Medical Design and Outsourcing Archives - Page 81 of 154

How Johnson & Johnson’s DePuy Synthes is shifting toward digital

Johnson & Johnson is increasingly digitizing in the medical device space, with the company even recently rebranding the business to Johnson & Johnson MedTech to reflect the shift.

Many medtech companies have embraced the trend. It’s all about providing software, knowledge and insights to boost healthcare outcomes and hopefully help the system operate more efficiently — versus simply providing devices.

Not only is J&J transforming in-house, but it’s engaging in M&A to boost its offerings. MedTech’s EVP Ashley McEvoy said during the company’s Q1 earnings call: “We’re going to continue to do tuck-ins and to really digitize the patient experience.”

Come to DeviceTalks Boston, May 10-11, 2022, and hear a panel of top officials from J&J’s DePuy Synthes discuss how the company is evolving.

They’ll discuss how DePuy Synthes is changing its product development process, setting up a s…

How Insulet created its next-gen Omnipod 5

Insulet (NSDQ:PODD) added to its portfolio of life-changing diabetes management technologies when its Omnipod 5 received FDA clearance in January.

Omnipod 5 provides easier glucose management, with no multiple daily injections, no tubes and zero fingersticks. Paired with Dexcom’s G6 continuous glucose monitoring (CGM) system, Omnipod 5 is the first tubeless, wearable, automated insulin delivery system. Users can use a dedicated handheld controller or control the system with a secure app on their smartphone, marking another first.

Join us at DeviceTalks Boston on May 10-11, 2022, for a keynote interview with Insulet CEO Shacey Petrovic to learn about the story behind the game-changing Omnipod 5.

DeviceTalks Boston will unite medtech’s most innovative professionals and help attendees clear troublesome bottlenecks in the critical stages of medical device development. We will explore the trends and technology that are shaping the future of the medical device…

50 of 2021’s best-selling pharmaceuticals

Drug sales in 2021 hit record heights, with a handful of pharmaceutical companies handsomely rewarded for creating COVID-19 vaccines and treatments.

Pfizer alone raked in $36.9 billion in sales from the Comirnaty vaccine it developed jointly with BioNTech. Demand for the COVID-19 vaccine helped catapult Pfizer to be 2021’s top pharmaceutical company. Continued demand for the Pfizer-BioNTech vaccine is likely to keep Pfizer as the biggest pharma firm of 2022 as well. (Look out for more insights from our annual Pharma 50 report.)

The second-best-selling drug of 2021 was AbbVie’s injectable biologic Humira, which generated $20.7 billion in sales. Next in line was Moderna’s COVID-19 vaccine, which drove $17.7 billion in revenue. Merck’s megablockbuster Keytruda rounded out the top four with $17.2 billion in revenue.

Novartis and Roche have struggled to commercialize COVID-19 therapies, although the latter has introduced a series of SARS-CoV-2 diagnostics. T…

FDA approves GE Healthcare software that automates anesthesia, reduces greenhouse gas emissions during surgery

GE Healthcare recently announced that it received FDA premarket approval for its End-tidal (Et) Control software for general anesthesia delivery.

The software is cleared for use with GE Healthcare’s Aisys CS2 anesthesia delivery system. The Chicago-based company initially released the technology in Europe in 2010 and is currently used in over 100 countries.

Et Control software semi-automates the delivery of anesthesia using software to allow anesthesia providers to set targets for end-tidal oxygen and anesthetic agent, according to the company. The software quickly achieves and maintains set targets and improves anesthesia delivery accuracy while simplifying the workflow and reducing drug waste.

“In the past, we continually adjusted vaporizer setting and fresh gas flow to control inspired concentration in an attempt to achieve and maintain the end-tidal concentration we wanted for our patients. To have direct control of the end-tidal concentration …

Where are LVADs headed in the future?

The HeartMate 3 LVAD. [Image courtesy of LVAD]

Abbott (NYSE:ABT) became the dominant provider of left ventricular assist devices (LVADs) after Medtronic’s decision to leave the market last year.

The Abbott HeartMate 3‘s advantages include its Full MagLev flow technology — which involves a free-floating magnetically levitated rotor that prevents surface-to-surface contact that could cause blood trauma. In addition, system batteries provide up to 17 hours of uninterrupted power, and the LVAD’s creators designed the system’s HeartMate Touch communications system to be intuitive and user-friendly.

Join us at DeviceTalks Boston on May 10-11, 2022, and find out where top Abbott officials would like to take LVADs next to better sustain heart failure patients’ lives.

Abbott officials on the panel include Chris Cotter, principal R&D engineer, Chad Dague, staff systems engi…

Sanolla’s smart infrasound stethoscope wins FDA clearance

The startup Sanolla has won 510(k) clearance for the clinical use of the VoqX stethoscope. The device is reportedly the first to capture infrasound, which is below the range of human audibility. The infrasound spectrum of 3–40Hz contains diagnostic information overlooked by traditional stethoscopes.

The technology recently won approval from the Israeli Health Ministry.

The Nesher, Israel–based startup has developed AI algorithms for the stethoscope that can classify common cardiopulmonary diseases such as COPD, pneumonia, asthma and cardiac morbidities.

The device has won eight patents to date. To date, the company has submitted 20 patents for the stethoscope technology.

The company also seeks regulatory authorization for VoqX-based AI algorithms for disease classification. The algorithms will be uploaded to the device after regulatory authorization.

Photo by Tiko Product Design Studio<…

Ariste Medical co-founder sees great potential for drug-coated implants and orthopedics

Lisa Jennings [Photo courtesy of Ariste Medical]

It’s been more than a decade since Lisa Jennings launched not one but two companies in the Great Recession.

In 2020, she sold CirQuest Labs to MLM Medical Labs, where Jennings serves as chief scientific officer and managing director of U.S. operations.

More recently, her pre-commercial medtech development startup, Ariste Medical, won FDA 510(k) approval for its antibiotic-coated hernia mesh in March.

You can expect more to come from that technology, Jennings told Medical Design & Outsourcing in an interview covering future applications, the drug-device development process and what she’s learned through it all.

“We hope this encourages thinking about more ways of mitigating complications with implantable devices,” Jennings said. “There are so many possibilities out there, new drugs being developed all the time…

MDO wins honors from American Society of Business Publication Editors

Judges reviewed the March and May 2021 editions of Medical Design & Outsourcing before awarding the publication with a design award. [Cover designs by Matt Claney/MDO]

Medical Design & Outsourcing received awards for design and content at the American Society of Business Publication Editors’ 2022 Azbee Awards of Excellence yesterday.

The annual awards program honors outstanding work by U.S.-based business-to-business, trade, association and professional publications, including magazines, websites, email newsletters, social media and blogs. The organization calls its awards program “one of the most competitive” in publishing.

Art Director Matt Claney won a regional silver award for magazine design and was a national finalist. Judges considered the March 2021 and May 2021 editions of MDO.

“MDO showcases the ability to cover everything from hot topics such as post-COVI…

Corindus opens new HQ; take a photo tour of the facility

The new Corindus headquarters has a cleanroom that is three times larger than the previous headquarters. [Photo courtesy of Corindus]

Corindus announced the opening of its new headquarters this week, moving to Newton, Massachusetts, for a space that’s more than twice as big.

The precision vascular robotics developer’s new facility totals 77,000 ft², compared to 35,000 ft² in the former headquarters in Walham, Massachusetts.

The production area alone is tripling in size to 25,000 ft² and was designed to facilitate the flow of materials through the building. The 6,000 ft² R&D space is also three times larger than the previous headquarters, including a dedicated lab for remote robotic R&D activities and a model shop for quicker prototype machining and shorter development timelines.

The new headquarters will also serve as the global Center of Excellence for Siemens Healthineers end…

How medtech is tackling supply chain challenges

A host of medical device companies with manufacturing in Puerto Rico found their supply chains impacted by Hurricane Maria in 2017. It was a harbinger of what was to come. [Image is public domain]

Join us at DeviceTalks Boston on May 10-11 to hear how medical device companies are propping open supply lines and ensuring a steady flow of products to customers in a constantly changing world.

Sharing best practices is more important than ever because supply chain challenges aren’t expected to diminish post-pandemic. That’s because superstorms, fires, droughts and other extreme events driven by climate change are already straining the industry’s supply chain — and it could get a lot worse.

(Go to DeviceTalks Boston’s site to register!)

Over the two-day meeting we’ll hear how companies large and small are adapting to new demands, including:

How Viant and Vapotherm combined forces to meet unforesee…

What is the future of cardiac ablation?

Boston Scientific in July 2021 exercised its option to acquire the remaining shares of PFA tech developer Farapulse. [Image courtesy of Boston Scientific]

Pulsed-field ablation (PFA) — a non-thermal method for cardiac ablation — has the potential to positively disrupt the atrial fibrillation market.

Amid the excitement around the technology, Medtronic announced in January that it would acquire cardiac mapping and ablation technology developer Affera for nearly $1 billion. Meanwhile, Boston Scientific in February closed its $1.75 billion acquisition of Baylis Medical — the creator of advanced transseptal puncture platforms to enhance safety, efficacy and efficiency when crossing the atrial septum to deliver therapies in the left side of the heart. Months before, Boston Scientific exercised its option to acquire the remaining shares of PFA tech developer Farapulse.

Come to DeviceTalks Boston — May 10-11, 2…

How to pass the patent eligibility test for Software as a Medical Device

Kathleen Daley is a partner at Finnegan, Henderson, Farabow, Garrett & Dunner. [Photo courtesy of Finnegan]

There’s “significantly more” to it than a good idea for an SaMD algorithm.

Kathleen Daley, Angeline Premraj and Jason Zhang, Finnegan

Technology continues to change the practice of healthcare, and one area where this has become evident is the increasing prevalence of software aimed at healthcare applications. This can include software that is integral to a medical device, software used in the manufacture or maintenance of a medical device, or software that is itself the medical device, also known as Software as a Medical Device (SaMD).

SaMD is an area of tremendous growth in the medical healthcare field. However, there is still significant unpredictability in the patent eligibility of SaMDs. This article provides an overview of the challenges facing the patent eligibility of SaMDs and…