MedAccred announced Volex Tijuana, Mexico achieved MedAccred accreditation for cable and wire harness assembly, the first company in Mexico to hold the accreditation.
MedAccred announced Volex Tijuana, Mexico achieved MedAccred Accreditation for Cable and Wire Harness Assembly, making it the first company in Mexico to hold the accreditation for the critical manufacturing process.
Volex achieved accreditation after meeting the exacting audit requirements, as set by MedAccred subscribing members including Bausch Health, BD, Boston Scientific, Baxter, Edwards Lifesciences, Johnson & Johnson, Medtronic, Philips, Stryker, and Roche Diagnostics.
MedAccred is the sole industry-managed supply chain oversight program for key critical manufacturing processes in the medical device industry.
“We applaud Volex Tijuana, Mexico manufacturing facility for achieving MedAccred Cable and Wire Harness Assembly Accreditation and becoming the first company in Mexico to do so for this process,” says Connie Conboy, Director, MedAccred. “Volex has continued to show the world its dedication and support for the medical device industry and, most importantly, patient safety. It has met the strict audit criteria, created by 10 of the leading medical device companies, and demonstrated commitment to continuous improvement by focusing on achieving its customers’ highest expectations.”
"Our recent MedAccred Accreditation of the Tijuana, Mexico facility further supports our medical sector strategy by increasing our value-added offering to medical customers seeking enhanced global support, and new MedAccred-accredited manufacturing processes,” says Mark Kray, Volex COO for North America. “Volex provides our customers with the assurance that their products are built with strict adherence to quality, reliability and performance to the highest of safety-critical standards."
Dayon Manufacturing specializes in the design, engineering, and manufacturing of custom miniature and micro springs.
Lee Spring, a global provider of stock and custom springs, acquired Dayon Manufacturing. Dayon Manufacturing, located in Farmington, Connecticut and established in 1957, specializes in the design, engineering, and manufacturing of custom miniature and micro springs.
“The acquisition of Dayon Manufacturing, which has over a half century of miniature spring experience, expands our diverse manufacturing capabilities in support of continued growth and the needs of our customers,” says Steve Kempf, CEO of Lee Spring. “We are seeing a trend towards smaller assemblies and micro devices, and this acquisition strengthens our capabilities in this promising area. Dayon Manufacturing’s expertise and focus on miniature spring design and manufacturing is a great fit for our customers and our future. Dayon’s outstanding team and their highly skilled specialization in miniature springs is in perfect alignment with our growing business.”
Kempf continues, “Dayon will continue to serve customers from their existing facility in Farmington, Connecticut. In addition, they will now also have access to a wider range of capabilities through Lee Spring’s global manufacturing operations. This acquisition enhances the spring products and services available to Lee Spring customers worldwide with the addition of highly experienced resources dedicated to the micro and miniature spring specialty.”
This is the second-highest monthly total and only the fifth instance monthly orders have exceeded $600 million since the beginning of the program in 1998.
Orders of manufacturing technology surpassed $650 million in November 2021, according to the latest U.S. Manufacturing Technology Orders Report published by AMT – The Association For Manufacturing Technology. This is the second-highest monthly total and only the fifth instance monthly orders have exceeded $600 million since the beginning of the program in 1998. The value of orders was up nearly 14% from October 2021 and more than double the value of orders received in November 2020. The year-to-date total topped $5.3 billion, about $340 million short of becoming the best year in the history of the program.
“November orders illustrate continued recovery despite ongoing challenges brought on by the pandemic. Tool and die, valve manufacturing, forging, and stamping, and hardware – sectors in decline due to decades of outsourcing prior to the pandemic – continued to make a comeback due to reshoring,” says Douglas K. Woods, president of AMT. “Job shops showed a modest decline in dollars spent but a double-digit increase in orders, indicating an industry-wide need for increased capacity.”
Two primary sectors showing increased orders despite continued challenges are aerospace and off-road equipment. The aerospace sector has experienced challenges with flight cancellations and staffing issues that may dampen any near-term plans to increase fleet sizes. However, despite these disruptions, this sector has nearly doubled its orders from the previous month. Heavy off-road equipment used for agriculture, mining, and construction have also increased by multiples over October 2021, likely due to anticipated interest rate hikes.
“The sectors that make large-scale off-road equipment require more complex and highly customized machinery to make them, and they tend to be dependent on financing and sensitive to interest rates,” says Woods. “Orders coming from these rate-sensitive sectors in November may have been an attempt to lock in financing prior to the December Federal Reserve meeting, preempting any surprises that would increase the cost of borrowing.”
Despite the index slipping in December 2021, the ISM Manufacturing Purchasing Managers’ Index remained solidly within growth territory. “Manufacturers have learned that supply chain disruptions and labor shortages are part of the landscape and are developing short and long-term strategies to address these challenges,” says Woods. “If manufacturers can continue to successfully adapt, I can see the momentum of the manufacturing technology industry continuing into 2022.”
Acquisition to expand company’s cardiac ablation portfolio, including first-time entry into mapping and navigation, within one of the fastest growing medtech markets
Medtronic plc, a global provider of healthcare technology, acquired Affera, Inc., a Boston area-based, privately held medical technology company. Affera designs and manufactures cardiac mapping and navigation systems and catheter-based cardiac ablation technologies, including a differentiated, focal pulsed field ablation solution, for the treatment of patients with cardiac arrhythmias (irregular heartbeats) such as atrial fibrillation (AF). Medtronic, through its minority investment portfolio, has been a strategic investor in Affera and currently holds a 3% ownership stake in the company.
The acquisition expands the Medtronic portfolio of advanced cardiac ablation products and accessories to meet physician needs within a growing patient population. Affera’s technologies include the Affera Prism-1 cardiac mapping and navigation platform and Sphere-9 cardiac ablation catheter, investigational technologies designed to enable the rapid creation of detailed maps used by electrophysiologists (EP) to diagnose arrhythmias and deliver cardiac ablation therapy. The Affera full-suite of solutions and technologies will complement the existing Medtronic atrial and ventricular arrhythmia disease management portfolio and support the company’s efforts to offer simple, safe, and effective cardiac ablation solutions to improve patient outcomes.
“The EP ablation market is an exciting and fast-moving segment of cardiology,” says Rebecca Seidel, president of the Cardiac Ablation Solutions (CAS) business, which is part of the Cardiovascular Portfolio at Medtronic. “Bringing Affera into our organization, with our established footprint in the cardiac ablation space, will strengthen our ability to provide innovative therapies and enable Medtronic entry into additional EP technology segments, such as mapping and navigation, for the first time.”
“Affera offers technologies that support physician customers as they work to improve clinical workflows, procedural efficiencies, and ultimately optimize patient care,” says Stacy Beske, Ph.D., vice president of strategy, CAS.
Within the $8 billion worldwide EP ablation market, the prevalence of cardiac arrhythmias is growing rapidly, and the need to provide treatment to the increasing patient population, which encompasses AF, supraventricular tachycardia (SVT), and ventricular tachycardia (VT), is increasing. AF represents the largest disease segment, with nearly 60 million people affected worldwide. AF is a progressive disease, meaning over time patients can experience more frequent, and longer episodes, and medication as well as catheter ablation can become less effective. Additionally, AF is associated with serious complications including heart failure, stroke, and increased risk of death.
“This is an exciting day for patients who suffer from the burden of AF and other arrhythmias. This acquisition directly aligns with our vision of delivering novel solutions to address the rapidly growing demands for cardiac arrhythmia treatment,” says Doron Harlev, founder and chief executive officer of Affera. “We are excited to focus on the integration of our technology with Medtronic and are confident that together we can increase patient access to ablation therapies.”
In December 2021, Affera announced the commencement of the recently approved SPHERE PerAF Trial, a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) pivotal randomized trial, to evaluate the safety and effectiveness of the Affera system for the treatment of persistent AF. Affera’s product portfolio is not currently approved or available for sale or commercial use. The acquisition is expected to close the first half of Medtronic fiscal year 2023, subject to the satisfaction to certain customary closing conditions. Following close, the transaction is expected to be less than 1% dilutive to Medtronic’s adjusted earnings per share in each of the first three years, and neutral to accretive thereafter. The company expects dilution of approximately 5 cents in both year 1 and year 2 and approximately 3 cents in year 3.
In collaboration with leading clinicians, researchers, and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world.
Terry Wohlers, founder of Wohlers Associates, powered by ASTM International where he serves as head of additive manufacturing market intelligence, offers a look at where AM is headed in 2022.
In the past 20 years additive manufacturing and growth over the last 10 years has averages almost 25.7% annually. Learn about this and more from Terry Wohlers, founder of Wohlers Associates, powered by ASTM International where he serves as head of additive manufacturing market intelligence.
View the on demand webinar here.