Medical Design and Outsourcing Archives - Page 116 of 154

Medicine-saving Nanodropper makes history in Minnesota Cup win

The Nanodropper [Photo courtesy of Nanodropper]

The Minnesota Cup has awarded its grand prize for innovative entrepreneurs to a student-led startup for the first time.

Medical device developer Nanodropper took home top honors from the awards ceremony, held yesterday at the University of Minnesota.

“We have created an eyedrop bottle adaptor that will save billions in medication waste, one drop at a time,” Nanodropper CEO Allisa Song said.

Song, an MD candidate at the Mayo Clinic Alix School of Medicine in Rochester, Minnesota, launched the company with three other founders after learning that drug companies make eye drops too large to be fully absorbed, and that smaller drops are more efficient and just as efficacious.

Nanodropper CEO Allisa Song [Photo courtesy of Nanodropper]

Rochester-based Nanodropper reduces drop size from 40 mic…

Medtronic’s Hugo team ‘waiting for the phone call’ for approval in Europe

Medtronic’s Hugo robot-assisted surgery system [Image courtesy of Medtronic]

It sounds like European approval of Medtronic’s soft tissue robotically-assisted surgery system, Hugo, could come any day now.

“We’re sitting at the tip of our chair waiting for the phone call that the product will be approved,” Medtronic EVP and EMEA President Rob ten Hoedt said Friday.

Fridley, Minnesota-based Medtronic (NYSE:MDT) filed for European approval in March, starting a process that takes about six to nine months. Medtronic’s now “in shooting range,” ten Hoedt said.

“The launch is going very, very well and it’s now waiting for the approval to come along,” he said.

Medtronic has requested initial European approval for gynecology and urology procedures (estimated by ten Hoedt as about 54 percent of the market), likely followed by requests for abdominal and colorectal procedures, approvals that would take a…

Ivy Brain Tumor Center sees promise in sonodynamic therapy for glioblastoma

Ivy Brain Tumor Center and its partner Sonalasense have announced positive initial results in a first-in-human Phase 0/1 clinical trial involving recurrent glioblastoma patients.

Sonalasense has developed a noninvasive sonodynamic therapy (SDT) that pairs low-intensity ultrasound with chemotherapeutic agents known as sonosensitizers. The therapy is noninvasive.

Data from the trial indicate that SDT swiftly causes targeted oxidative stress and cell death in human glioblastoma tissue. In addition, the therapy was well tolerated in the study.

Get the full story from our sister site, Drug Discovery & Development.

Former Theranos scientist testifies to blood test inaccuracies prior to Walgreens deal in Elizabeth Holmes trial

Former Theranos CEO Elizabeth Holmes leaves after a hearing at a federal court in San Jose, Calif., on July 17, 2019. [Image courtesy of Reuters/Stephen Lam]

A former Theranos scientist testified on the inaccuracies of the company’s device during Elizabeth Holmes’ federal fraud trial.

Surekha Gangakhedhar worked at Theranos from 2005 to 2013 and reported directly to Holmes at one point. She testified on Friday that Holmes allegedly pressured her to validate blood test results to speed up a rollout of the Edison device to several Walgreens locations despite its inaccuracies, CNBC reports.

Gangakhedkar said that she returned from a vacation in August 2013 to discover that the company was on track to launch the Edison 3.0 and 3.5 in Walgreens stores. She resigned from the company the following month because she was uncomfortable with the pending launch and plans to test patient blood samples. Gangakhedkar m…

Medtronic, Johnson & Johnson warn of hospital worker burnout headwind for medical devices

[Photo by Eugene Chystiakov]

Medical device manufacturers are worried that the COVID-19 pandemic’s latest wave will make for a tougher recovery in elective procedures after Delta variant cases subside.

Top officials from Medtronic (NYSE:MDT), Johnson & Johnson (NYSE:JNJ), NuVasive (NASDAQ: NUVA) and Zimmer Biomet Holdings (NYSE:ZBH) warned investors that the highly contagious COVID-19 mutation filling U.S. hospitals with mostly unvaccinated patients is leaving a lasting mark on the healthcare workers who will be needed to catch up on routine procedures.

Johnson & Johnson’s hardest-hit business in the pandemic is its Medical Devices line, which faces another slowdown from elective procedures delayed again due to the Delta wave. But a looming shortage of hospital system workers is “a little bit of a new dynamic” facing the business, J&J CFO Joseph Wolk said Wednesday at the Morgan Stanley Globa…

Medline inks a strategic partnership with Arnot Health

Medline announced that it has forged a $40 million prime vendor partnership with New York-based Arnot Health.

As the system’s primary supplier, Medline will exclusively provide an extensive portfolio of medical supplies and services to three diverse healthcare campuses across the southern tier of New York, the company said yesterday. The two organizations will identify new strategies for enhancing patient outcomes and streamlining supply chain operations.

“Care is evolving and so should our approach to ensuring we are not looking solely at cost but overall value and impact,” Susan Houghtelling, system director of supply chain at Arnot Health, said in a news release. “Working with Medline allows us to leverage their entire scope of expertise in the areas of supply chain logistics and clinical solutions, as well as their proactive hands-on approach, to ultimately help improve our operating performance.”

GE warns of supply chain strain well into 2022

GE CEO Larry Culp [Photo courtesy of GE]

Medical device makers and suppliers seeking relief from the global semiconductor shortage will have to hold on a while longer.

GE (NYSE:GE) is warning investors that supply and labor shortages are squeezing its Healthcare business this quarter, and that the pressure won’t likely let up in 2021.

GE’s Healthcare business “largely is a supply chain story right now,” GE Chair and CEO Larry Culp said this week, specifically citing semiconductors, resin and logistics as supply chain barriers to meeting “strong, if not robust” demand.

“It has been a bit of a whack-a-mole game in making sure we’ve got what we need to fulfill demand at the levels we’d like to. … We’re really engaging that challenge on a daily basis,” he said Tuesday at the Morgan Stanley Laguna Conference.

The Boston-based conglomerate recently warned those supply constraints “may impac…

Theranos whistleblower testifies to blood analyzer inaccuracies in Elizabeth Holmes fraud trial

Former Theranos CEO Elizabeth Holmes leaves after a hearing at a federal court in San Jose, Calif., on July 17, 2019. [Image courtesy of Reuters/Stephen Lam]

One of Theranos’ whistleblowers testified on the inaccuracies in the blood analyzers that Theranos had touted to investors on the third day of Elizabeth Holmes’ federal fraud trial.

Erika Cheung, a former Theranos lab associate, testified yesterday that the machines the company was using to conduct patient blood tests had inaccuracies of quality control test results that would result in inaccurate patient tests, Silicon Valley News reports. She said that some 30% of prostate cancer tests were inaccurate and thyroid tests returned with a failure rate of more than 50%.

Cheung claimed that Theranos would throw out outlier data points to get the tests to pass quality control checks, The Washington Post reports. She said choosing those outliers was like …

CMS aborts launch of MCIT payment program for breakthrough devices

CMS intends to kill the Medicare Coverage of Innovative Technology (MCIT) program that would have accelerated government payments for medical devices designated by the FDA as breakthroughs.

CMS (the U.S. Centers for Medicare & Medicaid Services) disclosed its proposal in the Federal Registrar on Wednesday — three months before the rule was set to take effect on Dec. 15 — saying the rule “is not in the best interest of Medicare beneficiaries.”

CMS created the MCIT pathway in the last days of the Trump Administration, and it was among a host of regulations the Biden Administration immediately put on hold for further consideration.

“While the rule tried to address stakeholder concerns about accelerating coverage of new devices, significant concerns persist about the availability of clinical evidence on Breakthrough Devices when used in the Medicare population as well as the benefit or risks of these devices with respect to use in the Medicare population…

One of FDA’s top lawyers leaves to join Greenberg Traurig

James C. Fraser, Greenberg Traurig

Greenberg Traurig recently announced that James C. Fraser, a former associate chief counsel for litigation at the FDA, has joined its Litigation and Health Care & FDA practices in Washington, D.C.

Fraser left FDA in August. He has more than 16 years of experience in life sciences litigation and most recently worked in conjunction with the U.S. Department of Justice representing the FDA in civil litigation throughout the United States.

Robert P. Charrow recently returned to Greenberg Traurig as senior chair of the firm’s Health Care & FDA Practice after a stint as HHS general counsel.

“Having worked with Jim for several years, I am certain that his significant ability to successfully litigate complex matters concerning pharmaceuticals, medical devices, and other FDA-regulated products is of tremendous value to our clients,” Charrow said in a news…

September 2021 Issue: Our latest Medical Device Handbook is out!

Making medical devices: Everything you need to know

The innovation-fueled evolution of drug eluting stents

Dexcom CEO Kevin Sayer says G7 will be ‘wonderful’

Getting the inside scoop behind top medtech innovations

Autumn is upon us, and it is once again time to sip a pumpkin spice latte — or a pumpkin beer — and crack open our latest Medical Device Handbook.

Once again, we’ve reached out to experts across the industry to curate dozens of “what is” and “how to” types of articles that cover a breadth of categories: components, drug delivery, manufacturing and machining, materials, product design and development, regulatory, software, sterilization services and tubing.

As the years go by, I’m proud that we’re including more insights from the major medical device companies in each succeeding issue. This time around, we spoke to experts involved in some of the major industry innovations of the past decade:

Now VP of R&D …

Steris launches two new vaporized hydrogen peroxide biodecontamination systems

The VHP 100i (left) and 1000i (right) systems [Image courtesy of Steris]

Steris has launched the next generation of its vaporized hydrogen peroxide (VHP) biodecontamination systems to achieve 6-log bioburden reduction in good-manufacturing-practice pharmaceutical, medical device and research environments.

It’s possible to integrate the new VHP 100i and 1000i systems into a facility’s building automation and HVAC systems, running a decontamination cycle at programmed intervals or at the push of a button. The result, according to Steris, is easy and frequent decontamination of rooms, isolators, filling lines, RABs, pass-through chambers and more.

“The new VHP systems incorporate input received at thousands of VHP customer sites on five continents,” said Andrea Conroy, VP of marketing for Life Science Equipment and Service at Steris, said in a Sept. 9 news release. “They are engineered to streamline t…