small Business Tax Season Stress
Are you stressed about tax season? It certainly breeds its own intense levels of anxiety for many business owners. Whether you outsource your tax preparation to an accounting professional or handle your taxes in-house, it pays to be prepared.
Bonuses, Parties and Gifts: How Small Business Owners Can Navigate the Holiday Season
Reader Resource Position yourself for growth in 2017—join us live at the Entrepreneur 360™ Conference in Long Beach, Calif. on Nov. 16. Secure Your Seat » Pumpkin spice lattes are flowing and leaves are changing color, which can mean only one thing: This year’s holiday season is right around the corner. For small business owners who already juggle more than their fair share of responsibilities, it also means they’ll need to manage some unique situations that only arise in November and December.
Being a Small Business Can Be a Big Recruiting Advamtage
It’s no secret that small businesses find hiring to be a top HR challenge. In fact, a recent ADP study found that 40 percent of small businesses believe filling an open position is more difficult than expected and 32 percent said it took longer than expected. However, despite the fact that recruitment can be challenging for small business owners, they employ nearly half of the U.S workforce, and account for more than 60 percent of the private sector’s net new jobs.
Tulsa vs. East Carolina - Tulsa
Recap | Quotes | Photo Gallery East Carolina vs Tulsa (Nov 12, 2005) East Carolina vs Tulsa (Nov 12, 2005) Game Summary Team Statistics Individual Statistics Drive Chart Defensive Statistics Game Participation Play-by-Play <!File source:C:\TASFB\2005\REPORTS\GAME.SUM> Scoring Summary Scoring Summary (Final) 2005 Golden Hurricane Football East Carolina vs Tulsa (Nov 12, 2005 at Tulsa, Okla.) East Carolina (3-6,2-4) vs. Tulsa (6-4,5-2) Date: Nov 12, 2005 Site: Tulsa, Okla.
University of Tulsa Athletics
Recap SMU vs Tulsa (Oct 25, 2003) SMU vs Tulsa (Oct 25, 2003) Game Summary Team Statistics Individual Statistics Defensive Statistics Game Participation Play-by-Play <!File source:C:\TASFB\2003\REPORTS\GAME.SUM> Scoring Summary Scoring Summary (Final) 2003 Golden Hurricane Football SMU vs Tulsa (Oct 25, 2003 at Tulsa, Okla.) SMU (0-8,0-5) vs. Tulsa (4-4,2-2) Date: Oct 25, 2003 Site: Tulsa, Okla.
Improving Clinical Data Collection with Effective eCRF Completion Guidelines
In clinical trials, study personnel use case report forms (CRFs) to standardize the collection of clinical data from study participants. This makes the CRF one of the most important documents in a clinical trial, as the design and content of a CRF can affect the quality and reliability of the data collected from participants. While CRFs have been created as paper documents in the past, today, the accuracy and ease of electronic case report forms (eCRFs) mean they are often used instead of paper.
Show More
loading
Actions
Is this you?
As a journalist, you can create a free Muck Rack account to customize your profile, list your contact preferences, and upload a portfolio of your best work.Get in touch with Chris
Contact Chris, search articles and posts on X, monitor coverage, and track replies from one place.
Learn more about Muck Rack