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Articles from 2018 In April

B A Die Mold celebrates 50 years building 'badass' molds for intricate plastic parts

B A Die Mold celebrates 50 years building 'badass' molds for intricate plastic parts

You read it correctly! The “B A” in B A Die Mold Inc. (Aurora, IL) stands for “badass,” meaning “of formidable strength or skill,” as defined by Merriam-Webster, explains the company’s latest release. During B A Die Mold’s 50-year history, the company has become widely known for its innovative solutions, including the patented PERC system for servo-unscrewing molds.

Alan Petrucci, founder and CEO of B A Die Mold Inc. and daughter Francine, President.
Alan Petrucci, founder and CEO of B A
Die Mold Inc. and daughter Francine, President.

“For 50 years, our company has worked hard to enhance our customers’ revenue streams by successfully designing and manufacturing molds that many other mold builders won’t or can’t build,” said Francine Petrucci, President of B A Die Mold. “We are proud that several have been loyal clients of B A for most of these years. They return time and again for innovative solutions like our Programmable Electric Rotating Core (PERC) system, a time-tested and proven alternative to conventional hydraulic unscrewing.”

B A Die Mold builds small- to medium-sized, complex molds primarily for the medical device, water filtration, automotive, beauty and caps/closures industries. Services also include mold and new product design, as well as re-engineering of existing products, using 3D solid modeling. Rapid prototyping and prototype molds, in-house mold sampling and short-run production services are also available. “We pride ourselves on providing close-tolerance molds that meet unwavering U.S. quality and high standards,” said Alan Petrucci, company founder and CEO. “Customers, which also include other mold builders, have continually endorsed the statement with testimonials about the quality of our molds.”

Petrucci was honored by the American Mold Builders Association (AMBA) as its 2011 Mold Builder of the Year. In addition, B A Die Mold was a founding AMBA member. “Community involvement and outreach is part of our DNA,” daughter Francine said. Both she and Alan continue to serve on AMBA’s Chicago chapter board of birectors and Alan is a past director of AMBA’s national board. Giving back to the trade is a heartfelt pursuit and is exemplified by the strides the Chicago AMBA has made in the area of workforce development, with Francine at the helm. 

“We could not have achieved this business milestone without the incredibly talented team here at B A,” Francine says. “In addition, we simply must mention the amazing support we have received from many excellent, local vendor partners who have supported our operations for many, many years.”

Stepping beyond the medical zone at NPE2018

Stepping beyond the medical zone at NPE2018

A Tale of Two Telehealth Acquisitions

Pixabay A Tale of Two Telehealth Acquisitions

Telemedicine companies are actively looking for ways to open the sector up to broader adoption. Partnerships and acquisitions seem to be the fastest means to that end, as two recent telemedicine deals would suggest.

InTouch Health, a Santa Barbara, CA-based telemedicine firm, said it will acquire REACH Health, an Alpharetta, GA-based telemedicine software company.  Shortly after the deal was announced, Boston, MA-based American Well, reported its agreement to acquire Avizia, a prominent player in the acute care telehealth space. Financial terms were not disclosed for either deal.

"The telehealth industry is fragmented and health systems demand a single telehealth platform that can overcome interoperability challenges, ensure data management continuity, and scale from a single physician office to a multi-hospital enterprise," said Joseph DeVivo, CEO of InTouch Health. "With InTouch Health, healthcare providers have access to the complete telehealth package for any use case in any care location. REACH Health fits nicely with InTouch Health's recent open-platform, device-agnostic strategy."

The merging of these two companies will allow REACH customers to expand their telehealth services leveraging a fully integrated virtual care platform, InTouch noted.

REACH was born in an Augusta, GA hospital in 2003 out of necessity due to the scarcity of stroke specialists in rural hospitals. The stroke neurologists at the Medical College of Georgia (MCG) at Augusta University were frustrated by the arrival of ischemic stroke patients outside the treatment window for tPA therapy because most of the patients first went to their local hospitals that didn't have access to a stroke specialist and had to be transported to Augusta, arriving too late to benefit from tPA.

That frustration led to the development of a telemedicine software system that combined video conferencing, medical imaging, and patient data into a single platform. Stroke specialists could access the platform through the use of a standard PC with a webcam to be connected to a bedside clinician at the hospital to facilitate diagnosis and emergency treatment. 

"We developed the telehealth system to enable MCG stroke specialists to work directly with hospitals and healthcare providers to provide timely stroke care to patients in more rural areas of our state," said David Hess, MD, dean of the Medical College of Georgia (MCG) and REACH Health's board chairman. "This system was commercialized when REACH Health was founded and in the past dozen years, has helped providers in states including Pennsylvania, Massachusetts, Mississippi, and South Carolina provide life-saving treatment for some 50,000 patients. We are pleased to see the growth of REACH Health accelerate as it joins forces with InTouch Health, another telemedicine industry pioneer."

American Well said its acquisition of Avizia will bring a comprehensive acute care capability to the company, including a hospital-based cart lineup and custom software workflows for more than forty clinical telehealth specialties, including stroke and behavioral health.

 The move will enhance options available to clients across American Well's diverse telehealth ecosystem, including health systems, health plans, consumer aggregators, and healthcare service innovators, enabling clients to choose one comprehensive single platform solution, the company noted. This acquisition is scheduled to close in late Q2 subject to the attainment of certain conditions.

Fitbit Dives Deeper in Healthcare Through Google Partnership

StockSnap/Pixabay Fitbit Dives Deeper in Healthcare Through Google Partnership

Fitbit is continuing to make good on its promise to become more deeply entrenched in the healthcare market. The wearables giant has announced a collaboration with Google – a company that’s no stranger to teaming up with healthcare firms.

San Fransisco, CA-based Fitbit said it intends to use Google’s new Cloud Healthcare API to help integrate wearables further into the healthcare system, such as by connecting user data with electronic medical records.

The companies said that connecting to the healthcare API can make it easier for clinicians and patients to collaborate on care, leading to better health outcomes.

"At Fitbit, we’re focused on providing our users with data and insights that drive meaningful and lasting behavior change, and we will continue to partner with leading healthcare companies across the industry to offer new tools that can help people achieve better health outcomes,” said Adam Pellegrini, General Manager, Fitbit Health Solutions. “Our new collaboration with Google is just one example of how we will continue to build bridges across the industry in order to accelerate innovation in wearables and digital health and bring the benefits of wearable technology to people around the world.”

The companies will also look to help better manage chronic conditions like diabetes and hypertension.

Get in where you Fitbit in

Over the past few months Fitbit has been making important collaborations and acquisitions to further its ascent into the healthcare market. Google alliance follow’s Fitbit’s proposed acquisition of Twine Health, a health coaching platform aimed at lowering healthcare costs.In 2017, Fitbit began workingwith San Diego-based DexCom to add continuous glucose monitoring (CGM) data to its latest gadget – the Ionic smartwatch.

Through the collaboration, DexCom CGM users on either Android or iOS devices would be able to see both activity and glucose levels, right on their wrist. DexCom has also worked with Google’s Verily Lifesciences in a separate collaboration. Fitbit also announced in 2017 that the Fitbit Charge 2 device is now part of UnitedHealthcare Motion’s wellness program.

Nearly two years ago, Fitbit began a collaboration with Dublin-based Medtronic on a technology known as the iPro2 myLog. The device will partner with a mobile app to enable patients with type 2 diabetes to monitor their glucose levels and physician activity data in one application.

Fitbit seems to be following in Google’s footsteps when it comes to entering the healthcare market. Google through its Lifesciences unit Verily, has been very active in establishing joint ventures, agreements, and key collaborations with companies in the healthcare space.

In April, MD+DI published the top seven partnerships that allowed Google to successfully establish a strong presence in healthcare. The collaborations ranged from the diabetic space to surgical robotics. 

New Cardiology Guidelines are Causing Heartache for Some Doctors

Boston Scientific Corp. New Cardiology Guidelines are Causing Heartache for Some Doctors

Clinical guidelines put forth by medical associations are usually intended to guide treatment decisions, but just how much influence do guidelines have over the adoption and reimbursement of new technologies?

This question recently sparked a debate among a group of experts during a virtual panel organized to discuss updated guidelines released late last year for the management of U.S. patients with ventricular arrhythmias and the prevention of sudden cardiac death. The discussion focused, in particular, on the inclusion of subcutaneous implantable cardioverter-defibrillator (S-ICD) therapy.

Most commercial payers look to peer-reviewed literature when developing coverage decisions for new medical devices, according to Jim Cross, MD, the former head of national medical policy and operations who is now a private consultant.

"When the literature is not all that defining in a particular question of who should get the device, then they do look at the appropriate professional societies to guide them along," Cross said.

For example, the guidelines published in October 2017 by the American Heart Association (AHA), American College of Cardiology (ACC), and the Heart Rhythm Society (HRS) included the use of Boston Scientific's Emblem S-ICD as it was the first time the guidelines had been updated since FDA approved that device back in 2012. The European Society of Cardiology beat its U.S. counterparts to the punch in 2015 by including the S-ICD in its guidelines that year.

According to Cross, most of the major private payers lump all ICDs into the same coverage policy, with S-ICDs being a subset with more or less the same criteria as for the transvenous ICDs. Good in theory, but that certainly does not seem to be the reality for physicians who have come to consider S-ICDs to be an important treatment option for a lot of their patients.

"I've run into too many situations where the payers are denying coverage for something that's been FDA approved for six years and being deemed investigational," countered Bradley Knight, MD, medical director of cardiac electrophysiology at Northwestern Memorial Hospital.

If the patient is going to get an implantable defibrillator either way and the costs of a subcutaneous ICD is comparable to the cost of a transvenous ICD system, Knight said, what difference does it make to the payer which device the physician and patient decides is best?

"For devices, the level of evidence that is typically needed for FDA approval is not at the level of evidence required for a drug," Cross said. While a pre-market application approval is based on more rigorous data than a 510(k) clearance, even devices approved through the PMA process tend to fall short of payer expectations in terms of developing a clinical policy, he said.

"So the payers are all going to look for additional peer-reviewed evidence that supports that technology, and if it is not all level I evidence and much of it is level II prospective evidence then they're going to look to the societies," Cross said.

The problem with that process, pointed out Joshua Cooper, MD, director of cardiac electrophysiology at Temple University Health System, is that peer-reviewed literature doesn't cover complications that have a zero occurrence rate. 

"This whole discussion really revolves around the lead," Cooper said, meaning that one of the primary benefits of subcutaneous ICD systems is that there is no lead in the bloodstream as there is with the more conventional ICD systems, and leads are the weakest part of transvenous ICDs.

"The various ways that the lead can be problematic for transvenous systems are, for the most part, absent for subcutaneous ICDs," Cooper said. "The risk of infection is lower if the lead is not in the blood space. The risk for thrombus is zero if the lead is not in the blood space. The risk of scaring or narrowing vessels is zero if the lead is not in the blood space."

"In the medical literature we often see reports of things that happen and there is a much lower incidence of people reporting things that don't happen," he added. So if insurance companies are basing coverage decisions on what they see in the published literature, they, of course, will not find as much evidence around S-ICDs as there is for ICDs.

Both Knight and Cooper were early adopters of the S-ICD and both doctors agreed that there are several types of patients who are better suited for the subcutaneous approach than the transvenous approach.

"Patients who have no veinous access, previous infections, the need for their vascular space for other reasons like chemotherapy ports and dialysis, and patients with many years ahead of them would be the low-hanging fruit patients I would consider an S-ICD," Cooper said.

He explained that young patients, in particular, may benefit from an S-ICD rather than an ICD because the leads used in conventional ICDs pose a greater risk the longer they sit in the bloodstream.

"As we move forward to getting more experience with the S-ICD option, and see how it works in different populations and the incidence of new arrhythmias in patients who have never had one before, my personal practice has been to shift to considering a subcutaneous ICD after having a long discussion with the patient about the pros and cons of a transvenous lead versus a purely subcutaneous system," Cooper said.

Knight agreed and said that for patients who need an implantable defibrillator, he actually considers the subcutaneous option first unless there are reasons the individual patient should not get an S-ICD.

Stephen Hammill, MD, a member of the AHA/ACC/HRS guideline writing committee, a former HRS president, and a professor of medicine at the Mayo Clinic, explained that the guidelines are updated about once every six to 10 years and the writing committee includes 19 members who have no relationships with industry to avoid conflicts of interest.

After the committee writes the guidelines they are sent out to 36 official reviewers from each of the participating societies and then refined based on reviewer input.

"For this go around with the subcutaneous sudden cardiac death guidelines there were over 1,000 comments that had to be individually reviewed and addressed and the guidelines were then altered based on that input," Hammill said.

ProLung Breathes Life Into Lung Cancer Detection

Courtesy of ProLung ProLung Breathes Life Into Lung Cancer Detection

Three years ago, the U.S. Preventative Services Task Force and Centers for Medicare and Medicaid Services added annual screening for lung cancer with low dose computed tomography as a covered Medicare benefit for patients meeting certain criteria. The measure opened up the door for companies like Salt Lake City, UT-based ProLung  hoping to take part in the lung cancer detection market.

The company’s test uses volume-averaging bioconductance technology to measure the difference in conductivity between malignant and benign lung tissue. The data is analyzed to produce a personalized and predictive score indicating the likelihood that a particular lesion in the lungs is malignant.

ProLung said the noninvasive, radiation-free test is for use at the front end of lung cancer screening and could be used as an adjunct to low-dose CT screening. The test could improve the timeliness and cost of lung cancer diagnosis.

 “We’re not a blood specimen and we’re not a CLIA or laboratory developed test that’s limited to a state by state approval, Steven Eror, president and CEO of ProLung told MD+DI. “We’re involved in a fresh technology that has the ability to ascertain the likelihood of the differences between the malignant and benign nodules in the chest.”

Eror added, "we’ve always known that while CLIA is an option for some it lacks the ability to survive the reimbursement round. We’ve always had our eye on the FDA."

The firm’s test includes a probe, scanner, tower, monitor and keyboard, and a test kit that includes a unique code, six diaphoretic electrodes with adhesive backing, a probe tip, and other ancillary disposables.

ProLung’s test might not have approval from FDA but it has already obtained CE mark.

“Europe is a vastly smaller market because they are not screening,” Eror said. “They’re only relying on the smaller population of incidentals in large measure. For that reason our purpose is to really focus on being one of the first risk applications approved by the FDA for the U.S. market.”

ProLung was launched in 2004 as Fresh Medical Laboratories. About a year ago, the company changed its name to keep more in line with its mission for lung cancer detection.

The #MeToo Era Finally Catches Up to OrbiMed

Pixabay The #MeToo Era Finally Catches Up to OrbiMed

Five months after an investigative report accused him of sexually harassing and demeaning women for years, OrbiMed Founder Sam Isaly has transferred his controlling interest in OrbiMed and stepped down from his position as managing member of the firm.

On one hand, Isaly's departure could suggest that the #MeToo era has finally caught up with his alleged behavior. On the other hand, there is the fact that the hedge fund's press release this week does nothing to address the real issue behind the founding partner's exit.

Instead, OrbiMed suggests that this move is "part of ongoing succession planning." The transfer terms were not disclosed.

MD+DI reached out to OrbiMed for comment, but as of press time, the firm had not responded.

The firm’s five other partners, Sven Borho, Carl Gordon, Jonathan Silverstein, W. Carter Neild, and Geoffrey Hsu, will continue their ownership of OrbiMed and the managing member role has been transferred to Borho, Gordon, and Silverstein.

According to the firm's press release, Isaly intends to continue to practice his investment skills as the chief investment officer of the Isaly Family Office, and in other future activities, subject to his obligations to OrbiMed.

In the story STAT published in December, former employees complained that Isaly routinely subjected female assistants to pornography in the workplace, lewd jokes, and sexist comments. Five people who once worked at the firm described how Isaly would often handle a set of breast implants that he kept on his desk, palpating them during conversations with employees as though they were stress balls. One former assistant described a supposed prank Isaly played on her involving a sex toy.

Four women said they repeatedly complained about Isaly’s behavior to senior executives at OrbiMed, getting sympathy, but no action. Though their jobs paid well and came with many perks, the boorish environment eventually drove each to quit, the women said.

HP drives distributed design, manufacturing and supply chain transformation with Jabil and Forecast 3D

HP drives distributed design, manufacturing and supply chain transformation with Jabil and Forecast 3D

HP (Palo Alto, CA) announced new industry agreements with Jabil (St. Petersburg, FL) and Forecast 3D (Carlsbad, CA) at the RAPID + TCT conference last week in Forth Worth, TX. The agreements are expected to drive the future of distributed design, manufacturing and digital supply chains leveraging the power of HP Multi Jet Fusion 3D-printing technology, said the company. 

As the global economy enters what many call the fourth industrial revolution, technologies such as 3D printing are enabling an array of new business opportunities such as distributed design and manufacturing, supply chain services and increasingly localized production.

3D printing infographic from Jabil
Image taken from an infographic published by Jabil.

“From multinational design engineering and manufacturing to localized production, industry leaders such as Jabil and Forecast 3D are demonstrating 3D printing’s expanding role in the digital transformation of the $12 trillion global manufacturing economy,” said Stephen Nigro, President of 3D Printing, HP Inc. “HP Multi Jet Fusion customers and partners represent critical links in a new value chain that’s rewriting the rules of design, production and delivery, ultimately ushering in a new era of digital manufacturing.”

Also at RAPID + TCT, Jabil announced its Additive Manufacturing Network to drive greater manufacturing speed and agility while helping customers improve how they design, make and deliver products. “Jabil’s digital thread fuels a growing footprint of 3D printers and additive manufacturing capabilities to benefit customers through localized production, consolidated supply chains, reduced costs and faster time-to-market,” said John Dulchinos, Vice President of Digital Manufacturing for Jabil. “Our new Jabil Additive Manufacturing Network is the connective tissue that scales globally to integrate every printer, facility and work order across our enterprise and crystallize our vision of truly distributed manufacturing.”

Over the past year, Jabil has steadily increased its 3D-printing capacity with more than 100 3D printers now in operation at facilities in the United States, China, Hungary, Mexico, Singapore and Spain. A variety of 3D-printing machines have been installed for high-speed sintering, fused filament fabrication, polymer and metal laser sintering and other processes to address emerging customer needs in the footwear, industrial machines, transportation, aerospace and healthcare industries. Jabil’s distributed manufacturing strategy is anchored by this growing ecosystem of 3D printers, which includes a dozen production-ready HP Jet Fusion 4200 3D printers, following the recent installation of six HP Jet Fusion 4210 printers at its Singapore facility.

Dulchinos commented, “HP Multi Jet Fusion gives us the foundational 3D-printing platform we need to deliver truly industrial-grade production applications for our globally distributed customers. Our aim is to harmonize the multiple regions, technologies, materials and manufacturing workflows of the fourth industrial revolution, and HP is an important partner in that effort.”

Forecast 3D, one of the oldest and largest privately held 3D-printing companies in the United States, is adding six new HP Jet Fusion 4210 solutions to expand its fleet to 18 systems in response to increasing customer demand. Forecast 3D plans to produce several million end-use parts on HP’s 3D printers in the coming year, delivering commercial-grade applications for clients in multiple industries including the medical, consumer goods, aerospace, defense and auto sectors.

“Our customers across all industries have spoken, and they are looking for more of the speed, quality and cost benefits for production applications unleashed by HP Multi Jet Fusion,” said Corey Weber, CEO of Forecast 3D. “We are investing in this important 3D-printing technology platform as we scale up to meet rising demand from international and domestic clients seeking to reinvent their product lifecycle.”

HP is committed to democratizing 3D design and manufacturing and recently expanded its portfolio with the introduction of the Jet Fusion 300/500 series, the world’s first 3D printers to deliver engineering-grade, functional parts in full color, black or white in a fraction of the time of other solutions, stated HP in its release.

Chinaplas: New polyamide 66 engineering resin bridges gap to more costly, high temperature alternatives

Chinaplas: New polyamide 66 engineering resin bridges gap to more costly, high temperature alternatives

The transition from internal combustion engine-powered vehicles to full electric vehicles will take some time due to driving range and infrastructure limitations. In the interim hybrid electric vehicles (HEVs) in their various guises will play a key role in the shift to a low carbon future. This is the view of Bertrand Lousteau, General Manager, Performance Polyamide APAC, at Solvay Performance Polyamides.

Tensile strength after ageing: Test results have confirmed that 2,000 hours of working temperature at 220°C are perfectly manageable with Solvay’s cost-effective new Technyl Red J high-heat technology for automotive turbo engine components.
Solvay Performance Polyamides’ Technyl e-range focuses on surging demand for materials capable of handling the cost/performance challenges of automotive electrical and electronic components, including signal orange colored grades for high-voltage applications such as connectors, circuit breakers, sensors and insulators in the growing market segment of e-mobility.

During what will probably be a ten-year transition period, the smaller engines employed in HEVs will operate at higher temperatures to realize higher efficiencies, hence necessitating the use of polyamide (PA) 66, polyphthalamide (PPA), and polyphenylene sulfide (PPS) engineering resins. Solvay is working to bridge the gap between PA 66 and higher temperature PPA resins with the debut of its Red J PA-based material specially designed for turbocharger systems running at continuous temperatures up to 220°C.

“Auto makers have recently been refining the real operating temperatures needed for thermal management systems. They realized that traditional high-heat polymers appear to be over-engineered and can also be too brittle to maintain required thermal, pressure and chemical performance over time,” says Didier Chomier, Automotive Global Marketing Manager for Solvay’s Performance Polyamides Global Business Unit. “In response to these specific auto industry needs we developed and are introducing Red J material. Red J is the top-of-the-range building block of our Technyl Red offering for thermal management systems. The superior property profile of Technyl Red J targets applications such as air intake manifolds, charge air coolers, turbo air ducts, resonators, cylinder head and engine covers.”

Technyl Red J reportedly offers outstanding long-term heat ageing performance of up to 220°C (at 2,000 hours) or 210°C (at 3,000 hours). Based on patented PA 66/6T technology, Technyl Red J flows like PA 66, ensures high chemical resistance and excellent surface aspect.

In addition, it is highly suitable for both vibration and hot gas welding, delivering high burst pressure levels confirmed in extensive pulsated air pressure tests at Solvay’s Application Performance Testing (APT) centers. Recommended melt and mold temperatures are significantly lower than competitive PA 4.6 or PPA resins, which saves energy during processing and minimizes part cooling time.

On the electric side of the HEV, Solvay sees high demand for high temperature flame-retardant grades used in connectors and charging infrastructure such as the company’s e-range of PAs developed to “provide fit-for-purpose and cost-efficient solutions to meet major challenges and disruptive trends such as connectivity and autonomy as HEVs, all-electric vehicles (xEV) and autonomous vehicles share a common and growing need for improved electrical and electronic components performance.”

“China is playing an increasing role in the field of e-mobility,” says Nicolas Batailley, Global e-Mobility Leader for Solvay Performance Polyamides. “While the country nearly accounts for one-third of the world’s automotive production, the share of both hybrid and fully electric vehicles manufactured in China has been set to an ambitious target of 20 percent by 2025, which represents almost seven million vehicles. Our Technyl range has been further enriched to help reach this challenging goal.”

The enhanced Technyl range comprises flame retardant (FR) solutions, electro-friendly products in both pure and high purity grades and the novel ion-free PA 66 grade for fuel cell applications. Developed in close collaboration with OEMs and Tier 1 partners, the range reportedly meets the challenges in terms of cost, performance and sustainability at the highest levels in the market.

“We have also developed a range of highly stable Technyl orange colored grades as we continue to innovate our portfolio for e-driven vehicle applications,” adds Batailley. “Orange is the new black for ease of identification as we focus on components designed to handle high voltages, such as connectors, circuit breakers and insulators.”

4 Trends Advancing Medtech

4 Trends Advancing Medtech

For the past 20 years, the Medical Design Excellence Awards have celebrated medical products that improve the quality and accessibility of healthcare. Our finalists this year carry on this tradition, while also keeping in step with today’s high-tech digital and consumer trends.

With the help of our esteemed jurors, we have identified four key trends in this year’s group of finalists: risk reduction; faster, more-efficient healthcare delivery; the influence of the Internet of Things; and the consumerization of healthcare.

We’ve been tracking a few of these trends in past awards programs, so they’re not necessarily new. In fact, when we launched the program in 1998, we noted a trend in the very first group of MDEA finalists toward “meaningful focus on the patient.” This year’s group of finalists are just as focused and may very well be addressing unmet needs in their respective categories. In this article, we cover a few of the trend-setting finalists; for the complete list, click here.

First, Do No Harm

Medical devices enable doctors and nurses to save and sustain lives every day, but invasive procedures can present risks of infection and trauma. Many finalists this year aim to minimize those risks.

A number of devices intended to ease surgical procedures or reduce their risk competed in this year’s ER and OR Tools, Equipment, and Supplies category. The VersaOne Fascial Closure System, for instance, is designed to deliver consistent port-site closure, added procedural efficiency, and ease of use, Medtronic reported in its submission. The system enables the trocar to remain within the patient while closing the defect, allowing for tissue alignment and pneumoperitoneum. MDEA juror Uli Chettipally, physician, researcher, and an innovator with InnovatorMD, called it a “smart and clean solution.” 

The CleanCision wound retraction and protection system (below) for use during abdominal surgery aims to consistently and continuously irrigate the wound edge with a surgeon-selected fluid therapy to actively fight and remove the root cause of surgical site infection—wound contamination—without disrupting current surgical practice, Prescient Surgical explained in its submission.

The CleanCision would retraction and protection system. Image courtesy of Prescient Surgical

Ethicon Endo-Surgery’s ENSEAL X1 Large Jaw Tissue Sealer can seal and cut vessels and tissues. Juror Carmen Chacon, medical designer, Chacon Design, noted that “the product focuses on the end user and patient safety.”

The Minne Ties Agile MMF system is a noninvasive alternative to existing wire or hybrid devices for maxilla-mandibular fixation. Jurors found the system to appear “simpler and faster” than the current standard of care. Juror Mary Kay Smith, director of the Michigan State University Learning and Assessment Center, noted its potential to “eliminate ulcerations in the mouth from wires,” while Chacon noted “better stability through use of material to protect doctor and patient comfort.”

To prepare for surgery, patients could use the MediClear PreOp silicone film drape to clean and prepare a site up to seven days before surgery. Using chlorhexidine and silver-embedded silicone adhesive, the drape provides constant broad-spectrum antimicrobial protection, while its transparent polyurethane backing acts as a barrier to external sources of contamination, Covalon Technologies stated in its entry to the OTC and Self-Care Products category. Juror David Copeland, director of human factors industrial design for Ximedica, described it as “a very novel approach that removes the burden of excessive skin prep and cleaning (and effort) from the patient, and in essence, makes it more passive with application of the patch. Addressing the potential non-compliance factor by providing a wear-it-and-forget-it solution simplifies the HCPs job as well.”

Patients face risks outside of surgery, too. For instance, the Flusso bypass adapter aims to prevent patient disconnection from a mechanical ventilator during a circuit change or disconnection of the patient for transport, McArthur Medical Sales reported in its entry into the Nonsurgical Hospital Supplies and Equipment category. Copeland found the solution “very clever and simple,” adding that it “has immediate benefits to patient, user, and hospital by providing a simple, elegant, and safe means to transition from stationary vents to portable vents and vice versus, all the while having a minimum impact to the patient's care.”

Faster, More Efficient Care

Many finalists are attempting to speed up healthcare screening and procedures, which can benefit patients, clinicians, and healthcare systems.

Built on “deep learning,” PowerLook Tomo Detection (below) is designed “to optimize breast tomosynthesis reading efficiency, streamline workflow, and support cancer detection without compromising reading performance or increasing recalls,” iCAD Inc. wrote in its submission to the Radiological, Imaging, and Electromechanical Devices category. Juror Mark Wehde, section head for Mayo Clinic’s Division of Engineering, called it “an impressive addition to the tomosynthesis being sold in the [United States]. Tomosynthesis has been shown in several studies to generate significantly improved results. The system from iCAD adds to the impressive diagnostic ability of this modality with reduced screening time due to its significantly improved detection algorithms and user interface.”

PowerLook Tomo Detection. Image courtesy of iCAD Inc.

For head and neck imaging, the portable OmniTom 16-slice CT scanner could be used by a single operator. Samsung NeuroLogica claims that the system offers rapid scan time and immediate image viewing of high-quality, noncontrast CT angiograph and CT perfusion scans at the point-of-care.

Submitted in the Implant and Tissue-Replacement category, the GRYPHON Anchor with PROKNOT Technology is a pre-tied knot for loading onto the GRYPHON Anchor for shoulder and hip repairs. The product is 64% smaller than traditional arthroscopic knots and is more consistent than arthroscopic knot-tying due to requiring only one half hitch, according to the submission from Johnson & Johnson Medical Devices Companies. “A simple half-hitch stich and anchor combo eliminates steps in a traditional repair procedure,” said Chacon.

The Alinity s Series blood and plasma screening instrument aims to improve the testing efficiency of blood and plasma donations to screen for infectious diseases. Juror Andra Blomkalns, MD, believes it “could allow for the more rapid delivery of pathogen free blood needed for emergent transfusions by rapidly testing samples for disease like HIV and hepatitis.” Blomkalns serves as vice chair of academic affairs and business development, Department of Emergency Medicine; and medical liaison to the Office for Technology Development, UT Southwestern Medical Center.

Submitted in the Cardiovascular Devices category, the HyperView system employs noninvasive, nonionizing hyperspectral imaging technology to assess tissue oxygenation in cases involving local, regional, and systemic flow ischemia. “The device, while utilizing initial tech from 2006, has incorporated the diagnostic benefits of hyperspectral imaging technology into a portable, point-of-care device to determine tissue oxygenation/perfusion,” observed Blomkalns. “Benefits include that it is real-time, non-invasive, and more efficient than existing methods. It has potential use in several specialties, including vascular surgery, podiatry, plastic surgery.”

The AeroForm Tissue Expander System helps patients prepare for breast reconstruction. The patient-controlled needle-free device can be used at home and could reduce time to reconstruction, noted Blomkalns. “AeroForm is a first-of-its-kind, patient-controlled, tissue-expansion system for patients planning reconstructive surgery after mastectomy for breast cancer,” she said. “The product innovation is the patient controlled and gradual tissue expansion decreasing the need for doctor visits and has led to faster tissue re-expansion period by roughly half. The benefit to the patient and healthcare system is substantial.”

The SPEEDTRAP Graft Preparation System (below) for soft-tissue grafts in orthopedic procedures employs a fingertrap needleless technique to compress rather than pierce the graft. Jurors noted that graft preparation time is 77% faster and that it could reduce vascular injury. Chacon called it a “simple device that minimized procedural time [and] increased strength and reliability for the patient and surgical staff.”

The SPEEDTRAP Graft Preparation System. Image courtesy of DePuy Synthes Companies

Submitted in the Drug-Delivery and Combination Products catgeory, SURGICEL Powder Absorbable Hemostat is designed to quickly stop blood flow across broad surfaces and on friable or raw tissue. Johnson & Johnson Medical Devices Companies report that the structure of the powder penetrates the surface of the blood to get to the sources of bleeding and is proven bactericidal against pathogens. Juror Scott Thielman, chief technology officer, Product Creation Studio, described it as a “beneficial delivery form factor and effective homeostasis; this seems like a welcomed product for surgeons.”

Even faster product sterilization times could offer healthcare benefits. The STERRAD VELOCITY is a hydrogen peroxide biological indicator (BI) system that confirms proper sterilization of reprocessed surgical instruments within 30 minutes, reported Advanced Sterilization Products, part of Johnson & Johnson Medical Devices Companies. “Rapid, 30-minute BI readings are a huge win for the hospital system,” said Thielman.

Internet of Things

There’s very little today that hasn’t been influenced by IoT. Juror Stephen Wilcox, PhD, principal and founder of Design Science, noted an acceleration of IoT and connections to the cloud among this year’s finalists. In hospitals, such connectivity may be controlled or locally limited to protect privacy and minimize risks, but there’s a definite trend in medtech toward some level of connection. Somewhat related, juror Lance Black, MD, medical device innovation lead for the TMC Innovation Institute, also observed that the presence of “software as a service is tribute to what is happening in healthcare.”

The StealthStation S8 visualization and surgical navigation system, designed for cranial, spine, and ear-nose-throat procedures, allows users to track several instruments in real time using optical and electromagnetic localization technologies. The system offers wireless connectivity to hospital and medical devices, allowing the import and export of exams from anywhere within the hospital network, Medtronic reports on its Web site. To maintain cybersecurity, users can define the level of security for user authentication, antivirus protection, encryption, and firewall protection.

Offering remote visibility through RFID, the IntelliGuard Linked Visibility Inventory System tracks medication and reconciliation. Wehde called it a “very sophisticated and well-though-out design” that “allows for seamless tracking of items removed from storage without error-prone human intervention. [The device] facilitates organization of needed medications to help minimize user error. Quality improvement advocates will love this system because it helps drive out user error through elegant 5S design and automated tracking.”

A finalist in the Testing and Diagnostic Products and Systems category, the Sofia 2 (below) uses advanced fluorescence detection in a benchtop system that allows clinicians to test for diseases such as influenza, streptococcus, and respiratory syncytial virus in a point-of-care setting. “Portability, connectivity, and simplicity make the Sofia 2 a great choice for point-of-care diagnostic settings,” said Thielman. “The touch-screen and automated reporting connectivity suggest a modern design.”

The Sofia 2. Image courtesy of Quidel Corp.

Devices used outside healthcare settings are increasingly becoming connected. For instance, the MoMe Kardia electrocardiograph monitoring wearable continuously streams data to the cloud. Blomkalns called it a “novel, sleek, heart rhythm monitoring wearable with three modes (Holter, event, and mobile cardiovascular telemetry). Positive attributes include non-intrusive design, ease of use with simple display and sound prompts, [and] wireless transmission of HIPAA compliant cloud based data accessible to care providers remotely.” The system’s design may also help overcome user struggles. Jurors stated that it is “hard to find an easy-to-use monitor for patients—the leads come off.” Such utility could ultimately make a difference, as “Thousands of patients go undiagnosed,” said Wehde.

Entered into the Rehabilitation and Assistive-Technology Products category, the Podimetrics Remote Temperature Monitoring System for monitoring inflammatory foot diseases such as foot ulcers employs a “telemedicine mat” and an online portal for clinical decision support, Podimetrics Inc. stated. The system provides a compliance indicator that lights up and then generates a phone call if needed, jurors observed. The system has a “great form factor and integration of electronics/algorithms,” noted juror Eric Richardson, associate teaching professor at Rice University.

The nfant Feeding Solution from NFANT Labs measures an infant’s tongue movement during feeding. It can turn a baby bottle into a smart bottle to collect and analyze “real-time, reviewable biofeedback” and report it to clinicians, the company reported. Smith said the design appears to be “very easy to use and not obtrusive to feeding of vulnerable infants. Benefits appear most relevant to decrease in healthcare costs as it is more diagnostic in nature.” It appears to bring technology to a previously manual, perhaps subjective evaluation, as Black stated that the “pinky finger is the standard.”

Consumerization of Healthcare

Copeland saw among the finalists evidence of the consumerization of healthcare products in interfaces and touchpoints, while Blomkalns noted a trend toward allowing patient to do things at home.

The injection devices for Eli Lilly and Co.'s Taltz (below) demonstrate such a user-centric direction. Indicated for patients with moderate to severe plaque psoriasis and psoriatic arthritis, the medication is provided in both autoinjector and prefilled-syringe form. The “auditory click is impressive and provides additional layer of reinforcement for patient to verify medication is injected correctly,” noted Smith. “Attention to arthritic patients is also notable given the growth in patients falling within older demographic. Option for users to choose between two devices provides for more flexibility.”

Taltz Injection Devices. Image courtesy of  Eli Lilly and Co.

Methofill (methotrexate) utilizes the self-injecting Self Dose, an alternative to standard injectors. A lot of usability data has been collected. “The summative user testing is compelling for the Self Dose,” said Thielman. “It is clear that user needs drove the design.”

Designed for use without a prescription, ZipStitch is an alternative to stitches for minor cuts and lacerations in seconds. Thielman said that “this is a better method for serious cuts versus bandages and stitches. [It] belongs in every hiking, hunting, scouting, and boating first aid kit.”

The Willow Breast Pump is a hands-free pump with few parts to assemble, noted jurors. “I believe design and technology will revolutionize healthcare,” Thielman said. “Willow is confirmation of this. Great design focused on a better outcome for the user.”

To hear the Gold, Silver, and Bronze MDEA winners as well as the Best in Show winner announced, join us June 12 at the Jacob K. Javits Center in New York City. We’ll host a pre-ceremony cocktail reception at 4:00 PM in Room 1E15 - 1E16 and then we’ll start the show! The ceremony is open to all attendees of Medical Design & Manufacturing East, held June 12-14. Click here to register for the show.

Click here for a complete list of all 2018 finalists and images.

For trends among last year's finalists, please see our May 2017 feature, "The 4 Essential Elements of Device Design Today."