An independent panel of experts convened by the U.S. FDA voted 9 to 0, with one abstention, that the benefits of a fully dissolving heart stent outweigh the risks. Abbott’s Absorb fully bioresorbable, drug-eluting coronary stent, is a first-of-its-kind device for the treatment of coronary artery disease. Instead of metal, the stent uses naturally dissolving material which dissolves completely after two-to-three years, during which it has kept the clogged artery open and promoted healing.

The FDA panel voted 9 to 1 in favor of the device’s safety and 10 to 0 in favor of its efficacy. The advisory committee reviewed data from multiple studies of the Absorb dissolving stent and found that the device has demonstrated comparable outcomes to the leading permanent metallic stent. Abbott submitted its pre-market approval application in mid-2015, and the FDA’s final decision is expected later this year. www.abbott.com

Ethicon acquires NeuWave

Ethicon officials have announced the completion of its acquisition of NeuWave Medical Inc., a privately held medical device company that manufactures and markets minimally invasive soft-tissue microwave ablation systems.

“Currently, there are limited treatment options for soft-tissue, non-resectable lesions,” says Michael del Prado, company group chairman of Ethicon. “Together with NeuWave Medical, Ethicon can bring minimally invasive treatment options to make a difference for patients around the world.”

NeuWave Medical’s products are used by physicians in more than half of the top cancer centers in the United States, and the Certus 140 ablation system’s high-powered computer and touchscreen interface enables the activation of single or simultaneous multiple-probe procedures for patients with soft-tissue lesions. This allows physicians to tailor ablations for lesions of varying shapes and sizes.

“This acquisition provides NeuWave Medical the ability to accelerate our innovation pipeline and expand the global footprint of our technologies, while allowing Ethicon to reach new patients by expanding the availability of a novel intervention that goes beyond surgical options in use today,” says Dan Sullivan, CEO and president, NeuWave Medical. www.ethicon.com

Olympus helping target therapy in lung cancer

Olympus’ 510(k)-cleared ViziShot Flex 19G EBUS-TBNA needle is for use in endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA) – a minimally invasive alternative to surgical procedures and considered the gold standard for lung cancer staging.

EBUS uses a bronschoscope equipped with ultrasound capabilities to see beyond the walls of the airways and detect diseased tissue, lymph nodes, or lesions. Suspect lymph nodes can then be sampled using a special aspiration needle. This ViziShot Flex 19G provides a larger sample size, which can provide more material for molecular biomarker testing, potentially leading to more targeted therapy for the patient. The ViziShot Flex 19G offers a 72% increase in inner surface area compared to the Olympus ViziShot 21G needle and 144% increase compared to the ViziShot 22G needle.

Benefits include:

• Larger sample size: Substantial tissue collection even in highly challenging areas, enabling genetic biomarker testing to determine the correct therapy
• Better access during EBUS-TBNA: Flexibility allows the scope to flex up to 84° for improved access to difficult-to-reach areas, sample acquisition; needle echogenicity improves precision and control
• Safety: Includes a double-locking mechanism to help avoid accidental needle protrusion www.medical.olympusamerica.com

Depuy Synthes acquires Biomedical Enterprises

DePuy Orthopaedics Inc., part of the DePuy Synthes companies of Johnson & Johnson, has acquired privately-held BioMedical Enterprises Inc. (BME), a manufacturer of Nitinol orthopedic implants for small bone fixation. The implants are used to treat bunions, hammertoes, and other foot, ankle, hand, and wrist deformities. The BME acquisition reinforces Johnson & Johnson Medical Devices’ focus on strengthening DePuy Synthes’ portfolio for elective extremity procedures.

“The BME portfolio will be integrated into our trauma platform, where we will be able to expand the availability of these solutions, increase the pace of innovation in this area, and reach more patients around the world,” says Ciro Römer, company group chairman, DePuy Synthes. www.depuysynthes.com

Implementing a medical device evaluation system

A report from the planning board for a national medical device evaluation system (NMDES) describes how the nation can implement a coordinated network of partners to improve evidence on the safety and effectiveness of medical devices. The system will work to improve patient outcomes by being smarter and more efficient when generating and evaluating real-world electronic health data on medical devices.

In a previous report, the planning board described how major gaps in the nation’s ability to reliably track medical device safety and effectiveness significantly affect public health. The inability to collect robust and timely evidence on devices increases the costs and inefficiency of our healthcare system. The new report describes how the United States can establish a national system by coordinating and building on the work of a nationwide network of partners, including the FDA and other public agencies, patient communities, provider systems, medical device manufacturers, academic institutions, and healthcare payers.

The NMDES should give device manufacturers a faster, more predictable path to approval and health care coverage decisions. Once products are on the market, the NMDES would provide more cost-effective approaches to developing real-world evidence, which would give clinicians and insurers greater confidence in the products they use. The system would develop resources that improve medical device safety updates, recall management and effectiveness data, and a recommended public-private coordinating center would be responsible for demonstration projects to show the value of NMDES in its early stages. www.healthpolicy.duke.edu

ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry. It has recently been revised, with the new version published in March 2016.

The new ISO 13485:2016 standard is more focused on identification of interested parties and their expectations and the implementation of a process-based system for planning, monitoring, and improvement of the overall quality management system. It requires additional emphasis on identification and monitoring of all suppliers’ processes to ensure that the overall company objectives are met. This includes industry-specific specialists responsible for raw materials, plastics processing, and precision tooling as well as suppliers to the medical device industry.

Successful suppliers know their customers’ needs and fulfill requirements because they control their processes and ensure quality. A tool for managing an organization and improving performance, it acts as a quality management system that identifies opportunities for improvement and fulfills the requirements of customers and suppliers, allowing organizations to optimize their processes while reducing costs.

For smaller organizations, survival in today’s economy relies upon ISO 13485 certification. Organizations are turning toward this certification to control the quality and effectiveness of management systems and reduce costs associated with poor quality. Some seek certification because their clients demand it or because their competitors are certified. Others become certified to grow market share and sell overseas. A company’s ISO industry-specific specialist has a monumental responsibility to know the business, both operationally and financially, to improve performance reporting.

These services are customized to meet the needs of each supplier, requiring a background in supporting clients with supplier and process assessments for improvements and audits. Clients access their expertise and global footprint to gain relevant information quickly and cost-effectively.

An ISO industry-specific specialist will provide an independent and expert assessment of a company’s management system, assuring top management that the system conforms to the requirements of the standard. The insight gained from an assessment/audit on whether the management system is suitable for achieving the desired results is important. The specialist will suggest improvements and support the decision-making process.

Lewis Yasenchak is the founder/owner of P&Y Management Resources, specializing in ISO compliance/certification, quality training, and related management issues for the plastics industry. Yasenchak can be reached at lewis.yasenchak@windstream.net or 706.694.2977.

Life in Cleveland looked a little different, a little brighter by 10:35pm on Sunday, June 19, 2016. The 52-year curse was lifted – but it wasn’t an easy road to success. The Cleveland Cavaliers – led by LeBron James scoring his 16th triple double in the playoffs, the chasedown block on Andre Iguodala, and Kyrie Irving’s epic 3-point shot with 53 seconds left – brought home the NBA Championship title. And, with that win in game seven came a moment Cleveland fans will never forget, a storybook ending for Clevelanders, who will always be able to tell you about their sports nightmares, with phrases such as The Drive, Red Right 88, The Fumble, and the ’95 and ’97 World Series.

However, no one wants to wait 52 years to hold the top title in their industry. In the world of sports getting to the top requires the right balance of players with talent and coaching. To have success in manufacturing you need the right talent in the workforce, and if the workforce you need doesn’t exist, you need the right coach to develop it.

Last month, PwC, along with the Manufacturing Institute, surveyed 120 U.S. manufacturers for the report, “Upskilling manufacturing: How technology is disrupting America’s industrial labor force.” Findings from the survey show that:

• Skills shortages are not uniformly felt, with 33% of manufacturers saying they have no or only a little difficulty in hiring talent to exploit advanced manufacturing technologies, while 44% have moderate difficulty
• The worry is that it will worsen, with 31% seeing no manufacturing skills shortage now but one is looming in the next three years, while 29% say it exists and will only worsen in the next three years

Also revealed in the PwC survey was that the most common strategy for getting employees into advanced manufacturing is to train in-house – apprenticeships, something we promote through our #WhyMFG campaign (www.WhyMFG.com) – followed by recruiting local STEM students and outside vocational training. Then came the response that robots are not stealing manufacturing jobs; 37% believe that the adoption of advanced manufacturing technologies will result in their hiring additional employees; 45% said robots will have no impact on their hiring plans. Only 17% said it will result in hiring fewer employees.

However, the key take-away from this report is how advanced manufacturing technology is the game-changer, with nearly three-quarters of non-factory floor manufacturing jobs requiring candidates to have a four-year or advanced degree.

While robotics, the Internet of Things (IoT), and advanced technologies – such as additive manufacturing – are changing the way companies manufacture products today and plan for tomorrow, they can be keys to a road to success. The changes that are transitioning traditional factory jobs and workforce into advanced technology machinists and designers is not going to slow down anytime soon. This should be the spark in company CEOs who want to stay on the right road. They should always be looking for ways to invest in their company, putting it one step ahead of the other teams by hiring leaders (coaches) and workers (players) that will be well-prepared with the right tools in their toolbox for today and well into the future.

With the right equipment, plans, and support, it shouldn’t take 52 years to get your company to the top – and keep it there. ~ Elizabeth

Ossur has acquired Touch Bionics Ltd., an upper limb prostheses and supporting services company, for $39 million. The acquisition allows Ossur to offer a complete bionic product portfolio to customers in the prosthetics industry. Synergies between the operations of Ossur and Touch Bionics are expected to be achieved during the next two to three years, ultimately increasing the pre-tax earnings margin of Touch Bionics to a level similar to Ossur.

“Touch Bionics has developed cutting edge upper limb technology and created a strong brand presence over recent years,” says Jon Sigurdsson, president and CEO of Ossur. “This acquisition is an important milestone for Ossur as it marks our entry into the upper limb prosthetic market. Ossur and Touch Bionics are committed to pushing the boundaries of bionic technology to enable amputees to live a life without limitations.” www.ossur.com

3D surgical software approved

The FDA has approved spineEOS, an online 3D planning software for spine surgery based on EOS stereo-radiographic 2D/3D imaging. The software is intended for treatment of adults suffering from degenerative or deformative spine conditions and pediatric patients with adolescent idiopathic scoliosis. Surgeons can create treatment plans to achieve optimal sagittal alignment from pelvic and vertebral 3D data obtained in the functional standing position from an EOS exam. Planned surgery and virtual post-correction 3D anatomy can be used to plan for the 3D shape and length of the spinal implants. Data can also be shared pre-operatively to engage patients in the intended course of therapy. It is also available in the operating room through a custom planning report. www.medtronic.com; www.eos-imaging.com

ResMed to acquire Brightree for $800M

ResMed officials have agreed to acquire privately-held Brightree, a business management and clinical software applications provider for the post-acute-care industry. Brightree’s cloud-based software helps customers improve clinical and business performance in home/durable medical equipment (HME/DME), home health, and hospice – all areas with high prevalence of sleep-disordered breathing, chronic obstructive pulmonary disease (COPD), and neuromuscular disease.

Brightree will continue to operate as a separate entity under the Brightree brand name, and will be managed independently, with its headquarters remaining in Atlanta, Georgia. ResMed expects Brightree employees, including President and CEO Dave Cormack, to continue in their current roles. www.resmed.com; www.brightree.com

FDA approves world’s smallest pacemaker

The U.S. Food and Drug Administration (FDA) has approved the world’s smallest pacemaker, the Medtronic Micra Transcatheter Pacing System (TPS), making it the first FDA-approved product with miniaturized pacing technology. Comparable in size to a large vitamin, the Micra TPS is small enough to be delivered through a catheter and implanted directly into the heart.

The Micra TPS attaches to the heart with small tines, delivering electrical impulses that pace the heart through an electrode at the end of the device. Unlike traditional pacemakers, it does not require leads or a surgical pocket under the skin, and responds to patients’ activity levels by automatically adjusting therapy. In clinical trials, the Micra TPS was successfully implanted in 99.2% of patients – 96% of patients experienced no major complications, 98.3% had low and stable pacing thresholds at six months, yielding projected average longevity for the device of more than 12 years. www.medtronic.com

Ampronix acquires Perkins Healthcare Technologies assets

Ampronix officials have announced the acquisition of two Perkins Healthcare Technologies’ product lines and service capabilities – the Perkins Scan Converter and Medical DVD Recorder lines. The Perkins acquisitions complement Ampronix’s growing image-enhancing product lines including SCANMAXX and DVMAXX.

“They have been very good products over the years and we are eager to continue our work with their medical imaging line,” says Nausser Fathollahi, Ampronix president and CEO.

“Perkins’ decision to sell some of its products and services included a careful evaluation of the other companies’ technical expertise and customer service,” says Richard P. Kincheloe, president of Perkins Healthcare Technologies. www.ampronix.com

Stryker’s new acquisitions; completion of purchases

Stryker’s acquisition of SafeWire’s product portfolio includes the Y-Wire guidewire and Tiger Jamshidi needle family for use in minimally-invasive spine surgery. The Y-Wire’s design mitigates potential wire-based complications, such as inadvertent advancement of the guidewire through bone, accidental pullout, kinking, or wire migration. The Y-Wire also reduces surgical steps and helps to optimize workflow for minimally invasive spine cases, and reduces patient and surgeon exposure to fluoroscopy.

Completing the acquisition of Physio-Control International Inc. adds monitors/defibrillators, automated external defibrillators (AEDs), and CPR-assist devices along with data management and support services to Stryker.

The completed acquisition adds Sage Products LLC solutions for oral care, skin preparation and protection, patient cleaning and hygiene, turning and positioning devices, and heel care boots.

The Synergetics USA Inc. all cash transaction by Stryker includes the Malis generator, Spetzler Malis disposable forceps, and Stryker’s existing Sonopet tips and RF generator. www.stryker.com

Livongo Health completes $44.5 million funding

Livongo Health officials have announced the completion of $44.5 million Series C financing that includes Merck Global Health Innovation Fund; Cowen Private Investments; Sapphire Ventures; Zaffre Investments, the investment arm of Blue Cross Blue Shield of Massachusetts; and Wanxiang American Corp., as well as existing investors General Catalyst, Kleiner Perkins Caufield & Byers, DFJ, and 7wire Ventures.

In recent months, Livongo Health’s growth trajectory increased significantly, driven by rapid adoption of its diabetes management solution among the country’s largest self-insured employers, payers, and healthcare providers. The new funds will be used to support that growth, accelerate the launch of new products and services, and expand into new market segments. www.livongo.com