Medical Design and Outsourcing Archives

The Critical Role of Partnerships in Medical Device Development

Key considerations for OEMs in medical device design and manufacturing.

‘Miniature is big’: How Virtual Incision designed the small but mighty MIRA surgical robot — and then shrank it again for space

The Virtual Incision MIRA Surgical System’s design was small to start with — and then came an opportunity to test aboard the International Space Station.

Virtual Incision’s MIRA (Miniaturized In Vivo Robotic Assistant) Surgical System [Photo courtesy of Virtual Incision]

In conversations with Medical Design & Outsourcing, surgical robotics developers often say they try to use as many off-the-shelf components as possible.

That wasn’t possible for the MIRA (Miniaturized In Vivo Robotic Assistant) Surgical System, Virtual Incision co-founder and Chief Technology Officer Shane Farritor said.

“Everything in our device is quite custom … from scratch, bespoke,” he said in an interview. “… Our robot’s different than everyone else, because it’s miniature, and we think miniature is big.”

Virtual Incision’s MIRA won FDA de novo class…

Cobalt Polymers partners with HnG Medical for tubing distribution

NEWS RELEASE: Cobalt Polymers Announces Partnership with HnG Medical

Distribution agreement to expand customer access to heat shrink tubing in Asia

HEALDSBURG, Calif. —Cobalt Polymers, a leading manufacturer of heat shrink tubing for the medical device industry, recently announced an exclusive, multi-year agreement with HnG Medical Inc. to distribute its tubing products in Asia. The agreement will allow Cobalt to better serve its OEM customers in Asia with local representation and local access to tubing samples and inventory.

HnG Medical represents U.S. and European component suppliers and equipment manufacturers to many top-tier medical device manufacturers in Asian markets, leveraging local languages and market understanding to provide marketing, sales, customer service and technical support. HnG will represent Cobalt Polymers in China, Malaysia, Singapore, South Korea, Taiwan, Thailand and Vietnam.

“This partnership is a natural next step i…

First look: Medtronic’s Sphere-360 pulsed field ablation catheter design has some new tricks

The investigational Medtronic Sphere-360 pulsed field ablation and mapping catheter uses nitinol for a feature that’s unique within Medtronic’s PFA device portfolio.

The Medtronic Sphere-360 pulsed field ablation catheter is adjustable, allowing it to take different shapes inside a patient. [Illustration courtesy of Medtronic]

Medtronic recently offered a first look at its Sphere-360 pulsed field ablation (PFA) and mapping catheter, an investigational device with some design features that are new for the world’s largest device manufacturer.

In an interview with Medical Design & Outsourcing, Tim Laske, VP of research and business development for Medtronic Cardiac Ablation Solutions, discussed the Sphere-360’s design and features.

The large-lattice, over-the-wire PFA Sphere-360 catheter — which Medtronic purchased through its acquisition of Affera — is investigational in the EU …

CroíValve’s Duo takes a unique approach for treating tricuspid regurgitation

The Duo tricuspid valve device [Image courtesy of CroíValve]

CroíValve is making inroads in the tricuspid regurgitation (TR) treatment market currently occupied by Abbott and Edwards.

In February 2024, Edwards’ Evoque tricuspid valve became the first TR treatment to win FDA approval, followed by Abbott’s TriClip transcatheter edge-to-edge repair (TEER) system in April.

Edwards designed its device to replace the native heart valve, while Abbott designed its TEER system to repair it.

CroíValve’s investigational Duo tricuspid coaptation valve system is different, with an approach that CEO Lucy O’Keeffe calls “the best of both worlds.”

O’Keeffe, who comes from an engineering background, was working on early TAVR programs at Medtronic when she met CroíValve co-founder Dr. Martin Quinn, the cardiologist who placed the first transcatheter aortic valve replacement (TAVR) implant in Ireland.<…

May 2024 edition: Intuitive’s DV5, pediatric device design and diabetes tech

The Intuitive da Vinci 5’s top design changes: ‘This is groundbreaking for robotic surgery’ Small patients, big design challenges: Pediatric device experts guide engineers on solutions The biggest diabetes tech news out of ATTD 2024 5 things that will shape surgical robotics over the next decade All eyes on Intuitive’s da Vinci 5

It’s hard to think of a product update with higher stakes for a device developer — and the medtech industry — than Intuitive Surgical’s da Vinci 5 robotic-assisted surgery system.

All eyes are on the world’s leading surgical robotics developer as it rolls out the next generation of its flagship system after winning FDA clearance. Will the new features and long list of design changes put even more distance between surgical robotics and conventional laparoscopy? Is Intuitive advancing its technology rapidly enough to maintain or expand its lead ahead of larger device manufacturers, maturing surgical robotics developers and fas…

Tips on Bluetooth, batteries and Apple vs. Android from Eko Health co-founder and CEO Connor Landgraf

Eko Health’s Core 5000 digital stethoscope has a rechargeable lithium-ion battery that lasts up to 300 minutes of continuous use, or up to 60 hours of regular clinical use. The stethoscope uses Bluetooth 4.2 low-energyand offers a wireless listening option. [Photo courtesy of Eko Health]

Eko Health has learned a bit about batteries and Bluetooth while developing AI-powered medical devices to help physicians detect cardiovascular disease.

Eko Health’s devices include hardware — in the form of its Duo and Core digital stethoscopes — and algorithms that analyze the acoustic and electrocardiogram (ECG) signals collected by those handheld devices. Together, their hardware and software is cleared by the FDA to detect heart murmurs, atrial fibrillation (AFib) and signs of low left ventricular ejection fraction.

Related: How Eko Health’s AI-powered stethoscope detects early signs of heart failure

…

Plastics industry veterans launch Polymer Medical

NEWS RELEASE: Plastics industry vets launch Polymer Medical in Western New York

ORCHARD PARK, N.Y. – Plastics industry veterans Benjamin Harp and Tom Rybicki have launched Polymer Medical Inc. to provide healthcare and biosciences clients with contract injection-molding and assembly services. The new company’s focus will be producing critical drug-delivery systems, medical disposables like syringes, medical devices for home healthcare to orthopedics, specialty packaging, and pharmaceutical disposables among other services. Harp and Rybicki each have decades of experience founding and operating plastics industry manufacturers for healthcare, pharmaceuticals, and nutraceuticals.

“There’s a rising demand for medical devices partly because of changes in demographics and approaches to home healthcare; the time is right for a new entrant like Polymer Medical,” says Harp, president of Polymer Medical. “Our knowledge of the…

Zeus hires first chief technology officer

Zeus Chief Technology Officer Suresh Sainath [Photo courtesy of Zeus]

Zeus today announced it hired Suresh Sainath as chief technology officer, effective immediately.

The chief technology officer position is newly created. Sainath will lead the Orangeburg, S.C.-based polymer extrusion and catheter manufacturing company’s efforts to accelerate innovation and leverage the advanced capabilities of its component and contract manufacturing platforms.

“We are making significant investments in research and development, and it’s exciting to have one of the industry’s top innovators lead us into the future,” Zeus CEO Paddy O’Brien said in a news release. “Suresh has a wealth of experience and expertise across med device design, emerging technologies, and developing next-gen catheter solutions. I’m confident his leadership over R&D will further strengthen our commitment to innovation and excellence and reinfor…

New features of updated Medtronic GI Genius include room for third-party SaMD developers

Medtronic Endoscopy Chief Artificial Intelligence Officer Ha Hong discusses new GI Genius features, design improvements and how other device developers can jump aboard.

Medtronic Endoscopy Chief AI Officer Ha Hong [Photo by Hardy Wilson for Medical Design & Outsourcing]

The latest version of the AI-powered Medtronic GI Genius system for colonoscopy is smarter, more helpful, and has room for third-party apps developed by other devicemakers.

Those third-party software-as-a-medical-device (SaMD) apps “could be anything,” Medtronic Endoscopy Chief Artificial Intelligence Officer Ha Hong said in an interview with Medical Design & Outsourcing.

“The beauty of the GI Genius system is that it’s already been deployed by thousands of hospitals worldwide,” he said. “And as long as the hospital has the system already, the third-party application developers will be able to t…

Gamma brain waves might prevent cognitive effects of chemotherapy

Caption:A noninvasive treatment may help to counter “chemo brain” impairment often seen in chemotherapy patients: Exposure to light and sound with a frequency of 40 hertz protected brain cells from chemotherapy-induced damage in mice, MIT researchers found.[Image courtesy of Christine Daniloff, MIT; iStock]

MIT researchers say a noninvasive treatment could stimulate gamma frequency brain waves and potentially help treat chemo brain.

In a study of mice, the researchers delivered daily exposure to light and sound with a frequency of 40 hertz. They found that this protected brain cells from chemotherapy-induced damage — also called chemo brain. The treatment also helped to prevent memory loss and the impairment of other cognitive functions.

Originally developed as a way to treat Alzheimer’s disease, the team at MIT says this treatment could have more widespread effects capable of helping with a range …

Power tips for designing pulsed field ablation systems

An engineer develops the pulsed waveform output for a PFA system. [Photo courtesy of Minnetronix Medical]

An engineer experienced with radiofrequency (RF) ablation systems might wonder what all the fuss is about when looking at the design of a pulsed field ablation (PFA) system.

Compared to an RF ablation generator, a PFA generator is going to look much less complicated, perhaps with only a tenth as many parts. But the seemingly simpler schematics can be deceiving.

“The difference is that in a PFA power supply, the way that those components are being used is just so different, and they’re being stressed to the limits of what their ratings are in a way that just isn’t obvious to most engineers,” said Dan Friedrichs, an engineer at Minnetronix Medical. “… There’s more complexity than meets the eye.”

Friedrichs leads development engineering efforts at M…