Stryker Archives - Page 4 of 18 - Medical Design Sourcing

Stryker launches Ortho Q fully autonomous guidance system

The Ortho Q guidance system with Ortho Guidance software. [Image courtesy of Stryker]Stryker (NYSE: SYK) + announced today that it launched its Ortho Q guidance system.

Kalamazoo, Michigan-based Stryker says Ortho Q is the only fully autonomous system in the industry. Surgeons can easily control the platform from the sterile field. It combines new optical tracking options through a redesigned, state-of-the-art camera.

According to a news release, Ortho Q features sophisticated algorithms as part of the new software. This helps to deliver additional surgical planning and guidance capabilities. Ortho Q serves as a planning intraoperative guidance system for the Express Knee, Precision Knee and Versatile Hip offerings. Stryker said it enhances procedural speed and efficiency through a smart, streamlined workflow.

Ortho Q features a robotics-ready platform with dual PCs and a quick-refresh camera. Its implant-agnostic …

July 2023 edition: Life-saving LVADs, supplier innovations and AI breakthroughs

LVADs save lives: So why aren’t more available?

What’s new in 3D printing: medical devices, research, innovation, automation and partnerships

AI breakthroughs in medtech: 7 ways to enhance healthcare

Life-saving LVADs, supplier innovations and AI breakthroughs

Kyree Miller recalls the day his heart stopped beating.

“I remember the entire room going white,” he said. “And I actually turned over on my side and I said, ‘Tell my mom I love her.’”

A couple of weeks later, the heart failure patient — who was only in his 20s at the time — received his first left ventricular assist device (LVAD) implant while he waited for a heart transplant. One year passed, then two, then three. Finally, after surviving on LVAD technology for seven years, his new heart came.

“When you get your transplant, there’s a whole new energy that you get. … But I can honestly say there was a whole new energy that I got when I had my LVAD,” Miller said.

…

CAPA doesn’t have to be a four-letter word, Medtronic Quality/Regulatory Director Kathryn Merrill says

[Illustration by Vitalii Vodolazskyi via Adobe Stock]

Medtronic Quality/Regulatory Program Director Kathryn Merrill is a problem-solver’s problem solver.

Right now, the problem she wants to solve is the way device manufacturers approach corrective and preventative actions — CAPA, an abbreviation that can trigger an avalanche of documentation and headaches for medtech engineers.

For five years, Merrill’s been part of a Medical Device Innovation Consortium (MDIC) team developing a new approach to CAPA, stemming out of conversations across the medtech industry and beyond. The goal was to implement improvements in months instead of years and allow teams to be more proactive.

“I’ve been at Medtronic for 26 years and very often we’d say, ‘Hey, I think we’re making this more complicated than it needs to be,'” said Merrill, who is lead co-author of MDIC̵…

Artificial intelligence: What medtech’s top influencers think

Artificial intelligence’s effect on medtech was a question that came up continually during our DeviceTalks Boston show in early May.

Here is what some of the top influencers in the industry had to say:

Boston Scientific CEO Mike Mahoney [Photo courtesy of Boston Scientific]

Boston Scientific CEO Mike Mahoney on artificial intelligence and medtech

“I’ll give you some practical applications. … We have manufacturing plants around the world, and we have great quality systems, and we have great quality engineers who inspect everything, and we have a zillion microscopes looking at every little product that we have all over the world. Our team is leveraging AI capabilities for visualization inspection rather than the human eye constantly doing that with the mistakes that are inherent and scrapping products and so forth. … We’re seeing cost productivity and better quality by just leveraging AI in our…

FDA removes products from medical device shortage list, reports AED discontinuation

The FDA removed several products from its medical device shortages list and expects the shortage of prefilled saline flush syringes to end soon.

The agency also said Stryker is discontinuing certain automatic external defibrillators (AEDs), a product category for which manufacturers have faced heightened regulatory scrutiny in recent years.

Previously: FDA’s mandatory medical device shortage reporting ends

Relief in sight for prefilled saline flush syringe shortage

Prefilled 0.9% sodium chloride intravenous lock/flush syringes have been in short supply since at least March 2022 due to increased demand. At the same time, supply chain challenges and manufacturing discontinuances have reduced product availability.

These single-use syringes help to prevent blockage of vascular access systems and remove residual medication from the catheter site.

The FDA estimates the prefilled saline flush syringe shortage will end in October 2023. Until then, …

New ethylene oxide rules could trigger sterilization consolidation — and new options

Firefighters training on a simulated ethylene oxide leak [Photo via Adobe Stock]

The largest commercial sterilizers will likely absorb the costs of new ethylene oxide (EtO) regulations — and could consolidate smaller competitors, according to a new analysis from Moody’s Investors Services.

Tighter controls on EtO emissions would increase capital spending and operating costs for all commercial sterilizers who use the toxic gas, which is the most commonly used method for eliminating infection-causing microbes from medical devices.

“Large companies have enough liquidity to fund the significant increase in spending without incremental debt,” Moody’s said in a subscribers-only report this week. “But the higher costs and compliance requirements could make the business less attractive for some small companies.”

The largest commercial sterilizers can absorb the cost of new…

They said it at DeviceTalks Boston 2023

Medical device industry leaders from Boston Scientific, Abbott, ZimVie, Medtronic, Stryker and more met at DeviceTalks Boston to share lessons learned and their perspectives on industry trends, device design and medtech innovation.

BD Chair, CEO and President Tom Polen (right) at DeviceTalks Boston with DeviceTalks Editorial Director Tom Salemi [Photo by Jeff Pinette for Medical Design & Outsourcing]

Bidding farewell to DeviceTalks Boston 2023, we look back at an exceptional two-day medical device conference teeming with insights from over 100 top industry leaders.

These experts unfolded many complexities of the medtech industry in more than 35 sessions, walking attendees from the medical device product development continuum through the latest medical innovations and strategies to tackle regulatory challenges, prototyping, manufacturing, product launches and more.

Between the high-profile keynote int…

What’s new in 3D printing: medical devices, research, innovation, automation and partnerships

This 3D-printed robotic heart can simulate how a specific cardiac patient will benefit from different valve implants.[Image courtesy of Melanie Gonick/MIT]

3D printing is helping more patients than ever before through personalized medical devices, faster and cheaper prototyping and more affordable manufacturing.

Recent developments include research into tissue and organ regeneration, lightning-fast responses to supply chain shortages, wearables that improve patient treatment, and major investments by device manufacturers.

Here are some of the 3D printing advances that show what the future may hold.

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Stryker announces first completed cases with brain surgery guidance platform

The Q Guidance system for cranial applications. [Image courtesy of Stryker]Stryker (NYSE:SYK) announced today that surgeons began early product surveillance cases for its Q Guidance system with cranial guidance software.

Kalamazoo, Michigan-based Stryker designed the Q Guidance System as an image-based planning and intraoperative platform. The company launched the system for spinal applications in September 2022. This latest iteration offers support for cranial surgeries. Stryker received FDA clearance for it in February.

The technology provides surgeons with image-based planning and an intraoperative guidance system to support cranial surgeries. Its uses include intraoperative guidance where a reference to a rigid anatomical structure can be identified. The system tracks navigated instruments and displays the position and orientation of instruments in patient images.

Dr. Melvin Field is one of the first surgeons to bring the system to the OR. He serves as …

Surgical robotics trends and how to accelerate adoption

Moon Surgical Chief Strategy Officer Jeffery Alvarez. [Photo courtesy of Moon Surgical]

Some of the biggest names in the development of surgical robotics systems and virtual reality training technology discussed robotic surgery trends at DeviceTalks Boston.

Moon Surgical Chief Strategy Officer Jeffery Alvarez, Stryker Digital, Robotics, and Enabling Technologies President Robert Cohen, Osso VR CEO Justin Barad and FundamentalVR CEO and co-founder Richard Vincent see rapid changes ahead for surgical robotics and opportunities to win over surgeons, health systems and patients.

We’ve curated excerpts from the conversation, lightly edited for clarity and space.

Trends in surgical robotics

Alvarez: “There’s a transition from building robots that are hyper-specialized in one thing and do one thing really well, to platforms that are looking at how to solve bigger parts of the problem: H…

How device manufacturers are mitigating high-risk exposure to hospital budgets

Surgical robotics systems are among the most expensive hospital purchases. [Photo via Adobe Stock]

Medical device manufacturers face volatile equipment orders from hospitals in the next couple of years, with some more exposed to capital budget risk than others.

A new report from Moody’s Investors Service identified eight medtech companies with exposure to changes in hospital capital budgets and examined how well they mitigated that risk with recurring or noncapital sales.

This balance is an important consideration for medtech developers of all sizes as hospitals continue to face staffing and budget challenges with no relief in sight. The report also highlights the importance of innovation in overcoming macroeconomic challenges.

“With a potential recession and inflationary pressures driving up hospitals’ cost of labor, utilities and other expenses, medical device original equipmen…

Stryker faces another bribery investigation

Stryker (NYSE: SYK) + says the U.S. Justice Dept. and Securities and Exchange Commission contacted the company over potential anti-bribery law violations.

The Kalamazoo, Michigan-based orthopedic device maker disclosed these contacts in its first-quarter earnings report released on Tuesday. It said it’s cooperating with both agencies as an investigation ensues. Stryker engaged outside counsel to conduct the investigation. The company said it can’t predict the outcome of the investigation or the potential impact, if any, on its financial statements.

According to Stryker, the investigation centers around certain business activities in an undisclosed foreign country. It aims to evaluate whether Stryker violated provisions of the Foreign Corrupt Practices Act (FCPA). The law restricts companies from bribing foreign government officials to benefit their business interests. This marks the company’s third br…