Choosing a Partner for Precision Medical Device Components
A Customer Perspective on the First Step Difference for NPD

Three years ago, we launched our First Step program at Hobson & Motzer, our project-based rapid precision prototyping and new product development (NPD) platform. It was a natural progression to the work we had been doing with major medical device OEMs for over a century in precision metal components.

Customers in advanced industries have expressed a need for higher level NPD support: prototyping executed to precision tolerances, and greater metrology depth—providing an opportunity for the part and manufacturing process to evolve simultaneously, yielding valuable data and learning that does not occur when the two processes are separate.

Valuing customer input, we spoke with one very experienced Medical Device Development Engineer currently with a company that has worked with us on multiple NPD projects for different products developed with our First Step team. His feedback inspired this article. When directly quoting him, we will refer to him as “DE.…

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Janssen exec discusses company’s precision neuroscience strategy and partnerships

[Aliaksandr Marko/Adobe Stock]

In mid-April, San Diego–based Pipeline Therapeutics announced a global license and development agreement with Janssen Pharmaceutica NV (NYSE:JNJ), focusing on PIPE-307, an investigational compound targeting nervous system disorders. As a pioneer in precision neuroscience, Pipeline Therapeutics aims to create targeted treatments for patients. PIPE-307, an oral, highly selective antagonist of the muscarinic M1 receptor, embodies this approach, having completed two phase 1 clinical trials and obtained FDA clearance for clinical development in relapsing-remitting multiple sclerosis (RRMS) patients. Janssen received a worldwide, exclusive license to research and develop PIPE-307 in all indications.

Under the agreement, Pipeline will receive $50 million upfront from Janssen, with the possibility of receiving an additional $25 million in equity investments from J&J and Pipeline’…

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Tirzepatide versus semaglutide: Which contender will prevail in the battle against obesity and type 2 diabetes?

Eli Lilly‘s (NYSE:LLY) tirzepatide achieved up to 15.7% weight loss in the SURMOUNT-2 study, sparking a potential tirzepatide vs semaglutide competition in the obesity and type 2 diabetes treatment markets. The phase 3 study enrolled 938 participants with diverse backgrounds.

Tirzepatide promises to be a megablockbuster with a number of analysts pegging peak annual sales hitting $25 billion. Few drugs have surpassed the $20 billion threshold. One notable example is AbbVie’s monoclonal antibody Humira (adalimumab), which hit $21.2 billion in sales in 2022 and $20.7 billion a year earlier. The drug was the world’s bestseller until the COVID-19 pandemic stoked demand for the Pfizer-BioNTech vaccine, whose cumulative annual sales hit $59.1 billion in 2021.

Lilly has signaled its plans to submit tirzepatide to the FDA, potentially leading to competition between tirzepatide and semaglutide in the obesity and type 2 diabetes treatment markets.

Tirzepatide&#…
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Terumo announces first implant of custom thoracoabdominal hybrid device

Terumo Aortic recently announced the first implant of its custom-made thoracoabdominal hybrid device Thoracoflo in North America.

Dr. Randy Moore, co-director of the Calgary Complex Aortic Program at the University of Calgary in Canada, performed the first thoracoabdominal repair procedure using Thoracoflo. The University of Calgary team, led by Moore, received support from Professor Sabine Wipper, chair of vascular Surgery at University Hospital Innsbruck in Austria. Wipper has been a key contributor to the development of the device, according to the company.

“This unique hybrid graft was designed through Terumo Aortic’s custom device program, specifically for the patient we were treating. With no other device with similar technology currently available globally for thoracoabdominal aortic repair, the Thoracoflo graft is designed to reduce the risk of complications associated with thoracotomy and extracorporeal circulation,” Moore said. “This…

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Abbott FreeStyle Libre 3 authorized for automated insulin delivery in UK

[Image from Ypsomed]Abbott (NYSE:ABT) announced that its FreeStyle Libre 3 continuous glucose monitor (CGM) received UK authorization for use in automated insulin delivery.

Authorization enables FreeStyle Libre 3 — Abbott’s newest sensor — to work with the Ypsomed mylife YpsoPump and CamDiab’s CamAPS FX mobile app. The company called this a “major step forward” for type 1 diabetes management in the United Kingdom.

At the end of last year, the company received authorization to integrate FreeStyle Libre 3 with the mylife Loop from Ypsomed and CamDiab. That collaboration began in Germany. Abbott said at the time that it planned launches in the UK, Switzerland and the Netherlands in the first half of this year.

Combined, the technologies form an intelligent process to deliver insulin in the form of an artificial pancreas. The closed-loop system utilizes real-time glucose data to create an automated insulin delivery (AID) system. It remov…

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NuVasive, Globus Medical shareholders approve merger

NuVasive (Nasdaq:NUVA) and Globus Medical (NYSE:GMED) both saw shareholders approve their proposed merger yesterday.

In February, the companies announced an agreement to combine in an all-stock transaction. The deal values NuVasive at $3.1 billion, with Globus shareholders owning roughly three-fourths of the newly merged company.

BTIG analysts raised the question of potential anti-trust challenges for the deal. Such a merger would create the second-largest spine tech company behind Medtronic.

Both companies held separate special meetings of shareholders yesterday, April 27. NuVasive shareholders voted to approve the adoption of the merger, which sees them receive 0.75 of a share of Globus Medical Class A common stock for each share of NuVasive common stock owned at closing.

NuVasive and Globus expect the proposed merger to close after clearance from regulatory authorities and other customary closing conditions. At that time, they expect NuVasive s…

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ResMed sales up nearly 30% in Q3 amid rising demand

ResMed (NYSE:RMD) + shares ticked up today on third-quarter results that topped the consensus forecast.

Shares of RMD rose 1.2% at $228 apiece before the market opened this morning. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — started the day up 0.2%.

The San Deigo-based sleep respiratory technology maker posted profits of $232.5 million. That amounts to $1.58 per share on sales of $1.12 billion for the three months ended March 31, 2023.

ResMed posted a 29.9% bottom-line gain on sales growth of 29.2%. ResMed’s continued growth reflects a ramp-up in production as a result of growing demand. The company grabbed a hold of the sleep respiratory market as a result of the ongoing Philips Respironics recall.

Adjusted to exclude one-time items, earnings per share totaled $1.68. That landed 9¢ ahead of expectations on Wall Street. Sales…

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FDA clears Intuitive da Vinci surgical robot for prostatectomy

The da Vinci SP surgical robot. [Image from Intuitive]Intuitive Surgical (Nasdaq: ISRG) + announced today that the FDA cleared its da Vinci SP surgical robot for simple prostatectomy.

The clearance, which includes prostatectomy as a representative procedure, expands da Vinci SP’s (single-port) available urologic surgical procedures. Sunnyvale, California-based Intuitive’s surgical robot now offers the removal of an enlarged prostate blocking urine flow with this procedure.

In the same action, the FDA cleared da Vinci SP for the transvesical approach to simple and radical prostatectomy. With this procedure, the surgeon removes the entire prostate gland, most often for those diagnosed with prostate cancer.

The da Vinci system offers robot-assisted technology for deep and narrow access to tissue in the body. Intuitive’s da Vinci system is considered the gold standard in robot-assisted laparoscopic …

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Qosina unveils new AseptiQuik W Series connectors

[Image courtesy of Qosina]

Qosina announced that it introduced Colder Product Company’s (CPC) new AseptiQuik W Series connectors to its product line.

Ronkonkoma, New York-based Qosina added AseptiQuik W to its extensive line of aseptic, genderless connectors.

AseptiQuik W Series connectors feature a 1 ½” flow path and enable quick and easy sterile connections. Uses include in large-volume, high-flow production and process intensification environments. The system’s large diameter connection enables higher flow rates. This reduces the risk of flow restrictions or pressure drops that may negatively impact process performance.

The system also offers a genderless design to simplify system integration and minimize the risk of operator error. Its robust construction provides reliable performance without the need for clamps or fixtures. Qosina said biopharmaceutical manufacturers can benefit f…

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Fast Five: Diabetes tech scores big win in Canada, 3M’s hydromechanical wound dressings get FDA nod

Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, April 28, 2023.

Fast Five by MassDevice · Diabetes tech scores big win in Canada, 3M’s hydromechanical wound dressings get FDA nod

 

More diabetes wins are in the news this week. Dexcom announced that its G6 continuous glucose monitor won expanded coverage in Canada. Fast Five hosts Sean Whooley and Danielle Kirsh discuss how the indication could expand access to the diabetes management technology to underserved communities.

Innoblative Designs won FDA breakthrough designation this week for its ablation device that is indicated for breast cancer surgery. Whooley details how the device works and how the company anticipates it to streamline procedures and workflows.

It’s not your average bandage. Kirsh and Whooley discuss the technology behind …

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ATL Technology acquires manufacturing operations of Gyrus Medical

ATL Technology announced that it acquired manufacturing operations of Gyrus Medical from Olympus Surgical Technologies Europe.

Cardiff, Wales-based Gyrus also offers device outsourcing. ATL said in a news release that it expects the acquisition to increase its global footprint and capabilities.

ATL offers outsourced design, development and manufacturing services. The company focuses on providing engineering solutions to offer best-in-class medical device products. Olympus Surgical Technologies Europe serves as the European development and manufacturing center for medical technology within the Olympus Corporation.

“This is a very strategic event for ATL,” said ATL Technology CEO Joe Glover. “We look forward to incorporating Gyrus’ capabilities into ATL’s existing offerings and to expand our global footprint deeper onto the European continent.”

Glover added that the company is enthusiastic about adding the Gyrus team to its own. He…

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Dexcom grows revenues 18% in Street-beating Q1, raises guidance

Dexcom (Nasdaq:DXCM) today announced that it’s raising its 2023 financial guidance following strong first-quarter financial results.

Shares of DXCM dipped 3.7% to $119 apiece after the market closed. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the day up 0.2%.

The San Diego-based continuous glucose monitor technology developer posted profits of $48.6 million. That equals 12¢ per share on sales of $741.5 million for the three months ended March 31, 2023.

Dexcom reported a 50% bottom-line slide on sales growth of 17.9%. The company attributed sales growth to strong new customer additions. Dexcom noted this continues to drive revenue growth as awareness of real-time CGM increases.

Get the full story at our sister site, Drug Delivery Business News.

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