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Articles from 2018 In March

Avinger Assemble! Firm's Pantheris Pummels Plaque

Avinger Avinger Assemble! Firm's Pantheris Pummels Plaque

Avinger, a medical device company,  shares a lot in common with Marvel Comics' Avengers - beyond having similar spelling names. The Avengers have a premiere super hero called the Black Panther and Avinger has the Pantheris Lumivascular Artherectomy system. While Marvel's Avengers are fictional heroes that save lives, Avinger really helps improve the lives of patients suffering from peripheral arterial disease (PAD), through the use of the Pantheris device.

The Redwood City, CA-based company, which was formed in 2007 and went public in 2015 on a $65 million IPO, has been brimming with activity recently and is positioning itself to obtain a slew of indications and clearances to help expand the prowess of the Pantheris device. 

“We’ve been on the market now in the U.S. since 2016 and we’ve seen a number of opportunities to improve the device,” Jeff Soinski, CEO of Avinger, told MD+DI. “That has led to a 510(k) filing (in late December) for a next generation Pantheris [device].”

Avinger's Lumivascular technology allows physicians to see from inside the artery during an atherectomy procedure by using an imaging modality called optical coherence tomography (OCT). The modality is displayed on Avinger’s Lightbox console.

Physicians performing atherectomy with other devices must rely solely on X-ray as well as tactile feedback to guide their interventions while treating complicated arterial disease. With the Lumivascular approach, physicians can more accurately navigate their devices and treat PAD lesions, thanks to the real-time OCT images generated from inside the artery, without exposing healthcare workers and patients to the negative effects of ionizing radiation.

The next generation device includes a simplified single balloon system for both apposition of the device and occlusion of blood flow, a stiffer shaft for increased pushability.

During a conference call held in March, Avinger executives indicated that once the company receives FDA clearance for the next generation Pantheris, then the plan is to first introduce the device to a limited number. Then the firm would ramp up production and gain purchasing approvals for a rollout to its broader account base.

The company recently said it had successfully treated the first three patients with the extended nosecone version of the next generation Pantheris in European centers.

“That extended nose cone gives the ability for the storage capacity to be increased by 75 percent,” Soinski said. “The reason that’s important is that it should provide for more efficiency in the procedure, which would be particularly important when you’re treating these long-diffused lesions or lesions where there is a lot of plaque.”

The big story on the horizon for Avinger’s Pantheris is securing an indication to treat in-stent restenosis (ISR). In October, Avinger began enrollment to evaluate the safety and effectiveness of Pantheris when treating ISR. The study is expected to enroll up to 140 patients in 20 sites.  The company said ISR represents about 20% of PAD procedures in the U.S.

“We see ISR as an important opportunity for us and it is a particularly challenging lesion,” Soinski said. “Because of our imaging we can quite readily see the stent strut and provide the control for the physician, so they can target the plaque inside the stent, but avoid damaging that stent.”

The company would have a six-month-follow up for the patients, which should be complete in 2019. The firm would submit to the FDA sometime after. 

Soinski said the company doesn't have much in the way of competitors. 

"We're not aware of anyone else who is actively pursuing the combination of real time imaging with therapeutic catheters in a single device," Soinski said. "It's really challenging to do and there is a lot of intellectual property and technology know-how that's been developed over 10 years now at Avinger, to be able to do this." 

These Smart Socks Could Kick Diabetic Foot Ulcers to the Curb

Siren These Smart Socks Could Kick Diabetic Foot Ulcers to the Curb
Siren Diabetic Socks use Neurofabric to detect temperature changes between your feet, which are a sign of possible foot ulcers.

A new digital health company wants to has a new wearable technology that could knock the socks off of patients with diabetes.

San Francisco, CA-based Siren launched a diabetic sock and monitoring system designed to proactively and continuously track foot temperature, helping patients detect signs of inflammation, the precursor to diabetic foot ulcers, a condition that leads to more than 100,000 foot and leg amputations each year in the United States.

The socks are made of Neurofabric, a textile wearable with embedded microsensors. According to the company, the sensors are virtually undetectable to the user. The socks have the same look and feel of a normal sock, are machine washable, and contain moisture-wicking fabric to remove moisture from the foot. The company also has a companion smartphone app to compile data. 

Monitoring foot temperature has been clinically proven to be the most effective way to prevent diabetic foot ulcers, but for years foot monitoring methods have relied on non-continuous manual measurements. This usually requires patients to go to a physician to get six spots on each foot manually measured for temperature. The process is not only laborious and time-consuming, it’s also proven to be insufficient when it comes to preventing diabetic foot ulcers, a condition that can often lead to serious complications.

Roughly 56% of diabetic foot ulcers become infected, and 20% of these infections lead to some form of lower extremity amputation. Almost 50% of diabetic patients who undergo foot or leg amputations die within five years of losing their limb, according to the National Institutes of Health.

“We built this technology because foot ulcers are the most common, costly, and deadly complication for people with diabetes, yet there was no way to continuously monitor for these massive problems,” said Ran Ma, CEO and co-founder of Siren. “Our Neurofabric has endless applications across healthcare, sports, military, and fashion, but it was obvious to us that solving this specific problem is where we had to start because it impacts so many, and can mean the difference between losing a limb or not.”

The company is selling the technology as a monthly subscription service to patients for $19.95 a month, which includes a new package of socks every six months, access to the mobile app, and live customer service.

Moldmakers dodge impact of steel and aluminum tariffs thanks to Trump’s exemptions

Moldmakers dodge impact of steel and aluminum tariffs thanks to Trump’s exemptions

steel productionMoldmakers may have escaped the impact of tariffs on steel (25%) and aluminum (10%), thanks to Trump’s exemptions for steel and aluminum produced in Canada and Mexico—the first to be announced—along with the European Union, Argentina, Australia, Brazil and South Korea, which were announced on March 22.

A few moldmakers were a bit nervous. One wrote that he had received a notice a few weeks ago from one company alerting him to the fact that “steel tariffs are kicking in on our steel,” resulting in a 25% price hike after April 1. On the large molds that this company produces, this could add $10,000 to the price of a mold, said the moldmaker, which could make the company non-competitive in its bids. “Good thing I have 30-day terms on my quotes,” he wrote to me.

Trying to get responses from various mold steel and aluminum suppliers was unsuccessful. Only Bohler Uddeholm replied—it gets steel from Europe, so it won’t be affected by the tariffs.

It looks like the moldmaking industry will be okay thanks to the exemptions, except for those who buy steel or aluminum from Chinese suppliers. But then any company that buys steel and aluminum from China is taking a big risk with quality, so perhaps the tariffs on Chinese steel and aluminum are their saving grace.

The new tariffs “will apply to all goods entered, or withdrawn, from warehouse for consumption on or after 12:01 AM EDT on March 23, 2018,” said a news item from PlanteMoran. “With objectives to increase U.S. steel mill operating capacity to 80% (from an estimated 72.3% in 2017) and primary aluminum production to 80% (from an estimated 39% in 2017), the Department of Commerce found that ‘excessive’ steel imports and the ‘present quantities and circumstances’ of aluminum imports are weakening both the domestic economy and national security.”

In attempting to help manufacturers assess the impact of these tariffs, PlanteMoran acknowledged the “uncertainty about where the material is purchased, particularly when buying steel or aluminum through distributors and service centers. For the auto industry, provenance may be more certain given the strict material specifications that may limit where materials are sourced. For other manufacturers, contractors and those with steel and aluminum in their bills of materials, the primary source of materials may be a surprise.”

PlanteMoran recommends that OEMs identify the materials, material processes and processors, and fabricators in their supply chain . . . “as far down through the supply chain as possible.” PlanteMoran also suggests that OEMs “carefully review contracts with suppliers and customers to [ensure their] company is as material-neutral as possible, and not accepting material cost increases from a supplier that cannot be mitigated with the customer.”

Now that the exemptions are in place, it should be easier for moldmakers to purchase their steel and aluminum from exempt countries, thus not incurring additional costs in the mold build.

It’s important to remember that these tariffs are about more than just addressing the dumping of materials from China. A blog post from the Alliance for American Manufacturing—“Don’t Forget: China Has Stolen American Trade Secrets for Years Now,” by Elizabeth Brotherton-Bunch—notes that the bill is a “three-pronged approach designed to address China’s rampant intellectual property (IP) theft, which will include about $50 billion in tariffs, the filing of a complaint at the World Trade Organization and an investigation into Chinese investments in the United States.”

We have long known that China’s practice of IP theft, counterfeiting and other unfair trade practices have harmed American businesses and cost American jobs.

Just the other night on the evening news it was noted that China has announced it is now willing to talk about trade matters.

I guess that a little of Trump’s “tough love” is starting to work!

Platinum Equity completes $3.85 billion Husky acquisition

Platinum Equity completes $3.85 billion Husky acquisition

The acquisition of Husky Injection Molding Systems International Ltd. by Platinum Equity (Beverly Hills, CA) has successfully closed.

Bolton, Ontario–based Husky is a global supplier of injection molding equipment and services for the plastic injection molding equipment industry, and a leading provider of PET systems, hot runners, aftermarket tooling, medical molds and specialty closure molds.

Platinum Equity made an initial announcement on Dec. 18, 2017, of its intention to acquire Husky IMS from Berkshire Partners and OMERS Private Equity for $3.85 billion.

Members of Husky’s management team remain important investors in the business through continued equity ownership.

Husky is a technology provider to the plastics processing industry with state-of-the-art manufacturing equipment delivered to a wide range of customers in various end markets. Approximately 70% of sales are generated outside North America.

Stamping or Machining: What Do You Choose for Your Metal Devices?

A machined reusable surgical instrument
A machined reusable surgical instrument. Image courtesy of MICRO

You’re developing a metal medical device and balancing a budget, deadlines, design considerations, and more. Which process do you choose—stamping or machining? MD+DI asked metal manufacturing veteran Steve Santoro, executive vice president for MICRO, to compare the two processes as well as look forward to the future in metal manufacturing. Santoro has been at MICRO since 2002 and has been in the contract manufacturing industry his entire career.

MD+DI: What are the basic differences between stamping and machining when it comes to medical devices?

Santoro: The main determinant when considering stamping versus machining has to do with the fit, form, and function of a component coupled with the geometry of the part and material used. If a medical device is designed for an indefinite number of uses, then machining works best, as it produces complex parts that support durability. For products that are meant to be used just one time, stamping is a better approach as it can produce precision parts that tend to be less durable.

Volume can also be a significant driver in the decision-making process. When several million components a week are needed, such as ligation clips, this can be easily achieved with stamping. To machine such quantities might require 100 machining centers. Thus, scaling to this degree with machining may not be practical in terms of capital outlay.

Tooling costs are another consideration. For example, if a device requires tight tolerances of +/-0.0005 inch and has volumes of 3000-5000 pieces a week, machining usually is the technology of choice as it is more versatile and precise. Assuming the right machining center is available, it merely needs to be programmed to accommodate the part geometry. This is in sharp contrast to a progressive stamping die, which will take longer to design and build, in addition to being costlier.

Part geometry is also a major consideration. There are some components that simply cannot be stamped. For example, a part made of full hard 304 stainless steel, 1/8-in.-thick with a hole that is 0.040 diameter cannot be stamped. There is no punch material that can take the load required to pierce that material at that diameter. Machining works best in this case coupled with laser technology.

MD+DI: Are there any market needs/requests that could be best solved by either technology?

Santoro: With the wide-spectrum of clients that MICRO supports, there are certain technologies that are more suitable to their needs and end goals. For example, stamping is valuable for clients that are designing single-use devices, as they tend to be less robust and involve significantly lower costs to build than do reusable devices. Machining, on the other hand, lends itself to the development of reusable devices as they need to withstand repeated use—though this durability tends to come at a higher cost. Metal injection Molding (MIM) or MIM plus machining offers a compelling middle ground in terms of price and durability.

MD+DI: Are there any material selection differences?

Santoro: Regarding whether stamping or machining is the best approach for the development of a medical device, material thickness and material hardness need to be considered for the most effective and efficient outcomes. As it relates to material thickness, for example, stamping can be limiting because thickness needs to be uniform throughout the part. With regard to material hardness, virtually any hardness can be machined. In stamping, material hardness needs to be considered more carefully given the potential for cracking during forming. Also, in many cases, titanium is the material of choice for implantables and is best for CT scanning. Titanium is available in wire, rod, and sheet forms; however, it is not commonly available in continuous strips, which are needed for most stamping operations.

[Image at right: A stamped part]

Material selection has its limitations. In general, most red metals, stainless steels, titanium (wire), and cold rolled steel can be stamped. The general consideration to be aware of is that the heavier the gauge and the higher the hardness, the more difficult it is to stamp.

Most medical stampings are from 302, 304, 17-4, or 17-7 stainless steel. At MICRO, we stamp the full range of commercially available tempers up to and including full hard as well as thicknesses up to 0.060 in. Machining can work on all the same materials up to and including full hard temper. It also offers far more capabilities when it comes to creating complex shapes out of very thick blanks at extremely accurate tolerances from any of those materials that can be stamped. There is, however, a cost consideration with machining, as it is generally more expensive per unit.

At MICRO, we have more than 50 metal stamping presses, up to a 220 ton, including over 30 Bruderer 30- to 60-ton high-speed presses running at speeds up to 1200 strokes per minute. Most are equipped with the latest sensor technology. Parts are typically supplied loose or in reel-to-reel configurations.

MD+DI: Any differences in precision design or device strength?

Santoro: When the product designer elects stamping, there is little room for error given the potential cost of a complex progressive die. Therefore, it is important that the designs are reviewed and approved by the manufacturer early during the design process.

It should also be noted that once the product is designed using machined components, it can be extremely difficult to re-engineer the part as a stamping to reduce cost without fundamental design changes.

MIM or MIM plus machining can provide a middle ground in terms of cost versus a fully machined part.

Above: MIM part with machined slot

MD+DI: How has each technology been modernized over the years?

Santoro: Citizen has recently combined Swiss turn machining and laser cutting in one advanced machine. Particularly suited for fabricated tube production, the Citizen L200 CNC machining center combines a Swiss style 7 axis CNC lathe and an integrated 400 W laser cutter. It laser-cuts slots and holes and simultaneously machines differing outside diameters, thus reducing setup time, secondary processing, and handling costs.

Robotics have been incorporated into stamping and machining centers to decrease the time that it takes and decrease human errors in repetitive tasks.

MD+DI: Is either one suited better for certain secondary processes or finishing steps?

Santoro: Secondary processes need to be addressed on a case-by-case basis. This may not be not a machining-versus-stamping issue unless it is dictated and designed out of necessity because of volume and upfront cost in the product design phase.

Part geometry may dictate the secondary process steps. For example, part geometry may allow bulk passivation where required, or it may dictate that parts be racked for passivation. These are very different processes with very different costs (with bulk almost always being lower), regardless of whether they are stamped or machined.

Nonetheless, stamping may be better suited for secondary operations and automation because, in many instances, the part can be left on a carrier strip to facilitate automated secondary processes such as degreasing or selective plating. This also lends itself to performing a secondary operation that cannot be done in stamping such as welding on a threaded nut, adding a silver contact, laser marking, sharpening, etc.

MD+DI: Are there any user challenges that can be solved with either technology?

Santoro: Speed of development is improved using machined components. It is usually faster to make a design change and get development samples in a machined part as opposed to a stamped part given the lack of dedicated tooling.

Above: PEM machined part

MD+DI: How will each technology change in the next 5 years? 20 years?

Precise Electrochemical Machining (PEM) is a revolutionary new technique that offers some advantages over any of the above in terms of material selection, surface finish, etc. It is a powerful, non-contact metal-shaping process that pairs a PEM Machine with an electrolyte processing unit, power generator, and operator control station. Using electric current and an oscillating tool bathed in a conductive electrolyte (salt water), PEM dissolves metal by liquefication. A positively charged workpiece (the anode) takes the form of the negatively charged tool (the cathode) as the metal is dissolved. The result is a high-quality, burr-free part. And, since the electrode or “tool” never touches the anode or “workpiece,” there is no wear on the final part. (Please see at right for a PEM part and the illustration below for the process.)

PEM Benefits and Capabilities:

  • Produces highly complex, contoured, intricate shapes.
  • Tolerances capabilities of 5 microns (0.0002 in.).
  • Processing of Super Alloys, MIM’s components, all grades of stainless steel, titanium, aluminum, and carbide.
  • Material removal rate (MRR) is not affected by hardness of the metal.
  • Feed rate 0.1 – 2.0 mm/min.
  • Roughing, finishing, polishing in one operation.
  • Surface finish Ra ≥ 0.03 microns (1.2 micro inches).
  • No burrs, cracking, or material deformation.
  • No stress imparted to the work piece.
  • Grain structure unchanged.

Above: An illustration of Precise Electrochemical Machining (PEM)

MD+DI: Will 3-D printing replace either technology?

Santoro: As additive manufacturing improves in quality, there is an expectation of some erosion of low-volume machining. Stamping, on the other hand, is a low-cost, high-volume process that is less likely to be affected in the foreseeable future.

For more details, visit MICRO at BIOMEDevice Boston Booth #317 April 18-19.

[All images courtesy of MICRO]

New iteration of Moldex3D accelerates plastic product innovation

New iteration of Moldex3D accelerates plastic product innovation

Moldex3DCoreTech System Co., Ltd. (Moldex3D; Farmington Hills, MI), a leading provider of plastics simulation products, yesterday announced the availability of Moldex3D R16. The software reportedly achieves a new level of efficiency and reliability in plastics simulation, and enables productive design-to-analysis workflows to accelerate the pace of product innovation. The company will showcase it at NPE2018 in booth S27079.
Moldex3D R16 incorporates significant advances in processing speed, enabling 20 to 30% faster filling and packing simulation results, according to CoreTech. In addition, users will benefit from a new flow analysis program that can drastically reduce the time it takes to determine the best gating locations.

Quick Flow allows users to rapidly test multiple gating iterations and quickly apply the optimal gate location to a regular flow analysis for in-depth validation and optimization. Users are able to minimize weld lines in the early analysis stage, saving a great deal of time and effort on running a gate location analysis, especially when analyzing large parts.

Moldex3D R16 offers new Viscoelasticity-Flow (VE-Flow) Analysis, which employs a novel coupling approach to realistically capture real-world visco-elastic flow behavior. Coupling visco-elasticity to flow enables more accurate predictions of warpage, optical properties and flow-induced issues to meet stringent quality demands.

Composites part designers and engineers will benefit from a capability for predicting the behavior of composite materials. Moldex3D Resin Transfer Molding (RTM) Analysis now supports warp analysis, and enables users to directly import the deformation of the fiber mat from LS-DYNA for a better assessment of structural performance. Fiber-orientation predictive capabilities have been further deepened in this version by adding a patented simulation approach, which combines the Herschel-Bulkley model with yield stress and the Cross-WLF viscosity model. Other enhancements include predictions of cell size and cell density in polyurethane (PU) chemical foam molding and improved prediction of deformation in the compression molding charge.

Expanding on the capabilities of previous versions, Moldex3D R16 further extends the non-matching mesh technology to mold inserts and mold plates, making it easier and simpler for users to simulate the entire mold by automatically generating solid meshes on non-matching faces. Additionally, Moldex3D R16 allows users to assign material properties to each individual mold component and visualize the temperature variation over the parting plane to optimize cycle time.

The new release supports the simulation of valve pin movement, allowing users to take into account the influence of pin position and velocity during flow simulation. This can help validate the effectiveness of using pin movement technology to prevent flow marks and other cosmetic defects.

A powerful model healing tool automatically repairs imported geometry before generating Boundary Layer Mesh (BLM) in Moldex3D Studio, which greatly reduces model preparation time. New visualization tools to measure distance between points and to display the value at a specific point are available. This makes it easier and more effective for users to compare and analyze results.

Moldex3D R16 frees users from repetitive manual tasks by automating the entire simulation workflow with Moldex3D API, which allows users to customize the simulation workflow with predefined parameters, removing human error to ensure simulation consistency. Companies can now harness the power of API to create custom workflows; integration with other product design and structural analysis programs accelerates product development.

“Major features and functions of this release are driven primarily by our customers’ feedback,” said David Hsu, President of Product Development. “By providing greater efficiency enhancements and more reliable simulation technology, we are fulfilling our promise to help our customers solve the most complex plastics engineering problems in the most efficient manner possible.”

TPE-based syringe stoppers are smooth operators

TPE-based syringe stoppers are smooth operators

Teknor Apex syringe stopperNew medical-grade thermoplastic elastomers (TPEs) from Teknor Apex (Pawtucket, RI) for injection molded plunger stoppers provide improved syringe performance and are less costly and easier to mold than natural and isoprene rubber, said the company. The TPE-based stoppers also have processing advantages compared with thermoplastic vulcanizate (TPV) elastomers. Teknor Apex Co. will introduce the compounds in booth S22045 at NPE2018.

A low coefficient of friction enables the stoppers molded from the new Medalist TPEs to achieve a consistent piston release and travel force in both glass and plastic syringe barrels, said Teknor Apex. The compounds can be over-molded onto plungers, eliminating an assembly step. In addition to grades for over-molding onto polypropylene, specialty grades are available that, unlike TPVs, can be over-molded onto engineering resins like polycarbonate, ABS, PC/ABS, acrylic, acetal, PBT and COPE. Unlike most TPVs, the Medalist TPEs do not require pre-drying.

The Medalist TPEs exhibit improved compression set in comparison with competing TPEs, making possible a more secure seal, said Teknor Apex. The compounds can be molded in high-cavitation tooling. All grades are sterilizable and are available in natural or black colors.

Rubber has been the predominant material for use in syringe stoppers, but TPEs are a better alternative, according to Teknor Apex. For one thing, the curing step required in rubber processing is eliminated, minimizing concerns about extractables and leachables. Also, TPE scrap can be recycled and the molding cycles are shorter. More intricate designs and tighter dimensional tolerances can be achieved, as well.

“Stoppers must move smoothly against the wall of the syringe barrel, provide an exceptional seal to preserve the integrity of the drug and be chemically inert to prevent interaction with the syringe contents,” said Ross van Royen, Senior Market Manager, Regulated Products. “Teknor Apex has developed a portfolio of Medalist TPEs that meet these performance requirements while providing substantial economic advantages because of their ease of processing.”

Medalist compounds are produced in ISO 13485–certified facilities in the United States and Singapore.

Can Colon Irrigation Help You Win the Brawl with the Bowl?

HyGIeaCare Inc. Can Colon Irrigation Help You Win the Brawl with the Bowl?
A recent study suggests that colon irrigation using the HyGIeaCare system, which was developed for colonoscopy prep, may offer a safe and effective option for constipation relief.

Japanese children's author Tarō Gomi was right, "Everyone Poops." Unfortunately, that particular bodily function is easier said than done sometimes.

"Constipation can have a dramatic impact on the patient's overall well-being, including anxiety, depression, and time lost off work," Gavriel Meron, chairman and CEO of HyGIeaCare Inc., told MD+DI.

Constipation about 60 million people in the United States alone, Meron said, which is why there is no shortage of over-the-counter constipation products on pharmacy shelves. But for a lot of people, Meron said, those products simply don't help. 

"And their life, it's really not a life because they take very, very strong laxatives and the thing with the laxatives is they don't work, they don't work, and then all of a sudden they have an explosive event and it's an urgent explosive event," Meron said. "What happens is when they start taking these strong laxatives they don't want to go out. They don't want to go to a wedding, they don't want to go to a movie, they don't want to go to a restaurant because they're waiting and wondering 'when is this explosion going to happen'?"   

A study recently published in the Journal of Clinical Gastroenterology and Hepatology suggests the HyGleaCare colon irrigation system could be a good solution for chronically constipated patients.

Meron was the founding CEO of Given Imaging, the company that developed the PillCam, which Covidien bought for $860 million before its merger with Medtronic. He founded HyGleaCare in 2015 as a way to leverage his experience in GI and to develop a better way to prep patients for colonoscopy.

The FDA-cleared HyGIeaCare Prep replaces conventional preps, which typically include a lot of laxatives and/or enemas the night before the procedure. The company currently has four U.S. centers that provide HyGleaCare as a service that can be done on the same day as a patient's scheduled colonoscopy, with additional centers in the works. The system works by placing a sterile, disposable nozzle in the patient's rectum, and infusing it with a stream of warm water, loosening the stool and allowing the patient to evacuate their colon right there on the basin in a private room, under the supervision of a technician.

"The study came because we had numerous physicians who started referring us patients who are constipated," Meron said.

The study enrolled 175 patients who were consecutively referred (not pre-selected) to the company's centers for constipation relief, and 100% of these patients achieved a bowel movement and relief from their constipation, and there were no adverse side effects, Meron said.

The primary endpoint of the study was the successful passage of stool during the colonic irrigation with secondary endpoints being patient satisfaction and a favorable side effect profile. Meron said the centers are already seeing repeat visits from patients who suffer from chronic constipation.

"In one of our centers a patient was referred to the emergency room because of severe constipation and blockage, and at the emergency room they decided to refer the patient to the nearby HyGIeaCare Center for relief, which was successfully achieved."

It's possible that the system has another benefit for chronic constipation patients beyond the immediate relief of unclogging the pipes, so to speak, because it may theoretically alter the microbiome with the hopes of repopulating a more favorable microbial profile.

I’m an Engineer, But I Can’t Fix Stupid

IvWatch I’m an Engineer, But I Can’t Fix Stupid
IvWatch enables tracking of clinician adherence to a hospital's defined assessment protocol to its product with a "check mark" button for nurses to press each time they check the IV site. 

“You can’t fix stupid,” a phrase I’ve heard engineers use about consumers, can and should be applied to medical device companies that refuse to adapt to customer needs. Consumers lead enterprise, and healthcare must start thinking like the consumer-oriented market we are becoming and develop products that are stupid simple to use.

Some of us are regular consumers of the healthcare system, but more often than not, most people, especially younger generations, have infrequent interactions with the healthcare system because they don’t have to make significant decisions related to their well-being. As this group ages, many factors will impact healthcare consumption and force a change in the space. As the patient empowerment movement mounts, tech giants enter the industry, and value-based care practices are developed, we’ll embark on a new and high-growth period in healthcare.

And now as I look back, I realize I've been fortunate to be involved in industries during a similar stage of change and growth. In the 1980s, I was involved with leading-edge work in aircraft and computer simulations. In the ‘90s, I worked on the Internet at the beginning of the “WWW” and in Internet security when viruses just started making headlines. Perhaps most relevant is my time in the mobile device space during the Blackberry era in the early 2000s, when I tried to convince a major airline to make ticketing easier for customers by having a check-in option via a mobile app. I was told there is no future in putting applications on smartphones. And you can bet I thought, “You can’t fix stupid.”

Like the mobile market shift, we will soon see the day when the healthcare enterprise takes note of patient desires. Healthcare is not going to dictate what a consumer uses; consumers are going to dictate the direction of the healthcare system to meet people where they are and where they want to go. Because of this, I believe we will start to see many of the accepted problems in healthcare become unacceptable to both patients and care providers.

Medical device manufacturers must be among the first in the ecosystem to adapt. Startups and emerging-growth companies have the resources to help set the standards for defining the medical device industry’s future.

Technology Must Supersede the Current Standard

Intravenous (IV) therapy has been used for more than 350 years, with widespread adoption beginning in the 1950s. It’s the most common invasive medical procedure performed worldwide, and unfortunately for the average hospital and in-home care patient, it comes with an overall failure rate of 35% to 50% in even the best of hands.1 IV infiltration is a real problem affecting patients every day, but the good news is many hospitals and healthcare systems want to solve the problem.

Early on as a company, we were fortunate enough to have a team of people saying, “We’re behind you; help us solve this problem.” That access is invaluable, but what is even more important was the acknowledgment of a problem before a solution was developed. Ahead of device development—or a business concept, for that matter— consider the marketplace and your team’s abilities. Can you make the device intuitive enough that in practice it is so much better/faster/safer/easier, etc. that it can quickly become preferred over the old way of doing things?

If we don’t develop products people can use correctly without a manual, it’s not ready for today’s market. You must also consider the physician workflow. Making devices too difficult to use or demanding considerable amounts of training will only land the device back on the shelf beside the box full of pagers and Blackberry devices. Is your product or service something that care providers simply can’t live without?

Accept and Interpret Feedback

The greatest gift we can offer our designing teams is removing barriers to those in the field or giving them the chance to go into the field to hear market feedback. Engineers always think they are at the top of the pyramid, but I tell ours all the time they are actually at the bottom, and that’s where the development process works best.

One of the more enjoyable things about working in this industry and at ivWatch is the depth of science a research team is able to develop and continuously build upon. The tools available to quickly design, simulate, and test ideas have never been so accessible. Between 3D printers, computing clusters built with gaming PCs and GPU cards, inexpensive electronics, and the spread of the entrepreneurial spirit, small companies are able to compete with established brands. It’s critical to set up an operation so passion becomes the culture and eventually is a fluid process. The advantage of a small company is the feedback loop is really short, people have the ability to take responsibility and run with it, and that’s how innovation is born.

When you have access to resources and customers, the traditional human factors approach is almost irrelevant. We have our product in hospitals, and we are constantly soliciting input on what customers would like to see done differently. With an “I can’t fix stupid approach,” a R&D team would make changes to whichever feature was in question, and we’d eventually get the same feedback. To fix our stupid, we must realize that what consumers are asking for isn't always what they want. To be successful, you must do the interpretation and give clinicians a device that can easily fit into their workflow to become the new standard of care. One of the best examples I can share was a request to add a monitor feature for tracking clinician adherence to a hospital’s defined assessment protocol. After interpretation of the request, we added a “check mark” button for nurses to press each time they checked the IV site, which added the site check digitally into the monitoring run. Not only did that small addition address the request, it allowed for better functionality and made the device easier to implement into the existing workflow.

It’s nearly impossible to tell if people want a product to do something different until they have it in their hands. To reference the changes in the mobile world, think about all the different variations of cell phones we’ve had over the years and the number of software upgrades you’ve downloaded for the phone that’s in your pocket or purse. They make updates to meet us where we are at and give us the tools we didn’t know we needed to solve the problems we encounter each day.

That's how human factors should work in medtech, too.


1. Helm, R. E., Klausner, J.D., Klemperer, J.D., Flint, L.M., and Huang, E. (2015). “Accepted but Unacceptable: Peripheral IV Catheter Failure.” Journal of Infusion Nursing, 38(3), 189-203.

Frigel introduces CT option, allowing Microgel Chiller/TCUs to operate seamlessly with open cooling towers

Frigel introduces CT option, allowing Microgel Chiller/TCUs to operate seamlessly with open cooling towers

Frigel MicrogelFrigel (East Dundee, IL) has announced that its line of Microgel combination Chiller/Temperature Control Units (TCUs) can now be configured with a CT option, allowing them to work seamlessly with open cooling towers. Intelligent process cooling provides plastics processors with the ability to leverage the chiller/TCUs for improved productivity, profitability and quality. The Microgel produces less scrap and can improve cycle time by as much as 20%, according to Frigel.

The CT option, one of several new Microgel innovations on display at booth W193 at NPE2018, filters out potential open-cooling tower water contaminants. Ideal for machine-side process cooling, the CT option also alerts users to potential problems with contaminated cooling-tower water to ensure maximum uptime of the chiller/TCU. Previously, Frigel recommended the use of Microgel units only with an Ecodry central cooling system, since it’s a closed-loop, clean-water system. 

The CT option is available on the Microgel RCM, RCD and RCX models. Other options now available on the chiller/TCU and on display at NPE include:


  • External temperature sensors, which complement internal sensors for accurate temperature readouts/control at each mold to further optimize cooling temperatures for improved mold performance;
  • variable-frequency drives on the unit’s pumps, allowing them to deliver only the necessary amount of water pressure differential and flow needed for peak operating efficiency with the least amount of energy consumption; and
  • digital flow meters that provide an unprecedented level of accurate flow data, according to Frigel, to ensure optimal mold performance based on the unique characteristics of each tool.

According to Frigel North America Marketing Manager Al Fosco, the latest advances in the Microgel line of chiller/TCUs are designed to give plastics processors a clear-cut advantage in an increasingly competitive industry.

“Each processor and each application is unique,” Fosco said. “Some rely on open cooling towers for cooling water and some don’t. Most need very precise temperature control data. Some need exact pressure differentials based on a given mold. All need turbulent flow.

“It’s why we take a scientific approach when we analyze customer applications and configure a system to their exact needs. It’s the Frigel Diamond Service advantage, which ultimately gives them what they need to optimize productivity, profitability and quality,” he added.

Frigel’s presence at NPE 2018 extends beyond its own booth—32 Frigel units will be operating in 14 booths of leading plastics machinery manufacturers. Frigel claims this level of support is unprecedented for any process-cooling equipment company.