Medical Design & Outsourcing — JULY 2018

JULY 2018

www.medicaldesignandoutsourcing.com

HOW SENSORS ARE HELPING HEMODIALYSIS MOVE INTO THE HOME New sensor technology is enabling a massive migration from hospitals to home care environments.

WORKING WITH SUPPLIERS ON DRUG-DELIVERY TECHNOLOGIES

Medical device industry suppliers and outsourcers are helping to enable the latest drug-delivery technologies.

How’d they do that?

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FROM MEDICAL DEVICE CONTRACT MANUFACTURERS

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Medical Design & OUTSOURCING medicaldesignandoutsourcing.com ∞ July 2018 ∞ Vol4 No4

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

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7 • 2018

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HERE’S WHAT WE SEE

What will a trade war mean for medtech?

Medical device industry executives have a lot to like so far when it comes to President Donald Trump and the Republican Congress: U.S. corporations got a big tax cut, the moratorium on the 2.3% medical device excise tax has been extended to 2020, and Dr. Scott Gottlieb is proving himself to be the business-friendly FDA commissioner everyone thought he would be.

A trade war with China, however, could end the party.

Trade spats Trump started with Canada and the European Union could matter, too, but the disagreements so far have not focused on medical devices, explains Greg Crist, executive VP of public affairs at trade group AdvaMed. The escalating trade war with China is a different story. Under its “Made in China 2025” plan, the Chinese government seeks explosive growth in biomedical and high-end medical device manufacturing.

So the Trump administration has

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

included finished medical devices in the billions of dollars in tariffs the U.S. Trade Representative has levied against China.

The irony is that a decent chunk of the medical devices made in China and imported into the U.S. are actually made by U.S. medical device companies.

“U.S. medical device companies have benefitted from setting up factories in China,” Grace Palma, CEO of China Med Device, told Medical Design & Outsourcing. “With five times the U.S. population and low healthcare standards, as well as a very under-developed medtech industry, most of the large U.S. companies have benefitted from setting up local factories [in China] to reduce cost and provide easier access to local populations.”

As of this writing, medtech faced a nearly $1 billion hit from U.S. tariffs imposed against China, according to AdvaMed. That estimate doesn’t include items such as circuit boards and other components that go into medical devices.

China so far hasn’t targeted medical devices in its retaliatory tariffs, according to Palma.

It’s also worth noting that some of the major contract manufacturers serving the industry, including Integer and PhillipsMedisize, have facilities around the world.

So it isn’t just the big legacy medical device companies that are vulnerable to international trade disputes.

Other top stories for the medical device industry during the first half of 2018 included: • GE announces plans to spin out its GE Healthcare business, which has long been a money-maker for its parent.

GE Healthcare chief Kieran Murphy is slated to stay on board the $19 billion enterprise, with the spinout expected to take 12 to 18 months.

• In early June, the Wall Street Journal posts a report claiming that orthopedic giant Stryker was looking to buy Boston Scientific in a deal that would have created a company worth approximately $110 billion. The rumors send Stryker shares down and BSX stocks up, only to be dismissed after two days by Stryker.

• IBM Watson Health reportedly lays off between 50% to 70% of its workforce in May due to a softening market for value-based healthcare offerings. A number of reports from ex-employees seemed to reflect that major layoffs occurred across not only Watson Health, but also from acquisitions it had made earlier including Merge Healthcare and Truven Health Analytics. M

| | | |

Associate editor Fink Densford and assistant editor Danielle Kirsh contributed to this editorial.

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CONTRIBUTORS

JACOBSEN

DYKEMAN

JACOBS

BETTEN

ROWAN

POTTER TOURIGNY

BUTLER

STOKES DELPORTE

BILL BETTEN is the president of Betten Systems Solutions, a product development realization consulting organization based in Minneapolis-St. Paul. Betten taps into his years of experience in the medical industry to advance device product developments into the medical and life sciences industries. Betten most recently served as director of business solutions for Devicix/Nortech Systems, a contract design and manufacturing firm.

STEVE JACOBSEN is process development engineering manager at Micro (Somerset, N.J.), a full-service contract manufacturer. Micro draws on 70 years of experience in medical device assembly, precision metal stamping, insert and injection molding, machining, sharpening and finishing to deliver products to customers in a variety of industries including medical device, automotive, aerospace and electronics.

ALEX BUTLER is MasterControl’s manager of medical device solutions. He leads the development efforts for MasterControl Registrations. He’s also responsible for developing and improving other software solutions, including MasterControl Customer Complaints, MasterControl Bill of Materials (BOM), MasterControl Projects, MasterControl Risk Management and MasterControl PDM Connector.

ANDREW POTTER joined Bonifacio Consulting Services, (BCS) in 2012 and leads the company’s strategic planning and M&A engagements. He has more than 20 years of global manufacturing experience and helps corporate and financial groups maximize the value of their companies for long-term growth and competitive advantage, or for the best possible exit.

CHRISTOPHER DELPORTE is a journalist, messaging leader and content strategist with more than 20 years of experience.

He is an editor, storyteller and multiplatform communicator, with expertise in Capitol Hill coverage of Congress and federal regulatory agencies, as well as investigative journalism.

DAVID J. DYKEMAN, is a registered patent attorney with more than 20 years of experience in patent and intellectual property law, and co-chair of Greenberg Traurig’s global Life Sciences & Medical Technology Group. Dykeman's practice focuses on securing worldwide intellectual property protection and related business strategy for medical device clients, with particular experience in medical devices, wearables, robotics, life sciences and information technology.

SOL JACOBS is VP and general manager for Tadiran Batteries. He has over 25 years of experience in developing solutions for powering remote devices. His educational background includes a BS in engineering and an MBA. 8

Medical Design & Outsourcing

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JOE ROWAN is Junkosha‘s president and CEO for USA and Europe. Founded in Japan in 1954, Junkosha is a pioneer of sophisticated fluoropolymer application technologies across the medical device and microwave interconnect sectors. Junkosha has three operations in Japan including its headquarters, as well as sites in the U.S., U.K. and China.

BETHANY A. STOKES is an associate at Greenberg Traurig.

Stokes counsels clients on all aspects of procurement and enforcement of IP rights, including domestic and international trademarks and copyrights. She also focuses on technology licensing, including negotiating and drafting of licensing, joint venture, collaboration and other IP- related agreements.

JAY TOURIGNY is SVP at MicroCare Medical. He has been in the industry more than 25 years and holds a Bachelor of Science degree from the Massachusetts College of Liberal Arts. Tourigny holds numerous U.S. patents for cleaning-related products that are used on a daily basis in medical, fiber optic, and precision cleaning applications.

www.medicaldesignandoutsourcing.com

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MPD m e m o ry p r o t e c t i o n d e v i c e s

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CONTENTS

medicaldesignandoutsourcing.com ∞ July 2018 ∞ Vol4 No4

DEPARTMENTS

42

How’d they do that?

Top innovations from medical device contract manufacturers

Photo courtesy of istockphoto.com

ON THE COVER:

06

08 CONTRIBUTORS

12

49 How sensors are helping hemodialysis move into the home

New sensor technology is enabling a massive migration from hospitals to home care environments.

54 Working with suppliers on drug-delivery technologies

Medical device industry suppliers and outsourcers are helping to enable the latest drug-delivery technologies.

58 Five things medtech manufacturing executives learned from their dads

We talked with a group of second- and third-generation medtech manufacturers about following in Dad’s footsteps. Here’s what they learned.

62 Medtech contract manufacturing: Then and now

A decade ago, a number of notable trends and market forces began to change how the medical device manufacturing sector brought its products to market. They’re still shaping the market today.

66 Medical device product development: Here are the basics (Part 2)

The strategies for achieving medical device product development success could easily fill a book. Here’s the second in a short two-part primer on the subject.

10

Medical Design & Outsourcing

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7 • 2018

IP ISSUES: Drafting contract manufacturing agreements for success

18 REGULATORY: Three ways to streamline global medical device registrations 22 BATTERIES: Powering the wirelessly connected hospital 26

THE CATH LAB: Peelable tubing technology could transform miniaturized catheters

28

MATERIALS: Three ways advances in cleaning and coatings are driving medical device innovation

32

PRODUCT DEVELOPMENT: Will medtech see more neuroscience-based human factors research?

FEATURES 42 Seven innovations from medical device contract manufacturers

In many cases, innovations out of contract manufacturers are helping to enable advances in the medtech space. Here are some examples.

HERE’S WHAT WE SEE: What will a trade war mean for medtech?

38

TUBING TALKS: Creating articulated medical instruments

70 DEVICETALKS: Highlights from the sixth annual DeviceTalks Minnesota 72

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IP ISSUES

Drafting contract manufacturing agreements for success Successful collaborations between medical device OEMs and contract manufacturers are critical for advancing medtech, but they can backfire without carefully considered written agreements that protect their rights.

David J. Dykeman | G r e e n b e r g Tr a u r i g |

Bethany A. Stokes | G r e e n b e r g Tr a u r i g |

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Medical device manufacturers are under increasing pressure to reduce costs and improve margins. Outsourcing certain operations, including product manufacturing, packaging and distribution, to a third party is becoming a popular business strategy for the top medical device original equipment manufacturers (OEMs). Medical device OEMs are outsourcing assembly and eliminating factories and equipment, while contract manufacturing organizations (CMOs) are becoming their new operational partners.

With contract manufacturing playing a larger role in medical device development, it is critical for medical device OEMs to form successful collaborations with contract manufacturers. Similar to the beginning of any relationship, medical device OEMs and contract manufacturers often enter into a collaborative relationship, trusting each other with confidential information and pooling patent rights held prior to the partnership. Unfortunately, these contract manufacturing relationships may end unexpectedly, leaving the parties in vulnerable positions unless their rights 7 • 2018

have been protected with a carefully considered written agreement.

Successful collaborations involve complex and intense negotiations related to issues such as research and development, control, profits – and ultimately, termination. Although each collaboration is unique, medical device OEMs and contract manufacturers should ensure that a written contract manufacturing agreement addresses the key aspects discussed below.

Ownership of intellectual property (IP) Issues of ownership are often the biggest cause of disputes in collaborations.

To avoid conflicts, the contract manufacturing agreement should clearly state the division of intellectual property ownership. In collaborations, ownership rights are often granted in proportion to the contribution made toward the invention, but can also be divided by technology field or level of expertise.

Special consideration should be given to pre-existing intellectual property that each party brings into the collaboration.

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IP ISSUES

Medical device OEMs should make sure their background intellectual property is adequately protected. Additionally, contract manufacturing agreements should address each party’s responsibilities regarding (i) filing and maintenance of patent applications and patents; (ii) litigation obligations related to patent infringement suits and disputes; and (iii) improvements to the product or technology.

Grant-back provisions Although the contract manufacturer may benefit from access to OEM technology, the OEM desires control over improvements to the product or technology. A thorough contract manufacturing agreement will include grant-back assignment or license provisions to ensure that any improvements to the product or technology are granted back to the OEM.

YOUR IDEA

realized

Payments and royalties Valuing the contribution of each party can create conflict because it often determines the power balance between the parties. Contract manufacturing agreements should detail each party’s contribution and how each party will be compensated for its efforts. Payments can be made as upfront payments, milestone payments or running royalties.

Typically, once the agreement is in place, one party provides funds to cover initial costs. Alternatively, payments can be made when key milestones are achieved to minimize the risk associated with upfront payments.

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Regulatory approval and inspection For FDA regulated products, OEMs will need the assistance of contract manufacturers throughout the regulatory approval process. The contract manufacturing agreement should require that contract manufacturers assist in product and process documentation and plant inspections before and after regulatory approval.

Indemnification In the event the collaboration deteriorates or is challenged in any manner, the medical device OEM should ensure its interests are protected. An

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indemnification provision is a fair treatment clause that should be included in all agreements with contract manufacturers. For example, if a contract manufacturer produces defective products, the contract manufacturer should indemnify the OEM for the cost of a product recall or replacement.

Back-up supplier Sometimes unforeseen circumstances (plant capacity, machine breakdowns, shipping delays, natural disasters or other events) mean the contract manufacturer is unable to supply the requested quantity in a reasonable timeframe.

In these instances, the contract manufacturing agreement should clearly state that the OEM has a right to find a back-up supplier and is able to use the designs and molds of the original contract manufacturer. The designs and molds can be held in escrow by a third party, but the parties should be sure to clearly define the triggering events to release the escrow materials.

Assignment and change of control Although a standard provision in any agreement, assignment clauses should not be overlooked.

The current wave of consolidation in contract manufacturing requires more attention to these provisions. If a contract manufacturing agreement can be automatically assigned without consent, parties may end up working with competitors or other parties they did not initially intend to. Parties should consider whether contract manufacturing agreements should be automatically assigned upon a merger, acquisition or change of control, or if prior written consent is required.

Termination No matter how successful, most contract manufacturing arrangements will come to an end.

Agreeing to the details of an orderly termination before entering the collaboration is critical to avoid a messy dissolution. Termination clauses

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IP ISSUES

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should address (i) when a party may terminate the collaboration; (ii) what happens to the patent and other intellectual property rights upon termination; (iii) and the circumstances of termination. Parties will typically agree to termination in the event of a material breach of the agreement, insolvency, change of control, force majeure or failure to timely supply product.

Parties should also require adequate notice of termination and agree on what, if any, contractual obligations will survive termination, for example confidentiality, intellectual property and payment obligations. In particular, ownership and control of the designs, molds and manufacturing documentation upon termination should be clearly addressed.

Confidentiality Negotiating a contract manufacturing collaboration often requires disclosing confidential information to the other party, who may also work with your competitors. Prior to divulging any confidential information, parties should execute a written confidentiality agreement that prohibits sharing confidential information with any third parties or using confidential information for purposes other than its intended use. If a separate confidentiality agreement is not entered into by the parties, adequate confidentiality provisions should be included in the contract manufacturing agreement.

Conclusion Contract manufacturing is driving innovation and cost-savings in the medical device industry, trends that will likely continue.

Prior to disclosing confidential information or addressing intellectual property rights, parties should protect their interests with a thoroughly negotiated written contract manufacturing agreement, which is the key to successful collaborations. M

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REGULATORY

Three ways to streamline global medical device registrations Global medical device registrations can be time-consuming and costly for organizations. Here are some ways to improve the process.

Alex Butler | MasterControl |

18

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Obtaining clearance or approval for a medical device in the U.S. is cause for celebration. Obtaining clearance or approval for a medical device in multiple foreign countries is cause for jubilation.

Medtech firms see an average of 177 days pass before receiving a 510(k) clearance from the FDA. In other regulated markets, the wait times can vary widely. In addition, the difference in requirements and product registration is a source of constant anxiety and pressure for regulatory, submissions and quality professionals.

Every day a product is not on the market means lost income. Device makers do not want to incur any unnecessary delays in the product registration process.

7 • 2018

Whether developing a new and innovative device or re-launching an iterative product, the key to a timely and successful regulatory submission is effective dossier management. Here are some common dossier management challenges: 1. Automate through the red tape Every country or region has its own regulations for medical devices. Even after winning CE Mark approval for an entire region, such as the European Union, companies must still mind the nuances of each market, as some countries require additional registration depending on the class of the device.

The challenges grow exponentially

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Make your next medical breakthrough possible As a world leader in advanced medical device outsourcing, Integer’s technology and manufacturing can be found in virtually every medical device brand you trust.

Our engineering, quality, regulatory and manufacturing associates are here to make your next medical breakthrough possible.

Integer.net or call 833.722.3657 Products pictured Š 2018 Greatbatch Ltd. and its affiliates.

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REGULATORY

when the requirements are just different enough to create extra information demands. Imagine writing the same article 100 times – but changing every numerical reference by 5% each time. Managing 100 iterations with the subtlest of changes from one document to another requires a special knack and a whole lot of patience.

The E.U.’s adoption of the new Medical Device Regulation (MDR) in 2017 came one year after the United Kingdom’s referendum deciding its withdrawal from the E.U. For medtech firms, these developments brought twice as much new information and regulatory change to monitor, and that’s just in one part of the world. Companies must also keep up with new guidance issued by the FDA and any revisions to ISO 13485 international standards. The more markets targeted, the more regulations there are that must be adhered to and monitored.

Automating a paper-based or hybrid system is an important first step toward improving quality management in general and dossier management in particular. Because complex global regulations can be so difficult to manage, automated systems with reliable track records offer the safest and most economical means of addressing changes and improving dossier management. Instead of keeping massive volumes of information in electronic servers or in hard-copy formats, choose a robust solution that will improve your control and tracking of documents, workflows and timelines.

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2. Make transparency the priority Lack of transparency is one of the biggest stumbling blocks in a manual process, due to the poor collaboration across departments that inevitably results from siloed information. It can be difficult for team members to be proactive if they can’t readily see the status of a project or monitor milestones.

The importance of project visibility is multiplied for regulatory and quality managers dealing with several products and markets.

Reducing the number of inefficient manual processes can allow everyone involved to see all the countries and regions where products are being registered and the geographic locations where products are due for re-registration. This kind of realtime transparency is possible only with automation.

3. Connect disconnected systems It’s a common practice for companies to invest in multiple systems, such as PLM, MES, ERP and QMS, based on the specific needs of separate business units. When those systems can’t talk to each other, the business units can’t efficiently work together. Worse, the different systems create silos that often result in miscommunication and wasted resources.

This causes massive headaches for the regulatory department. For example, consider a company headquartered in New York City. The New York team is responsible for management of the dossier for a new dental implant system designed and developed by a team in Dublin. But the company’s E.U. authorized representative, charged with obtaining CE Mark approval, is based in Berlin. If each person in this chain isn’t on the same page at the same time, it’s easy for any document change made by the Dublin team to fall through the cracks, leaving the New York team and the Berlin AR out of the loop and in a bind. Companies should not rely on spreadsheets, phone calls and emails.

They need a system that holds all the regulatory data and documentation in one system.

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BATTERIES

Powering the wirelessly connected hospital The wirelessly connected hospital requires battery-powered medical devices designed to operate reliably at all times.

Faced with rapidly aging populations and limited resources, hospitals worldwide are turning to wireless technology to make healthcare systems more economical, scalable, secure, measurable, accountable and efficient.

As nurse-to-patient ratios continue to grow, the “connected hospital” provides access to accurate and timely data that frees caregivers to spend less time on administrative work so they can focus on providing the best quality of care possible to a growing patient population.

Advanced lithium batteries ensure continuous connectivity To deliver the highest quality of patient care, battery-powered medical devices should be

Comparison of primary lithium cells

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

designed to operate reliably at all times. This demands a thoughtful choice of batteries.

Various primary (non-rechargeable) battery chemistries are available, including alkaline, iron disulfate (LiFeS2), lithium manganese dioxide (LiMNO2), lithium thionyl chloride (LiSOCl2) and lithium metal oxide. (See Table 1.)

Lithium batteries power a wide variety of medical devices, including automatic external defibrillators, surgical power tools, robotic cameras, RFID asset tags, infusion pumps, bone growth stimulators, glucose monitors, blood oxygen meters and cauterizers. Lithium battery chemistry offers the highest specific energy (energy per unit weight) and energy density (energy per unit volume) of any battery

Primary Cell LiSOCL2 LiSOCL2

Bobbin-type with Bobbin-type

Hybrid Layer Capacitor

Li Metal Oxide Modified for high capacity

Li Metal Oxide Alkaline Modified for high power

LiFeS2 Lithium Iron Disulfate

LiMnO2 CR123A

Energy Density (Wh/1)

1,420

1,420

370

185

600

650

650

Power

Very High

Low

Very High

Very High

Low

High

Moderate

Voltage

3.6 to 3.9 V

3.6 V

4.1 V

4.1 V

1.5 V

1.5 V

3.0 V

Pulse Amplitude Excellent

Small

High

Very High

Low

Moderate

Moderate

Passivation

High

Very Low

None

N/A

Fair

Moderate

Fair

Excellent

Excellent

Low

Moderate

Fair

None

Performance at Excellent Elevated Temp.

Performance at Excellent Fair Moderate Excellent Low Moderate Low Temp.

Poor

Operating life Excellent

Excellent Excellent

Excellent

Moderate Moderate

Fair

Self-Discharge Rate

Very Low

Very Low

Very Low

Very High

High

Operating Temp.

-55°C to 85°C, can be extended to 105°C for a short time

-80°C to -45°C to 85°C -45°C to 85°C 125°C

Very Low

Moderate

-0°C to -20°C to 60°C 60°C

0°C to 60°C

Table courtesy of Tadiran Batteries

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BATTERIES

Lithium thionyl chloride (LiSOCl2) batteries

Image courtesy of Tadiran Batteries

type, along with nominal open circuit voltages ranging from 1.7V to 3.9V, which allows products to be miniaturized.

Bobbin-type LiSOCl2 batteries are ideal for wireless medical applications that require low average daily current and permit extended battery life of up to 40 years. Due to the absence of water and the chemical and physical stability of the electrolyte materials, bobbin-type LiSOCl2 cells can also withstand extremely high temperatures.

Bobbin-type LiSOCl2 batteries are also uniquely suited for the medical cold chain, where transplant organs, tissue samples, and pharmaceuticals must be continuously monitored during transport at -80°C. The typical hospital setting also offers abundant opportunities for deploying consumer grade alkaline and rechargeable lithium-ion (Li-ion) batteries, especially for non-essential medical devices that do not pose a life safety threat if the battery fails and needs replacement.

Consumer grade rechargeable Li-ion batteries have limitations such as a limited lifespan of five years and 500 full recharge cycles, a relatively narrow temperature range (-20°C to 60°C), and the inability to deliver the high pulses required for two-way wireless communications. By contrast, industrial grade Li-ion batteries can operate for up to 20 years and 5,000 full recharge cycles while offering a wider temperature range (–40°C to 90°C) with the ability to handle 15A pulses and 5A continuous current.

(See Table 2.)

Understand the challenging operating environment Medical devices often require secure WiFi connections throughout the hospital to form robust and secure networks that are free of potential disruptions.

Hospitals are notoriously complex and difficult RF environments, with large, multi-floor campuses and obstructions such as lead-lined walls making for potential connectivity problems. To complicate matters, hospitals face the risk of interference from a wide range of portable handheld wireless devices possessed by hospital staff, patients and guests. To address 24

Medical Design & Outsourcing

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these challenges, the Enterprise version of WiFi Protected Access 2, or WPA2, is typically utilized to provide user authentication and data encryption that is HIPAA compliant.

Conclusion Lacking industry-wide standards, medical device manufacturers, wireless module manufacturers, infrastructure providers and IT personnel must work together to achieve the full potential of the “connected hospital.”

Turning concept into reality is a complex challenge that requires careful due diligence and expert technological deployment to ensure robust performance, comprehensive data security and system reliability. Identifying the ideal battery-powered solution is a critical step that enhances long-term product reliability and reduces the total cost of ownership. M

Comparison of consumer versus

TLI-1550 (AA) Li-Ion industrial Li-ion rechargeable batteries

Industrial Grade 18650 Diameter (max)

[cm]

1.51

1.86

Length (max)

[cm]

5.30

6.52

Volume

[cc] 9.49 17.71

Nominal Voltage

[V] 3.7 3.7

Max Discharge Rate

[C]

15C

1.6C

Max Continuos Discharge Current

[A]

5

5

Capacity

[mAh]

330

3000

Energy Density

[Wh/l] 129 627

Power [RT]

[W/liter]

1950

1045

Power [-20C]

[W/liter]

> 630

< 170

Operating Temp

deg. C

-40 to +90

-20 to +60

Charging Temp

deg. C

-40 to +85

0 to +45

Self Discharge rate

[%/Year]

<5

<20

Cycle Life

[100% DOD]

~5000

~300

Cycle Life

[75% DOD]

~6250

~400

Cycle Life

[50% DOD]

~10000

~650

[Years]

>20

<5

Operating Life

Table courtesy of Tadiran Batteries

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THE CATH LAB

Peelable tubing technology could transform miniaturized catheters Here’s how peelable tubing technology is leading to advances in catheterization.

Joe Rowan | Junkosha |

Medical tubing makers face a variety of pressures to provide cost-effective, highest-quality products on shorter timescales. This is mainly driven by the global healthcare market, which continues to demand products and solutions that push the boundaries of what’s possible at highly competitive price points.

Take the catheter market as a prime example. Neurovascular procedures have clinicians pushing for solutions that enable them to deliver complex procedures more efficiently, not only reducing costs and saving time but enabling the provision of higher quality of care. Procedures including delivering stents, coils and even transmitting signals or therapy via catheter are all moving from “nice to have” to the mainstream over the next few years.

The evolution of peelable heat-shrink tubing Peelable heat-shrink tubing not only addresses healthcare customers’ unmet needs, but also paves the way for progressively smaller catheter-based procedures – an ongoing requirement for medical device manufacturers.

PHST ultimately reduces total cost of ownership for the catheter manufacturer.

Because companies no longer must skive heat-shrink material from the catheter, PHST helps them produce final product more rapidly, with improved yields and lower inspection levels, all with a more ergonomically safe process.

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The peelable heat shrinking process involves a very specific set of tasks, typically using a mandrel, etched PTFE liner (EPL), braiding sleeve, Pebax, PHST and a laminator.

After stretching the EPL liner over the mandrel and tying a knot on both ends, the catheter manufacturer then places it into a vertical laminator with a heating chuck on the top and a weight on the bottom to apply a consistent amount of heating and stretching. An important consideration for catheter manufacturers at this stage is the tensile strength of the EPL. In general, high tensile strength is desirable; many manufacturers have a proprietary process for developing that strength.

The etched PTFE-lined mandrel is then removed from the laminator and the sleeve of metal braiding is placed over the liner (this delivers tortuosity to the surgeon, helping ease the catheter through the vasculature), followed by the tube of Pebax and then, lastly, the PHST.

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7/19/18 11:27 AM

LASER

PARTS? LEFT: Junkosha’s peelable heat-shrink tubing technology, Junflon, promises time-saving and process improvements in catheter manufacturing.

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Image courtesy of Junkosha

All of this is now placed into the laminator, where the PHST enables the reflow of all of the materials used into a continuous, robust tube. The catheter manufacturer can peel off the PHST with ease, neck the mandrel and pull it out.

Taking small to the next level The latest innovations in PHST are based on the needs of medtech manufacturers, which asked for tubing that works on the miniature guide wires used to navigate tiny vessels within the brain or heart. This technology requires ultra-small PHST and high-shrink ratios. Ultra-small PHST is suitable tubing for laminating jacket coatings to tiny guidewires (e.g. 0.011 in. and 0.014 in.). PHST has shown a recovered inner diameter down to 0.009 in. A high-shrink ratio PHST (2:1) can be employed in manufacturing processes where tapered microcatheter shafts are used or where tolerance take-up is an issue.

A key benefit of PHST is that it can reduce scrap rates and decrease assembly time. Requiring only a single slit in one end to get it started, PHST peels easily along its entire length without the need for extra tools in the process, therefore saving significant time over the removal of fluorinated ethylene propylene heat-shrink tubing (FEP-HST). In addition, it enhances productivity for catheter manufacturers who can remove the PHST with ease without damaging the catheter or guide wire, therefore resulting in an ability to use the same catheter more frequently.

Miniaturization and ‘active’ catheters The trend toward miniaturization covers a wide spectrum of www.medicaldesignandoutsourcing.com

Catheters_7-18_Vs4.indd 27

applications, including neurovascular delivery of coils and stents for stroke or aneurysm therapies. The technology also enabled signals/energy to help support treatments such as neuromodulation or neurostimulation, such as for potential Parkinson’s disease treatments.

These “active” catheters are designed to provide conduits for the delivery of signals or energy, such as intravascular ultrasound. Diagnostic applications include intravenous examination of atherosclerosis, a condition in which fatty material collects along the walls of arteries, with the distal end providing signals back to data collection equipment.

Therapeutic applications include pulsed ultrasound to remove plaque and transcranial MRI-guided high-intensity focused ultrasound for the non-invasive treatment of brain cancer, Parkinson’s and stroke.

Peripheral arterial disease, in which plaque obstructs blood flow in the arms and legs, is usually treated using balloon angioplasty and stents. A new device, pioneered

by Shockwave Medical, combines lithotripsy (sound waves to break up calcium, often used to treat kidney stones) with an angioplasty balloon catheter.

Enabling catheter innovations The miniaturization of catheters and the growing use of active catheters is challenging the medical device sector worldwide to produce solutions that enhance their use in previously inaccessible areas of the body. New tools, such as PHST, are cost-effective in reducing scrap rates whilst also increasing throughput by shortening assembly times. M

7 • 2018

Medical Design & Outsourcing 27

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MATERIALS Innovation in lubricants and precision cleaning has had to keep up with innovation in medical device design.

Image courtesy of MicroCare Medical

Three ways advances in cleaning and coatings are driving medical device innovation

Advances come with many benefits, but also bring new cleaning and coating challenges with their set of new solutions.

J a y To u r i g n y | MicroCare Medical |

Innovative thinking around medical device design helps move the industry forward and create new devices that address more health issues than ever before. This innovation is driven not only on the manufacturers’ side but on the patients’ side. For example, patient demand for more portable and lightweight devices is driving a trend toward smaller, wireless devices. Touchscreens are replacing hardware controls and wearable devices are increasingly popular. As with most innovation, these advances come with many benefits, but they also bring new cleaning and coating challenges – and therefore, a need for new solutions.

Here are three ways cleaning and coating advances are helping medical device designers overcome recent challenges: Overcoming complex cleaning challenges Making devices smaller and more portable has positive implications for patient compliance, but also creates new cleaning challenges for device manufacturers and design engineers. One is that smaller devices also 28

Medical Design & Outsourcing

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mean smaller components and smaller spaces that require cleaning (and drying) during manufacture.

Some cleaning solutions, such as water-based options, have a tendency to leave water spots and, because of surface tension, often aren’t able to easily clean small crevices. Devices must be cleaned to the highest of standards to ensure their readiness for the next step in the manufacturing process, whether it’s packaging, sterilization or coating.

Any remaining particulate can lead to inconsistent outcomes that could have an impact on device performance. And if the device is not completely dry when it’s packaged, bioburden can occur, which in turn can lead to infection. This is especially common with aqueous cleaning solutions when water is trapped in the small crevices of a device.

What’s a design engineer to do? Luckily, rather than stifling progress on truly innovative device design, new solvent-based cleaning technologies address these challenges. Due to the solvents’ lower surface tension, they are better at cleaning small spaces and also dry completely, eliminating concerns that spots or other particulates could affect the next steps in the process. Furthermore, unlike water, solvents present an environment that is inherently hostile to bacterial growth, which significantly reduces the risk of bioburden.

Overcoming stacked tolerances Recent medical device design incorporates singleuse devices that make procedures less complicated.

This often involves a device design that is minimally invasive, meaning a device that’s smaller and more complex, with many tiny parts. The higher the part count, the more likely stacked tolerances

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MATERIALS

Using solvents for cleaning medical device components is beneficial because they are more easily able to clean small spaces and also dry completely, eliminating concern around spots or other particulate affecting the next steps in the manufacturing process.

Image courtesy of MicroCare Medical

will be an issue for medical device design engineers and manufacturers. In engineering, tolerances refer to the permissible limit or limits of variation in a physical dimension. These dimensions leave some room for variation within certain limits, but when tolerances begin to stack up against each other, it often requires more force to actuate the device, ultimately affecting device performance.

Cost often plays a role in the decision-making process as design engineers and manufacturers think about dealing with stacked tolerances. Although it’s true that engineers can design everything with tighter tolerances to gain higher precision, this commonly means more frequent inspection and maintenance of tooling and fixtures during manufacture, driving up the unit price of a finished device.

Applying a low-friction coating such as dry lubricant using polytetrafluoroethylene (PTFE) particles or a lubricious coating such as silicone to the finished assembly to reduce friction can be a more cost-efficient solution.

Dry lubricants typically reduce the force needed to actuate or execute a device by 25% to 30% and provide smooth actuation during use of the device. Compared to oil-based

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silicone coatings, dry lubricants are nonmigrating, so they minimize clean room housekeeping requirements and will not transfer to packaging.

Overcoming lubricant application challenges Many of these medical device design trends also create challenges in the coatings application. Because of the complex nature of some medical device designs, coatings cannot simply be applied in a “one-size-fits-all” way. New options for applying lubricant coatings address these challenges – such as dipping or wiping and brushing, which allow for consistent and uniform coatings to virtually any surface or internal geometry. Other application methods include air spraying, airless spraying, aerosol sprays, drying and heat-curing. A knowledgeable coatings partner can recommend the best process for your particular application.

Another challenge in lubricant application is environmental regulation.

Carrier fluids once used to dilute lubricant dispersions are banned; their replacements either posed safety concerns or did not meet performance requirements. Luckily, new nonflammable carrier fluids meet environmental standards and have good solubility and materials compatibility.

The solution There’s no question that advances in medical device design have contributed to improved patient outcomes, but also created new challenges for medical device design engineers and manufacturers. New advances and innovations in solvent and coatings technology mean that the solvent vapor degreasing process may not only be the most cost-effective solution but also the most environmentally sound option in designing smaller devices and components. By choosing an experienced cleaning and coatings provider to partner with, you’ll receive expert advice and the right recommendations for your specific needs. M

Low friction coatings can be used on finished assemblies to reduce the force needed to actuate or execute a device.

Image courtesy of MicroCare Medical

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PRODUCT DEVELOPMENT

Will medtech see more neuroscience-based human factors research?

Human factors research may be due for an overhaul in the medical device space, with more neuroscience- and data-based tools.

Heather Thompson | Senior Editor |

The FDA’s 2016 human factors research guidance represented a big step for the industry, and some believe that sophisticated technology can play an even bigger role in determining medical devices’ safety, efficacy and usability.

Dr. Charles Murphy, the Inova Heart & Vascular Institute’s chief patient safety officer, drummed home the point earlier this year when he said that human factors research in medical technology development needs improvement.

“In healthcare, we’d love to see safety built and designed into the system,” Murphy said during the World Patient Safety, Science & Technology Summit in March. “So, I think about human factors being incorporated, and I think that’s exceedingly important – we don’t have that to the same level as other safety-critical industries have.”

Sophisticated neuroscience-based methods could boost human factors research, according to Charles Mauro, president of Mauro Usability Science, a product usability and design firm.

The New York-based company has found that electroencephalography (EEG) can reveal far more information than other neuroscience-based tools.

Nancy Crotti | Senior Editor |

Image courtesy of Mauro Usability Science

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Mauro’s firm uses EEG research methodology to address cognitive workload, valance (approach/avoidance) and engagement. EEG can also measure cognitive and affective responses in the absence of a behavioral report or even subjective awareness, but the system must be properly configured, maintained and calibrated to do so, according to the company.

In its 2016 guidance on Applying Human Factors & Usability Engineering, the FDA suggested using automated data capture for human-device interactions that are “subtle, complex, or occur rapidly, making them difficult to observe” in simulated-use testing. That would be in addition to the standard observations and interviews.

Mauro Usability Science employs several techniques beyond what FDA guidance suggests. These tools provide multi-dimensional and scientifically valid data on patient interactions with drugdelivery devices, according to Mauro.

They include:

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Mauro is a pioneer in expanding human factors research in this direction, according to Stephen Wilcox, principal of Philadelphia-based Design Science. While his firm hasn’t adopted all of Mauro’s methods, Wilcox is a big believer in eyetracking technology, especially when it comes to determining whether users have read the directions for a device.

“The eye tracking is a record of precisely and correctly where they’re looking,” Wilcox said. “We look at that pattern and we correlate that with the kinds of errors that they’re making.”

Companies like theirs also attach sensors to prototype syringes to measure the amount of fluid being dispensed and the timing in

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Medical Design & Outsourcing

7 • 2018

7/19/18 2:51 PM

which it occurs. Before, such measurements were guesswork, Wilcox added.

These methods produce vast amounts of data that are useless without advanced data aggregation and data analysis methods, according to Mauro.

“If you look at the traditional system where you just had an observer in a room with a respondent, you may have a videotape of the session, but that’s it. The videotape can be viewed over and over again if you want to, but in these more advanced data capture systems, a 60-minute trial with one respondent produces about 30 gigabytes of hard data.”

To get a true picture, hardware and software systems must combine the channels into a unified collection stream that provides hard data that researchers must be able to visualize in real time, Mauro added.

The teams must also have a skill set that includes statistical analysis. Traditional human factor studies have minor levels of statistical validity because the methodologies are unstructured and sample sizes are small.

The new methods allow the application of extremely robust, contemporary statistical methods to the data, such as conjoint analysis, multidimensional scaling and factor analysis. These

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are familiar methodologies in marketing but are rarely employed in the human factors field.

“I’m not fully convinced that all that is that useful,” Wilcox said, particularly facial expression analysis that might require follow-up questions. “However, I certainly share the general principle that if you can find a very empirical way to measure something instead of just relying on just basic observation, just what people say, you’re always better off.”

As the technology matures, Mauro said he foresees a huge gain in patient outcomes, even if the cost of conducting human factors research rises, and noted some less-obvious benefits.

“When you convert human factors engineering or patient usability data to a format that is basically engineering terms and engineering quantities, the engineering, product and development teams really adopt the information much more directly than they otherwise might with traditional observation-based subjective studies,” Mauro explained.

In addition, the robust level of data provides clear direction for design enhancements that benefit the patient directly. Mauro also predicted that the data could allow companies to write patent and intellectual property claims on innovations to get patents based on human factors engineering performance. “It produces a whole new area of IP for companies that want to capture and protect their devices,” he said.

Mauro also suspects that the main reason traditional observational research persists is that there are no alternatives yet.

“My bet is that the FDA guidance is going to change, and it’s going to change quickly because they’re responsible for the quality of the safety of the patient,” Mauro said. “It’s really a sea change in terms of what the methodologies can do.” M

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TUBING TALKS

Technical challenge: Creating articulated medical instruments Articulating instruments that include metal tubing offer more bend, flex and reach – and thus more freedom for surgeons who require minimally invasive tools for minimally invasive procedures.

ILT tube laser cutting machine

Image courtesy of Micro

Steve Jacobsen | Micro |

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The ability to grasp different angles, degrees and rotations is not typically easy with straight, rigid medical instruments.

Articulating instruments, especially as it relates to their tubing parts, can offer better access to difficult-to-reach areas for tip and positioning control. They also provide surgeons with more natural dexterity when operating through small incisions and offer support when their shoulders, arms and hands grow fatigued.

Adding functionality to instruments with tubing means that greater attention to detail is necessary during design planning, especially before development, to avoid challenges and pitfalls.

That’s why design for manufacturability, or designing products so that they’re easy to make, is extremely important. DFM allows potential problems to be identified and addressed during the design phase, which can save money and wasted resources in the long 7 • 2018

run. Product design engineers many times find themselves facing a dilemma, from cost, time or other factors, and dismiss manufacturing considerations – which could prove detrimental in producing the parts.

Here are some challenges to keep in mind when laser-cutting metal tubing to achieve articulation. It’s possible to rectify all of these in the design phase, before a first build.

1. Cutting approach There are advantages and disadvantages to the laser-cutting or machine-cutting of metal tubes, including application requirements, cost-effectiveness and production capabilities. With articulating instruments (which involve shaping and forming materials, including milling and drilling), there can be a considerable cost involved if errors in design are missed and not addressed early on.

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TUBING TALKS

2. Design for articulation Before the development of articulating instruments, itâ&#x20AC;&#x2122;s prudent to weigh the options, including the number of times a tube must articulate and to what degree, the amount of fatigue it will undergo, the temper a tube needs to be, the effect of stress concentrators, and the impact of cold-working the material.

3. Slugs Articulating instruments are built to have flex and bend capabilities; therefore, there will inevitably be unwanted pieces of metal (slugs) that are cut and removed from tubes to allow for independent movement. If these slugs, which can be as small as a human hair, are not properly controlled, they can cause issues for both the machine they are cut on as well as the product itself. Precise design certainty is imperative.

Volume and costs play a significant role in determining the best technology to use to help with slug control and mitigation in tubing development. The ultra-short-pulse femtosecond laser, for example, is ideal for cutting plastic and extremely thin stents â&#x20AC;&#x201C; virtually no heat is transferred into the part due to the short pulse, which vaporizes the

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Typical articulated laser cut tubes Image courtesy of Micro

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material completely. While these lasers have their advantages, they are infinitely slower and naturally cost more. A solidstate cutting laser with millisecond pulse durations is more cost-effective and best for disposables. Although this method will produce slugs, because the only material removed will be that of the beam diameter, there are techniques and technologies to ensure that they’re easily and efficiently removed from the tubing.

4. Programming Laser cutting articulated tubes poses specific challenges that can be mitigated with the proper programming techniques.

Traditional methods adopted from CNC milling and turning don’t directly translate to laser cutting of thin-walled articulating components. Laser focus and power output modulation are some of the process parameters that must be optimized to ensure efficient cutting.

Cut geometry and laser feed rate are also very important. A programmed cutting path that’s the most efficient for a particular cut may not be efficient for the removal of the resultant slug. The section to be removed can lock or entangle itself within the base component, requiring multiple passes to break the cut up into smaller sections.

Conclusion For single-use disposable devices, a highend femtosecond or picosecond laser is not necessary. Although a standard lasercutting machine produces slugs from tubes, it’s much less expensive. And, with the right manufacturing process, the impact of these slugs can be mitigated with programming and machine additions (e.g., magnets).

Partnering with an experienced CMO with manufacturing expertise and historical product knowledge can extract the most value from a DFM approach. M

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DISRUPTIVE INNOVATIONS

N AN CY CROT T I | SEN I OR EDI TOR

The finished medical devices often get the publicity. But in many cases, innovations out of contract manufacturers are helping to enable advances in the medtech space. Here are some examples.

CHARLES DARWIN wrote, "In the long history of humankind (and animal kind, too) those who learned to collaborate and improvise most effectively have prevailed."

Medical device manufacturers get the credit for many innovations, but many need the ingenuity and commitment of contract manufacturers who design and produce the components that make those big splashes possible. The end result of such collaborations may improve or even save lives.

Here are some examples of recent advances out of contract manufacturers that are enabling medical device innovation.

www.medicaldesignandoutsourcing.com

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DISRUPTIVE INNOVATIONS

MAXON MOTOR'S STEAM-STERILIZABLE ENCODER Maxon Motor introduced a steam-sterilizable encoder for surgical robots and handheld surgical power tools. The ENX Easy encoder’s ability to withstand sterilization enables medtech manufacturers to assemble motors that can be completely autoclaved, according to Carsten Horn, business development engineer for Sachseln, Switzerland–based Maxon.

ENX Easy is available in incremental (1,024 counts) and absolute versions (4,096 steps), both designed for 1,000 autoclave cycles. The ENX Easy can be combined with matching BLDC motors and planetary gearheads.

The encoder can be integrated into the brushless drives ECX 13 and ECX 16 Speed (up to 120,000 rpm and 104 W) without any increase in length. When the gearheads GPX 13 and GPX 16 SPEED (0.2 Nm max. continuous torque) are added to the combination, customers receive a fully sterilizable positioning system.

“That’s the missing part to really generate a drive system for a closedloop drive,” Horn told Medical Design & Outsourcing. “It gives the engineers many more options. They now have the option to do positioning requirements in an autoclavable system, which hasn’t been so easy for a while.”

Autoclave cycles are hard on materials, so the company had to take measures to protect the motor’s chip and printed circuit board (PCB).

“You need to take care so no water or steam can come in between the pins and the PCB because that will immediately destroy the PCB,” Horn said.

Maxon Motor's ENX Easy is a steam-sterilizable encoder for surgical robots and handheld surgical power tools.

Image courtesy of Maxon Motor

HERAEUS' COIL TECHNOLOGY WITH DUAL-DIRECTIONAL TORQUE RESPONSE Heraeus Medical Components developed a coil technology that the company said could disrupt the catheter-based treatment of complex coronary and peripheral artery diseases.

Heraeus’ three-layer TriFlex coil technology platform with dual-directional torque response was designed for numerous therapies. It resists compression, providing better pushability for improved access to hard-to-reach places, can cross complex lesions and delivers the flexibility needed to go through complex, tortuous anatomy.

The company says the unique coil configuration can Heraeus' TriFlex is a threeenable design layer coil with dual-directional teams to develop torque response designed delivery systems for use in microcatheters and with improved other medtech applications.

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accuracy, and ultimately an improved experience for both the physician and the patient.

Heraeus (St. Paul, Minn.) uses TriFlex in its own latest microcatheter to address critical clinical issues such as improved torque transmission for optimal vessel selection. The technology is used to treat cardiovascular disease, and chronic total occlusions (CTO) in coronary and peripheral vasculature such as critical limb ischemia (CLI), which frequently results in the amputation of lower limbs.

The coil’s precise torque response makes it a suitable component for inclusion in devices designed for other conditions that require precise therapy delivery to hard-to-reach parts of the body such as transcatheter aortic valve replacement (TAVR), mitral valve replacement (MVR) and repair, atrial septal defect (ASD) occlusion and left atrial appendage (LAA) occlusion.

The innovations could result in faster procedures, a reduction in failure rates, and a reduction in overall treatment costs, the company added.

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DISRUPTIVE INNOVATIONS

GUILL TOOL & ENGINEERING'S ONE-BOLT EXTRUSION CROSSHEAD Guill Tool & Engineering completely reengineered a crosshead that the company believes could streamline the extrusion process for thinwalled jacketing and precision ID/OD tubing.

Standard crosshead designs with four adjustment bolts located 90° apart require operators to loosen one bolt and tighten the opposing bolt in order to yield a tube with a uniform wall thickness. Adjusting out any unacceptable eccentricity requires obtaining a measurement of the product’s current concentricity, which is either done as an inline process or after the extrudate has been fully cooled and cut for sampling.

“The whole time you’re making these adjustments, you’re wasting time and plastic,” product development engineer Denis Finn Jr. told us.

The new Micro Medical crosshead has just one bolt that controls 360° of concentricity adjustment. Having just one bolt that can orbit freely around the outside of the die should reduce the time it takes to get the line running and producing quality product versus standard concentricity adjustment, Finn said.

Concentricity adjustment precision with the Micro Medical reaches 0.008 in. or finer per revolution, according to Guill (West Warwick, R.I.). The singlepoint crosshead includes a patented cam-lock deflector for quick changeovers. The deflector has a residence time of 1 min. at 0.5 lb/hr material flow. It has optimized usage with extruders measuring 0.5 in. and 0.75 in., and a max die ID of 0.25 in.

“In essence, it’s a total overhaul of an offering that’s existed for awhile,” he added.

“Every single facet of it has been carefully revised to keep operators’ efficiency as high as possible. We’re maximizing the efficiency of the die assembly.”

The Micro Medical crosshead also accepts both vacuum and micro-air accessories and works well in pressure and sleeving applications, according to the company. Fluoropolymer designs are available upon request.

Guill's Micro Medical is a single-bolt crosshead that controls 360° of concentricity adjustment and can help keep extrusion work flowing.

Image courtesy of Guill Tool & Engineering

3M MEDICAL TAPE THAT STICKS FOR UP TO TWO WEEKS

Image courtesy of 3M

The latest addition to 3M’s line of medical-grade tape can remain in place on the skin for up to two weeks, according to the company.

That’s good news for users of infusion pumps, cardiac monitors, glucose monitors, health monitors and other devices worn on the skin, who have long complained that existing adhesives are not good enough. Long-term adhesives have had issues with lift (in which part of the adhesive loses stick), pain at removal, and skin conditions under the adhesive.

3M 4077 is a single-coated, water-resistant, non-woven elastic blend with omnidirectional stretchability and improved air penetration. It combines adhesive with a white meltblown elastic nonwoven backing on a silicone release liner. It is compatible with ethylene oxide sterilization, electron beams and gamma sterilization, compliant with ISO:10993 sections 5 and 10, and is approved for use on intact skin. www.medicaldesignandoutsourcing.com

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Medical device manufacturers and engineers need long-term wear adhesive solutions that increase patient comfort and provide strong and reliable bonds in challenging applications when adhering to skin, according to Marcello Napol, global business director in 3M’s critical and chronic care solutions division.

“As soon as we launched the 4076 about a year ago, we knew we were going to have to produce 4077 to add to our family of go-to products, giving design engineers even more skinfriendly options," Napol told MDO. “Our newest product, 4077, is water-resistant, breathable and offers improved conformability with omnidirectional stretch. Design engineers have a variety of factors to consider when selecting adhesives for skin, so we’re constantly iterating in response to market needs. We anticipate leveraging this technology to expand our long wear platform with additional products in the future.”

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DISRUPTIVE INNOVATIONS

TE CONNECTIVITY HAS A SIMPLER ULTRASONIC AIR BUBBLE DETECTOR TE Connectivity has fine-tuned its AD-101 ultrasonic air bubble detector by making its electronics less complex.

Using analytics to model the behavior of the device’s ultrasonic waves, the company’s engineers altered its sensors so they could drastically simplify its printed circuit board (PCB), explained Susan Zaks, product manager for TE Connectivity (Schaffhausen, Switzerland). The ultrasonic waves detect air bubbles in infusion lines, which deliver fluids to the body. If allowed to enter the bloodstream, these bubbles could cause a heart attack or a stroke.

“We modeled it using finite element analysis so we could predict the behavior of the ultrasonic waves so we could reduce the electronic complexity,” Zaks said. “It’s all in the modeling.”

The refined bubble detector may be used as

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part of any manufacturer’s infusion pump or dialysis machine. Upon detecting a bubble, it produces a flashing red LED signal. The sensor output can also be used to generate a sound alarm for a nurses’ station.

Although the PCB was designed specifically for air bubble detectors, the company has used the same analytical methodology to design other sensors for improved performance and to hasten the development cycle. For example, TE Connectivity is using the same modeling process to design new ultrasoniclevel sensors to detect the liquid level in a container.

Simplifying the circuit board has also reduced prices significantly, Zaks added. She declined to reveal prices, saying they depend upon order volume.

“To offer competitive performance at this big of a cost advantage is a big deal,” Zaks said. “And it opens up some huge markets that we weren’t looking at before.”

TE Connectivity used analytics to model the behavior of ultrasonic waves to make its AD101 ultrasonic air bubble detector less complex Image courtesy of TE Connectivity

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DISRUPTIVE INNOVATIONS

INTEGER’S IMPROVED FEEDTHROUGH FOR IMPLANTABLE DEVICES Integer's new feedthrough is much smaller than the traditional feedthrough and is hermetically sealed to protect the electronics and the patient.

Image courtesy of Integer

Integer (NYSE: ITGR) has found a way to enable manufacturers of neuromodulation and other implantable devices to significantly shrink their products.

The company has designed a feedthrough that is much smaller than the traditional feedthrough and is hermetically sealed to protect the electronics and the patient, according to Keith Seitz, senior director of research and development for Frisco, Texas–based Integer.

The traditional feedthrough is formed of aluminum oxide with goldbrazed platinum wires. The new technology injects platinum into a green aluminum oxide ceramic body and is then co-fired at high temperatures to form a biocompatible hermetic feedthrough.

The proprietary forming method for the co-fired platinum/ aluminum oxide technology enables the creation of smaller openings and less aluminum oxide ceramic between vias when compared to traditional feedthrough insulators that require core rods to be extracted from the green body during pressing of aluminum oxidepressed ceramics.

Heraeus introduced a similar-concept feedthrough late last year, the CerMet. Integer says its technology is different in a couple of ways. For example, Integer claims its platinum conductor is of the same purity or higher when compared with the standard platinum in use for pin feedthroughs by other manufacturers. This is meant to ensure the same or better electrical performance and attachment by soldering, welding or wire bonding as the present feedthrough technology. Integer’s technology also demonstrates perfect alignment layerto-layer, yielding very consistent conductor diameter control, the company added.

“We’ve gone from tens of channels to hundreds if not thousands of channels with this technology,” Seitz said.

The technology has potential uses in cochlear and retinal implants and for deep brain and spinal cord peripheral nerve stimulators, as well as for implantable cardiac defibrillators and pacemakers, Seitz said. It’s been under development for six years and is the subject of several patents.

“Now we’re moving forward with specific customer shape and product development,” he said. “This new feedthrough technology is extremely exciting and is being deployed in a wide variety of med device applications.”

SPECTRUM PLASTICS GROUP AND RAPID PROTOTYPING FOR FINISHED CATHETERS A Spectrum Plastics Group company has refined a rapid-prototyping technology so it may be used for finished catheters.

Vector+ allows customers to design a catheter component in any shape, and the company can produce it with the same speed and design of prototyping, according to Mike Schultz, vice president of operations for Spectrum’s Apollo Medical Extrusion, Sandy, Utah.

“Currently, catheter components are either injection molded or 3D printed. This is a huge roadblock in designing catheters,” Schultz said. “With only a limited number of materials that can be 3D printed and product design being limited by what shapes can be injection molded, a lot of product design is constrained by what’s achievable.”

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Vector+ is fabricated from medical grade, USP Class VI and/or ISO 10993 certified materials and additives. It is thermally welded to the catheter, creating a seamless dimension that allows for a smooth, low profile, but high-strength transition, according to the company.

Traditionally, such a process is limited to early prototyping through 3D printing.

Vector+ makes it possible for the full-scale production of the component and catheter, leading to lower tooling costs and a fast track to manufacturing. By using the same materials for the catheter shaft and for the Vector+, customers reduce the numbers of materials in their device and thus reduce waste and material testing costs associated with catheter design and development.

Image courtesy of Spectrum Plastics Group

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FI N K DEN SFORD | ASSOCI ATE ED I TO R

Homeward

bound:

How sensors are helping hemodialysis move into the home Providing advanced medical care in a patient’s home once required the help of trained professionals. No longer – new sensor technology is enabling a massive migration from hospitals to home care environments.

MEDTECH IS ON THE MOVE AGAIN. New technological advances are enabling systems that have, for years, been shackled to hospitals and clinics, to travel home with their users.

For decades, hemodialysis systems have been limited to use within highly-controlled and monitored healthcare environments, but new developments are helping change that paradigm.

What’s at the heart of that change? Sensors.

Improvements in sensor technology have been an “absolutely vital advance” for home hemodialysis platform developer Outset Medical, CEO Leslie Trigg told Medical Design & Outsourcing. Though the device features a streamlined touchscreen interface, a small size and other factors that may impress patients and doctors alike, the real core of its effectiveness lies in its sensors.

“The backbone of simplicity starts with sensors and software,” Trigg said.

The industry is taking note. Investments in home hemodialysis tech have been on the rise; last year, Fresenius Medical Care put in a $2 billion bid to acquire home hemodialysis developer NxStage Medical.

Over the past three years, Outset Medical brought in more than $200 million to support its Tablo platform. Advances in sensor technology have been essential in the development and success of Outset’s platform, Trigg told us.

“The Tablo is sensor-rich in its construction, in its design. We’ve been able to effectively use sensors to automate not only the treatment management, but the maintenance of the machine, and make the whole experience from beginning to end less laborintensive for the patient. And when something is less labor-intensive, the cognitive burden is lower, and then when the cognitive burden is lower, you expand the number of people who can capably manage their own [treatments] using the technology,” she explained.

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Advances in sensor technology are driving more change than just in hemodialysis care, according to TE Connectivity’s Pete Smith. They’re also changing how medtech developers think about care across the spectrum, said Smith, senior manager for sensor product knowledge & training.

“I’ve been in the sensor industry for 47 years, so I’m kind of the old man of the place,” Smith, a 32-year TE Connectivity veteran, said. “For a few years now, the medical industry has been trying to move patient care out of hospitals and into the home for a number of reasons – things like the fact that people are more comfortable in the home, they’re surrounded by people they know and they get as good care as they would in the hospital.”

As patient care moves toward the home, so too must the machines necessary to their care and survival. This includes simple devices, such as diagnostics and monitors, and more advanced machines such as hemodialysis systems.

“Because it’s more convenient for the patient, it’s easier to do. They can schedule around their availabilities,” Smith told MDO. “Better scheduling means an increase in compliance, which can be critical to the well-being of patients undergoing hemodialysis.”

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And self-managing care comes with other advantages, Outset CEO Trigg said.

“We’ve seen this in other fields – diabetes is one that comes to mind immediately. It’s a case where putting the patient in charge of their own care has absolutely lowered the event rate, lowered hospitalization rates, lowered ER visits. And I think a similar movement is likely to hit dialysis, finally,” she said. “We know that the more you miss dialysis, the higher your risk for hospitalization and ER visits. So simple things like that – the patient missing fewer visits, and being less likely to be in the hospital.”

But it’s not as simple as sending patients home with a new appliance.

“There are things that you have to worry about when you take one of these medical machines and send it outside the hospital environment. First of all, when it’s in the hospital, it’s being operated by a professional – someone highly trained who knows how to work it, understands indications on the machine and can determine if it’s not working right,” Smith noted.

Hospital equipment isn’t generally designed with the layperson in mind, he added, and the indicators and data they display often requires medical training to interpret.

“If it’s not effective, or there’s some problem with the treatment the machine is delivering to the patient, professionals at the hospital will quickly recognize that,” Smith said.

For decades, this requirement has limited home care to those who can afford a trained attendant along with the equipment. But that’s beginning to change due to advances in sensor technology, he said.

That technology allows equipment engineers to streamline the care process and design machines that don’t require advanced medical training to be safely and effectively operated.

“To make this work, the machine has to be aware of the patient’s situation. What is the status of the patient, what are their vital signs?”

Smith explained. “They collect that information regularly in the hospital, but how do they do it at home? The machines have to be designed not only to do their job, but to monitor all of the various physiological parameters that are important to a recovery procedure, the recovery process for the patient. And much of this awareness that the machine has to have is delivered from sensors.”

For applications in home hemodialysis, this includes advanced blood pressure sensors, temperature sensors and flow sensors, among others, Smith said.

At Outset Medical, a wide array of sensors were necessary to enable the system to provide home-based care.

“To power Tablo’s unique functionality, conductivity, temperature, pressure and ultrasound sensors are key. For example, conductivity sensors are essential in quantifying Tablo’s real-time water purification performance, ensuring that the dialysate is mixed properly and confirming the patient has set up the concentrates correctly. Ultrasonic sensors are important for detecting fluid versus air in lines, which helps enable automated priming and prompting the machine to proceed to the next step. These sensors also provide indispensable patient safety protection,” said Outset Medical COO Martin Vazquez.

Beyond monitoring patients’ status, home equipment has an even harder job – monitoring its own status.

“There’s a second feature that these sorts of machines have to worry about, and that’s its own health. The machine needs to be

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HOME DIALYSIS

aware of it, it needs to know if it’s operating properly. It needs to be able to determine, in its role as a machine to the patient, ‘Am I doing the right thing, the therapy that the doctors ordered?’”

TE Connectivity’s Smith said.

This requires, essentially, an entirely different set of sensors intended to monitor the device’s safety and effectiveness. And in a world where malfunctions can mean actual life-or-death consequences, those sensors play a vital role.

“There’s a whole set of sensors inside these machines that essentially monitor only the machine operation,” Smith said.

This includes another separate set of pressure and temperature sensors, flow sensors and even simple things like balance and stability monitors, Smith said. It’s also important that machines like this can identify internal or non-obvious damage.

“You’re actually not only monitoring the health of the patient, but you’re also monitoring that the machine is accurately monitoring the health of the patient, and simple things too, like if the machine was dropped on the floor, was it dropped hard enough that it might have caused damage?” Smith said.

On top of self-monitoring, home-care devices also need to be simple, Smith added.

“The perfect machine designed to go home with a patient has two controls on it – an on button and an off button,” he said.

Patients can’t be expected to understand or manipulate various advanced controls that a professional in a hospital environment would be required to, as that introduces yet another opportunity for device failure.

“If you put advanced settings on a machine and give it to someone that’s not trained in it, there’s a fairly high likelihood that they’re going to set it wrong – that some agent out there will figure a way to do it wrong. So you want to minimize the number of patient controls,” Smith said.

This calls for, yet again, more sensors – to monitor the device’s condition and settings, and stop operation if incorrectly set. And if the machine can’t function safely, it can’t rely on the patient to notify the appropriate bodies – it has to do it itself, he added.

“Most of these machines are now, I believe, connected to the Internet. They have Bluetooth, they can hook up to your phone.

And doctors give patients the home monitoring equipment so that once a day, or once every two days, or whatever interval the doctor directs, the machine will send all the data it has collected back to the doctor’s office where it can be reviewed and analyzed.

And the machines can also send back a report saying, ‘Hey, something happened to me. I got dropped on the floor and this part of me isn’t working,’” Smith said. “These machines can turn themselves off, call the doctor and say, ‘I’m not working.’”

For Outset Medical, taking into account both software and sensor capabilities was necessary to produce a machine that could be safely operated by both inexperienced and experienced users, according to COO Vazquez.

“Our primary goal was to ensure that Tablo was easy and accessible for the broadest possible user base. To get there, we needed to design something that could be as easily used by a 70-year-old dialysis patient as by a professional dialysis nurse in an ICU. We also had to consider how to design for a new user versus one who is more experienced with dialysis,” he said. “To 7 • 2018

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address the needs of an inexperienced user population, we employed three strategies.”

Those strategies are providing low information density on each screen, using animations to show each step of the process and requiring no memorization or mental math of the user, Vazquez said.

While those simplified features can be a boon for inexperienced users, they can often leave more advanced users and medical professionals wishing for more, he said.

“By contrast, advanced users are often looking for more information – they want to compress the workflow and can move to more advanced troubleshooting on their own. To ensure we also served this audience, we designed default settings to aid the inexperienced user, but included advanced features and displays behind the defaults,” Vazquez said. “In this way, we were able to keep the core Tablo experience simple and relatable without restricting the extra bells and whistles for those who want them.”

Sensor technology is still actively improving, Smith said. It’s getting smaller, more energy efficient and more capable at monitoring multiple spectrums and could enable even more advanced medical technology to travel home with its users.

“The future is that they’re trying to make all this medical equipment sort of ‘invisible,’ or at least unobtrusive,” Smith said.

For Outset’s Trigg, hope lies in the idea that this sensor tech, and the devices it enables, will allow more people to receive treatment. Currently, less and less areas in the U.S. can handle massive dialysis facilities, and many areas go under-served with the current infrastructure, she said.

“There are still many pockets across the United States of patients who are underserved, patients who are still driving long distances just to get their dialysis,” Trigg said. “It’s been really gratifying to have patient feedback, like wow, this is just so much easier, and it’s so much better and it’s made a dramatic impact on their life – that’s been really gratifying.” M

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7/19/18 3:05 PM

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DRUG DELIVERY

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www.medicaldesignandoutsourcing.com

Image courtesy of Lubrizol LifeSciences

7/19/18 12:41 PM

DRUG DELIVERY

Medical device industry suppliers and outsourcers are helping to enable the latest drug-delivery technologies.

HEATHER THOMPSON | SENIOR EDITOR

DRUG-ELUTING TECHNOLOGIES ARE MOVING BEYOND STENTS, thanks in part to the development of polymeric hydrogels engineered to respond to a range of different physical and chemical stimuli.

Medtech innovators have figured out how to use hydrogels as components of micro-shells or nanoparticles to assist with controlled, long-term drug delivery. They’ve also figured out how to take soluble polymers integrated into the coatings for drug-coated balloon and use them as excipients to optimize shortterm local drug delivery.

In nonvascular applications, specialized polymers have been used for drug release in the eye and in 3D matrices for tissue engineering and stem cell applications.

Add to that the need to encourage better compliance, and drug-delivery technology is booming.

The global market, valued at about $200 billion this year, is expected to near $300 billion by 2025, according to Research & Markets.

A range of new uses are making their way through the pipeline, according to experts at suppliers and outsourcers – everything from treating glaucoma, to contraception, to helping implanted sensors and rhythm control devices work at a higher level.

And as the technology advances, future uses could include treating organs and diseases in the body beyond the vascular system, Ingolf Schult, director of business development & clinical affairs at Freudenberg Medical/Hemoteq, told Medical Design & Outsourcing.

Medtech companies are feeling increased pressure to get drug-delivery technologies to market; suppliers in turn are seeking to improve drug-eluting polymers, shepherd pharma companies through the device world and improve manufacturing capabilities to lower risk and cost and increase quality.

Here are some of the product development and technological challenges – and solutions – facing drugdelivery technology companies and the suppliers:

www.medicaldesignandoutsourcing.com

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DRUG DELIVERY

1. The need to determine primary modes of action At the beginning of any conversation with a supplier, the device maker should know the primary mode of action.

“Combination products typically fall into one of two buckets,” explained James Arps, director of pharma services, ProMed Pharma. “If the device is the primary motive (mode of) action and the drug is secondary, then representatives from the device side of the FDA will usually be assigned lead the regulatory assessment, with support from [the

Center for Drug Evaluation and Research]. If the drug is the primary actor, then CDER usually takes the lead.”

Combination products include steroideluting electrodes for cardiac pacemakers and implantable sensors. In these cases, the drug’s application could be to minimize fibrous encapsulation, Arps said.

“Simply put, you’re trying to mitigate the effect of delivering an implant into the body, how it scars over,” he told us.

Pharmaceutical experts can also infuse devices with antimicrobial or antibiotic agents to prevent infection, or with bioactive agents to encourage bone regrowth and fusion, Arps said. Or the drug might be part of an intrauterine device, an ophthalmic drug-delivery implant or subcutaneous implants.

Determining the primary mode of action determines how the FDA will manage the approval or clearance process. Arps noted that most product developers have a good sense of which path the federal safety watchdog is likely to use because “the statutes and guidances are pretty clear.”

2. Other product development challenges There are other hurdles when it comes to developing drug-delivery products. Many are similar to what any medtech developer

TOP: Intrauterine device prototype for long-term contraception.

BOTTOM: Molded silicone subcutaneous implants.

RIGHT: Various cardiac pacing components that can be loaded with a steroid to minimize fibrous encapsulation.

faces, according to Schult. Crossover issues encountered by manufacturers of some combination products – those with primary “device” and secondary “drug” functions – include increased time to market, “up to 10 years from project ideation to global roll-out,” decreased value for incremental improvements and extreme price erosion.

Arps sees additional development challenges, particularly when a

All courtesy of ProMed Pharma LLC

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pharmaceutical firm attempts to make a device, or vice versa. Pharma companies might not be familiar with the intricacies of device development; unfamiliar processes, such as managing design history files, require a learning curve.

“We try to help them as much as we can, but being more of a contract developer/manufacturer, we don’t own the design of the product, so we have to work with them closely to make sure that all happens appropriately,” he said.

Joey Glassco, global market manager at Lubrizol, said working with both pharma and medtech companies can be a challenge because “it literally is two different languages.” For example, she said, when pharma companies look at clinical trials they’re looking for parameters that have nothing to do with the parameters set by the medtech company. From a supplier standpoint, it helps to have expertise in both company’s requirements, Glassco said.

3. Knowing your polymer options The technological challenges can be very complex, Arps said, especially making sure a drug is matched with the right polymer and release rate. Although each supplier might have a different idea of how to accomplish that, there are many similarities in how they approach the challenge.

Bruce Frank, VP of project management & operations at Lubrizol LifeSciences, explained the most common polymer options for drug delivery, including ethylene-vinyl acetates (EVA), thermoplastic urethanes (TPU), polylacticco-glycolic acids and polycaprolactone.

The first two are biodurable, meaning they don’t degrade within the body; the second pair are biodegradable, meaning water and enzymes in the body eventually break down and absorb them. Frank also noted that silicones are increasingly used for their ancillary benefits, such as ease of manufacturing for injection molding and long-term biostability.

Lubrizol’s contract development and manufacturing services division tends to prefer TPU because it can be modified for physical and chemical properties, he said.

“We can more easily tailor the exact properties we want into the polymer to give us the drug elution profile we’re looking for. What we found really is that

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DRUG DELIVERY

RIGHT: Biodegradable polymercoated drug-eluting metallic stents in crimped and expanded state.

Images courtesy of Freudenberg/Hemoteq

every drug and every drug-delivery profile can benefit from having a polymer with different physical and chemical properties.”

4. The need to build expertise A deep knowledge base is a priority for suppliers. ProMed put a lot of effort into constructing a library of experience, according to Arps, including investments in internal R&D to evaluate materials. The company partners with suppliers to assess new materials, analyze the initial formulation development and screen and test products for clinical studies or commercial use. That knowledge base cuts down on development time, he noted, so that the company can anticipate and minimize problems, such as degradation of the drug during processing, for example.

“If you have manufacturers that have these capabilities that can plug them in on an as-needed basis and have this flexible manufacturing capability – that’s going to be critical to future planning,” noted Mark Gordon, product manager at Trelleborg Sealing Solutions Americas Healthcare & Medical. “For instance, we have subsets of materials that we can use, say for small-molecule drugs, such as liquid silicone rubbers that lend themselves toward formulation with certain active ingredients. There are different polymers that can be used, primarily silicone, but in some cases other polymers that can be used as raterelease controls. All of these things work in conjunction and need extensive data to support the product specifications.”

Image courtesy of Lubrizol LifeSciences

5. Determining release rates There are two primary configurations for implanted release reservoirs, Gordon said. In one, a matrix, such as a silicone collar, “could be mixed with dexamethasone acetate, for example, for devices like pacemaker leads.” www.medicaldesignandoutsourcing.com

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These drugs are designed to be effective for a short time, say six to 12 weeks, after which there’s no longer a need for them because as the surrounding tissue heals the inflammation goes down, he said.

The second set of products requires release rates that can dose the drug over months or even years. Those products, Gordon explained, require a “throttle” of some sort to control the rate of release.

6. Shelf life Shelf life for drug delivery is also a big issue, Frank said.

“You want to get at least two years of stability and still maintain potency,” he said.

Stability tests should be run in early prototyping, he advised, and ideally should run at least one year longer than the requirements call for. He said calculating for chemical stability is a concept that is new to medical and a continuous challenge.

What’s next As the drug-delivery technology moves forward, Gordon said the drivers for better costs, higher production speeds, faster time to market, increase quality and risk reduction won’t change. But he also predicts an increased move to personalized medicine. That will mean even more pressure on suppliers for rapid development, turnaround and qualification.

“We as manufacturers will need to be able to plan for personalized medicine to provide pharmaceutical and drug related products on a more custom basis,” Gordon predicted. M

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LONGEVITY

Five things medtech manufacturing executives learned from their

Lucas Karabin (left) and his sister Rebecca KarabinAhern (right) currently serve as co-presidents of Acme Monaco, with their father Michael (center) as CEO.

Image courtesy of Acme Monaco

DADS

We talked to a group of

DAN I ELLE KI RSH | ASSI STAN T EDI TOR

second- and third-generation

ERIC CRAINICH, president and owner of Design Standards (Charlestown, N.H.), was told from a young age that it was his destiny to take over the company his father founded in Connecticut in 1971.

“Nothing would make him prouder or happier, and in the back of my mind, I knew that’s where I would land,” Crainich told Medical Design & Outsourcing.

As with many second- and third-generation business owners, though, Crainich didn’t take a straight path to the top of his dad’s firm. He forged his own path – even as he kept the lessons learned from Larry Crainich close to his heart.

The younger Crainich went to work for a carpenter for two summers during high school; his father was upset that he went to work for someone else. After graduating from Northeastern University in Boston, Eric went to work for U.S. Surgical in Germany, again much to his father’s dismay. But after talking it through, they came to an understanding that working for other companies and gaining experience would better position Eric to take on a leadership role at Design Standards.

medtech manufacturers about following in Dad’s footsteps.

Here's what they learned.

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LONGEVITY

Osypka’s dad sold the company in 1996, but Osypka bought it back in 1999. After regaining control, he told us, he realized that instead of competing with the larger companies he should be treating them as customers.

“I soon realized that better than competing in this industry with a finished device against larger competitors, it is much more profitable and fun to change Eric Crainich (left) and his dad Larry your competitors to customers by Crainich (right) have kept Design Standards offering turnkey finished devices in the family for more than 40 years. and accessories they don’t like to Image courtesy of CRDC make themselves,” Osypka said.

Over the last five years, Oscor has grown an average of 20% and is In 1988, Design Standards opened a expected to reach more than $60 million in second facility in New Hampshire. By 1994, revenue this year. when Eric Crainich joined the company, Acme Monaco (New Britain, Conn.) market uncertainty during Clinton-era has been a family business for three healthcare reform forced consolidation, generations. Lucas Karabin’s family resulting in the closing of the Bridgeport, purchased Acme Spring in 1965. Through Conn., facility. Although he was the the years, Karabin’s grandfather, uncle founder’s son, the elder Crainich forced his and father have had a chance to run the scion to work his way up through the ranks. company. Now, Karabin and his sister “He put me in a sales role, which Rebecca Karabin-Ahern are co-presidents. quickly turned into an inside sales role because we communicated like a small Acme Monaco is a manufacturer of company, yet we were working with very medical guidewires stampings and springs large organizations,” Eric Crainich recalled. and uses a number of materials including “At that point, we did not put a premium on communication. It was just something that we needed to do, and we’d get around to doing it.”

By 2002, Eric Crainich was handed the responsibility of running Design Standards; satisfied the enterprise was in good hands, Larry Crainich retired in 2006.

Oscor was founded in 1982 by Thomas Osypka’s father as a sister company of its main Germany-based company. Originally a manufacturer of finished implantable pacemaker leads, Oscor is now a finished device company with its own regulatory approvals, competing with larger device companies.

Osypka hardly thought he’d end up going to work at the family business; he wanted to have his own company.

“I never knew I would be working for my dad or taking over his company,” Osypka said. “In the end, once I started working for my dad, I fell in love with medical devices and was falling in love with the business.”

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nitinol. However, the company started off as Acme Spring making miniature bearing ring enclosures for aeronautics, defense, motion controls and rapid advances in small machining. Acme Spring later bought Monaco Spring in 1972 and merged in 1984 to become Acme Monaco.

The company has since expanded and has two manufacturing facilities in the U.S. and recently consolidated its two Presque Isle, Maine, facilities into one. It also has a manufacturing space in Singapore.

Karabin sort of knew he would end up working for the family business. He started working for the company at the age of 14 by just going in and cleaning up different areas and sweeping the parking lot.

“I kind of had it in the back of my mind for a better portion of my life,” he said.

Even though it was a family business, he still had to work his way through the ranks. Karabin’s interview for Acme Monaco was done by his uncle and his dad.

“Going through the interview process with your uncle and your dad is kind of a memorable experience,” Karabin said.

They gave him tasks like working in sales processing, working in customer service and driving grandma to the post office every once in awhile.

Here are five lessons these

Thomas Osypka (left) and his father Peter Image courtesy of Oscor

www.medicaldesignandoutsourcing.com

7/19/18 12:49 PM

LONGEVITY

manufacturing company executives have learned from their dads while taking over the family business.

1. Anticipate what’s next.

One of the lessons Eric Crainich learned from watching his dad run Design Standards was to try and look at what’s next. “[My dad] was always looking at what’s next and what could be the next competitive advantage,” Crainich said. “Markets are always changing.”

For example, Design Standards has been a molding company for 30 years. Recently, they moved into the tooling business and started doing tooling in-house for injection molds. Crainich says that’s been a successful move and allowed for speed and control.

2. Be personable to employees.

One lesson Crainich learned from his dad that he still practices today is making himself available to customer and employees.

“One of my big takeaways with 110 [employees] is when I give someone a tour, they’re always amazed that I know everybody’s name.

It’s important. I don’t want to be distant. I want to be approachable,” he explained. “I want to be able to find out what’s going on. If I get a call at five at night and need to answer somebody’s question, I don’t want to have to go downstairs to introduce myself to the second shift.

I want to be able to go down and have a conversation.”

Osypka said he strives to treat employees and customers with the highest respect, never underestimating anyone.

“Over the years I’ve learned that the small customers can eventually grow to become very large partners,” he said.

Karabin’s father also taught him to be honest and treat everyone at the company with respect. “[My dad] is very charitable with giving people the opportunity to prove themselves. Sometimes people recognize that, and sometimes they don’t, from an employer’s standpoint,” Karabin said. “We try to install some confidence in the person to take on things that they normally wouldn’t do and giving them responsibility.”

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3. Never get too comfortable.

“Never feel too comfortable, since you never know where the wolf is waiting for you,” Osypka advised, noting that this means staying costconscious and growing carefully so the company can be prepared for curveballs thrown in the future.

4. You’ll need more time – and funds – than you think.

Osypka said he learned from his dad that most of the time you’re going to need more time and funds than you think – but to never give up, regardless of the hardships.

“One of our mentalities is we commit to the project and we will never give up – no matter what the challenge is,” he said.

5. Do something different.

Karabin said his dad taught him to always look ahead and do something different than everyone else, even if the task is a little more difficult.

“Don’t be afraid of taking on the harder jobs,” he said. “Usually [the more difficult jobs] are the ones that are going to help you survive.” M 7 • 2018

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CONTRACT MANUFACTURING

A decade ago, a number of notable trends and market forces began to change how the medical device manufacturing sector brought its products to market. They’re still shaping the market today.

A ND R EW POT T ER | B O NIFA C IO C O NSULT I N G SERVI CES

THE CONTRACT MANUFACTURING SECTOR serving medical device technology has grown over the last two decades into an integral part of medtech’s success story.

Companies have adeptly changed to meet new clinical demands. They've reshaped manufacturing models to better respond to shifting economic realities.

Evolution in the space includes the expanding role of additive manufacturing, cloud computing and increased supply chain efficiencies, among many others. So what are the changes we've seen over the last decade, and what are the trends we see now?

A historical look at medical device manufacturing trends In the early 1990s, computer and other industrial outsourcing proliferated as companies such as Flextronics International (now Flex Ltd.), Jabil and Celestica quickly acquired their customers’ manufacturing operations and grew in areas such as consumer electronics. Despite the expansion, outsourcing in the medical device sector lagged in market share due to the regulatory nature of the business as well as the inherent risks associated with medical products. There were only a few significant players, and a lot smaller highly specialized process-based shops providing unique skills. But, slowly, a 62

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CHRI STOPHER DELPORT E

more robust medical device outsourcing market and supply chain began to emerge. About 10 years ago, some notable trends and market forces started to change how the medical device manufacturing sector brought products to market.

They’re still shaping the market we have today.

Major consolidation Companies merging – combining complementary skills to secure more market share – has been one of the top trends in medtech outsourcing in the last decade. Accellent, for example, acquired Lake Region Medical in 2014, and Greatbatch, in turn, purchased the combined company in 2015 — with the new medical device manufacturing juggernaut evolving into the $1.5-billion-a-year Integer by 2016.

Other significant consolidations included Jabil’s acquisition of Nypro in 2013, the Flextronics purchase of Avail in 2007, and the Molex buyout of Phillips-Medisize in 2016. These manufacturing conglomerates combined account for nearly $3 billion in medical manufacturing revenue a year. Also, Viant (formerly MedPlast) has neared the $1 billion revenue mark based on the acquisitions it has made the last few years, such as Vention, Coastal Life and Integer’s Advanced Surgical and Orthopedics business.

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7/19/18 12:55 PM

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CONTRACT MANUFACTURING

New entrants Another defining characteristic of the medical device manufacturing space over the last decade has been companies entering the sector without much prior experience in medical technology, but eager to create a healthcare niche within their business. Molex is an exciting example of this trend. The company, which is owned by the Koch brothers, didn’t have much of a history in medical device manufacturing.

It focused mostly on consumer electronics, information technology, automotive and other industries. Other large industrials that have moved into medtech manufacturing in the recent past include Freudenberg, Trelleborg, Nordson, Lubrizol and TE Connectivity. Many other global and broadly diversified manufacturers have been active in medtech mergers and acquisitions but so far have come up short in their bids to assemble market-leading medical device manufacturing portfolios.

Distributors evolving Medical technology distributors have moved from being simply hospital suppliers to creating a niche as supply chain and healthcare solutions providers. For example, MedLine Industries has been an active manufacturer in the distributor world for a long time (and with many private-label commodity products, many made in Asia with contract manufacturers). However, two of their competitors have made recent moves to add to their own manufacturing capabilities and product portfolios. Cardinal Health acquired Cordis from Johnson & Johnson and Covidien’s Medical Products Division from Medtronic. Just recently, Owens & Minor purchased a large chunk of the surgical supply business from Halyard Health (formerly Kimberly Clark Health Care).

Minimally invasive Depending on whose research you use, the global market for minimally invasive

medical technology will be worth $50 billion by the end of this decade. With the move to more catheter-based and laparoscopic procedures and the miniaturization of technology in general, the potential of this market will continue for some time to come.

For contract manufacturers, it has emerged as a particularly desirable segment to target and attempt to provide a full range of outsourcing capabilities. Companies such as TE Connectivity (with its purchase of Creganna, AdvancedCath), Nordson (though the acquisitions of Vesta and Vention Medical Advanced Components), and Freudenberg (with its MedVenture Technology Corp. buyout), clearly demonstrate that companies are willing to invest to meet the minimally invasive sector’s needs and create a one-stop-shop solution for their OEM customers.

Contract manufacturing sophistication As medical device OEMs have looked

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7 • 2018

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e

CONTRACT MANUFACTURING

to decrease their brick-and-mortar operations and turn manufacturing over to one-stop shops, they’ve demanded more from their suppliers. This demand has changed the complexity of the work for contract manufacturers over the last 10 years. Not long ago, the legacy medical device companies and OEMs simply told contract manufacturers what products to manufacture and how, but the relationship has now shifted. Contract manufacturers have created value propositions in being able to provide services from product concept and development, to highly specialized manufacturing and even supply chain management and delivery to the end customer.

Medical device manufacturing probably will never look like the tiered system used in the automotive industry, but some aspects are similar. For example, OEMs value suppliers that have tightly integrated themselves into the OEM supply chains.

They also call on top suppliers to manage other smaller and non-strategic suppliers on behalf of the OEM. OEM consolidation has, in turn, forced consolidation within the contract manufacturing space. Contract manufacturers turn to mergers and acquisitions to quickly expand and position themselves as trusted partners.

Private equity Over the last five to seven years, private equity investment has had a profound impact on medical device contract manufacturing.

Private equity investment has brought liquidity, mergers and acquisition knowledge and professional management to what mainly has been an industry consisting of smaller owner/operators. Examples include: Golden Gate Capital purchasing Phillips-Medisize (now owned by Molex) from Kohlberg & Co. (another private-equity firm); the RoundTable Healthcare Partners purchase of Vesta (and

its subsequent sale to Lubrizol); Permira’s acquisition of Creganna (which later was sold to TE Connectivity); Inverness Grahams’s ownership of AdvancedCath (which also was sold to TE Connectivity); Ampersand Capital Partners’ purchase of MedVenture Technology (which later was bought by Freudenberg Medical), and many others.

What’s next The trends we’ve seen over the last decade have reshaped the medical device contract manufacturing landscape. They're not over yet, either. Expect further development of a tier system in coming years, as well as more consolidation.

To achieve success, CMOs will need to focus on increasing velocity even amid pressures from OEMs. They’ll need to be nimble as they adopt new technology.

The competitive advantage will go to the firms that demonstrate the most responsiveness. M

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This is the second of two articles intended to provide basic guidelines for the critical elements to consider before diving into product development. The first article discussed the first four items. This article concludes the series by discussing regulatory/ reimbursement and verification/validation.

Idea – Without it, nothing to be developed; Process – The structure for development; Plan – The blueprint; Requirements – The details; Regulatory/reimbursement – Critical to the medical device space; and • Verification/validation – The right product doing the right thing.

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A regulated environment Virtually every market in the world has some form of regulatory body that impacts the product development process, but we will focus on the U.S. FDA. The agency has a responsibility to protect the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, food supply, cosmetics and products that emit radiation. It is also responsible for advancing public health by enabling medical innovations and by helping the public get the information required for the use of medicines and foods for the maintenance and improvement of health.

The agency organizes medical devices into three classes, increasing in regulatory control from Class I to Class III. Device classification depends on the product’s intended use, indications for use, risk to the patient and risk to the user (e.g., caregiver). The FDA reviews device applications via either the Premarket Notification 510(k) clearance or the Premarket Approval (PMA). In general, most Class I devices are exempt from 510(k), while most Class II devices require 510(k), and most Class III devices require PMA.

(Part 2) www.medicaldesignandoutsourcing.com

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The 510(k) is a premarket submission that demonstrates that a new device to be marketed in the U.S. is “substantially equivalent” to a predicate device already being legally marketed in the U.S. and that doesn’t need the PMA. Class III devices usually have a much higher risk factor, requiring a PMA. A PMA calls for significant support for device claims, typically in the form of clinical data. In addition, manufacturers of the product must undergo a facility inspection by the FDA prior to the products’ clearance.

Such an inspection is not needed prior to 510(k) clearance, but a manufacturer should expect an inspection after clearance is received.

All submissions are reviewed and either cleared or approved by the FDA

averaged 177 days. In 2015, FDA reported that PMAs averaged 209 days.

An additional clearance process is the “de novo” application, created in 1997. This approach is for devices that are automatically classified as Class III devices because no substantially equivalent predicate exists for them. It is intended to help avoid a lengthy and costly PMA submission for devices with low or easily mitigated risks. In 2012, the process was simplified to allow the applicant to directly submit a de novo application for the FDA to review and either approve or deny the application. While the targeted decision date is within 60 days of submission, the uncertain nature of de novo can lead to additional discussion and delays as the decision is reached.

is done as an integral part of the design and development process.

• The Device Master Record (DMR) includes everything necessary to build and test the device, including much of what is contained in the DHF, but also incorporating the manufacturing, test, quality, packaging and documentation that goes with the device.

• The Device History Record (DHR) contains everything done to make the device. The FDA requires that the manufacturer “shall establish and maintain procedures to ensure that DHR’s for each batch, lot or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part.”

The regulatory process for medical devices extends into virtually every aspect of the design, manufacturing, test and support of medical products. Compared with general consumer product regulations and quality requirements, regulated products easily show an overhead of at least 50% in additional requirements, standards and testing, which results in additional effort, cost and time, not including the impact of lengthy and costly clinical trials.

before the device can be marketed in the U.S. While the impact of the regulatory process is felt throughout the development and manufacturing processes for the product, the immediate impact from a schedule perspective is that the targeted time to clearance for a 510(k) is approximately 90 days, while FDA regulations provide 180 days to review a PMA. However, particularly in the case of a PMA, these determinations often take much longer. FDA is able to ask additional questions and request more information, which can reset the clock. According to Emergo, in 2017 510(k) clearances 68

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The FDA requires submitters to compile documentation of the development process, as follows: • The Design History File (DHF) contains the records to demonstrate that the design was developed in accordance with your approved design plan and established quality system. It also includes the design inputs and outputs, as well as design verification and validation protocols and results, essentially everything that went into the design of the product. The document is much easier to produce and record if it

Approaching reimbursement Reimbursement, while having much less of an impact on the design and manufacturing processes, is no less important to the overall success of product introduction. It addresses a vital question: “Who pays for your product?”

Developing a reimbursement strategy requires data, discussion and negotiations by stakeholders, including the providers and payers. Coverage, coding and payment are the three major components of the reimbursement process.

Coverage is in the realm of the payers and describes the types of services and procedures that will be paid. These typically are services and procedures considered “medically reasonable and necessary.”

Coverage can vary by plan depending on what each payer decides to cover.

Coding is the intricate system of descriptions that describe the procedures being performed. The International Classification of Diseases, Tenth Edition (ICD-10) is the clinical cataloging system

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owned and published by the World Health Organization that went into effect for the U.S. healthcare industry on Oct. 1, 2015.

The healthcare industry uses ICD codes to properly note diseases on health records, to track epidemiological trends and to assist in medical reimbursement decisions. ICD-10 is split into two systems in the U.S.: ICD-10CM (Clinical Modification), for diagnostic coding (68,000 codes), and ICD-10-PCS (Procedure Coding System), for inpatient hospital procedure coding (87,000 codes).

This level of granularity should help enable big data analytics to assess procedures being performed, although at the expense of greatly increased complexity.

Even with coverage determined and a code established, the payment may not necessarily cover the full cost of the treatment or service being rendered, since each payer may negotiate with providers for pricing specific to their overall plan. However, without coverage and a code, no payment will be made.

Understanding whether you will be working to establish a new code (difficult and time-consuming as well as requiring significant clinical evidence) or whether your product will be designed to fit under existing descriptions may impact the design of the product and will certainly impact the intended use statements and documentation associated with your product.

Beyond the issue of getting paid for your product, however, additional implications of the reimbursement decisions exist. These include assessment of what your product does, who it is intended for, its efficacy at solving a specific problem and its value.

testing process and should be used for the appropriate activity.

The FDA outlines its expectations in Design Controls 21 CFR 820.30. Design controls are the quality practices and procedures that form the basis for the design and development process and are intended to ensure that the device requirements meet the user needs and the intended use of the product. The V&V processes provide confirmation that a product meets the design controls.

Verification requires confirmation by examination as well as objective evidence that the output meets the input requirements (21 CFR 820.30(f)). These tests are typically performed at the subsystem as well as the full system level as part of the development process. The results of verification tests must be documented and are archived as part of the DHF. Validation requires objective evidence that the requirements match user needs and the intended use of the devices (21 CFR 820.30(g)). This is confirmed by objective testing on production units (or equivalents) under actual or simulated use conditions.

Since validation is focused on the user needs, the testing is done as a more cohesive effort near the end of the product development process. Depending on the classification of the product, validation may encompass clinical testing on production units. These results are also documented and submitted to the FDA as part of the premarket submission.

Here’s a simple way to remember the difference between verification and validation:

Validating and verifying Many think that verification and validation only occur at the end of the medical device development effort — but that is only partially true. Yes, V&V takes place after some portion of the product has been built and is available to be tested.

But planning for these two tasks is critical.

Definition of the tests to be performed and plans for that testing need to take place early in the development process.

Verification and validation are both elements of the overall testing process.

Although the terms are sometimes used interchangeably, they really demonstrate very different aspects of the product

• Verification – Building the system right • Validation – Building the right system Building the wrong system in exactly the right way will almost certainly result in market failure, even though all the process steps were followed, and the product verified. Ultimately, user or market acceptance will determine success. A technical success that doesn’t sell or meet the users’ expectations won’t last long.

Linking initial product requirements and the V&V testing demonstrates that the user needs and requirements established early in the project and refined during the development process are reflected in the www.medicaldesignandoutsourcing.com

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final product. A traceability matrix maps the requirements all the way through to the test results. Many software tools for automation of this process are available, but fundamentally, a spreadsheet can also work.

V&V testing is generally applicable to hardware, software and systems. In practice, software may be somewhat more difficult to verify and validate. It is difficult to address all possible test combinations, particularly those related to misuse. In that case, software validation may involve reaching a “level of confidence” that the device software meets all requirements and user needs. In some instances, user site software validation may also be described in terms of installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).

FIND MORE ONLINE For a deeper dive, check out Bill Betten’s online series of articles on the product development process. www.medicaldesignandoutsourcing.com/ medical-device-startups-secrets-success/

Conclusion Hopefully this series has provided a high-level perspective of the complexities and complications of medical product development. Medical device development is often characterized as anywhere from 60% to 80% documentation. While much of that documentation is driven from a regulatory perspective, it is also generally good engineering practice. From a practical perspective the medical product development process can be summarized as satisfying the need to know…

1. What is important and why, 2. Why decisions were made, and 3. The product does what it is supposed to …without having to ask anyone!

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DEVICE TALKS

DeviceTalks Minnesota 2018 Highlights from the sixth annual DeviceTalks Minnesota event June 4-5 in St. Paul

It’s hard for us to believe, but we held the sixth annual DeviceTalks Minnesota event last month in St. Paul, drawing a record number of exhibitors and attendees to our new, expanded two-day program. Here are some highlights:

Nancy Crotti | Senior Editor |

Getting to the exit Beyond their altruistic and sales goals, medical device startups generally keep an eye out for the exit. Getting there requires planning, patience and persistence, according to a couple of medtech executives who’ve been through it.

Martha Shadan headed Plymouth, Minn.– based Rotation Medical, a private company sold to Smith & Nephew in December 2017, just three years after launching its regenerative shoulder repair treatment. Bob White has been through two exits, selling privately owned TYRX, a New Jersey-based maker of surgical infection prevention products, to Medtronic in 2014 for an up-front cash payment of $160 million, and public company Entellus Medical of Plymouth, Minn. in February for $668 million to Stryker. Founded in 2006, Entellus makes a family of minimally

invasive balloon device products, including its flagship Xpress device, that are designed to treat blocked sinuses.

While White advised against building a company to sell it, both counseled carefully cultivating relationships with would-be buyers, making sure that the startup is on solid financial and regulatory footing, and that its products have repeat customers.

“We didn’t go out talking to the strategics saying we’re selling,” Shadan said. “We went out to the strategics to educate them. You run a fine line between being a pest and being appropriate in the timing and what you update them with.”

Although Stryker started looking at Entellus in 2009, the company wasn’t going to stand still waiting to be acquired, according to White. It continued innovating, launching 24 new products in the past few years while its big-league competitors, Johnson & Johnson and Medtronic, commercialized just a handful.

Being a public company and having so much of its information available to the public made the process of preparing for the

Bob White (left) led public company Entellus Medical through a $668 million sale to Stryker in February. Martha Shadan (center) headed Rotation Medical, a private company sold to Smith & Nephew in December 2017.

They discussed exit strategies with Medical Alley Association CEO Shaye Mandle (right) at DeviceTalks Minnesota last month.

Image by Bradley Voyten/WTWH Media

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sale easier than the due diligence that private companies must undergo. Shadan thought Rotation Medical was in good shape going into the process until Smith & Nephew came at it with 600 questions, many of which the smaller company couldn’t answer.

There’s no magic to knowing the right time to sell, however.

“There’s a little bit of science that goes into it, but mostly it’s gut feel,” said Shadan, now vice president of global marketing for Smith & Nephew. “It’s one of the hardest questions that I had to deal with as a CEO… In the throes of making the decision, I had to go on the best information that I had.”

Innovation is alive at big medtech Startups and smaller firms outnumber the big medtech companies, but they haven’t cornered the market on research and development. The major players are always working on new devices and use their scale to quickly assemble teams to develop them.

R&D executives from Abbott and Boston Scientific explained how their processes work and dispelled some myths about the medtech giants to a standingroom-only crowd at DeviceTalks Minnesota.

About 75% of what these companies introduce in a 12-to-15-month period will be improvements to existing devices, and the rest will be attempts at blockbusters, said Mark Strong, divisional vice president of R&D at Abbott. Devices with gamechanging potential require bigger investments and can take three to five years to develop, added Randy Schiestl, vice president of R&D at Boston Scientific.

“The key thing is to have a really active pipeline where you’ve looked at one-tothree- and five-year timelines and you’ve got launches worldwide, every region, every year,” Schiestl said.

Big companies also have the ability to source talent internally for product development teams, particularly across engineering disciplines. Abbott also looks to universities, because recent graduates’ energy and desire to make a name for

Randy Schiestl (left), VP of R&D at Boston Scientific, and Mark Strong (right), divisional VP of R&D at Abbott, explained how their R&D processes work and dispelled some myths about the medtech giants to a standing-roomonly crowd at DeviceTalks Minnesota last month.

Image by Bradley Voyten/WTWH Media

themselves make them attractive to the company, Strong said.

Acquisitions immediately bring new talent on board, which makes R&D fun, Schiestl added. In the last 10 years, Boston Scientific has been more aggressive in adding talent through acquisitions and through partnerships with universities, third parties, contractors and others. “It’s a much more robust model, much quicker to bring in the right team, and just more dynamic in terms of the resources that are available to the company in terms of partnering,” he added.

Big companies also combine their R&D structure with flexibility. Boston Scientific’s seven businesses use the same product development process, manufacturer infrastructure, innovation initiatives and procedures, and the same control system, but the company is flexible in the types of products that teams can work on, Schiestl said.

Abbott tries to be agile and keeps its product development teams small so it can “turn them loose and let them innovate,” Strong said. The company implements its higher-level controls and safety mechanisms www.medicaldesignandoutsourcing.com

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with review boards and late-stage processes, he added.

The public-private Medical Device Innovation Consortium and Jeffrey Shuren’s leadership of the FDA’s Center for Devices and Radiological Health have each boosted collaboration and quality in the industry, both men said.

“The opportunity is to get everybody engaged,” Schiestl said. “Everybody should have this general attitude that they can innovate, that they can bring new ideas to the table.” M

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