Stryker Archives - Page 4 of 17 - Medical Design Sourcing

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…

Stryker completes acquisition of Cerus Endovascular

Stryker (NYSE:SYK) + today announced it completed the acquisition of Cerus Endovascular. The financial details of the deal were not disclosed.

Cerus Endovascular designs and develops neurointerventional devices for the treatment of intracranial aneurysms. Cerus Endovascular’s CE marked products, the Contour Neurovascular system and Neqstent could assisted flow diverter, will expand Stryker’s portfolio of aneurysm treatment solutions.

Most recently, Cerus Endovascular was granted IDE approval from the FDA for a clinical trial of its Contour Neurovascular system in April. The company designed it with a fine mesh braid to target the neck of the aneurysm away from the vulnerable dome. It self-anchors the system for stability and is re-sheathable for precise placement, and the sizing criteria are less restrictive because of the deployment across the neck. The system also received FDA breakthrough designation in …

Stryker boosts guidance — but perhaps not enough — after Street-beating Q1

Stryker (NYSE:SYK) + handily beat Wall Street expectations during its first quarter, though its guidance range increase may have disappointed investors.

The morning after Stryker’s earnings announcement, SYK shares were down more than 1% to $294.12 apiece. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was up slightly.

The orthopedic and surgical device giant earned $592 million, or $1.54 per share, off of $4.78 billion for the quarter ended March 31, 2023. The bottom line was up 83.3%, and the top line was up 11.8% compared with the same quarter a year ago.

Adjusted to exclude one-time items, Stryker’s EPS was $2.14. The result was 14¢ ahead of The Street, where the analyst consensus was EPS of $2 and revenue of $4.56 billion.

“Demand remains strong for our products, and supply chain pressures are gradually improving,” CEO K…

May 2023 edition: Endolumik’s big step for safety, ortho hot topics, SaMD development lessons

Endolumik’s illuminated device takes a big step for safety

The top orthopedic device news out of AAOS 2023

SaMD development lessons from Cordio’s voice AI heart failure app

Orthopedic device tech advances

High in the Wind River mountains of present-day Wyoming, the inhabitants of a remote alpine village — perhaps the oldest in North America — may have used fresh rawhide soaked in water as a splint to immobilize fractured bones thousands of years ago.

Before them, the ancient Egyptians used tree bark and linens, and native tribes of South Australia used thick clay.

They would all no doubt be amazed by the modern practice of orthopedics on display at this year’s American Academy of Orthopaedic Surgeons (AAOS) annual meeting — after they recovered from the shock of the scintillating sights of Las Vegas.

In this edition of Medical Design & Outsourcing, Executive E…