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New grade of silicone elastomer eyes microfluidic and implantable medical device applications

New grade of silicone elastomer eyes microfluidic and implantable medical device applications

Materials innovator Gelest Inc. (Morrisville, PA) has introduced ExSil 50, a softer grade of an ultra-high elongation material that has been formulated to meet the requirements of soft-tissue implants or extracorporeal device applications. 

The ExSil class of elastomers have unprecedented elongation greater than 5000% and shape recovery behavior, according to Gelest. They also have self-sealing and tear-resistance properties. The materials are available in an industrial grade, Gelest ExSil 100, as well as soft-tissue compatible ExSil 50. 

Gelest is a manufacturer and supplier of commercial and research quantities of organo-silicon compounds, metal-organic compounds and silicones. The company serves advanced technology markets, including specialty polymeric materials, through a materials science–driven approach.

Milacron reports increased revenue, but analyst deems pace of recovery ‘erratic’

Milacron quarterly reportAs plastics processors invest in capital equipment to expand production capacity, replace older equipment or take advantage of new technology, Milacron’s revenue has “picked up,” noted Stephen Simpson, CFA at Seeking Alpha, in his analysis of the latest report from Milacron (Cincinnati, OH). Seeking Alpha (New York, NY) provides market insights and financial analysis.

“With better results and higher multiples across the machinery space, Milacron’s shares have done okay since my last update in May 2016,” said Simpson in his June 22 analysis (“Milacron Delivering, But The Road Is Getting a Little Rockier”). “Though the shares have sold off about 10% recently, they’ve still generated a double-digit return over the past year despite rising input costs offsetting a lot of the progress the company has made with operating expenses. Although I think Milacron’s multiple should have room to improve from here, I’m a little more cautious on the near-term outlook for machinery investment, particularly with trade protectionism bubbling up,” said Simpson.

Milacron has continued to deliver better-than-expected quarters, with revenue exceeding sell-side expectations for five straight quarters. Organic revenue growth “perked up” from 1% in the second quarter of 2017 to 6% in the third quarter and 9% in the fourth quarter, before slowing to 3% in Q1 2018. “The latter was due at least in part to the company’s decision to walk away from some capital equipment business in the auto sector; the company’s largest end-markets continue to do reasonably well,” said Simpson.

Despite the good news, Simpson pointed out that revenue compensation has been “erratic,” with two main revenue drivers “in play for Milacron to varying degrees—demand for molding equipment (the APPT segment) to replace an aging installed base and ongoing conversion from cold runners to hot runners” (the MDCS segment which includes hot runners). 

The MDCS segment saw double-digit organic growth in the second and third quarters of 2017 before a slowdown partly tied to order timing in the fourth quarter and a rebound to 9% growth in the first quarter of this year (against nearly double-digit year-ago comparables). “APPT revenue growth has likewise been all over the place, with growth decelerating sharply from 16% in the fourth quarter of 2017 to flat in the first quarter [of 2018],” commented Simpson.

Simpson noted that Milacron’s margin improvement efforts have had mixed results, as higher input costs have weighed on gross margin, with significant gross margin pressure in Q2 2017 through Q4 2017 before a “modest improvement” in Q1 of 2018 driven by a “more concerted effort to manage the mix” (by walking away from lower-margin business). 

Milacron’s cost reduction program, which is about 75% complete, has paid dividends, as EBITDA margins have remained relatively stable with a slight upward bias, and free cash flow generation has improved a bit, Simpson said.

Simpson’s primary concern involves “slowing demand for capital equipment” in spite of the fact that orders “remained healthy in the first quarter, and machine tool orders remain strong,” even given that capital equipment manufacturers are making “cautious statements.” He added that he’s “taking a little more conservative position at this point in the cycle.”

Looking at the long term, however, Simpson believes there are opportunities for Milacron to grow, particularly since the automotive market accounts for about one-quarter of Milacron’s business (and one-third of the more profitable MDCS and Fluid Technologies businesses). The continued trend to substitute metal parts with plastic to reduce weight and cost will also benefit Milacron, as it is projected that 18% of cars will be made of plastic in 2020. 

Simpson also believes that there’s “more room for increased penetration of hot runners in plastic molding operations” to reduce plastic waste and clean-up labor costs, as well as achieve faster production cycle times.

“I also believe Milacron has opportunities to grow through M&A,” stated Simpson in his analysis. “The company still has too much debt on the balance sheet, but I believe the company could start thinking about meaningful M&A in a year or two. Although plastic molding equipment is a very fragmented market, I’m less interested in seeing Milacron act as a consolidator and more interested in seeing the company acquire more consumables/aftermarket components and technology-driven products,” said Simpson.

10 Medtech Stories That Kept Us on Our Toes in Q2

Second Quarter Brings Layoffs, Lawsuits, and Criminal Charges (oh my!)From layoffs and lawsuits to product delays and criminal charges, the medical device industry certainly kept us on our toes during the second quarter. But it wasn't just the negative headlines that captured our readers' attention, stories of clinical trials and regulatory progress also made it to the top 10 most read stories on MD+DI over the past three months.Click through to see the full list. Also, for a look back at the first quarter of 2018, check out: 10 Events that Rattled Medtech in 1Q18.

Are We in Store for More M&A in the Liquid Biopsy Space?

Frolicsomepl Are We in Store for More M&A in the Liquid Biopsy Space?

M&A activity in the liquid biopsy space is picking up as Bio-Techne said it will acquire Exosome Diagnostics for $250 million plus $325 million in milestones.

Waltham, MA-based Exosome has developed the urine-based test ExoDx Prostate (IntelliScore) to assist physicians in determining the need for a prostate biopsy in patients with an ambiguous PSA test result.

“This is a very strategic acquisition for us as we also expand in the CAR-T cell marketplace, leveraging our growing critical mass in cell culture-focused product lines,” Charles Kummeth, president and CEO of Bio-Techne said in a release. “Following this acquisition, the company now sells solutions to the entire workflow of cancer: research, diagnostics and therapeutics.

Minneapolis, MN-based Bio-Techne said the transaction is expected to close in July or early August. The deal will be financed through a combination of cash on hand and a revolving line of credit facility that Bio-Techne said it expects to obtain prior to the closing of the acquisition.

Liquid Biopsy has always been a hot sector venture capitalists. For instance, Grail, which was spun off from San Diego-based, Illumina raised $1 billion in a series B round. The company brought in about $100 million in initial funding. Grail’s rival, Redwood City, CA-based Guardant Health raised $360 million in May of last year.

But now it seems as if the space is ripe for M&A. Over the past few years there have been several high-profile liquid biopsy acquisitions.

Earlier this month, Roche flexed its M&A muscle by making a play to pick up the remaining shares of Foundation Medicine for $2.4 billion. The deal marks a turning point in Roche's relationship with Foundation Medicine, which dates back to January 2015 when Roche invested roughly $1.03 billion to acquire a majority interest in Foundation Medicine.

Precipio acquired Transgenomics last year and stressed the driving point behind the merger was the technology. Precipio became a public company through the acquisition.

And in 2016, Siemens acquired German Startup, Neo New Oncology. Through the acquisition, Siemens was able to obtain a NeOliquid test for the analysis of genomic profiles of solid tumors from a simple blood sample.

CMS Will Reconsider Its Stance on TAVR

Pixabay CMS Will Reconsider Its Stance on TAVR

Centers for Medicare & Medicaid Services (CMS) took an unprecedented stance in 2012 when it decided to cover transcatheter aortic valve replacement (TAVR) with strict restrictions regarding its use in patients with symptomatic aortic stenosis.

One of the key issues regarding that CMS decision is that it included specific procedural volume restrictions, limiting the use of TAVR to high-volume hospitals and medical centers. Some doctors have argued that procedural volume is an outdated metric.

To understand just how unprecedented the agency's decision on TAVR was six years ago, we look back at this MD+DI story quoting Scott Gottlieb, MD. FDA Commissioner Gottlieb was a resident fellow at the American Enterprise Institute and a senior policy adviser at CMS at that time.

"It shows CMS becoming, I think, far more aggressive than it has been in the past,” Gottlieb said. “And in a lot of respects, CMS is behaving in this context like a traditional insurer.”

But CMS is not, nor has it ever been, a traditional private insurer and the impact of the agency's decisions tend to run wide and deep.

“If you are an institution and Aetna says you have done something to get coverage, you can make a decision if you want to get coverage from them or not,” Gottlieb said. “But if you are an institution and CMS puts in place certain requirements, you have no choice. So it ends up setting up the standard for the entire marketplace.”

Fast forward six years to today, when CMS has opened a national coverage analysis (NCA) to reconsider its national coverage determination (NCD) for TAVR.

"As we move forward, our priority will be on assuring that the NCD provides all people with heart valve disease with access to all treatment options, enabling patients to choose the right treatment at the right time," Edward Lifesciences said Thursday in a press release. "We look forward to continuing to engage with CMS and other stakeholders in the finalization of this important policy, which will define the future of heart valve patients' access to this life-saving care."

Edwards continues to be considered the market leader in TAVR, although it does share the space with Medtronic and others.

On July 25, CMS will convene a panel of the Medicare Evidence Development & Coverage Advisory Committee (MEDAC), during which the agency will seek the committee's recommendations regarding the evidence on procedural volume requirements for hospitals and heart team members to begin and maintain TAVR programs.

The agency is soliciting relevant public comment and said it is particularly interested in comments that include scientific evidence and that address the breadth of the issue. To comment on this NCA, click here.

First, do no harm, medtech industry urges Trump

First, do no harm, medtech industry urges Trump

China and US containersThe medical device industry is increasingly rattled by the tit-for-tat tariffs imposed by the United States and China and the prospect of a full-blown trade war. Approximately $800 million worth of medical devices and components made in China are targeted by the Trump administration for a 25% tariff, scheduled to go into effect on July 6. That is sending a chill through Minnesota’s medtech industry, reports the StarTribune.

“U.S. hospitals and distributors will likely absorb the brunt of the new import taxes hitting Chinese-made medical devices and components next month, but jobs and research in Minnesota's bustling medical-technology sector could be threatened if a full trade war with China breaks out,” writes StarTribune reporter Joe Carlson.

Home to medtech giant Medtronic, Minnesota and the Minneapolis-St. Paul area, in particular, have positioned themselves as one of the United States’ premier medical technology hubs. Minnesota was ranked second, just behind California, by sister brands Qmed and MD+DI in a survey of the top 10 medical manufacturing states. China is an important trading partner for the state’s medical technology industry.

“China is the largest single buyer of medical devices and optical supplies from Minnesota, with exports up 14 percent to $192 million in the first three months of this year,” writes Carlson. It is also a substantial sales market for Medtronic, which has nearly one million square feet of manufacturing and research space in China, slightly more than it has in Minnesota, according to the StarTribune. At a gathering for investors, Medtronic CEO Omar Ishrak said that the “China market is going to be, at some time in the future, the biggest market in medtech.”

The medical imaging sector is especially worried that the tariffs will have a negative impact on its industry and potentially affect patient access to medical innovation.

“We have serious concerns the proposed tariffs will impede patient access to medical innovation by taxing inter-company transfers, wherein a company will manufacture component parts in China before shipping them to the U.S. for final assembly and export,” said the Medical Imaging & Technology Alliance (MITA; Washington, DC) in a press release distributed on June 26. “Slowdowns in imaging R&D impede patient access to higher quality healthcare over time. Further, under the proposed tariff environment, rather than immediately halting component manufacturing operations in China, which is unfeasible with a mature supply chain, companies will likely evaluate the most cost-effective locales for final assembly operations, including outside of the United States,” wrote the industry association, which represents companies whose sales make up more than 90% of the global market for advanced imaging technologies.

“The current tariff proposal runs counter to the idea of putting American patients and some workers first,” said Patrick Hope, MITA Executive Director, in the press release. “Rather than make it more difficult for our member companies to do business in America, elected officials should be supporting the United States as the current global global leader in medical imaging innovation.”

Through the tariffs, the Trump administration hopes to pressure China to cease unfair trade practices and, notably, halt coercion of U.S. companies doing business in China to share technology and intellectual property. Trump has also railed against the trade deficit with China.

On that last point, Carlson notes that the “U.S. and China import about the same value of medical technologies from each other—roughly $5 billion—undercutting any notion that tariffs are needed to correct a medtech trade imbalance.”

Top 10 best definitions of a plastics engineer revealed

Top 10 best definitions of a plastics engineer revealed

The people have spoken…or at least voted. PlasticsToday’s audience of plastics professional readers have selected the best answers to the complete the sentence “You know you’re a plastics engineer if…” that we posed throughout April.

In the first round that ran for a 30-day period starting in January readers provided answers that filled in the blank. These ran the gamut from the straightforward and thoughtful to the clever and tongue-in-cheek and all variations therein. Many made us nod knowingly, others made us smile.

We narrowed the many to an even dozen for the second round and asked readers to vote for the “best” among those. Participation was high—we tallied more than 230 votes that decided the Top 10 that we present now in reverse order.

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We're also upping the interactive ante by using Graphical Interchange Format (GIF) files for short video snippets to accompany the selections, the first time GIFs have been used at PlasticsToday.

So grab your popcorn virtual or real and follow along to the big reveal of the #1 choice.

10. You start all of your part designs at the parting line and are frequently overheard stating "the parting line is the starting line" to anyone starting a new part design.

 

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10. You know that HDTs are not High Density TVs.    

Because you know that in this business HDT stands for heat deflection temperature.  

Caution: Curves ahead.

 

 

PLASTEC Minneapolis 2018 held October 31-November 1 is part of the Midwest’s largest advanced design and manufacturing event that also includes MinnPack brings you the latest in materials and additives, injection molding, rapid prototyping, coatings, automation, packaging and more. For details, visit PLASTEC Minneapolis.

The next two ended in a photo finish separated by a single vote, so we’ve paired them together even though they are an unlikely match. Both have test measurements in common. While #9 links a technical understanding with the savvy knowledge that comes with experience, #8 combines a standard polymer test measurement with a celebrity in an unexpected way.

9. You know the specific density of most materials without having to look it up.    

 

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8. You’re more interested in rheology curves than you are in Rihanna's curves. 

 

Next: Little green men

 

The next two also finished neck and neck and again we’ve bundled them a twosome.

7. Your spouse (who has not worked in the plastic industry) can also evaluate plastics parts in the store and identify and name all the molding defects.

While some people are married to their job, it seems a near-certainty that all of those same people are indeed married to their spouses. And through the process of osmosis, spouses over time exchange much of their knowledge professional and otherwise.

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6. You laughed at the flash on the little green army men in Toy Story.

That scene resonated nostalgically with me, too, and the flash was a much-appreciated detail by “those in the know” who staged battles with those durable, skirmish-tested little green men back in the day.

On to the Top 5 countdown...

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#5. You can say, write, spell and abbreviate "polytetrafluoroethylene (PTFE)" and you know common people call it Teflon.

Plastics is an industry abounding with acronyms, which make sense when some of the formal chemical names can be a mind-testing twister of the brain and tongue, and the above is exemplary of why terms like PET and brand names like Teflon have their place. They certainly roll off the tongue effortlessly and universally. But professionals can flash their know-how by reverting to the formal names, especially among like-minded colleagues.

Next: You know where to look.

 

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#4. You look at the bottom of a plastic bottle to see if it’s blow molded or injection molded.

Plastics professionals have an inquisitive nature about all things plastic, you want to find out more through examination. It's simply second nature to pick up a part or container and assess it. Also, plastics are a very touchy feely and that tactile experience reveals a lot about the object’s makeup and perhaps how it was molded.

Over time it becomes a habit that you may not even be aware of unless you draw the unwanted attention of a fellow shopper or store clerk.

Next: You are observant.

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3. Regardless of timing or location, you notice plastic components everywhere...like on holiday, walking down the street or hitting the slopes. Plastic design is always around you.

This one is an extension of #4: those within the industry who are especially plastic conscious and those without would find it quite challenging to take a step without being within sight if not touch of plastic.  In fact, there’s close to a 100% chance that those reading this are holding something made with plastic or looking at a polymeric thing when they do. Or looking through polymers if you wear glasses or contact lenses.

From the ABS in the automobile dashboard to the EVA in our tennis shoes to the polyester in our clothes, we’re surrounded by plastic design because we’re surrounded by plastic.

 

Next: You have a critical eye.

 

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2. You visually inspect and complain of poor design and quality on household items or any plastic item…anywhere.

Here's how I'd have done it: There's always room for improvement. It's something that's inherent in your nature as you assess molded plastic products everywhere and anywhere in your walk through life.

And the #1 selection by PlasticToday’s audience of packaging professionals…

 

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1. You can't put down an injected-molding part without finding where it is gated.

It’s a habit for some that goes with the territory. For those professionals and for all who have so much more to explore we wish you well in your journey of learning. It’s one that will likely continue through your retirement because old habits die hard—and you’ll always be a plastics engineering professional.

 

PLASTEC Minneapolis 2018 held October 31-November 1 is part of the Midwest’s largest advanced design and manufacturing event that also includes MinnPack brings you the latest in materials and additives, injection molding, rapid prototyping, coatings, automation, packaging and more. For details, visit PLASTEC Minneapolis.

Sensile, Sanofi, and Verily Form Diabetes Dream Team

GERALT/PIXABAY Sensile, Sanofi, and Verily Form Diabetes Dream Team

There has been a lot of movement in the diabetes space lately – especially with the 78th Scientific Sessions of the American Diabetes Association ending earlier this week.

One of the latest developments in the diabetes space is a “dream team” collaboration with Sensile Medical, Sanofi and Verily (formerly Google Life Sciences) to develop a connected insulin patch pump. Olten, Switzerland-based Sensile Medical develops devices for liquid drug delivery.

The three parties said they will develop and commercialize a new generation of “all-in-one” pre-filled insulin patch pump, primarily to serve people living with type 2 diabetes.

The alliance will use Sanofi's expertise in patient-centered diabetes solutions and insulins; Sensile Medical’s specialty in developing micro-pump technologies for medical use; and Verily’s experience in micro-electronic integration and digital healthcare technology.

“Our goal is to develop a new type of pump technology that is simple to use and appropriate for people with type 2 diabetes, as well as by those with type 1 diabetes who are the primary users of insulin pumps today,” said Derek Brandt, CEO of Sensile Medical in a release.

Verily has heavily relied on partnerships to help it establish its presence in healthcare. MD+DI has chronicled seven key collaborations that have helped build Verily into a healthcare juggernaut. Several of Verily’s partnerships reach far into the diabetes space.

Verily has even formed a joint venture with Paris-based Sanofi in 2016 called Onduo. The Cambridge, MA-based company said its mission is to help people with diabetes live full, healthy lives by developing comprehensive solutions that combine devices, software, medicine, and professional care to enable simple and intelligent disease management.

Romaco debuts blister packaging line with advanced automation

Romaco debuts blister packaging line with advanced automation

Romaco (Karlsruhe, Germany), a global supplier of processing and packaging equipment predominantly for the pharmaceutical industry, introduced its new Unity 500 blister packaging line at the Achema 2018 tradeshow, which was held on June 11 to 15 in Frankfurt, Germany. This monobloc machine was showcased along with the Promatic PTT for seam track & trace and the new Promatic PAK 130 case packer. A compact, GMP-compliant design was a key priority for the fully integrated blister packaging line with a maximum output of 500 blisters and 150 cartons per minute. The Romaco Unity 500 is mainly intended for high-performance jobs at medium speeds.

Romano Unity 500
Apart from an advanced level of automation, the Romaco Unity 500 also offers opportunities to improve overall equipment effectiveness.

Romaco Unity 500 was teamed up with a Combo v2 Feeder from Elizabeth Europe. This patented system gives Romaco increased flexibility for feeding pharmaceutical solids in various shapes and sizes. The finished blisters are passed directly to the cartoner’s bucket chain by means of a vacuum-assisted overhead conveyor and QuickTransfer, which works according to the positive transfer principle. Separate servo drives ensure safe operation at individual stations.

Apart from an advanced level of automation, the Romaco Unity 500 also offers opportunities to improve overall equipment effectiveness. Optimized access to all components speeds up and simplifies cleaning of the blister line. The fast product changes add up to significantly less downtime for the Romaco Unity 500. Blister formats from Romaco Noack can be created quickly and easily using the new BlisterMagic software. The system checks automatically whether the desired formats are feasible based on product specifications. 

Romaco, part of the Truking Group, develops engineered system solutions for pharmaceutical applications, but also supplies the cosmetics, food and chemical markets.

Thunderbird LLC acquires Indiana Plastics and Kruis Mold

Thunderbird LLC acquires Indiana Plastics and Kruis Mold

M&AThunderbird LLC (Elk Grove Village, IL) has acquired the assets of Indiana Plastics/Kruis Mold Inc., based in Elkhart, IN, and named the new companies Indiana Plastics LLC and Kruis Mold LLC. Indiana Plastics is a custom injection molding company. Kruis Mold builds and repairs custom tooling and molds for a variety of companies.

According to Kevin Prunsky, co-founder of Thunderbird LLC, the purchase complements Thunderbird’s recent acquisition, announced Feb. 28, 2018, of Williams Plastics LLC (Shelbyville, IN). Williams Plastics provides injection molded drinkware and custom art, design and print services. The string of acquisitions will form a stronger, more complete offering of plastic injection molding design, execution and delivery. Thunderbird has retained the Indiana Plastics/Kruis Mold Inc. management team and added marketing and financial management.

Indiana Plastics maintains a skilled production staff that uses the latest molding practices and modern equipment, along with 50 years of experience, to produce superior injection molded products, explained Thunderbird. Kruis Mold builds and repairs custom tools for the molding industry. 

The companies’ capabilities include injection molding (85 to 660 ton), assembly, in-mold decorating, high-volume molding, multi-material molding, insert molding, design, prototyping, and testing. 

As a member of the Thunderbird LLC portfolio of companies, Indiana Plastics can now cross-manufacture various products with Metal Impact, a manufacturer of impact extruded and machined metal parts, and F&B MFG, a manufacturer of hydroformed and machined metal parts, with Kruis providing mold and tooling support with CNC and wire EDM capabilities, said Thunderbird’s information.

Thunderbird’s portfolio consists of American companies that manufacture their products in America but aim for a larger world market. They specialize in industries including automotive, military, power, industrial and consumer. Thunderbird is looking for opportunities to expand its portfolio to include more businesses in these industries that need financial, marketing and management skills to reach higher levels of growth and revenue.