Medical Design & Outsourcing - JANUARY 2016

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www.medicaldesignandoutsourcing.com JANUARY 2016

W O M E N

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M E D T E C H

Women account for about 78% of the workforce in healthcare but are only 1 in 7 of the industry’s executive officers.

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INSIGHTS

In the trenches but not on top: The glass ceiling remains firmly in place in medtech Cathy Burzik, the former CEO of Kinetic Concepts Inc. and one of the most respected leaders in the medical device industry, keeps a plaque on her desk to remind her of the challenge, opportunity and, sometimes, insanity of being a woman in business.

“Women have to work twice as hard as men to be thought of as half as good. Luckily, this is not difficult,” the plaque reads.

Women represent the lion’s share of the healthcare industry: About 78.4% of the labor force is female, according to the Center for American Progress. But women are vastly underrepresented in the decision-making chain, with just 14.6% holding executive officer positions and even fewer maintaining the top jobs in healthcare, according to the think tank.

In fact, not a single woman occupied a corner office at the top 100 medical device companies by the end of last year, according to an analysis of data collected by Medical Design & Outsourcing.

The lone entrant on this list, Philips Healthcare CEO Deborah DiSanzo, was ousted in July 2014.

(She has since landed at IBM, heading up the tech giant’s Watson Health unit.)

Brian Johnson Publisher Medical Design & Outsourcing bjohnson@wtwhmedia.com

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That list doesn’t include Burzik, either; she stepped away from KCI in 2012 after shepherding the wound care company through a $6 billion acquisition.

I asked Burzik a few years back what advice she had for women hoping to follow her lead to the top ranks of industry, and her reply was succinct and informative.

“You have to take the tough assignments, you do have to stick your neck out. You can’t be afraid and you have to be courageous,” she told me. “It’s a choice you make. Do you sit back or do you speak up and take the tough assignments?”

For this issue of Medical Design and Outsourcing, Managing Editor Nic Abraham asked women to tell us about their starts in medtech, where their career paths took them and the challenges they faced along the way.

We also spoke with Aum Cardiovascular founder & CEO Marie Johnson. Interviewed for our DeviceTalks event in September, Johnson told us how she’s turning tragedy into hope for potential victims of sudden cardiac arrest. It’s truly an inspiring story.

We hope you enjoy this issue of Medical Design & Outsourcing, and that you’ll take a moment to let us know how we’re doing. I can be reached at bjohnson@wtwhmedia.com.

Also follow us on twitter at @MedTechDaily. And don’t forget to check out MedicalDesignandOutsourcing. com and MassDevice.com for the latest news on the business of building medical devices. M

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CONTRIBUTORS

MEHREGANY

DYKEMAN

VON ARX FAYERBERG

COSHNITZKE

LANGNAU

TAI

LAMPROPOULOS

TISSONE

JAMES COSHNITZKE, a business consultant and counselor, led CIL Communications, the in-house press relations shop at Clippard Instrument Labs. Prior to joining Clippard, he served as an application engineer, field sales engineer, and Marketing Communications Manager at Cincinnati Milacron Robot Division.

DAVID J. DYKEMAN, JD is co-chair of Greenberg Traurig’s Global Life Sciences & Medical Technology Group and co-chair of the firm’s Boston Intellectual Property & Technology Group.

A registered patent attorney with nearly 20 years of experience in patents, intellectual property, and licensing, David can be reached at (617) 310-6009 or dykemanD@gtlaw.com.

ROMAN FAYERBERG, JD is a patent attorney and shareholder in the Boston office of Greenberg Traurig, LLP. His practice focuses on the development and management of strategic patent portfolios and counseling clients on patent issues, primarily in technologies related to life sciences. Roman can be reached at (617) 310-5206 or fayerbergR@gtlaw.com.

FRED LAMPROPOULOS, Fred has been in the medical device industry for almost 30 years. After serving as the Chairman and Chief Executive of Utah Medical, Lampropoulos founded Merit Medical Systems in 1987, where he currently serves as Chairman and CEO. LESLIE LANGNAU is the Managing Editor of Design World magazine, and been an editor for more than 28 years. She has been covering the 3D printing/ additive manufacturing industry since joining Design World more than nine years ago.

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MEHRAN MEHREGANY is the Goodrich Professor of Engineering Innovation at Case Western Reserve University, Director of the Case School of Engineering San Diego programs and editor of a recent book titled “Wireless Health: Remaking of Medicine by Pervasive Technologies.

ALVIN TAI is the founder & CEO of FastQS (www.fastqs.com). Tai, who spent several years as a medical device consultant, is dedicated to improving healthcare policy in order to lower patient risks and costs.

LUIS TISSONE is the Director of Life Sciences at Trelleborg Sealing Solutions. Luis, a former Regional Sales Manager for Helix Medical, has a Bachelor of Science degree in Industrial Engineering from Argentinean Catholic University and a Business Administration & Management degree from Harvard University.

LUKAS VON ARX began his career with LEONI Studer in 1999. After having passed through the LEONI Global Executive Management Program (EMP) with assignments with LEONI facilities in Switzerland, Serbia, and Germany, he now serves the company from its offices in Canada. Since 2015, Lukas has been the Director of Sales with LEONI Elocab Ltd. in Kitchener, Ontario, Canada.

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CONTENTS

medicaldesignandoutsourcing.com ∞ January 2016 ∞ Vol2 No1

DEPARTMENTS

ON THE COVER:

02

38

Women account for about 78% of the workforce in healthcare but are only 1 in 7 of the industry’s executive officers.

04 CONTRIBUTORS

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SEALING SURGICAL TOOLS: Innovation in powered surgical instruments leads to safer procedures

12 REGULATORY: Understanding FDA observation reports 16

38

Women in medtech

Women account for about 78% of the workforce in healthcare and

26

THE CATH LAB: Making endoscope connections easier to sterilize

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FDA NEW PRODUCTS: Some of the pre-market approvals the U.S. Food & Drug Administration granted in October 2015.

34

PATENT PROTECTION: Design Patents Provide Additional Protection for Products

68

PRODUCT WORLD Enteroscope, intramedullary-lengthening nail, UV disinfection device, micro gas pump

70

DEVICE TALKS: Marie Johnson and the mission the stop deaths from sudden heart attacks

social assistance but are only about 14% of the industry’s executive officers or higher.

51

Printing prosthetics and guiding a surgeon’s knife

3D printers have found homes in hospitals and healthcare facilities by printing custom fit and durable prosthetics along with models of organs displaying tumors that will improve surgical outcomes.

58

A closer look at micro-molding: Big possibilities in small details

Most medical-device designers are unfamiliar with the fine limits of micromolding. For instance, today’s capability can shape parts with details down to 0.005 in. But even that limit may give way with more recent developments.

78 LEADERSHIP: Spotlight on Leadership: Merit Medical continues its history of innovation 128

Medical Design & Outsourcing

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TUBING TALKS: Proportional control valve builds a better oxygen concentrator

20 ENGINEERING DESIGN: Improving healthcare with smart, wireless, and wearable sensors

FEATURES

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PUBLISHER’S COLUMN: In the trenches but not on top: The glass ceiling remains firmly in place in medtech

1 • 2016

AD INDEX

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SEALING SURGICAL TOOLS

Innovation in powered surgical instruments leads to safer procedures

Luis Tissone | Director of Life Sciences | Tr e l l e b o r g S e a l i n g S o l u t i o n s |

TOP: Rigorous conditions for powered surgical instruments require flexible construction with a high-grade seal integral to the construction.

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Today’s surgical procedures are rapidly evolving within a highly technical healthcare environment. In the case of powered surgical instruments, the market is witnessing transformative and innovative advances, especially for neurological, ophthalmic, orthopedic, oral and cardiac surgical procedures.

Constant advances have surgeons looking for higher-quality instruments that let them perform diverse surgical interventions rapidly and efficiently, without sacrificing patient safety. New and improved designs for powered surgical drills and screwdrivers are launched every year, providing a level of control, accuracy and performance never before achieved in the operating room.

The market landscape According to Markets and Markets’ Powered Surgical Instruments Global Forecasts to 2019, the aging population, the exponentially growing number of global surgical procedures, and the increasing demand for minimally invasive surgeries, is fueling market growth of powered surgical instruments. The

report anticipates a rise in the moderate compound annual growth rate through 2019 reaching $2.1 billion.

Incorporating the best components and technology in surgical drills and screwdrivers is providing positive results in surgeries, including reduced damage, heat, and trauma to the tissues as well as faster operations overall, and improvements in post-surgical healing.

An example of an innovative trend in surgical instruments is a new, cuttingedge powered screwdriver designed specifically for use in highly sensitive surgical procedures, which features sensors integrated with software to provide intelligence to the user.

In the most sensitive of procedures Since surgical drills and screwdrivers will be used in the operating room, a sterile and demanding environment, it is important that these surgical tools have a high level of reliability. This often comes with ISO certifications and FDA compliance.

Precision is critical because these screwdrivers are used for delicate

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procedures, such as neurosurgery to treat brain tumors or brain trauma caused by accidents. In these operations, a piece of the skull, either small or large and often of an irregular shape, is usually removed. After perfoming the surgery, the skull piece is reattached using a metal plate, sometimes held by 15 or more screws.

Rigorous development process To design, develop and manufacture surgical devices, engineering teams of equipment manufacturers must work closely with the company’s material and component suppliers. They must also work internally with groups dedicated to ensuring product requirements are met by its suppliers, including reliability engineering, inspection services and quality control. Performance requirements are considered throughout the prototyping, design verification and validation processes, and the supplier is presented with any challenges they need to overcome.

Equipment manufacturers conduct many evaluations to find a good and proven supplier of components, such as seals, so they meet quality and longevity requirements.

Custom-designed solution Suppliers to the life sciences industry must have strong knowledge and R&D experts on hand to assist in determining the best design to be integrated into equipment. One Trelleborg example is in the design of seals for a powered screwdriver, in which the seals needed to have a metal body to press into a bore without any retention or features to hold it in place.

The high quality needed for the important work of powered surgical drills and screwdrivers means the highest care must be put into the design process to produce precision instruments.

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It was a challenge to develop a press-fit seal designed to lock into the outside diameter to maintain a static seal. The seal was made of a high-grade composite of polytetrafluoroethylene-based resin with anti-wear additives, crimped inside a metal body that is press-fitted into the bore, creating a static seal and establishing a lip that will run on the shaft itself. As the shaft rotates, this lip sits and rides on top of it, delivering a low coefficient of friction.

A slant coil spring within the seal has an energizing property, maintaining a relatively constant load as it is deflected. As the seal wears or changes dimensions due to thermal variations, the force generated by the spring is constant. The force also helps ensure that the product has a long life and consistent heat generation.

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Meeting specific seal requirements Powered screwdrivers and drills are currently being designed to minimize the amount of time it takes for surgeons to perform procedures, such as feeding screws into plates attached to skulls. Thanks to recent advances, 15 or even 20 screws are put into the plate in a matter of minutes.

The time saved, of course, depends on the type of surgery and how many plates and screws are involved. And the advances can potentially reduce operating room time and patient exposure to anesthesia, while also reducing stress on a surgeon’s hand. At the same time, surgical instrument manufacturers are attempting to extend the hours of operation and life of their instrument and need a seal that will perform over a long equipment life.

THE TIME SAVED, OF COURSE, DEPENDS ON THE TYPE OF SURGERY AND HOW MANY PLATES AND SCREWS ARE INVOLVED.

LEMO offers a variety of connectors for medical devices:

Withstanding cleaning regimes Surgical screwdriver or drill applications require not only small but robust sealing solutions that can withstand sterilization in an autoclave or specialized washer. These processes subject the surgical device to high-pressure saturated steam at 121°C (250°F) for around 15 to 20 minutes, depending on the size of the load and the contents. As seals can deteriorate in these processes, it is vital that the right materials are specified to prevent seal damage. Compatibility of seal materials is a key element.

Emerging markets The powered surgical instruments segment is large and growing, with new developments and technology constantly being introduced. The transition from traditional surgeries to minimally invasive procedures has helped fuel the growth of this market segment.

According to Markets and Markets, North America is expected to contribute the largest share to the global powered surgical instruments market in 2019. Europe will have the second-largest, with Asia-Pacific close behind.

In the coming years, Asia-Pacific will yield the highest growth opportunities, as it begins to tap its market for surgical devices. From a sealing solutions supplier’s standpoint, there will be substantial opportunities to show leadership and support manufacturers in developing innovative equipment. M 1 • 2016

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REGULATORY

Understanding FDA observation reports With recent negative media coverage of an FDA observation report, complaint management has become a focus for many medical device companies. Two of the nine observations cited in a September 2015 report were related to the complaint system with the FDA reports stating:

A l v i n Ta i | Founder | FastQS |

1. “Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.”

2. “Complaints involving the possible failure of a device to meet any of its specifications were not reviewed, evaluated, and investigated where necessary.”

These two observations sound alike and use curiously similar language regarding receiving, reviewing, evaluating and investigating complaints. A review of these observations, in detail, is necessary to show just how serious the FDA takes customer complaints.

FDA arrives at a facility for an inspection, typically one of the first things they look through are a manufacturer’s complaints.

This is a critical part of a routine inspection. The complaint management system is one of the few communication paths a customer has to report safety issues. As part of the FDA’s responsibility to protect public health, they want to see that device manufacturers are responding to customer complaints.

Despite the FDA’s lack of detail behind these observations, a considerable amount of structure is required when establishing complaint management systems. The two observations are related but attack different parts of the quality system.

The first observation cites the lack of established procedures for complaint management. The FDA doesn’t just want to see that a company is processing complaints, they want to see that the process is well-documented. The FDA is a stickler for good documentation.

Companies should take careful note of what “formally designated unit” means to the FDA. A trained team of complaint specialists must be formed to manage complaints and all the processes associated with it.

For example, a team member that hasn’t been trained on the complaint process or how to identify specific safety issues in complaint language is a red flag during FDA inspections.

The second observation deals with lack of action when complaints are received. In this case, the company

FULLY UNDERSTANDING WHY COMPLAINTS ARE SO IMPORTANT TO THE FDA IS AS SIMPLE AS CONSIDERING THE SOLE REASON THE FDA EXISTS IN THE FIRST PLACE. Fully understanding why complaints are so important to the FDA is as simple as considering the sole reason the FDA exists in the first place. Their mission statement is to be “responsible for protecting the public health.” When the 12

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1 • 2016

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mentioned in the observation received reports of a possible device deficiency but failed to formally document it. Note that this doesn’t necessarily mean that they didn’t react to the complaint, but that they simply didn’t document it. There is a popular mantra in this industry: “If it wasn’t documented, it didn’t happen.”

This tends to have a snowball effect, because if there had been established procedures for this, then the actions of the regulatory team would have been documented.

The odd, yet specific wording of the observations, for “receiving, reviewing, evaluating and investigating” complaints are specific for a reason. They coincide with the critical regulatory phases that the FDA wants to see while processing complaints. Best practices for these phases can be summarized: • •

•

•

Receiving - Complaints must be formally received and documented with specific pieces of information.

Reviewing - Each complaint must be reviewed to make sure that the information is complete and that it does, in fact, represent the traditional definition for a complaint. Note, not all customer communication is considered a complaint – only those alleging device deficiency are considered applicable complaints.

Evaluating - Each complaint must be evaluated to determine whether further investigation or corrective action is necessary, and whether a significant patient safety issue has occurred. If a patient sustained an injury due to a device failure, regulatory action may be required and the incident must be reported to a governing body.

Investigating - For complaints requiring further investigation, results of the investigation must be fully documented. Investigations must attempt to identify root cause; anything short of this can raise a red flag.

From a regulatory standpoint, these complaint actions are non-negotiable. During an FDA inspection, it would behoove companies to show documentation for each of these defined phases.

In the medical device industry, issues with complaint management are not unique. They’re often the result of the growing pains experienced by many medical device companies. More important is the response to observations. Even if the FDA didn’t exist, systematically managing complaints is simply good business practice.

A robust feedback system lends itself to a stronger and more loyal customer base. M 1 • 2016

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TUBING TALKS

Proportional control valve builds a better oxygen concentrator

James Coshnitzke | Clippard Instrument Laboratory Inc. |

How the oxygen concentrator works 95% pure oxygen to patient

According to a recent study conducted by Wintergreen Research, the worldwide market for portable oxygen concentrators is expecting to continued growth through 2019. This is in part due to the baby-boomer population and the need for home-care oxygen therapy. Plus, the number of manufacturers and model choices has increased substantially over the past decade.

This increased need has been the catalyst for improvement in the technology and the demand for portability. Well known as the generation that likes to move about, baby-boomers are not satisfied to stay at home next to an oxygen tank. And, as unit weight decreases and battery life increases, there seems to be no limit to mobility.

In addition to mobility, portable oxygen concentrators (POCs) are much safer than traditional oxygen tanks. For example, they eliminate the possibility of leaks, which can cause fires and or explosions. Because of this, POCs are approved by the FAA and accepted on most domestic and international flights. Other common places for use are emergency rooms, military field operations, and certain industrial applications. Industrial-application concentrators are not approved by the FDA for medical use.

Several companies now manufacturer POCs. O2-Concepts, with a factory in Newtown, Conn., is one of the more recognized names.

Its “Oxlife Independence” portable unit offers both continuous flow (1 to 3 liters/min) and pulse mode settings (0.5 to 6).

Pulse-dose technology, a relatively new development in oxygen therapy, is incorporated in most new oxygen concentrators.

Traditionally, oxygen concentrators provided a continuous supply of oxygen, regardless of whether the patient was inhaling or exhaling.

A pulse-dose system delivers oxygen in fixed increments that correspond to the inhalation component of a patient’s breathing cycle. In doing so, pulse-dose technology prevents oxygen from being wasted and increases efficiency of an oxygen concentrator.

Pulse-dose technology is particularly important in portable oxygen concentrators, which have limited storage.

The typical oxygen concentrator consists of an air compressor, two cylinders filled with zeolite pellets, a pressure-equalizing reservoir, valves, and tubing. It works like this: Room air is pumped into a A typical oxygen concentrator consists of an air compressor, two cylinders filled with zeolite pellets, a pressure-equalizing reservoir, valves, and tubing. Room air is pumped into a cylinder, where the pellets absorb nitrogen and carbon dioxide and deliver 90%+ pure oxygen to a reservoir. As the oxygen depletes in one cylinder, it releases the nitrogen back into the air. At this time the other cylinder goes through the same process. Together, they create an alternating flow of oxygen into the reservoir, where is stays until the user breathes.

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1 • 2016

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Hackensack, NJ 07601, USA ∙ +1.201.343.8983 ∙ main@masterbond.com The Oxlife Independence is based on patented Energy Smart Absorption technology. This system uses multiple reservoirs to yield high purities and flow volumes of oxygen at lower energy levels.

cylinder where the nitrogen and carbon dioxide are absorbed by the pellets and 90%+ pure oxygen is pumped into a reservoir. As the oxygen is depleted in one cylinder, it releases the nitrogen back into the air. At this time the other cylinder goes through the same process. Together, they create an alternating flow of oxygen into the reservoir where is stays until the users breathes.

“The Oxlife Independence is unique, due to its patented Energy Smart Absorption (ESA) technology,” said Rob Kent, president of O2-Concepts. “This technology uses multiple reservoirs to yield higher purities and flow volumes at lower energy levels. One of O2-Concepts newest offerings is its Dynamic Network Analysis (DNA) technology. We will be using Verizon modems on all units to leverage real-time data.”

Success of the Oxlife POC is due in part to the Clippard EVP series Proportional Control Valves. These combine the features of the existing EV series valve – long life, low power, and high-quality components – with the additional capability of proportional control. This series provides air or gas flow control, and varies the output flow based on the current input to the solenoid. The upshot is a high degree of control for many applications. The EV series of valves is capable of over a billion cycles. The EVP valve is intended for analytical instruments, blood pressure monitoring, precise pressure control, patient simulators, gas flow controllers, mass flow control, gas chromatography, respirators, ventilators, and more.

“Clippard’s EVP electronic valve is critical to making our ESA technology work, by balancing the loads between the reservoirs.

Highly reliable components like this valve make our unit the most reliable on the market,” Kent said. “Since using the Clippard valve, the units score better in final inspections. It is now getting a consistent regulated flow and are no longer tackling issues from lot to lot. The valve is consistently manufactured and holds the needed tolerances.” M 1 • 2016

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Medical Design & Outsourcing 19

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ENGINEERING DESIGN

Improving healthcare with smart, wireless, and wearable sensors There are strong indications in the marketplace that a digital healthcare revolution is coming1 (often referred to as wireless, digital, or mobile health). The basic idea is to wirelessly connect the patient with care providers to monitor their health and intervene as needed – ideally preventatively – as the patient goes about their normal life. The enabling technology to do so would rely on miniature, smart sensors incorporated around (deployables), on (wearables) and inside (implantable) the patient. Wearables are attractive, because they require no medical procedure and travel with the patient. The rest of this article provides an overview of sensors, wearables, and wireless health.

Mehran Mehregany | Director of the Case School of Engineering | San Diego |

Sensors Miniature, smart sensors are based on microand nanofabrication technology, often simply referred to as MEMS (micro-electro-mechanical

The four Fitbit models provide examples of wearable devices. MEMS devices let the units measure steps taken through the day, stairs climbed, and (at right) heart rate. Blood pressure has been an elusive measurement for wearable devices and awaits it sensor’s development.

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systems) and NEMS (nano-electro-mechanical systems). These devices – in the form of sensors and actuators – augment the computational ability of microelectronics with perception (i.e., sensing) and control (i.e., actuation) capabilities.

To do their work, sensors and actuators require

1 • 2016

a transduction mechanism, such as that often provided by a mechanical element in the physical sensors.

Generally stated, the transduction mechanism converts nonelectrical parameters to electrical ones in a calibrated way.

MEMS sensors and actuators have been commercialized in a wide range of applications since the 1970s, including pressure measurement, motion sensing, optical projection, and fluid-flow control, to name a few.

Silicon, in single and polycrystalline forms, has been the platform semiconductor material underpinning the mechanical and electronic elements of micro and nanosystems.

MEMS pressure sensors gained commercialization momentum in the 1980s as they entered automotive (e.g., manifold absolute pressure sensors) and medical applications (e.g., disposable blood pressure sensors). MEMS accelerometers gained momentum in the early 1990’s as they entered the automotive market in crash detectors, followed by MEMS angular rate sensors, also called gyroscopes, in the late 1990’s. MEMS microphones entered the consumer market in mobile phones and other devices in the 2000’s.

With over 40 years of commercialization history behind it, MEMS sensor design and

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ENGINEERING DESIGN

Basic approaches to app-driven wireless health innovation6

Alone

The app alone comprises the innovation ­– providing one or more capabilities

+ Services

The app supported by a service comprises the innovation – providing one or more capabilities

Application + Sensing

The app, enabled by a phone’s embedded sensing, comprises the innovation – providing one or more capabilities

+ Service

+ Sensing

The app, enabled by the phone’s embedded sensing and supported by a service, comprises the innovation – providing one or more capabilities

Basic approaches to device-driven wireless health innovation6 manufacturing advances have enabled consumer electronics volume, pricing, and performance.

The MEMS industry is bullish on the prospects for a wide range of sensors. There is indeed gathering momentum to develop a trillion-sensors road map.2

Alone

The device alone comprises the innovation – providing one

or more capabilities. An example of this is a wearable patch that measures and stores data during an application period. The data is subsequently downloaded at a docking station.

+ App

The device, supported by an app, comprises the innovation – providing one or more capabilities.

Devices + Service

The device, supported by a service, comprises the innovation – providing one or more capabilities. An example: The patch above in this table, coupled by a service that returns to the consumer patient information from downloading and analyzing the data.

Wearables

Wearables are a new

application domain for MEMS sensors, with momentum rooted in activity monitors – initially standalone devices and now transitioning to smart watches. Activity monitors leverage the volume, pricing, and performance of MEMS accelerometers.

In these devices, physical activity is correlated with health and wellness and can be accomplished by using a MEMS accelerometer to sense motion and a suitable algorithm to translate the sensor data into activity information, which can also be used to estimate calorie consumption.

Wearables that similarly leverage commodity MEMS devices are quickly becoming a commodity themselves. Such wearables differentiate themselves mostly by their user interface engineering and business model.

Wearables are mostly motivated in the marketplace by their potential for health and wellness applications. They are attractive 22

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1 • 2016

+ App + Service

The device, supported by an app and a service, comprises the innovation – providing one or more capabilities.

compared to implantable sensors, particularly when nonintrusive and inconspicuous.

Implantable sensors require intrusion into the body, forcing substantially more stringent performance, size, and reliability requirements. The regulatory approval for medical wearables can be, by comparison, much cheaper and faster.

In general, MEMS technology is application-driven and technology-limited.

To harvest new application opportunities, wearables need a wide range of sensors – including chemical and biological – many of which are not yet available in consumer volume, pricing, and performance. Many such sensors are undergoing R&D, and many have not yet been identified.3 Many such MEMS devices will be challenged in part by packaging issues. Furthermore, thermal

management is more stringent in wearables than the historical applications for MEMS devices, in particular for medically regulated wearables.

Nevertheless, smart watches are moving rapidly to integrate new sensors for monitoring additional vitals, motivated by a goal of displacing simpler activity bracelets. For example, current smart watches are integrating sensors for pulse and blood oxygen. Cuffless, continuous blood-pressure monitoring is an extremely attractive function, but technology to accomplish it is not yet available.

Wireless health Ubiquitous connectivity and computing are bringing about unprecedented mobility – facilitating working, entertainment, shopping, socializing, gaming, and more, anytime,

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ENGINEERING DESIGN

anywhere. Wearables enable wireless health, which in turn enables diagnosis, therapy, and monitoring of health-related conditions by tracking biometric readings, relevant biomarkers, managing treatment regimen, and monitoring progress – while patients go about their daily life. Continued emergence of wireless health is a near certainty, given its significant potential benefits to healthcare delivery systems and increasing patient demand for mobility.1 The projection for the 2015 annual heath care expenditure in the United States is about $3.2 trillion – breaking the $10,000-per-person mark and well above other developed countries. Healthcare spending has grown between 3% and 4% in recent years, taking between 17% and 18% of the GDP.4 The U.S. healthcare system’s fee-for-service model is reactive to illness. An aging population, longer lives, and increasing cases of chronic diseases are some of the key drivers escalating healthcare expenditures.

Chronic diseases – hypertension, obesity, arthritis, asthma, chronic kidney disease, depression, chronic obstructive pulmonary disease, diabetes, sleep disorder, and heart failure5 – account for a sizable portion of the U.S. healthcare expenditures. That portion is one-third to three-quarters, depending on the source.

About 45% of the U.S. population has at least one chronic disease, and about 50% have two or more.

Generally speaking, there are three basic approaches to wireless health devices: app-driven, device-driven, and service-driven.6 Solutions often combine permutations of two or all of these approaches, to solve more complex needs, enhance differentiation, rationalize higher prices, and increase barrier to entry of competitors.

The following table at left describes several approaches to wireless health innovations. Because external devices are usually sensors – to make measurements – the terms ‘sensor’ and ‘device’ are used interchangeably here. Focusing on solutions enabled by external devices is not exclusive to also using a phone’s embedded sensors. It should be noted that external devices may be peripherals, such as biometric data routers, that facilite the transmission of data from sensors. The table includes descriptive examples for approaches that may be harder to grasp.

Apps may originate from payers, providers, or third parties. Providers are increasingly branding their own apps to engage their patients and enhance their services. Inevitably, these provider apps will tie into the provider’s electronic records, providing access to the patients. Payer apps enhance external-facing service enhancements for patients and providers. Third-party apps that facilitate a variety of workflow,

engagement, and care delivery needs may be for payers, providers, and patients to provide. M

For further reading 1. “Goldman Sachs says a digital healthcare revolution is coming,” http://www.businessinsider.com/ goldman-digital-healthcare-iscoming-2015-6, accessed July 7, 2015.

2. TSensors, http://www.tsensorssummit. org, accessed July 7, 2015.

3. “Pwc: 1 in 5 Americans owns a wearable, 1 in 10 wears them daily”, http://mobihealthnews.com/37543/ pwc-1-in-5-americans-owns-awearable-1-in-10-wears-them-daily/, accessed July 7, 2015.

4. “National health expenditure projections,” http://www.cms. gov/Research-Statistics-Data-andSystems/Statistics-Trends-andReports/NationalHealthExpendData/ NationalHealthAccountsProjected. html, accessed July 7, 2015.

5. Eric Topol, “Transforming Medicine via Digital Innovation,” Science Translational Medicine, Vol. 2, Issue 16, January 2010.

6. Wireless Health: Remaking of Medicine

by Pervasive Technologies, Mehran Mehregany, Editor, author House, Bloomington, IN, December 2014.

Basic approaches to service-driven wireless health innovation6

24

Alone

The service alone comprises the innovation — providing one or more capabilities. An example of this is a data transport and analytics solution.

+ App

The service, supported by an app, comprises the innovation — providing one or more capabilities. In this approach, data entry would be from the user, e.g., manual, gesture, and voice.

Services + Sensor

The service, enabled by a sensor, comprises the innovation — providing one or more capabilities. An example: remote monitoring of patients with heart disease, analogous to remote security monitoring of a home.

+ App

+ Sensor

The service, enabled by a sensor and supported by an app, comprises the innovation — providing one or more capabilities. An example would be that of the row above, where an app is used to also engage the patient as to the monitoring results.

Medical Design & Outsourcing

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THE CATH LAB

Making endoscope connections easier to sterilize Continued improvements in hygiene are possible, along with lowered risk of infection, by using specific materials in the design of modern cable systems.

Maximum hygiene from properly sterilized equipment and excellent image transmission are essential to all endoscopic applications.

Lukas von Arx | Director of Sales | LEONI Elocab Ltd |

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Flexible endoscopy is a frequent diagnostic and therapeutic procedure. But endoscopes are also medical devices often associated with infections in hospitals.

The transmission of bacteria, viruses, and spores by endoscopes can result in serious infections that must be avoided under all circumstances. Efficient sterilization after every use is mandatory for flexible endoscopes that enter or penetrate the mucous membrane (as in the case of biopsy or gastroscopy). Strict rules and standards govern the cleaning and disinfecting of these devices.

Due to their structure, most endoscopes have grooves, crevices, and gaps that make straightforward cleaning difficult. Furthermore, materials in an endoscope’s individual components that do not tolerate heat or chemicals make them unsuitable for particular sterilization processes and hence difficult to clean. This allows for an increased risk of infection transmission.

The FDA and endoscope manufacturers require the highest cleanliness, so suppliers must develop 1 • 2016

and produce components with a focus on efficient preparation – a proper sterilization.

How geometry improves hygiene While the main focus of sterilizing endoscopes is on the endoscope channels and instruments, the same strict preparation criteria also apply to connection hoses and other leads. Steam or chemical sterilizations are preferred methods. The endoscope cables and connected components must withstand several hundred cycles using these sterilization methods. Along with materials, the design and structure of a modern cable system can contribute to the proper sterility of a flexible endoscope.

Grooves, gaps, and cavities in the connection of flexible endoscopes can be avoided by overmolding the connection, thereby making the system nearly 100% sealed. Combined with a silicone jacket and LSR molding, the endoscopy system can then be exposed to safe and durable sterilization for up to 1,000 cycles in an autoclave while maintaining optimized gliding properties.

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THE CATH LAB

Shown separately, a hybrid endoscopy cable would have a data cable (left) and fiber bundle for video signals extruded in a shared jacket.

The technology means endoscopic systems are bound to have grooves and crevices. For instance, a connection between different materials often leads to problems when connecting plugs or ferrules. When metal and plastic parts in an assembly come into contact, a biofilm can form in cavities or recesses that provide fertile ground for microorganisms.

Such gaps and holes at connection points can be prevented by applying a special overmolding technology.

The penetration of fluids can also be prevented at these points. Overmolding with a silicon-based material can eliminate grooves and crevices, and achieve a nearly 100% seal in these tricky locations. Built-in connectors are also molded with materials such as an epoxies and silicones.

With several materials to choose that make good seals mean standards can be established in the manufacturing plans for endoscope cable systems that enable lasting sterilization of a complete endoscopy system. Thanks to biocompatible silicon jackets with a nearly 100% seal, endoscopy cable systems can withstand up to 1,000 autoclave cycles at 290°F. Comparable results also come from the use of other biocompatible materials, such as thermoplastic polyurethane (TPU), ethylene

The endoscopic cable provides separate video and data channels in a common extrusion that allows a thorough sterilization.

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1 • 2016

tetrafluorethylene (ETFE), and fluorinated ethylene propylene (FEP).

Few limits in cable design The key function of an endoscope is to provide the best possible image resolution to ensure fast diagnosis and proper treatment. The reliable transfer of video signals is a necessity.

Image and video transmissions are based on copper and fiberoptics. The CCD, chip-on-the-tip and CMOS-based 3D, highend endoscopes of various manufacturers are deployed with differing transmission systems. These latter devices will help select a preferred cable design.

Copper cables are flexible and provide a strong and reliable signal transfer. On the other hand, fiberoptics provide greater bandwidth together with a small diameter. Fiberoptics also save weight and protect against sources of interference (EMI). For example, while a bronchoscopy system in development may be focused on a minimal outer diameter, a high level of illumination is essential for laparoscopy along with reliable signal transmission.

Technologically sophisticated hybrid cable structures facilitate the integration of copper, fiberoptic, fiber-bundle elements, and hoses.

Hybrid round cables that include copper components and fiber-optic conductors can run in parallel in a shared and extruded jacket. An

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1/7/16 3:22 PM

THE RELIABLE TRANSFER OF VIDEO SIGNALS IS A NECESSITY. integrated fiber bundle transmits light to the surgical site, while the fiberoptic conductor transfers the signal from a 3D camera to the monitor. Copper components supply electrical power.

Only a few cable specialists are versed in the development and production of such customized cable solutions, in addition to making copper and fiber-optic cables. Upon customer request, such solutions can be fitted with power, signal, data, and light-transmission components as well as polyurethane hoses. Additional application-optimized connections are possible, thanks to cables miniaturized down to AWG 50, as well as microsoldered connections as small as AWG 44.

Lastly, regarding component tests, endoscopic cable systems that provide optimum image quality and can be sterilized are checked in standardized and specialized function tests. Among other aspects, the number of fibers, distribution, light loss, and impermeability of the light source as well as suitability for certain sterilization methods are established in a special fiber-bundle test. M

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1 • 2016

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FDA NEW PRODUCTS

The U.S. Food & Drug Administration’s list of pre-market approvals granted in October 2015 Summary of PMA Originals & Supplements Approved Originals: 9 Supplements: 133

Summary of All PMA Submissions Originals: 7 Supplements: 74

Summary of PMA Originals Under Review Total Under Review: 58 Total Active: 32 Total On Hold: 26

Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 133 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 161.5 FDA Time: 97.9 Days MFR Time: 63.6 Days

Summary of PMA Supplements Under Review Total Under Review: 597 Total Active: 433 Total On Hold: 164

PMA original approvals APPLICATION NUMBER / DATE of APPROVAL

30

DEVICE TRADE NAME

COMPANY NAME CITY, STATE, & ZIP

DEVICE DESCRIPTION / INDICATIONS

P150003 SYNERGY 10/2/15 Everolimus-Eluting

Platinum

Chromium

Coronary Stent System

Boston Scientific Corporation Maple Grove, MN 55311

Approval for the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System. This device is indicated for improving luminal diameter in patients with symptomatic heart disease, stable angina, unstable angina, non-ST elevation MI or documented silent ischemia due to atherosclerotic lesions in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter in lesions ≤34 mm in length.

P150013 10/2/15

Dako North America, Inc. Carpinteria, CA 93013

Approval for the PD-L1 IHC 22C3 pharmDx. This device is indicated for the following: PD-L1 IHC 22C3 pharmDx is a qualitative immunohistochemical assay using Monoclonal Mouse Anti-PD-L1, Clone 22C3 Antibody intended for use in the detection of PDL1protein in formalin fixed, paraffin embedded (FFPE) Non-Small Cell Lung Cancer (NSCLC) tissue using EnVision FLEX visualization system on Autostainer Link 48. PD-L1 protein expression is determined by using Tumor Proportion Score (TPS), which is the percentage of viable tumor cells showing partial or complete membrane staining. The specimen should be considered PD-L1 positive if TPS ≥50% of the viable tumor cells exhibit membrane staining at any intensity. PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying NSCLC patients for treatment with KEYTRUDA (pembrolizumab).

PD-L1 IHC 22C3 pharmDx

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1 • 2016

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FDA NEW PRODUCTS

PMA original approvals APPLICATION NUMBER / DATE of APPROVAL

DEVICE TRADE NAME

COMPANY NAME CITY, STATE, & ZIP

P150014 10/14/15

cobas HBV

Roche Molecular Systems, Inc. Pleasanton, CA 94588

Approval for the cobas HBV. This device is indicated for: cobas HBV is an in vitro nucleic acid amplification test for the quantitation of hepatitis B virus (HBV) DNA in human EDTA plasma or serum of HBV-infected individuals. This test is intended for use as an aid in the management of patients with chronic HBV infection undergoing anti-viral therapy. The test can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment. The results from cobas HBV must be interpreted within the context of all relevant clinical and laboratory findings. The cobas HBV is not intended for use as a screening test for the presence of HBV in blood or blood products or as a diagnostic test to confirm the presence of HBV infection.

P150015 10/14/15

cobas HCV

Roche Molecular Systems, Inc. Pleasanton, CA 94588

Approval for the cobas HCV. This device is indicated for: cobas HCV is an in vitro nucleic acid amplification test for both the detection and quantitation of hepatitis C virus (HCV) RNA, in human EDTA plasma or serum, of HCV antibody positive or HCV-infected individuals. Specimens containing HCV genotypes 1 to 6 are validated for detection and quantitation in the assay. cobas HCV is intended for use as an aid in the diagnosis of HCV infection in the following populations: individuals with antibody evidence of HCV with evidence of liver disease, individuals suspected to be actively infected with HCV antibody evidence, and individuals at risk for HCV infection with antibodies to HCV. Detection of HCV RNA indicates that the virus is replicating and therefore is evidence of active infection. cobas HCV is intended for use as an aid in the management of HCV-infected patients undergoing anti-viral therapy. The assay can be used to measure HCV RNA levels at baseline, during treatment, at the end of treatment, and at the end of follow up of treatment to determine sustained or non-sustained viral response. The results must be interpreted within the context of all relevant clinical and laboratory findings. cobas HCV has not been approved for use as a screening test for the presence of HCV in blood or blood products. Assay performance characteristics have been established for individuals treated with certain direct-acting antiviral agents (DAA) regimens. No information is available on the assay’s predictive value when other DAA combination therapies are used.

P150025 10/9/15

PD-L1 IHC 28-8 pharmDx

Dako North America, Inc. Carpinteria, CA 93013

Approval for the PD-L1 IHC 28-8 Pharmdx. This device is indicated for the following: 1) PD-L1 IHC 28-8 pharmDx is a qualitative immunohisto-chemical assay using Monoclonal Rabbit Anti-PD-L1, Clone 28-8 intended for use in the detection of PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) non-squamous non-small cell lung cancer (NSCLC) tissue using EnVision FLEX visualization system on Autostainer Link 48; 2) PD-L1 protein expression is defined as the percentage of tumor cells exhibiting positive membrane staining at any intensity; and 3) PD-L1 expression as detected by PD-L1 IHC 28-8 pharmDx in non-squamous NSCLC may be associated with enhanced survival from OPDIVO (nivolumab).

DEVICE DESCRIPTION / INDICATIONS

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PATENT PROTECTION

Design patents provide additional protection for products

Roman Fayerberg, JD | Patent Attorney and Shareholder | G r e e n b e r g Tr a u r i g , L L P |

David J. Dykeman, JD | Co-chair | G r e e n b e r g T r a u r i g ’s G l o b a l Life Sciences & Medical Te c h n o l o g y G r o u p a n d Boston Intellectual Property & Te c h n o l o g y G r o u p |

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In today’s challenging economic climate, a strategic patent portfolio is crucial to a medical technology company’s growth and survival, because it can provide numerous business advantages. Although patents are extremely important for medtech companies of all sizes, patents make up a significantly greater portion of enterprise value for early-stage medtech companies. Patent portfolios are often the only way for investors to place a value on an early-stage company’s technology, as sales often cannot begin until after FDA approval.

When developing patent portfolios, design patents are often overlooked in favor of utility patents. Although generally having a more limited scope of protection, design patents can still deter potential infringers in the U.S. and foreign countries. For example, in a recent case involving smartphones, a substantial portion of the plaintiff’s billiondollar verdict was based on the infringement of design patents. Design patents may play an important role in protecting the medtech company’s innovations and creating competitive advantages.

Differences between design patent and utility patents In developing patent protection strategies for a product, medtech companies often rely solely on utility patent protection and fail to consider design patent protection. Yet many medtech companies can gain additional product protection by using design patents.

Both utility and design patents grant the owner the right to exclude others from making, using, selling, offering for sale or importing the patented invention in the U.S. Both utility and design patents also conclude with at least one claim that provides a concise legal definition of the invention.

However, in most aspects, design patents and utility patents are very different.

Utility patents protect the operational or functional features of a product.

They are complex and lengthy legal documents that include a thoroughly written description, detailed drawings of the invention, and multiple claims of varying scope defining the invention. Often, the claim coverage is different (broader or narrower) than the exact product shown in the drawings. The term of utility patents is generally 20 years from the effective filing date of a patent application.

To keep issued utility patents in force, maintenance fees must be paid at 3.5, 7.5 and 11.5 years after the utility patent is issued.

In contrast, design patents protect the ornamental or nonfunctional features of a product. They have no written description and are limited to one claim. The claim of the design patent covers only the exact product shown in the drawings. Beginning on May 13, 2015, the term of design patents was extended from 14 years to 15 years from the issue date. Design patents also do not require any maintenance fees after issuance. Design patents typically provide a more limited coverage than utility patents, but are quicker, easier and less expensive to obtain than utility patents.

Due to the differences between the two patent types, design patents may supplement protection provided by utility patents, creating comprehensive product coverage. www.medicaldesignandoutsourcing.com

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PATENT PROTECTION

Protecting both functional and ornamental aspects of a medtech product A comprehensive patent portfolio should protect all aspects of a product.

Design patents may supplement a utility patent portfolio by providing additional protection covering the appearance of a medical device. For example, design patents can cover the appearance of femoral hip prostheses, heart valve prosthesis, syringes, catheters, thermometers, infusion pumps and even medical device packaging.

Obtaining a utility patent does not preclude a company’s obtaining a design patent on the same product, or vice versa. For example, in the case of a heart valve prosthesis, a utility patent may cover the functional features and methods of use (at least in the U.S.) of the heart valve prosthesis.

A design patent may cover the

A COMPREHENSIVE PATENT PORTFOLIO SHOULD PROTECT ALL ASPECTS OF A PRODUCT.

product’s ornamental appearance, which may not be covered by the utility patent.

Protecting the product’s appearance with design patents can supplement the protection of the functional features provided by utility patents, thus strengthening the overall patent coverage of the product.

Design patent infringement and damages The scope of protection offered by design patents is generally more limited than the scope of protection offered by utility patents. For design patents, courts determine infringement by comparing the design patent drawings to a competitor’s “infringing” item. A design patent is

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infringed if an ordinary observer, familiar with the prior art and giving such attention as a purchaser usually gives, would have been deceived by the resemblance of the design shown in the patent figures.

Competitors may thus be able to “design around” a design patent by making minor changes to the patented design to avoid infringement. Consequently, the appearance and selection of the drawings is critical in design patents.

If infringement is found, an owner of a design patent has two alternatives when seeking damages. The first alternative is to seek damages under the standard patent damages statute available for both design and utility patents. Under 35 U.S.C. 284, the minimal damages are “a reasonable royalty for the use made of the invention by the infringer.” The second alternative is the damages statute for design patent infringement, 35 U.S.C. 289, which permits the patent owner to recover the infringer’s total profits, a remedy not available for utility patent infringement. Further, the Court of Appeals for the Federal Circuit – the appellate level court that hears all appeals of patent cases from all U.S. courts – recently rejected an argument to limit the profits to the portion of the product that incorporates the patented design, rather than the total profits for the entire product. Accordingly, it may be possible for the patent owner to collect total profits on the entire product, even when the patent design constitutes a small portion of the product. For example, an owner of a design patent covering a catheter handle may be able to obtain all profits of the infringer from selling a catheter incorporating the infringing handle, not just a portion of the total profits attributable to the infringing handle.

Accordingly, even though design patents provide a somewhat limited coverage, design patents can still serve as a strong deterrent to infringement and provide a competitive benefit to their owner.

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New option for expedited patent protection in foreign countries On May 13, 2015, the U.S. joined the Hague System for the International Registration of Industrial Designs; U.S. design patent applicants can now take advantage of an often simplified process pursuant to the Hague System to obtain protection for their inventive designs in foreign countries.

With the U.S. included in the Hague System, U.S. applicants can file a single, standardized international design application directly via the U.S. Patent & Trademark Office’s (USPTO) electronic filing system (EFS-Web) in English for registering up to 100 designs in over 64 designated member countries and intergovernmental organizations, and can receive the same effective filing date in each jurisdiction. U.S. applicants may often avoid complexities related to

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filing separate national applications in multiple countries, such as, for example, foreign language translations, procedural requirements, fees, and deadlines for renewal. Depending on the application, this streamlined process can reduce the barrier to entry for applicants to acquire geographically broader design protection through simplification and reduced costs.

In addition to the U.S., the Hague System also includes Japan and the European Union, among other Contracting Parties. Countries absent from the Hague System that may be of interest to U.S. applicants are China, Canada, Australia, Brazil, but these nations are also likely to join the Hague System in the near future due to the recent addition of the U.S. and Japan.

Conclusion Design patents may play an important

role in protecting innovations and creating competitive advantages, whether they are the only available protection or part of a larger patent strategy. Often overlooked and sometimes undervalued, design patents are typically easier and less costly to obtain than utility patents.

Although generally having a more limited scope of protection, design patents can still deter potential infringers in the U.S. and foreign countries. Medical technology companies should consider filing design patents covering a product’s appearance as part of the overall patent portfolio to provide stronger protection for the product. M This article is presented for informational purposes only, and it is not intended to be construed or used as general legal advice nor as a solicitation of any type.

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WOMEN IN MEDTECH

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www.medicaldesignandoutsourcing.com

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WOMEN IN MEDTECH

WOMEN IN MEDTECH Women account for about 78% of the workforce in healthcare and social assistance but are only about 14% of the industry’s executive officers or higher. As the medical technology industry continues to grow, it is important that we find ways to bridge the gender gap and encourage innovation, while tackling the toughest issues together. Below are a few top women leaders in medtech who are paving the way for future generations.

www.medicaldesignandoutsourcing.com

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G

erardine Ferlins began her career as a medical social worker, a teacher and played several different roles at Worcester Controls. Having moved through all the ranks, she was given the opportunity to start Cirtronics in 1979 for Bob McCray, when he sold Worcester Controls.

In 2002, Gerardine transitioned Cirtronics to an ESOP company.

Gerardine has a BA in Sociology from the College of St. Rose. She actively participates in: NH Catholic Charities, BIA, NH Community Loan Fund, and Vested for Growth.

GERARDINE FERLINS President & CEO Cirtronics Corporation

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HOW DID YOU GET STARTED? It was back in the ‘70s, and I recognized an opportunity in the world of printed circuit board assembly [PCBA]. There was a gap in the industry that begged for a manufacturer that could provide more than just working products, but the service and problemsolving skills to match.

For a woman to establish her own business in the 1970s was quite a feat!

But I used my background in teaching and sociology to bring a very different perspective to the new company – I’ve always had a passion for people and believe in the ability of the team to exceed customer expectations. So I’ve focused on developing a culture of co-ownership and of extending true value in ongoing staff enrichment and in technical excellence while supporting the wider community.

WHAT CHALLENGES HAVE YOU FACED? The industry of contract manufacturing is extremely competitive. We focus on the excellence of our service, offering mid-volume, complex products that require both depth of skill, time, energy and a wide range of knowledge. Our goal is to provide a level of service unmatched by the larger contract manufacturers in the industry. Our attention to detail and

range of expertise set us apart.

After years of being focused on board-building, we realized an opportunity to go completely turnkey back in 1997. It’s compelling for customers to shift their entire assembly to Cirtronics, rather than just have us involved for PCBA assembly; our full-service skill set now rivals much larger competitor’s offerings.

Diversification into new markets while sustaining strong customers in the medical arena continues to be a critical piece of our growth strategy. Cirtronics continues to invest in 3-5 industries, which keeps our market portfolio diverse and has helped us combat the effects of the economic downturn. Building trusted interpersonal relationships with customers over the years has allowed Cirtronics to leverage the company’s early successes and explore new markets. It takes a lot of time and resources to learn how to produce new products, so growing with existing customers and supporting their new programs is key. Many of our customers have been with us for more than 20 years.

An example of a customer challenge comes to mind. The first was after 9/11, we supported critical customer needs to rapidly ramp up and provide a large volume of product needed for airport security.

Our employees worked day and night to ensure that we delivered on these extremely tight demands as everyone wanted to keep people safe.

Extending our strong collaborative culture into our interactions with customers helps build mutual respect and trust. We call this Precision Engagement, and it means that we focus on providing purposeful, proactive communication and the deliberate application of our extensive capabilities in ways that best serve each of our customers as individuals. We value each of our customers, and we want each customer to feel truly valued by us.

This impacts everything we do.

www.medicaldesignandoutsourcing.com

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WOMEN IN MEDTECH

Gerardine Ferlins stands with her Cirtronics team in front of the New England headquarters.

WHAT CHALLENGE OR ISSUE DID YOU SOLVE THAT LED TO YOUR PRESENT POSITION? Founding the company in 1979 and as a sociologist by education, Cirtronics was based on principles that cultivate personal motivation with a team-based, balanced structure.

Certainly an organizational chart exists, but the dedication of each employee stems from their own drivers for success, not from a chain of command or predetermined channel of communication. This unique kind of structure has proven to be a significant contributor to employee satisfaction and retention.

At Cirtronics, our competitive advantage depends on the strength of our talent pipeline. So we deliberately build from within and our leadership team is focused on nurturing our team environment through the application of our core value of “Do Unto Others.” We work hard at maximizing individual potential, maintaining an emphasis on product quality and integrity, while growing an environment where creativity can flourish. We share a fundamental belief in our people and their abilities, and this continues to be the key to our success.

WHAT ADVICE WOULD YOU GIVE NEW MEDICAL TECHNOLOGY WOMEN PROFESSIONALS? Follow Cirtronics’ mission statement, “Do Unto Others;” treat everyone with dignity and respect – from colleagues, to consultants, to customers, to suppliers and to the community.

An example is our open-book philosophy, internally and with our customers, because transparency keeps things simple, and also allows for the employees to learn about the success of the business and share in its accomplishments.

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WOMEN IN MEDTECH

Seek customers and partners who challenge you to improve and to continue learning. To surround yourself with people who are diverse in their thinking and talents who will challenge your ideas – avoid surrounding yourself with people who will “yes” you.

Finally, to take initiative; raise your hand to ask what you don’t know, participate in a network or project that will offer growth.

IS YOUR CURRENT POSITION WHAT YOU EXPECTED IT TO BE? I love what I do. The most fulfilling aspect of my journey is that Cirtronics became a vehicle for our employees to be successful personally and professionally.

It is extremely rewarding that the success of Cirtronics is due to the people that work here each and every day and we have stayed true to our values. It’s an honor and a privilege to see Cirtronics fostering the discovery and development of individual employee talents and taking us to its current size of 170 employees.

WHAT ARE YOU MOST PROUD OF ACCOMPLISHING? Our environment and culture allows people to contribute to their fullest potential because they feel safe and valued. The average – average, mind you --Cirtronics employee has been with the company for about 14 years.

We have people who are highly trained and skilled at what they do: This is more valuable to us than the revenue they help generate each day. The Employee Stock Ownership Program (ESOP) isn’t just something we’ve adopted; it’s who we are as a company. We truly have a culture of ownership (40% employee owned).

I think our country would be in much better shape if more companies went ESOP; then, we’d be rowing in the same direction rather than in circles.

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WOMEN IN MEDTECH

D

ebbie Paul is CEO of EvaluatePharma USA, Inc. a division of life science market intelligence firm Evaluate Ltd. (HQ London). Evaluate provides commercial market intelligence services to the life science industry. It established the EvaluatePharma product in 1996 and then, due to client demand, EvaluateMedTech was launched

where I led strategic and product planning. I also worked at in the pharmaceutical and medical products practice of management consultancy McKinsey & Co. I received a Masters of Business Administration from Rice University in Houston, Texas, following a 17-year career as a Critical Care Nurse manager. I also have a Bachelor of Science in Nursing from State University of New York in Albany.

Debbie Paul and her EvaluatePharma team stand strong at a recent tradeshow.

DEBBIE PAUL CEO EvaluatePharma USA, Inc.

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in 2012. Evaluate is known for its comprehensive commercial coverage, and consensus forecasts of leading equity analysts, currently forecasting to 2020. Evaluate offers complimentary industry reports including EvaluateMedTech World Preview, an annual medtech industry overview and market forecasts. This report, along with the EvaluatePharma World Preview, have become industry standards.

HOW DID YOU GET STARTED? I joined Evaluate in 2004 as the only U.S. employee, bringing more than 25 years of diverse healthcare industry experience. I led the U.S. business as senior vice president, and now lead as CEO, Americas. Previously, I had the privilege of serving as director of market research at Sandoz, the generics division of global pharmaceuticals company Novartis,

WHAT CHALLENGES HAVE YOU FACED? A key challenge was building a cohesive team of professionals who all worked remotely prior to establishing a U.S. headquarters in Boston in 2010. Today, we have approximately 20 employees in two offices, Boston and San Francisco, and we continue to grow. Evaluate has been very successful and it has been steadily growing at approximately 20% year over year.

WHAT CHALLENGE OR ISSUE DID YOU SOLVE THAT LED TO YOUR PRESENT POSITION? My success in building Evaluate’s U.S. business came as a result of building a strong, collaborative team with considerable industry expertise that is very client focused.

It also involved developing and executing a comprehensive sales

www.medicaldesignandoutsourcing.com

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WOMEN IN MEDTECH

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WHAT ADVICE WOULD YOU GIVE NEW MEDICAL TECHNOLOGY WOMEN PROFESSIONALS? Establish a positive team culture that embraces clients, continuous learning, collaboration, & execution. Develop a sound strategy and plan that leverages the company’s core strengths. Prioritize and focus on customer centric objectives; hire the most qualified people for the roles you need. On a personal level, make sure that you do your best to build a good work/ life balance to remain healthy and reinforce this as part of the company culture. Assess where you are at key intervals and make course corrections as needed.

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IS YOUR CURRENT POSITION WHAT YOU EXPECTED IT TO BE? Fortunately, yes, as I expected it to be challenging every day, as well as very fulfilling, plus there’s so much more to come! We just celebrated the fifth anniversary of the Boston office Ribbon Cutting Ceremony that was attended by the late Mayor Tom Menino, whose office actively recruited life science companies from across the globe to Boston. This event was a reminder of how quickly the years pass and how important it is to stay focused to achieve your goals.

WHAT ARE YOU MOST PROUD OF ACCOMPLISHING? On a professional level, it is the long-term client relationships we have built as their thought partners, along with the successful team I developed over the past 12 years.

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WOMEN IN MEDTECH

M

artha Goldberg Aronson is executive vice president and president of Global Healthcare at Ecolab Inc. Previously, she served as executive vice president of Strategic Planning. Prior to joining Ecolab in 2012, Goldberg Aronson was senior vice president and president, North America, at Hill-Rom Holdings, Inc., a leading manufacturer and provider of medical technologies and related services for the healthcare industry.

Prior to Hill-Rom Holdings, Inc., she served as senior vice president at Medtronic. Throughout her 18 years with Medtronic, Goldberg Aronson held numerous positions in general management and led several functions both in the U.S. and Europe.

She began her career as an associate consultant at Bain & Company, a

working in consulting and was looking to differentiate myself to become a more attractive business school candidate. I moved from Boston back to Minneapolis and applied to several Fortune 500 companies in the Twin Cities. I was fortunate to receive an offer from Medtronic days before receiving an offer from another company, so I joined Medtronic and started my career in medical technology. When I learned more about Medtronic’s mission, which was written by the founder of the company, and saw how leaders in the organization truly lived this mission each and every day, I was hooked on the culture and the industry. Since then, being part of a purpose-driven organization has been very important to me.

Martha Aronson and the team at Ecolab promote a strong culture of growth for women in the medical profession.

global management consulting firm based in Boston. Goldberg Aronson graduated phi beta kappa and magna cum laude from Wellesley College with a bachelor’s degree in economics. She earned her master’s degree in Business Administration from Harvard Business School.

HOW DID YOU GET STARTED? To be completely honest, I fell into medical technology. I had been

WHAT CHALLENGES HAVE YOU FACED? I have a degree in Economics from Wellesley College and an MBA, but when I started in this industry, I quickly found myself interacting with scientists, researchers, and clinicians who all understood the technology and its applications far better than I did. To be effective, I had to ask a lot of questions of people on my team, clinical experts www.medicaldesignandoutsourcing.com

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MARTHA ARONSON President, Healthcare Ecolab

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WOMEN IN MEDTECH

and physicians. I am grateful for how generous so many physicians and other experts were with their time to help educate me. These experiences enabled me to become a better business leader.

Another challenge I faced occurred when I lived and worked in Switzerland.

I had to figure out how to interact with physician customers in many different cultures and countries. Initially, I was a bit worried about how some might react to a younger, female, American leader. The same approach that served me well when I first started in the industry also served me well there. By asking questions and learning from the insight our physician customers were sharing, I was able to form many great customer relationships and friendships during my time in Europe.

WHAT ADVICE WOULD YOU GIVE NEW MEDICAL TECHNOLOGY WOMEN PROFESSIONALS? Be open to job assignments that you may not have thought about for yourself. As an example, I never indicated to my colleagues or on my individual development plans that I was interested in an international assignment. It really wasn’t on my radar screen, but when I was presented with the opportunity to work abroad, my husband and I were open to the idea and thought it would be a great life adventure. I’m so thankful we took advantage of this opportunity because it turned out to be wonderfully rewarding both personally and professionally.

IS YOUR CURRENT POSITION WHAT YOU EXPECTED IT TO BE? Yes – it is exciting to be part of a mission-driven company such as Ecolab.

Every day, our team is committed to helping customers maintain healthy environments and provide clean water, safe food and abundant energy.

In our Global Healthcare business, we work very hard to ensure our customers – hospitals and other medical facilities – operate efficiently and in a more sustainable manner, while ensuring patient safety. I am proud that our solutions and services are key components in many hospital infection prevention programs. Our products and expertise help ensure that when patients enter a hospital, they do not contract a Hospital Acquired Infection (HAI).

WHAT ARE YOU MOST PROUD OF ACCOMPLISHING? When I think about the work we do, I am most proud of the positive difference we can make for patients, their families and healthcare professionals.

I am also proud of the relationships I’ve developed with my teams and colleagues throughout my career. I am passionate about helping leaders grow and develop, and hope that I’ve been able to provide encouragement and support for others as they have advanced in their careers. M

WHAT DO YOU THINK?

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3D PRINTING

Five-year-old Mia Gonzalez suffered from a double aortic arch malformation, in which a vascular ring wrapped around other organs, restricting airflow. Using a 3D-printed model of her heart, a surgical team visualized Mia’s cardiac structure and made repairs.

PRINTING PROSTHETICS and guiding a surgeon’s knife

3D printers have found homes in hospitals and healthcare facilities by printing custom-fit and durable prosthetics, along with models of organs displaying tumors that will improve surgical outcomes.

Leslie Langnau •

Contributing Editor The technology known as 3D printing is set to become one of the most useful tools for the medical market. In 2012, the global market for 3D printing in medical applications was $354.5 million. By 2019, that number will jump to almost $1 billion.

The news is filled with stories on the contribution 3D printing delivers:

www.medicaldesignandoutsourcing.com

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• Kids developing amateur prosthetic hands • Surgeons using 3D-printed body parts and systems to guide surgical procedures • Biodegradable bone and organ support structures implanted into patients

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3D PRINTING

In addition, future applications include: • Creating custom drugs • Building skin tissue • Potentially building organs 3D printing applications also include developing surgical guides and surgical instruments. The 3D printing machines – ranging from desktop to room-size – are used in orthopedic, dental, and especially crani-maxillofacial applications.

How they work 3D printers use a range of technologies and materials to build threedimensional objects that cannot be built using other technologies. 3D printers generally operate this way: A layer of build material is deposited onto a build tray. In some 3D printers it is exposed to a heat source (such as

Surgeons examine a 3D model of Mia’s heart along with the scanned images as they plan the surgery to repair her heart malformation.

a laser or UV light) to solidify the deposit; in other systems either a chemical or temperature process creates the bond between layers.

Then another layer is deposited on top of that layer, treated in some way to adhere to the previous layer, then another layer

is deposited, and so on until the object is complete. This is the layer-by-layer reference often mentioned.

The great advantage of 3D printing is that the machines can build objects with complex geometries, including holes and features that would be impossible to machine using conventional lathes, mills, or injection-molding systems. One example is the human thoracic cavity, with its ribs and organs. A conventional CNC machine would not be able to cut such a model.

Injection molding could be used, but the expense would be exorbitant. Some 3D printing machines can even build complex models using different materials and colors to represent all the structures.

The most commonly used 3D printing technologies for medical are: • Electron Beam Melting (EBM) or Laser Beam Melting (LBM) • Stereolithography or Digital Light Processing • Two Photon Polymerization • Droplet Deposition Manufacturing • Inkjet Printing • Fused Deposition Modeling • Multiphase Jet Solidification The sidebar at right provides for a brief explanation of each.

The most common materials used for medical 3D printing are:

To help a patient recover from strokerelated surgery, doctors 3D-printed a titanium skull cap. Because the implant had to fit as perfectly as possible, the best way to achieve this was with 3D printing. The 3D printer used a laser beam to sinter titanium metal powder into a piece that offered maximum individualization in form and size.

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• • • • • 1 • 2016

Metals Polymers Ceramics Biological cells Surgical guides

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3D PRINTING

THE 3D PRINTING TECHNOLOGIES MOST U S E D I N M E D I C A L A P P L I C AT I O N S There are many ways to additively build an object in 3D printing. The terms used here are not necessarily those accepted by the ASTM organization that monitors terminology. Many names are brand-specific. But here is a brief look at the technologies often used in medical applications.

Electron beam melting (EBM) is an additive manufacturing technique that uses a cathode ray as its heat source to melt metal powder. Because the metal is melted fully, there are no gaps in the finished product, making for dense, heavy parts. For medical applications this technology is used to build surgical instruments and sometimes skull caps, acetabular caps or other joints and bone replacement sections of the human body.

Laser beam melting (also known as laser sintering) is essentially the same as EBM, except that the heat source is a laser beam. In addition to metal powders, this technology can work with polymer powders.

Stereolithography (SL) uses photo-reactive (usually acrylic-based) polymers that instantly harden when exposed to an ultraviolet beam. As with most 3D printing processes, intricate parts or objects are made one layer at a time. SL offers excellent dimensional accuracy and showcases small features well. It is often used in the medical industry to model organs, body cavities and parts for surgical planning needs.

Digital Light Processing is similar to SL, except that the curing mechanism is a digital light projector. Depending on the manufacturer, the projector uses multiple mirrors and lights to cure a photo-reactive material. These printers work quickly, with high resolution and feature accuracy.

Two Photon Polymerization is a three-dimensional fabrication method that uses ultra-short laser pulses to initiate polymerization of a photosensitive material. It is supposed to deliver better resolution and quality than stereolithography.

It suits applications that require the development of 3D structures with a resolution of 100 nm or better. The light source is near infrared. This process can be used to develop drug delivery systems, such as micro needles.

Droplet Deposition Manufacturing deposits droplets of material onto a substrate where they solidify to near net shapes. The material is often metal. Part quality depends on droplet size, velocity, and temperature, among other factors.

It is often used to develop miniature metal parts.

Inkjet Printing is also known as material deposition. Here, inkjet-type nozzles shoot material onto a build platform, one layer at a time. The material is either a polymer or a type of binder. This method allows building several objects at a time.

Fused Deposition Modeling is a trademarked term by Stratasys, the developer of this 3D printing method. Also known as extrusion, it uses a type of thermoplastic filament that is moved through a heated deposition nozzle head that softens the filament enough to deposit it in layers, one on top of another, to build a part. As the material hardens, it binds to the previous layers. Polymers, like those used in injection molding, are the main materials used. It suits the need to build models of body organs and parts.

Multiphase Jet Solidification is a method developed by the Fraunhofer Institute for Applied Materials Research. It primarily works with metal or ceramic materials. Low-melting metal alloys or a ceramic powder-binder mixture are squeezed through a nozzle, layer by layer.

Then the jetted material is sintered to bond the layers together. The benefit for medical with this technology is it is one of the few processes that works with ceramic materials.

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3D PRINTING

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The most frequent use of 3D printing in surgical situations is to print a model of the body parts that will undergo surgery. Such a model helps surgeons plan the operation for a more efficient, less risky procedure. For example, fiveyear-old Mia Gonzalez suffered from a double aortic arch malformation, in which a vascular ring wrapped around the trachea and esophagus, restricting her airflow. A 3D-printed model of her heart enhanced the planning phase so the surgical team could visualize Mia’s specific cardiac structure.

Dr. Redmond Burke, Director of Pediatric Cardiovascular Surgery at Nicklaus Children’s Hospital, part of Miami Children’s Health System, said, “By making a 3D model of her complex aortic arch vessels, we were able to further visualize which part of her arch should be divided to achieve the best physiological result. It’s powerful when you show a family, ‘This is your baby’s heart and this is how I’m going to repair it.’”

“Once a patient’s scan data from MR or CT imaging is fed into the 3D printer, doctors can create a model of the scan with all its intricacies, specific features, and fine detail. This significantly enhances surgical preparedness, reduces complications, and decreases operating time,” added Scott Rader, GM of Medical Solutions at Stratasys.

Stratasys reseller AdvancedRP supplies 3D anatomical models to Nicklaus Children’s Hospital for surgical planning.

The models are produced by a Stratasys Objet500 Connex3 Multi-Material 3D Printer. The 3D printer offers a range of material properties, enabling anatomical models to accurately replicate organs, flesh or mimic the rigidity of bone. Based on the success of recent surgeries, the hospital has now installed its own Stratasys 3D Printer.

Printing a precise implant In another use, 3D printing is used to create implants. For example, an Argentine patient required a large implant after stroke-related surgery.

The implant had to fit as perfectly as possible – a classic requirement of 3D printing applications.

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3D PRINTING

The 3D printer in this application used a laser beam to sinter titanium metal powder into a piece that offered maximum individualization in form and size.

The medical requirements for the implant were that it had to integrate with biological functions and dissipate as little heat as possible into the cerebral tissue. The medical technology experts at Novax DMA and Alphaform worked to develop a porous structure that could be impermeable to tissue fluid from the brain.

The lattice-structured implant with skull-integrated, screw-in fixings allows both the passage of fluids and fusion with the bone of the skull. In addition, such a design has an insulation effect such that the heat dissipation into the cranial cavity is minimized. The dimensions of the pores themselves are approximately 1mm size, while the cell-

BUILDING

links are about 0.2mm thick.

For the 3D design of the implant, Novax staff worked with CAD software.

As soon as the CAD work was complete, Alphaform took on the manufacture of the implant, using an EOSINT M 280 system from EOS. The build time was just a matter of hours.

The implant’s porosity level reached 95%, so liquids could flow through with the least possible resistance. In addition, the bone tissue was able to penetrate the outer edges of the implant and grow together with it. At the same time, the metal was stable enough to return the patient to the desired level of normality in everyday life. The structure, constructed in the form of a regular lattice, also provided the required level of thermal conductivity – so the patient can even enjoy time in the sun.

War on cancer Colored, multi-material 3D printing is being successfully used to aid cancer surgeons in treating patients. In one example, physicians use the models during presurgery planning of complicated kidney tumor removal, helping to perform precise and successful kidney-sparing surgery and improving patient outcomes. The 3D printed models are also used to improve surgeon training, as well as help physicians better explain the surgery to patients.

The surgical process uses transparent and color 3D-printed models produced on the Objet500 Connex3, Stratasys’ color, multi-material 3D printer, at the Department of Urology and Kidney Transplantation at the University Hospital (CHU) de Bordeaux, in France. According to CHU surgeon Dr. Jean-Christophe Bernhard, this is currently the only hospital in France – and one of the

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3D PRINTING

To plan the surgery that would remove a complicated kidney tumor, doctors first used a 3D printed model of the kidney.

A transparent material was used for the organ, but inside, color was used to show tumor (the red lump) in relation to arteries and cavities. The goal was to save as much of the kidney as possible.

first in the world – to deploy Stratasys’ multi-color, multi-material 3D printing technology for complex kidney tumor removal cases.

“Having a 3D-printed model of the patient’s kidney tumor, main arteries and vessels – each in a different color – provides an accurate picture of what we will see during operations,” said Dr. Bernhard.

“More importantly, the ability to visualize the specific location of a tumor in relation to these other elements, all in three dimensions, greatly facilitates our task and is not something that is easily achievable from a 2D scan,” he added.

According to Dr. Bernhard, the clearer view offered by the 3D-printed model aids in identifying and avoiding damage to the delicate nearby arteries and vessels that can result in complete kidney removal.

The CHU de Bordeaux uses three Stratasys PolyJet materials: transparent VeroClear to show the volume mass of the kidney, red for the arteries and yellow for the excretory tract. The red and yellow is then mixed on the fly – unique to Stratasys multi-material capabilities – to produce the orange for the tumor.

“The transparent material is of fundamental importance, because it allows us to see inside and estimate the depth at which the tumor resides,” said Dr. Bernhard. “It lets us see the arteries and the cavities that collect urine, so we can see if any of the arteries are touching the tumor. We need to remove the tumor, but not at the expense of other vital elements that together enable the kidney to do its job.

Finding that balance is much easier to achieve thanks to 3D printing.” www.medicaldesignandoutsourcing.com

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Another major benefit for the CHU of Bordeaux and Dr. Bernhard is the ability to use the 3D printed models to more easily explain procedures to patients prior to surgery, thereby offering increased reassurance.

“Describing kidney tumor removal with 2D scan or a diagram will invariably leave most patients somewhat bewildered,” he explains. “Presenting them with a 3D printed model that clearly shows the tumor puts them at ease and helps the patient grasp exactly what we’re going to do. Indeed, research from patient questionnaires shows that having 3D-printed models increases their understanding of the surgery by more than 50%, so it’s a considerable benefit in terms of overall patient care.” M 1 • 2016

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MICROMOLDING

A new look at micromolding:

Big possibilities in small details Most medical-device designers are unfamiliar with the fine limits of micromolding. For instance, today’s capability can shape parts with details down to 0.005 in. But even that limit may give way with more recent developments.

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Lindsay Mann • Director of Marketing • MTD Micro Molding

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M

any design engineers have expressed interesting but incorrect assumptions relating to micromolded parts.

Because micromolding is an emerging technology with a shortage of accurate information, this data vacuum creates fertile ground for myths and misconceptions. Most myths relate to the designers’ prior experience with “normal” or “macro” injection molding.

Here are two common myths: Myth #1: You can be successful molding micro-sized parts on standard sized molding machines.

The assumption is that with a little adjustment and some refinements to make closer-tolerance tools, most smaller injection-molding machines should be able to make micromolded parts.

This is perhaps the most dangerous myth because it’s completely untrue. It also impacts the customers’ supplier selection and sets the unprepared supplier up for failure. About 20% of MTD’s new business each year comes from “rescuing” projects such as this.

Notwithstanding the highly specialized ability to create a mold capable of producing micro-sized geometries and tolerances, the entire micromolding system must be designed to operate differently than does a “macro-system.”

The source of the problem is failing to understand that miniature volumes of any material – plastic, resin or steel – behave differently than larger or normal volumes.

Every variable in the system behaves differently in the micro world, including thermaltransfer rates, mechanical strengths, flow characteristics, and so forth. The differences are all driven by differences in material volumes.

The result is that micromolding may look like conventional molding, but micro is a considerably different process requiring high-precision molds and real-time process monitoring.

Myth #2: The part must be microscopic to be considered a “micro part.

Parts as large as 1 in. square may have a compelling reason to be micromolded, such as critical tolerances (i.e. < ±0.005 in.) or microsized features. It is common for designers of these “larger” parts to call for small holes with diameters down to 0.003-in.

The limits of micromolding Due to the size of the mold bases used at our company, the approximate maximum part size we take on is 1 x 1 in. Such dimensions are considered gigantic in the “micromolding” world, but the parts this size can have extremely challenging features that qualify it for a micro project. A few of those challenging features include walls without draft, micro holes, sharp corners, and exotic materials such as polydioxanone.

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MICROMOLDING

TOP: A technician holds a mold insert. The small dot between the lines in the middle is the area that creates the part geometry.

BOTTOM: The 100x magnification photo provides a look at a mold for the “smallest part in the world.” Even at 100X, the part is barely visible.

This bioabsorbable material is rather unique in that it is rubbery at room temperature, which is below its glass transition point. Furthermore, it does not possess significant structural properties, so it will never be strong material. Its flexibility seems to limit its uses.

Its claim to fame: 50% of its initial modest strength is gone in three weeks, with complete degradation in the body in six months. This is significantly faster than all other bioabsorbable resins. The quicker something degrades in the body, the less chance of complications for the patient.

Polydioxanone has been around for a while, but you don’t often hear of it because it has a reputation for being difficult to mold. Also, because of a lack of strength, there are few useful medical devices to make from it. It is also extremely expensive (~$15,000/ kg). But we are working with this material more often and having success molding some parts. This opens more applications for it.

The smallest part in the world As you would expect, there are limitations to small details. However, we are pushing those limits every day. Micro-molded parts continue to get smaller and so are getting more precise with nearly invisible details.

The smallest micro-molded plastic part ever reported was a PET component weighing 0.00012 grams, which went into mass production in 1998. It was first reported in 2002 (molded by MTD Micro Molding, formerly Miniature Tool & Die). Also, a POM micro bobbin weighing only 0.00015 g was reported

by Sodick Inc., in Kanagawa, Japan.

It was molded in 2005 on a TR10EH2 micromolding machine.

From late 2010 to 2012, MTD successfully molded an EVA ophthalmic part used for glaucoma treatment that weighs only 0.00000313g. This feat required MTD's Sarix technology, which uses cutting tools that are the diameter of a red blood cell, to make a precise gate measuring 0.0018 x 0.0008 in.

Sarix precision Sarix milling equipment is responsible

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for making these tiny parts and features.

The machine is known for its high quality and precision. Sarix lets micro-machinists create fine details with little electrode wear. Although graphite electrodes can machine sharp corners with 0.001 to 0.0015-in. corner radii, Sarix has such minimal wear that corners can measure at five microns (0.0002 in.), with a tolerance resolution of 0.000004 in. and glass-like surface finish (Ra 0.05). Sarix micro EDM capability lets us make edge features that were not possible before it, with finishes that are mirror-smooth and perfectly detailed corners, edges, and surfaces.

This capability gives more flexibility when making more innovative, complex product designs. The capability has been in house since June of 2009.

What’s in your toolbox?

Understanding what’s possible is just as important as knowing what is not. Many part designers would be surprised to learn what’s possible with micro-injection molding. Understanding what materials, features, and tolerances are actually feasible with molded plastic adds tools to their toolboxes to considerably broaden design possibilities. Such knowledge lets better medical devices enter the marketplace. This makes next-generation products work more effectively, provide better patient results, and at many times, cost less money and time to produce.

Choosing a micro-part’s material Material selection is a critical step in product design and manufacturability.

The correct material drives tolerance, dimension, strength, usability, design, speed-to-market, critical features, and cost.

Know what is needed from the selected material. There may also be a better – and sometimes, less expensive – choice. For example, you may have had success machining parts out of PEEK and assume it is the best material choice for injection molding the same part. You may be surprised to learn that you can get the same (or better) results from a material such as polypropylene.

The result? Injected molded parts that meet or exceed functional requirements

www.medicaldesignandoutsourcing.com

1/7/16 4:24 PM

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MICROMOLDING

with savings measured in thousands of dollars per kilogram. Hereâ&#x20AC;&#x2122;s a primer on micromolded materials: Bioresorbable materials are widely used in micro-medical applications because they dissolve or are absorbed by the body. Bioabsorbable stents, implantable staples, and screws are frequent applications.

Additives and fillers for bioabsorbable materials include color concentrates, pharmaceuticals for drug elution, and TCP (tricalcium phosphate).

Thermoplastics are polymers that become pliable and moldable above a specific temperature, and return to a solid state upon cooling. This property makes thermoplastics an ideal choice for micromolding miniatures such as fixation screws and thin-walled components.

Common additive and fillers for thermoplastics include barium sulfate, carbon

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MICROMOLDING

A few specs for several bioabsorbable materials

Material

Molding ease (1 to 5)

Ave. IV loss

Cost ($ to $$$)

Comments

4

9%

$$$

Tough to fill. Good flow with “normal” wall thickness.

PURASORB PLG 8218 (82/18 4 4% $$$ L-lactide/glycolide copolymer)

Easy to flow, can fill very thin walls and details

PURASORB PLG 8531 (85/15 L-lactide/glycolide copolymer)

PURASORB PLG 1017 (10/90 L-lactide/glycolide copolymer)

3

6 to 10%*

$$$

Extremely difficult to dry.

Very high glycolide content.

PURASORB PDLG 5010 (50/50 DL-lactide/glycolide copolymer)

3

6%*

$$$

Difficult to dry, difficult to flow

RESOMER LR 706 (Poly-L- lactide-co-D, L-lactide) 70:30

3.5

20%

$$$

RESOMER LR 708 (Poly-L- lactide-co-D, L-lactide) 70:30

3

45%

$$$

RESOMER LR 704 (Poly-L- lactide-co-D, L-lactide) 70:30

4 10% $$$

RESOMER X 206 S

1

4%

$$$$

Extremely narrow melt temperature window, degrades quickly

P4HB-based (poly-4- hydroxybutrate)

3

**

$$$

Does not dissolve in chloroform

PCL-based (polycaprolactone)

2

***

$$$

Tough to feed but runs OK after initial feed

Ultra-high molecular weight, hard to push

PLGA-based (poly lactide-co- 4 4% $$$ glycolide) * Based on material manufacturer data. ** Custome Material - proprietary results *** Indeterminate, limited data

fiber, color concentrates, glass fibers, glass spheres, and nucleating agents.

Selecting a manufacturer to build a tool, validate the molding process, and be a partner through full-scale production is a big and important decision to the success of a medical-device program. An experienced molding house will have a proven, standardized process and will work to meet expectations and requirements.

On the horizon Several promising techniques for molding will soon be available for wider use. Here are three: Ultrasonic molding – Some say ultrasonic molding is the most radical approach to molding in perhaps 100 years. Our company has invested in an ultrasonic molding machine. It uses an ultrasonic horn to push plastic pellets into the mold, which are not heated in advance as they are with a traditional

molding machine. The expectation is that ultrasonic molding will increase flow and reduce waste. Smaller and thinner parts with more details may be possible.

There is one big difference between an ultrasonic and conventional injection molding machine, such as those from Sodick and Battenfeld.

Those conventional units employ a screw-over-plunger design in which the screw melts material and meters it to a plunger system, which pushes the molten material to the mold.

In ultrasonic molding equipment, pellets are transferred to a plunger pot in front of an ultrasonic horn. The horn is brought in contact with the pellets and energized to nearly instantly melt the material and deliver it to the mold cavity. This results in almost no residence time for the resin, which minimizes the heat history the material sees during the process. www.medicaldesignandoutsourcing.com

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MICROMOLDING

A few thermoplastics that work well in micromolding

Material

ABS (Acrylonitrile Butdiene Styrene) ABS/PC alloys

Molding ease (1 to 5)

Cost ($ to $$$)

Comments

5 $ 5 $

Acetal/POM

COC (Cyclic Olefin Copolymer)

4 $ 4

$

Material conditioning is critical

COP (Cyclo Olefin Polymer)

4

$

Inert to many chemicals. Hard to flow. Variation in material.

ETFE (Polyethylenetetrafluoroethylene)

2 $

LCP (Liquid Crystal Polymer)

4

$$

Can fill very thin walls & details

PEEK (Polyetheretherketone) 3 $$$

Easy to get back specs, quick degradation, extensive & rigorous flowpath clean required, high temperature molding

PEI (Polyetherimide)

3

High melt temperature

PBT (Polybutylene Terephthalate), includes elastomeric grades

4 $

$$

PE (Polyethylene)

5 $$ Soft material. Be careful with automation.

PC (Polycarbonate)

5

PEKK (Polyetherketoneketone)

PET (Polyethylene Terephthalate), includes elastomeric grades PMMA Copolymers (Polymethyl Methacrylate)

3

$ $$$$

4 $ 4 to 5

$$

Polyamide (Nylon), includes 3 $ elastomeric grades

Difficult to dry, moisture sensitive.

Dry too long at high temperature and yellowing will occur

PP (Polypropylene) 5 $$

Does not need drying prior to molding

PS (Polystyrene)

5

$

PSU (Polysulfone) 3 $ to

$$$

Easy to get black specks, quick degradation, high temperature molding

PU (Polyurethane), includes elastomeric grades

Can be difficult to de-mold

3

SAN (Styrene Acrylonitrile)

$$

5 $

TPE (Thermoplastic Elastomers) 3 $ to $$

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Similar to PEEK, easy to dry

1 â&#x20AC;˘ 2016

Can be difficult to de-mold

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1/7/16 4:24 PM

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MICROMOLDING

Materials doped with drugs â&#x20AC;&#x201C; Expect to see more drug-and-material combinations now that it has been successfully molded. MTD has experience molding materials compounded with active drugs and maintaining a high level of drug throughout the molding process.

3D printing of inserts â&#x20AC;&#x201C; Current technology allows 3D printing as an option only for limited, simpler geometries.

However, there is technology for achieving micro-level detail. The technology has demonstrated that ultraprecise 3D printing can be done on a micro scale, so the expectation is that it will grow to a larger platform to let us use the technology for mold inserts. As it stands, there is a large gap between tiny, fine detail 3D printing and larger, without fine detail 3D printing. This gap is starting to close which gives us hope that the technology will be expanded to a more useful size in coming months. Technology for printing is available so the challenge is to feed it to something useful so prototyping can be done with the machines. One goal is to scale the technology and add more material options, making it useful for prototyping. M

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WHAT DO YOU THINK?

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DEVICE TALKS

DeviceTalks: Marie Johnson’s mission to stop sudden heart attack deaths

Marie Johnson never had any intention of becoming the CEO of a medical device company with a mission of “changing the world,” but then again she never had any intention of becoming a widow with two small children, either.

Johnson, the founder and CEO of Northfield, Minn.-based Aum Cardiovascular, was a PhD student in 2002 when her 41-yearold husband died after suffering a sudden heart attack caused by a ruptured plaque in his left anterior descending vessel – also known as “the widowmaker.” The loss devastated Johnson and left her searching for answers to how a man in seeming perfect health could be struck down in the prime of his life.

By diving into her work, she found not only answers, but a mission to turn her tragedy into a discovery she says could change the world.

Aum Cardiovascular has commercialized a noninvasive test designed called the CADence, which the company says can quickly detect significant coronary stenosis before it turns deadly. Aum hopes the device, which is currently on the market in Germany, will eliminate needless death due to coronary artery disease, saving the healthcare systems millions of dollars in the process.

The CADence is designed to identify obstructions in the coronary arteries by detecting acoustic signals generated by the turbulence created as blood flows past the obstruction, according to the company. Aum’s name is based on a Sanskrit syllable meaning “to make a continuous low humming sound,” akin to the information the CADence device is designed to extract from diseased coronary arteries.

Aum recently raised $5 million of a hoped-for $6.3 million funding round it plans to use to support its commercial growth overseas and its an ongoing U.S. pivotal trial.

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The following is a transcript of a conversation, edited for clarity, between Marie Johnson and Medical Design & Outsourcing publisher Brian Johnson (no relation), recorded at the DeviceTalks Minnesota event held by our sister publication, MassDevice.com, in September 2015.

BRIAN JOHNSON: You’re an accidental entrepreneur. Thirteen years ago you were the mother of 2 very young children, you were working at 3M on a computerized stethoscope at the time. What were your ambitions then? Was being the CEO of a medical device company anywhere on your bucket list?

MARIE JOHNSON: Thirteen years ago, I was working on my PhD, which was to develop a computerized stethoscope. I’m an engineer, and not an MD, so I needed to learn how to use a stethoscope. I collected data from my husband, who was 6 foot 1, about 180 pounds, 41 years old at the time, looked absolutely normal, swam 3 days a week. I collected data from him, learning how to auscultate. Nine months after I started my project, he died from a sudden cardiac event. My daughter

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DEVICE TALKS

was 4, she’s 17 now, my son was 7 weeks old at the time. At that point, I knew that I was going to do something to stop this terrible disease and sudden cardiac arrest.

BRIAN JOHNSON: Your husband was, for all intents and purposes, a very healthy man. As you said, you used him as a test case for your stethoscope. When you were doing it, you saw his heartbeat as a healthy heartbeat. Did either of you have any clue about coronary artery blockage? Did you know anything about sudden heart attack? What was your knowledge about the condition?

MARIE JOHNSON: I think all of us know someone who’s had a heart attack, right? One in three Americans suffer from heart disease. I think, just like everybody

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in this audience, maybe the people here actually more so because you’re in medtech, have heard about this. It’s just that experiencing one personally made it so much more real.

BRIAN JOHNSON: You had your husband actually go to a cardiologist, right?

MARIE JOHNSON: I did. When I was pregnant with my son, I started having premonitions that he was going to die.

I talked to our general practitioner, during a well baby visit, about these premonitions. I asked her if she would prescribe a treadmill stress test, which she did, and it came back normal. Actually, the technician said that he was kind of a star patient. He had the treadmill stress test, was absolutely normal.

BRIAN JOHNSON: It turned out that his heart was far more damaged than anyone anticipated, right?

MARIE JOHNSON: After my husband died, I had to make the decision on whether or not I was going to get a job or finish my PhD. I decided I was just going to suck it up and finish my PhD. After a period of about 3 months of grieving, I went in to meet with my faculty advisor, he was a cardiologist working in the echo lab. I know that he was expecting this, but we talked about the project and how to get reengaged.

I pulled out the autopsy report, and I said, “Tell me what happened.”

He took his hand and looked down and explained to me that he had died from a vulnerable plaque that ruptured

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in his LAD, his widowmaker artery, and had severe blockage, 90 to 99% in the rest of his major coronary vessels. At the end of this discussion, with his hand like this [puts head in hands], I asked him, “If you had known that it was there, could you have done anything to fix it?”

He said, “Yes.” I knew right then that the work I was doing on my stethoscope, the data I had collected from my husband, and the alignment of having all of this information together, was by the hand of God, that I was supposed to do something about it.

BRIAN JOHNSON: Thinking back to that moment where the doctor puts his head on his hands, I’m thinking about what that must feel like for the family. You must have talked to hundreds of people who have experienced the same feeling that you’ve felt. Emotionally, you’ve already been kicked as hard as you could get, but then when you find out you could have prevented that, is that insult to injury?

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MARIE JOHNSON: Sure. You think it’s really unfair. It shouldn’t be that way. Your life is turned upside down. I don’t know a single widow or widower who would look at it and say, “Yeah, I expected something like this to happen to me.” It’s a complete shock.

BRIAN JOHNSON: It was at that moment where you, in your sleepless nights, started digging into the data looking for this sign of a sudden heart attack, right?

This sound? Did you know what sound you were looking for at that time?

MARIE JOHNSON: Absolutely not.

The field of data mining was pretty new then. I changed my minor in my PhD program to statistics and started to employ a variety of statistical techniques – vectorization, matrix algebra, things that probably a lot of you had heard before, ARMA methods. I twisted and turned at this data, every way that I could. I remember the night where I found the signature, the frequency signature associated with coronary disease. The house was dark, the kids were in bed, I had my computer screen

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on, I was working. I did a frequency plot and I saw the frequencies in 50 to 100 Hertz region, and I heard a voice that said, “There it is.”

I knew I had it then, at least a portion of it. Then, what I did was I dug into the clinical literature, because I’m a scientist.

I discovered that in 1967 a guy named Dock, D-O-C-K, he had a case study where he described a guy, 49-year-old guy, who had a moderate to severe stenosis in his widowmaker artery and consequent, moderate to severe murmur found at his

second-left and third-left intercostal space on the peristernal border. I knew that we had it. From there, I always say that I found it by accident but it’s always been there.

BRIAN JOHNSON: At that moment are you saying, “I’m going to build a company?” Or are you saying, “I found this algorithm or I found this something, I’m just going to sell it to a company or I’m going to give it to somebody.” You have that answer that you were looking for, now what happens?

MARIE JOHNSON: I discovered this frequency and a way to process it and disclosed it to the University of Minnesota, where I was doing a post-doctorate. The tech transfer office has a website and they put all their mentions on it, they look for entrepreneurs to take the device forward and build companies. They patented it, put it out on the website and nobody could see the vision, because it was math.

It sat there for a few years and I did a post-doc out at Stanford with the folks at Bio-Design. I thought, “They’re not doing anything, I’m going to ask them to give me the patents back.”

They gave it back. I said, “Well, I have it, better do something now.” I didn’t do much for a long time, a few years.

The Obama administration put out a call for grants in July of, I think, 2010. It was a very simple application. I filled it out and within about 3 months, the government gave us $250,000. I was working, I was leading a think tank at the university and I thought, “Well, the only way to spend this money responsibly is to leave the university.”

My turning point was for this grant, I had to set up this business account, so we had an LLC for a long time. Which, probably most of you know, is really nice, it’s a pass-through entity. I went to the bank and I met with a small business banker and we set up this account and the guy said to me, “Do you want a credit card and checks?” I said, “Why would I need a credit card and checks?”

I got the credit card and the checks in the mail and all of a sudden it was a real business to me.

BRIAN JOHNSON: Even when you were starting this, you don’t think it’s a business?

MARIE JOHNSON: No. BRIAN JOHNSON: Again, what’s pushing you at this moment? You just couldn’t stand to see that technology sitting there doing nothing?

MARIE JOHNSON: Yeah. I think, at that point, it still wasn’t deliberate, to be honest with you. I had this chunk of money, I sort of had a vision about how we should spend it. I knew I wanted to get this product 74

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I THINK THAT, FOR THE FIRST MONTH, ANY OF THE PEOPLE THAT ARE ON MY TEAM, THEY’RE STILL PRETTY ENAMORED WITH THE STORY. THEN THE REALITY OF WHAT WE’RE TRYING TO DO HITS THEM. IT’S A LOT OF HARD WORK. on the market. We just started moving forward. Of course, I live and breathe this mission, this is everything to me and I think it’s the purpose and meaning of my life at this point. If I die with this product on the market, I’ll die having done something.

BRIAN JOHNSON: You do, in fact, have it on the market in Germany.

MARIE JOHNSON: We do, we are selling.

BRIAN JOHNSON: Here you are, you’re an accidental entrepreneur and you’re raising money now. Did you go out and raise money through venture capitalists?

MARIE JOHNSON: No, no way. When I was on at Stanford, they always suggested the venture capital model; you developed the pitch stack, and you go in to reimbursement, regulatory. [St. Jude Medical founder and serial entrepreneur] Manny Villafana said to me, “You know, you can just use a PPM.” He gave me his PPM from Spain and said, “Read it.”

I looked it over, for those of you who don’t know, that’s a private placement memo and it’s a way to raise money from private individuals. Unbelievably, I have some incredible, high-net-worth individuals who have financed me to this point. I’ve raised about $10.3 million using that method. I’ve had a lot of people say, “Wow, you’ve gotten really far on that amount of money.” You can really ask anybody on my staff about spending money, they fill out purchase orders and they throw them on my desk and run away, nervous about my signing it. That’s the honest-to-God truth, you can ask any of them.

BRIAN JOHNSON: What have investors told you make them write the check? Is it the impact they see they could have or are they just drawn to this, a mission in the story?

MARIE JOHNSON: I think that, for the first month, any of the people that are on my team, they’re still pretty enamored with the story. Then the reality of what we’re trying to do hits them. It’s a lot of hard work. The same thing happens with the high-net-worth 1 • 2016

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DEVICE TALKS

individuals. They don’t give you money because they’re in love with a story. They fund this company and this mission because one-third of all Americans suffer from heart disease; we all know somebody that’s had a heart attack, someone that’s died from it or lives with it currently; their friends suffer from this. They see that we can detect obstructive coronary disease in about 20 minutes, and that’s taking the data to receiving the report back. We do it quickly, we do it non-invasively, and it’s actually a relaxing test. It takes only 8 minutes for us to collect the data, the patient’s lying on their back in supine position. No pharmaceuticals. It’s a no-brainer.

BRIAN JOHNSON: I think back when Tim Russert passed away from his sudden heart attack, and one of the things that the newspapers wrote was that it was a reminder that a visit to the doctor is not a bullet-proof vest and that even in the best of cardiology, there’s still this level of medicine that’s a guess. I wonder if that, as a scientist, that must still seem very shallow, that we’re still at the point of a guess.

MARIE JOHNSON: I’m an engineer by training. This always surprises me, that the treadmill stress test, which is really the first test they will prescribe to determine if you have heart disease, is only 67% sensitive, which means that 33% of the time, they miss disease in a patient who’s sick.

On the other side of it, it has a sensitivity of about 72%, which means 28% of the time they tell a normal person that they’re diseased. You said, “Okay, that’s a treadmill, maybe it’s not so accurate.” An echo-cardiogram, a stress echo, which is a myocardial perfusion test, it’s 80-80. There really are no perfect tests for assessing heart condition.

BRIAN JOHNSON: The cardiologists that you’re working with, do they believe in what you’re doing when you’re talking to them for the first time, or do you find that there’s resistance, at all, to your device?

MARIE JOHNSON: They usually say it’s too good to be true. Our FDA pivotal study is a non-inferiority study against 76

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WE'RE BACK FOR ANOTHER SEASON OF INSIGHT FROM MEDTECH'S BRIGHTEST MINDS! FEB. 29

DeviceTalks, the live interview series from MassDevice, returns in 2016 for another season of insight from the brightest leaders in medtech.

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nuclear stress tests. Nuclear stress test’s a $5,000 study, it’s a three- to five-hour test.

We’re saying we’re not inferior to them.

They want to see the data and that is our challenge, are the data.

We have a 1,000-patient pivotal study, we’re 957 patients into it, we’re a hair away from finishing that study. That’s a lot of data, but they want even more data, so we have another 1,000-patient post-market study going on in Europe. We have a 100-patient study, scientific-based study, going on here

Read the full interview online! devicetalks.com

in St. Paul, but then also in Washington, D.C., so we’re all about the clinical proof.

We want to show people that it works, because it does seem unbelievable.

BRIAN JOHNSON: It’s a $5,000 test?

How much does the CADence test cost?

MARIE JOHNSON: CADence is $100.

BRIAN JOHNSON: That’s a pretty dramatic savings right there. M

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LEADERSHIP

Spotlight on Leadership: Merit Medical continues its history of innovation

Fred Lampropoulos | President and CEO | Merit Medical |

RIGHT: Merit Medical’s first product, a polycarbonate coronary syringe designed to replace glass and polypropylene syringes.

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The medical device industry is full of opportunities, and Merit Medical is capitalizing on those by continuing to cultivate the entrepreneurial mindset it was founded upon. For almost 30 years, Merit Medical has developed, manufactured and distributed proprietary, single-use medical devices used in interventional and diagnostic procedures. By thinking like serial entrepreneurs, we have found ways to be successful partners with doctors, hospitals and other medical device manufacturers while improving patient outcomes.

Merit Medical, with myself as the company founder, and a team of leaders, including my son Justin, have nurtured the underlying entrepreneurial spirit to keep our business focus and fulfill the corporate mission of advancing the medical industries we touch, which in turn advances healthcare.

As business professionals, we are always trying to figure out how to maximize opportunities. We have paid attention to and evaluated industry issues such as the world’s aging population, emerging markets, increased regulation and healthcare consolidation. But some of the major reasons Merit has been successful are because we push ourselves to create products in response to feedback from healthcare professionals, provide a breadth of products, and have found an effective formula to sell our products. To achieve all of this, we subscribe to the concept of being perpetual medical pioneers, while thinking like entrepreneurs.

Strive for innovation Merit Medical was founded with a single product, the polycarbonate coronary syringe, which was designed to replace the glass and polypropylene models of the day. Our first product taught us that we could always compete and grow if we came up with good ideas. In other words, there is always room for innovation. We have had long-term success because we seriously believe in our mission and are in constant entrepreneurial mode to create cutting-edge products. We have more than 3,500 products, including the ConcierGE Guiding Catheter, Medallion Syringes and the Blue Diamond Inflation Device. And, between Merit and myself, we have approximately 600 patents.

One of the company’s areas of strength is our OEM division.

Merit Medical OEM is a preferred supplier for some of the largest and most well-known medical device manufacturers around the world. The company sells finished devices and components to manufacturers for use in their finished devices and kits. Our OEM customers have the benefit of using our products in Merit’s direct sales to hospitals and doctors. We have already worked through international regulatory hurdles, so our engineers can customize products and devices to meet customer specifications. We hear time and time again that one of the biggest reasons our OEM customers enjoy partnering with Merit Medical is our ability and willingness to customize products and components. We can customize catheters, syringes, inflation devices and most of our other products. We are flexible for our customers.

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Merit Medical’s headquarters in South Jordan, Utah.

In addition to innovating devices, Merit Medical devises new ways to move healthcare forward by offering training programs for clinicians who want to advance their fields. Our ThinkRadial education program trains clinicians to transition from using the femoral artery for interventional procedures to using the radial artery. The transradial approach has been proven to reduce costs and patient downtimes. In Europe, we offer Prostate Artery Embolization workshops. We also have plans to launch additional programs like these for other medical procedures in the future.

AS BUSINESS PROFESSIONALS, WE ARE ALWAYS TRYING TO FIGURE OUT HOW TO MAXIMIZE OPPORTUNITIES. An entrepreneur must invest and commit Merit strives to ensure quality by employing vertical integration when possible. Our Utah campus has a wafer fabrication facility where we manufacture the pressure sensors found in some of our devices. We have expansive molding capabilities, and wireand tube-coating capabilities. This controls the quality of our final products and components and allows us a greater ability to be flexible in customizing products for our OEM customers.

Another great example of Merit’s entrepreneurial drive is a focus on manufacturing processes and operations. We’ve made a significant investment to automate many of our processes which increases our efficiency and lets us service customers around the world. For example, at our South Jordan, Utah, manufacturing headquarters, we recently launched a state-of-the-art automated inventory system to increase productivity.

We also ensure our products are of the highest quality in the field by continuously gathering feedback. We collect field data and have a listen-first approach for product development, working with physicians around the world to improve our finished devices.

It’s a big world out there Our entrepreneurial spirit is also demonstrated by successful international expansion. Merit has been in Japan for more than 25 years and has recently grown about 25% in Europe. In 2010, Merit focused on markets from Russia to Eastern Europe, central Asia and Turkey, the Middle East and Africa. We have an international network of manufacturing, distribution, sales and customer service operations, with knowledge of the healthcare industry and regulatory processes worldwide, which benefits our OEM customers around the world.

The next chapter I have described Merit before as being just in our teenage years, just starting to fill out. We are curious and hungry and don’t plan on letting ourselves get lazy. If we are going to grow Merit to a $3 billion company in my lifetime, then it is imperative that the company’s motto, “Understand. Innovate.

Deliver,” continues to be driven home by our present and future Merit entrepreneurs. M

Merit Medical employees in the South Jordan facility. www.medicaldesignandoutsourcing.com

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2016 I N T R O D U C T I O N L E A D E R S H I P

I N

M E D I CA L T E C H N O LO GY

Nominate the company you think has provided leadership in the medical technology industry.

The medical device industry just wrapped up another record year, with blockbuster mergers grabbing headlines around the world and new, innovative technologies emerging seemingly every day.

This level of success wouldn’t be possible without the innovation, ingenuity and determination of the people who drive it: leaders. These individuals and companies are working for the growth of the entire medical device industry.

The future of medtech will build on the foundation of today’s efforts. Medical Design & Outsourcing would like to acknowledge such achievements on the following pages.

We think they deserve recognition from you, too.

Vote online for one or more of the companies listed through October.

VOTE

ONLINE

medicaldesignandoutsourcing.com/leadership Nominate the company you think has provided leadership in the medical technology industry.

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M E D I CA L T E C H N O LO GY

UNRIVALED EXPERIENCE UNRIVALED RESULTS Medical manufacturing is constantly evolving. In order to compete in today’s market you need to rely on a company that has the experience to bring your design to life without compromise. This experience is why AIM Plastics is considered a premiere medical plastics manufacturer.

AIM collaborates with some of the industry’s largest medical design firms looking to fulfill their mid to high volume medical manufacturing needs.

Tool manufacturing

AIM’s state of the art tool room provides the foundation for our manufacturing by supplying high precision molds, fixtures and gauges.

Advanced molding

AIM’s Manufacturing Center, which houses a 6,000 square foot ISO Class 7 (10k) Cleanroom, features a full complement of general molding capabilities along with several advanced molding technologies with a tonnage range of 30 to 440 tons. AIM has the ability to support your high volume production needs.

AIM Plastics

Scientific Processes / Quality validation

22264 Starks Drive Clinton Township, MI 48036

AIM utilizes the latest scientific injection molding techniques/ qualification procedures (DOE, IQ, OQ and PQ) to ensure the most robust injection molding processes and tooling capabilities are attained.

586.954.2553 aimplastics.com

Pad Printing

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AIM’s value added services include one to four color pad printing with the ability to print 360º. All equipment has gone through installation and operational qualification to meet demanding medical/customer requirements. AIM can support low to high volume productions.

Assembly

With intimate knowledge of your program gained throughout the tooling phase, AIM is best suited for your assembly needs, allowing us to cost effectively ship turnkey sub-assemblies.

www.medicaldesignandoutsourcing.com

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As technology continues to demand precision and smaller tolerances, engineers are turning to Bird Precision microdrilled inserts, fittings and filter components. We offer a high value solution in nozzle, restrictor and orifice applications, all designed with Bird Precision accuracy.

If you’re involved in product design and production, you’re always on the lookout for ways to improve manufacture, performance and quality in your products. Now is the time to investigate the wide range of accuracy and workmanship Bird Precision continues to supply for micro miniature components and assemblies.

Bird’s early experience in aircraft instrument bearings & micro assembly techniques for timing mechanisms has prepared us well for the critically demanding needs of modern instrumentation.

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Bird sapphire and ruby orifices are scientifically designed to insure repeatable flow control of both liquids and gas.

Ruby and sapphire materials are used exclusively because of their durable material characteristics. This economical man made crystal has amazing credentials 1. Extreme hardness, 9 mohs scale, next to diamond 2. Practically chemically inert, highly resistant to most alkalis and acids

3. Extreme abrasion resistance, 5 x that of tungsten carbides.

4. Does not outgas, zero porosity 5. Non-thrombogenic, for medical applications 6. Excellent insulator 7. High temperature material, 2000 degree C melting point.

8. No flash points, extensively used in oxygen environments.

With such impressive material characteristics, the designer can design with confidence in even the harsh environmental applications

With the development of new laser drilling and wire lapping techniques, we have transitioned into micro miniature orifices, nozzles, filters, and connectors.

We offer a whole line of micron level standard products ranging in size from 10 microns (.0004”) up through .080”.

Flow rates from under 1cc/min are available.

Bird Precision maintains an impeccable reputation for precision component fabrications.

A full complement of Swiss CNC, production assembly and specialized secondary machines provide a vertical in house capability, enabling fast prototype and production delivery.

Join us as one of our valued customers. We will work together to improve your product through a mutual exchange of ideas, service and quality.

One Spruce Street Waltham, MA 02454 800.454.7369 Fax: 800.370.6308 sales@birdprecision.com birdprecision.com

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Bird’s unique manufacturing process

those most demanding applications.

Bird Precision offers a unique series of laser drilled, wire lapped Ruby and Sapphire orifices.

It is this precise methodology and attention to detail that distinguishes us from all other manufacturing methods, yielding production quantities of highly precise flows at reasonable prices.

This unique wire lapping method insures that our orifices are round and highly polished. .

This method also removes all possibilities of burrs or loose particles in the orifice area. The orifices are all lapped both sides to impart a very uniform sharp edge to our orifices. It is this edge along with the roundness and high polish that yields a highly repeatable Cd value (Coefficient of Discharge).

Further the wire lapping method guarantees hole tolerance .0002” or less as standard.

Our orifices and micron level filters are conveniently packaged in a huge variety of stainless, plastic and brass fittings, inserts and connectors.

Bird Precision continues to focus on putting orifices and filters where you need them.

We also offer a host of standard Swagelok, Smc, Parker and Value Plastics, retrofits

Bird Precision has recently introduced our new Golden Orifices with .0001” total spread for

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The Bishop-Wisecarver Group is a WBENC certified woman-owned family of companies who work with manufacturers to engineer, manufacture, and build custom complex assemblies, linear motion solutions and optimal embedded intelligence systems.

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THE BISHOP-WISECARVER GROUP SERVICES AND PRODUCTS THAT FIT YOU TO A VEE Bishop-Wisecarver grew through the innovation and problem-solving of co-founder Bud Wisecarver more than 60 years ago. To this day, the company continues to craft this creative way of thinking when tackling tough application challenges. We keep these principles in mind as our services and products have evolved — our core fundamentals have never changed: • We deliver – whether it is 98 percent same-day ships from stock or a customized linear system in two weeks.

Through the integration of mechanical, electrical, software, control and systems

• We value initiative – our team possesses the drive to solve your most difficult challenges.

design engineering expertise, over 60 years of experience and 20,000+ unique clients, we continue to provide a single point of service that results in custom designs, increased efficiencies, and accelerated time to market.

• We cherish innovation – our ability to help solve problems is led by creativity and expertise.

• We are empowered – we work together to find the perfect solution to fit your needs.

• We have respect for all – everyone is encouraged to share ideas.

As we head into the future, the BishopWisecarver Group returns to its roots with a renewed focus on solving your design and engineering challenges. Discover our in-

• We value superior customer satisfaction – being your first choice is our first priority.

house engineering and manufacturing team

• We continually grow and develop greater value – we wisely invest in our internal resources, education, and communication in order to offer you superior design and product differentiation.

online at www.bwc.com.

• We have fun – we don’t just work together, we play together.

The world is our playground, and these ground rules were created with you in mind. When Bishop-Wisecarver refers to “we” this includes you, the customer. With our expanding engineering and manufacturing resources, Bishop-Wisecarver is more than a company that offers linear guide wheel-based solutions built on DualVee Motion Technology®. Our goal, to be your number one choice, is what drives us to continually develop our industry knowledge, services and imagination – whether it is an off-the-shelf product or a custom solution.

The Bishop-Wisecarver Group

DISCOVER OUR FAMILY OF SOLUTIONS Bishop-Wisecarver helps manufacturers and automation solution providers engineer linear and rotary motion products. With 60+ years of engineering expertise and manufacturing best practices working with over 20,000 customers, we understand our customers’ design and application requirements which enables us to develop unique solutions that ship within 2 to 3 weeks. Customers achieve 50% faster time to market, up to 50-75% lower maintenance and installed costs, product differentiation and longer product life.

925.439.8272 888.580.8272 2104 Martin Way Pittsburg, CA 94565 sales@bwc.com www.bwc.com

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Black Diamond Manufacturing is a specialty contract manufacturer that works with other industrial companies to build mechanical sub-assemblies, manufacture specialty parts, and lower overall production costs. Specialty services include heat treating, linear grinding, milling and made-toorder parts. We provide a single source solution that combines motion components with custom sub-assemblies. Our clients have experienced upward of 35% reduction in overall manufacturing, logistics and labor costs.

WRW Engineering helps companies integrate mechanical, electrical and software engineering to deliver custom mechatronic solutions. By understanding the interplay between these three disciplines, we design and develop optimal embedded intelligence systems such as automated flexible testing stations, smart products, and autonomous machines. Through this holistic approach, our customers realize higher production efficiencies, faster time to market, and increased revenues.

www.medicaldesignandoutsourcing.com

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Boyd Coatings Research Co. applies

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With great precision, Boyd coated this filter containing thousands of microscopic holes which needed to remain open. A non-stick coating was applied to promote quick and easy cleaning.

a wide variety of high-performance coatings, specializing in the medical, industrial and aerospace markets. In addition to applying virtually every coating from every manufacturer on the market, Boyd manufactures a line of customdeveloped fluoropolymer coatings for specialty applications.

Boyd Coatings is an ISO 9001:2008 certified, registered and licensed applicator for Teflon®, Whitford, 3M and hundreds of popular coatings and finishes providing nonstick, heat resistant, conductive, insulative, hydrophobic or many other desirable properties. Boyd is a Licensed Industrial Applicator of Teflon® fluoropolymers including PTFE, ECTFE, ETFE, FEP, PFA, PVDF. Other fluoropolymer brands and formulations are also available.

Boyd Coatings Research, Inc. 51 Parmenter Road Hudson, MA 01749 P: 800.258.0110 or 978.562.7561 Fax: 978.562.9622 info@boydcoatings.com boydcoatings.com

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Depth of Knowledge – Experience – Proven Capability From its state-of-the-art, ISO 9001:2008 facility, Boyd Coatings applies high performance coatings to meet clients’ specific medical device needs in full compliance with FDA regulations. Boyd Coatings also can create and/or manufacture custom coatings for performance characteristics not currently available elsewhere. Able to process a wide variety of materials as well as shapes and sizes, Boyd has both manual spray capability for small quantities and automated robots for larger volumes. Boyd is a licensed applicator of advanced technologies such as Dupont Teflon® and Whitford Worldwide Xylan®. Our high volume, flexible manufacturing capabilities allow us to coat both small quantities and larger weekly releases, quickly and cost-effectively.

From project definition and design, including on-site consulting and custom color matching, all the way to delivery, Boyd continually works to ensure customer satisfaction.

We take great pride in maintaining state-of-theart resources and talent required to accomplish any coating task. We have grown to become a solid force in the industry, serving customers on four continents. Our growth is based on listening to our customers’ needs, attention to detail, and solid engineering.

We are experts in the application of highperformance coatings and can advise you on which brands offer the best performance, longevity and overall value for your particular application. Experienced with and knowledgeable of the unique characteristics

www.medicaldesignandoutsourcing.com

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of literally hundreds of brands, our coatings engineers can evaluate your product specification / project objective and recommend the ideal solution based on the proven strengths and weaknesses of each type.

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Branson Ultrasonics, a business of Emerson, is the leading global manufacturer of plastics joining, ultrasonic metal welding and precision cleaning equipment for 70 years.

Branson’s goal is to create value in our customers’ manufacturing processes, serve as a long-term strategic partner and provide a high return on investment to our customers.

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Branson Ultrasonics uses a “process neutral” approach to provide the best product technology solution for today’s medical industry customers. Our in depth medical industry experience provides a competitive advantage to our customers in all aspects of product development and regulatory compliance by delivering the most robust manufacturing solutions available today.

Employing a “process neutral” approach to application development insures customers receive the best solution to address product specification, regulatory and budgetary needs.

With more than 1,800 employees in 70 sales and support offices worldwide, Branson is committed to leading the industry in products, solutions, service and support.

Branson’s 3g/3i Laser Welding Systems feature our patented Simultaneous Through-Transmission Infrared (STTIr) technology to provide ultra-fast particulate free welds that are precise, visible, have uniform collapse and are gentle on delicate parts. Laser welding provides the freedom to design parts with complex, contoured shapes for superior aesthetics, maximum product integrity and enhanced production efficiency. Branson’s innovative tool map provides unmatched energy control along the weld channel.

Branson Ultrasonics Corp.

41 Eagle Road Danbury, CT 06810 203.796-0400 info@bransonultrasonics.com www.bransonultrasonics.com

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Branson 2000Xc Ultrasonic Welding System is the latest offering in our ultrasonic portfolio; delivering consistent and precise high quality welds, fast cycle times and the process controls needs of today’s benchtop and automated medical manufacturing environments. The 2000Xc helps you meet the global compliance, traceability and security needs of your industry; including regulation FDA 21CFR, part11.

Tool Map improves ease of use

Branson’s Ultrasonic Precision Cleaning systems provide aqueous and solvent solutions range from small benchtop to industrial, automated solutions.

Whatever your needs, Branson Makes It Possible!

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www.medicaldesignandoutsourcing.com

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Cadence is a single source contract manufacturing partner that is ranked among the top companies providing outsourced design and manufacturing solutions for medical and life science applications.

Cadence makes new products a reality and delivers outcomes that simply make the world work better.

Cadence locations include: • Advanced Manufacturing — Massachusetts, Rhode Island, Virginia, and Wisconsin

What sets Cadence apart from other companies? Cadence is all about improving product performance and economics. We help develop new products that others cannot, build processes that others will not, and deliver outcomes that simply make the world work better.

We also provide a very broad set of core capabilities that are competitive and differentiated in the marketplace. Unlike most contract manufacturers, we also have significant manufacturing expertise; making new products a reality.

With over 30 years in business, we continue to create new manufacturing technologies and invest in highly technical solutions to make finished devices as a single, turnkey manufacturing partner for medical and life science OEMs. At Cadence, we understand that trust is earned and that’s why we have built our business on honesty, respect, and doing the right thing for our customers and employees.

Metals Expertise:

• Product Realization Center™ — Pittsburgh, PA • Nearshore Operations — Dominican Republic

9 Technology Drive Staunton, VA 24401 sales@cadenceinc.com Tel: 540.248.2200 Fax: 540.248.4400 cadenceinc.com

Cadence offers complete services that range from initial design through manufacturing and full supply chain management for single use and disposable medical devices.

• Design Services • Rapid Prototyping • Certified Cleanroom Manufacturing • Finished Device Assembly • Complete Supply Chain Management • Final Packaging and Labeling • Sterilization Management

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• Swiss Machining & Micro Machining • Laser Cutting, Welding, & Marking • Tube Fabrication • Precision Metal Stamping • Multi-slide Stamping & Microstamping • EDM – Wire, Ram, & Sink • Nitinol Shape Setting • Advanced Welding Lab™ • IncisionLab™ • Sharps – Specialty Blades & Needles • Custom Automation

Plastics Expertise: • Engineered Resins Expertise • Plastic Injection Molding • Insert Molding • Cleanroom Molding • Microcellular (MuCell) Molding • Reel-to-Reel Molding • 17 ton to 550 ton Presses

medicaldesignandoutsourcing.com/leadership Voting for this company will identify it as a leader in the medical technology industry.

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For more than 40 years, CGI has enabled design excellence in motion control across a range of industrial applications. The people at CGI have demonstrated a deep commitment to providing the latest technology, innovative product, and unrivaled customer service to earn the reputation as one of the most trusted experts in the business.

CGI’s engineering footprint is seen in a range of industries including medical, aerospace, robotic, semiconductor, machine tool, packaging, food/beverage, textile, material handling, telecommunications and specialty machine design.

You will find CGI components integrated into industrial robotics and machine automation systems including applications for artificial hearts, robotic surgical systems, laser eye surgical equipment, drills and attachments used for orthopedic surgery. CGI components have played a role in the repair of the Hubble telescope.

Astronauts used a CGI precision-crafted wrench to repair the telescope that allows scientist to peer into the deepest recesses of space. CGI technology is also used on the spectacular Bellagio Resort dancing fountains and other hotels in Dubai and China also use CGI technology in their fountains.

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M E D I CA L T E C H N O LO GY

Advanced Products for Robotics and Automation CGI enables design excellence. Our leadership in the market features a careful blend of cutting edge technology and renowned reliability. With CGI you can count on us to provide the highest levels of manufacturing acumen and expertise while delivering it with the customer service you deserve. Our goal is to be the most trusted partner in your supply chain. Whether it’s an improvement on a current design or groundbreaking new designs, CGI has the know-how and team to enable design excellence.

Our team is renowned for being able to provide complex precision- machined component parts of high quality and hold tolerances as tight as 2.5 microns (.0001”). These parts are machined from diverse metals, and involve a variety of hardness, surface treatment, heat-treating and plating requirements. One of the distinct competitive advantages we are able to provide our customers with is an engineering team that is knowledgeable and easy to work with.

When comparing the manufacturing capabilities offered by CGI with those of our competitors the clear difference is in the commitment have to exceeding expectations. This commitment can be seen by our customers each day through our investment in technology, our attention to precision and the high level of service we provide.

CGI, Inc. 3400 Arrowhead Drive Carson City, NV 89706 775.882.3422 Toll free: 1.800.568.GEAR (4327) F: 775-882-9599 cgimotion.com

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2016 A D ribbon V Ecables, R T variations I S Eof these M E Named A Dwas V founded E R in T 1956 I SwithE anM E Cicoil flat cables are used today most innovative newstill product for theinearly computers, printers, and many mainframe computers - the flat electronic ribbon devices. cable. The ribbon cable allowed compa-

2016

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TCicoil high-flex flat cables are the Future of Cabling. Our patented T extrusion technology produces the most high performance flat cables available with the superior attributes you’re looking for:

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Try our Online Configurator, Fax: 661-295-0813 NEW EZ-Flexx™ maximize their flexibility.

Cicoil flat cables are rated for over ten million VOTE ONLINE where you can design your own cable in minutes and get an immediate Cicoil can provide complete cable assemblies, with any connectors Extreme Environments www.cicoil.com Cable Design robotics, in some of the most demanding applications possible.

So you where you can design your own cable in minutes and get an immediate www.cicoil.com Cable Design cycles, and our cables have performed for hundreds of millions of flexing vote online drawing and quote! required by the customer.

Every cable assembly is 100% tested by our Capabilities • Easy to Separate A assured D V quote!

E that R Tyour I cable S E assembly M E N Twill receive the same dedicacan rest drawing • Easy to Separate cycles inand the most demanding robotic, continually flexing equipment Visit Cicoil.com to learn more, automated testensuring equipment, so cables reliability and performance is guaranteed. and Strip Conductors tion and care, reliable, high performance operation.

Visit Cicoil.com to learn more, Check out our many standard and assemblies, all available from applications. and Strip Conductors www.designworldonline.com/leadership Check out our many standard cables and assemblies, all available from or call (661) 295-1295 to speak directly Our award-winning quality system is certified to ISO 9001 standards, in• Lighter and More or call (661) 295-1295 to speak directly stock for immediate delivery.

Nominate engineering leadership for a person or • Lighter and More Cicoil Corporation stock for immediate delivery. to an Application Engineer. cluding theorstrict AS9100 aerospace specification. Cicoil cable assemFlexible to an Application Engineer.

Standard Custom Cables inventor, engineering leadership by a specific departFlexible 24960 Avenue Tibbitts blies arepatented used on extrusion the spaceprocess shuttle,makes supersonic and industrial Cicoil’s custommissiles, cables easy, so you ment, or an overall company accomplishment.

Complete Cable Assemblies VOTE Valencia, ONLINE Complete Assemblies CA 91355, USA can quickly get the cable you want. Try our Onlinepossible.

Configurator, robotics, inCable some ofexact the most demanding applications So you vote online Cicoil canwas provide complete cable assemblies, with any connectors Cicoil founded in 1956 with ancable Cicoil can provide complete cable assemblies, with connectors where you can design yourcable own get an immediate can rest assured that your assembly A inD minutes V will E receive Rand Tany Ithe S same E M dedicaE N T Phone: 661-295-1295 innovative newcustomer. product for the early cable assembly is 100% tested by our required by the Every required by the customer.

Every cable assembly is 100% tested by our drawing and quote! tion and care, ensuring reliable, high performance operation. mainframe computers - www.designworldonline.com the flatso ribbon 182 DESIGN January 2016 automated Fax: WORLD 661-295-0813 Drag & Drop Fla www.designworldonline.com/leadership Future of is Cabling is Here test equipment, reliability andThe performance guaranteed. automated test equipment, so reliability and performance is guaranteed. cable.

The ribbon cable allowed compaCable Configur Check out our many standard cables and assemblies, all available frominNominate engineering leadership for a person or www.cicoil.com Our award-winning quality system is certified to ISO 9001 standards, nies like IBM to replace bulky,system stiff round Combine video, air Our award-winning quality is certified to ISOpower, 9001 signal, standards, in-& liquid in a crystal-clear flat cable. stock for immediate delivery. inventor, engineering leadership by a specific departcables with sleek, flexible ribbon cables. specification. Cicoil cable assemcluding the strict AS9100 aerospace cluding theribbon strictcables, AS9100 aerospace Cicoil flat cable assemCicoil high-flex cables are the Future of Cabling. Our patented ment, or an overall company accomplishment.

Named variations of these specification. blies are used on the space shuttle, supersonic missiles, andproduces industrial extrusion technology the most high performance flat Data Cables Visit Cicoil.com to learn more, blies are used space shuttle, missiles, and industrial flat cables areon stillthe used today in most supersonic VOTE ONLINE robotics, in has some ofcovered the most demanding applications possible.

So youattributes you’re looking for: VOTE ONLINE Cicoil was founded in data 1956 with an superior cables available with the computers, printers, and many electronic Yes! Cicoil you for video and high speed transmission robotics, in some of the most demanding applications possible. So you vote 295-1295 online or call (661) to speak directly vote online innovative new product forthe the same early can rest that USB your3.0, cable assembly receive withdevices.

Catassured 5e, Cat 6A, Camera Link, will and Controlled •Coax, Ultra f!exible: Tens of dedicamillions of flex cycles in the tightest bend cable assembly receive the 182 WORLD Engineer. January 2016 can rest assured that your www.designworldonline.com mainframe will computers - the flatsame ribbon dedica- The Future of Cabling is Here toDESIGN an Application radius applications tion and care, ensuring reliable, high performance operation.

Impedance flat cables in bulk and finished assemblies.

Design your own cable.

The ribbon cable allowed compawww.designworldonline.com/leadership tion Cicoil and care, reliable, high performance operation.

Todayensuring – Innovating www.designworldonline.com/leadership

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2016 2016

Leadership in Engineer

CICOIL

Leadership

CICOIL

Nominate engineering leadership for a person or Nominate engineering leadership for a person or inventor, engineering leadership by a specific departinventor, engineering leadership by a specific department, or an overall company accomplishment. ment, or an overall company accomplishment.

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medicaldesignandoutsourcing.com/leadership Voting for this company will identify it as a leader in the medical technology industry.

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• toUnlimited variation: Micro size to 400mm wide cables, wires from nies like IBM replace bulky, stiff round in just in minutes!

O Combine power, signal, video, air & liquid a crysta

for the Future 4 toflexible 44 gauge, also including fiber optics, tubing, or coax, so you Complete Cable Assemblies cables with sleek, ribbon cables. million potential Cicoil continues its proud history of of Cabling get theconnectors exact of cable you need Cicoil high-flex flat cables are the Future Named ribbon can cables, variations these Cicoil can provide complete cable assemblies, with any rations. Drag an innovation, with the company’s autoextrusion technology the most high perform • still Extreme Environments: Our cables perform from -65°Cproduces to flat cables are used today in most simplicity. required the customer. cable assembly is 100% tested by mated, by state-of-the-art facilityEvery in Valencia, cables available with the superior computers, printers, andand many electronic +260°C, under exposure to water, steam, chemicals, and oils attributes you’re loo By implementing the latest leanaward-winning quality system is ourCalifornia. automated test equipment.

Our devices.

• Ultra f!exible: Tens of millions of flex cycles in con the manufacturing production techniques, Submit your certified to ISO 9001 standards, including the strictFlexibility AS9100 aerospace Built-In Cicoil continues to design and manufacradius applications to receive a no-o www.designworldonline.com specification.

Cicoil Today – Innovating www.designworldonline.com In addition to the strong,flexible cable •jacketing, every Cicoil cable ture the highest quality products, with fast, Unlimited variation: Micro size toquote 400mm wide and finalcad

responsive lead times for our custom- for the Future incorporates finely stranded, ultra-flexible 4wire conductors.

Conductors to 44 gauge, also including fibering. optics, tubing, Order and ro its proud of ers. Our efforts have earned numerousCicoil continues and shields arehistory also specially heat-treatedcan andget plated to maximize their the exact cable you need your cable in les innovation, flexibility, with the company’s autocustomer and industry awards for quality, while providing extremely long life in the most demanding • flex Extreme Environments: Our cables perform from weeks. facility Valencia, delivery, and continuous improvement,mated, state-of-the-art applications.

Cicoilinflat cables are rated for over tenand million cycles, and to water, steam, che +260°C, under exposure implementing the latest lean and our continued R&D has resulted inCalifornia. By our cables have performed for hundreds of millions of flexing cycles multiple US and worldwide patents. manufacturing production techniques, in some of the most demanding robotic, continually flexing equipment Built-In Flexibility Cicoil continues to design and manufacapplications.

In addition to the strong,flexible cable jacketing, every ture the highest quality products, with fast, Cicoil Corporation responsive lead times for our customincorporates finely stranded, ultra-flexible wire conduc 24960 Avenue Tibbitts Standard or Custom Cables ers. Our efforts have earned numerous and shields are also specially heat-treated and plated Valencia, CA 91355, USA customer and industry awards for quality, Cicoil’s patented extrusion process makes custom easy,extremely so you flexibility, while providing Phone: 661-295-1295 www.medicaldesignandoutsourcing.com 1 • 2016 Medical Design & cables Outsourcing 89 long flex life in the delivery, and continuous improvement, can quickly get the exact cable you want.

Try our Online Fax: 661-295-0813 NEW EZ-Flexx™ applications.

CicoilConfigurator, flat cables are rated for over ten m and our continued R&Dcan hasdesign resulted in own cableour where you your in minutes and get an immediate www.cicoil.com Cable Designof cables have performed for hundreds of millions multiple USdrawing and worldwide patents. and quote!

• continually Easy to Sepa in some of the most demanding robotic, fle Visit Cicoil.com to learn more, and Strip Co applications.

Check out our many standard cables and assemblies, all available 1/8/16 from 1:32 PM Cicoil Corporation or call (661) 295-1295 to speak directly • Lighter and M stock for immediate delivery.

2016

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CPC offers thousands of proven quick

Smart fluid handling to take you forward, faster

disconnect couplings and fittings to securely connect and disconnect tubing in a wide

CPC is the medical industry’s leading provider of quick disconnect couplings, fittings and connectors for plastic tubing. CPC thinks beyond the point of connection to improve patient safety and equipment reliability through innovative fluid connector and fitting solutions.

We engineer our connection solutions to improve the overall functionality and design of medical equipment and processes. The result? Absolute value for every fluid handling application.

variety of medical equipment, including designs for preventing misconnections. The company’s broad range of connector types – non-spill, subminiature, RFID-enabled and hybrid connectors that integrate electrical signal and fluid handing into a single unit – provides solutions for numerous medical applications, including alternatives to luer fittings. For specialized applications, CPC designs and manufactures custom products and provides cleanroom manufacturing when required. Additionally to ensure a high level of reliability, CPC’s quality management

Answers for every need CPC products are ideal for the medical device industry’s critical fluid and air handling applications—providing connections for surgical, dialysis and IVD equipment, as well as patient and cold and pressure therapy devices. Whether an application calls for non-valved or non-spill, low flow or high flow, reusable or disposable, our broad range of components can meet every specification.

If a standard product does not suit your needs, CPC can design a custom solution for your application.

system is ISO 13485:2003 certified.

We believe fluid handling should be safe and easy. Special features of our products include precise hose barbs for superior grip, builtin shutoff valves for preventing spills, and easy-to-use, push-button thumb latches for quick connecting and disconnecting.

CPC – Colder Products Company 1001 Westgate Drive, St. Paul, MN 55114 U.S.A. 800.444.2474

Innovation and collaboration

F: 651.645.0091 info@cpcworldwide.com cpcworldwide.com

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CPC’s team of expert engineers is uniquely qualified to answer fluid handling product questions, from tolerances and flow rates to material compatibility and more. Plus we specialize in matching both standard and customized solutions to the requirements of device manufacturers’ toughest applications. To date, CPC has produced over 10,500 products to meet the fluid handling challenges of manufacturers and users around the world.

Smart fluid handling to take medical technology forward, faster. That’s what CPC delivers through our unmatched combination of innovation and collaboration. www.medicaldesignandoutsourcing.com

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Eagle Stainless Tube & Fabrication, Inc. delivering stainless steel, high nickel alloy & titanium components to customers in medical, aerospace and high tech manufacturing.

Since its inception in1982, Eagle Stainless has a sterling record of on-time delivery, fair pricing, product quality and highly skilled employees dedicated to continuous improvement and training. Eagle has earned its reputation as a supplier of choice for off-the-shelf stainless steel products and fabricated stainless steel products.

With “Eagle Eye Quality” you are assured: 100% parts made to your specifications.

100% on time delivery. 100% traceable certified material.

Call us. We are ready to help with any of your metal needs!

Laser welding/cutting -

Eagle’s computer controlled laser welding equipment (laser center shown above) enables us to produce extremely close-tolerance cutting, notching, etching and welding operations.

Cut-to-length tubing -

Eagle’s facilities enable us to cut and deburr any diameter tubing in quantities from a single piece to millions of pieces or more…and from lengths of .010” and longer with standard tolerances (see cutting tolerances below).

Closer tolerances are certainly possible, simply request a quote with the details of your application, and we’ll be glad to help.

ISO 9001 • AS 9100 • ISO 13485 P: 800.528.8650 F: 800.520.1954

Bending / Coiling -

The ability to bend tubes without excessive distortion, wrinkling or fracturing is an art born of experience.

Eagle craftsmen working with state-of-the-art machinery supply uniformly smooth bends - meeting the tightest customer specifications.

Custom shaped tubing in sizes from .040” to 1.00” to lengths to 17 ft.

• Round • Oval • Square • Triangular • Rectangular • Hexagonal • and more!

CNC / Swiss machining

Specializing in CNC machining for more than two decades, Eagle Stainless has been delivering some of the most intricately machined part imaginable. Working in diameters ranging from .030” to 2”, we’re ready to meet the requirements of your most demanding application!

Flaring and reductions

Flaring and end reduction of tubing is an every day precision process at Eagle.

Special tools and procedures have been developed to insure repeatability for proper mating of flared and endreduced tubes.

With a complete in-house tool and die facility, experienced toolmakers will develop a custom extrusion die to yield tubing that will meet or exceed your expectations.

eagletube.com

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Fluid Metering, Inc. (FMI) manufactures unique, patented, valveless piston metering pumps and dispensers.

FMI Pumps utilize only one moving part, a rotating and reciprocating ceramic piston to accomplish all fluid control functions within the pumps, thereby eliminating valves and their associated maintenance.

Flow rates range from 2.5 µl/dispense to flows of 4,600 ml/min with pressures to 100 psig.

FMI pumps will dispense and meter fluids for millions of cycles with a drift free accuracy precision of 1% or better.

These pumps are ideal for Medical Applications including precise dispensing, aspirating, rinsing, & mixing systems and for syringe pump replacement in diagnostic, clinical chemistry, dialysis and medical equipment manufacturing.

Also for dispensing adhesives and lubricants used in assembly of disposable medical components.

Ideal in other industries with typical applications including fluid metering, dispensing and sampling for chemical process, laboratory, pilot plant, food processing, water treatment, and environmental analyzers.

Ultra-Precise Fluid Control. . . from Microliters to Liters FMI is a metering pumps and dispensers manufacturer, who pioneered the first valveless rotating and reciprocating piston metering pump concept over 56 years ago. Enhanced and improved over the years FMI metering pumps continue to provide innovative fluid control solutions. Our dispensers and metering pumps are the industry standard for high degree of accuracy, precision and reliability.

Utilized in a broad range of Medical, Laboratory, Analytical, Industrial Process, Environmental and OEM applications requiring precision fluid control, FMI pumps have provided users with the ultimate performance Our Unique Valveless Pump Design Features: • Patented “No-Valve” Pump Design Eliminates problems and errors caused by valves which clog, leak, hang up, and require service.

One Moving Part!

FMI’s CeramPump® design utilizes a single, dimensionally stable, chemically inert CERAMIC piston ensuring long term, drift free fluid control. The valveless pumping function is accomplished by the synchronous rotation and reciprocation and reciprocation of the ceramic piston in the precisely mated ceramic cylinder liner. One complete piston revolution is required for each suction/discharge cycle.

Fluid Metering, Inc. 5 Aerial Way, Suite 500 Syosset, NY 11791 USA

• Accuracy, Precision, & Reliability Long term drift free performance measured in millions of “trouble-free” cycles. Fluid Metering Pumps accuracy is held from microliters to the full flow range. Output does not change more than ± 1% of set value. An important cost saving factor considering the waste generated by inaccurate pumps.

516-922-6050 800-223-3388 Fax: 516-624-8261 Pumps@fmipump.com www.fmipump.com

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• Proven Performance!

Over 56 years of experience and more than 1 million metering pumps and dispensers in service.

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Groschopp Inc. is an American fractional horsepower electric motor and gearmotor manufacturer for OEMs and distributors.

CUSTOMER SERVICE

Groschopp has a strong focus on making sure customers are a top priority.

This is clearly displayed through the company’s website and their chat line to give immediate help. With all their departments under one roof, it’s easy to come together as a team to find solutions. Groschopp strives to provide excellent customer service.

SEARCH TOOL

Groschopp’s new motor search tool allows users to have more control of search parameters when choosing a motor or gearmotor. Unlike other tools in the industry, Groschopp’s search tool contains speed, torque and power settings that can be broadened or narrowed as needed. This allows users to more effectively search for a motor or gearmotor to fit their specifications.

CUSTOMIZABLE

420 15th St. NE, Sioux Center, IA 51250 800.829.4135

Groschopp offers both standard catalog products and custom designs. With their proprietary software, they can quickly search through 150,000 possible design combinations. Customers also have the ability to begin virtually modifying their motor or gearmotor selections online through our “Customize It” tool.

sales@groschopp.com groschopp.com

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Heatron is a US-located manufacturer of heating elements and thick film circuit solutions for the medical device industry.

- Etched foil Kapton®, all-Polyimide, polyester or silicone heaters - Clearview optically-clear heaters - Cartridge heaters and heat exchangers - Thick film metal or ceramic heaters and circuits - Self-regulating PTC heaters Our in-house engineering and design teams help you navigate every aspect of heater development.

- Technology selection - Control - Testing We specialize in custom design of heating elements and thick film circuits, but can also work from pre-existing drawings.

Heatron’s manufacturing centers in Kansas and Pennsylvania generate millions of units per year for customers that include some of the largest medical device brands in the world.

Heatron is ISO 9001:2008 registered and an FDA registered establishment.

Today, our customers include some of the world’s largest and most recognizable medical device brands, who seek out Heatron’s unique combination of design expertise and USA-based production capacity to bring their medical products to market.

Heatron designs for the full product life cycle, creating unique heating solutions for each product application.

Our in-house manufacturing and design capability encompasses a wide range of heater technologies. More than one technology may work for an application, and our engineering team can prototype different options quickly.

Subsequent design generations may require different technologies entirely, moving from cartridge to flex to thick film. Our engineering team considers the full product lifecycle, giving unique insights into form factors, power consumption or control options that may not be available elsewhere.

Heatron, Inc. 3000 Wilson Avenue Leavenworth, KS 66048-4637 1.913.651.4420 heatron.com

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Heatron, Inc. is a global leader in the design and manufacture of heaters, circuits and related thermal management products for the medical device industry. For nearly four decades, Heatron has worked closely with customers to create specialized heating element solutions for their specific product needs.

ONLINE

Ask Heatron about in-house assembly and manufacturing services (including reflow, pick-and-place, dicing and cutting, testing and hand assembly) that can substantially reduce production costs for your next project.

Value-added services, including supply chain support, marking and document control are also available. Heatron follows lean manufacturing principles, and our adherence to quality and sustainability means we can meet the most stringent regulatory requirements.

By centralizing design, manufacturing and assembly services in one US-based facility, Heatron customers speed time to market and gain confidence needed for the regulatory process.

Learn more about Heatron heating elements and services at www.Heatron.com.

ISO 9001:2008. FDA Registration: 3001297547

Medical device heater options include: - Etched Kapton®, all-Polyimide, polyester or silicone heaters - Clearview optically-clear heaters - Cartridge heaters and heat exchangers - Thick film metal or ceramic heaters and circuits - Self-regulating PTC heaters

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In 1958 Helical invented the beam style flexible shaft coupling by taking a novel concept and developing the method to generate the versatile HELI-CAL® Flexure into a piece of stainless steel. Over time, the adaptability of the HELI-CAL Flexure in flexible couplings, u-joints and machined springs has helped to solve thousands of mechanical misalignment problems.

Helical Products Company manufactures parts that provide a competitive edge combining simplicity of manufacture/ assembly with durability and quality in a

HELI-CAL Machined Spring®: The HELI-CAL Flexure used as a machined spring is a single piece of material machined into a spring configured as either a compression, extension, torsion, lateral translation or lateral bending spring, to specific design requirements that provide more precise performance, feature and functions than other more traditional types of springs. Manufactured in a wide range of materials from Titanium, Stainless Steel, MP35N, Inconel, etc. The possibility of integrated attachments and multiple-start coil configurations (for squareness-under-load) give an endless array of solutions, offering engineers new levels of possibilities in their designs.

compact design at a reasonable cost for virtually any industry from military and aerospace to medical and energy. AS9100

U-Joints:

certified, RoHS Compliant and ITAR

The “HELI-CAL Flexure” is an advanced and unique u-joint solution that generally exceeds the capabilities of common u-joint designs. A Helical u-joint is really a Flexure capable of over 5° angular misalignment.

It may accommodate up to 90° of angular misalignment in certain circumstances. This type of u-joint will also compensate for axial and parallel misalignment. Replacement with a maintenance free Helical Flexure u-joint can save money, both on initial purchase price and on maintenance costs.

registered. Helical Products Company is part of the MW Industries (MW-Ind.com) family of premier manufacturers which includes Century Spring, Hyperco, Servometer and Bellows Tech.

Helical Products Company MW Industries, Inc. 901 West McCoy Lane Santa Maria, California 93455 877.435.4225 engineering@heli-cal.com. www.heli-cal.com www.MachinedSprings.com

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Couplings: The HELI-CAL Flexure used as a coupling will transmit torque while compensating for lateral, axial, and angular misalignment movements.

This technology enables customer specified end attachments such as tangs, clamps, flanges or threaded ends, to be integrated into a single multifunctional component. Helical offers an extensive line of standard flexible couplings and has designed and manufactured over 20,000 custom couplings to maximize value and performance for 1000’s of customers.

medicaldesignandoutsourcing.com/leadership Voting for this company will identify it as a leader in the medical technology industry.

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Herrmann Ultrasonics, the technology leader for ultrasonic welding technology, is a solution provider for industrial ultrasonic technology and your ideal partner for welding thermoplastic materials with ultrasonic vibrations.

Ultrasonic welding is used whenever two plastic parts have to be joined permanently: i.e. surgical tools, luehr adaptors, connectors, membranes but also medical infusion collectors, functional components, fluid containers and hermetic housings.

Other typical applications include: medical packaging for disposable syringes, heat

The quality and safety standards of medical parts are very high: in addition to tightness, strength and minimal generation of particles, process validation and process stability also are important factors in manufacturing. Ultrasonic welding allows for outstanding process monitoring and traceability, as well as data acquisition.

patches and inhalers. Laminating and embossing of nonwoven materials such as embossing of surgical facial masks, production

Surgical tools

of baby diapers, wound dressings and

Strength, functionality and high-quality visual appearance are important requirements for surgical tools and devices. Typical applications: Grip plates of instruments, endoscopes, disposable clippers and devices for sclerotherapy.

adhesive bandages.

Herrmann Ultrasonics, Inc.

Luehr adaptors and connectors

1261 Hardt Circle

Unrestricted functionality, weld tightness, and particle purity, along with high outputs, are needed for these medical components.

Typical applications: luehr adaptor, lock, connector, coupler, checkvalve and cuvette with luehr lock fittings. In addition, plug valve housing, piercing membrane and needle embedding.

Bartlett, IL 60103 Tel: 630-626-1626 Fax: 630-736-7514 info@herrmannultrasonics.com www.herrmannultrasonics.com

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Membranes are used for a large variety of tasks in medical and life science applications.

These range from particle filtration in the field of infusion, to cell and tissue culture growth, to various aeration and ventilation requirements. Membranes can be welded or bound by means of ultrasonics.

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Who is Humphrey Products?

We have been in the manufacturing industry for more than 110 years in Kalamazoo, Michigan as a leading producer of pneumatic and fluid control products, serving organizations worldwide. These products are proudly built by a group of loyal and dedicated Humphrey employees, of whom the average service is 15 years. Our products are made in Michigan with 96% of our suppliers from the USA. Industries utilizing our products and engineered solutions include medical devices, healthcare rehabilitation, transportation, general industry and factory automation, and analytical instrumentation. Our subsidiary, South Haven Coil, in South Haven, Mich. manufactures coils and other electrical components and for over 50 years, we have maintained an alliance with Japan-based Koganei Corp, one of the largest and highest quality fluid control companies in the world.

Our quality management system has been assessed and registered by Intertek Testing Services NA, Inc. as conforming to the requirements of: ISO 13485:2003 and ISO 9001:2008.

• Visit www.humphrey-products.com • Download Literature, Catalogs and Engineered Solutions Case Histories • Find Product Specs • View and download 3D CAD Drawings for Valves and Cylinders • Request a Quote • Find one of more than 50 Humphrey Distributors Worldwide Or contact customer service at 1-800-477-8707

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Humphrey designs and manufacturers pneumatic and fluid control components – specifically valves and cylinders – for a variety of applications, including medical devices, analytical instrumentation, factory automation, package conveyor systems and many more.

Our expertise in a wide range of industries is based on technologies proven in our standard products, enabling us to create engineered solutions for critical commercial and industrial applications.

We work to solve not only your fluid control challenges, but to also improve the ease and efficiency of your manufacturing process. This comprehensive approach offers you tremendous outsourcing advantages, significantly reducing your product development cycle and creating vital cost efficiencies. You gain access to our advanced manufacturing technologies, reduced time-tomarket, and the ability to leverage critical resources to focus on your core competencies.

Our Standard Products • Solenoid Valves • Electronic Pressure Regulators and Flow Control Valves • Air Piloted Valves • Manual and Mechanical Operated Valves • Cartridge Valves • Quick Exhaust Valves • Pneumatic Auxiliary Components • Air Cylinders The Humphrey tradition of innovation continues as our familyowned company introduces three new valve technologies: The ProControl Proportional Control Series; Balanced Solenoid Valve Series; and Latching Valve.

Our Engineered Solutions We are an innovative company of pneumatic and fluid handling experts. We develop Engineered Solutions for customers with unique and challenging needs, where standard components fall short. Drawing from our years of experience and unique valve designs, we tailor “best solutions” for the difficult customer problems. www.medicaldesignandoutsourcing.com

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igus® develops industry-leading iglide® plastic bushings, DryLin® linear bearings and guides, igubal® spherical bearings, Energy Chain® cable carriers, and Chainflex® motion cables.

These seemingly unrelated products are linked together through a belief in making functionally advanced, yet affordable plastic components and assemblies. With plastic bearing experience since 1964, cable carrier experience since 1971 and its own line of flexible cable since 1989, igus®

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Plastics for longer life® igus® is committed to using its innovative polymer materials to develop products that provide creative solutions and exceed customers’ expectations, while delivering fast, accurate service. These plastic blends are used throughout each of igus® product lines of plastic bearings, guides and slide tables, spherical bearings, and cable carriers. igus® has been manufacturing engineered plastics for more than 50 years and develops each of the materials and all technology behind its products.

With constant breakthroughs, igus® is continually expanding its base of plastic materials and performs rigorous testing to prove its products meet and exceed industry standards.

provides you with the right solution based

Throughout the medical industry, igus® products are used for a wide variety of applications around the world, based on their cleanroom-compliance, self-lubricating abilities, excellent service life, and lack of required maintenance.

on a very broad selection of standard components, from stock. No minimum order is required.

Services include full in-house harnessing,

iglide® plain bearings and DryLin® linear solutions are all 100% self-lubricating and maintenance-free, and available in FDA compliant and EU certified, and offer lowvibration and quiet operation in a vast array of applications.

design consultation, on-site value analysis visits, guarantee and warranty. igus® works with its customers on an individual basis to deliver solutions that meet the specific needs of an application.

igus® Chainflex® motion cables offer more than 800 cable s certified for cleanrooms by the IPA institute, and corresponding Energy Chain® cable carrier systems allow for safe protection of cables in hoses without lubrication or corrosion, even in chemical and washdown applications.

1-800-521-2747 sales@igus.com www.igus.com

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A variety of online product selection and lifetime calculation tools are available online, without registration, and product samples are widely available across the igus® product range. To learn more about igus® products for the medical industry, visit www.igus.com/medical

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Design. Easy. Fast. We at Interpower®

Interpower® is the premier supplier of

want to make it easy for you to design, build, and maintain products for North American and worldwide markets—that’s our mission. We strive to provide our customers with quality products that delight—fast. Designing products with the global customer in mind can give a company a competitive advantage and may increase customer relations. It’s imperative that companies know that their products will function properly in the areas they are meant to be used.

power system components offering a full line of North American and international products, including hospital-grade products, power cords and cord sets, IEC 60320 inlets and outlets, accessory power strips, power entry modules, cable, plugs and sockets, the International Power Source, plus more.

There are no minimum order requirements, same day shipping on in-stock products, and a 1-week U.S. manufacturing lead-time on non-stock Interpower products. All Interpower manufactured products are made in Iowa and 100% tested.

As the premier supplier of AC power system components, Interpower hospital-grade products are designed for use in medical settings throughout the world. We have an extensive range of clear, black, and gray plugs along with C13 and C19 connectors available in five different configurations (straight plus four angles). Connector locks can help prevent accidental removal or interruption. For those products that will be used in North America, they are UL and CSA approved and carry the green dot.

Additionally, we carry power cords and cord sets, accessory power strips, cable, IEC 60320 inlets and outlets, power entry modules and more! We offer value-added options such as custom packaging, labeling, cord lengths, and colors.

®

®

Interpower® Group of Companies

Interpower offers a 1-week U.S. manufacturing lead-time on non-stock products. We have same day shipments on in-stock products and no minimum order requirements. Interpower manufactured products are made in Iowa and 100% tested.

P.O. Box 115, Oskaloosa, IA 52577-0115 (800) 662-2290 sales@interpower.com www.interpower.com

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Free technical support at Interpower is available. Please check our website at www.interpower.com, e-mail us at sales@interpower.com or contact Customer Service at (800) 662-2290.

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INTROTEK INT’L designs, manufactures and markets non-invasive ultrasonic air bubble and liquid level detection systems Beginning operations in 1981, we became a wholly-owned subsidiary of Magnetrol International—a worldwide leader in industrial level and flow instrumentation in 1986. Since then the companies have engaged in collaborative R&D efforts for the enrichment of both firm’s product lines. Introtek’s production operations represent the leading-edge in manufacturing. Our manufacturing practices conform to the identical standards as those of medical device manufacturers. An ISO certified company, our quality system is also TUV certified to meet the established requirements for the development, production and distribution of our complete product line. Introtek stands behind the quality of every product with a three-year product warranty. Whether you require standard or custom designed sensors and electronics, our comprehensive design and manufacturing capabilities—along with our solid record of O.E.M. service proficiency—will provide you with the most reliable ultrasonic-based detection products available today.

M E D I CA L T E C H N O LO GY

INTROTEK, the Global leader for almost 35 years, has produced non-invasive, ultrasonic air bubble detectors, continuous liquid and point level sensors, and optical blood component detectors for companies in industries such as medical device manufacturing, chemical

150 Executive Drive Edgewood, New York 11717 Phone: 631-242-5425 Fax: 631-242-5260 General E-Mail: info@introtek.com Sales: sales@introtek.com

OD tubing to overcome conditions such as relaxation, slippage or vibration, which would normally cause false air alarms. These sensors are designed to meet OEM form, fit and functional specifications. Sensors are available with integral or remote circuitry and panel mount or self-standing designs.

Introtek’s line of Non-invasive liquid level detectors provide the ultimate solution for almost any liquid level detection application.

AD8/9 Air Detector ADU Air Detector

processing, pharmaceutical development, clinical laboratories and food & beverage manufacturers. Since it’s early conception, Introtek has maintained its commitment in providing safe, reliable products to ensure customer satisfaction. Our products lead the way in meeting O.E.M. customers’ needs for sensors and electronics that are compact, accurate, highly reliable and reasonably priced.

Introtek’s standard sensors attach at the desired point of detection to the outside of stainless steel, or rigid and flexible plastic Introtek’s Engineering Design Team specializes in taking custom requirements from concept to completion using highly innovative ideas, while working closely with the customer in order to obtain maximum results.

Introtek’s AD8 / AD9 / ADU Integral Ultrasonic Air-In-Line, Air Bubble Detectors incorporate Introtek’s latest generation “MEC” pulse-type ultrasonic circuitry. The microcontroller based circuitry is located integrally in the sensor assembly. Custom algorithms to control functionality, such as response times, time delays and more can be designed at Introtek based on customer requirements. ADU Series Sensor for non-standard soft tube sizes between 1/8” - 3/18” where standard AD9 housings are not available and can eliminate tooling costs for low volume requirements for some odd sized tubes.

Introtek International

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INTROTEK® Dual and Single Point Drip Chamber Level Sensors are custom designed for use with soft-bodied drip chamber or larger

Introtek’s PLD – Point Liquid Level Detector is extremely user-friendly with a sleek compact, non-invasive design, incorporating integral electronics that never require calibration. The PLD is the most advanced pulse wave, ultrasonic sensor available for liquid level detection, emphasizing reliability, accuracy and repeatability. Single Drip Chamber Level Sensor

Introtek’s CLD – Continuous Liquid Level Detector is a pulsed ultrasonic, continuous level sensor, scalable for small to large vials, containers and tanks for industrial, laboratory, pharmaceutical medical & beverage applications. Our unique, non-invasive design enables the liquid level from the bottom of vessel to be monitored quickly, accurately and dependably. Dual Drip Chamber Level Sensor

Introtek’s CLM – Continuous Liquid Detector for Metal Tanks delivers the answer for challenging non-invasive liquid level monitoring for a variety of fixed tanks and vessels comprised of, Stainless Steel, Copper, Aluminum, Teflon and Plastic. The CLM is designed to operate under a wide range of supply voltages. Additional features include a bi-color LED visual indicator assuring optimum transducer placement, standard dip switch capability providing field adjustment for 8 various discreet tank levels.

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CLM – Continuous Liquid Detector for Metal/Steel

PLD – Point Liquid Level Level Detector

CLD – Continuous Liquid Level Detector

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HELPING ENGINEERS SUCCEED J.W. Winco, Inc. is a leading supplier and manufacturer of standard industrial machine components, and specializes in offering value-added services to engineers.

Along with an extensive selection of high quality parts, J.W. Winco strives to make engineers’ jobs easier. The company website at www.jwwinco.com is user-friendly and easy to search. Free CAD models are available for almost the entire product line, downloadable in all formats. Customers can check availability and pricing online, and purchase easily 24/7 with credit card, or set up an account.

Meanwhile, J.W. Winco prides itself on its knowledgeable technical sales associates, who provide assistance with products and applications. Customer service is a top priority. To provide customers with complete solutions, J.W. Winco also offers manufacturing of custom engineered products, secondary machining of our standard products, special kit packaging, and barcoding.

Stainless steel leveling mounts have tear-drop design

GN 440.6 Stainless Steel Leveling Mounts with Tear-Drop Design from J.W. Winco, Inc. are offered in inch and metric sizes. They are available with tapped socket or threaded stud, and may be ordered plain, with plastic base cap, or with rubber pad.

These RoHS-compliant leveling mounts are a simple and economical product. The base is stainless steel with a shot-blast finish and is equipped with one lag bolt hole. The tapped socket or threaded stud is also stainless steel (American Standard Series 304), with a stainless steel (American Standard Series 303) assembly screw loctited into place. Versions with optional plastic base cap of black Elastomer (TPE) plastic are also available, as are optional vulcanized non-skid pads of black Nitrile Butadiene rubber.

These leveling mounts are offered in a range of base diameters and threaded stud lengths, and available in a zinc plated steel version as well.

They are able to bear static loads from 8 to 16 kN (1,800-3,600 lbf).

800-877-8351 fax 800-472-0670 sales@jwwinco.com jwwinco.com

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J.W. Winco has also introduced GN 115.6 Stainless Steel Mini Latches, available in metric sizes.

These economically priced, RoHS-compliant mini-latches have smaller dimensions than our standard GN 115 series, making them perfectly suited for small doors and flap closing applications. They offer a straightforward latching action rather than a locking and clamping action. The latch distance of mini-latches is made to accommodate 8, 14 and 20 mm.

Latch housing and hardware are stainless steel. Offered types include with triangular spindle, with square spindle, and with slot.

Keys for the latches are ordered separately; key can be removed from latch in both open and locked positions. In the standard key latch versions, all latches have the same barrel and can be operated with the identical key. Latches requiring different barrels and keys are available upon request.

Hinges have extended wing design

J.W. Winco’s GN 237 Hinges with Extended Hinge Wing have a compact and sturdy design.

They are used when wider spacing is required on the mounting surface.

These RoHS-compliant hinges are offered with countersunk holes or threaded studs for mounting. Versions are available with one or both hinge wings extended. Additional styles of square hinges under the same GN 237 series are available, which also offer a wide variety of sizes and mounting options.

Hinge body is zinc die-cast, with black powder coated, textured finish or silver powder coated, textured finish; stainless steel hinges are also available in all versions. Hinge pins and threaded studs for all types are stainless steel. www.medicaldesignandoutsourcing.com

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Quality Interconnect Components and Electronic Hardware Leading edge technology and precision manufacturing have defined Keystone’s performance since 1950. Their latest catalog M65 reflects this tradition.

Keystone personnel take pride in meeting all requirements, efficiently and promptly. Our skilled and dedicated technicians, experienced production personnel and customer service teams have made us an industry leader.

All Keystone facilities are fully integrated with 3D/CAD product modeling and CAD/CAM precision tool and die operations. Applications and Engineering specialist utilize progressive dies, four-slide, wire forming, in-die tapping and highspeed blanking along with automated machining to produce tight tolerance standard and custom products. Secondary operations include Tapping, Drilling, Assembly and Finishing.

Battery Clips, Contacts, Holders & Retainers Advances in portable electronics and LithiumIon battery technology demand dependable battery connections. Keystone leads the way with a vast range of reliable, high-quality, costeffective products for most battery types.

Space-Saving Fuse Clips & Holders Fuse clips and holders for Electronics, Datacom, Telecom, Automotive and Solar use. Keystone answers your needs with SMT, ThruHole and rivet mount products.

PCB Test Points & UL Approved Terminals Low Profile and limited space drive today’s PCB connectivity designs. Keystone is the right fit with Solder and Solderless PCB Quick-Fit, Snap-on, Snap-Fit and Screw-on Terminals as well as Color-Coded Screw Terminals & THM and SMT Test Points and more.

Spacers, Standoffs/Supports - Metallic & Non-Metallic Diverse insulated and non-insulated spacers and standoffs are available in a wide range of lengths, thread sizes, hole sizes, mounting styles & materials. Choose from English or Metric type products for your PCB, panel and mounting applications.

Pins, Plugs, Jacks & Sockets, Industry’s Most Diverse Group Keystone’s USB 2.0, 3.0 & 3.1 Jacks & Plugs, Micro Pins/Jacks, Banana and Phono Plugs & Jacks are designed for use in the latest Mobile & Computer Electronics, Home Theatre, Test Gear and Industrial Interconnects.

Panel Hardware, Handles, Screws & LED Spacers Check out Keystone’s value-added products: Fan Filters & Guards, LED Lens Caps, Holders & Spacer Mounts, Jack Screws and Connector Hardware, Instrumentation Handles, Cable Clamps, Knobs and more.

Application engineering services are available for product modifications or special design requirements.

Keystone is an ISO-9001:2008 certified company and complies with RoHS and REACH directives.

View inside the walls of Keystone Electronics and learn about our design and manufacturing capabilities, our customer service team and our complete line of interconnect components and electronic hardware. https://www.youtube.com/ watch?v=YhVH3DCngH0 There’s a Keystone in every great invention… Follow our latest blog. http://www.keyelco.com/blog.cfm

31-07 20th Road, Astoria, NY 11105-2017 800.221.5510 or 718.956.8900 www.keyelco.com

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LEMO®, founded in Switzerland in 1946, took its name from the company founder, engineer Léon Mouttet. Originally a manufacturer of contacts in noble and rare metals, the company took a major step forward in 1957 with the introduction of the push-pull self-latching connector.

This year LEMO will be celebrating their 70th anniversary in the connector industry.

LEMO USA, INC. 635 Park Court, Rohnert Park, CA 94928 USA 707.578.8811 F: 707.578.0869 info-us@lemo.com www.lemo.com

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The Original Push-Pull Connector

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LEMO is the acknowledged leader in the design and manufacture of precision custom connection and cable solutions. LEMO’s high quality push-pull connectors are found in a variety of challenging application environments including medical, industrial control, test and measurement, audio-video, and telecommunications.

LEMO has been designing precision connectors for seven decades. Offering more than 75,000 combinations of product that continues to grow through custom specific designs LEMO, and it’s affiliated sister companies REDEL, NORTHWIRE and COELVER, currently serve more than 100,000 customers in over 80 countries around the world.

LEMO USA most recently acquired ISO13485:2003 Certification for the medical cable assembly market. www.medicaldesignandoutsourcing.com

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Lin Engineering’s diversified customer base includes: • Aerospace & Avionics • Automation • Food & Beverage • Medical & Instrument Devices • Printing & Packaging • Security & Surveillance • Semiconductor • Solar & Green Technology • Tracking Systems

Founded in 1987 as a consulting company specializing in step motor applications, Lin Engineering has grown to be a global supplier of cutting edge, quality stepper motors with manufacturing in both the United States and China.

Making it Work with Custom Designs With full manufacturing capabilities in the United States and a complete team of Design and Manufacturing Engineers, we are capable of providing you with custom solutions regardless of how simple or complex the request may be.

From modified shafts, connector assemblies, and custom wiring harnesses to vacuum ratings, sealed motors for use in water, and windings for higher torque or more efficiency, we have the engineering expertise and manufacturing capability to provide you with the right solution.

Free Online Tools with Designer’s Corner We have released a variety of online engineering tools to help you get the information you’re looking for. Quickly and easily select the right stepper motor and instantly view a performance curve.

Lin Engineering Corporate Headquarters 16245 Vineyard Blvd Morgan Hill, CA 95037 408.919.0200

An online forum, FAQ and step motor basics are also available.

408.919.0201 www.linengineering.com

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Quality You Can Count On One of the reasons that more and more engineers are turning to Lin Engineering is due to our reputation for developing and manufacturing high quality and consistently reliable products.

The Leader in Step Motor Technology 15 Patents on step motor technology with a few more on the way. What more can be siad about being the leader in step motor technology?

www.medicaldesignandoutsourcing.com

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Master Bond is celebrating 40 years of formulating cutting edge adhesives, sealants, coatings and potting/encapsulation systems for challenging medical device applications.

High Performance Adhesives, Sealants & Coatings Our expansive line of epoxies, silicones, UV curable and LED curable compounds can be customized to meet a myriad of property requirements including: • High/low temperature resistance • Electrical conductivity/insulation • Thermal conductivity • Sterilization resistance • High/low viscosity • Flexibility and toughness • Optical clarity Developed to withstand harsh environmental conditions, our products feature superior longterm durability. They are used in a variety of industries and are designed to meet stringent industry standards and are certified for:

Outstanding Customer Support

• USP Class VI • ISO 10993-5 • NASA low outgassing • FDA CFR 175.300 & FDA CFR 175.105 • UL 94V-0 & UL 94V-1

MasterSil 912Med: Biocompatible Silicone Passes USP Class VI Testing MasterSil 912Med is a single component silicone with a paste viscosity offering a non-corrosive, neutral cure. Complying with USP Class VI and ISO 10993-5 specifications, it resists many kinds of sterilization including gamma radiation, EtO and some types of liquid sterilants. MasterSil 912Med withstands rigorous thermal cycling as well as thermal and mechanical shock.

Master Bond makes customer support a fundamental priority in the adhesive selection process. Our technical specialists have decades of experience and will work with you, one-on-one, throughout the design, prototyping and manufacturing stages of your application.

UV15DC80Med: Features Superior Sterilization Resistance Master Bond UV15DC80Med is a special dual cure epoxy based system that offers a primary cure using UV light along with a secondary heat curing mechanism. This enables the adhesive to cure areas on parts that do not allow UV light curing because of “shadowing” issues. It also meets USP Class VI specifications and passes ISO 10993-5 cytotoxicity testing.

Master Bond 154 Hobart Street

See how Master Bond began in a video that celebrates our 40 year history as an adhesives formulator.

Hackensack, NJ 07601 Tel: 201-343-8983 Fax: 201-343-2132 www.masterbond.com technical@masterbond.com

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maxon drives set the world in motion. maxon motor combines electric motors, gears and DC motor controls into high-precision, intelligent drive systems that can be custom-made to fit the specific needs of customer applications. maxon motor helps provide innovative solutions at competitive prices for numerous applications in various markets, such as industrial automation, medical technology, security technology, instrumentation, communications, and consumer applications, among others.

M E D I CA L T E C H N O LO GY

Offering solutions that fit your customized needs maxon motor manufactures small, high-quality brush and brushless DC motors ranging in size from 4 mm to 90 mm and up to 500 watts. maxon’s rhombic wound ironless rotor motors provide exceptionally high efficiency, low EMI emissions, fast acceleration, no preferred rotor position, torque constants and long service life. The drive components are assembled and designed within our modular system according to your individual needs. You can combine, according to your requirements, motors with 10 different product classes with planetary, standard or special gearheads, feedback devices, brakes and control electronics.

Brushed and brushless configurable DC motors - more versions, more power Now even stronger, more efficient and with yet more combination options: There are new additions to the maxon family of X drive products. Several long versions of brushed DC motors, with higher torques and more power, have been added to the product range along with matching planetary gearheads. Each of the 3-stage versions can now be combined with the next smaller motor. This saves space, weight and costs.

In addition, maxon launched a brushless DC motor (ECX) line to its configurable online program.

These motors are available with diameters of 8, 16 and 19 mm achieving speeds of up to 120,000 rpm. They run very smoothly and are highly efficient in standard or sterilizable versions (up to 2,000 autoclave cycles). Ideal for use in hand-held surgical tools and industrial spindles. maxon motor’s X drives are extremely powerful and are now available in maxon’s online shop, where customizing the drives is easy. Customers can fit the drives with specific mechanical and electrical components specific to their application needs. It is possible to customize the shaft lengths, winding types, ball bearings and much more. When combined together with maxon encoders and planetary gearheads, you form a high-precision, robust drive system ideal for any application from aerospace to medical to robotics. In fact anywhere that requires a compact, powerful, quiet and strong drive system.

maxon precision motors, inc.

101 Waldron Road

The X program is a lean and automated process which ensures that all configurable drives are ready for shipment within 11 working days. In addition, detailed product data may be viewed immediately online and 3D CAD data for the configuration is available for downloading.

Fall River, MA 02720 508.677.0520 info@maxonmotorusa.com maxonmotorusa.com

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• Full Service Contract Manufacturer • ISO 13485:2003 Certified.

• FDA registered.

• Clean Room Molding.

Medbio

• Clean Room Assembly.

• Clean Room Packaging.

Located in West Michigan, Medbio is an ISO 13485:2003 certified contract manufacturer offering innovative manufacturing solutions for the Life Sciences. We specialize in precision injection molding, assembly, packaging, design support, and project management. We have experience with most medical-grade thermoplastics and implantable-grade resins. We currently mold products for OEMs in Orthopedics, Cardiovascular, Ophthalmology, Neurological Surgery, General Surgery, Wound Care, Biotech (diagnostics & cell growth), and Dental.

• Precision Injection Molding • Insert & Over Molding • Micro Molding

Members of our leadership team average over 20 years of medical device industry experience, so we know what it takes to get a new product to market.

Supported by a staff of 19 Engineers, Medbio is able to help our customers through all phases of their project.

Our commitment to deliver quality products, service, and value to every customer is a priority for every Medbio employee from the top down, as evidenced by the continued business and referrals we receive. We’ve earned a reputation of excellence in our industry and strive every day to exceed those expectations.

Please contact John Woodhouse, Director of Sales & Marketing, to begin your next project with Medbio and become one of the customers we so greatly value.

Medbio 5346 36th St SE Grand Rapids, MI 49512 P: 616.245.0214 medbioinc.com

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MICROMO (FAULHABER Group) is the quality leader for custom micro motion solutions and full service capabilities. MICROMO offers excellence in micro motor and encoder technology as well as design customization.

MICROMO brings together value-added services and cutting-edge technologies from around the world through high efficiency, high performance offerings, such as brushed, brushless, stepper, thin-profile DC, piezoelectric and linear motors for diverse applications (www.micromo.com). Founded in 1961 and based in Florida, MICROMO provides a variety of linear and rotary motion solutions for the North American market. MICROMO is part of the global FAULHABER Group, which has over 1,600 team members worldwide.

MICROMO is your full service, value added outsourcing partner: • •

ISO 9001 and 13485 certification Custom design and complete clean room subassembly Express prototyping Machining center State-of-the-art testing laboratory Energy-efficient solutions and enhanced product life

• • • •

MICROMO’s benchmark contributions with motion solutions are a part of many leading products and applications in markets such as Medical Devices, Robotics and Automation, Optics and Photonics, Aerospace, Defense and Instrumentation.

MICROMO 14881 Evergreen Ave. Clearwater, FL 33762 T: (800) 807-9166 F: (727) 572-7763 www.micromo.com

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MICROMO WHY IS MICROMO THE LEADER WITH MICRO MOTION SOLUTIONS?

EXCELLENCE IN MICRO MOTION SOLUTIONS

For over 50 years, MICROMO has partnered with a range of markets to provide the highest precision and highest performance motion systems and components based on dc motor technology. MICROMO combines the widest range of linear and rotary motion solutions with value-added services and the global resources of the FAULHABER Group to provide a variety of benchmark custom motion solutions for medical applications such as drug delivery systems, medical robotics, surgical tools, diagnostics systems and prosthetic devices.

QUALITY LEADERSHIP

MICROMO is ISO 9001 13485 certified and RoHS compliant. With the FAULHABER Group’s ISO 14001 certification, MICROMO provides the highest quality standards for the design, development and manufacturing of fractional horsepower drive systems for diverse markets.

TECHNOLOGY LEADERSHIP--IT ALL STARTED DECADES AGO WITH THE “FAULHABER COIL.”

Decades ago, Dr. Faulhaber patented the first selfsupporting, ironless, skew-wound rotor coil, and the FAULHABER Group motor technologies grew from this revolutionary patented system. The system centers on winding hollow, low-inertia moving coils for maximum power and efficiency in the smallest physical spaces. By remaining close to the company’s engineering roots, MICROMO is the premier provider of micro motion control systems. MICROMO’s product line includes fractional horsepower DC coreless motors, PMDC motors up to 1,000 Watts, brushless DC motors, stepper motors, piezo motors, linear servo motors, precision gearboxes, optical and magnetic encoders, fail-safe brakes, tachometers and tachogenerators, controllers, micromechanical systems, complete servo systems, and custom subassemblies that incorporate these products for integration into OEM devices.

IT’S ALL HERE IN NORTH AMERICA

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From concept to delivery, MICROMO (Clearwater, FL) provides it all. With on-site machining and assembly facilities, a versatile standard product line, and over 5,000 special executions, customization is MICROMO’s strength. MICROMO’s operations include a state-of-the-art CNC machining center, a 12,000 ft² clean room assembly operation (class 100,000 capable), online product acceptance of both finished product and incoming goods, and a design, R & D and engineering testing center. All application work is carried out by in-house engineering staff.

MICROMO’s engineering team partners with over 3,000 customers for the design, specification and after sales support of industry leading motion control products. With extensive local inventory and online product analysis and purchase via the MICROMO Motion System Selector™, many products can be delivered in three days or less to meet immediate design and testing requirements.

Voting for this company will identify it as a leader in the medical technology industry.

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Minnesota Rubber and Plastics is a

Company History

Global System Solutions Provider. We are a

Since 1945, Minnesota Rubber and Plastics has built a worldwide reputation in the molding of elastomer and thermoplastic components and assemblies.

“We are known in the medical industry for our design expertise and providing the best optimal solution to our customers. And, for our science-based approach that has made us the preferred manufacturing partner for industry leaders in North America, Europe and Asia,” stated Lih Fang Chew, vice president of global marketing.

trusted leading solutions provider partnering with customers worldwide to enhance the performance of critical and demanding applications. Our leadership is based on our expertise in material science solutions, engineering design and integrated solutions combined with customer collaboration.

Our 5 manufacturing facilities, located in North America and Asia, are complemented by 4 warehousing operations in the U.S., Europe and Asia.

Product Design.

Our product design engineers conceptualize and evaluate ideas by combining science and technology to create value. Utilizing the latest CAD programs and FEA models, our designers mathematically model and fabricate components and their function in your applications. Our rapid prototyping decreases development time, errors and changes while improving deliveries.

Manufacturing/Process Development.

Manufacturing/Process Development. Minnesota Rubber and Plastics provides the most comprehensive facilities. Our scientific approach ensures product compliance with products produced on time and on budget utilizing finest: • Tool design and construction • Four types of molding processes including compression, transfer, injection and liquid injection silicone (LSR) •Scientific molding with cycle time optimization and productivity • Latest vision inspection technology •FMEA •Analysis and (PPAP) documentation • Component assembly in class 10,000 and 100,000 certified clean rooms • Comprehensive testing • Customized packaging and labeling.

Sourcing/Quality Systems

Global Headquarters 1100 Xenium Lane North Minneapolis, MN 55441-7000 1(800)-927-1422 Phone: (952) 927-1470 Fax: (952) 927-1470 Email: webmaster@mnrubber.com

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Meeting the expectations of our worldwide customer base requires diverse and strategically located manufacturing capabilities. Within these facilities, we combine: • Benefits of worldwide sourcing capabilities and pricing with technical resources and project management capabilities • Corporate wide quality systems including ISO 13485, ISO-TS 16949, ISO 9000 and ISO-14001 in all facilities.

Material Sciences Knowing materials, their properties and structures, how processing changes them and how materials perform in an application are all vital to the success of your molding project. We provide: • Onsite technical support at each facility • R&D center staffed with 23 technicians • Custom formulation materials laboratory • Over 1,600 different rubber compounds • Plastic materials expertise.

Micro-Molded Parts for the Medical and Pharmaceutical Industry Providing micro-sealing solutions to the medical and pharmaceutical industry with expertise in the precision molding of elastomer and thermoplastic parts including; PEEK and other high performance materials. All final part processing and inspection is completed in class 10,000 and 100,000 clean room environment. • Implantables and non-implantables •Surgical components and minimally invasive surgical tools • Catheter tips and components •Valves and seals •Over-molding

Quniton™ in the Medical & Pharmaceutical Industry medicaldesignandoutsourcing.com/leadership Voting for this company will identify it as a leader in the medical technology industry.

Quniton™ serves the medical industry as a highly lubricious compound designed to reduce stiction allowing care providers to administer services to patients with ease. This proprietary compound gives an extended life to pre-filled syringes with its ability to maintain lubricity and sealing force

throughout the product life span.

www.medicaldesignandoutsourcing.com

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Moog Animatics is a global leader in integrated motion control. Located in Silicon Valley in Milpitas, California, Moog Animatics designs, manufactures and markets motion control products and systems. Leading the way in SmartMotorTM design, Moog Animatics provides innovative solutions for today’s expanding machine requirements and sets a pace ahead of the competition.

Additionally, unmatched customer support and training provides another key advantage.

With over 28 years of experience in the motion control industry, the company has

The Pioneer and Leader in Fully Integrated Motion Control

Moog Animatics offers the most highly integrated automation solutions in the industry. Starting with the SmartMotor™, the world’s first fully-integrated servo system, and extending through a large variety of I/O, machine control and linear actuator products. Moog Animatics offers total solutions with a much smaller footprint, lower cost and a simplicity that reduces your machine development and build time – getting you to market faster.

For over 28 years, Moog Animatics has been providing customers in a wide variety of industries with the products and customer service to help them succeed. Moog Animatics’ products are at the heart of applications ranging from material handling, pan/tilt, winding/spooling, process tension control to biomedical and life sciences. Our returning customers are a testament to our continued innovation and support.

international offices in Germany and Japan and a network of Automation Solution

A Complete Motion Control System Inside the SmartMotorTM

Providers worldwide.

For more information: www.animatics.com

What makes the Moog Animatics SmartMotor by far the most powerful integrated motor in the industry is its unique ability to control an entire machine. The SmartMotor is not just a product -- it is a complete motion control system and a byproduct of an innovative design philosophy. The unsurpassed programming ease, networking capability, highly flexible and expandable I/O, and high power density servo performance is exactly what you should expect from the pioneer and recognized global leader of truly integrated motion control. Our line of advanced rotary and linear motion control products feature the ability to perform multi-axis motion, including standalone coordinated motion. The SmartMotor brings real-world additional savings to the machine builder by eradicating other expensive and complicated elements in the machine such as PLCs (if desired), sensors, I/O blocks and control cabinets.

Unparalleled Flexibility Easily integrating with not only PC-based control systems, the SmartMotor also integrates with PLC technology and a wide variety of communication protocols. Additional axes can be easily added in the field, bringing additional processing power, but without parallel growth of existing cabinet size. This simplicity and ease of use goes beyond just “compactness.” It results in overall reduced machine development time (shortening time to market), lower total machine cost, greater field reliability, and simplified machine design and build time eliminating heavy procurement and support activities.

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MTD Micro Molding is a focused micro medical device manufacturer that’s built for high performance in one area: the micro molding of advanced medical products.

Medical Micro Molding is what we do.

And all we do. Our operation isn’t a small corner of a bigger plant; it’s our entire

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Company History MTD Micro Molding is the only U.S. company 100% dedicated to micro molding. Founded in 1972 as Miniature Tool & Die, Inc., MTD quickly established itself as a leading manufacturer of miniature connector molds for the electronics industry. Today, MTD Micro Molding is fully dedicated to the medical industry and continues to grow. In our facility in Massachusetts, our team of designers and engineers work together under one roof to mold microscopic components for the medical industries. Our expert staff continues to lead the way in designing and manufacturing micro molded products at the micron level, for components of nano weight, creating some of the tiniest and most precise medical device components in the world.

plant. MTD is vertically integrated with tooling operations and molding operations occurring under one roof and all molding and inspection takes place in an ISO Class 8 cleanroom environment.

100% Medical. 100% Micro.

MTD is a contract manufacturer exclusively for the medical device industry. 20% of new projects come to us as “rescues” – failed attempts by others. Our success rate with these rescue projects? 100%.

80% of the components we produce are implantable products, with 75% of those being bioresorbable applications. Micro medical devices produced by MTD Micro Molding support a variety of medical categories: Cardiac, Biomed Pharma, Pharmaceutical, Neurosurgical, Bronchoscopy, Oncology, Urology, Orthopedic, Endoscopy, Ears-Nose-Mouth, Acupuncture, Drug Delivery, Gastrointestinal, Men’s and Women’s Health and other areas to help improve life. Thermoplastic examples include permanent screws, micro links, ejector rings and bioresorbable examples include absorbable stents, staples, and screws.

Ultra-Precision Micro Molding Micromolded parts can be so small you can only see them with a microscope or be as large as 1”x1” and possessing micro features. MTD Micro Molding qualifies “micromolding” with the following criteria: MTD Micro Molding 15 Trolley Crossing Rd Charlton, MA 01507 508.248.0111 mtdmicromolding.com

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Headquartered in Cleveland, Nook Industries is an ISO9001:2008- and AS9100C-registered company that provides controlled motion solutions in a wide range of industries including transportation, medical/diagnostics, paper, chemical, food/ beverage, solar/aerospace, entertainment and communications markets. For more than 45 years, Nook has provided comprehensive engineering, design and analysis in providing the highest quality linear motion manufacturing solutions on the market today. For more information, visit nookindustries.com or call 800-321-7800.

Nook Industries Since 1969, Nook Industries has been a leader in the linear motion solutions which serve countless applications in the medical technology industry. Nook produces precision, costeffective mechanical, electrical and controls solutions for medical and diagnostic applications.

The company has medical and diagnostic experience in biotech imaging, optical testing and gauging, blood analysis equipment, transportation lifts for hospitals and personal use and medical packaging systems, just to name a few.

Devices which utilize Nook’s linear motion include: MRI machines, patient tables, hospital beds, prosthetics, syringe/infusion pumps and wheelchairs. Medical and diagnostic products are manufactured from a variety of high-quality materials and high-precision processes to meet engineering performance and budgetary requirements.

NOOK Industries, Inc. 4950 East 49th Street

Nook’s in-house capabilities include: thread rolling, induction heat treatment, custom end machining, engineering analysis and precision test and measurement procedures. The company’s engineering expertise help customers implement the right medical motion solutions.

Cleveland, Ohio 44125 P: 216.271.7900 800.321.7800

Instead of dealing with the hassle of needing multiple firms to provide all the answers, Nook’s in-house, integrated capabilities and overall engineering expertise provide customers with a one-stop, total solution.

F: 216.271.7020 nookindustries.com

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Established in 1916 and headquartered in Tokyo, Japan, NSK is a world class manufacturer of motion and control products, leading the industry with superior quality, engineering research and technical innovation. NSK produces and distributes a wide range of rolling element bearings, linear motion and automotive component products for a variety of applications.

Operating in the Americas, NSK Corporation is a member of NSK Ltd. and is headquartered in Ann Arbor, Michigan. NSK Corporation has a network of sales, engineering, customer service and marketing teams who support customers throughout the purchase cycle. The company’s strategically located manufacturing and distribution centers supply both original equipment manufacturers and the industrial aftermarket.

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Advancements in medical technology are enhanced with NSK linear motion innovation.

In the field of motion control, innovative engineering is paramount to optimal design and performance. Nearing its 100th year anniversary, NSK has proven to be an industry leader dedicated to applying innovative, technical solutions for the future advancements required in medical, biotech and pharmaceutical industries.

NSK linear motion and bearing solutions have been used for imaging, diagnostic, surgical robotic and medical equipment applications. As NSK continues to expand its capabilities, new product solutions are engineered. Our dedicated team of engineering staff collaborates with the customer to develop an integrated system. We understand the importance of delivering solutions to an environment that is constantly evolving and looking to new technology in order to improve outcomes within the field of medicine.

Medical Imaging

NSK’s NH/NS Series Linear Guides™ achieve the world’s highest load rating, while maintaining superior precision and accuracy required for medical imaging such as CT, PET and MRI scanning devices. Optional K1™ Lubrication Units reduce maintenance cost and extend operating life.

Diagnostics

Diagnostic devices, such as blood analyzers, need to process multiple samples while delivering consistent, accurate results in an efficient manner. NSK’s Monocarrier™ linear actuators are a low-maintenance solution. The MCM Series is ideal for light to medium loads and is available in miniature sizes for a compact, space-saving design. Smooth motion, low vibration, high rigidity and long operating life are all achieved when utilizing the MCM Series. Optional K1™ Lubrication Units reduce maintenance cost and extend operating life.

Robotic Surgery NSK Americas 4200 Goss Road Ann Arbor, MI 48105 1-800-255-4773 info@nsk-corp.com nskamericas.com

To ensure reliable and repeatable results that deliver smooth, accurate and precise movement, NSK recommends BSS Series ball screws for surgical robotic applications. The BSS Series is available in miniature sizes and can be used within the arm of a surgical robot. Each ball screw is designed for high precision, accuracy resulting in unparalleled smooth motion.

With the use of K1™ Lubrication Units maintenance costs are significantly reduced.

K1™ Lubrication Unit

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The K1™ Lubrication Unit combines oil and resin into a single unit designed for environments where grease replenishment is undesirable or where grease may be easily washed away.

These units can be installed on NSK ball screws, linear guides, Monocarrier™ and Robot Module™ products. Effective in any mounting orientation, the K1™ Lubrication Unit can be installed in various medical applications including NH/NS Series linear guides for medical imaging devices, MCM Series Monocarrier™ for diagnostics and BSS Series ball screws for robotic surgical equipment. These units are maintenance-free for up to 5 years or 10,000 km of operational distance; however, longer operating conditions can be achieved. An FDAcompliant option is also available.

For more information about NSK and our innovative product solutions for medical applications, visit www.nskamericas.com www.medicaldesignandoutsourcing.com

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ODU is one of the world’s leading connector systems suppliers and employs about 1,650 people around the world. ODU combines all relevant areas of competence and

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Advanced Connector Solutions ODU connector solutions ensure reliable transfer of power, signal, data and media for a wide range of next generation applications. Our advanced customer benefits include:

• Completely integrated system solutions • Competitive lead time • Rapid prototyping & Product development • Local one-to-one engineering support

key technologies relating to design and

• Cable assembly integrated solutions

development, machine tool and special

• Custom connector capabilities

machine construction, injection, stamping,

• Factory direct

turning, surface technology, assembly and cable assembly. Aside from the company headquarters at Mühldorf am Inn, the ODU Group has also an international production and distribution network in Europe, North America and Asia. The ODU group sells its products around the world and has an international distribution network that includes eight sales companies in Denmark, England, France, Italy, Sweden, the USA, China and Japan, along with numerous worldwide sales partners. The ODU connectors ensure reliable transmission of power, signal, data and media in numerous demanding applications: medical technology, military and security, energy, industrial electronics, measurement and testing and automotive technology.

ODU-USA Inc. 4010 Adolfo Road Camarillo, CA 93012 USA +1 (805) 484.0540 F: +1 (805) 484.7458 sales@odu-usa.com www.odu-usa.com

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Phase 2 Medical designs, develops, and manufactures single-use powered devices. The latest generation disposable devices require motors, batteries, and electromechanical functionality similar to consumer-based devices used in other industries.

Our engineering team is experienced at getting these complex products launched and transferred into our state-of-the-art LEAN manufacturing environment.

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Company History Phase 2 Medical was founded in 1995 as a contract manufacturer of medical devices and continues to serve this market exclusively. We have continually focused on the manufacture and packaging of devices that are terminally sterilized. In 2014, we opened an additional location in Tijuana, Mexico and vertically integrated with the addition of cleanroom injection molding. We were recently recognized by Business NH as the #5 fastest growing company in the state.

Why Phase 2?

Phase 2 is committed to transparency. As a manufacturing partner, we continuously improve using LEAN manufacturing principles. Continuous improvement comes in the form of cost reductions, higher throughput, less scrap, and best in class on-time delivery. We work with companies of all sizes with a commitment to get products launched quickly.

Phase 2 Medical Manufacturing, Inc. 88 Airport Drive Rochester, NH 03867 603.332.8900 F: 603.332.3766 phase2medical.com

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Tijuana, Mexico Manufacturing Our facility south of the border allows cost savings without the added hassle and expense of overseas production.

Our experienced team is capable of transitioning legacy production lines or new products directly into a low cost labor environment while utilizing our LEAN manufacturing improvement methodology.

New Product Development Our 4 stage development process helps customers launch validated medical devices into the market quickly. Engineering focus is on design for manufacturability to provide for a smooth transition to volume. Additional capability with planning for packaging and sterilization validation helps speed up the process and reduce risk.

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Proto Labs is the world’s fastest digital manufacturing source for custom prototypes and low-volume production parts. It’s a technology-enabled company that uses advanced 3D printing, CNC machining and injection molding technologies to produce parts within days. The result is an unprecedented speed-to-market value for designers and engineers and an on-demand manufacturing resource throughout a product’s life

Company History Proto Labs began in 1999 specializing in the quick-turn manufacturing of custom plastic injection-molded parts.

In 2007, the company introduced its CNC machining service and in 2014, expanded into 3D printing with the addition of additive manufacturing.

Proto Labs is a global company with full-service manufacturing operations in the United States, Europe and Japan.

Why Proto Labs?

cycle.

Proto Labs has radically changed the economics and lead times traditionally associated with manufactured parts. The rapid manufacturer provides a fast, easy and cost-effective way to obtain 1 to 10,000 parts within days, routinely shipping parts before conventional suppliers can even quote them. These quick delivery times are possible because it has automated the manual process of mold design and toolpath generation through the use of proprietary software.

Interactive Quoting Product developers can upload a 3D CAD model online at any time and receive an interactive quote with real-time pricing information and free design analysis within hours. The manufacturability analysis helps eliminate problems, like sink or warp, so modifications can be made before any actual production begins.

3D Printing Proto Labs uses the latest additive manufacturing (aka 3D printing) technologies to provide precision accuracy to plastic and metal part production — from small pieces with complex geometries to large, highly detailed patterns. 3D printing is ideal for 1 to 50 parts and works well for form and fit testing, reducing multipart assemblies and as fully functional components in some cases.

Global Headquarters

CNC Machining

5540 Pioneer Creek Dr.

The company’s CNC machining service uses three-axis milling and turning with live tooling to machine up to 200 parts from more than 30 stocked plastic and metal materials. The result is functional parts made from engineering-grade materials for prototype testing, jigs and fixtures, and end-use applications.

Maple Plain, MN 55359 USA 877.479.3680 customerservice@protolabs.com

Injection Molding

protolabs.com

For those who need low-volume production, bridge tooling or on-demand parts throughout a product’s life cycle, rapid injection molding can manufacture up to 10,000 parts from hundreds of different engineering-grade plastic, metal (including magnesium) and liquid silicone rubber materials.

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PTI Engineered Plastics is a custom injection molder and manufacturer of plastic components and assemblies. Their diverse global customer base varies from small tier suppliers to large OEM’s within the medical, automotive, defense, aerospace and consumer product markets.

The customized 155,000 square foot facility in Macomb Michigan offers full design services, engineering, tooling, low and high volume production, and an array of

Capabilities

secondary services.

Design

PTI Engineered Plastics 50900 Corporate Dr. Macomb, MI 48044 586.263.5100 teampti.com

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Their production floor currently hosts (44) injection molding machines ranging from 12-750 tons of clamping force with .33 to 98 oz. shot capacity. Manufacturing capabilities include low and high volume production, insert/overmolding, high-temperature molding, contract manufacturing, assembly and packaging.

Tooling

Services within ISO Class 8 Cleanroom include injection molding, assembly, secondary operations and packaging.

PTI’s Tool Room is home to the new Lumex Avance-25, the only machine in the world with the unique capability of manufacturing complex molds and parts in a single process.

On the Tool Room floor you’ll find a fully integrated tooling network, (18) high-speed vertical machining centers, three of which are Makino with spindle speeds of 20,000 RPM’s complimented by a Makino Horizontal Machine. All machines utilize thermal shrink collet tooling for precision and accuracy. Their EDM department includes (4) high-speed graphite robotic load machining centers with spindle speeds up to 54,000 RPM. We offer plunge EDM machining as well as wire EDM capabilities. PTI uses an array of materials from aluminum, mild steel, hardened steels and stainless. Injection mold types include: unit-mold insert, free standing, shuttle loading, hot runner, single cavity and multiple cavity. PTI’s proprietary capability, the P3™ Process, creates ready for-production prototypes, providing their customers’ with speed to market without compromise to product design or material choice.

Voting for this company will identify it as a leader in the medical technology industry.

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Production

PTI can take you from mind to manufacturing® starting with their industrial design and development studio. PTI Design can optimize your design, or take your idea through their five-phase process to insure your product has the competitive edge in the market. PTI uses 3D CAD software and moldflow simulation tools to test and validate your product prior to manufacturing.

Cleanroom Manufacturing

Validation

PTI is fully versed and staffed in the IQ/OQ/ PQ validation protocol.

Certification

PTI is FDA, UL, and ITAR registered and ISO 13485:2003, ISO 9001:2008, ISO 16949:2009

Value Added Services in clude: Plastic Joining services:

• Ultrasonic Welding • Staking • Vibration Welding • Swaging • Spin Welding • Thermal Imbedding • Hot Air Cold Staking • Thermal Processing

Part decorating services:

• Laser Marking • Pad Printing • Appliqué Assembly • In-Mold Decorating 1 • 2016

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A success story for 40 years Over the past 20 years, it has become common practice to purchase DC/ DC converters as a finished module.

This applies to all segments of the electronics industry, including industrial automation, transportation engineering, telecommunications, data technology, measurement technology, and medical electronics. Even for very large production runs, it’s rarely worthwhile for a company to develop their own DC/DC converter, particularly in view of the stringent international standards that apply nowadays.

At RECOM, when it comes to power conversion, we’ve always been very attentive to our customers’ needs and wishes, and have invested millions over the past decade in product development, growing our quality assurance lab, and expanding the scope of our worldwide distribution activities.This means we’re close by to our customers’ production facilities around the globe, offering the most reliable products available on today’s market ... with top-notch support – and, of course, competitive prices.

One of the fundamental principles of medicalgrade devices is hazard-based (HB) design and risk management. In practice this means that although an individual power supply might be fully certified to the 3rd Edition of the 60601 safety standard, all applications still have to be evaluated as part of their overall use within the medical environment. Therefore, we see requests for medical grade power supplies even in applications that are not directly related to clinical devices, for example, in the sanitary areas of hospitals or the audio-visual control equipment in the wards.

to be able to release our new range of 250Vac/2MOPP rated DC/DC converters in a DIP24 case size. The technical challenges of meeting the strict isolation, creepage and clearance specifications in such a small package were daunting, but through clever transformer design and the use of internal mezzanine PCB’s, we have succeeded. The three new product lines of 3W, 6W and 10W offer enhanced patient safety over our existing reinforced isolation DC/DC converters because they can withstand fault conditions of full mains voltage indefinitely. These new series were developed specifically to meet the demands of major global medical equipment manufacturers who wanted additional safety margins for their products.

The impact this has on RECOM as a manufacturer is that the breadth of demand for 60601-certified power supplies is widening to include areas which previously were covered by industrial safety standards. This is why we have introduced new product ranges of AC/DC semienclosed power supplies which are suitable for building-in to both clinical devices and into industrial enclosures.

RECOM Power Inc. 718.855.9710 admin@recom-power.com recom-power.com

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Although we are very proud of the cuttingedge specifications of our new AC/DC power supplies, RECOM is traditionally a DC/DC manufacturer, so we are equally pleased

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Resonetics provides laser micro manufacturing for life sciences and specializes in applications requiring precision laser processing of polymers, metals and glass. After 29 years in the business, we’ve cemented our reputation as a leader in laser micromachining. With core capabilities in laser cutting, welding, ablating and drilling, we create features as small as 1 micron and machine materials up to 1mm thick.

Resonetics has three manufacturing facilities in Boston, Dayton and San Diego with ISO13485:2003 certified quality systems and lean six-sigma practices.

Why Resonetics?

44 Simon Street Nashua, NH 03060 603.886.6772 603.886.3655 Fax sales@resonetics.com resonetics.com

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Big solutions for small problems - In the life sciences marketplace, the biggest problem might be really small — like 2 microns. We know how critical size and precision are when you need to ablate a polymer layer to expose the metal of a coated wire, microcut and weld a hypotube, or drill blood-cell-sized holes in a filter. You can depend on our expertise in laser micro manufacturing to help fabricate diagnostics and devices with the smallest possible features.

The leader in laser micro manufacturing for life sciences - Our team includes a large engineering staff, PhDs, optical scientists and automation experts who take a holistic approach to address critical design requirements with a cost-effective and repeatable approach. Our seven patents are proof that the team’s expertise is unmatched. This brainpower dovetails with impressive horsepower: Resonetics has the world’s largest capacity of laser micromachining systems in the ultra-violet wavelengths.

Medical device and diagnostics manufacturing services - Medical device and diagnostics manufacturing is a complex process. We’re more than just experts in laser micro manufacturing; we’ll handle program management, material outsourcing, and value-added services like catheter cutting, tipping and flaring to name a few. Our automation capabilities will help keep your costs down.

Fast prototyping - Our Lightspeed ADL application development lab can deliver results in days, not weeks or months, getting your product to market faster.

www.medicaldesignandoutsourcing.com

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Top equipment and facilities - Our facilities include laser systems (excimer, diode-pumped solid state, fiber, picosecond, femtosecond and CO2) running 24 hours per day, six days per week, as well as a large clean room manufacturing space. Whether your challenge is welding, ablating, drilling, skiving, stripping, etching or cutting, we have the laser micromachining systems in-house to solve it.

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SAB North America is the North American

(PVC, Polyurethane, Thermoplastic Elastomer (TPE), Silicon, Polypropylene, FEP, ETFE, XLPE) and any combination of components such as power, control, signal, communication, and coax. Additionally adding pneumatic, hydraulic or air hoses are a possibility to make any cable perfect for your specific requirements. We have designed more than 2,000 specialty cables in the past year with great success in an assortment of diverse functionalities. SAB’s long history of flexible cable manufacturing enables us to provide cables for almost any application.

sales, distribution, and service center of SAB Bröckskes located in Viersen, Germany- the leading manufacturer and distributor of cables worldwide since 1947. We house a wide-ranging line of European and Domestic products in stock for immediate delivery and have the shortest manufacturing lead times in the industry.

For over 60 years SAB has not only provided our customers with a wide array of wire, cable, & accessories but also impeccable, unmatched service. Call one of our representatives or visit our website to experience our commitment to solving your problems faster than you think.

SAB North America is known in more than 40 countries and often specified by name. SAB’s adherence to product quality has proven itself in thousands of the world’s most demanding applications.

Our products are produced at our facility in Viersen, Germany ensuring a strictly controlled manufacturing environment producing consistently high quality products. They have been intensively tested for over 60 years and have proven to have a longer service life and are of an overall better quality than similar products on the market.

SPECIALTY: The strength of SAB lies in the development and manufacturing of special products that meet and exceed our customers’ exacting specifications. Many capabilities can be achieved by selecting different combinations of jacketing, shielding, conductor, and insulation materials.

Our competences are extensive including various jacketing materials

SAB North America 344 Kaplan Drive Fairfield NJ 07004 Tel: 973-276-0500 Fax: 973-276-1515 Toll Free: 866-722-2974 Email: info@sabcable.com www.sabcable.com

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STANDARD: At SAB North America, we stock a wide ranging line of European and Domestic wire, cable, and cable accessory products available for immediate delivery from our location in Fairfield, NJ. Our catalog contains a line of cables ranging from Flexible Control Cables and Continuous Flex Cables to Tray Cables and Halogen-Free Cables to name a few. SAB is pleased to offer worldwide approvals including UL, CSA, CE, and VDE Certifications to most of the product line.

ACCESSORIES: SAB also offers an extensive inventory and product line of high-quality cable accessories. The variety of polyamide and nickel plated brass Cord Grips, EMC Cable Glands, and other accessories complement our flexible control and automation cables perfectly.

SERVICE: With unmatched levels of customer service and an extensive in-stock inventory, SAB North America offers immediate off-the-shelf delivery on most of its cables. Specialty cables can be designed, manufactured, and delivered in just a few weeks.

For clarifications, details or explanations about any of our products and how they can be used in your specific applications, give one of our experienced Sales Staff a call.

Visit our website, www.sabcable.com, to experience our commitment to solving your problems faster than you think possible.

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Over our 40-year history, Seal Master has designed and manufactured a variety of custom rubber seals and parts, focusing on reinforced inflatable seals. Our inflatable seal capabilities range from large custom parts like seals for aircraft hangars, to products as small as a collar to harness laboratory mice.

So, if you have the need for quality rubber products— large, small, or somewhere in between—Seal Master has the solution for you. We pride ourselves in creatively solving industry needs with our custom rubber molding solutions. Seal Master Corporation consistently leads the industry in engineering and is always available for your custom sealing solutions.

Seal Master Corporation has paved the way for custom engineered; fabric reinforced inflatable rubber seals since 1974. With over 45 years of combined experience our engineering team has created over 7,800 unique inflatable rubber seals and other inflatable rubber products. Our enthusiasm and creativity have helped Seal Master Corporation service our customers’ needs for decades. Our capabilities span across numerous industries including medical design and bulk handling. Whether your application requires an airtight seal for sterilization purposes or quality measures for handling pharmaceuticals Seal Master Corporation has a solution for you. Quality, FDA compliant materials are used when producing custom engineered inflatable solutions for our customers. Our team of engineers works closely with our customers to collaborate and solve difficult sealing issues. Our design assistance program realizes that every application is unique and is on hand to troubleshoot, create and produce innovative products as solutions to the customer’s technical needs.

Seal Master Corporation works with you as a teammate to obtain an understanding of your specific project requirements so we are able to recommend the best possible solution. All products are hand built in our state of the art facility and thoroughly inspected by our trained quality professionals not only for cosmetic standards but also performance. With sealing solutions ranging from bulk handling to medical testing services (and everything in between), Seal Master Corporation consistently leads the Medtech industry and is available for your custom engineered sealing solutions.

368 Martinel Drive Kent, OH 44240 800.477.8436 sealmaster.com

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Servometer is the leading developer and manufacturer of electrodeposited miniature metal bellows responsible for “making the impossible, possible” in critical medical applications. It’s a solutions driven company providing premier custom products such as miniature bellows, bellows assemblies, contact springs, flexible shaft couplings, and structurally rigid electroforms. Today, Servometer precision products are used in hundreds of medical applications like catheter tip molds, infusion pumps, drug delivery, surgical instruments, implantable devices and more. The possibilities are as diverse as the research and development projects.

Company History

Servometer has been designing and manufacturing precision engineered electrodeposited metal bellows since 1957. The two engineers who founded the company were responsible for developing and patenting a unique manufacturing technologyelectrodeposition. What began as small precision metal bellows now includes flexible shaft couplings, gold plated electrical contacts, rigid electroforms and sub-assemblies. In 2007 Servometer acquired BellowsTech, a premiere manufacturer of edge welded metal bellows.

The two technologies complement each other in size, compatibility, pressure and temperature limitations without sacrificing performance.

Hallmark Manufacturing Process

Servometer® employs a proven, electrodeposition manufacturing process to produce parts in unusual shapes with close tolerances that are extremely light weight, and sensitive. Electroforming is the process of

973.785.4630 sales@servometer.com servometer.com

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depositing thin layers of metal onto a mandrel through electroplating, dissolving the mandrel chemically, and leaving the plating as the final electroformed product. Servometer’s custom designed products are typically made of electrodeposited nickel, copper, gold or combinations of all three. The resulting electroforms are thin walled, hollow metal parts as small as 0.20 inches (.5 mm) in diameter; 0.24 inches (.6 mm) in length and .0003 inches (.008 mm) thick.

Free Engineering Assistance

Servometer takes pride in developing the highest level of quality products from design through production to delivery. A technical team of engineers is available to act as an extension of an OEM’s design team to help optimize designs and to meet specific application requirements. Servometer electroforms can be made to meet almost any design challenge.

Servometer is ISO 9001:2008 certified.

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About Smalley: Innovation, quality and engineering excellence has driven Smalley to be the leading manufacturer of Spirolox® Retaining Rings, Constant Section Rings and Wave Springs. We believe that engineers should work with engineers. So our customers work directly with our experienced team. This access to technical expertise and problem solving, prototyping and collaboration is rare in the industry. But it allows you to take your designs further than you thought possible.

Every Smalley ring and spring is backed by our legendary customer support. Our commitment to service combined with our reputation for on-time delivery has earned us an approved supplier status with leading OEM manufacturers around the world. Our commitment is to quality, customer service, and finding the most cost-effective solution.

For over 50 years, Smalley has manufactured retaining rings and wave springs using our unique coiling technology. Smalley has become established as the top manufacturer of spiral retaining rings and flat wire wave springs.

Smalley is ISO 9001, ISO/TS 16949, AS9100 and ISO 14001 certified.

Products: Wave/Compression Springs: Smalley Wave Springs offer the unique advantage of space savings when used to replace coil springs. By reducing spring operating height, wave springs also produce a decrease in the spring cavity. With a smaller assembly size and less material used in the manufacturing process, a cost savings is realized.

Wave springs operate as load bearing devices. They take up play and compensate for dimensional variations within assemblies.

A virtually unlimited range of forces can be produced whereby loads build either gradually or abruptly to reach a predetermined working height. This establishes a precise spring rate in which load is proportional to deflection.

Spirolox® Retaining Rings:

Smalley Steel Ring Company 555 Oakwood Road Lake Zurich, IL 60047 Phone: +1 847 719 5900 Fax: +1 847 719 5999 Email: info@smalley.com www.smalley.com

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Spirolox Retaining Rings, available exclusively from Smalley, have No Ears To Interfere® with the mating components in the assembly.

Spiral rings offer a 360° retaining surface, require no special tooling for removal and are interchangeable with ordinary snap ring grooves.

Constant Section Rings: Constant Section Rings are often specified for heavy duty or impact loading applications.

Smalley offers eight series of rings from stock in over 1,000 sizes.

New from Smalley, Hoopster Rings fit into much shallower grooves than regular snap rings or retaining rings. Hoopster Retaining Rings are suitable for light to heavy loads and are ideal for thin wall tubes.

Manufacturing Process: Smalley offers an exclusive Circular-Grain® Process. This process is not a stamping, but rather a continuous coil that is made from edge-wound, pre-hardened, spring-tempered flat wire. The flat wire has a grain structure that is linear, providing exceptional strength and dimensional stability.

Smalley’s unique manufacturing process reduces scrap allowing for the economical production of special alloy products including a large selection of stainless steel retaining rings and wave springs.

No-Tooling-Cost™ Process: Smalley’s CircularGrain® Process offers unusual flexibility in production. There is no special tooling needed, even for prototype or custom configurations. This results in low prototype cost and quick deliveries.

Free Samples: Smalley will send samples of catalog items for your evaluation, free of charge.

Simply go to www.smalley.com/samples to request free samples, catalogs, download CAD models, design assistance or design your own application specific ring or spring.

Laminar Sealing Rings: A Smalley Laminar Sealing Ring is a metallic labyrinth seal consisting of multiple rings in a groove. This arrangement of the rings and the specific orientation of the rings are dictated by the application and the severity of the environment.

www.medicaldesignandoutsourcing.com

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Hoopster Rings:

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Innovating Shock & Vibration Solutions Sorbothane, Inc. serves widely varied market segments with Standard and Custom Engineered components.

MARKETS SERVED TRANSPORTATION SHIPPING & LOGISTICS • Sorbothane® Safeguards Precious Cargo PRECISION LABORATORY EQUIPMENT • Sorbothane® Isolates Disruptive Vibration MOBILE ELECTRONIC DEVICES • Sorbothane® Attenuates Impact Shock & Isolates Vibration CONSUMER & COMMERCIAL PRODUCTS • Sorbothane® Damps Unwanted Vibration & Noise INDUSTRIAL & MANUFACTURING EQUIPMENT • Sorbothane® Extends Equipment Life AEROSPACE & AERONAUTICAL • Sorbothane® Protects Critical Components MEDICAL EQUIPMENT • Sorbothane® Protects Performance SPORTING GOODS & FITNESS • Sorbothane® Protects, Cushions & Comforts Sorbothane, Inc. is located in Kent, Ohio and operates 10 specialized pouring machines.

With 64,000 square feet of manufacturing space and supply support systems in place, the Sorbothane team stands ready to meet any production need. Sorbothane, Inc. has an engineering design staff that specializes in shock and vibration solutions plus an in-house testing and quality assurance lab.

Sorbothane® is a proprietary visco-elastic material that has been specified by engineers worldwide for over three decades. Sorbothane® is a highly damped polymeric solid that “flows” like a liquid under load. Its superior damping and isolation properties have been scientifically and real-world proven. Sorbothane® is ideal for engineering design applications requiring shock absorption, vibration isolation and acoustic damping. Produced in a durometer range from 25 to 85 - Shore 00 scale Sorbothane® is considered a super soft polyurethane.

CUSTOM Sorbothane® SOLUTIONS Unique applications call for very innovative solutions. Our engineering team will help design the custom Sorbothane® component perfect for your individual product specifications. Since 1982, Sorbothane, Inc. has engineered individualized shock and vibration solutions for numerous and diverse markets.

Unique applications call for innovative solutions.

Standard Sorbothane® parts and custom engineered solutions are available to meet individual product objectives.

Sorbothane, Inc. - Innovating Shock & Vibration Solutions

STANDARD Sorbothane® PRODUCTS Sorbothane, Inc. offers an extensive line of standard Sorbothane parts.

Our goal is to protect the performance and integrity of your product.

For over 32 years Sorbothane, Inc. has been - and will continue to be - the innovative and trusted choice of engineers worldwide for developing materials and components that isolate vibration, attenuate shock and damp unwanted noise.

These standard products have been developed over 30 years and are selected for their specific shock absorbing and vibration isolating applications.

The Sorbothane® Standard Products Guide is available at www.sorbothane.com or by contacting Sorbothane, Inc. directly.

2144 State Route 59 Kent, Ohio 44240 Phone: 800.838.3906 www.sorbothane.com

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Sunrise Labs, founded in 1991 by MIT engineers, understands what it takes to turn innovative ideas into commercial medical devices. Clients leverage our extensive knowledge of key technologies and regulatory requirements to solve their design challenges. At Sunrise, our projects are more than just “a job.” Our team is passionate about improving patient outcomes, and helping our clients to succeed.

ISO 13485 Certified Medical Product Development Concept

User Research

Support Feasibility & Proof of Concept

Product Development Lifecycle

Manufacturing

Architecture & Design Test & Release

Implementation

Apply Sunrise’s ISO 13485 certified process to ensure compliance with regulatory bodies worldwide.

Sunrise offers a broad set of services to solve your challenges across the product lifecycle. From full product development (Concept to Launch) to subsystem development, we deliver clean sheet designs or design updates. Clients appreciate our flexible service offerings including independent design reviews, system engineering, electronics design, software development, SW verification and validation, documentation and testing, design for manufacturing (DFM), transfer to manufacturing, and post launch design maintenance.

Engineering and Design While Sunrise provides complete product development, we can also help you deliver subsystems and technologies that integrate efficiently and effectively with your overall delivery. We work with you to understand your needs and develop a customized set of skills and processes that are best designed to integrate with your delivery process and team. Leverage our deep systems, electronics, software, and imaging expertise to augment your team.

Verification & Validation (V&V) Meet FDA requirements for verification and software validation using Sunrise’s quality management system, testing expertise, and tools. Our focus is First Pass Compliance to remove delays and extra effort required for resubmissions by doing it right the first time.

Sunrise Labs Inc 5 Dartmouth Dr Auburn, NH 03032 Tel: 603.644.4500 sunriselabs.com

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Product Lifecycle Support Solve your field issues and on-going manufacturing issues such as part obsolescence and regulatory compliance (60601-1 3rd Edition, RoHS, etc.). Markets and technologies are dynamically changing.

Sunrise can help you navigate these changes, and keep your product portfolio shipping.

Consulting Leverage our extensive background and deep technical expertise to solve complex problems to yield innovative solutions. A Technology Readiness Assessment can prove invaluable to uncover potential issues early before you move from prototype to Commercialization.

Project Rescue® Get your project back on track no matter where you are in the product development cycle. Our system approach to trouble shooting and product development expertise has been proven successful to get projects back on track.

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ENGINEERING MAKES THE DIFFERENCE. As the pioneer of the linear motion system and the patent innovator of Caged Technology, THK continues to be the preferred world leader in re-circulating, ball linear motion guide technology. When engineers select THK as their motion control partner, they get the benefit of THK’s industry leading Global Engineering Team of Linear Motion Experts.

THK has developed a line of products that incorporateTHK’s latest innovation - Caged Technology that separates rolling elements with a synthetic resin cage that retains grease, and reduces maintenance costs.

Caged Technology offers these specific benefits: • Higher load capacities allow space-saving alternatives for design in smaller guides.

• Increased operating speeds for higher production quantities.

• Long-term, maintenance-free – 3x longer than others providing more than 30,000 kM of continuous operation.

• No vibration “noise” from ball-toball contact allows for high precision applications to run with smoother motion.

• Heat from friction is drastically reduced because the rolling elements never touch.

• Ultra-low particulate generation assures greater reliability in “clean” environments.

THK’s experienced Global Engineering Team can provide customized linear motion solutions with our standard linear motion products as well as our mechatronics products for your most demanding applications.

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Model SRG

Model BTK-V

Model SRG is an ultrahigh rigidity Roller Guide that uses roller cages to prevent rollers from skewing, thus allowing low-friction, smooth motion and achieve long-term maintenance-free operation.

This Rolled Ball Screw feed achieves a DN value of 100,000 by using a new circulation structure.

Since the nut outer diameter and the mounting holes of this model are dimensionally interchangeable with the previous model BTK, model BTK can be replaced with this model.

Features: • Ultra-high Rigidity - A higher rigidity is achieved by using highly rigid rollers as the rolling elements and having the overall roller length (L) more than 1.5 times greater than the roller diameter (Dw).

• Smooth Motion through Skewing Prevention - The roller cage allows rollers to form an evenly spaced line while recirculating, thus preventing the rollers from skewing (tilt of rollers) as the block enters a loaded area. As a result, fluctuation of the rolling resistance is minimized and smooth stable motion is achieved.

• 4-way Equal Load - Since each row of rollers is arranged at a contact angle of 45º so that the LM block receives an equal load rating in all four directions (radial, reverse radial and lateral directions), high rigidity is ensured in all directions.

• Long term Maintenance-free Operation - Use of the roller cage eliminates friction between rollers and enables the lubricant to be retained in grease pockets formed between adjacent rollers.

As the rollers recirculate, the grease pocket serves to provide the adequate amount of lubricant to achieve long-term maintenance-free operation.

Micro Cross-Roller Ring Model RAU The all-new micro-size Cross-Roller Ring RAU achieves rotary motion in a compact package.

• Micro Cross-Roller Ring with inner diameter of 10 mm and outer diameter of 21 mm • More compact than a conventional angular contact ball bearing • Spacer retainer enables smooth movement and high rotation accuracy

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Caged Ball LM Guide Actuator model SKR Caged Ball LM Guide Actuator model SKR is a compact actuator that has a inner block consisting of LM blocks and a ball screw nut integrated inside a U-shaped outer rail. In addition, this model achieves high speed operation, lower noise and longer-term maintenance-free operation by using ball cages in the LM Guide units and the Ball Screw unit. (A ball cage is used only for the LM guide section of models SKR20 and SKR26 and the ball screws are fitted with QZ lubricators.)

4-way Equal Load Each row of balls is arranged at a contact angle of 45o so that the rated load on the inner block is uniform under loads applied to the inner block in the four directions (radial, reverse radial and lateral directions). As a result, model SKR can be used in any mounting orientation.

Structure In the RAU, the rollers travel on the V-shaped raceways ground into the inner and outer rings.

• Alternating rollers are arrayed orthogonally so that one bearing can support loads and moments in any direction.

Also, because of the integrated structure, the RAU can be used for either inner ring or outer ring rotation.

• The RAU is more compact and lighter weight than a double row angular contact ball bearing. It is also more rigid, even though it is made as compact as possible.

• The cross-sectional area of the model RAU is 57% smaller than the Cross-Roller Ring model RA, which was previously the thinnest ever. This enables further weight reduction. The line-up also includes other models whose inner diameters are the smallest to date: 10, 15, 20, 30, and 40mm.

Light Weight

THK 200 E. Commerce Drive, Schaumburg, IL 60173 Phone: 800-763-5459, 847-310-1111 Email: chicago@thk.com www.thk.com

The cross-sectional area of the model RAU is 57% smaller than the CrossRoller Ring model RA, which was previously the thinnest ever. This enables further weight reduction. The line-up also includes other models whose inner diameters are the smallest to date: 10, 15, 20, 30, and 40mm

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Web Industries is a leading medical Contract Manufacturing Organization (CMO) providing automated manufacturing of IVD test cartridges, LFI devices, diagnostic testing strips, and medical consumables. Specializing in medical device commercialization, we provide a full range of services necessary to bring new and existing medical devices to market at commercial-scale volumes.

Company History

For over 30 years, the world’s leading medical device companies have turned to Web Industries when they need a proven silent-partner CMO to provide automated manufacturing of their medical diagnostic tests and consumables. Web offers a full range of contract services for successful commercialization of new and existing medical devices. We create highly-customized manufacturing and supply chain solutions that help our partners overcome limited or non-existent internal capacity while reducing their risk and capital costs.

Commitment to Quality

Our medical facilities hold all required ISO and industry certifications, and we have been audited and validated by some of the largest organizations in the industry. Our rigorous quality assurance systems and commitment to quality has allowed us to successfully produce over 100 billion medical tests over the past two decades.

Web Industries Offers:

• • • • • • • • • 377 Simarano Drive, Suite 220 Marlborough, MA 01752 508.898.2988 sales@webindustries.com

30+ years of flexible goods & device manufacturing experience 20+ years LFI manufacturing & product transfer knowledge Flexible automated manufacturing systems High commercial-scale capacity (>10MM units) Prototype-to-Product Launch one-stop solutions Comprehensive supply chain management Non-competing CMO-only services Robust ISO and FDA compliant quality systems Manufactured with pride in the USA

Why Web Industries?

Web Industries applies expertise, innovative thinking, and creative problem solving to help speed time to market, drive down costs, and continuously improve processes to maximize medical product success. We know what it takes to get medical diagnostic devices right every time.

webindustries.com

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AD INDEX

Accu-Mold LLC........................................... 31 AIM Plastics................................................... 3 B.Braun Medical Inc................................... BC Bird Precision.............................................. 72 Bishop Wisecarver...................................... 69 Boyd Coatings Research Co., Inc.............. 43 Branson Ultrasonics...................................... 5 Cadence Inc. .............................................. 29 CCS Inc........................................................ 62 CGI, Inc........................................................ 49 Cicoil............................................................ 27 CPC — Colder Products Company........... 42 Eagle Stainless Tube & Fabrication, Inc.... 73 Fluid Metering, Inc..................................... 75 Groschopp, Inc........................................... 25 Heatron Inc. ................................................ 46 Helical Products Company........................ 41 Hermann Ultrasonics.................................. 15 Humphrey Products Corp.......................... 66 igus, Inc....................................................... 67 Interpower................................................... 71 Introtek Int’l................................................. 37 J.W. Winco, Inc........................................... 75 Keystone Electronics Corp........................... 9 LEMO USA, Inc........................................... 11 Lin Engineering........................................... 77 Master Bond ............................................... 19 maxon precision motor, inc........................ 23 Medbio, Inc................................................. 19 MICROMO...........................cover/corner, 50 Minnesota Rubber & Plastics..................... 13 Moog Animatics......................................... 10 MTD MicroMolding.................................... 45 Multi-Contact.............................................. 33 NOOK Industries, Inc................................. 61 NSK Precision America............................... 14 ODU-USA.................................................... 65 Phase 2 Medical Manufacturing, Inc......... 56 Proto Labs, Inc.............................................. 7 PTI Engineered Plastics, Inc....................... 35 RECOM Power Inc...................................... 55 RESONETICS............................................ IFC SAB North America.................................... 21 Seal Master.................................................. 48 Servometer................................................ IBC Smalley Steel Ring Co................................ 17 Sorbothane................................................. 36 Sunrise Labs................................................ 72 The Lee Company...................................... 18 THK America................................................. 1 Web Industries, Inc..................................... 54 128

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2016 MEDTECH LEADERSHIP

Accu-Mold LLC.................................81 AIM Plastics.......................................82 Bird Precision....................................83 Bishop Wisecarver............................84 Boyd Coatings Research Co., Inc....85 Branson Ultrasonics..........................86 Cadence Inc. ....................................87 CGI, Inc..............................................88 Cicoil..................................................89 CPC ­— Colder Products Co............90 Eagle Stainless Tube & Fabrication, Inc.................................91 Fluid Metering, Inc...........................92 Groschopp, Inc.................................93 Heatron Inc. ......................................94 Helical Products Company..............95 Hermann Ultrasonics........................96 Humphrey Products Corp................97 igus, Inc.............................................98 Interpower.........................................99 Introtek Int'l.....................................100 JW Winco, Inc.................................101 Keystone Electronics Corp.............102 LEMO USA, Inc...............................103 Lin Engineering...............................104 Master Bond....................................105 maxon precision motor, inc............106 Medbio, Inc.....................................107 MICROMO......................................108 Minnesota Rubber & Plastics.........109 Moog Animatics.............................110 MTD MicroMolding........................111 NOOK Industries, Inc.....................112 NSK Precision America...................113 ODU-USA........................................114 Phase2 Medical Manufacturing, Inc..........................115 ProtoLabs, Inc.................................116 PTI Engineered Plastics, Inc...........117 RECOM Power Inc..........................118 RESONETICS..................................119 SAB North America........................120 Seal Master......................................121 Servometer/BellowsTech...............122 Smalley Steel Ring Co....................123 Sorbothane.....................................124 Sunrise Labs....................................125 THK America...................................126 Web Industries, Inc.........................127

SALES

LEADERSHIP TEAM

Mike Caruso mcaruso@wtwhmedia.com 469.855.7344

Publisher Brian Johnson bjohnson@wtwhmedia.com 617.905.6116

Michael Ference mference@wtwhmedia.com 408.769.1188 @mrference Todd Christenson tchristenson@wtwhmedia.com 440.381.9048 @wtwh_todd David Geltman dgeltman@wtwhmedia.com 516.510.6514 @wtwh_david Jim Powers jpowers@wtwhmedia.com 312.925.7793 @jpowers_media

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

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 Megan Hollis mhollis@wtwhmedia.com 440.821.2941 @wtwh_Megan MaryAnn Cooke mcooke@wtwhmedia.com 781.320.8533 Mike Francesconi mfrancesconi@wtwhmedia.com 630.488.9029 Michelle Flando mflando@wtwhmedia.com 440.670.4772 @mflando

CONNECT WITH US!

Follow the whole team on twitter @ WTWH_Medical

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Medical Bellows

ELECTROFORMED BELLOWS TECHNOLOGY

Applications: • • • • • • • • •

Catheters for Therapies Infusion Pumps Implantable Devices Surgical Instruments Blood Pump Circulators Drug Delivery Seals for Harmonic Scapels MRI and Imaging Equipment Intravascular Tubing

ISO 9001:2008 Certified RoHS Compliant

Contact us for Engineering Assistance

Making the Impossible....Possible!

(973) 785-4630 | servometer.com Servometer 1-16.indd 1

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If you’re looking for a single-source supplier, how about one that has a full range of parenteral

pharmaceutical solutions? Or one with a catalog of valves as thick as a phone book? Or one that

carries all the admixture accessories you could ever pack into a custom kit for your drug or device?

& there’s more. Besides a line containing hundreds of products, we offer a full range of capabilities.

Project management puts your product on a fast track to market without compromising quality.

Our engineering and quality systems maintain exacting standards of excellence. Other services under our roof include full sterilization capabilities and regulatory expertise to ensure compliance in this country and around the world. It all adds up to a single-source supplier that goes far beyond being a vendor to being a true partner.

B. Braun Medical | OEM Division | USA ©2016 B. Braun Medical Inc. Bethlehem, PA. All rights reserved. OEM 15-4993 6/15 LMN

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