MEDICAL DESIGN & OUTSOURCING - July 2017

T H E

C O N T R A C T

M A N U F A C T U R I N G

I S S U E

www.medicaldesignandoutsourcing.com JULY 2017

CAN THIS COLOSSUS OF A COMPANY EXECUTE ON ITS EXPANDED CAPABILITIES?

• Cleared to acquire: Why the medtech contract manufacturer M&A trend isn’t slowing down

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• The secrets of contract manufacturing longevity

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HERE’S WHAT WE SEE

Where have all the contract manufacturers gone?

Will there someday be only one medical device contract manufacturer? Seems like a silly question, but it’s the logical endpoint for the slew of mergers and acquisitions we’ve seen in the space in recent years.

M&A deals in one space beget M&A deals in another.

Start with the way the Affordable Care Act and healthcare reforms elsewhere in the world are incentivizing providers to be more efficient and effective in the way they treat patient populations. That shift in the way healthcare is paid for has providers merging into ever larger entities in order to better manage patients, as well as to have more leverage with suppliers – including medical device makers.

To better compete in the new healthcare environment, medtech companies have been merging: Medtronic combined with Covidien, Zimmer and Biomet became Zimmer Biomet, Abbott bought St. Jude Medical, BD is acquiring C.R. Bard, and so on.

With medical device OEMs merging, the suppliers who serve them increasingly need to expand their capabilities and vertically integrate to continue competing. And so the medical device contract manufacturing space has seen a wave of mergers, too.

Chris Newmarker Managing Editor Medical Design & Outsourcing c newmark er@wtwhmedia.com

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Case in point could be the subject of this issue’s cover story: Frisco, Texasbased Integer Holdings Co. One of the largest medical device contract manufacturers in the world, Integer came to be in the 2015 merger of Greatbatch and Lake Region Medical.

The new company enjoys an array of capabilities – enough to develop and manufacture a full structural heart delivery system or a full neuromodulation system according to customer specifications.

The merger also allows Integer to enjoy the cost savings that come from vertical integration – to be “a supplier to ourselves and control the supply chain,” as one company official told us. Those cost savings enable more competitive pricing for customers.

Do small manufacturers stand a chance competing against a giant company like Integer? The answer seems to be a qualified yes: They can survive, but only if they excel so much in a niche that medical device OEMs simply need them.

For example, MTD Micromolding (Charlton, Mass.) has thrived because it ventured into the then-little-known niche of micro molds in the late 1990s and hasn’t looked back since. The company has even enjoyed success in the fast-growing drug delivery device space. “Many of the drugdelivery micro molding projects we take on are rescue projects – those that failed with other molders or methods and may have been thought to be ‘impossible,’” president Dennis Tully told MDO. Medical device contract manufacturers, then, aren’t going away at any scale – but the urgency to compete and dominate a niche is stronger than ever. M

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Partnering to deliver life-changing innovation to people worldwide As a world leader in medical device outsourcing for the advanced surgical, cardio & vascular, cardiac rhythm management, neuromodulation, orthopedic and power solutions markets, Integer offers a breadth and depth of design, development and manufacturing capabilities unmatched by anyone. Our keen focus on quality meets the strictest standards.

With 10,000 Associates, including 600 engineers, and 26 manufacturing facilities in seven countries, we are proud of the role we play in enabling our customers to deliver innovative medical technologies that enhance people’s lives.

Let Integer solve your medical device needs.

Visit integer.net or email customersolutions@integer.net to learn more.

Products pictured Š 2017 Greatbatch Ltd. and its affiliates.

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Medical Design & OUTSOURCING

medicaldesignandoutsourcing.com ∞ July 2017 ∞ Vol3 No4

E D I T O R I A L EDITORIAL Founding Editor Paul Dvorak pdvorak@wtwhmedia.com @paulonmedical Executive Editor Brad Perriello bperriello@wtwhmedia.com Managing Editor Chris Newmarker cnewmarker@wtwhmedia.com @newmarker Senior Editor Heather Thompson hthompson@wtwhmedia.com Associate Editor Fink Densford fdensford@wtwhmedia.com Associate Editor Sarah Faulkner sfaulkner@wtwhmedia.com Assistant Editor Danielle Kirsh dkirsh@wtwhmedia.com

Publisher Brian Johnson bjohnson@wtwhmedia.com 617.905.6116

S T A F F

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7 • 2017

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The advantages are pointed: • Exceptional reliability • Only one moving part • Low noise & vibration • Long service life • Very low power consumption mption

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CONTRIBUTORS

HERZBERG

VANDEKERKHOF

KULWICKI

JACOBS

ROBERTS

VANDERKOOI

JOCHEN HERZBERG is an innovation leader at Schott Electronic Packaging in Landshut, Germany. He oversees the global pipeline of new business projects with a special focus on medical applications. Jochen works in cooperation with Schott’s R&D engineers as well as directly with customers to formulate customized connector solutions based on individual application needs. His career at Schott began 10 years ago as a development engineer, working at facilities in both Mainz, Germany and Tokyo, Japan.

SOL JACOBS is VP and GM for Tadiran Batteries.

Sol has over 25 years of experience in developing solutions for powering remote devices. His educational background includes a BS in engineering and an MBA. KYLE KULWICKI is a process engineer at PTI Engineered Plastics. Kyle has worked in the medical injection molding industry for the past 5 years and holds a master’s degree in plastics engineering and master molder 1 & 2 certifications.

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KEVIN ROBERTS is a validation engineer at PTI Engineered Plastics. Kevin has 7.5 years of experience in the injection molding industry, the last 4.5 years being in a medical molding environment. He holds a bachelor's degree in biomedical engineering.

SHANE VANDEKERKHOF is an RJG consultant/trainer. Shane is a certified master molder, qualified to teach scientific and decoupled molding methods and techniques.

He also has extensive field experience networking RJG’s eDART System and implementing cavity pressure sensor technology.

STEVE VANDERKOOI is quality engineering manager at PTI Engineered Plastics. Steve has over 9 years of experience in manufacturing and validating medical devices. He holds a Bachelor's of Science in both manufacturing engineering and quality engineering technology.

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Testing variables: Part Quantity -1 full bucket of parts from HP Jet Fusion 3D at 20% of packing density vs same number of parts on above-mentioned competitive devices; Part size: 30g; Layer thickness: 0.1mm/0.004 inches. Fast Cooling is enabled by HP Jet Fusion 3D Processing Station with Fast Cooling, available in 2017. HP Jet Fusion 3D Processing Station with Fast Cooling accelerates parts cooling time vs recommended manufacturer time of SLS printer solutions from $100,000 USD to $300,000 USD, as tested in April 2016. FDM not applicable.

2 Based on internal testing and public data, HP Jet Fusion 3D printing solution average printing cost-per-part is half the average cost of comparable FDM & SLS printer solutions from $100,000 USD to $300,000 USD on market as of April 2016. Cost analysis based on: standard solution configuration price, supplies price, and maintenance costs recommended by manufacturer. Cost criteria: printing 1build chambers per day/ 5 days per week over 1 year of 30-gram parts at 10% packing density using HP 3D High Reusability PA 12 material, and the powder reusability ratio recommended by manufacturer.

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CONTENTS

medicaldesignandoutsourcing.com ∞ July 2017 ∞ Vol3 No4

ON THE COVER:

DEPARTMENTS 2

38

6 CONTRIBUTORS

What is Integer?

Can this colossus of a company execute on its expanded capabilities?

10

REGULATORY & REIMBURSEMENT: AdvaMed unveils new tools to assess medical device value

16

COMPLIANCE & VALIDATION: Eight things you need to know about validation

18

PATENT PROTECTION: Two Supreme Court decisions take a whack at patent holders

22

ENGINEERING 911: How to power handheld surgical devices

26

MANUFACTURING & MACHINING: Four questions to ask when the mold will not fill right

30

THE CATH LAB: Advanced contact force ablation marries fiber optics, flexibility and 3D mapping

Image courtesy of istockphoto.com

FEATURES 38

44

48

52

8

What is Integer?

Greatbatch and Lake Region Medical merged nearly two years ago to become Integer Holdings Co., a giant medical device contract manufacturer that could theoretically do almost anything for an OEM. Why the medtech contract manufacturer M&A trend isn’t slowing down Contract manufacturing partners to OEMs are seeing their own abundance of M&A as larger players look to expand their influence and keep up with increasing demand.

Manufacturing drug-device products: Challenges and best practices Integrating a drug with a mechanical device can, in some cases, improve patient outcomes and boost sales. But manufacturing these products is no simple feat.

The secrets of contract manufacturing longevity Whether it’s a few decades or the better part of a century, there are important factors that enable a contract manufacturer to last for a long time – business traits that OEM customers should value.

Medical Design & Outsourcing

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HERE’S WHAT WE SEE: Where have all the contract manufacturers gone?

7 • 2017

34 CONNECTORS CORNER: Glass-sealed connectors increase longevity and reliability 60

DEVICE TALKS: 3M’s Cindy Kent on leadership, growth and inclusion in medtech

63

PRODUCT WORLD

64

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REGULATORY & REIMBURSEMENT

AdvaMed unveils new tools to assess medical device value The new AdvaMed initiative is another sign of the importantance of value-based healthcare in the medical device industry.

Chris Newmarker | Managing Editor |

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AdvaMed recently launched a value initiative designed to help medical device companies formulate value-based arguments.

The value framework also includes tools specifically designed for diagnostic technologies – and reports on understanding evidence and use cases.

“Value” has become an important word in recent years, as government and private healthcare payers in the U.S. and elsewhere move from traditional fee-for-service payments to outcomes-based and risk-sharing models, aiming for more efficient and effective care. That means device companies need to show how their products create value, to both persuade customers to use their devices and to win reimbursement from insurers.

“The challenge is that there hasn’t been a consistent way of talking about value, or even assessing the value of medical technologies and technologies,” according to Nadim Yared, AdvaMed chairman & CVRx CEO. To help its members navigate this new world, AdvaMed brought in Deloitte Consulting to look at existing economic and clinical evaluation tools and conduct extensive interviews with AdvaMed members, officials from healthcare providers and insurance executives.

The result, AdvaMed EVP Don May told Medical Design & Outsourcing, was a framework designed to help firms devise comprehensive, value-based arguments 7 • 2017

for their devices. The process can also help medtech makers incorporate that thinking during the earliest stages of the development process – from product ideation, study design and evidence collection to the FDA approval process and more.

“I actually think some of the VC companies will think of this approach when they’re asking, ‘Do we go with this product or that product?’”

May told us. “They’ll be looking at this value imperative right from the very beginning.”

Image courtesy of AdvaMed

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REGULATORY & REIMBURSEMENT

The value initiative advises medical device companies to examine four key value drivers: • •

Clinical impact: Efficacy – not exactly a new consideration.

Non-clinical impact: Patient experience and economics will be key proving grounds, as healthcare systems become more patient-centric and value-driven.

•

•

Care delivery, revenue & cost: Think readmission rates, infection rates and OR time – it’s about improving care and lowering costs.

Public health: Quickly getting people back to their jobs and providing better disease management over large populations.

The framework also takes into account different types of patient populations

IT IS IMPERATIVE THAT WE KNOW HOW TO DEMONSTRATE AND CLEARLY ARTICULATE HOW OUR TECHNOLOGIES CAN IMPROVE PATIENT OUTCOMES AND CREATE VALUE.

and urges companies to think about a device’s value over both the short and long term, May noted.

AdvaMed and Deloitte enlisted about a half dozen medical device and diagnostics companies to try out the value initiative’s framework. They included Rotation Medical (Plymouth, Minn.), an early-stage company with a novel, FDA-cleared rotator cuff system that includes a bioinductive implant reconstituted from bovine Achilles tendon tissue.

The value framework helped Rotation Medical officials come up with new value-based arguments for the technology that they may not have had otherwise, CEO Martha Shadan told MDO. For example, the system’s shorter procedure and recovery times reduce worker’s compensation expenses because people are able to return to work faster. Because people with the Rotation Medical system feel less pain,

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REGULATORY & REIMBURSEMENT

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they need to take fewer painkillers, so the system also reduces opioid addiction rates, Shadan said.

“This framework helped crystalize our thinking and helped us approach it in a different way,” she said.

“We’re premium-priced,” Shadan said of Rotation Medical’s rotator cuff system.

“But if we can show there’s greater throughput because the operating time is less, using less anesthesia, etc., then those are offset through the savings from using our product.”

The new value framework is useful because medical device companies that don’t think of value from the start risk getting stuck competing on price, according to Shadan.

“Companies should be thinking of the patient outcomes and the value impact at the very beginning of product development, because it will help inform their regulatory strategy as well as their clinical strategy,” she explained.

The tool is a useful one for medical device developers, said Tom Hughes, senior principal advisor for health economics and reimbursement at RCRI in Minneapolis.

“I’m seeing a growing number of medical device companies asking for help demonstrating the clinical and economic value of their products and services,” Hughes said. “Given the market’s increased focus on value-based medicine, AdvaMed’s new value initiative could not be more timely.” M

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COMPLIANCE & VALIDATION

Validation: Eight things you need to know Validation of manufacturing processes is extremely important, given our highly regulated environment.

Here’s a primer to get you started on the subject.

S t e v e Va n d e r K o o i | PTI Engineered Plastics |

Validation uses objective evidence to prove that a process is capable of consistently producing a product that meets pre-defined requirements, including customer and user needs, functional specs and regulatory hurdles.

The thought of validating new or modified existing processes can raise your anxiety level. To reduce your worries, here are some answers to basic questions about this not-always-difficult challenge: Why do I need to validate?

The short answer is that it is a federal regulation. A longer answer is to provide objective proof that a process is capable of consistently making parts to a specified confidence level.

Kyle Kulwicki | PTI Engineered Plastics |

What do I need to validate?

When the results of a process cannot be fully verified by inspection and testing, validation is required. And when the output of a process isn’t proven to meet acceptance criteria, it too likely requires validation.

When do I begin validation?

The validation process starts once you have a working design and a manufacturer capable of completing the validation process. At this point, you need to start the validation paperwork (IQ, OQ, PQ and possibly more). Keep in mind that design impacts validation, so the validation process should be considered from the earliest brainstorming stage.

Kevin Roberts | PTI Engineered Plastics |

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How much is “enough” validation?

The process is validated with objective evidence of high confidence of producing a good product. In process capability statistical terms, Cp and Cpk must exceed, say, 1.66 for a risk level 1 product (arbitrarily chosen for this example) with an appropriate product sample rate during validation – including all secondary and tertiary documentation and testing.

Are there different levels of validation?

In a word, no. All aspects of the process must be validated to ensure that they result in the intended form, fit and function and that the process is capable of consistently meeting the required level of quality. This all ties back to the risk level of the part.

What is the difference between a validated and non-validated product?

A non-validated product does not have an assurance level of quality outside of inprocess inspections, meaning that defects could be found within the manufactured lot. A validated product, on the other hand, will have a high level of quality assurance; no defects will be found in the lot when validation is done correctly.

Does my product design impact the validation?

Product design has a large impact on validation activities, depending on the critical dimensions of the part. As an

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example, an injection-molded tongue depressor might only have three critical dimensions that need a validation: Length, width and thickness. On the print for the product it is called out as a Class 1 device which requires a Cpk level above our arbitrary 1.66. Its validation revolves around those dimensions and that confidence level.

If we look at the whole design, there are round edges, but those were not called out as critical dimensions, so now they only need to be confirmed once, on a part to print.

Fewer measurements, most taken without a coordinate measuring machine (CMM), means a shorter validation time.

Now let’s say you are making a housing that has action in it, a circuit board and over-molded metal inserts. The print has three notes that call for action once assembled, plus 45 critical dimensions. The product is also called out as a Class 2 device requiring a Cpk level above 2 (another arbitrary example).

This product is much more complicated, so the validation will take substantially longer due to the higher number of measurements needed to confirm that the process is robust and meets requirements.

What can reduce the cost and timing of validation?

To reduce validation cost and duration, optimize as many factors as possible – material, part design, mold design, injectionmolding machine, etc. The material selected must not include extra additives, the material must not be a specialty grade and it must be readily available on the open market. The part design must have realistic dimensions, with the critical-to-quality dimensions identified only as needed. (Avoid details that add no value, such as a sunroof in Antarctica). The injection-molding machine selected must be repeatable and reliable. Last but not least is a robust injection-molding process that focuses on the parameters of the plastic that made the part, not the machine parameters.

To reduce duration, look at the entire pie chart. Typically, measurements and the mold-build stage take the most time.

Anything that reduces the time spent in those two stages will save the most on the full validation time. Working 24/7 on those parts of the process will provide give great gains to reduce cost. M 7 • 2017

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PATENT PROTECTION

Two Supreme Court decisions take a whack at patent holders

Landmark decisions signal an effort to shoot down patent trolls, but one expert says small business could get caught in the crosshairs.

Heather Thompson | Senior Editor |

Recent Supreme Court decisions dealing with patents have one expert concerned that, rather than clarifying the rules and combating patent trolls, the rulings will instead weaken the rights of patent holders.

Powdered drinks case rewrites the patent venue rules In TC Heartland v. Kraft Foods Group Brands, a venue case, the justices limited the ability of patent holders to sue in other states. Kraft sued TC Heartland in its incorporated state of Delaware over drink powder patents; a lower court blocked TC Heartland’s bid to move the case to its home base of Indiana.

In May, the Supreme Court reversed that decision, finding that the only place defendants can be sued is their home court, a place where infringement occurred or where the defendant has a regular and established place of business.

“It actually upsets decades of precedent,” said Rich Sampson, a shareholder at Davis, Malm &

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D’Agostine. The ruling was welcome to some interested in displacing the patent stronghold in the Eastern District of Texas, he noted.

Eastern Texas has seen “big business” in patent infringement suits and is a favored venue for patent trolls, Sampson said. The Heartland decision will likely shift patent cases to other districts, including medtech clusters in Silicon Valley, Boston, Minnesota and to states where many companies incorporate – including Delaware.

Although the ruling removes a known haven for patent trolls, Sampson said it doesn’t prevent patent trolling. Patent cases will be redistributed to predictable regions where many companies are incorporated and which “might” have a more defendantfriendly attitude, but that could be the extent of its effect on trolls.

Small firms, not patent trolls, could face the biggest obstacles in the aftermath. Larger companies have resources and don’t really have to worry about venue, Sampson explained.

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PATENT PROTECTION

“It might hurt small companies that would like to file suits in their home territories,” he said.

China-based Lexmark makes ink cartridges, priced on two different models. In the U.S., Lexmark offered a

WE SHOULD DEAL WITH THIS IN A MORE NUANCED MANNER [WITH LEGISLATION] INSTEAD OF A BLUNT INSTRUMENT. Printer ink cartridges and overseas pricing The second ruling, in Impression Products v. Lexmark International, has greater implications for tech-based industries and will also influence many small businesses on both the manufacturing and consumer side.

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discount incentive for its return program.

But outside the U.S., prices were lower than even the discounted U.S. price; Lexmark wanted to prevent cartridges sold overseas from being re-sold in the U.S. and undercutting its own price.

The Supreme Court ruled that a product can’t be sold with fewer rights or a subset of ownership rights. In effect, the high court found, once an entity purchases an ink cartridge, they can do what they want with it.

“If you sell it, you sell it with the full bundle of property rights,” Sampson explained. “It’s going to simplify things for purchasers to a large extent.”

The ruling will make it a little more challenging for small companies that sell overseas at lower prices – a model that many medical device companies adopt to get medtech to patients with less purchasing power.

For the most part, however, medical device goods can be produced for different markets with lesser feature sets. Sampson also noted that medical companies might want to consider licensing as opposed to outright sales.

The upside is that consumers have less complexity to deal with when purchasing from abroad, he added.

“They don’t have to be so concerned about the provenance of what they’re buying and being pulled into an infringement situation,” Sampson said. M

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ENGINEERING 911

BioAccess surgical power drills use high energy LMO batteries to achieve a 36% weight reduction with only 40% of the volume of comparable alkaline batteries.

Image courtesy of Tadiran Batteries

How to power handheld surgical devices High energy lithium metal oxide (LMO) batteries enable handheld surgical devices to be small and ergonomic, allowing surgeons to operate quickly and efficiently to reduce fatigue.

Battery-powered devices now span the entire medical spectrum: automatic external defibrillators (AEDs), robotic inspection systems, infusion pumps, bone growth stimulators and other wearable devices, glucose monitors, blood oxygen meters, cauterizers, RFID asset tracking tags and other remote wireless devices.

But handheld surgical drills and power tools present unique design and performance challenges, requiring specialized power supply solutions.

Sol Jacobs | Ta d i r a n B a t t e r i e s |

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Application-specific requirements dictate the ideal power supply Certain medical devices continue to be powered by inexpensive, consumergrade alkaline and rechargeable Lithium-ion (Li-ion) batteries. Meanwhile, there are a growing number of medical

applications that require the use of more rugged and reliable industrial grade lithium primary batteries.

For example, bone growth stimulators that require low continuous current to emit low-intensity, highfrequency sonic pressure waves to stimulate bone growth and healing rely on bobbin-type lithium thionyl chloride (LiSOCl2) battery packs to make the device more compact and lightweight for greater user comfort.

Another common example is the AED, which demands an industrial-grade lithium battery that offers extended shelf life, as this lifesaving equipment must remain idle for extended periods, then must operate instantly and reliably in the event of a cardiac arrest. A hybrid version of the bobbin-type LiSOCl2 battery is

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MS1048

Bobbin-type LiSOCl2 batteries are commonly used in bone growth stimulators and AEDs. Image courtesy of Tadiran Batteries

ideal for use in AEDs, featuring an annual self-discharge rate of less than 1% per year and able to deliver pulses of up to 15 A. Bobbin-type LiSOCl2 cells can also handle extreme temperatures (-80 °C to 125 °C), making them suitable for autoclave sterilization. Specially modified bobbin-type LiSOCl2 batteries can withstand temperatures as low as –80 °C for monitoring frozen tissue samples,

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pharmaceuticals and transplant organs transported in the cold chain.

Hand-held surgical drills present unique design challenges Applications that require continuous highrate power, such as surgical drills and power

tools, can benefit from the TLM series of lithium metal oxide (LMO) batteries, which deliver high voltage, instant activation and exceptionally long shelf life.

Constructed with a carbon-based anode, a multi-metal oxide cathode, and an organic electrolyte, LMO batteries can deliver up to 20-year operating life with an annual self-discharge rate of less than 1% per year. These small but powerful cells feature a nominal voltage of 4 V and up to 2 Wh of energy, with a discharge capacity of 135 mAh to 500 mAh, capable of handling 5 A continuous loads and 15 A maximum pulses. They also feature a wide temperature range (–40 °C to 85 °C), and a hermetic seal for added safety.

LMO batteries are being used to power Pro-Dex battery-powered automatic torque limiting surgical screwdrivers. Neurosurgeons use ProDex screwdrivers to firmly set titanium screws into thin titanium plates that

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ENGINEERING 911

cover portions of the skull removed during surgery.

An automatic torque limiting sensor is deployed to ensure that the titanium screws are properly driven to the right depth, completely flush with the top surface of the titanium plate, thus eliminating any unsightly bumps that cause patient discomfort.

The Pro-Dex screwdriver utilizes a specialized motor with advanced microelectronics, proprietary algorithms, state-of-the-art sensor technology to automatically limit the torque, reversible variable speed control, and touch sensors that provide tactile feel during screw insertion or extraction. This design results in a truly surgeon-friendly power tool that reduces size and weight without sacrificing power or performance.

Several primary lithium chemistries were tested and LMO batteries were chosen for their ability to deliver high continuous power, high pulse amplitude, and up to 4.1 V continuous current per cell during active drilling cycles. These small but powerful batteries also aid in product miniaturization.

Two types of Pro-Dex driver were developed: One powered by two LMO batteries to deliver up to 8 V of variable current to permit drilling speeds of up to 2,200 RPM; and a second version powered by four LMO batteries that deliver up to 16 V of variable current to permit extended drilling time and higher drilling speeds of up to 4,000 RPM. Pro-Dex screwdrivers are completely reusable, except for the battery pack, which is discarded after a single use. An alternative product could be developed using industrial grade rechargeable Lithium-ion (Li-ion) batteries.

Consumer grade Li-ion rechargeable batteries are not manufactured to sufficient medical grade standards, as their high selfdischarge rate may result in low battery availability if the cell is not properly recharged before the procedure.

Consumer Li-ion batteries also suffer from a relatively low power-to-size ratio, thus demanding the use of very large battery packs to deliver the required high pulses. In addition, consumer Li-ion batteries cannot handle high temperature autoclave sterilization.

By contrast, industrial grade Li-ion batteries can operate for up to 20 years and 5,000 recharge cycles and can draw up to 15 A of continuous current. These cells also feature an extremely low self-discharge rate, thus allowing medical devices to sit idle for extended periods and still operate reliably on demand. These ruggedized rechargeable Li-ion batteries also feature a hermetic seal and an extended temperature range.

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Using LMO batteries to replace alkaline batteries Surgical device manufacturer BioAccess also uses high energy LMO batteries as an optional upgrade for a surgical drill powered by alkaline batteries.

By substituting 6 AA-size TLM-1550HP batteries for the alkaline battery pack, BioAccess achieved a 36% weight reduction with only 40% of the volume. An equivalent alkaline battery pack would have required three times the weight and 2.5 times the volume (15 AA-size alkaline batteries vs. 6 AAsize TLM-1550-HP batteries). Use of an LMO battery pack also enabled the surgical drill to deliver faster drilling speeds, more active drill time (30 to 40 seconds at a time for up to 20 to 30 cycles), more instantaneous power and greater stall torque, resulting in more efficient drilling cycles with less operator fatigue.

These case histories demonstrate how advanced lithium battery technology is enabling handheld surgical devices to become more miniaturized while also improving product performance. M

LMO batteries make Pro-Dex surgical screwdrivers small and ergonomic, delivering high continuous power and high pulses for drilling speeds up to 4,000 RPM. Image courtesy of Pro-Dex

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MANUFACTURING & MACHINING

Four questions to ask when the mold will not fill right A pressure sensor can be a big help when your mold isn’t filling properly.

Here are four questions to ask when shopping for the right sensor.

Some molding problems can be diagnosed with a little pressure data from inside the mold. But whether you’re new to molding or a seasoned veteran trying to solve a problem, selecting a cavity pressure sensor and positioning it can be an uncertain decision.

There are now more options than ever to fit an application and make it work. Start the diagnosis with these simple questions:

S h a n e Va n d e K e r k h o f | RJG |

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1. What problem are you trying to solve?

Short shots? Flash? Incorrect dimensions?

Just put a sensor where the problem is. Most often, that will be the last location to fill, or what is commonly referred to as the end of cavity. Most quality defects can be correlated to the pressure at this location. Too much pressure and the parts get bigger; not enough and they get smaller. All in all, it’s a pretty straightforward correlation.

Placing sensors does require modification of the mold, depending on the type of sensor. For button-style sensors, a channel and pocket are milled into the ejector retainer plate where the sensor lead and sensor head will sit, underneath the ejector pin. Flush-mount sensors need a hole in the surface of the cavity, where the sensor is then placed so it has direct contact with the material as it flows in.

Pressure-related defects include short shots (non-filled parts), dimensional variation, flash, surface finish and strength issues. These further fall into two categories: high- and lowpressure conditions. Short shots, sinks, too-small dimensions and surface finish fall into the low-pressure condition. Flash and too-large dimensions fall into the highpressure condition. It will be necessary to select control limits for each application on a case-by-case basis.

7 • 2017

When determining the end of cavity, we typically ask customers to produce a short shot, find that place in the mold and place a sensor as close to it as possible. If the tool hasn’t been built, a flow simulation study can help determine that last place to fill. Short of that, experience and gate location is also an option for determining the end of cavity location.

2. How many transducers would be needed in a multi-cavity mold?

Start with whether the mold has a coldrunner or hot-runner tool. If it’s a cold-runner

Pressure sensors come in a variety of designs for a range of pressure applications and the temperatures they will encounter.

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MANUFACTURING & MACHINING

mold, the flow pattern will be consistent.

Typically, we can reduce the number of transducers necessary by putting a sensor at the end of the cavity that fills last. This strategy works well up to about eight cavities. As the cavity count increases, so will the number of needed transducers.

For hot-runner tools, the previous strategy grows more complex because of thermal cycling, which occurs in hot-runner manifolds and tips. The flow pattern has a tendency to change over time, so more transducers will be needed to catch quality defects.

3. How do you decide between flush-mount or ejector pin-style sensors?

This is simply determined by availability and real estate. Where there’s an ejector pin in the last place to fill, that’s the place to put the transducer. Where there’s no ejector pin nearby, the situation calls for a flush-mount sensor.

4. How do you know if the application calls for a piezoelectric or strain gauge sensor?

First, all flush-mount sensors are piezoelectric, but ejector pin transducers come in both technologies. Strain gauges are the cheaper of the two, and until recently, piezoelectric came in smaller sizes that work better in small parts. Our new 6 mm strain gauge sensor matches the performance and size of the smallest piezoelectric sensor head at a more cost-effective price. In the end, sensor selection comes down to what technology best fits an application.

A more recent option is a multi-channel setup. For those with high-cavity-count molds, the number of connectors and wires becomes an issue. To alleviate this, we developed a multi-channel solution for both piezoelectric and strain gauge sensors.

This significantly reduced the number of connectors and wires and therefore reduced breakage in these components.

The most common use for cavity pressure sensors is to automate the inspection of the molded part. The sensors provide data that allows a part inspection with every cycle.

Control limits are set, and any parts that do not meet those limits can then be segregated by a robot or conveyor. M

TOP: Part of the eDart system requires setting alarms for low and high pressure. That is accomplished with selections in an easy to read table.

BOTTOM: The Job Summary screen in eDart provides a pressure record of an entire cycle.

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THE CATH LAB

Advanced contact force ablation: Marrying fiber optics, flexibility and 3D mapping The new TactiCath contact ablation catheter unites Endosense and St. Jude Medical technologies that Abbott acquired.

Heather Thompson | Senior Editor |

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Close-up of the TactiCath tip.

If you want your grilled cheese to cook faster, you press it into the pan with your spatula. That’s contact force, the principle behind Abbott’s TactiCath contact force ablation catheter, according to Srijoy Mahapatra, Abbott’s VP of medical, clinical and scientific affairs.

Abbott acquired TactiCath with the purchase of St. Jude Medical this year. (St. Jude acquired Swiss company Endosense in 2013.) The latest version of the TactiCath, which won CE Mark approval in the European Union in May, unites the Endosense device with the EnSite Precision cardiac mapping system developed

by St. Jude.

Although cardiac tissue ablation is far more sophisticated than whipping up a grilled cheese, the physics of the issue are the same. The more force the surgeon uses when the catheter is touching the tissue, the bigger the lesion. “Too much force can be dangerous; too little force means no lesion,” Mahapatra explained.

The new TactiCath is sensor-enabled and emphasizes accuracy and precision through dual impedance and magnetic

technologies designed to precisely model the heart to determine where to apply optimal contact force.

TactiCath is built on Abbott’s FlexAbility catheter platform, featuring an ergonomic handle-shaft combination designed for reach, maneuverability and 1:1 torque.

“A big change from the old fiberoptic system to the new one is we moved it over to a catheter that’s much more maneuverable,” Mahapatra said, noting that Abbott is planning the same for all future catheters.

A BIG CHANGE FROM THE OLD FIBEROPTIC SYSTEM TO THE NEW ONE IS WE MOVED IT OVER TO THE CATHETER THAT’S MUCH MORE MANEUVERABLE.

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Fiberoptics bring contact force information into the hands of the surgeon, using a Fabry–Pérot interferometer of three fiberoptic lines and three glass wires. Light emitted from the system travels through the TactiCath toward

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7/17/17 12:23 AM

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THE CATH LAB

the tip and is reflected back and forth many times as it enters the force sensor’s micrometric cavities. The differing path lengths of the resulting beams create interference patterns; when force is applied, the cavity length changes and thus the interference pattern. Interference based on the signals returned by the three optic fibers are analyzed to determine the three cavities and the exact computation of both magnitude and orientation of the contact force. The fiberoptic technology works both axially and laterally, and the size of the fiberoptic lines allows them to be only 4 mm from the distal tip of the catheter (compared with competitor products with lines as far back as 9 mm, according to Abbott).

Mahapatra noted that although the force-sensing system provides high accuracy, it wasn’t as good on its own as it could be. Physicians wanted another form of data to create a more detailed heart model – hence the introduction of the Ensight Precision mapping element.

Magnetic sensors act as a coordinating system built under the operating table, coordinating with magnets within the catheter to provide tracking.

“It adds another layer of feedback to the system,” Mahapatra said.

Non-fluoroscopic cardiac mapping systems are designed to provide the required spatial anatomical information in combination with local electrical information. EnSite is an open system with 3D visualization, enabling both magnetic and impedance (resistance) data. Fusion algorithms and respiratory compensation allow for model-guided therapy with real-time non-fluoroscopic visualization of intracardiac catheters within registered 3D CT/MRI images.

The full system enables automated guidance of lesion marking, verification of the ablation catheter stability, the ability to automatically record the precise location of the catheter tip during radiofrequency energy application, the capability to add mapping points based on contact force and the ability to review and identify any potential gaps by viewing specific lesions from the display list.

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and lead the way in clinical outcomes for patients with cardiac arrhythmias – even during long and complex ablation procedures,” Mahapatra said. “Integration with the EnSite Precision cardiac mapping system provides an unprecedented opportunity to help patients suffering with atrial fibrillation.”

Abbott is launching the new TactiCath in select markets in Europe, with a full market release expected in the third quarter this year. The company is also pursuing approval in the U.S. M

Abbott's latest innovation to treat atrial fibrillation: the TactiCath contact force ablation catheter, sensor enabled with EnSite Precision cardiac mapping system.

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CONNECTORS CORNER

Glass-sealed connectors increase the longevity and reliability of medical devices

Autoclavable connectors enable superior reliability and performance in operating room devices.

As medical instruments and technologies grow more sophisticated and complex, it is increasingly important to guard sensitive components from the autoclaving process while supporting their longevity.

Glass offers a solution.

Jochen Herzberg | Schott Electronic Packaging |

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In today’s era of rapid technological advancement, medical devices have become more complex and capable than ever thanks to the integration of advanced electronic components. In the medical field, steam sterilization in the autoclave is a staple of the industry. The crucially important process pits devices against temperatures of 273 °F and two bars of pressure to ensure devices are sterile and safe to use before each procedure. The electronics inside modern medical appliances need protection from the intense conditions of the autoclave.

One of the most important components in this process is the connector, which makes electrical and data connections between device sections.

Implementation of high-quality connectors using the right materials is crucial. Inferior components can weaken the protection of the device’s electronics.

7 • 2017

Glass-to-metal sealing technology, already used in other harsh-environment applications such as aviation, aerospace and automotive safety, has emerged as an ideal solution in the development and manufacture of medical connectors.

Glass-to-metal sealed connectors offer a resilient and dependable option that remains reliably gas-tight for over 3,500 autoclaving cycles, subsequently helping extend the lifespan of medical devices.

Potential difficulties with polymersealed connectors Many medical connectors are sealed with polymers or epoxy resins, which are not capable of maintaining a dependable seal over a long period. During the autoclaving process and especially after repeated cycles, polymer-based connectors will allow for a certain permeability of moisture. This can cause

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Plastic Part Validation Have You Buried?

Let PTI Engineered Plastics Dig You Out. In this age of high-tech manufacturing, quality requirements have never been tougher.

That’s why PTI Engineered Plastics has built their operations to support validations throughout their manufacturing and assembly processes. Our team is highly trained to define and implement all facets of IQ, OQ, PQ protocol validations, including many other quality standards required in the plastic injection molding industry.

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CONNECTORS CORNER

damage to electronic components. The binders and chemicals that make up polymer seals deteriorate over time, leaving a brittle shield incapable of providing truly reliable protection from autoclaving conditions.

The aging process and breakdown of these organic materials can happen quickly, sometimes after as few as 100 autoclaving cycles. The potential inability of polymer seals to stand up to the fundamentally important autoclaving process can lead to a plethora of problems: shortened device lifespan, failure during a procedure and increased total cost of ownership from compromised seal integrity.

Autoclavable glass-sealed connector from Schott.

Connectors are strengthened by the integrity of glass A common argument against glass as a material is the idea that it is easily broken.

Glass-to-metal sealing technology challenges this concept.

Using advanced manufacturing processes, the glass preform and metal pieces are heated to a temperature that melts the glass, fusing glass and metal to create a gas-tight and pressure-proof seal.

During their use, glass seals maintain integrity because glass is inorganic and non-aging. It is nonporous and resistant to drastic environmental changes.

This makes it a choice material to use in the manufacture of medical connectors because it has a proven ability to withstand the autoclaving process more than 3,500 times. The strong seal effectively prevents the ingress of moisture and other outside contaminants, safeguarding electronics from damaging humidity and particulates.

Peace of mind for medical professionals Confidence is of the utmost importance in medicine. A doctor’s confidence in his abilities, decisions, colleagues and treatment all come together in the effort to create a successful patient outcome. The same need for confidence applies to medical devices. Medical professionals must be able to have trust in their equipment. The use of devices with glass-to-metal sealed connectors goes a long way to help establish this on many fronts.

Cross-contamination incidents are one of the most substantial threats to patient safety and professional

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integrity in the medical industry. Mitigating the risk of such incidents is why the autoclaving process is extremely important in medical environments. Traditionally, steam sterilization presents a major strain on devices because it can accelerate wear on components. With protection for electronics from glass-to-metal connectors, devices can undergo a complete and intensive autoclaving cycle over 3,500 times without risk of accelerated damage or wear on the electronics.

Increased reliability aided by the use of glass-to-metal connectors eases worry both in the operating room and finance office.

Glass-to-metal connectors can help extend device service life, reduce maintenance costs, and lessen the chance of warranty claims and physician frustrations. Surgeons and patients can experience the safety benefit of a decreased chance of device failure, while hospital budgets can experience a reduced burden thanks to a less-frequent device replacement schedule.

Design possibilities enabled by customizable glass-to-metal technology Versatility is another key benefit that sets glassto-metal sealed connectors apart in a constantly developing medical landscape. Integration possibilities for medical applications include surgical tools, endoscopes or instruments for spectrometry and pulse oximetry. Customization possibilities can be met for individual and exact application needs, enabling design flexibility for medical device engineers. This creates the opportunity to conceptualize distinct ideas while still meeting strict regulatory requirements for medical devices.

Glass-to-metal sealed medical connectors can be custom-designed in a number of ways, including varying shapes, sizes and pin configurations to match requirements for integration in medical devices that require power and data supply and must be repeatedly autoclaved.

Devices and techniques will change, but the rigid standards for autoclaving requirements for hygienic operating rooms will remain a constant. As medical instruments and technologies grow more sophisticated and complex, it is increasingly important to guard sensitive components from the autoclaving process while supporting their longevity.

Glass, in its distinct role as an inorganic and reliable sealing material, offers a way. M

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INTEGER HOLDINGS

GREATBATCH AND LAKE REGION MEDICAL MERGED NEARLY TWO YEARS AGO TO BECOME INTEGER HOLDINGS CO., A GIANT MEDICAL DEVICE CONTRACT MANUFACTURER THAT COULD THEORETICALLY DO ALMOST ANYTHING FOR AN OEM. BUT CAN THIS COLOSSUS OF A COMPANY EXECUTE ON ITS EXPANDED CAPABILITIES?

C H R IS NEW MA R K ER • M A NA GI N G EDI TOR

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INTEGER HOLDINGS

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INTEGER HOLDINGS

W

hen Greatbatch and Lake Region Medical merged in 2015, company officials decided they would rename the combined $1.4-billion-a-year company as Integer, the Latin for “whole,” to reflect the comprehensive products and services their customers would enjoy.

With much of its integration now complete, the Frisco, Texas–based company has turned a corner and appears to be set to spread the word and truly capitalize on its expanded capabilities.

Integer’s manufacturing expertise is vast, including micro machining, laser processing, injection molding, metal stamping, small diameter and multi-lumen

Medical Design & Outsourcing. “The next couple of years our focus is on optimizing what we have, taking full advantage of the technology and the Joe Dziedzic | Jeremy Friedman | abilities to vertically Interim CEO | COO | Integer | Integer | integrate.”

It’s crunch time for implantable pulse generator; Greatbatch the big kid on the block launched his own venture in 1970 to in medical device outsourcing. produce cutting-edge pacemaker batteries.

“If they execute, they’ll be more Fast-forward about 50 years, and the successful than they have been in the combined Integer has the capability to be past. This management team might be a major partner with OEMs developing putting forth a good effort,” noted Mark some of the newest and most exciting Bonifacio, a medical device manufacturing innovations in the medical device space. consultant based in the Boston area.

Take transcatheter heart valves as an example. Analysts predict transcatheter Capitalizing on innovation aortic valve replacement technologies Greatbatch and Lake Region will be a $5 billion market by the 2020s, Medical each had histories and medical device companies are of innovation dating back spending hundreds of millions of dollars to the founding story of to acquire transcatheter mitral valve Medtronic, the world’s replacement technology. largest medical device OEM. For Integer, that’s an opportunity Joseph Fleischhacker to unite Lake Region’s expertise in Sr. made fishing lures when components and delivery guidewires with he started Lake Region in Greatbatch’s molding, catheter delivery the 1940s as a backyard side business system and steerable sheath capability. outside Minneapolis; his connections with Medtronic co-founder Earl Bakken had him making all of Medtronic’s pacemaker leads by the 1960s, according to a 2014 article in the Minneapolis Star Tribune.

Medtronic got into the implantable pacemaker business in the early ‘60s after Bakken’s brother-inA steerable sheath law and coand transseptal access founder Palmer guidewire manufactured Hermundslie

by Integer’s Lake Region flew his own Medical part of the business.

Image courtesy of Integer airplane to Buffalo to meet with electrical engineer Wilson Greatbatch and Dr. William Chardack.

Hermundslie negotiated Medtronic’s exclusive rights to produce and market the Chardack-Greatbatch

SHEER SIZE ISN’T WHAT MAKES A COMPANY. WHAT WE THINK WE HAVE IS WE HAVE UNRIVALED CAPABILITY. plastic tubing, metal stamping and grinding, precious metal manufacturing, tube fabrication, wire coiling and more. Technical capabilities include metallurgy, catheters, guidewires, implantable pulse generators, batteries, software, battery packs, wireless charging, leads and robotics.

“Sheer size isn’t what makes a company. What we think we have is we have unrivaled capability. We can do something for everybody, because we can play in the full continuum,” said CEO Joe Dziedzic, a former Integer board member who took over in March after Thomas Hook stepped down from the top spot. (Integer’s board removed the “interim” from his title in July.)

Revenue – down 4% on a comparable results basis in 2016 – was up 4% year-over-year during the first three months of 2017. As of early July, Integer’s stock was up more than 40% for the year, trading at more than $40 per share.

“We’re wrapping up the formal integration process of combining the companies. We’re moving now towards business optimization,” Dziedzic told 40

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FDA Registered ISO 9001 ISO 13485 Compliant FDA Registered ISO 9001 ISO 13485 Compliant

METAL COMPONENTS FOR MEDICAL DEVICES Medical Device OEM’s rely on our speed and quality: • Fluid Delivery • Dispensing • Surgical • Drug Delivery • Life support • Diagnostic Rapid Prototyping

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INTEGER HOLDINGS

“In effect, we now can basically develop and manufacture a full structural heart delivery system,” COO Jeremy Friedman told us.

Another hot medical device area is neuromodulation – using pacemaker technology on the brain and nervous system to treat conditions ranging from Parkinson’s to back pain to obesity. Lake Region was focused on components and sub-assemblies such as headers, connectors, coils and cables; Greatbatch specialized in a different set of components and sub-assemblies, including batteries, enclosures, feedthroughs, shield assembly and leads – not to mention full systems.

“When we’re thinking about spinal cord stimulation or deep brain stimulation, again we can develop and manufacture the full system to the customer’s specifications, with required components

Image courtesy of Integer

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INTEGER HOLDINGS

and subassembly vertically integrated,” Friedman explained.

And, he added, Integer’s advanced surgical and orthopedics business can also play in another medical device field with a lot of buzz: Robot-assisted surgery.

Optimizing capabilities “I think our customers needed a year to know what Integer was,” said Andrew Senn, Integer’s VP of R&D for cardio and vascular, during a recent MDO visit to Integer’s facility in Chaska, Minn.

Integer in June was still in the process of swapping out the Lake Region Medical signs at Chaska, a 163,000-square-foot campus with five facilities specializing in guidewires. The Hazeltine National Golf Club was just across the lake, and the company had plastic coyotes placed strategically on the lawn to ward off geese.

One of Fleischhacker’s early wire coiling machines – the “Grandma” machine that serviced Medtronic’s 1960s pacemaker lead coil needs – was on display in one atrium.

Chaska is an Integer “Center of Excellence” when it comes to wire forming, coil-winding, machining and joining, as well as core development engineering and contract manufacturing. Nearly 50,000 sterilized products leave the site every week.

Lake Region Medical was already well-versed in vertical integration before the merger with Greatbatch. For example, wire comes to Chaska pre-coated and spooled from the company’s plant in New Ross, Ireland. Senn suspects the company has avoided many of the problems involving flaking PTFE coatings because of the Ireland plant’s focus on coating wires before winding them into coils, versus spray-coating or dip-coating them after the coiling process.

Company officials told us that the past two years have been about integrating and standardizing sales processes and systems, quality management and more – as managers and subject matter experts discover what’s available in their new corporate empire.

Now officials in Chaska hope to capitalize on those new capabilities. A former Greatbatch facility, for example, might be able to mold some of the plastic components that go with guidewires – parts that Integer presently outsources.

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Medical Design & OUTSOURCING “Now we’re in a position to be vertically integrated, be a supplier to ourselves and control the supply chain, which has all the cost benefits,” explained director of operations Terry Ostgulen.

Opportunities abound, added Aimee Garza, a Plymouth, Minn.-based director of Integer’s strategic marketing for cardiac www.medicaldesignandoutsourcing.com

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rhythm management and neuromodulation.

“We have the capabilities and the breadth to support any customer needs, from manufacturing miniaturized components all the way through to design, development and manufacturing of a full finished systems if that’s what the customer desires,” Garza said. M 7 • 2017

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CONSOLIDATION

Cleared to acquire: Why the medtech contract manufacturer M&A trend isn’t slowing down

Consolidation is increasingly shaping the medical device industry, but what about players on the other side of the fence? Contract manufacturing partners to OEMs are seeing their own abundance of M&A as larger players look to expand their influence and keep up with increasing demand.

O

ver the past four years, the medical device industry has looked to mergers and acquisitions to produce immediate growth and optimize competitiveness.

Major players are merging to consolidate their capabilities and looking to niche acquisitions to broaden their offerings and keep up with the shifting healthcare landscape.

Although moves like Medtronic’s $50 billion acquisition of Covidien hog the spotlight, behind the curtains medtech contract manufacturers are experiencing their own run of M&A activity, as manufacturers look to consolidate to keep up with their OEM partners.

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FI N K DEN SFORD ASSOCI AT E ED I TO R

In 2013, Phillips-Medisize snagged two Adval Tech Group manufacturing facilities.

The next year, Tecomet snatched up both 3D Medical Manufacturing and Symmetry Medical’s OEM Solutions business. And then in 2015, Greatbatch merged with Lake Region Medical and went on to rebrand the new medical device contract manufacturing giant as Integer Holdings Co. Last year Molex turned the tables on Phillips-Medisize, shortly after that company acquired Injectronics, and TE Connectivity expanded its interventional offerings by acquiring Creganna Medical Group.

This year we’ve seen private equity giant Kohlberg & Co. buy out specialty

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CONSOLIDATION

plastics manufacturer Pexco to merge it with PPC are also seeking efficiencies in their supply base with Industries to create Spectrum Plastics. These larger a preference for partners who can provide the widest plays are joined by a wealth of smaller M&A deals, range of capabilities for multiple products and at a as all companies in the global scale,” Stanton field try to ramp up to explained. stay competitive in an Consolidation allows MAJOR CMO increasingly demanding for faster adaptation, market. which is vital in the ACQUISITIONS OF And the trend isn’t ever-shifting healthcare THE PAST 4 YEARS: showing any signs of landscape for OEMs. stopping.

The same can be said for “I think that there CMOs, which not only will be continued have to meet previous • 2013: Phillips-Medisize acquires Adval consolidation. I'd say manufacturing demands Tech Group plants in China, Mexico it's hard to forecast but are also taking on the volume. We think more responsibility from • 2014: Tecomet acquires both 3D that there is efficiency their partners.

Medical Manufacturing and Symmetry for companies that Increasingly, CMOs Medical’s OEM Solutions consolidate, we think are being asked to that the OEMs prefer operate outside previous • 2015: Greatbatch merges with Lake to work with the elite boundaries – adding their Region Medical, officially renames itself provider, so they'd own product design and Integer Holdings Co. the next year rather deal with fewer development expertise contract manufacturers,” and filling in gaps for large • 2016: Molex acquires Phillipssaid Standard & Poor’s OEMs that make them vital Medisize, TE Connectivity acquires corporate ratings director to the supply chain.

Creganna Medical Group David Kaplan.

When time is at a The sentiment seems premium, consolidation is a • 2017: Kohlberg & Co. acquires Pexco, to be shared across the natural strategy for players merges it with PPC Industries to create industry: Consolidation looking to keep up and Spectrum Plastics allows CMOs to mirror their meet OEM needs without OEM counterparts – which the extended timeframes are increasingly focused necessary for organic growth. on consolidating their “Medical device OEMs supply chains – and stay are looking for partners that competitive as their size and capabilities expand. bring to bear broad and deep turnkey capabilities that “Consolidation in the specialist device component have the ability to fill technology gaps in their portfolios and general contract manufacturing base mirrors the and accelerate time to market for disruptive innovations. consolidation that is happening among the customer They are looking for partners with the scale and base. Both trends are interlinked,” said TE Connectivity sophistication required to support increasingly complex medical sales & marketing VP Jeffery Stanton. global supply chains,” said Spectrum Plastics medical Both OEMs and CMOs are reaping similar benefits from the consolidation, including immediate bumps to production scale, broadened capabilities and a diversified customer base – all things that are difficult to achieve with organic growth.

For OEMs, consolidation has become vital as efficiency objectives shift toward value-based care initiatives.

“Medical device companies are responding president Mauricio Arellano. on the frontline to ongoing pressures in healthcare For TE Connectivity, Stanton noted, the acquisitions spending. Mega-mergers and acquisitions are a route of both Creganna Medical and AdvancedCath allowed to achieving scale and efficiency while positioning for the company to place itself near the head of the pack success by delivering the widest portfolio of products for specialist solutions for interventional devices – and to hospital buyer groups. In parallel, these companies quickly. The company only took 12 months to integrate

I THINK THAT THERE WILL BE CONTINUED CONSOLIDATION. I’D SAY IT’S HARD TO FORECAST THE VOLUME.

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CONSOLIDATION

the acquisitions as strategic suppliers to its customer base.

“This could not have been accomplished through organic growth in that same timeframe,” Stanton said.

Other needs are much more easily met with consolidation than with organic growth, such as customer and manufacturing capability diversification.

“Consolidation is sometimes focused on increasing customer diversification. Some of them are very concentrated on their customers – diversifying in a way so that they’re not too [dependent] on just one or two of them,” Standard & Poor’s research assistant Sarah Kahn said.

Major players will often consider acquisitions based on diversifying their capabilities within a particular industry, like plastics, Kahn added. Larger companies often look to acquisitions to broaden their offerings within their niche, which more often comes from companies

that aren’t direct competitors but are offering similar products.

“It’s really about the capabilities they can develop and not just the niche.

If they can acquire a competitor that’s not a direct competitor, because they don’t have similar capabilities, that can

MEDICAL DEVICE OEMS ARE LOOKING FOR PARTNERS THAT BRING TO BEAR BROAD AND DEEP TURNKEY CAPABILITIES THAT HAVE THE ABILITY TO FILL TECHNOLOGY GAPS IN THEIR PORTFOLIOS AND ACCELERATE TIME TO MARKET FOR DISRUPTIVE INNOVATIONS.

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CONSOLIDATION

also be a target,” Kahn explained.

As large OEMs rely on consolidation to expand their businesses, the implications flow to the CMO space, meaning that smaller players are edged out over time. So who among the smaller CMOs will be the most safe?

Those with niche expertise, according to Standard & Poor’s Kaplan.

“I think as an existing business, it’s probably safe for most of them, certainly to the extent that they have niche expertise,” he said. “But I think that proportionately more of the new revenue will go to the bigger ones.”

Geographic advantages, such as being located near an OEM medical device company, could also play in favor of smaller businesses.

Although smaller companies might not have access to the capital needed

to fund buyouts, manufacturers with a specialized knowledge or production capabilities could stand out to larger companies as possible acquisitions.

In most cases, major players in the space prefer to acquire “mid-sized” companies, Kaplan said, with revenues in the 10s of millions. But a smaller company offering specialized expertise could pique interest from larger manufacturers looking to expand their own capabilities.

“They could be interested in some of the very small ones as long as there’s a niche expertise which is complementary to their own,” he said.

And although the M&A craze doesn’t seem to be slowing down on the OEM or CMO side, Kaplan thinks we may see some larger players taking time between acquisitions to “digest.”

“One element that might be a

constraint would be companies that have completed transactions recently.

There’s kind of a period of digestion, where a company makes sure they’ve fully absorbed and integrated the company, the culture, the system,” he said.

It’s difficult to consider consolidation a “trend,” as it’s likely here to stay so long as it’s one of the most efficient survival and growth strategies for both OEMs and CMOs. “For both medical device companies and contract manufacturing partners, scale and portfolio breadth are vital to competitiveness. All companies in the medical device eco-system will continue to work toward these strategic imperatives,” Stanton said. M Managing editor Chris Newmarker contributed to this story.

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DRUG DELIVERY

Manufacturing drug-device products: Challenges and best practices SARAH FAULKN ER ASSOCI AT E EDI TOR Image courtesy of ProMed Pharma

Integrating a drug with a mechanical device can, in some cases, improve patient outcomes and boost sales. But manufacturing these products is no simple feat: It often requires a specialized contract manufacturer with extensive experience in the field to make a drug-device combo buildable and scalable.

T

here’s a lot to consider when manufacturing a medical device. Add to that the challenge of incorporating a pharmaceutical component, and things can quickly go awry. MTD Micro Molding, a micro injection molding manufacturer that develops such products as atomizing nozzles and bioabsorbable polymers, points to this challenge as just one reason companies should rely on the experts.

“Active drugs compounded with bioabsorbable materials present a myriad of challenges,” said Dennis Tully, MTD’s president. “The handling of material from storage through prep, molding, packaging, shipping in order to preserve the drug –

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each step is an opportunity for failure.”

For companies that haven’t worked in the drug-device combination space, the increased development timeline can be shocking, noted Glenn Ogura, market development SVP at laser micro manufacturer Resonetics.

“Drug-delivery devices can follow lengthy development cycles before commercialization,” Ogura said.

That means companies need to be ready to approach contract manufacturers with a target product profile, according to contract R&D and manufacturing company ProMed Pharma, which specializes in manufacturing drug-releasing dosage forms and drug-eluting combination products.

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DRUG DELIVERY

There’s a plethora of factors companies must work through with clients, including the material of the device, drug formulations and the size of the end product, said Jim Arps, director of pharma services at ProMed. It’s not easy, so leave it up to the specialists From micro injection molding to laser ablation, contract manufacturers are specialists. At Resonetics, clients looking for laser micro-manufacturing capabilities can work with custom equipment and a team of highly-trained laser application engineers.

“Once the device company is ready to commercialize, then custom laser equipment can be seamlessly developed if the laser micro-manufacturer offers the unique product offering of both being a high-volume contract manufacturer and having an inhouse custom laser system design team. This powerful combination accelerates the development of complex, 3-D ablation processes while simultaneously engineering automated equipment,” Ogura said.

Even decisions that seem simple – like choosing a product’s material – can require an expert’s input.

ProMed Pharma’s Arps noted that his company helps clients pick the appropriate material for a drug-device product by considering the drug’s physical and chemical characteristics, such as solubility and thermal decomposition properties.

“We have a lot of experience in being able to work with our customers to try to identify the right types of materials that would be best for their application,” he said.

Product size can also affect where a device company will go in search of manufacturing help. When it comes to creating something that’s really small, companies should rely on manufacturers with expertise on that scale, according to Tully.

“In many instances, micro part features that can be seen with the naked eye require more specialized tools and techniques than what’s required for a microscopic part with simple geometry,” he said.

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The case for taking on a drug-device product Although the development process can be precarious, combining a drug with a device can be a beneficial move for companies looking to improve patient outcomes and boost sales.

“Pharmaceutical companies can opt for a business strategy to develop novel drug delivery platforms to reinvigorate drug sales by re-introducing drugs coming off patent protection,” Ogura said.

used its micro molding expertise to manufacture bioabsorbable implants, permanent implants and microneedles.

“Micromolding enables solutions for various drug delivery applications, making drug delivery devices more convenient, painless and effective for patients,” Tully said. “Many of the drug delivery micromolding projects we take on are rescue projects – those that failed with other molders or methods and may have been thought to be ‘impossible.’”

Image courtesy of MTD Micro Molding

Companies use Resonetic’s laser micro-manufacturing capabilities to build a wide array of drug delivery devices, including implants and drug-eluting infusion devices.

“There are multiple market drivers to use laser micro-manufacturing to fabricate drug delivery devices,” he said. “Novel pulmonary, ophthalmic and nebulizer delivery devices incorporate laser-drilled micro-hole arrays (typically 10µ to 100µ in diameter) in thin polymer membranes to improve the efficacy of drug delivery such as targeted localized delivery with smaller dosage.”

MTD Micro Molding has manufactured internal components like micro-molded, ultra-thin-wall cannulas in wearable bolus injectors and drug infusion sets. The company has also

Don’t let manufacturing be an afterthought in design Whether the contractor specializes in laser ablation, silicone or micro molding, they all seem to agree on one thing: Don’t wait until the last minute to involve a manufacturer.

“If possible, it is beneficial to the client to not be completely locked into their part design by the time they enter into a new supplier relationship with a micro molder,” Tully said.

Early on, companies should consider whether the design of a product is scalable and remain open to change in case it isn’t, the manufacturers agreed.

“We want to think very early on about how manufacturable it could be, because we don't want to get too far down the road in development and find out that

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DRUG DELIVERY

we're miles apart in terms of what the end product might need to cost,” Arps said.

“In the very early stage of development, device companies must understand the business roadmap to production to ensure that the chosen fabrication method can meet quality, cost and volumes requirements. There is no point going down a development pathway that has no means to scale into production,” Ogura added.

But whether clients come to them with the very beginnings of an idea or a product that is ready for full-scale production, the expertise of a contract manufacturer can help turn a drug-device combo from a vision into a reality.

MICROMOLDING ENABLES SOLUTIONS FOR VARIOUS DRUG DELIVERY APPLICATIONS, MAKING DRUG DELIVERY DEVICES MORE CONVENIENT, PAINLESS AND EFFECTIVE FOR PATIENTS. “Some people come right at the ground floor where they may have a medical device company that has a current device that doesn’t have a drug incorporated with it but has an idea for it and how can they get there,” Arps said.

“They may not have either the facilities, the knowhow, the scalability to do that, and then they can take advantage of the fact that we're a [good manufacturing practices] facility and have done this before. Then we'll take it from there.” M 7 • 2017

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CM LONGEVITY

The secrets of contract manufacturing longevity WHETHER IT’S A FEW DECADES OR THE BETTER PART OF A CENTURY, THERE ARE IMPORTANT FACTORS THAT ENABLE A CONTRACT MANUFACTURER TO LAST FOR A LONG TIME – BUSINESS TRAITS THAT OEM CUSTOMERS SHOULD VALUE. WE ASKED TOP EXECUTIVES FROM LONG-LASTING MEDICAL DEVICE INDUSTRY SUPPLIERS TO SHARE THEIR SECRETS.

DAN I ELLE KI RSH ASSI STAN T EDI TOR Mike Ondercin started Cleveland-based Criterion as a tool-and-dye company in 1953. Today Criterion is a precision manufacturing facility owned by Ondercin’s granddaughter Tanya DiSalvo – who bought out the former owner, her dad.

The company doubled its employee roster over the last 5 years, to about 40 people. That constant growth has Criterion bringing in $15 million to $20 million in sales a year, according to DiSalvo.

“The sales have grown by really working with our customers and being their go-to source. We had to earn the right with engineers that shows that we can deliver and provide added value services,” she explained.

Contract manufacturers like Criterion that have demonstrated their ability to last are highly prized in the medical device industry – especially because the highly regulated environment makes it difficult to change suppliers.

There are many other medical device industry suppliers with their own stories of success: 7 • 2017

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• Since its 1967 founding, Donatelle has grown into a contract manufacturer producing complex and precision components and assemblies for medical devices. “The founders and owners of Donatelle have been committed to excellence in technology,

on micro medical devices. Revenue quickly grew, to $8.5 million this year.

After Tully retired, his son Dennis Tully took over. “The growth that we are experiencing now is attributable to the seeds we planted 4 or 5 years ago,” the younger Tully said.

LEFT: Richard Tully started MTD Micro Molding in 1972 to make molding components for electronics.

Photo from MTD Micro Molding

RIGHT: Dennis Tully had the chance to buy out his

dad at MTD Micro Molding and has served as the quality and workmanship since the company president ever since. very beginning,” president Treasa Photo from MTD Micro Molding Springett told us. “Their passion for excellence and precision is still the foundation of our business • Lee Carver founded Sil-Pro in 1998, today and what has paved the way for centered around molding components continuous growth and success over for medical devices. Lee’s son, Kevin the past 50 years.”

Carver, has been involved with the

• Richard Tully started MTD Micro Molding in his basement in 1972; the company’s original name was Miniature Tool & Die. It graduated into different niches over time, eventually venturing into the then-little-known niche of micro molds in 1998. The niche became so important that the company changed its name in 2010, focusing exclusively

“[We’ve been] eager and hungry to take on business with customers and along with that, [we] continuously introduce new segments to our business to fuel growth as well.”

• Infus Medical has exclusively served the medical device industry since its 1991 founding. The Thailand-based company started with just 25 employees and has grown to employ approximately 1,000 workers. Infus has constantly updated its processes, an important reason it has been around so long, noted Prim Chanarat, a product engineer at Infus who has watched her dad run the company for the last 26 years.

“Our facilities’ versatile machinery and assembly and packaging processes – such as our in-house plastic conversion machines, blister packaging and ETO sterilization chambers – have enabled us to encompass a large product portfolio that is constantly growing,” Chanarat said.

So what are the traits that lead to contract manufacturing longevity – aspects of the business that OEM customers should try to spot? Here are 5 things that enabled Criterion, Donatelle, MTD Micro Molding, Sil-Pro and Infus Medical to be around for so long.

1. Invest in the future.

The medtech industry is a fast-changing one. Manufacturers should always keep up with the latest technology. As both DiSalvo and Tully said, “Invest in the future.”

“As a small company, you tend to be more nimble, and you have to work hard

WE HAD TO EARN THE RIGHT WITH ENGINEERS THAT SHOWS THAT WE CAN DELIVER AND PROVIDE ADDED VALUE SERVICES.

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company since its inception and is now president. “Sil-Pro has grown substantially over the years, and we currently have approximately 350 team members. We’ve seen 25%-plus growth year after year,” Kevin said.

to stay relevant in the market,” Carver added. “Update manufacturing processes, technology and the equipment being used, and continue to expand your capabilities.”

“Evolution is key. You need to remain relevant,” DiSalvo noted.

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CM LONGEVITY

DONATELLE CELEBRATES 50 YEARS IN MANUFACTURING After 50 years Donatelle shows no signs of slowing down. Its main focus in the medical device manufacturing business keeps it afloat.

Danielle Kirsh, Assistant Editor

For 50 years, Donatelle (New Brighton, Minn.) has supplied the medical industry with a variety of medical devices and manufacturing services. Founded in 1967 as a tool design and fabrication business, the privately-held company is now an FDA-registered medical device contract manufacturer that is ISO-9001 and 13485 certified and employs over 450 people.

“We moved from being known for one main niche of injection molding capability for highly engineered long-term implantable componentry and devices to what we offer today,” president Treasa Springett told Medical Design & Outsourcing.

Donatelle’s offerings span a variety of different applications including cardiac, diagnostics, drug delivery, neuromodulation, ophthalmics, orthopaedics, surgical technologies and vascular. To service these markets, Donatelle offers services including product design, expanded molding and assembly capabilities, precision machining capabilities, micro

Springett suggested that device companies are more than likely to seek forward-looking contract manufacturers.

“Are they investing in the future, such as people development and training, technology advancements, equipment upgrade and culture work around core values and purpose of the organization?” she said.

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manufacturing capabilities, packaging and complete device assembly that includes sterilization management.

The company’s main focus is on medical device design, development and manufacturing. Its work includes short- and long-term implantable devices and disposables that require critical precision, tolerances, validation and timelines.

“There are no shortcuts,” Springett said. “We always do what we know to be the ‘right thing’ and never give up on doing it with rigor and the highest regard for quality, integrity and accountability.”

Springett is optimistic about Donatelle’s future because the medical device industry is constantly seeing growth.

“We see significant growth opportunities within this space and believe our pure medical expertise is a value proposition that will continue to provide strategic growth opportunities (both revenue and technology advancement) for us, supporting our long-term objectives,” Springett said.

Donatelle recently celebrated its 50th anniversary as a contract manufacturing company. Treasa Springett is the current president.

Photo from Donatelle

2. Offer something special.

“Make sure you’re offering something special,” Tully said. “You really need to be able to survive the ups and downs of the economic cycle, and in order to do that, you need to have some sort of specialty that you offer.”

There are a lot of niche markets out there, so if two companies make

the same product, one must offer something special to stand out.

“If you’re doing the same thing that everyone else is doing, there’s still an awful lot of competition. If you’re doing something that hardly anyone else can do, then you’re not sharing the rest of the marketplace with a whole bunch of other people,” Tully explained. “It makes

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CM LONGEVITY

it easier to survive long-term if you’re one of a few rather than one of many.”

3. Put a premium on customer relations.

If a company builds a healthy relationship with customers, the customers will be more likely to return for future projects.

“Is the contract manufacturer someone that the OEM can build a business relationship with? Do they think beyond a project? Building a relationship in a business situation takes time, and a project is just one of those things that starts to establish that relationship,” said Carver.

4. Be open to new opportunities.

Companies need a variety of projects and capabilities to grow. They should always be starting new projects to keep the momentum going.

LEFT: Mike Ondercin started Criterion 64 year ago.

Criterion’s leadership has stayed in the family ever since.

Photo from Criterion

RIGHT: Dennis Ondercin (left) took over Criterion from his dad, Mike Ondercin, and eventually passed it down to its current president, his daughter, Tanya DiSalvo.

Photo from Criterion

RFID+ : added-value RFID Technology

Standard RFID protocols including additional customized performance Special performance in harsh environments with customized antennas

Special tag shapes and formats for perfect fitting

Proprietary protocols running on RFID bands for security performance

Extreme low temperatures down to -196°C

Tag-on-metal devices through frequency re-tuning

Passively LED driving tags for fast visual identification

Liquid items identification with no RF errors

Passively sensoring tags

IXYS SAN SEBASTIAN SA Zuatzu 3, E-20018 Donostia (Spain) Email: info@ixys.es Tel: +34 943 317 378, Fax: +34 943 317 800

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www.medicaldesignandoutsourcing.com

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WE’RE PREDICTABLE Because your success relies on it.

— Todd Owens

VP of Engineering

At Donatelle, we do what it takes to help make sure your product is engineered seamlessly from concept through delivery. Let us be your predictable partner for continuity and speeding time to market. Learn more at donatellemedical.com.

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CM LONGEVITY

LEFT: Lee Carver (right) co-founded Sil-Pro in 1998. When he was ready to retire, his son Kevin Carver (left) became president.

Photo from Sil-Pro

RIGHT: Kevin Carver is the current president of Sil-Pro. Photo from Sil-Pro

“They have to put a number of projects into the hopper to expect something to come out of the other end,” Tully said. “Part of our growth is filling the pipeline with opportunities. [We’ve] built a healthy pipeline, and continue to put new projects into that pipeline [to grow].”

5. Be consistent.

If you’re consistent with everything that you do in your company, more people will want to be around for the journey.

“It’s about consistency, right? Employees want consistency, customers want consistency, and it has to start with me,” DiSalvo said.

That consistency should apply to everything a company does, even if it means not compromising to get the bottom dollar.

“We don’t compromise the quality and effectiveness of the products or risk the safety of the end users for an edge on pricing,” Chanarat said. “I think when a contract manufacturing company finds itself focusing on how to make the product the best in the market, rather than how to make it the cheapest, it is usually more sustainable and healthy in the long term.” M

IF YOU’RE DOING SOMETHING THAT HARDLY ANYONE ELSE CAN DO, THEN YOU’RE NOT SHARING THE REST OF THE MARKETPLACE WITH A WHOLE BUNCH OF OTHER PEOPLE.

www.medicaldesignandoutsourcing.com

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DEVICE TALKS

3M’s Cindy Kent on leadership, growth and inclusion in medtech Cindy Kent is no stranger to medtech: She’s spent 20 years in healthcare, moving up the ranks and finding her way to president and GM for 3M’s infection prevention division. She spoke with MassDevice.com Publisher Brian Johnson at the DeviceTalks event in Minnesota in June about meeting Oprah, how she convinced Eli Lilly to pay for a divinity degree and why being an ordained minister enhances her skills as a leader.

BRIAN JOHNSON: You hung out with Oprah recently. How did that come about?

Sarah Faulkner | Associate Editor |

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CINDY KENT: I was invited to Johnson C. Smith, which is an historic black college and university, in Charlotte.

As we were ending the [first] night, the president and chairman of the board pulled us aside and said, with a very sheepish smile, “Oprah’s going to be there tomorrow. We don’t want you to be nervous.” And I said, “Oprah, as in what’sher-last-name?”

I had already prepared my message for the evening, but it went through my head, “Oh my gosh, I better read through it. Is there anything that might offend her?

What should I do?”

And I just had to turn the player off.

I had to push pause on that inner voice, saying, “You’re here for the students, the graduating seniors. You’re here to send them off into the world with your greatest words of wisdom, and ministerial and spiritual support. You can’t pander because of who’s in the audience.”

[Oprah] was there, front row by herself. She clapped and cried and stood up on her feet the whole time, and I didn’t learn until three weeks later that she was actually supposed to be ushered out 30 minutes before the service. She told them not to escort her out because she wanted to stay to greet me, and she greeted 7 • 2017

me and hugged me, and told me it was amazing. When I got back into the office the following week, there was a huge basket of peonies that she had shipped with a hand-written card.

JOHNSON: Who are the people who made you who you are today?

KENT: There have been many, and I think that’s why giving back and advancing talent is so important to me – because so many people poured into me. Being the first in college and first person in corporate America from my family, there was no playbook. I didn’t know how to be in industry. I didn’t know how to sit in a business meeting. I didn’t know what a boardroom looked like. And so it was mentors from very early on.

My very first mentor’s name was Paul Johnson, and he was the senior vice president of supply chain operations for Eli Lilly. I was a newly minted engineer, about six months into my career, and I had volunteered for this thing called “Diversity & Inclusion.” I had a lot of energy around the topic and wanted to do some training, and at the first meeting he said, “You’ve got these ideas, a lot of ideas. Meet me for lunch and let’s talk about what we want to do with diversity for the plant site.”

By our third luncheon, it was, “Where do you want to take your career?” And I said, “I don’t know, I’ve never seen anything else.”

I had gone to school as an engineer.

I’m designing these research laboratories and a manufacturing plant. I said, “I think I want to work with customers.” I didn’t even know what that meant. I don’t know what strings he pulled, but within six months I was in Detroit, selling product as a primary care sales rep.

After that, he made this commitment to me, which he honored before he

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7/14/17 3:21 PM

Behind the Scenes. Ahead of the Curve. Inside the Corner Office.

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DEVICE TALKS

passed away. He said, “Cindy, we see a lot of potential in you, so you take the next five years on us, and you go play, and you go work in as many disciplines and fields as you like, and in five years we’re going to come ask you what you want to do for this company, and we expect an answer.”

So I did sales for six months, and then I came back and did an HR stint for two years, and from HR I went to marketing.

HR wanted me to stay, and I wanted to go back to grad school. And my second mentor, the vice president of HR, went to the marketing organization and said, “So I’ll keep her on the HR headcount for a year, at the end of that year you decide you want to keep her, and then you put her on your book, if not, we’ll happily take her back.”

That year was the most amazing year for me because I was part of a five-person team that totally revamped the go-to-market strategy for the U.S. subsidiary of Eli Lilly & Co., and that was about 1997, at 25, 26 years old.

3M’s Cindy Kent

Watch the full interview online!

Behind the scenes.

Ahead of the curve.

Inside the corner office.

wtwh.me/mod

They came to me after the nine-month project and said, “What do you want out of it?” I said, “I want to leave and go back to grad school [for a dual MBA-divinity degree].”

And I don’t think anybody was expecting that!

The next thing I know I got a call from the [chief HR officer], who said, “Tell me why you want to get those degrees?” That ticket was five years for me, because they didn’t have a

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dual-degree program at Vanderbilt. I wanted to take a year off. I wanted the company to give me insurance benefits so that I would be covered and not take student insurance dollars away, and I wanted a stipend as a percentage of my paycheck while I was away.

And they said yes to all of that.

It’s the first and only divinity degree that Lilly’s ever paid for, and I’m sure they’re still scratching their heads saying, “How did that happen?”

JOHNSON: How do you balance being a business person and an ordained minister?

KENT: The joke about that is, “Shoot, if our business strategies don’t work, I’ll just pray about it. Somehow we’ll make our numbers.”

I do believe this is part of my purpose.

That’s why I’m up here. I believe this is an industry that is so aligned to my purpose.

I think about how many patients that we’re serving and how many more people that we’re helping, and if you can make it a winwin, then the better.

When I requested for Lilly to pay for me to go to a divinity school and they said yes, my first question was, “Why would you do that?” And the answer was, “Cindy, we can have, and we do, the best MBAs in the world working for this company, but there is an element to your leadership that we believe will only be worth more when you are through your divinity and theological studies. And we want to see you being the best leader for this company that you can be.”

I didn’t understand it fully then, but I’ve found it to be true, that in being comfortable operating in both of those spheres I can usually tell pretty early on when something is going on with my employees. I think of myself as a 360° leader. Yes, I’m going to hold you accountable to the business priorities, but I can also see if it’s a down day, if there’s something going on in your family. I have had employees come in my office and break down that I’ve prayed with.

It’s not something that I’ve advertised, but I want to make sure that they’re getting the support to be the best, because if you’re your best person, you’re going to be the best leader for a company that you can be. M

www.medicaldesignandoutsourcing.com

7/17/17 12:29 AM

PRODUCT WORLD

Fluid Metering now offering valveless waste transfer pump Fluid Metering is touting a new valveless waste transfer pump that is designed to remove waste fluid created by medical diagnostic instrumentation while analyzing patient fluid samples.

The valveless, brushless DC waste transfer pump uses Fluid Metering’s unique CeramPump valveless piston fluid control technology. It also includes a moving part, a rotating and reciprocating ceramic piston, that controls fluid within the pump and reduces the need to check valves. The pump can easily be integrated into existing system designs that have a 24V DC input supply. With its 6-by-2-by-2-ft footprint, flow rates can be factory calibrated from 20 ml per minute to 400 ml per minute.

Fluid Metering fluidmetering.com

Clippard touting subminiature electronic valves New direct actuating valves offered by Clippard respond extremely fast to give accurate dosages of minute volumes, according to the company. It is being offered in an 8 mm cartridge package. The valves are made with Clippard’s unique patented stainless steel “spider” with a moving part that moves at less than 0.007 in. Because of its low moving weight, the valves are extremely quiet and have very low vibrations. The valves also have a less than 5 ms response time, 1,000,000,000+ lifecycle, extremely small dead volume, low vibration and noise, exceptional repeatability and reliability and is ideal for sub-assemblies.

Clippard clippard.com

Low viscosity epoxy for electronics EP30Med, created by Master Bond, is ideal for use in encapsulation, bonding and sealing applications. It meets USP Class VI specifications, making it useable in a variety of medical devices, and offers electrical insulation properties with low shrinkage when it cures. The EP30Med has two components and is optically clear with low viscosity. Its high strength and rigid bonds allow for it to be resistant to chemicals like water, oils and other organic solvents. It is serviceable over a wide temperature range of –60°F to +250°F and can bond to different materials like metals, glass, ceramics, wood and many plastics. It also meets FDA requirements for indirect food contact.

Master Bond masterbond.com

www.medicaldesignandoutsourcing.com

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AD INDEX

Accu-Mold LLC....................................................19 ASCO......................................................................1 B.Braun Medical Inc............................................BC Cirtec Medical......................................................55 Clippard Instrument Laboratory, Inc....................9 CPC-Colder Products Company........................13 Donatelle..............................................................58 Eagle Stainless Tube & Fabrication, Inc.............14 Fluid Metering, Inc................................................5 Fort Wayne Metals...............................................11 Fotofab.................................................................51 Freudenberg........................................................31 HP Inc......................................................................7 Integer....................................................................3 Interpower............................................................49 IXYS.......................................................................57 John Evans’ Sons, Inc..........................................42 Master Bond.........................................................59

Medo USA..............................................................5 MicroLumen...................................................46, 47 Model Solution....................................................23 MW Industries......................................................41 Nelipak Healthcare Packaging...........................33 NSK Precision.......................................................12 Polaris...................................................................29 Proto Labs............................................................25 PTI Engineered Plastics.......................................35 Resonetics.......................................................... IFC SCHOTT Electronic Packaging...........................17 Smalley Steel Rings...............................................4 Sorbothane..........................................................20 Spectrum Plastics (was PEXCO) ........................37 Steute Meditech, Inc...........................................15 Tadiran..................................................................27 Tegra Medical....................................................IBC The Lee Company...............................................21

SALES Mike Caruso mcaruso@wtwhmedia.com 469.855.7344 Michael Ference mference@wtwhmedia.com 408.769.1188 @mrference David Geltman dgeltman@wtwhmedia.com 516.510.6514 @wtwh_david Jim Powers jpowers@wtwhmedia.com 312.925.7793 @jpowers_media

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LEADERSHIP TEAM Tom Lazar tlazar@wtwhmedia.com 408.701.7944 @wtwh_Tom Courtney Seel cseel@wtwhmedia.com 440.523.1685 @wtwh_CSeel Neel Gleason ngleason@wtwhmedia.com 312.882.9867 @wtwh_ngleason Jessica East jeast@wtwhmedia.com 330.319.1253 @wtwh_MsMedia

7 • 2017

Mary Ann Cooke mcooke@wtwhmedia.com 781.710.4659 Mike Francesconi mfrancesconi@wtwhmedia.com 630.488.9029 Michelle Flando mflando@wtwhmedia.com 440.670.4772 @mflando Garrett Cona gcona@wtwhmedia.com 213.219.5663 @wtwh_gcona

Publisher Brian Johnson bjohnson@wtwhmedia.com 617.905.6116 Managing Director Scott McCafferty smccafferty@wtwhmedia.com 310.279.3844 @SMMcCafferty

VP of Sales Mike Emich memich@wtwhmedia.com 508.446.1823 @wtwh_memich EVP Marshall Matheson mmatheson@wtwhmedia.com 805.895.3609 @mmatheson

CONNECT WITH US! Follow the whole team on twitter @WTWH_Medical

www.medicaldesignandoutsourcing.com

7/14/17 4:05 PM

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& Do you need a supplier that makes managing complicated projects look simple and speeds you to market?

&

How about one with world-class design chops and quality systems for ensuring excellence?

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If your answer is yes, then B. Braun OEM is the only supplier you’ll need. Beyond a full roster of capabilities, we offer a vast array of products. You’ll find parenteral pharmaceutical solutions in a variety of bags, a thick catalog of standard and custom valves, all the admixture accessories you’ll ever need, and the products and capabilities to build a custom kit for your device or drug. It all adds up to a singlesource supplier that goes far beyond being a vendor to becoming a true partner. Visit BBraunOEM.com.

B. Braun Medical | OEM Division | USA

©2016 B. Braun Medical Inc. Bethlehem, PA. All rights reserved. OEM 15-5024 7/15 LMN

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