ARTICLE SUMMARY:
The most-read Market Pathways articles of 2020 reflect a year of non-stop emergency decision-making and creative policymaking.
In 2020, the COVID-19 pandemic propelled the medical device and diagnostics industry into the world spotlight, as healthcare systems moved into crisis mode. On the policy side, that meant the standard rulebook had to be rewritten to facilitate bringing new medical technologies to patients as fast as possible. Illustrating the incredible strategic pivots, as well as other achievements across the healthcare ecosystem, we present some of our most-read articles in Market Pathways in 2020 (in publication date order):
“FDA Leads Revival of US Early Feasibility Studies; Can Industry Keep Up?”
The initial findings from an Medical Device Innovation Consortium working group indicate that FDA’s efforts to promote early feasibility studies appear to be working to increase both the number and efficiency of these trials in the US, demonstrating that, at least on occasion, regulators can be ahead of industry. Now the burden is on device companies to follow suit. (Published January 21, 2020)
“Novel Device Approval Numbers Drop Sharply, But All is Well, FDA's Shuren Says”
From the pre-COVID-19 era, FDA device chief Jeff Shuren affirmed the strengths of the agency’s review program, despite a sharp drop in the number of novel devices approved by FDA in 2019. This was a look at the FDA trend numbers crunched by Market Pathways, and our discussion with Shuren about the state of the review program and what he expected in 2020 before he knew the storm that was coming. (Published February 3, 2020)
“Addressing a Global Health Emergency: Tips on Applying to FDA for a Novel Coronavirus Diagnostic EUA”
Early in the outbreak of the novel coronavirus, first identified in December in Wuhan, China, we spoke to IVD regulatory expert and former FDAer Haja Sittana El Mubarak, PhD, who offered valuable tips on the agency’s Emergency Use Authorization process for IVD manufacturers interested in responding to what was still a few days away from being formally dubbed “COVID-19.” (Published February 7, 2020)
“Real-World Evidence and Johnson & Johnson: NESTcc Unlocking Doors to Medical Device Innovation and Collaboration”
NESTcc Test-Case company Johnson & Johnson has nearly completed a proactive post-market surveillance for safety and effectiveness of Class II lumbar interbody system device procedures. Real-World Evidence gathered from this and other Test-Cases promises to open the door to new opportunities for device stakeholders to work together to share and leverage powerful real-world data—and shift the paradigm for how medtech innovates. (Published February 19, 2020)
“China’s Rapid Switch to eSubmissions Reaps COVID-19 Benefits; FDA on Slower Path”
China appears ahead of most countries in adopting an online, electronic system for pre-market device submissions. The country says its eRPS platform has helped speed emergency approvals and reduce face-to-face contacts amid the coronavirus. Also: a brief look at FDA’s progress toward eSubmissions. (Published March 17, 2020)
“Reform in the Time of Coronavirus? Diagnostics Bill Surfaces as Pandemic Escalates”
Establishing a more cohesive regulatory system for diagnostics has been a goal of FDA and test kit makers for decades. It was uncanny, then, that a bill representing the best chance of finally accomplishing that surfaced just as a global pandemic raised extremely high-profile scrutiny on the US testing infrastructure. Whether the current emergency makes eventual passage more or less likely remains to be seen. (Published March 24, 2020)
“Caption Health: Transforming Cardiac Imaging with AI”
In keeping with its proactive stance on establishing a regulatory framework for the upcoming wave of AI-based software technologies, the FDA in February granted de novo authorization for the first AI-based product for acquiring cardiac ultrasound images. Deployment has begun in high-need acute point-of-care settings, including those treating COVID-19 patients. (Published March 24, 2020)
“The Enormity of SARS-CoV-2 Testing: The Challenges for Laboratory Leaders”
The debacle over delayed SARS-CoV-2 testing put the spotlight on laboratory medicine in ways that are unprecedented, forcing the public to become quick learners. Heads of laboratories for two of the nation’s largest healthcare systems, NorthShore in Chicago and Northwell Health in NY describe their roles in a new, uncertain reality. Part 1 of a two-part series. (Published April 1, 2020)
“NorthShore’s Game Plan for Scaling COVID-19 Testing”
As the full scale of the pandemic makes its way around the country, one of the nation’s top laboratory experts discusses how Chicago-area NorthShore University HealthSystem is preparing. Part 2 of a two-part series. (Published April 1, 2020)
“Harmonization in the Fast Lane? COVID-19 Could Accelerate Medtech Regulatory Convergence”
If this global pandemic is not a shot in the arm to medtech regulatory convergence efforts, then what will be? Kim Trautman, the longtime global policy leader at FDA and IMDRF, who spearheaded the Medical Device Single Audit Program, is optimistic. Previous harmonization progress has supported the ongoing COVID-19 response, she tells Market Pathways, and it could serve as a catalyst for future success toward, among other things, a global single review program. (Published May 22, 2020)
“The First Wave: One Company’s Maiden Journey Through the MDR”
Hearing implant maker MED-EL is one of a select few firms that have already gained CE marks under the EU Medical Device Regulation. Here is how they did it. (Published July 16, 2020)
“Medicare’s Breakthrough Coverage Proposal: Innovation, Evidence, and the Valley of Death”
CMS’ proposal for setting out an automatic coverage pathway for FDA-designated Breakthrough Devices seeks to address the period when medtech firms say innovative new devices are most vulnerable to failure. It also raises questions about the best approach to ensuring robust, long-term evidence collection for these new products that still have something to prove. (Published September 18, 2020)
“A Venture Capitalist Goes to Washington: Doug Kelly’s FDA Awakening”
Doug Kelly has spent decades investing in and founding new medtech companies, viewing FDA as more of a barrier than an accelerator to innovation. But his career recently took an unexpected turn—Kelly is CDRH’s new deputy director for science. He says the role offers a chance to help improve the medtech ecosystem, making it a place where more investors want to play. So far, Kelly tells Market Pathways, the job is going very well: “The people at FDA are amazing." (Published October 26, 2020)
“Digital Diagnostics’ Autonomous AI Technology Clearing Reimbursement and Payor Hurdles”
The company’s autonomous AI diabetic retinopathy diagnostic system has received a CMS proposed coverage rule that goes into effect January 1. It is now working toward a fair, cost-saving reimbursement rate, and to rigorously validate its precedent-setting technology. (Published November 9, 2020)