Medical Design & Outsourcing — NOVEMBER 2018 by WTWH Media LLC

NOVEMBER 2018

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2018

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Off-The-Shelf-Custom

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HERE’S WHAT WE SEE

Let’s face it: Medtech development is hard Medical device creation can require manufacturing know-how in areas as wide-ranging as electrical components, high-performance polymers, molding and machining – and that doesn’t even include the required expertise in design, regulatory requirements and achieving reimbursement. The shift toward making medical devices “smarter” means that medical product makers need to know more about sensors and software, too. The good news is that the companies serving the medical device industry have become specialized experts, and we harness their expertise through our annual Medical Device Handbook. We request articles from medical device designers, outsourcers and consultants that avoid marketing pitches and instead provide useful information for the medical device development community. Here are a few examples of the expertise to be found in this year’s Handbook: • As the medical industry migrates more to multi-layer, multi-lumen tubing for various uses, the extrusion die design and manufacturing supply chain has likewise evolved. That includes new crosshead designs, said Bill Conley, sales manager at Guill Tool & Engineering.

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

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• While manual resistance welding is common in the device manufacturing industry, automated electrode welding processes can enhance the consistency, quality, performance and efficiency of electrode ring assemblies, according to Paul McCormick, senior research and development engineer for Integer. • Impregnating vulcanized silicone with active drugs is a promising method to reduce colonization of bacteria on implantable medical devices, said Andrew Gaillard, global director of Healthcare and Medical at Trelleborg Sealing Solutions. • Digitizing processes such as informed consent can streamline studies to rapidly collect quality data while reducing costs, according to Michael Tucker, senior product solutions specialist at Medidata. • Vaporized peracetic acid (VPA) has become a game-changer in medical device sterilization, providing for a room-temperature process designed to preserve newer device materials and components, said Mason Schwartz, R&D and operations director for Revox Sterilization Solutions. • Advances in catheter components are paving the way for improved, more sophisticated devices, according to Zeus. A super-thin-walled PTFE catheter base liner presents new opportunities for smaller devices. MRI-compatible LCP braiding is stronger than previous non-metal braidings and rivals the strength of some stainless steel braidings. • When it comes to getting medical device product development back on track, a “red team” or “tiger team” approach leverages an independent team of experts to question assumptions, validate (or refute) previous findings and identify new paths to investigate, explained Jeff Champagne and Eric Claude at MPR Associates. M 11 • 2018

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STANDARD AND CUSTOM MOTION CONTROL PRODUCTS

Medical Design & OUTSOURCING medicaldesignandoutsourcing.com ∞ September 2018 ∞ Vol4 No5

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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 Senior Editor Nancy Crotti ncrotti@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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CONTENTS

medicaldesignandoutsourcing.com ∞ November 2018 ∞ Vol.4 No.6

INSIDE

the Medical Device Handbook 5

HERE’S WHAT WE SEE

MACHINING

Crosshead construction for

Let’s face it: Medtech

medical tubing; Six-axis robots;

development is hard

Tooling up

Latest technology in image-

Automated laser welding for ring

CATHETERS

MANUFACTURING

guided catheters; Key extrusion

electrode manufacturing; Medical

considerations

device packaging decisions; Improving project management;

Packaging pitfalls; Simplifying your

CONSULTING

Using digital health in clinical trials

supply chain; Early collaboration

MATERIALS

Adhesives for diabetes

DESIGN SERVICES Mapping for solutions; Tiger teams; Connected medical devices; Wearable sensors

management devices; Silicone soft skin adhesive coatings; Keeping bacteria from colonizing silicone

MOLDING

ELECTRICAL/ ELECTRONIC COMPONENTS

Electronic design problems;

Lithium thionyl chloride batteries; Electronic skin tech; Connectors

Liquid silicone rubber prototypes and components; Polymer

LVADs

HIGHPERFORMANCE POLYMERS Materials for needle-free

injection technology; High-heat thermoplastics

REGULATORY, REIMBURSEMENT AND IP

Quicker and stronger medtech

patents; ISO 13485:2016; Contracts versus purchase orders; Getting reimbursement; European Union’s MDR

102

SOFTWARE

E-consent in clinical trials; Patient safety, data security and reliability; Connected medical devices pros and cons

107

STERILIZATION SERVICES

Enabling in-situ curable silicone;

Peracetic acid sterilization

110

TUBING

What’s new with vascular catheter

components for medical devices

construction; Metal tubing

114

MOTION CONTROL COMPONENTS

VALIDATION & TESTING

technology; DC brushed versus

testing lab; Worst-case

brushless motors; VCA (voice coil

conditions in ISO 18562 testing;

actuator) technology

ISO 10993-1 and the MDR

119

Multifunctional joystick

FLUID POWER COMPONENTS

NEEDLES & SYRINGES

Needle washing for analytics

equipment

Working with a third-party

DEVICETALKS

Intuitive Surgical’s Gary Guthart

120

AD INDEX

RAPID MANUFACTURING & PROTOTYPING

Carbon’s 3D printing technology

Medical Design & Outsourcing

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CATHETERS

How imaging, AI and other catheter technologies are changing cardiology Philips is betting on the latest technology in image-guided catheters to advance cardiology. Heather Thompson Senior Editor

Interventional cardiologists use an IVUS catheter system in the OR. Image courtesy of Philips Image Guided Therapy

Interventional cardiology is a key therapeutic space for medical devices and has been for decades. But the companies that serve this area are not resting on their catheters and stents. The latest in percutaneous coronary intervention aims to improve minimally invasive image guidance by providing real-time guidance using intravascular imaging, fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) and similar indices. Companies in this sector are also aiming to improve image resolution and introduce tools such as image co-registration, said Andrew Tochterman, coronary segment leader at Philips Image Guided Therapy. A percutaneous coronary intervention (PCI) starts with an angiogram, said Tochterman, but from there it takes multiple pieces of information and equipment. “Getting it right for the patient is the ability to bring together all the relevant information to localize and personalize treatment.” Here’s how Philips officials are seeking to achieve their goal: 1. Improving catheter flexibility. With intravascular imaging, success starts with a flexible catheter. “The arterial pathways are tortuous, so the catheter can’t be rigid,” said Tochterman. 2. Taking advantage of miniaturization technology. Tochterman noted that further miniaturization will play a big role in improving the resolution of the technology. He said Philips spends a lot of its energy on intravascular ultrasound (IVUS) and catheters

Medical Design & Outsourcing

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overall, with the goal of helping clinicians better decide, guide and confirm the right treatment. In an IVUS catheter, a transducer emits high-frequency sound waves that echo off vessel walls. These are sent back to the system in varying intensities depending on the tissue. System electronics process the signal to display the cross-sectional image. Philips’ technology has a miniature transducer as a tiny dot array around the catheter tip. “That innovation allowed us to get away from having a drive train and transducer spinning inside the artery, and we’re able to send pulses out to the artery in a circumferential pattern to collect the information at once,” Tochterman said. 3. Using hard data to empower surgical decision-making. The pressure and flow sensing technology allows interventionalists to rely less on the angiogram and use hard numbers to make decisions for treatment – something the angiogram has a hard time doing. “Interventional X-ray systems take an outside-in view – it looks at the silhouette of the arteries,” Tochterman said. IVUS catheters look at the makeup of the vessel lining and the medial layers to best determine

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CATHETERS

if the artery is calcified or fibrotic, for example. Based on that information, the interventionalist can determine the risk profile of the patient, and better chart a course for success. For example, with a calcified artery the interventionalist might choose atherectomy or scoring balloons, also offered by Philips, which may be different interventional tools than with a thrombus or plaque rich environment. Beyond today’s technology, Tochterman said Philips and other companies are looking at how AI and machine learning will play a role in helping interventional cardiology advance. “We’re in those very early days of artificial intelligence. I think it will be very disruptive, but in a really positive way for the healthcare system and, most importantly, for patients.” Tochterman compared the technology to cell phones. “We knew that cell phones would be important, but very few of us probably predicted just how central they would be in our lives just 15–20 years later.” Along the same vein, he can’t yet predict exactly how AI will transform the therapeutic space in 10 to 15 years, but noted that it will improve personalization and specificity of treatments. Tochterman said Philips, like its competitors, is very committed to the space. “We’re very excited about the potential of AI overall. It’s going to be a big shift and we don’t know how it will play out in the long-term, but it will be a shift that benefits patients and clinicians.” The objective is to bring information together, to aid in more efficient decision making. Tochterman explained that although the iFR/FFR and imaging technologies are useful, there come with tradeoffs. For example, it takes interventionalists away from the angiogram, visually speaking. Doctors have to look at two different screens, mentally mark that information and then piece it together as they look back at the angiogram. Technologies like Philips’ co-registration platform take the iFR/FFR data and imaging data and overlay it onto the angiogram to aid in interpretation. “It is such an obvious thing to do to provide seamless, integrated information,” Tochterman said. “We need to do more of it.” M

WE’RE IN THOSE VERY EARLY DAYS OF ARTIFICIAL INTELLIGENCE. I THINK IT WILL BE VERY DISRUPTIVE, BUT IN A REALLY POSITIVE WAY FOR THE HEALTHCARE SYSTEM.

11 • 2018

Catheters_11-18_Vs4.indd 13

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CATHETERS

Key extrusion considerations for catheter development The extrusion and catheter finishing processes are inextricably linked. Balancing them can be a complex undertaking. Paul Weafer VistaMed, a Freudenberg Medical company

There are a number of variables that can ultimately affect the performance of a finished catheter – the most paramount being the properties of the raw material and the extrusion process. Careful consideration of the extrusion process is essential to ensure consistency and repeatability. Including extrusion engineers in the development and decision-making process is integral. Collaborative communication between customer and supplier will enhance concept development and ultimately get devices to market faster. It is important to keep in mind that there is far more to tubing than dimensions. Establishing a “see it, say it, fix it together” culture is key to getting a tube from concept to production. Control inputs and outputs Manufacturing high-quality extrusions that are designed to be used in sophisticated catheter systems depends on tight control of the “inputs.” Initially, the inputs start with people, because people can influence all other inputs such as

A braid to coil delivery system.

Image courtesy of Freudenberg Medical

Medical Design & Outsourcing

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11 • 2018

training, material handling, storage conditions, control of drying and equipment and tooling design. Having the right mix of people is a good starting point. The greater the control of inputs to the extrusion process, the higher the probability of achieving the desired output necessary to develop and manufacture high-quality extrusions. “Outputs” begin with process stability, and then the spotlight turns to achieving the agreed upon customer specifications, such as critical dimensions, visual criteria and functional performance. The tolerance expectations from customers are constantly challenging the boundaries of extrusion capability. It has become more significant than ever for tubing manufacturers to maintain close control of their inputs and process. Polymer science and material behavior A good understanding of polymer science and material behavior is undeniably crucial for producing high-quality catheters and balloons. The morphological structure of the thermoplastic material can change with varying thermal conditions which, in turn, determines key physical properties such as strength and flexibility. The polymer exits the die head of an extruder in an amorphous state. The rate and length of the cooling downstream from an extruder determines the degree of crystallinity in the final product. In some medical applications, such as balloon forming, it is critical that the extruded tubing is amorphous prior to the balloon forming process. Therefore, the cooling parameters and cooling method used are critical to ensuring that crystallization does not occur in the tube during the extrusion process. In other applications, such as the extrusion of PEEK tubing, it is critical that the PEEK tubing achieves a relatively high level of crystallinity during extrusion to ensure that the tubing utilizes the outstanding properties that PEEK possesses.

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Off-The-Shelf-Custom

Mammotome® is a registered trademark of Devicor Medical Products, Inc.

Custom Options (No tooling or NRE) • • • • • • • • •

Actuator styles Consoles/platforms Selectable actuating forces Strain reliefs Handles/foot rests Floor contact pads Cable type/color Cable length Pedal and pushbutton color

• • • • •

Console color & finish Wiring configuration IP-rating Labeling/Bar coding Electrical output format... on/off, proportional, USB, other • Connector style • Graphics (logo, icons, text)

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CATHETERS

To produce high-quality balloons and catheter systems, it is fundamental to have all the extrusion inputs under control. A capable process with highquality melt is critical to producing tubing for consistent balloon quality and desired performance. Additionally, a sophisticated extrusion process with precise in-line monitoring and control is also crucial to achieving high-quality balloon tubing. Small process variations can undoubtedly hinder the quality and performance of the final product. These variations potentially impact melt homogeneity and can result in variability in balloon tubing performance. Polymers can degrade due to excessive temperatures or high shear stress. causing deterioration in the material molecular weight which,

in turn, compromises the material’s performance. An important first step in achieving optimal catheter performance is to choose the right materials for the catheter delivery system. In recent years leading-edge polymers have begun to replace traditional materials. These new polymers are being integrated into the design of next-generation catheters. For optimal performance, engineers need to consider the biological, physical and chemical characteristics of polymers and the growth of new breakthrough manufacturing processes. Enhance performance and design To enhance catheter performance and achieve optimum results, several features should be considered and incorporated where appropriate:

•

Braid/coil reinforcement for strength, rigidity and torque control along the length of the catheter should balance the need for flexibility and kink resistance to navigate tortuous pathways. Use of hydrophilic coatings delivers high lubricity to achieve low insertion force or a reduction in friction for a specific delivery application. Soft tip and multi-durometer segments along the length of the catheter provide atraumatic entry and maneuverability. Radiopaque contrast at the tip and key segments offer better visibility for the physician to visualize accurate anatomical placement. Steerability and deflection help attain optimal navigation.

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To achieve some of these attributes, a number of design aspects can affect performance and design: • •

•

Varying material durometer along the outer jacket length will provide a number of flexibility options. Different levels of flexibility and kink resistance can be achieved by varying the pitch of the braid on the shaft. Braid patterns (e.g. diamond pattern) will effect flexibility and torque response. Wire options (e.g. flat or round) can also effect catheter performance; round wire will provide a more flexible shaft while flat wire will deliver a lower profile and less flexibility. Hybrid coil-braid designs can also offer the best balance between torque, flexibility and a thin wall solution. Laser profiled metal hypotubes with a spiral type design can assist in maximizing trackability.

Product differentiation is trending Requests are on the rise for braided shafts with the lowest possible wall thickness while maintaining adequate levels of track and kink resistance. Achieving the best performance in one characteristic can often directly affect other characteristics. Applying a polymer jacket to a metal hypotube is a popular choice when high lubricity is a key design requirement, and choosing a unique color for the polymer jacket can also assist to differentiate a product. Controlled extrusion inputs combined with a robust extrusion process play a key role in achieving success with next-generation catheters. M Paul Weafer is R&D manager at VistaMed, a Freudenberg Medical company and extrusion and catheter provider to the medical device industry worldwide.

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CONSULTING

How to use digital health in clinical trials to improve patient engagement Digital health technology can improve reporting of patient data during clinical trials, but it can also lead patients to drop out. Vicki Anastasi and Matthew McCarty ICON Plc

Digital health technologies are changing the way companies design and implement clinical trials, shifting responsibility from investigator to the patient. Adding multiple digital health technologies into trial design – including mobile health (mHealth), health information technology, wearable devices, telehealth and patient-reported outcome measures (PROs) – can increase the burden on the patient. This extra burden can reduce patient compliance and retention. Studies have shown that more than 30% of patients drop out of clinical trials before their results can be evaluated, and that about 85% percent of clinical trials fail to reach completion due to problems with patient retention. Companies must adopt a unified patient experience.

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What is a unified patient experience? A trial with a unified patient experience enables patients to manage every aspect of the trial via a single, one-touch access point. This could be an integrated smartphone app that includes features under one login, such as ePRO, sensor connection, notifications, gamification, reimbursement, travel management, study information and profile management. Giving patients the choice between a digital touch and personal contact (e.g. a patient contact hub) may further increase patient engagement in a clinical trial by: • Using the right channel for the right use; • Providing patients with choices to suit their preferences and circumstances; • Marrying the convenience and efficiency of digital technology with the trust and depth of personal contact. A unified patient experience can improve patient engagement For example, many mHealth wearables acquire data remotely and passively with little to no effort on the part of the patient. When patients must manually enter data, they can do so on the app’s digital diary or by calling the patient contact hub at their convenience, rather than visiting the trial site. Reducing the number of site visits cuts travel costs and time. When patients do need to travel to the study site, they can use the same patient app or contact hub to organize travel plans – from a full concierge service to booking local taxis – removing the burden of planning or paying for travel.

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Integrating a unified patient experience can enhance patient retention Having a unified patient experience can also improve retention by resolving problems that could cause patient dropout or lack of usable trial data. When a patientâ&#x20AC;&#x2122;s digital health device indicates noncompliance such as patient failure to record a blood pressure reading, the patient contact hub can immediately ask whether the patient needs help or whether the mHealth device needs repair. A quick response to these issues can keep a trial running smoothly and improve the quality of data collected while retaining patients. By successfully integrating digital health into clinical trials via a unified patient experience (offering a single digital and personal contact solution) sponsors and device developers can optimize data collection, improve patient retention and engagement, and ultimately avoid costly delays or failure. M Vicki Anastasi is VP and global head of medical device and diagnostics research for ICON plc. Matthew McCarty is senior director and global head of patient engagement for ICONâ&#x20AC;&#x2122;s commercialization and outcomes division.

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DESIGN SERVICES

Here’s how you map for meaningful healthcare solutions Delivering human-centered healthcare solutions means thinking about the total user experience from start to finish. Each design decision lies within a deeply interdependent, complex system, and the process of creating a seamless experience is complicated, too. An experience map is a model to establish a shared understanding of various users’ experiences. Image courtesy of Design Concepts

A m i Ve r h a l e n Design Concepts

Experience and system-level maps are powerful tools to help teams to design the right things. They help keep the big picture and details in mind – at-aglance – over months and even years. Maps enable teams to keep focused on the experience and serve as a catalyst for design and innovation efforts. Here’s a concrete example: A medical device company believed customers wanted their diagnostic instrument to work faster and tasked their R&D teams with creating speedier systems and technologies. After they had a complete experience map in hand, they learned that labs do indeed want faster results, but their instrument wasn’t the issue. The gap was in accessing the samples: collecting, labeling, entering the data and sample, and transferring it to the lab.

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This was a very different challenge, and this insight was a catalyst for the team. The map continually reinforced this big picture to keep everyone focused on meaningful priorities rather than assumptions. Designing in a vacuum can lead to solutions that are isolated and cause issues or embarrassing oversights. Mapping can help a team set priorities so that it delivers thoughtful, integrated solutions that show you understand the users’ whole experience and your organization’s ability to deliver. By creating detailed maps, the project team has a full understanding when it chooses to focus on one area over another. Maps also provide an understanding of contextual and systemic implications, guiding the team in identifying gaps and pain points and how new solutions must integrate to succeed. These maps may be created from existing data, information and hypotheses, but you will need to do some research along the way to get additional accurate information. This will inform proportion and importance on the map, so that you can derive meaning. Experience map The most critical type of map is an experience map, which is a model to establish a shared understanding of various users’ experiences. It visually illustrates the steps in the processes, the journeys of various users and the interconnectedness of the overall experience. This map is most helpful for informing and inspiring design teams to create human-centered solutions. Key elements include:

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DESIGN SERVICES •

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Users: All user types including 1) end users (patients, lab techs, maintenance); 2) influencers (sales staff, channels, payers, the FDA); and 3) decision makers (lab manager, hospital CEO, group purchasing organization). Tasks: Everything along their work process, including how users acquire, use, store, re-use and dispose of products and tools. Over time, this may include daily, weekly, monthly, annual or seasonal variations. Tools: The hardware, software, information, commodities and communication tools used throughout the experience and workflows, such as devices, middleware, electronic medical records and patient information. Environments: All the environments in which users may work and where their tools and systems may reside, including offsite and remote locations and virtual environments.

Across the map, these elements should: • Show progress over time; • Represent scale or proportion of the experience’s stages relative to one another; • Signal the interconnectedness of the various elements. For medical devices, a simple list of key map elements becomes a complex system very quickly, and your team will find it invaluable. However, if you need a catalyst to inform human and business-centered implementation, you may find this next type of map – a service blueprint – to be very valuable. Service blueprint A service blueprint is a model that captures an organization’s systems, which must be in place to ensure the product can be delivered, as well as the

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users’ interactions and workflow. The key elements of a service blueprint include people, props, places, partnerships and processes. Using such a map allows teams to understand the execution requirements and provides cues to potential resource and process needs within an organization. Maps are only effective when your team has insights that highlight each element’s pain points, gaps and interdependencies. Use this information to identify opportunities and set priorities that match your organization, your strengths and your project goal. M Ami Verhalen is VP of design at Design Concepts, a design and innovation consulting firm with offices in Madison, Wis., San Francisco and Boston.

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DESIGN SERVICES

When product development goes sideways (and how to fix it) Product development going wrong? You may need a tiger team. Jeff Champagne and Eric Claude MPR Associates

We would all like for product development projects to go smoothly and predictably, but you know what they say about “the best-laid plans.” Robert Burns aside, when needed technologies do not integrate as easily as planned, hardware or software bugs crop up at the last minute (or worse, cause failures in the field), or project teams struggle to complete work on schedule, forward progress is stalled. Fixed costs stay the same, but time to launch date deadlines are compressed. This is only one example of when things go sideways. Recovering from situations like these involves tough choices. Options can include: • Do nothing and keep trying to slog it out. (Wishful thinking is sometimes successful but is not a guaranteed success path.) • Pivot the team to a new direction that avoids the problems that are being experienced. • Bring in additional resources with a fresh perspective and perhaps additional knowledge to help out. The consequences of failure can often be high, but it’s not the end of the world. Often failing early can help to avoid: • Staff reductions until the problem is solved; • Furloughs; • Abandon ship. Often, groups are hesitant to bring in an independent perspective in the midst of an on-

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going project. But getting outside help can be the most effective approach to get back on track. A “red team” or “tiger team” approach leverages an independent team of experts to question assumptions, validate (or refute) previous findings, and identify new paths to investigate. The key is to quickly get to the root of the problem so that it becomes clear what needs to be done to recover. Albert Einstein put it this way: “If I had an hour to solve a problem, I’d spend 55 minutes thinking about the problem and 5 minutes thinking about solutions.” Once the problem is known, the solution is more easily revealed. Too often, people jump to unsubstantiated conclusions in search of quick fixes. This usually leads to a prolonged period of trial and error iterations; rarely is it a trial and solution. Coming into a problem situation is a little like looking at a crime scene. Things that the team might do include: • Observe the environment involved in the situation. Are there aspects of the environment that might contribute to the problem? • Meet with the people involved. What are their skill sets and perspectives? Are there any gaps with regard to working with the relevant technologies? • Construct a timeline of events leading up to problems that have occurred. There are often subtleties in the sequence of events that can cause unexpected interactions and issues. • Examine the evidence by collecting the relevant data. Some useful tools can also be employed to help with the problem investigation process.

www.medicaldesignandoutsourcing.com

11/21/18 9:37 AM

• The “five-whys” technique. This involves a series of questions that are posed to determine the cause and effect of situations that ultimately lead to the problem. The goal is to dig deep to find the underlying reason as well as the sequence of events. With such insight, solutions become apparent. • A fishbone or Ishikawa diagram, which is a visual way to depict issues that potentially could lead to the problem. Typically, branches of the diagram cover several main categories of causal factors which are each broken down into further details: o People – including skills, training, or motivations. o Equipment – considering potential functional or performance limitations, wear, reliability issues or other failures. o Materials – including variability in raw materials. o Environment – considering the impact of noise, lighting, temperature, etc. o Methods/processes – covering the sequence of operations, maintenance, set-up. • FMEA or fault tree analysis to systematically identify potential causes of failure. • Engineering analysis to determine safety factors and margin to failure in a design. • Scenario evaluation or “what if” analysis to walk through different sequences of events and postulate consequences, considering the potential cascading effect. (Often a series of individually unlikely events can ultimately lead to real trouble). • Testing of known good and faulty devices to characterize behaviors.

good practice to tabulate the potential causes along with the data that supports the potential cause and any data that would refute it. The key is to ensure that the supporting and refuting evidence is factual and not opinion. Once the suspected root cause or causes are identified on the basis of all the data, the next step is to plan and execute a series of tests to confirm the conclusion. For example, if a component failure on a circuit board is suspected of causing the problem, a known good board can be modified to simulate the component failure and then tested to determine if it replicates the behavior of known faulty devices. M Jeff Champagne is director of business development, and Eric Claude is VP of product development at MPR Associates.

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DESIGN SERVICES

Typical connected device block diagram. Image courtesy of Betten Systems Solutions

How to design a connected medical device Any company designing a medical device today needs to take connectivity into account. The days of isolated medical data tied together in a patchwork of paper, photos and electronic means is coming to an end. Bill Betten Betten Systems Solutions

Developing connected devices in the highly regulated medical space carries specific challenges, so let’s go over some of the considerations for the design and development of connected medical devices. While much of medical device design is consistent between a traditional device and a connected one, additional requirements must be considered early in the design to ensure a smooth development. The critical design considerations include: • Sensor type – What data do you want to collect? • Body location – External or implanted, where on the body? • Frequency of data acquisition – Continuous or periodic? • Frequency of data transmission – Continuous, hourly, daily, etc.? • Architecture – Local processing, distributed or cloud? • Connectivity – Wired or wireless; WiFi, cellular or Bluetooth? • Power – AC or battery (rechargeable or not)? • Communication protocols and standards.

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• User experience – Who are the users? Look and feel, displays. • Security – Data locationsm connection points, physical security. • Regulatory – FDA, FCC, UL, CE, radio licensing by country, etc. Space doesn’t permit a detailed discussion of each of these, but they are all linked together and thus need to be considered from a system perspective. Of particular importance are the periodicity of data collection and its transmission, as well as distance from the sensing device to the gateway. These considerations drive many of the other design elements, including size, power and storage. Devices inside the body also pose a different challenge due to the absorption of the signal by body tissue. Connected medical devices have certainly evolved over the past several decades and will continue to do so as technology advances. In addition, the aging population, the rise of chronic diseases and the challenges of providing cost-effective health care will continue to drive their adoption.

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Patients will benefit from improved health outcomes and quality of life, real-time support and interventions, the extension of care at home after discharge, and reduced hospital stays. Providers will benefit through the extension of clinical environments into a patient’s home, increased frequency and accuracy of patient health data, and the ability to continue monitoring patient health, particularly for chronic cases. The result should be reduced costs from re-admissions and reduced hospital stays. Payers will have a better view of patient compliance practices and more accountability from patients, which should result in lower costs. Finally, connected devices enable medical service in remote environments. The fusion of objective, reliable and timely patient information may truly usher in the era of “big data,” revolutionizing the assessment and delivery of health care. While we may not yet quite have developed the Star Trek tricorder, we certainly have come a long way from the two-way wrist communicator of Dick Tracy in the ‘40s. The technology is no longer a gating item to the potential reform of our medical health care delivery system, and hopefully, the payment and delivery system will evolve to fully utilize those capabilities. M Bill Betten is the president of Betten Systems Solutions, a product development realization consulting organization. Betten uses his years of experience in the medical industry to advance device product developments into the medical and life sciences industries, helping clients to develop innovative medical devices and adapt to a changing environment. He most recently served as director of business solutions for Devicix/Nortech Systems, a contract design and manufacturing firm.

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DESIGN SERVICES

How to design wearable sensors that work for users, FDA Medical devices worn outside the clinic must be designed differently than those designed for clinic use. Here are several factors to consider when planning for a successful wearable or smart device development effort. To m K r a M e r Kablooe Design

When developing new, innovative medical devices, designers and engineers have always had to take into account the needs of physicians, nurses, technicians, hospital and clinic buyers, and the patients. These considerations allowed them to make a device that would be properly used and adopted. The rise in patient-worn and -operated devices dictates different needs than those of the past. Many are used at home or in public, and device designers must take into account the environmental challenges posed by these settings. They include:

Do the research One of the best ways to do this is with ethnographic research. An ethnography is an observational episode in which the developer or researcher watches users interacting with the predicate device or situation to learn about the users’ needs during this episode of care. Ethnographic research can often be done during the course of product development and used as early formative studies. Finding usability data early and showing how your design fulfilled the user needs uncovered in the data does three things:

• Weather, e.g. moisture and temperature; • Abuse (asphalt, trees, bleach, shampoo, motor oil); • The ambulatory nature of the user in the space.

• Generates input to direct the design of your device; • Helps you design a device that users won’t quit using; • Creates a formative study to supplement your FDA submission.

These challenges pose new and different ways that a user could break or abuse a device that might not be possible in the clinical setting. Finding a way to study the users in their environment is critical for success. Here are some of the several factors to consider when planning for a successful wearable or smart device development effort. Device adoption Perhaps the most important thing to consider is device adoption. Without this, you have no sales, and your innovation will not reach those whom you intend to help. Let’s face it, no one will want to continue to use your device if it is difficult to operate in the home or in a public setting. They can just take it off, leave it behind, or turn it off, and no nurse will be there to put it or turn it back on. The users we are targeting with home healthcare devices need to figure out how to use it themselves. Even if they have a bit of initial training from a caregiver, when they are on their own and have a question or a problem (which they will), they most likely don’t have the medical training that their caregivers do and will have to figure things out for themselves. We must target our device features to be used and understood by this population.

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Action plan A good action plan for the proper development of in-home, wearable, connected devices must include these steps: • Conduct observational research with all types of users; • Find pain points by watching and probing, not asking for answers; • Convert these pain points to design inputs; • Use the design inputs as part of your design requirements; • Let all early, front-end development work use these inputs as a checklist for success. Employing these principles will greatly increase the chances that users will successfully adopt your device, comply with the usage requirements and see better outcomes. It may also help you get to market more quickly and realize a more successful product launch and lifecycle, too. M Tom KraMer is president & CEO of Kablooe Design, a design and development firm for medical and consumer products.

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ELECTRICAL / ELECTRONIC COMPONENTS

7 electronic design problems that boost medical device costs When developing electronic devices, design for manufacturing (DFM) often takes a back seat without regard for the long-term consequences. Even if the manufacturing cost is within the target, companies should consider and address the device’s manufacturability. Mike Labbe Va l t r o n i c

Products that are challenging to build typically result in longer lead times, lower margins and possibly lower quality compared with products that are designed with manufacturing in mind. Common electronic design issues to consider include: Over-tolerance/over-dimensioning You may need tight component tolerances, but the cost to make the product is directly correlated. If your design margin can tolerate 5% or 10% resistors, do not specify 1%. Similarly, mechanical tolerances should be only as tight as needed to ensure functionality. A contract manufacturer will build according to its customer’s requirements to meet the tolerances of the finished product. To reduce cost and avoid additional delays, only add tighter requirements as necessary.

quality issues. This saves time and cost by allowing correction or rework of a failing product before shipping. Plan for functional testing at the factory as early as possible in the design cycle. Electronic component placement Most of a contract manufacturer’s automated equipment relies on conveyors and fixtures to transport products through the process. Components placed close to the edge of the board (unless critical to design parameters), at odd angles, or placed without regard for good practices for design layout and spacing may require additional paneling/tooling to facilitate fixturing and increase manufacturing cost.

Mixed technology Different technologies on a printed circuit board assembly (PCBA), such as surface-mount technology (SMT) and through-hole components, can increase cost and manufacturing time. Minimizing mixed technologies and designing for as much automated assembly and SMT placement as possible reduces manufacturing complexity and cost, while improving quality. Always minimize hand component placement and other manual secondary operations. Electrical testing You should electrically test all devices at the factory to ensure that only quality product ships and to provide near real-time feedback on performance or

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ELECTRICAL / ELECTRONIC COMPONENTS

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Under the broad category of primary lithium battery types, numerous types of primary (non-rechargeable) lithium battery chemistries are commercially-available that differ in their performance characteristics. The critical considerations are voltage, discharge current, service life and temperature range. LiCFX (poly carbon monofluoride) and LiMN02 (manganese dioxide) chemistries are commonly used in consumer applications. LiSO2 (sulfur dioxide) batteries are mainly found in high power military radios. LiSOCl2 (thionyl chloride) chemistry is commonly utilized in industrial, remote and medical applications. Lithium thionyl chloride (LiSOCl2) batteries can be manufactured two ways, using spirally wound or bobbin-type construction. Bobbintype LiSOCl2 batteries offer the following performance characteristics: •

•

Greater energy density and higher capacity: Bobbin-type LiSOCl2 batteries offer the highest energy density of any primary cell: up to 710 Wh/Kg and 1420 Wh/I. These cells also feature the highest capacity by weight and volume of any commercially available battery technology. Extended temperature range: Bobbintype LiSOCl2 batteries can operate in temperatures ranging from -55°C to +125°C. However, to maximize the capacity, standard cylindrical wafer type cells are rated to a maximum temperature of +85°C. Specially modified cells can extend the maximum high and low temperatures. Higher operating voltage: Bobbintype LiSOCl2 cells have an open circuit voltage of 3.67V and an operating voltage of up to 3.6V. Longer life: Bobbin-type LiSOCl2 batteries feature an outstanding shelf life and long-term reliability due to a very low annual self-discharge rate. Over a 10-year period, a bobbin-type LiSOCl2 battery stored at room temperature can

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•

lose between 7% and 30% of its initial capacity depending on the manufacturer. Patented safety features: Bobbin-type LiSOCl2 cells offer unmatched safety due to their unique “fail-safe” construction. These batteries are also free of heavy metals, making them among the most environmentally friendly of all batteries.

Bobbin-type LiSOCl2 batteries can be combined with a patented hybrid layer capacitor (HLC) to deliver periodic high pulses to support two-way wireless communications and other advanced functionality. How does it work? In medical applications, the extended temperature range of a bobbin-type LiSOCL2 battery makes it ideal for use in RFID asset tracking tags that monitor the location and status of medical equipment throughout a hospital, nursing home or medical research facility. Equipped with this battery, the equipment can undergo high temperature autoclave sterilization cycles of up to 125°C without having to remove the battery from the RFID tracking device, providing an uninterrupted data stream. These robust batteries can also be modified to operate in the medical cold chain, where wireless sensors must endure temperatures as low as -80°C to continually monitor the safe transport of tissue samples, transplant organs and pharmaceuticals. The high capacity, high energy density and incredibly long shelf-life of a bobbin-type LiSOCl2 battery also makes this chemistry well suited for automatic external defibrillators (AEDs) as well as powering twoway wireless communications. M 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.

Component sourcing Many devices require tight control over approved component vendors or have only single sources. Components should be chosen with multiple alternatives and included in the approved bill of material. This can save cost by allowing for competitive sourcing and eliminate minimum-buy quantities. Allowing for substitution of available components without requiring significant additional testing or approvals can also dramatically improve lead times. Component sensitivity For many applications, you can’t avoid challenges around moisture- and temperature-sensitive components. When designing electronics and selecting components, consider factors that will affect manufacturing process flow such as components that cannot withstand SMT reflow profiles or be exposed to a water-wash process. These components require hand placement, resulting in significantly more labor and higher assembly cost than an identical functional part that can tolerate these environments. Some common examples include: •

•

LEDs, switches and connectors, which have a variety of heat tolerances. When used on a Restriction of Hazardous Substances (RoHS) PCBA, ensure they are compatible with reflow temperatures for RoHS processes. Many variable resistors, capacitors, switches and connectors cannot be washed or conformal-coated. If you intend to use a water wash or flux, specify components that are compatible with the process. For projects that require conformal coating, roomtemperature vulcanization or underfill, work with your contract manufacturer during design to determine optimal processes and materials. Specifying a unique material or unconventional process will require additional development and may increase product cost significantly.

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11/21/18 9:47 AM

PC board design Conduct a DFM review on the PCB design before transferring to production. This should include careful review and optimization of several factors, such as layer count, component density, panelization design, fiducial markers and required assembly tooling. The PCB is often most expensive and the longestlead component on a bill of materials, so clear communication with your board house or contract manufacturer during design and prototyping will prove invaluable to achieving the highestquality and lowest-cost PCB design. M Mike Labbe is director of R&D for Valtronic and has more than 25 years of experience managing full life-cycle development and commercialization of complex medical devices and technologies.

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ELECTRICAL / ELECTRONIC COMPONENTS

How electronic skin tech is improving home wearable devices Advances in form factors, such as electronic skin, are solving many of the problems in the wearability home health market. Jiang Li VivaLNK

Patient care is moving closer to primarily being administered in the home. Kaiser Permanente’s CEO, in fact, recently said that the home is the future of healthcare. Along with this trend comes an increasing number of transactions being conducted online, enabled by remote patient monitoring (RPM). In fact, 52% of last year’s patient transactions at Kaiser Permanente were conducted online. Decentralization is inevitable, and the transition is already happening. As a result, the growth rate of hospital devices and equipment will likely pale in comparison to the investment and innovation in RPM and devices that can be used in the home for health monitoring. It’s a market opportunity that device manufacturers, particularly those focused on non-invasive vital signs monitoring, should get ahead of. The historically distinct markets of regulated medical devices and consumer health wearables are blending, driven by the advance of wearable technologies and the progress of telehealth.

VivaLNK's eTattoo (left) and form factor (right) aim to improve accuracy in eSkin technology. Image courtesy of VivaLNK

Medical Design & Outsourcing

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Traditional consumer technology companies are moving deeper into the device space – such as Apple with its latest upgrade to the Apple Watch, allowing for medical-grade quality monitoring available directly to consumers yet viable for a doctor to use in treatment and diagnosis. The result is an exciting new category of connected healthcare devices that have three key attributes that allow them to gain more traction in the market: The data is of medical-grade quality, the device is user-friendly, and it is more affordable than traditional medical devices. The last is an important point considering the growing portion of healthcare expenses that patients are now responsible for in a volatile pricing market. Form factor is an important driver in order for a device to achieve user-friendliness, meaning it is designed with user wearability in mind. In fact, it may be the most important factor and one key for medical device companies to understand, as designing for ease of use has not been the device engineer’s primary concern historically. An exciting frontier for form factor is electronic skin (eSkin) technology. The growing popularity of the eSkin market is delivering more slender, flexible, sleek and barely-there devices packed with advanced sensors and wireless transmitters. Electronic skin technology is making headway in monitoring health and vital signs such as heart rhythm, respiratory rates, heart rate variability, ECG, temperature and more. These wireless devices resemble Band-Aids in that they conform to the natural shape of the human body. They can be snugly placed at the most ideal location on the body based on the type of data to be monitored, which contributes to accuracy. Prior to eSkin technologies, wearables had hard surfaces and were either loosely attached, thereby sacrificing data consistency and quality, or were uncomfortable to wear.

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Image courtesy of Omnetics

A CONNECTOR? Danielle Kirsh | Assistant Editor

A connector provides interconnection routes in medical electronic systems, giving a power pack or supply to multiple modules in an instrument, according to Bob Stanton, director of technology at Omnetics Connector Corp., based outside Minneapolis. Different units inside equipment do different work, which means they require different current and voltage levels to operate. Connectors are used in EEG or other diagnostic devices. The connector size, pin count and wiring help prevent signal degradation and low-quality information about a patient, according to Omnetics. “The connector and cable must be designed to meet the output capacity and resistance of each type of equipment and each signal format it carries,” Stanton said. How does it work? Connectors act as the meeting point for cables and instruments. “Connectors are the interface between the cables and the instruments they serve,” Stanton said. “In addition to different voltages and current flow, each instrument often uses different electrical signal processes to provide the best quality flow of data and information to the other units that need it.” Connectors have pins to help maintain flexibility and low resistance. Spring pins are made from tempered beryllium copper and can slide into smaller solid tubular sockets within a connector body. Connector pins that are micro-size are placed in a 1.27 mm pitch. Nano-size connectors are 0.635 mm in size. Pins made from different materials help the connectors have different characteristics. For example, pins and sockets plated with nickel and gold help connectors reduce wear. The back of each pin or socket has ruggedized attachment methods that allow for permanent wire or solder lead attachment to mating elements. M

Medical device company officials around the world like how simple and comfortable the monitoring device can become with the use of eSkin technology. It’s a rapidly growing space enabling multi-vital sign monitoring capabilities and, ultimately, a competitive edge as healthcare moves out of the hospital and into people’s homes. Electronic skin technologies and medical wearables will not only make healthcare more efficient and cost-effective, but also deliver care to a larger population around the world. M

Jiang Li, founder and CEO of VivaLNK, started the company after a heart attack scare led him to observe the outdated tech used in patient monitoring. VivaLNK is a provider of connected healthcare products including wearable clinical-grade, continuous monitoring devices.

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FLUID POWER COMPONENTS

A LEFT VENTRICULAR ASSIST DEVICE AND HOW DOES IT WORK? Danielle Kirsh | Assistant Editor

A left ventricular assist device (LVAD) is a mechanical pump that attaches to the left ventricle of the heart to supplement the function of the pumping chamber, according to Jodi Hutchins, a regulatory and quality consultant at Proven Process Medical Devices. The left ventricle of the heart is responsible for pumping blood from

the heart to the rest of the body. The LVAD differs from an artificial heart because it helps the heart pump more blood to the body with less work, whereas an artificial heart replaces the heart completely. An LVAD is needed when a patient is in the advanced stages of heart failure and the heart cannot pump enough blood for the body.

With the lack of donor hearts to replace a failing heart, the LVAD is the next best alternative. They can be used for three things. Health providers could implant an LVAD as a temporary fix while a person waits for a donor heart. Or the LVAD could be a destination therapy, where a patient may be implanted with an LVAD if they are not eligible for a heart transplant. The third way LVADs are used is for bridge-to-recovery cases where the device is implanted so that the heart can regain its strength with the help of the LVAD. How does it work? An LVAD has internal and external components. The internal components include a pump that rests on or adjacent to the heart’s left ventricle with a tube that acts as the pathway for blood to travel from the left ventricle to the aorta. A driveline cable is attached to the pump and goes out through the skin to connect to an internal mechanical pump and an external controller with a power source attached to the outside of a patient’s body. The driveline and power source need to be connected at all times for mechanical circulatory support to function. Power sources can include a form of a battery, an AC adaptor or DC adaptor, and the controller requires two power sources connected at all times. Most controllers for LVADs have a built-in warning system to alert a patient if the batteries are running low. M

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Medical Design & Outsourcing

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HIGH-PERFORMANCE POLYMERS

Materials for needle-free injection technology: What you need to know Specially formulated polycarbonates help advance drug delivery innovation that improves patient experience and promotes better medication compliance.

Makrolon Rx1805 polycarbonate is used in the production of the insulin-delivery interface and for molding the ampoules (left) containing the medication used in the needle-free injection equipment. Image courtesy of QS Medical Technology Co.

Douglas Hamilton Covestro

Diabetes is on the rise. The International Diabetes Federation (IDF) estimates there are roughly 415 million people affected by this chronic condition. By 2045, this is expected to rise to 629 million. For many, living with diabetes requires injecting insulin on a regular basis – a painful yet necessary ritual. In addition, it’s believed that there are some people who do not adequately treat their condition due to a fear of needles. Increasingly, medical device companies are looking for alternative methods of delivering medicine to those who need it. One area of promise is needle-free injection technology, a drug-delivery system that directly transfers medicine into patients without piercing the skin with a conventional needle. With biologics and other drugs that require selfinjection entering the marketplace, needle-free injection technology offers many advantages over needle injections, including more efficient and less painful drug administration for patients. It is hoped that providing a more comfortable, efficient injection experience will help increase medication compliance.

Medical Design & Outsourcing

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Bringing this type of advancement to market requires pharmaceutical developments. But that’s just half of the equation. Lifeenhancing medical technology like this also requires materials that can meet the rigorous challenges these applications demand. New healthcare technologies = new material challenges For decades, medical devices and equipment creators have depended on polycarbonate resins formulated specifically to meet the unique requirements of the healthcare industry. Polycarbonates have been proven for decades in a number of life-enhancing applications, including blood separation, cardiovascular, surgical instruments, and syringes and catheters, among others. As needle-free injection technology advances, polycarbonate is proving itself in this burgeoning application, due to its light weight, toughness, design flexibility and processability for injection molding. A helpful reference for needle-free injectors is the International Organization for Standardization

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HIGH-PERFORMANCE POLYMERS

H I G H - H E AT T H E R M O P L A S T I C S A N D H O W D O T H E Y W O R K ? Jonathan Jurgaitis | Spectrum Plastics Group

High-heat thermoplastics are a group of polymers that receive this designation because of their elevated processing temperatures, typically between about 550°F to 750°F. Some of the more common high-heat polymer types are PEEK, Ultem, PSU and PPS, but many other material types also fall into this category. These materials are considered engineering materials but are at the pinnacle of all thermoplastic performance characteristics. One performance property of these polymers – directly related to the designation of high-heat thermoplastic – is that they have a higher maximum operating temperature, compared to other engineering materials. Maximum operating temperatures for highheat thermoplastics range between about 380°F up to 450°F or even 500°F depending on polymer type. High-heat polymers are all rigid, hard and extremely tough. These materials also have extreme chemical resistance properties. They’re able to withstand multiple cycles of all sterilization types, and tend to be inherently flame retardant. High-heat thermoplastics make up a very small percentage by weight of all plastics used in the world, less than 5%. Costs for these materials can start in the mid-teens of dollars per pound on up to the $30 to $50 per pound range. Specialty grades, implant grades and custom compounds have even dramatically higher costs.

Medical Design & Outsourcing

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How do they work? High-heat thermoplastics are made up of less common chemical constituents, and the processes to make the polymers can be more difficult and complex. The various chemical makeups of these materials have more powerful bonds between the constituent atoms. The more powerful bonds give the high-heat thermoplastics their high strength, and chemical and heat resistance. It requires more energy to loosen those bonds, in the form of heat to process them into finished products and other forces that might weaken them in their respective applications. The properties listed above mean that high-heat thermoplastics are useful in the most demanding and extreme environments and applications. A variety of industries use high-heat thermoplastics, with the materials found in aerospace, military, high-end automotive, industrial, electronic and medical components. Because of Image courtesy their extreme of Spectrum capabilities and Plastics Group high costs, highheat thermoplastics are reserved for the most demanding and niche applications within those industries. In the medical industry, this means that they are sometimes used to replace stainless steel, but are increasingly used in neuro, pediatric, orthopedic and access device applications where they

can provide more design freedom and functionality than previous rigid materials and multi-component constructions. Many raw material suppliers offer medical-grade versions of these materials and some are offered in permanent implant grades as well. High-heat thermoplastics require specialized machinery and processes to mold them into their finished parts. Necessary enhancements for machinery includes heaters capable of maintaining process temperatures up to 800°F. The barrel needs to be made of metals and alloys with higher heat resistance, such as high-nickel alloys, to maintain the tight tolerances between barrel and screw, and in some cases, tooling will need to be made of similar high-heat-resistance metals for the same reasons. Most highheat thermoplastics are hygroscopic and need to be dried at higher temps, which will require specialized driers as well. Most of these high-heat materials will need to be cooled down slowly in the forming process to minimize molded-in stresses and/or maximize crystallinity. This will require special heated molds and downstream calibration that slows heat loss. High-heat thermoplastics have become greatly utilized materials in a wide array of technical, niche and demanding applications and have been key in advancing technological growth in our modern world. M Jonathan Jurgaitis is a senior extrusion engineer at Spectrum Plastics Group’s Apollo Medical Extrusion Technology business. Jurgaitis has been in the custom medical extrusion industry since 2006, helping to manufacture catheter and medical device components. He’s held a variety of positions in the extrusion industry since 1993.

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(ISO) standards listed in ISO 21649:2006. This international standard provides safety, performance and testing requirements for single-use and multipleuse needle-free injection systems intended for human use. The most recent example of a medicalgrade polycarbonate in action for such an application is a needle-free injection insulin delivery device from QS Medical Technology Co. (QS). New research studies indicate needle-free injection is a viable therapy for diabetes and effective blood glucose control. In fact, compared to a conventional insulin pen, needle-free injectors are predicted to result in faster absorption and greater glucose-lowering effects in the period after administration. With more than 114 million Chinese patients with diabetes, this application is an important one for the Beijing-based company.

Polycarbonate forms the insulindelivery interface and ampoules containing the medicine. For this application, the material needed to meet QS’ requirements of precise size, high strength and toughness for the plastic drug-delivery components and ampoule bottles. These properties are necessary to ensure that the drugsuction component can consistently and safely puncture through the plug of an insulin reservoir. The material also needed to fulfill the medical OEM’s design requirements, so that the drugtransfer needle and the protective cover of the drug suction component could be manufactured in one shot via injection molding. QS kept several other important material considerations in mind, which should be considered for all needle-free

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HIGH-PERFORMANCE POLYMERS

It’s important to note that a device manufacturer still must evaluate medical-grade polycarbonate for suitability to ensure the final product meets relevant biocompatibility requirements, performs or functions as intended, is suitable for its intended use and complies with all applicable FDA and other regulatory requirements.

AS MEDICINES CONTINUE TO EVOLVE, NEEDLEFREE INJECTION TECHNOLOGY IS EXPECTED TO INCREASINGLY HELP FACILITATE MORE EFFICIENT AND LESS INVASIVE DRUG DELIVERY.

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MACHINING

Crosshead construction for medical tubing: What you need to know As the medical industry migrates more to multi-layer, multi-lumen tubing for various uses, the extrusion die design and manufacturing supply chain has likewise evolved. That includes new crosshead designs. Bill Conley G u i l l To o l & E n g i n e e r i n g

Medical tubing manufacturers are increasingly turning to assorted types of multi-chambered crossheads to produce tubing with high precision. The goal is consistent wall and layer dimension plus structural integrity on even the smallest diameter or wall thickness. Here are the basics you need to know about creating multi-chambered crossheads: •

To help meet demands related to high-precision, multilayer or multi-lumen medical tubing, Guill offers its 800 Series extrusion crosshead. Image courtesy of Guill Tool & Engineering.

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The die designer must start with the very latest technology in 3D CAD and a state-of-the-art computer flow simulation program. It’s important to accurately predict the flow mechanics and potential temperature challenges that might impact the sensitive materials and thin wall or multi-layer constructions of today’s medical tubing.

• A finite element analysis program can combine with SolidWorks or other final output to enable custom design of all types of extrusion tooling products – including crossheads, inlines, spiderless inlines, rotary heads, deflectors, tips, dies and the die handling apparatus such as clamps, swing gates, flanges and breaker plates. Proper die performance and assembly accuracies are essential. 11 • 2018

• A quality rheology lab is also critical in the preparation of multi-layer and multi-lumen tubing dies. The flow characteristics of the disparate materials used can often impact heater placement, temp sensor types and placement, so the extra rheology lab effort will invariably reduce delays in the design process as well as reworks and inline iterations, which can be very costly to the tubing processors. • When such diework is ready for production, the best machine tools are an absolute necessity, including full wire and small hole sinker EDM, plus true five-axis machining centers to work super alloys and exotic metals to very close tolerances. This level of capital investment is needed to produce diework that will last in the field, with proper maintenance, producing highquality tubing on a consistent basis. • Also notable is the need for the diework to be inspected, disassembled, thoroughly cleaned and reassembled, using die carts and swing gates specifically designed for use with such equipment. Ask your die and crosshead manufacturers for suggestions and maintenance manuals to ensure they can support such high-precision equipment in your plant. Guill Tool is a world leader in complex diework, providing medical device industry extrusion tooling that can produce medical micro-tubing measuring 0.005 in. in diameter with consistency, as well as complex multi-layer and multi-lumen tubing. M Bill Conley is sales manager at Guill Tool & Engineering (West Warwick, R.I.).

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MACHINING

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The increasing popularity of six-axis robots is part of the growing industry 4.0 trend. Robots help streamline production lines, increase productivity and optimize workflows. They can be used for a variety of medtech production processes including medical device assembly, quality control & packaging and implant polishing. Device manufacturers are faced with strict regulations to maintain tight tolerances and reproducibility. To keep up with the pace of innovation, medical manufacturers must be able to change manufacturing lines when new products are being developed. They also require consistency in the quality of the production press and high repeatability with minimized risks of human errors. Robotics offer manufacturers modular systems that promote efficiency and workflow, as well as high repeatability.

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Medical Design & Outsourcing

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Automation of spiral-tubing manufacture As an example of the capabilities of six-axis robots, consider an endotracheal tubing product created by systems integrator Elettrosystem. The system was once considered so complex as to be beyond the scope of automation. But four six-axis robots have created a production line for the sophisticated process. The spiral tube is a special hollow probe, which is used in anesthesia as well as in intensive care medicine. In the case of the automation solution implemented by Elettrosystem, a fine steel coil spring is wound onto a PVC tube and an adhesive sheath applied. The unique challenge here lies in the strictly defined uniform distribution of the spring windings as well as in the handling of the two flexible components. The plant for the simultaneous production of four spiral tubes consists of two cells in a mirror-image layout. The complicated winding of the spring takes place in an integrated process circuit, which is linked via linear systems. The robotic arms require exemplary precision and path accuracy. Surface treatments, testing and cleanroom capabilities The polishing of orthopedic implants is one of many high-precision applications in robotics. Established providers rely on six-axis robots which can achieve the accuracy required for high-precision machining to tight tolerances of 0.03 mm. The robots can also test inhalers and their components to destruction inside a compact robot cell. www.medicaldesignandoutsourcing.com

When production runs are in the millions of units, the most stringent safety and quality standards apply. Tensile and high-pressure testing operates in parallel with production under cleanroom conditions. Parts to be tested can be handled by a cleanroom robotic arm. This automation of testing represents a quantum leap. In addition to a significant increase in productivity, the system facilitates adherence to the highest quality standards under reliably reproducible conditions. The fast pace of six-axis machine ensures low cycle times. Furthermore, the cell boasts ease of service and maintenance as well as low-energy consumption. Used in combination with refined solutions, the compact and reliable robotic arms can provide inspection quality and product safety within a confined space.

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Italian manufacturer Elettrosystem uses a six-axis robot to manufacture specialized spiral tubing. Image courtesy of Stäubli

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MACHINING

Conclusion Robots cover a wild scope of applications in the medtech industry. Increasingly, we are seeing additional uses, not only on the manufacturing floor and research labs, but also as a new trend in the surgical field and in hospital automation. For example, Arxium recently developed an automated compounded pharmacy solution. With new robots capable of working in aseptic environments at high speed, we also see a strong evolution in pharma production processes. M

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How medical equipment manufacturers tool up Medical product tooling decisions play a major role in per part cost and turnaround time.

TOP: A progressive die machine BOTTOM: A row of stamping presses

Images courtesy of DureX

Bob Denholtz DureX

In the medical industry, metal parts play an integral role in diagnostic, testing, medical instruments and equipment. Although certain complex metal parts can only be machined, thinner-gauge parts and enclosures are typically stamped using hard tooling or fabricated using lasers, turret presses or press brakes. To meet functional and longevity requirements, medical device OEMs frequently turn to contract metal fabricators and stampers for assistance with tooling decisions that can significantly reduce the price-per-part and turnaround time. The progression ranges from soft to hard tooling; hybrid approaches; staged tooling; and fully progressive dies. Soft tooling Low volume part manufacturing for the medical industry often involves soft tooling for sheet metal fabrication. Usually, this process entails having a flat or slightly formed part that has holes, slots or tabs punched in it by a CNC laser or turret punch press, followed by bending using a press brake. Soft tooling typically costs $75 to $500, but can cost up to $2,000 to 3,000 for more complex

parts. It can work for part prototyping and low volume orders, but the cost per part is higher because it can take minutes of machine time to make each part. A strategy to lower or eliminate soft tooling cost is to borrow tooling from a supplier’s “library of tools.” Contract metal manufacturing facilities that have served a variety of markets for decades can offer an inventory of soft tools in many sizes and shapes without charge. Hard tooling When critical tolerances are required or volumes increase to 15,000 units or more annually, OEMs often benefit from moving from soft tooling to hard tooling to reduce costs. The cost of hard tooling can vary from $5,000 to $300,000 depending on size, complexity and whether it is designed to produce a finished part. One OEM started at 500 parts per month with soft tooling. However, when production requirements increased to 4,000 parts a month, they moved to hard tooling to reduce the price from $22 to $15 a part. With a hard tooling cost of about $85,000, they achieved ROI in about four months.

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MACHINING Hybrid tooling As the name implies, hybrid tooling is a combination of soft and hard tooling. Depending on the part, it might begin as a flat piece of metal that is punched or formed with a soft tool, with further forming by a hard tool. For example, an enclosure could be started in a turret that punches all the holes and slots before it is moved to a hard die that forms up the sides into a box in one operation. Instead of putting a flat piece of metal in a brake and hitting it four times to bend the two sides and two ends, a die could be used to hit it once so it only takes 30 seconds to make the part instead of 2 minutes. Staged tooling To create metal parts for medical equipment manufacturers at greater speed

and volume as well as lower price per part, staged tooling can be used. This involves moving a metal part between multiple stage tools, so the work is performed in unlimited processes that utilize hard tooling. For example, instead of taking 5 minutes in a machine to punch all the features individually using a soft tool, a blanking die could be used to punch everything in one hit in seconds. Then it could be put into a forming die and formed into shape. Progressive dies The fastest, highest volume part production is achieved by a progressive die. This method accomplishes multiple operations in a single process using hard tooling. Depending on the part, a progressive die utilizes metal coil and can often produce a finished part with every machine cycle.

For example, a customer was spending about $125 for a metal card cage that held circuit boards. When volume rose to 1,000 parts a week, the cost was reduced to $55 per cage by switching to multiple staged tools. Although the hard tooling cost was substantial â&#x20AC;&#x201C; about $350,000 â&#x20AC;&#x201C; the OEM achieved ROI in only 5 to 6 weeks. M Bob Denholtz is president of DureX, an ISO 9001 registered contract metal manufacturing facility of 120,000 square feet based in New Jersey.

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How automated laser welding outperforms conventional welding for ring electrode manufacturing

Electrophysiology basket catheter with ring electrode.

Image courtesy of Integer

While manual resistance welding is common in the device manufacturing industry, automated electrode welding processes can enhance the consistency, quality, performance and efficiency of electrode ring assemblies. Paul McCormick Integer

Multielectrode electrophysiology (EP) catheters have become the new mainstay for the mapping of complex arrhythmias. Advanced electrogram mapping is delivering breakthrough results in the diagnosis and treatment of one of the most common arrhythmias – atrial fibrillation (Afib). As this market grows, demand for improved electrogram mapping is fueling the innovation of new high-density mapping catheters. While much of the focus in high-density mapping has been on the spline and basket assemblies, the electrode and wire sub-assembly is an equally important, but often overlooked, component of the finished device. Precise electrode and wire assemblies are increasingly important because accurate mapping requires greater electrode density and optimal electrode connections, yet manual resistance welding is still commonly used in device manufacturing. The resistance welding process falls short in some key areas, including:

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• Multiple testing cycles. Due to potential variation in electrode assembly performance, product performance is typically more complicated to test, inspect and resolve. • Increased cost. Reliance on labor-intensive processes with higher scrap rates increases the cost of goods sold and reduces the device supplier’s ability to competitively price the product. • A higher rate of product failures. During the manual resistance welding process, the risk of weld failures is greater. This hampers electrical performance and has the potential to negatively affect product performance in the field. Automated electrode welding processes have become a more effective way to produce higher electrode densities. Compared to manual resistance welding, automated laser welding can provide higher-quality electrode and wire assemblies and greater precision and

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11/21/18 10:17 AM

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manufacturing efficiency, delivering more reliable EP catheter performance. Laser welding also produces a flatter and smaller weld spot than typical resistance welding (0.003 in. versus 0.007 in. for typical resistance weld). This creates additional space for precise positioning of multiple wires or extrusions inside the electrode ring to support the electrode miniaturization needed for high-electrode-density catheters while reducing the risk for fluid leaks. The automated laser welding process also boosts manufacturing efficiency. In development, it strengthens reliability

by minimizing the number of variables to investigate, evaluate and troubleshoot during the design process. Automated quality control also minimizes the potential for waste and product failures downstream in the supply chain â&#x20AC;&#x201C; in the testing of spline assemblies or finished EP mapping catheters â&#x20AC;&#x201C; where the cost of repairing poor quality is greater. Outsourcing complex EP electrode assemblies allows device manufacturers to maintain their focus on high-value initiatives while leveraging core manufacturing capabilities from an outsourcing partner. M

Paul McCormick is a senior research and development engineer for Integer. He is responsible for product and process design and development for new internal and co-development product opportunities. Most recently, his projects have focused on process development for electrophysiology catheters.

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11/21/18 10:18 AM

Medical device packaging: It’s not a last-minute decision Your medical device packaging design and related equipment are validated. Can you live with a hurried decision for the next 10 years? John Abraham A t l a s Va c M a c h i n e

The packaging engineer is too often invited “late to the party” when a new medical device is being launched. The device packaging design process is no time for shortcuts or missing critical details. The potential failure of the packaging is just as critical as the numerous potential deficiencies that can cause a device failure. Similar issues can arise when transferring a product to an outsourced supplier where duplication of an existing packaging protocol is too easily assumed. Package design considerations If the new rigid package design is based on familiar materials and sources, the packaging engineer will likely know what to expect for performance and timeline. If the project requires a new material type, a thinner material, a unique design feature or a different testing protocol, it would be best to understand the risks introduced and any impact on the timeline. Is it wise to have a Plan B if Plan A is too nuanced? Asymmetrical features and depth variations will cause tray wall thickness as well as sealing flange thickness to vary. This is normal for thermoformed packaging. There are numerous opinions about what the correct sealing flange width should be. If it was a simple precise calculation, why do we see so many design variations? Likewise, the testing methods for that seal are based on closely held viewpoints. Are there better methods available, or is the current one providing reliable data from all responsible parties in the packaging process? Tray-sealing equipment An often-overlooked issue is existing cleanroom equipment capacity. Has the packaging engineer engaged operations to understand why (or why not) the needed equipment and capacity are on hand? If not, it would be easy to procure a duplicate piece of equipment unless the original is too old, not up to current safety standards, lacking in features that may

A precision tooling nest for tray sealing is set on the shuttle of a tray sealer, ready to load and seal. Image courtesy of Atlas Vac Machine

solve existing operational issues, not data-enabled, not sustainable, or lacking a record of reliability under hard use. Consider reviewing the equipment and options available from reliable suppliers who offer a long-term solution. Get into the technical details. Also, attempting a custom equipment design adds risk to the timeline, so buying “off the rack” may be advised. Training This ISO requirement is typically not thought of until the new packaging equipment is delivered. Training at the OEM factory can offer numerous advantages. Something as simple as reviewing an installation qualification (IQ) checklist and the related equipment features can save hours of backtracking should someone who is uninformed install the equipment incorrectly. Having an initial hands-on familiarity with the controls system in a relaxed environment without

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MANUFACTURING

clean room gowning can increase the proficiency of the packaging engineer and perhaps their ability to conduct the upcoming operational qualification (OQ) with confidence. A hand-in-hand review of the equipment manual is essential to provide the packaging engineer with the ability to train others (maintenance, calibration, operators) as well as to find IQ data recommended by the OEM. Staff members who provide in-house calibration need to be familiar with the new equipment and would benefit from a factory visit to explore the OEM calibration approach vs. any assumed “tried & true” methods. Too often, incorrect calibration of the new equipment leads a product launch down a dead end.

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The packaging engineer should be involved in the project timeline earlier than typically permitted if these decisions are to be made with vetted confidence. Once validated, the packaging design and equipment will be something to be lived with over the lifecycle of the medical device. M John Abraham, president of Atlas Vac Machine, is an engineer and MBA with 18 years experience in medical device packaging as well as 20+ years in aerospace, military and heavy industrial products. Atlas Vac’s core expertise is capital equipment for medical device cleanroom packaging.

11/21/18 10:18 AM

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How to improve project management in a resource-constrained environment Startup companies would be wise to heed the words of Andrew Carnegie: “Put all your eggs in one basket and watch that basket.” The “basket” is the project that will make or break a fledgling company, and the project manager’s job is to keep an eye on it. Randy Nelson Heraeus

Project management for any complex medical device project can be a daunting task. For companies with resource constraints, typically startups, project management requires skills that are not as critical for an established company. All companies and projects have the same historic quality-cost-schedule requirements. In an established company, excellent quality is assumed, the schedule is planned and monitored by executives, and the cost is initially budgeted and perhaps not monitored and evaluated until further into the project. Startups must monitor spending much more closely or risk failure. Startups will typically have a small staff and contract most of the work to outside experts, whether that be development, regulatory, quality, etc. The project manager will manage limited internal resources and a variety of critical external resources, depending on the stage of the project. There are three key skills that become more important for a resource-constrained organization: communication, prioritization and technical leadership. Communication While internal communication is important for all projects, the project manager must also establish excellent communication with each external resource. Frequency and form of communication will depend on the stage of the project and how well the project is tracking to budget and schedule. At a minimum, a weekly meeting with detailed meeting minutes is critical to ensure everyone is on the same page (literally). During critical periods, a brief daily update between the external source and startup can ensure quick decisions and schedule compliance or resolution to issues. Too many meetings take unwarranted time and become costly. While face-to-face meetings can be costly and time-consuming, periodically planned meetings can greatly benefit decision making and overall communication. Prioritization Planning and prioritization of project tasks depend upon the amount of available capital and commitments made to investors. Ideally, a project manager will plan the entire project from concept through regulatory submission. In

Medical Design & Outsourcing

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reality, a company will have capital available in stages and be dependent on the success of early commitments in order to raise additional capital to complete the project. It is often prudent to make a commitment only to the initial stage of a project and “watch that basket” to make sure the concept is sound and becomes an acceptable risk for further funding. Without managing priorities, it becomes easy to add unimportant features that cause time and cost delays. Focusing on the aspects of the technology that differentiate the startup from other companies is key to success for many projects. Project managers should prioritize the key differentiators and plan to keep the nondifferentiating technology off the critical path. Technical leadership In an established company, project management may focus on the schedule and maybe the budget. In a startup, the better project managers are often the technical leaders. They need to have a first-hand knowledge of the technical requirements and difficulties for their project and may also be the primary engineer for the project. While not expected to personally solve all problems, the better project managers will be able to identify the potential time/cost/quality risk factors early enough to work with the extended team to mitigate issues and resolve problems before they become larger problems. The objective for project management in companies large or small is the same: successful development and release of a new medical device. For a resource-constrained startup, project management needs to be tuned to the internal capabilities and funding of the company. Emphasis on these three skills can help make a startup successful for the employees, investors, and the eventual patient. M Randy Nelson is senior director of business development at Heraeus Medical Components (St. Paul, Minn.). Until recently, he was CEO and founder of Evergreen Medical Technologies. Nelson has been responsible for developing medical devices for more than 35 years at both emerging and larger medical device companies and taught a graduate-level course in the valuation of new medical innovations at the University of Minnesota.

www.medicaldesignandoutsourcing.com

11/21/18 10:18 AM

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What you need to know about medical device packaging Medical device packaging is certainly not easy. Here are some pitfalls you should avoid. Nancy Crotti Senior Editor

A recent study about recalls of foot and ankle implants included a portion that likely drew less attention than the headline. Some of these implants were recalled because they arrived at the hospital in an unsterile condition, and the authors said faulty packaging may have been the cause. Poor packaging can cause a host of problems for medical device companies and their customers. A package that holds a sterile medical device not only has to arrive at the hospital or clinic free of holes, tears and broken seals, it also has to withstand sitting on a shelf, possibly for years, without breaking down. Improperly designed and validated packaging can even derail a product launch in the 11th hour, according to a couple of medical device packaging experts who shared their insights into what device-makers should know about packaging. Manufacturers like to use the smallest possible containers for shipping, which can compromise package integrity, according to David Furchak, launch architect with Keystone Solutions Group, an engineering, product development and medical device manufacturing company in Kalamazoo, Mich. “Specifically, it’s a concern with sterile, which is what we almost exclusively deal with,” Furchak said. Keystone works closely with Kentwood, Mich.-based Packaging Compliance Labs (PCL), which validates sterile medical device packaging according to FDA-recognized standard ISO 11607. The standard has three main pillars, according to Ryan Erickson, a packaging engineer at PCL: 1. A manufacturer must be able to consistently form and seal a package, meeting requirements for the strength

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and seal of the bond after heat-sealing, the seal’s visual aesthetics and the ability to open the package. If the end user in an ambulance, hospital or clinic has trouble opening a package, it may rip or tear, exposing the device inside to contamination and rendering it unusable.

Image courtesy of Packaging Compliance Labs

2. The package design must be sufficiently robust to withstand shipping through all types of climates and a variety of physical hazards. PCL simulates different types of hazards that packages might encounter, exposing them to subzero, desert and tropical conditions, dropping, compression, vibration, impacts and altitude simulations.

3. A package must be able to maintain its integrity over time. For a sterile, disposable device package, that’s usually two years, Furchak noted. PCL uses real-time aging in a controlled environment as well as accelerated aging, which requires baking the package. “Forty days in the oven is equivalent to one year sitting on the shelf,” Erickson said. If the material hasn’t weakened too much and the heat seals remain secure, a company can officially market the device with the validated expiration date claim. Many other considerations come into play. A package can neither be too small nor too large. Labeling must be easily understood and well-placed. Raw materials used in sterile medical device packaging must be traceable, safe and effective in creating a microbial barrier. Package manufacturing machinery must be set up and maintained in a validated state and produce a result that can be measured and monitored over time for performance to

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11/21/18 10:19 AM

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specification. The resulting packages must pass a variety of quality assurance checks. PCL likes to receive two to five prototypes of package designs to compare their relative defect rates, understand the modes of failure and make a plan to fix them, according to Erickson. The company recently

of these issues could have been worked out,” Erickson said. “The very first time you test something, there’s a very good chance of something going wrong.” Packaging problems can be averted if the customer gives contract manufacturers such as Keystone the ability to change the design after validation testing, Erickson said. Sending prototype devices that are the same size and weight of the proposed finished product can also avert disaster. PCL once received a 3D-printed hip replacement implant prototype in packaging that passed all the tests. When testing the same packaging containing the actual, much heavier implant months later, packages were cracking, lids were popping off and the implant’s rough coating was rubbing off and shredding, Erickson said. “I’m glad we caught it in development,” he added. “A lot goes into making a good package. It’s not easy, certainly.” M

IF COMPANIES WERE MORE FOCUSED ON DOING ENGINEERING FEASIBILITY TRIALS PRIOR TO UNDERTAKING A VALIDATION STUDY, A LOT OF THESE ISSUES COULD HAVE BEEN WORKED OUT. performed its own study of packaging systems that came through its lab as saleable goods, representing products as they would be presented to a hospital or clinic. One in three failed validation. “If companies were more focused on doing engineering feasibility trials prior to undertaking a validation study, a lot

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MANUFACTURING

Workers at Tegra Medical's Costa Rican plant. Image courtesy of Tegra Medical

How to simplify your supply chain while still mitigating risk So many factors can disrupt a medtech manufacturer’s supply chain, sometimes to disastrous effect. Thoughtful planning about facility siting can make all the difference.

Sean Mikus Te g r a M e d i c a l

You can’t always have your cake and eat it, too. But some companies are doing that when it comes to supply chain management in the medical device manufacturing industry. First, let’s talk about mitigating risk in your supply chain. The recent blast and widespread flooding from Hurricane Florence in North Carolina and the massive, deadly Typhoon Mangkhut in the Philippines are chilling reminders that natural disasters are unavoidable and, often, terribly destructive. Storms, floods, earthquakes, fires – all are bad news for companies trying to keep manufacturing plants up and running without interruption. Manufacturing a product in two different locations mitigates risk for OEMs if there’s a natural disaster or another type of interruption in one location. But spreading the manufacturing out often requires the use of two different suppliers, which then can complicate the supply chain. The risk/complexity conundrum The first step in dual-sourcing requires finding and validating the second source supplier, which is not a simple, quick or inexpensive process. Moving forward, it creates another supplier relationship to be managed from the executive suite to accounts receivable – and nearly every department in between. Then, as manufacturing progresses, there is the risk of differences in the actual product or part manufactured. Quality can be inconsistent from one supplier to another, or parts may not be delivered on time. Depending on where the supplier is located, corporate social responsibility issues can also rear their ugly heads. Assuming it’s a different country, an OEM must be aware of the norms for environmental and worker rights issues. Problems such as sweatshops, unsafe factories and child labor have tripped up many unsuspecting and otherwise well-respected companies in other industries. Quality and compliance issues are a nightmare no manufacturer wants to face.

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The Costa Rica connection Working with a contract manufacturing organization (CMO) such as Tegra Medical – with an operation in Costa Rica – addresses these issues head-on. Manufacturing can be dual-sourced between their U.S. and Costa Rica plants, which provides the benefits of geographic dispersion in case of natural disaster or other localized disruptions. Yet, because it’s within the same CMO, there is no additional supplier to find and validate and no additional relationship to manage. Work is still being done in a U.S.-owned company, with close ties to its U.S. operations. Quality procedures and ISO certifications are apt to be the same in the company’s multiple locations. The technology and personnel training are consistent, so parts made in one location mirror those made in another. Risk is mitigated without making the supply chain more complex. Other advantages include: • •

You avoid the time-zone challenges of working, say, with colleagues in Asia, and travel and shipping times are shorter. Costa Rica has a steady supply of well-educated, English-speaking workers.

As a country, Costa Rica is dedicated to the medical device industry. According to the Costa Rican Investment Promotion Agency, Costa Rica is the second largest exporter of medical devices in Latin America and among the top seven suppliers to the U.S. market. Exports have tripled since 2007. No one wants more risk or added complexity. With dual-sourced manufacturing in Costa Rica, you can have your cake and eat it too. M Sean Mikus is Costa Rica general manager for Tegra Medical.

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11/21/18 10:19 AM

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Early collaboration: Why it’s key to medical device success Early engagement and close partnerships between medical device developers or OEMs, contract manufacturing organizations (CMOs) and suppliers can reduce delays to the market, decrease costs and prevent common roadblocks. Claudio Hanna Web Industries

Getting a medical device from concept to market takes a significant amount of time and money. Supply delays, unforeseen costs and production challenges can all make the path to commercialization daunting. How can these challenges and delays be avoided? The answer is simple: proactive and effective collaboration. By engaging with trusted partners early in the product design, developers can avoid material and manufacturing challenges that can create delays and impact costs. The importance of design for manufacturability Developing a medical device is a complicated endeavor that involves a network of suppliers, different types of materials, reagents and other parts. At the development stage, the goal is just to get the device to work, but the component selections made during this stage can have huge implications on cost and manufacturability. Raw materials and components are typically selected based on performance, but there is also a need to consider other important design for manufacturability (DFM) factors such as quality, availability and scalability. When a developer or OEM approaches a contract manufacturer, the DFM factors are the first thing that the manufacturer should consider. They need to understand the format that the material is available in and whether that format can easily be integrated into the production process. They will need to evaluate material width, roll length, core sizes and tensile strengths to better understand the material’s limitations. Variations in material quality can increase scrap, limit run rates, create production delays and possibly decrease the quality of the medical device itself. By collaborating with a CMO and materials suppliers during the design phase, developers can eliminate material and manufacturing challenges that may affect the manufacturing process while still being able to optimize device performance. It’s crucial to leverage collaboration partners’ resources to make the device design successful through to commercialization. This will allow the CMO and suppliers to plan for their responsibilities in getting a device to market. If the product requires new equipment or modifications to the manufacturing process, this will be discovered well in advance. Instead of looking for a “turn-key” solution at the

Medical Design & Outsourcing

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end of the road, use the CMO and materials suppliers to help create the right solution from the beginning. Effective collaboration When choosing a collaboration partner, consider their record of accomplishment and references. Try to get a sense for the company’s place in the market, who they do business with, how long they’ve been in the industry and if there are any violations or complaints in their history. Another consideration is the company’s willingness to show their operation. Can you readily visit their facilities? Are they willing to undergo regular audits? This can indicate their openness and commitment to collaboration, help you determine how the company will manufacture a safe and effective device and how they will overcome problems along the way. They should be willing to discuss their process and manufacturing controls and their quality assurance strategies. Their answers should instill a sense of confidence in their ability to successfully manufacture the devices and manage the supply chain. Remember: Trust trumps all The ideas of “trust” or “trustworthiness” can seem like a soft skill or capability – something nice to have but hard to quantify alongside more tangible metrics such as cost, quality and delivery time. However, without trust, there is no effective collaboration. Trust can be earned through clearly defined needs, transparency and honest communication. The earlier in development collaboration begins, the more defined each partner’s expectations and scope of work. Planning is everything in the life cycle of a medical device. Without proactive thinking and time considerations, delays and costs are bound to increase. Every company has weaknesses, and every product will encounter challenges. Good partners are willing to communicate those weaknesses or shortcomings in their capabilities and provide strategies to overcome them, and the best partners will always find ways to help each other succeed. M Claudio Hanna is business development director for Web Industries, a specialist in outsourced flexible material converting and end-product contract manufacturing.

www.medicaldesignandoutsourcing.com

11/22/18 4:55 PM

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MATERIALS

The right adhesive can help people manage their diabetes Wearable glucose monitors have changed the lives of many people living with diabetes. These monitors must stick to the skin, but not too much. Learn how the science behind sticking to skin affects a device’s success and how to mitigate three diabetic device design challenges with adhesives. An adhesive is a critical component in ensuring diabetes Image courtesy of 3M devices’ accuracy and reliability. It not only helps extend diabetic device wear time but keeps users safe from Del R. Lawson device-associated skin injuries. 3M To help mitigate potential issues and enable diabetic device innovation, it’s important to understand how to overcome common diabetic device design issues, as well as the science behind sticking to skin. Sticking to skin Skin is a highly complex organ that needs to breathe, move and expel moisture. When improperly designed, wearable devices inhibit all three of these functions. To set your device up for success, consider the following characteristics that affect skin: • Age. Aging takes a toll on skin, and every stage of life comes with its own characteristics. For instance, infants and the elderly have thin, fragile skin that’s easily damaged, whereas healthy young adults have more durable, elastic skin. Knowing the intended user for your device is critical to understanding the level of adhesion their skin can withstand. 68

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• Moisture. Because skin is largely made up of water, both the device and adhesive must allow moisture to escape. When moisture gets trapped, it can cause maceration (a medical-adhesive related skin injury, MARSI, that results from essentially drowning the skin) and can cause the device to fail. • Hair growth. While not a consideration for all areas of the body, hair growth can cause the device to fall off by pushing up against it. • Lifestyle. Know how active your intended user will be and where (geographically) the device will be used. If the user lives in a humid climate and has an active outdoor lifestyle, their sweat levels may be higher than those of someone living in a cold, dry climate. How to mitigate three common diabetic device design issues Adhesives, though a seemingly small component, can make or break a device’s functionality. Here are three diabetic device design issues related to adhesives you need to be aware of, as well as advice on how to mitigate them: • Device prematurely detaches from skin. To keep this from happening, consider a pressuresensitive medical adhesive with a breathable backing. Some adhesives can adhere for up to two weeks, and a breathable backing will help the skin function as normally as possible. Also, using an adhesive skirt that extends beyond the device can reduce lift from everyday wear.

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11/21/18 10:24 AM

An improved design process yields improved designs.

Visualization of contaminant concentration in the dialysate, membrane, and permeate (from left to right) based on inputs into an app. Improving the hemodialysis process for renal patients involves designing high-performance equipment that more effectively removes contaminants. Numerical modeling is a useful tool for analyzing and optimizing designs, but it can also be timeconsuming. What if there was a way to test and improve designs faster without sacrificing accuracy? By building simulation apps, you can. The COMSOL MultiphysicsÂŽ software is used for simulating designs, devices, and processes in all fields of engineering, manufacturing, and scientific research. See how you can apply it to dialysis device design. comsol.blog/dialysis-design-app

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• Wearer experiences skin irritation. When designing devices that will adhere to skin, remember that “tape is tape” is a major oversimplification. Incomplete finishing or curing of an adhesive can leave a high concentration of residual contaminants that migrate into or onto the skin, leading to potential skin irritation. • Adhesive strength is too high. The strongest adhesive isn’t always the best adhesive. If too strong of an adhesive is used, the bond between adhesive and skin can be stronger than skin-to-skin, causing the skin to strip away from the body upon removal. Consider the device’s or sensor’s intended wear time and select an adhesive that matches up. Over-designing will only lead to additional problems – not to mention pain to the user.

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Managing diabetes can feel endless, but a well-designed device can make living with the disease less cumbersome. Carefully considering your adhesive options to choose the right stickto-skin adhesive may make life a bit simpler for people living with diabetes. Partnering with a knowledgeable expert can also help mitigate these and other unforeseen issues. M Del Lawson has more than 25 years of experience at 3M in laboratory management, strategic product platform creation and Lean Six Sigma operations. His experience has involved new technology creation in advanced analytics and sensors, biotechnology solutions and medical adhesives. Lawson leads new product development and commercialization efforts in 3M’s Medical Solutions Division.

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11/21/18 10:25 AM

What to consider when manufacturing a silicone soft skin adhesive coating All stages of the manufacturing process are important to obtain the soft skin adhesive or wound contact layer that meets both the manufacturer’s productivity targets and the customers’ quality requirements. Teamwork among the silicone supplier, the manufacturer and the final product designer is key to ensure success. Clément des Courières Elkem Silicones

The proven biocompatibility and tissuepreserving properties of silicone soft skin adhesives (SSA) have made them a material of choice for modern wound treatment. The gradual switch to silicones for over-the-counter (OTC) applications has made it more important for wound-care companies to be efficient when manufacturing and supplying their silicone dressings to medical professionals and consumers. Silicones have a unique set of properties that distinguish them from traditional, acrylicbased adhesives. They are highly biocompatible, hypoallergenic, comfortable, resist bacteria and offer easy and gentle removal from the skin. These superior properties also make silicones different to use. SSAs are made up of two-component, low-tomedium-viscosity silicones. One component contains the platinum catalyst, while the other contains the crosslinker. Both parts should be mixed homogeneously, typically in a 1:1 ratio, before being applied by direct or indirect coating onto the chosen substrates and cured in an oven. Here are some processing considerations and tips for manufacturers seeking to obtain the perfect skin adhesive or wound contact layer using silicone. Choose the right silicone adhesive product Silicone suppliers will offer a wide range of SSAs to choose from. However, each product is different and developed for a different purpose. Two main parameters will help you

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make a decision. The material’s viscosity should be adapted to your equipment and process. And the level of adhesion to the skin should be suitable for your application. In case of doubt, ask your silicone supplier to make a recommendation. Combine the SSA with the correct substrate as a backing layer Backing substrates for skin adhesive applications should be both very flexible and breathable, which makes polyurethane films and open fabrics like non-wovens outstanding for use in this field. When coating most silicones directly onto a polyurethane film, no chemical adhesion will be formed, and therefore there is a risk of delamination that could lead to residues being left on the skin. The silicone supplier can recommend several options, including film treatment or using a specific primer. On open substrates, the challenge is to avoid penetration by the gel into the fabric. For this application, a high-viscosity silicone (at least 50.000 mPa.s) is preferred. Make sure the silicone is fully cured on time Once the silicone is correctly applied, it should be cured, typically in an in-line oven. Two parameters will affect the cure: temperature and time. While silicones can easily withstand high temperatures (up to 180°C), the substrates mentioned above do not, and will dictate the maximum temperature limit. The length of dwell time in the oven will depend greatly on the temperature and the silicone chosen (namely its kinetic profile) but should be in the range of a few minutes. Silicone suppliers will be able to provide support to help determine the optimal cure time and improve the overall productivity.

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MATERIALS

BOOTH #648

Use a relevant test method to assess the coating’s performance Due to its 3D structure and the great variations between individuals, skin is one of the most challenging surfaces to stick to. Traditional methods for selfadhesives include measuring the peeling force from steel or polycarbonate, but they fail to differentiate soft adhesives and to represent skin. Other materials like structured paper or artificial leather can be much more relevant. In any case, great care should be taken when trying to predict the performance of an adhesive on the skin. Nothing will replace actual wear tests. M Clément des Courières is business development manager for skin adhesives at Elkem Silicones. He works closely with skin-adhesive and woundcare companies to provide the best solutions for their needs.

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OPERATIONAL EXCELLENCE

MANUFACTURING REDEFINED. At Freudenberg Medical, operational excellence is a mindset, an approach and a philosophy to continuously improve product quality and the efficiency of our processes and services. Our customer-centric manufacturing transfer process ensures that needs and expectations are explicitly documented, translated into requirements, and project plans are executed on-time and within budget. From next-generation designs, enhancements to production, and scale up for volume manufacturing. Contact us to learn more.

CATHETERS. COMPONENTS. COATINGS. freudenbergmedical.com

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MATERIALS

Here’s how you can keep bacteria from colonizing silicone Three production techniques can reduce the colonization of bacteria on devices made of silicone for placement inside the body. Tests have shown that the newest method shows promise. Andrew Gaillard Tr e l l e b o r g Sealing Solutions

Healthcare-associated infections (HAI) are a major yet often preventable threat to patient safety. They can have a significant impact on the survival rate of patients who undergo procedures and treatments. Catheter-associated infections are particularly difficult to prevent, even when products are made of silicone, due to their inherent positioning both inside and outside of the body. Though silicone is biocompatible and biostable, it is not immune to bacterial colonization. Three techniques can reduce this colonization: • • •

ABOVE: Applying active pharmaceutical ingredients to silicone has a powerful inhibitory effect on the growth of Staphylococcus aureus, according to the tests Trelleborg conducted.

Image courtesy of Trelleborg

Coating with active pharmaceutical ingredients (API); The addition of API to raw silicone; The impregnation of vulcanized silicone with API through immersion.

API coatings are applied to silicone catheters by spraying or dipping. Though probably the most cost-effective method of treatment, achieving good uniformity and long life is challenging. The coatings may crack or peel, and in some cases, it can be hard to apply a coating to the inner lumen surface of a catheter. The second and well-proven method used to prevent bacterial buildup involves adding antibiotic API – such as chlorhexidine, gentamycin, rifamixin or doxycycline in powder form – to silicone raw materials using various types of mixing equipment. After homogenization, the silicone-drug mixtures can be formed into desired shapes and vulcanized using various fabrication processes, including molding and extrusion. The key advantage of this method is that the API is effectively and consistently present within the silicone. However, compatibility of the API with the silicone grade must be confirmed as some API can inhibit or even poison the cure system of certain silicones. Also, certain drugs are not stable at elevated temperatures. In these applications, silicones that can be vulcanized at relatively low temperatures may be used, but this limits the type of API that can be used. The third and newest method to reduce bacterial colonization is the impregnation method. Most silicone

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medical components are manufactured from raw material formulations containing polydimethylsiloxane (PDMS) polymers reinforced with amorphous noncrystalline silica. Vulcanized PDMS elastomers can be readily swollen by immersion in various organic solvents. Because of this characteristic, vulcanized silicone can be immersed in a solution containing API to impregnate the vulcanized silicone with active drugs. The advantage of the impregnation method of vulcanized silicone with API is that the API cannot interfere with the cure chemistry of the silicone and that the API is uniformly impregnated on the surface of the inner lumen. Immersion is usually conducted at room temperature, thereby eliminating concerns regarding the thermal degradation of the API, and thus expanding the types of APIs that can be used. In addition, dissolved drugs are impregnated within the silicone elastomer as discrete molecules. This minimizes concerns and costs associated with specifying and maintaining a particular size and distribution of particles. Immersion experiments have conclusively demonstrated the mass transfer of two antibiotics, clindamycin hydrochloride (CLIN) and rifampicin (RIF), from chloroform solutions to silicone tubing. Following these tests, a study of the Kirby-Bauer zone of inhibition (ZOI) assessed the impact of drug content of silicone tubes on the gram-positive coccal bacterium, Staphylococcus aureus. This in-house study showed that drug-impregnated tubing had a powerful inhibitory effect on the growth of Staphylococcus aureus and revealed clear zones of inhibition surrounding test articles. As expected, the higher the drug concentration, the larger the ZOI. Though still in the early stages of use, the impregnation method looks positive, potentially allowing the expansion of the drug types that can be delivered via silicone-implantable devices. M Andrew Gaillard is global director, Healthcare and Medical, at Trelleborg Sealing Solutions.

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MOLDING

How to design liquid silicone rubber prototypes and components

Image courtesy of Protolabs

Liquid silicone rubber (LSR) parts are used in a wide variety of medical devices. The process of molding LSR shares many similarities with conventional injection molding, but there are a few notable differences. To n y H o l t z Protolabs

Liquid silicone rubber (LSR) or elastomeric parts are frequently used in the medical industry because they are strong and elastic with excellent thermal, chemical and electrical resistance. They maintain their physical properties at extreme temperatures and can withstand sterilization. LSR parts are also biocompatible, so they work well for products that have skin contact. Examples of applications abound: surgical instruments, handheld devices, operating room equipment, cartridges, ventilators, pumps, monitors, implantable prototypes, medical device components and prosthetic components. LSR molding has a great deal in common with conventional injection molding, but there are a few notable differences. Unlike thermoplastic resin, which is melted before injection, LSR is a two-part thermoset compound that is chilled before being injected into a heated mold and ultimately cured into a final part. Since LSR is a thermosetting polymer, its molded state is permanent. Once it is set, it canâ&#x20AC;&#x2122;t be melted again like a thermoplastic. Designing parts for LSR and thermoplastics is also similar, but there are some LSR-specific guidelines to consider: Dimensions Part sizes are guided by press size. As an example, at Protolabs, we allow for a maximum LSR part size of 12 in. (304 mm) by 8 in. (203 mm) by 4 in. (100 mm) with depths no greater than 2 in. (50 mm) from any parting line. Note that deeper parts are limited to a smaller outline. Molding pressure can damage the mold itself as short and sharp mold geometries would break under extreme pressure. To allow for a certain amount of safety mold material, deeper parts must have smaller length and width. Our maximum surface area is 48.4 sq. in. (312 sq. cm.) and maximum volume is 13.3 cu. in. (217cc).

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Wall and rib thickness LSR typically fills thin wall sections with minimal challenges, and walls as thin as 0.010 in. are possible, depending on the size of the wall and the location of adjacent thicker sections. Rib thickness should be 0.5 to 1.0 times the adjoining wall thickness. LSR is accommodating to variations in wall thickness and sink is almost nonexistent. Shrink and flash The shrink rate on LSR is fairly high with an expected tolerance of 0.025 in./in. LSR also tends to flash very easily during molding, in gaps as small as 0.0002 in., which can be reduced by incorporating additional features into the mold design. Parting lines Simplifying and minimizing parting lines in your design will help you get cleaner LSR parts as quickly as possible. Undercuts LSR can be molded to accommodate parts with undercuts, which are manually removed by a press operator. Part ejection Ejector pins are normally not used during LSR molding due to the flashy nature of the material. Thus, parts should be designed so they can be retained on onehalf of the mold when it is opened at the end of the molding cycle. The part is then manually de-molded, often with air assistance. M Tony Holtz is an applications engineer at Protolabs and has extensive knowledge and experience in both traditional and advanced manufacturing processes and material.

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11/21/18 10:27 AM

Providing High Speed Solutions... ...in a High Paced Market. In this industry, the demand for new products can rise in a heartbeat. And if you’re not first to market, you may as well be last. That’s why more OEMs turn to PTI Engineered Plastics. We specialize in complex, low volume plastic injection molding. We can design, engineer and manufacture any part to your specifications and deliver it in record time — without ever missing a beat.

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MOLDING

6 questions to ask when designing polymer components for medical devices Choosing the right polymer for the job can be a daunting task. Here are the right questions to ask before you begin the process. Karen Heroldt PolyOne Distribution

Choosing polymers is complicated in the high-stakes world of medical and healthcare devices. Materials can have varied tool design, molding and secondary processing requirements that can affect time to market and total production costs. Here, we explore six critical questions to ask when considering polymer options for healthcare applications and pharmaceutical packaging. 1. Will the polymer work in the design? Material selection and product design should be parallel processes. Parts may utilize undercuts, threads, living hinges, thick or thin wall sections, snap features or draft allowances. Strategically designing parts with material characteristics in mind from the onset will optimize performance, durability and functionality. Itâ&#x20AC;&#x2122;s important to understand how a material will behave during manufacturing. For example, mold shrinkage is a key factor to consider during the design phase. Some polymers shrink at one rate with the flow path and at another rate across the flow path within the tool. This means the dimensions of a part can vary when different materials are used. Even the slightest of changes in final dimensions can affect form, fit or functionâ&#x20AC;&#x201D; especially with parts that have critical dimensions and components that go into a multipart assembly.

3. What is the operating environment for the device? When evaluating material options, consider the environmental exposures that are commonly present in healthcare applications. Some products will come in direct contact with aggressive drugs or bodily fluids. Many will require repeated sterilization. Products might also be subjected to temperature extremes, and could come into contact with strong disinfectants. Materials must be able to maintain physical and performance properties such as strength, flexibility and seal integrity, in these conditions. Images courtesy of PolyOne Distribution

2. What are the limitations of your chosen processing method? Different grades of thermoplastic resin families each have different processing and moldability traits. While some materials can be used in several different processes, others can cause problems. Engineers might be able to adjust a process to make an incompatible material work, but cycle times, throughput and product consistency generally suffer. Properly matching processing technique and material will generate both economical and robust components. Identifying processing methods and material combinations will not only optimize performance and minimize production costs but also reduce cycle time and decrease scrap due to out-of-tolerance parts.

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MEDICAL INTERCONNECT SOLUTIONS

Technical data sheets offer a basic indication of a material’s ability to withstand chemicals, temperature and pressure. However, materials are measured using a specimen of a particular size and shape determined by ASTM and/ or ISO standards. Your part will almost certainly be different than the standardized test sample and will, therefore, behave differently. Ultimately, product testing under anticipated environmental conditions should be your deciding factor.

etc. on technical data sheets. However, the material manufacturer might omit this information, so it is good practice to ask your supplier outright for compliance ratings. Manufacturers are not required to submit documentation for a material to the FDA Drug Master File (DMF). But choosing a material that already appears on the DMF may help you obtain other necessary regulatory approvals for a new medical device.

4. What forces (impact, load, wear, etc.) will my device need to withstand? Your application may require a certain degree of impact strength, flexural strength, tensile strength, elasticity, wearability or hardness. Determine these properties early so you have targets in mind as you evaluate potential materials. Physical and mechanical property information on technical data sheets is a starting point. But the thickness, weld lines, corners and unique geometry of your component can make it respond markedly different than the test specimen. Conducting finite elemental analysis (FEA) testing can identify weak spots or potential failure points under a particular load. Design engineers will use stress/ strain ratings from technical data sheets to conduct these tests – although some FEA software already has a database of stress/strain information for many thermoplastic grades.

6. What are the most likely ways my part might fail, and how can I mitigate the risk? In high-risk scenarios, choosing a highly engineered but more expensive material may be justified. But choosing materials that are “over-engineered” for your needs can add unnecessary cost or complexity to your product. Appropriately assess the risk of your application and do your due diligence in selecting a material. Using the considerations listed here will help you identify the ideal material for your application and establish confidence in the performance of your product. M Karen Heroldt is senior industry manager, healthcare, at PolyOne Distribution.

5. Can I use prequalified materials to speed the required regulatory approvals? Depending on your product’s classification, you may need to acquire certain regulatory certifications, plus comply with particular manufacturing environment requirements, quality control systems and traceability methods before you can go to market. One common regulation for healthcare applications calls for using materials that have FDA approval. Other regulatory groups have established additional standards to ensure the safety of the patient or end user. Look for these ratings such as FDA, USP IV,

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LEMO offers many connector options for medical device manufacturers. • Metal Connectors • Plastic Connectors (PEEK or PSU) • Single-Patient Use Connectors • Hybrid and Custom Configurations • Integrated Electronics • Custom Wire & Cable Assembly • ISO 13485 Certified

LEMO begins with Quality, Reliability, and Innovation

Images courtesy of PolyOne Distribution

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LEMO USA, Inc. 800-444-5366 info-us@lemo.com www.lemo.com

11/21/18 10:27 AM

MOTION CONTROL COMPONENTS

Beyond gaming: How joysticks enhance medtech Multifunctional joystick technology solves complex interface challenges in a wide range of medical applications. Precision, quality, ergonomics and haptics are specially tailored into each medical joystick application to offer optimum control and a superior user experience. Image courtesy of RAFI-USA

Alfred Klein RAFI-USA

As medical device technology requires more functionality from human operators, combining intuitive and safe joystick operation has become more important. This includes simple applications such as the up-down function for a hospital bed that needs variable speed to extremely critical applications like controlling surgical robots. Intuitive joystick technology often requires a custom solution to meet the medical application requirements. Joystick technology must not only offer reliable and advanced multifunctional performance that improves human-machine communication, but it must also address safety considerations, the need for sterilization and decontamination, haptics with/without surgical gloves and more. Complex customer-specific control systems may appear to be more expensive than off-the-shelf solutions at first glance. However, when taking a closer look, the numerous advantages will often outweigh the added time or investment. Customization In modern medical applications, the joystick handle is typically tailored to the customer’s requirements for a specific application. Customer-specific handle designs are centered around the ease of interface operation and ergonomics, as well as mechanical and electronic performance. Joystick outputs are variable for precise tuning of equipment and critical sensitive movements,

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where mistakes can be dangerous for both the patient and the doctor. The interface between a doctor or technician and the equipment is the most critical way a company’s brand is identified and differentiated. As more medical designs demand smaller equipment to offer portability, multi-function joystick controllers help designers overcome space constraints as they incorporate switching and variable output as well as safety functions directly into the grip. The technologies might include rotary function (including rotary encoder), push function (confirmation), buttons with short-travel key-switches, LED indication, thumb joystick, momentary rocker switches, capacitive sensors and near field communication (NFC). The haptics of a switch within the joystick system is paramount in medical applications. The touch, feel and sound of a switch’s actuation are vital. User interfaces must respond and provide consistent feedback in medical applications to ensure proper and uniform performance. Haptic features are also customized for specific medical joystick systems and are often accomplished by advanced switch configurations that must combine ruggedness with design flexibility. Environmental performance Medical equipment is often exposed to rugged conditions such as water, dust, sunlight, vibration and electromagnetic radiation. Joysticks must be

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11/21/18 10:32 AM

SMOOTH. PRECISE. SAFE. WHEN IT MATTERS THE MOST NSK employs cutting-edge friction control technology, precision accuracy and dedicated customer collaboration to deliver custom integrated solutions for medical diagnostic imaging systems and equipment.

PRECISION PRODUCTS FOR LINEAR MOTION AND CONTROL

www.nskamericas.com

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MOTION CONTROL COMPONENTS

THE DIFFERENCE BETWEEN DC BRUSHED AND BRUSHLESS MOTORS? HERE IS AN OVERVIEW OF THE FACTORS YOU'LL NEED TO CONSIDER WHEN DECIDING BETWEEN A DC BRUSHED OR BRUSHLESS MOTOR. Carsten Horn | Maxon Motor

The key difference between brushed and brushless motors is service life. The service life of a brush motor is shorter and limited by wear of the brushes, while a brushless motor has far more gradual ball bearing wear. For many applications, the shorter service life of a brush motor is not a concern because it is more than offset by lower cost. Service life can range from 100 to 10,000 hours depending on factors such as current load, speed, vibration and frequency of reversal, with the average around 2,000 hours. A brushless motor, on the other hand, can deliver many tens of thousands of hours of service life. Another consideration is speed. Typically the maximum speed of brush motors is 20,000 RPM, but in this range, electrical and mechanical wear sharply increases, greatly reducing service life. In practice, brush motors tend to be run below 10,000 RPM. A brushless motor of similar size and magnetic design can be operated at much higher speeds, reaching 100,000 RPM in some cases. These are perfect motors for applications where speed is critical. But these are generalizations. You’ll have to look at the data sheets for each motor for precise information about speed and torque capabilities. Ambient conditions are another factor. If electromagnetic interference is a worry, brush motors may not be suitable due to a phenomenon called brush fire. In an explosive gas environment, brush sparks are a serious problem. Brushes made of graphite need humidity and oxygen in the atmosphere to work properly, and produce dust that might pollute clean rooms, high vacuums or optical devices.

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For these reasons, most motors in special ambient conditions are brushless. There are no physical brush residue or spark-related emissions. Brushless motors are not inherently explosion proof, but can easily be made so with special modifications. They can be sterilized, operated in ultrahigh vacuum applications that require pre-heating and are therefore ideal for medical applications. Brushless motors can also survive high levels of vibration and temperature. There is no motor as simple to operate as a brush DC motor – just apply a voltage and the motor turns. A brushless motor requires an electronic controller and additional cabling, adding complexity and cost. But this advantage is negated in applications needing higher levels of control, where both brush and brushless motors alike require controllers for motor speed, shaft position or torque feedback. So whether brushed or brushless, in the end, you have to make the choice based on speed, service life, installation complexity and ambient requirements of your specific application. M

Maxon Motor DC brushed (left) and brushless (right) motors Image courtesy of Maxon Motor

Carsten Horn is a business development engineer for medical applications at Maxon Precision Motors, a leading supplier of high-precision drives and systems. Horn studied physics and mechatronics in his native Germany. He headed the product management R&D team at Maxon Germany and focused on the design of components for medical device products. Horn now resides in the United States.

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11/21/18 10:32 AM

designed to handle harsh environments and meet the necessary hygiene regulations. In terms of reliability, strength, hygiene and vandal-proofing, joystick designs in medical electrical equipment must adhere to IEC 60601. Rugged 3D Hall technology Joysticks using a zero-wear 3D Hall sensor system offer a compact design with enhanced reliability. Offering at least 5 million operations, zerowear 3D Hall sensor systems can be designed as a redundant sensor system for applications with extremely high safety requirements. Based on Hall elements, the mechanical design of all components are extremely robust. The metal housing can be made from ferromagnetic steel to ensure optimum shielding of the sensor systems and additional robustness. In a customized design, the mounting hole can also be reduced to minimize the folds in sealing bellows, enabling deeper cleaning. Haptic properties of joysticks with 3D Hall sensor systems can be adjusted by selecting from a variety of compression springs to customize the feel and ease of using the joystick.

Alfred Klein, CEO of RAFI-USA, is an electrical engineer with a master’s in project management and more than 30 years of designing custom interface solutions for the medical industry.

INTUITIVE JOYSTICK TECHNOLOGY OFTEN REQUIRES A CUSTOM SOLUTION TO MEET THE MEDICAL APPLICATION REQUIREMENTS.

IMPACT CAN DESTROY AN OBJECT OR A SINGLE ELEMENT OF THAT OBJECT

Force sensor technology Force sensor joysticks, which often use strain gauge sensors, offer nearly zero travel operation that results in very little wear and eliminates the need for complicated sealing bellows that can trap germs in medical applications. For this reason, strain gauge joysticks are suitable for use in harsh environments where shock and vibration are common. Force sensor technology is often used on operating tables, where the doctor can precisely move the table via a joystick, with very deliberate, precise movements and feedback. The force sensor in the joystick forwards the signal to the servomotors, which support the movement initiated and thereby reduce the effort involved. With thorough functional testing, a joystick is individually calibrated prior to shipment in order to eliminate any effects of component tolerances, thermal drifts, etc. over the complete temperature range. M 11 • 2018

INNOVATING SHOCK & VIBRATION SOLUTIONS Visit sorbothane.com for Design Guide and Technical Data

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MOTION CONTROL COMPONENTS

Image courtesy of Sensata Technologies

What medical design engineers need to know about VCA (voice coil actuator) technology Evolving from audio speakers to medical devices, voice coil actuator (VCA) technology has emerged as an extremely valuable solution for precision motion applications including ventilators, drug dispensing pumps, blood analyzers and other medical lab equipment. James McNamara Sensata Te c h n o l o g i e s

Originally developed for audio speakers, voice coil actuation technology is now being utilized to provide precise and reliable motion control for a wide range of medical applications. Although it has been around for decades, VCA technology is still a mystery to many design engineers as, until recently, the application spaces for which it was a cost-effective solution were relatively restricted. Many designers had to settle for more traditional, but less flexible, solenoid-based devices. Now that powerful microcontrollers (MCUs) and precise and efficient drivers are readily available, advanced linear motion designs using VCAs are easier and less expensive to implement. Any time an engineer is looking at developing a product that requires highly reliable, highly repeatable and highly controllable motions, they need to consider VCA. VCAs offer many benefits to the medical design engineer. They are very simple and extremely robust,

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yet are as exactly precise as the input given them. VCAs accelerate smoothly and quickly to any position within their stroke with nearly zero hysteresis and are only limited by the system’s position-sensing precision and driver capability. Because of this accuracy, these devices lend themselves extremely well to applications such as medical devices, robotics and industrial process equipment. Precision control for medical devices One application area that demands critical precision is the medical industry. Devices like drug-dispensing pumps and ventilators do not work on approximations – every microliter of liquid (or air) has to be carefully measured and managed. The precise motion control a VCA-based solution provides in a medical flow-management system increases accuracy without complexity or bulk. The challenges in designing medical devices are compounded beyond strict performance and regulatory

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DESIGN

Our intelligently designed mobility solutions have been honored with renowned design awards and satisfy the highest demands when it comes to esthetics. They can be adapted seamlessly to the individual design of our customers and allow for easy brand differentiation. We provide entire product ranges for medical and institutional market applications to compliment your design and requirements. Our broad selection of casters, wheels and accessories offer the right features for every need, while maintaining a uniform appearance. TENTE solutions never fail to impress when the design needs to fulfill a specific function for the user. This is because they open up a wide range of customization options that allow the casters to communicate information, such as assigning codes, color coordination, or improving your brand presence by including your logo and corporate colors.

TENTE Casters, Inc. info.US@tente.com www.tente.com

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MOTION CONTROL COMPONENTS

standards; there is also the need for small and lightweight devices to allow for portable use by caregivers moving roomto-room in a facility. This demand for performance in a constrained space lends itself well to a VCA solution. Linear voice coil actuators can be designed to meet the ultra-small size and exacting motion control requirements needed in the medical industry. These compact VCAs are often used to control inhalation and exhalation valves on ventilators to provide the exact amount of air specified and the necessary reliability for life-critical applications. Small VCAs measure just 0.75 in. in diameter and weigh only 2.3 oz., yet can deliver a peak force of nearly 2 lbs. in an operating stroke of ±2mm with low hysteresis, zero cogging, high acceleration and a long-life cycle. This accurate linear motion control can also serve other precision medical systems like anesthesia machines as well as ultrasound probes, blood analyzers and lab equipment. Development tools to help the medical design engineer Design tools that aid the engineer in understanding and implementing any given technology are critical to its adoption and VCAs are not exempt. Selfcontained kits like Sensata’s Voice Coil Actuator Developer’s Kit – which include a VCA with a built-in feedback sensor and a programmable controller with PCcompatible motion control software – allow users to take advantage of the benefits of VCAs without needing to specify the electronics required for a complete control system. This type of tool can help designers quickly develop an actuation system and demonstrate a working design with velocity, position, force, reciprocation and acceleration control to address nearly any application. M

Used in a wide range of medical and industrial applications, an axial voice coil actuator is composed of a permanent magnet situated within a moving tubular coil of wire, all inside of a ferromagnetic cylinder. When current runs through the coil, it becomes magnetized and repels against the magnets, producing an in and out, back and forth motion. Image courtesy of Sensata Technologies

James McNamara is a senior applications engineer at Sensata Technologies, where he is an expert on voice coil actuator technology. He has been with the company for 12 years and has 40 years of experience working in the electric motor industry. McNamara holds a BS degree from National University in Computer Science. 86

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From Concept To Finished Device, For Over 25 Years.

81 Turnpike Road, Jaffrey, NH 03452 Ph ( 603 ) 532-5656 m.trombley@medefab.com www.medefab.com Medefab resized to float.indd 1

11/20/18 1:36 PM

NEEDLES & SYRINGES

Needle washing for analytics equipment: What you need to know Here’s a look at the different methods, pump types and popular options to consider – and potentially optimize – when it comes to needle washing for clinical diagnostic and analytical lab equipment. D a v i d Va n d e r b e c k KNF Neuberger

Syringe-type needles are commonly used to meter or dose liquid samples onboard clinical diagnostic and analytical lab equipment. These needles must be washed after each use to avoid cross-contamination with the next test. Diaphragm pumps have long been applied toward needle washing, and similar washing approaches can also apply to other system components including cuvettes and microtiter plates. Washing the needle The typical needle wash process involves forcing deionized (DI) water, solvent, surfactant (soap solution), sodium hypochlorite (NaClO) or other liquid through a needle that is positioned inside a wash station (volume ~10 ml to 25 ml open-top well; 5 ml to 50 ml of liquid typically consumed). Starting with the basics, only the tip of the needle is actually in contact with the sample, so cross-contamination is mainly a concern with that portion of the needle. After the sample is dispensed into a well or other device, the needle is moved to a wash station where it is inserted into a cup. Cleaner is pumped through the needle from the top at a rather high speed, taking any leftover sample out the tip and into the cup. After the cleaner is pumped through the needle it accumulates in the cup, and the liquid level in the cup rises, thus cleaning the outside of the needle. Sometimes, the geometry of the well is specially designed to enhance the swirling action of the wash fluid, resulting in a better cleaning. Next, a valve is opened to the vacuum line, and the liquid waste is aspirated from the cup into the main waste container. After a specific amount of flushing time, the cleaner fluid is stopped, and deionized (DI) water, a buffer liquid or air is pumped through the needle to carry out any leftover liquid and dry the inside, again from the top to the tip. Meanwhile, the vacuum line continues to aspirate the waste air/liquid slurry

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mixture. Change in pressure (ΔP) and suction duration should be optimized to assist needle drying after all liquid has been removed. Alternatively, some systems incorporate a separate pump to blow air over/through the needle to aid drying. The needle is never in contact with any hard surface, liquids only, so the X-Y-Z table positions it in the proper location to draw sample, dispense it and then wash it without ever touching any other component. Why a diaphragm pump? Diaphragm pumps are the most popular choice for both wash and waste removal functions. Reasons include: • • • • • •

Ability to handle liquid/air mixtures; Chemical compatibility; Self-priming ability; Long service-free lifetime; Good vacuum for suction; Ease of adjustability to accommodate a wide and varying range of flow rates.

Other pump types, such as peristaltic, gear or centrifugal may be used, but include limitations and tradeoffs that must be accommodated. Pump optimization configurations Different materials? Standard wetted materials are polypropylene (PP) and ethylene propylene (EPDM) that are compatible with most wash fluids. Many other materials including PVDF, PTFE and FFPM are readily available. Higher pressure? Pump pressure output is typically ~1 bar gauge (14.5 psig). It may be desirable to increase the pressure output to increase the cleansing action, allow for smaller

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ID tubing, or possibly reduce the amount of wash fluid consumed. High-pressure versions can provide the ability to operate continuously for a long lifetime at a much higher psig. Overpressure safety recirculation? If pressure downstream of the pump increases for whatever reason (blockage, narrow restriction, etc.), a recirculation feature, like the one on KNF pumps designated .27, provides safety for the pump and system. This option is field or factory adjustable to open and even run continuously at set pressures from 1 bar gauge (14.5 psig) to greater than 6 bar gauge (87 psig). Tandem pump? Some systems use a dual-headed pump where one head is for needle wash and the other is for waste transfer. This approach makes sense since both functions are performed nearly simultaneously. The waste pump flow rate must be greater than that of the needle wash because it will handle the same volume of flow going into the cup, plus a large amount of aspirated air. A single tandem pump is usually smaller and less expensive than two individual pumps. Speed control? Pump speed may be lowered or even increased to match system requirements, resulting in a longer lifetime for the pump and fluidic components, as well as quieter operation. Conclusion While syringe-type needles used for metering or dosing liquid samples pose cross-contamination risks, they are regularly eliminated through proper cleaning. Because protocols differ across applications, it is necessary for laboratory technicians and systems engineers to understand the benefits and limitations of various cleaning methods. Among other considerations, a well-optimized pump configuration should account for needle design, washing solution, and, most importantly, longterm cleaning efficacy. Before the installation of a new cleaning system, it is recommended purchasers consult with a wellregarded pump manufacturer who can guide them through available methods and configurations. M David Vanderbeck is the OEM product manager at KNF Neuberger (Trenton, N.J.) A 28-year veteran of KNF, Vanderbeck provides critical input for new product platform development and roll-out and assists sales in optimizing those constructions to match the unique operating parameters of customer devices. He is a graduate of Fairleigh Dickinson University, with a BS in mechanical engineering. www.medicaldesignandoutsourcing.com

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RAPID MANUFACTURING & PROTOTYPING

3 ways Carbon might have an edge with its 3D printing tech Think of Carbon’s 3D printing technology enabling a host of customized medical devices and parts. Here’s how. Chris Newmarker Managing Editor

Over the 10 minutes that Carbon CEO Joseph DeSimone spent describing his company’s 3D printing technology to a TED audience, a buckyballshaped part rose in its entirety out of a pool of liquid polymer resin. The 2015 event generated a lot of buzz because it overcame perceptions that 3D printing was a slow, cumbersome process. And Redwood City, Calif.–based Carbon has made significant strides since then, including a $200 million fundraise earlier this year that included Johnson & Johnson Innovation. Johnson & Johnson, in fact, has a more than two-year-old strategic collaboration with Carbon to produce customized orthopedic surgical instruments and other medical devices. So how is Carbon’s 3D printing tech potentially better, and what does that mean for medical devices? Steven Pollack, an FDA veteran who joined Carbon as a senior staff research scientist in 2015, thinks Carbon’s advantages rest on three pillars:

Carbon’s proprietary 3D printing technology combines light and oxygen to rapidly make products from programmable and biocompatible liquid resins. Image courtesy of Carbon

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1. Carbon figured out how to make stereolithography work Carbon’s roots go back to the University of North Carolina at Chapel Hill, where DeSimone and his colleagues tried to overcome 3D printing’s speed and quality problems. A potential solution to the layer-by-layer tediousness of other 3D printing methods was to create a part through stereolithography, using light to convert a photocurable resin into a solid. “You do it by projecting a series of images that end up being the cross sections moving from the bottom to the top of the object and placing the next amount of material on the previous one that you created. And the big shortcoming for that is that you either have a very large vat of resin that you hold your part down into as you build parts, or you have a very shallow pool of resin that you hold your part out of. But you suffer from the problem in that latter version that your part is continually stuck to the bottom,” Pollack explained to Medical Design & Outsourcing earlier this year. DeSimone and his colleagues realized that they could take advantage of the fact that oxygen frustrates the polymerization process, something that researchers had previously found to be a nuisance. Carbon’s original intellectual property involves a special window at the bottom of the resin reservoir, Pollack said. The window is transparent to UV light, but it’s also permeable to oxygen. Carbon’s technology drives oxygen intentionally into the very lowest part of the

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resin pool, saturating the first 30 to 40 microns with oxygen and creating a “dead zone” where polymerization doesn’t take place. “So now when you start to grow your part, you’re never growing it at the window, you’re growing it 30 microns away from it. And when you pull the part away from the window to introduce the next step of the process, the part acts like a pump, pulls fresh resin in behind it, which dilutes out the oxygen and makes that material polymerize,” Pollack said. The result is fast printing with little or no mechanical impact on the growing part, according to Pollack. “In our technology, there are no layers. If you broke a part in half, you’d find it was perfectly monolithic,” he explained. “Mechanical-properties-wise, it is comparable to an injection-molded part. And surface-texture-wise, it’s comparable to an injection-molded part.” 2. Using production-worthy materials When it comes to polymers that only photochemically harden, they’re unable to match the mechanical properties of, say, a nylon or an elastomer, according to Pollack. When it comes to the few UV-only resins used on Carbon machines, you can get a “nice part that’s easy to look at but not necessarily mechanically robust.” Carbon’s solution to the materials challenge was to turn to a host of thermally-activated polymers. “You use the build process to set up a scaffolding, if you will, that’s photochemically generated, that holds the part’s shape and accuracy. You take that part, clean it of any residual resins, and then you bake it – much like you would take a porcelain (pot) that was thrown on a wheel and put it into a furnace to fire off the secondary chemistry. … It’s the same thing. We use epoxy chemistry, cyanate ester chemistry, and urethane chemistry to create this second network that imbues the part now with real engineering properties,” Pollack said.

“We can make a material that’s equivalent to an injection-molded urethane, or a cast urethane, or an injection-molded nylon.” 3. Software-driven 3D printing technology Carbon’s VP of engineering, Craig Carlson, came from Tesla Motors, where he was VP of software and electrical integration. “He came to Carbon with the mindset that we can capture every detail of the manufacturing and operation process of the printer and have that captured and codified, and that’ll be very important if anybody wants to know about the history of the part,” Pollack said. Think data about the provenance of the part, what resin it came from, which printer was it on, how was that printer behaving that day, the characteristics of a particular layer. “We capture every piece of that data, and we have it all available for every part that’s printed. It’s available to the manufacturer to create a digital master

Manufacturers don’t own the printer; they have a subscription for it. “They keep their intellectual property on their side of the firewall. We don’t get to see the actual object they’re printing. We just get to monitor the machine’s health,” he said. One of Pollack’s major jobs at Carbon is to work with his old colleagues at FDA to shepherd the new materials and processes through medical device approval and clearance processes, and Carbon’s technology has some regulatory challenges to overcome. But Pollack thinks it could eventually prove disruptive. “You can now throw away the molds, throw away the inventory,” Pollack said. “You can throw away the notion that, ‘Oh, I have to make that part from seven pieces and glue them together so I can get channels to go through them.’ … I put negative space where I want it as I build it. I don’t have to take things away to get it there. It’s the difference between subtraction and addition.” M

IN OUR TECHNOLOGY, THERE ARE NO LAYERS. IF YOU BROKE A PART IN HALF, YOU’D FIND IT WAS PERFECTLY MONOLITHIC. … WE THINK … MECHANICALPROPERTIES-WISE, IT IS COMPARABLE TO AN INJECTIONMOLDED PART. AND SURFACE-TEXTURE-WISE, IT’S COMPARABLE TO AN INJECTION-MOLDED PART. device record – a manufacturing device record,” Pollack said. Carbon’s printers are Internetconnected, so the company is able to collect performance information and continually improve the machines through software upgrades. “That said, we also recognize the medical device manufacturing world does not like software that upgrades every six weeks, because they then have to revalidate and verify. So we have a model that lets us lock essentially the software branch for manufacturing and production,” Pollack said.

www.medicaldesignandoutsourcing.com

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REGULATORY, REIMBURSEMENT AND IP

6 tips for quicker and stronger medtech patents By developing a strategic patent portfolio quickly and successfully, medtech companies can navigate a path to commercial success. This article focuses on savvy strategies that can lead to a quicker and stronger medtech patent issuance. David J. Dykeman G r e e n b e r g Tr a u r i g

In general, well-drafted patent applications make it easier to succeed before the patent office. With a clear understanding of the patent landscape, it is essential that a medtech patent application have claims of the right scope including claims to the systems, devices, key components, methods of treatment, and methods of manufacturing. Also, searching for and addressing prior art before filing will create a stronger patent application and help reduce the risk that a patent will be invalidated. Below are six tips that companies should consider to quickly secure strong medtech patents for their innovations: 1. File provisional patent applications early and often. Filing provisional applications, which provide one year of protection, can be both a time-saving and cost-saving measure. Using this strategy, medtech companies can defer larger filing costs for up to one year and file follow-on provisionals to cover incremental improvements as the invention develops. 2. Consider the USPTO’s fast-track programs. Medtech companies should consider utilizing the United States Patent & Trademark Office’s (USPTO) fast-track programs – Track 1 and Accelerated Examination. These programs offer medtech companies a way to beat the wait time at the patent office and get patents issued faster. The USPTO currently has a backlog of about 540,000 patent applications, which has created a logjam for the patent review and allowance process. It currently takes an average of at least two years for a utility application to obtain its final disposition (36 months for applications with a request for continued examination). In contrast, the USPTO Track 1 program strives to achieve a final disposition of utility

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patent applications within 12 months of filing. As of September 2018, the average pendency of a Track 1 patent application was only about 6.4 months. Another USPTO fast-track program is an age-based program which speeds up examination for inventors aged 65 or older by filing a simple petition with the USPTO. Fast-track programs are also available in other key geographies, such as the Pace Program in the European Patent Office. The USPTO fast-track programs may require additional filing fees and accelerate costs that would normally be spread over a period of years. However, medtech companies can still utilize these programs for their key patent applications to quickly obtain issued patent claims covering the most important features of the product. Additional patent applications with claims of different scope can then be filed via regular examination to form a “picket fence” of patent protection around the core aspects of the technology. 3. Get on the patent prosecution highway. Another way to accelerate USPTO examination involves the Patent Prosecution Highway (PPH) program based on an issued foreign patent or a favorable search report. Under bilateral agreements between the USPTO and various foreign patent offices, an applicant receiving a favorable ruling from a first patent office may request that a second patent office fast track the examination of a corresponding application pending in the second office. Therefore, a potential strategy is to obtain allowable claims in the USPTO under the Track 1 procedure quickly, and then use the PPH to fast track examination in other countries. This combined strategy could allow applicants to obtain patents in both the USPTO and eligible foreign patent offices faster and more efficiently. Consequently, the PPH may help an applicant save time and reduce costs.

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Precision Welding For Critical Plastic Components 4. Utilize examiner interviews. Patent examiner interviews can be an effective tool in advancing the prosecution of the patent application. In recent years, the USPTO has made a concerted effort to reduce its patent examination backlog and accelerate the patent prosecution process. To help accomplish this, the patent office suggests that patent examiners get directly involved with applicants as early as possible. Early and ongoing communication between a patent attorney and the examiner can help to improve the quality and speed of patent examination. An interview with the patent examiner is typically conducted by telephone, although it may be conducted in person at the USPTO. Examiner interviews are an opportunity to explain the novelty of the invention, discuss rejections and prior art, clarify positions and resolve issues. To help ensure a successful interview, it is important to keep in mind that good preparation, cooperation and communication are key. Applicants should also have at least one contingency plan in case the examiner does not agree with the primary line of reasoning. When conducted properly, examiner interviews can be an effective tool that benefits both examiner and medtech patent applicant. For challenging cases, examiner interviews can resolve a stalemate, and lead to allowance of a patent application. 5. File international patent applications strategically. Filing international patent applications further strengthens a patent portfolio and expands a medtech company’s presence in the global marketplace. While foreign patent applications can be expensive, filing in strategic countries with a large target market for the product can be critical to the commercial success of the technology. 6. Pursue continuations and divisional applications. A cost-effective strategy to grow a strategic patent portfolio is to file a continuation and/or divisional patent application before a patent issues. By filing the same application with claims of different scope, medtech companies can often get multiple different patents to issue from a single patent application. Continuation and divisional patent applications are a thrifty way to increase the number of issued patents and the scope of protection. Overall, patent prosecution will likely never be a quick or easy process, but by following these six tips, medtech companies can accelerate the process and achieve their patent goals. M David J. Dykeman is co-chair of Greenberg Traurig’s global Life Sciences & Medical Technology Group. A registered patent attorney with more than 20 years of experience in patent and intellectual property law, Dykeman’s practice focuses on securing worldwide intellectual property protection and related business strategy for high-tech clients, with particular experience in medical devices, robotics, life sciences and healthcare information technology. 11 • 2018

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REGULATORY, REIMBURSEMENT AND IP

Here’s what you need to know about the new ISO 13485:2016 If your business manufactures, installs or services medical devices, you know it’s essential to transition to the new 13485:2016 ISO standards as soon as possible. Tim Lozier EtQ

The latest revision of ISO 13485 revised compliance and regulations to enhance quality management throughout the medical device lifecycle. This includes new provisions that impact how your business manages the design, development, manufacture, test, distribution, installation and servicing of your medical device products. Let’s explore what these changes mean to your business. Emphasis on a risk-based approach Risk-based thinking is a central principle of recent ISO updates. You need to adopt and emphasize risk-based thinking throughout the medical device lifecycle including: • • • • • • •

Identification of potential risks; Cataloging risks for likelihood, urgency and priority; Taking steps to reduce or remove risks; Creating mitigating action plans for risks; Creating incident plans if risks to manifest; Document all plans, actions and other artifacts; Store documents in an easily-accessible location like a quality management system.

Controls and quality measures in design and development ISO 13485:2016 has new standards for quality throughout the design and development process. This is particularly important in the change and release management system, to ensure that any risks, issues, defects or feedback are properly addressed and resolved. Employees need to review all changes and document approaches, testing and similar areas to maximize a quality output. Verification is baked into the new compliance rules, which should be supported by documentation and an auditable history. Finally, ISO 13485:2016 provides new regulations when transferring devices from design, development, and testing into production. Upskill employees and document any training Quality management and ISO compliance demands that employees receive the right training to perform their roles and responsibilities to the required level of competence. Skills and experience for any staff involved in quality or the medical device lifecycle must be recorded and documented. You must also identify gaps in knowledge and provide ongoing training. This ensures employees have the right skill set and approach to deliver products that meet business, customer and patient needs. 94

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Management of suppliers ISO 13485:2016 introduces new regulations for monitoring and managing suppliers. These include: • • • •

Transparency and insight into a supplier’s performance; Risk-based approach for supplier-based risks that could impact performance; Re-evaluations of supplier performance on a regular basis; Documented assessments of potential risks, together with mitigating actions.

Handle complaints appropriately Your business must implement a robust complaint handling process. This includes: • • • • • • • •

Creating and documenting all complains handling processes; Collecting and documenting complaints; Identification of complaints from all areas, not just customers; Surveying customers after medical device installation to gather feedback; Reporting of complaints to the proper regulatory bodies; Identification of corrective actions; Tracking and delivery of tasks to resolve complaints issues; Resolving the impact of complaints and addressing them in the medical device lifecycle.

As you can see, ISO 13485:2016 has several new requirements for the modern medical device business. You need to start your transition as soon as possible, to ensure you can maintain ISO certification, and to guarantee you can deliver the quality medical devices that your customers and patients need. ISO compliance is built on excellent quality management. The right quality management system (QMS) will work throughout your medical device business to integrate with your development and production systems, centralize quality throughout the medical device lifecycle, manage risks and issues and support effective problem resolution, and much more.

Tim Lozier until recently was director of product strategy at EtQ.

www.medicaldesignandoutsourcing.com

11/21/18 10:46 AM

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REGULATORY, REIMBURSEMENT AND IP

Medtech contracts versus purchase orders: Why contracts might be the better option Contracts are underused by medical device companies. Here’s why they are worth a second look. C o u r t n e y Yo u n g Medmarc Insurance Group

Contracts are both one of the most effective risk management mechanisms available to medical device companies for mitigating products liability risk, and one of the most underused. Contracts effectively transfer risk and assure that each party is liable only for eventualities within their control. Life sciences companies may assume that their use of purchase orders with terms and conditions suffice for contracts, but for the reasons briefly outlined below, this is often not the case. Contracts versus purchase orders Many companies, particularly those in the life sciences industry, rely on purchase orders and order confirmations, sometimes with terms and conditions appended, to conduct business. In fact, in Medmarc’s most recent survey of their defense panel conducted in 2018, 80% of defense panel respondents indicated that some or most of their life sciences clients relied solely on purchase orders to govern the relationships between themselves and their vendors. There is a misunderstanding in the industry that these documents sufficiently protect the parties by including terms important to them. Although such documents can be preferable to operating without any documentation, they are fraught with problems and a poor substitute for a contract governing an entire relationship. They become particularly problematic when the terms appended to the purchase order differ from those issued from the vendor in a receipt or confirmation. This scenario gives way to something called the “battle of the forms,” after which a contract is hobbled together – often judicially through litigation – from the various terms of the different forms. This process can be time-consuming and expensive to litigate and often yields a result that neither is satisfactory to either party nor reflects the subjective intent of the parties in their dealings. Contracts for the sale of goods are generally governed by the Uniform Commercial Code (UCC) as it has been adopted by the particular state in which the contract is being litigated. The UCC addresses the “battle

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of the forms” in § 2-207, Additional Terms in Acceptance or Confirmation. This provision stipulates that any different or additional terms appearing in the “acceptance” or receipt will be deemed accepted and become part of the contract unless: the offer expressly limits acceptance to terms of the offer; the additional terms materially alter the agreement; or notification of objection to the additional terms has already been given or is given within a reasonable time after notice of the terms is received. This means that those including terms and conditions in their purchase orders would be wise to include among those terms an express statement that no additional terms will be deemed accepted except by express mutual consent of the parties in writing. Even this method, however, misses many of the benefits and protections of a contract of mutually agreed upon terms which govern not just one transaction but the entire relationship between the parties. Conclusion The absence of a contract leaves parties too vulnerable to cost and uncertainty. Conversely, contracts offer drug and device companies the opportunity to contemplate the details of a particular transaction or relationship and memorialize those details to the parties’ mutual satisfaction before a claim arises. In the event of a product liability lawsuit, contracts can and should assist in identifying the responsible party and obtaining the appropriate indemnification from that party. M Courtney Young is senior attorney for risk management at Medmarc Insurance Group. Her primary responsibilities include assisting brokers, policyholders and underwriters with efforts to evaluate and mitigate products liability risk. Young publishes articles on products liability risk management for industry organizations, such as IMDA, and publications, such as Life Sciences Panorama. She also maintains a blog on products liability issues for the life sciences industry, on which she discusses recent products liability litigation, FDA regulatory activity and industry news.

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11/21/18 10:46 AM

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REGULATORY, REIMBURSEMENT AND IP

Your device design looks great: Now how do you get reimbursement? Until recently, medical device companies were mainly focused on designing devices and earning regulatory clearance for their new technologies. How times have changed. While innovative design and FDA approval are important for market entry, reimbursement is now a top concern for medical device CEOs, their investors and other stakeholders. To m H u g h e s Regulatory and Clinical Research Institute (RCRI)

Continued increases in the cost of healthcare are driving stakeholder interest in reimbursement. Investors want to know up front whether there will be coverage, coding and payment before they risk investing in new technologies. Payers increasingly expect new technologies to demonstrate better outcomes at equal or lower costs before they pay for them. More hospitals are establishing value analysis committees to evaluate all new products prior to allowing them to enter a hospital or clinic setting. Physicians are interested in products that not only help their patients but also meet quality metrics imposed by government and private payers. Perhaps most importantly, patients are becoming more educated and prefer interventions that improve quality of life at the lowest cost possible. Make reimbursement a priority. With reimbursement planning, medical technology companies can boost the chances of market success for new technology. Planning a reimbursement strategy should

Activity

begin early in the product development phase. Early planning can contribute to device design considerations that take advantage of reimbursement requirements. Also, early planning can save time, money and effort by adding clinical and economic value endpoints to regulatory approval studies for a new technology. Conduct an assessment. Develop a strategic plan. Making reimbursement a priority is a simple two-step process. First, conduct an assessment to understand the existing reimbursement landscape for the new technology. Second, use the assessment to develop a plan to take advantage of payment opportunities or to address gaps in reimbursement such as the need for evidence development, coding initiatives or obtaining payment from payers. Conduct a reimbursement landscape assessment. A reimbursement landscape assessment is a snapshot of the current coverage, coding and payment landscape

Product Development Phase

Clinical Study Phase

Post Launch

Prepare reimbursement budget

Build reimbursement expertise

Collect meaningul data to show value

Gain payer acceptance

Implement coding initiatives

Obtain payment

Align capabilities to execute initiatives

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Image courtesy of RCRI

for a particular technology or procedure. It tells innovators what reimbursement challenges and opportunities exist for the adoption of their product. While individual assessments will vary depending on the technology, common elements include determining payer coverage status (i.e. Medicare, private payers, etc.); identifying existing coding used by providers, hospitals, homecare, etc.; determining payment assigned to existing codes; assessing evidentiary needs to show improved outcomes/costeffectiveness of new technology; and preparing findings and recommended action steps. Develop and implement a strategic reimbursement plan. The information obtained from the landscape assessment should be used to develop an effective reimbursement strategy and timeline. A well-designed strategic plan should help companies gain clarity on what reimbursement initiatives need to be completed and when. On the opposite page are examples of key elements to consider when developing a strategic reimbursement plan. In summary, reimbursement is a major focus for healthcare stakeholders in today’s cost-conscious healthcare environment. Companies that begin early to understand the reimbursement pathway for their new technology and conduct a well-conceived reimbursement strategy based on a thorough reimbursement assessment will be positioned to succeed in this changing marketplace. M Tom Hughes is an attorney and senior principal advisor for health economics and reimbursement for Regulatory and Clinical Research Institute (RCRI), based in the Minneapolis area.

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REGULATORY, REIMBURSEMENT AND IP

Ready or not: How medical device manufacturers can prepare for E.U. MDR The deadline to comply with new medical device regulations in the European Union is coming up fast. Here are some ideas on getting ready for the changes. Mike Edwards Sparta Systems

By mid-2020, medical device manufacturers selling products in Europe must comply with the significant regulatory changes embodied in the European Union Medical Device Regulation (E.U. MDR), or lose their ability to sell in the European Union. The E.U. MDR replaces Directive 93/42/EEC for medical devices (MDD) and Directive 90/385/EEC for active implantable medical devices (AIMDD). One of the reasons for this major change is the need for greater control of medical device reporting, which aims to minimize country-by-country differences in regulations and product quality. In describing the purpose of the new MDR, the Official Journal of the European Union explains: “This regulation aims to ensure the smooth functioning

While the MDR goes into extensive detail about the changes, key requirements to note include: • Clinical investigations: Requirements for conducting clinical investigations differ greatly from those in the MDD but will align with requirements elsewhere in the world. • Clinical evaluation: The E.U. MDR significantly expands manufacturer pre-market clinical evaluation requirements, requiring substantially more clinical evidence supporting device efficacy and safety. • Notified bodies: Manufacturers will face greater scrutiny from the notified bodies that perform pre-market assessments and routine surveillance audits to consider the conformity of products before they are put on the market.

THIS REGULATION AIMS TO ENSURE THE SMOOTH FUNCTIONING OF THE INTERNAL MARKET AS REGARDS MEDICAL DEVICES, TAKING AS A BASE A HIGH LEVEL OF PROTECTION OF HEALTH FOR PATIENTS AND USERS, AND TAKING INTO ACCOUNT THE SMALL- AND MEDIUM-SIZED ENTERPRISES THAT ARE ACTIVE IN THIS SECTOR. of the internal market as regards medical devices, taking as a base a high level of protection of health for patients and users, and taking into account the small- and medium-sized enterprises that are active in this sector… At the same time, this regulation sets high standards of quality and safety for medical devices in order to meet common safety concerns as regards such products.” Though many E.U. MDR requirements are similar to current requirements under the MDD, the MDR is much more prescriptive and provides greater detail and direction to manufacturers. For example, manufacturers and their authorized representatives must provide regulatory bodies with considerably more data and information than they may have been accustomed to in the past. 100

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Two years might seem like plenty of lead time to ensure compliance, but time may actually be the most challenging aspect of the transition to the new requirements. To fully understand the E.U. MDR – this process can prompt new challenges and will be incredibly time consuming. But it can be done with a strategic approach. Here are four best practices to successfully rollout MDR-ready processes: • Get smart early and plan ahead. The new MDR involves many changes to existing processes and protocols – some more significant than others – so every team member should receive the proper education on the new requirements early on.

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• Conduct a thorough assessment. Under the new E.U. MDR, there will be no grandfathering of legacy or pre-MDR devices. Once the 2020 deadline arrives, every device must be fully compliant. To make sure nothing slips through the cracks, it’s important to perform a series of assessments to get a clear picture of where any issues might arise within an organization as it relates to compliance. • Don’t cut corners. Invest in time and resources. Learning the nuances of how E.U. MDR differs from MDD, and then actually implementing short and long-term change will take a significant amount of time from everyone within a medtech company. A strong multi-disciplinary

team is required to implement the organizational changes necessary to become MDR compliant. • Walk before you run. As the MDR goes into effect, a medical device company’s instinct may be to immediately start patching visible MDR “holes” throughout the organization as quickly as possible. While the 2020 deadline inches closer – and faster than expected – there is no need to make rushed decisions or put into motion half-baked plans. Companies should start small at the beginning, and as more people grow comfortable with adhering to new protocols and meeting the necessary requirements, these processes will naturally speed up.

Ultimately, the E.U. MDR calls for several changes that will affect the processes and priorities of medical device companies, with increased emphasis on patient safety and quality management. Device manufacturers can start preparing now by gaining a comprehensive understanding of the new regulation, asking the right questions and getting the answers they need to develop a plan for compliance before they begin implementing it. M Mike Edwards is director of product management for Sparta Systems.

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SOFTWARE

Putting patients first: e-consent in clinical trials Medical device developers do not always consider the process of informed consent for clinical trials, since it is often handled at the trial site. But the industry is changing, and digitizing processes such as informed consent can streamline studies to rapidly collect quality data and reduce costs. M i c h a e l Tu c k e r Medidata

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As the medical technology industry shifts toward patient centricity, novel methodologies and technologies like mobile sensors and cloud software that collects and stores data can save time, reduce costs and increase adherence to regulatory standards. In addition, these technologies can help address challenges in patient recruitment and enrollment. This is especially true when evaluating precision medicine or therapies for rare diseases. In such cases, there are many hurdles such as shortages of specific patient populations required to complete accurate, timely trials, which is often

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exacerbated by the increased frequency of trials conducted in tandem. Using e-consent systems during the enrollment process can reduce the cumbersome activities associated with paper-based consent documents, leading to more efficient patient enrollment and quicker study start-ups. E-consent is an ethical imperative Patients comprehend the e-consent enrollment process better than paper consent forms, making e-consent a more ethical way to recruit participants. A recent pilot study found that people with a paper version recalled about 58% of the material in informed consent documents, while 75% recalled information accurately when viewed in an e-consent format. Moreover, informed consent documents are notoriously difficult to understand. The Center for Information & Study on Clinical Research Participation published a study revealing 35% of potential participants dropped from a study because they couldn’t understand the informed consent documents. Due to technical terminology, participants could not understand their rights and responsibilities, and were therefore wary of participating in the study. In contrast, a digital consent platform that tailors trail information and the way it’s delivered to a patient’s needs enables that patient to participate confidently. E-consent software accomplishes this by using multimedia tools (e.g., participant-led videos, characters, virtual trial examples) that track and improve comprehension. Finally, to measure comprehension after completing the e-consent form, participants take a comprehension quiz that reveals whether the testing site staff needs to further clarify risks and benefits of the study.

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Saving money and time A software platform that digitizes the process and eliminates paper consent improves patient understanding and engagement, therefore accelerating and streamlining start up times. It can also lead to cost and time savings. Estimating the costs associated with informed consent can be difficult as individual CROs often tally total costs into one sum, estimating that the cost per participant can range from $50 to $1,000. But if stakeholders consider the costs associated with copying paper documents, shipping, storage, archive management and source data validation, the value of a digital record begins to emerge.

look for systems that incorporate tools such as comprehension quizzes following the presentation, which can enhance understanding and allow participants the opportunity to review any confusing sections. Third, adopting a unified enrollment system ensures consistent consent review across all sites. To help reduce monitoring and site costs, the system should:

Meeting and exceeding regulatory standards Information compiled in an e-consent format can be tracked automatically. Participants receive immediate updates, and auditors have access to that data at any point, not just on site. Also, e-consent forms reduce participant errors, such as inputting the wrong date. According to a Quorum report, from 2011 to 2016, the FDA reported 214 inspectional observations related to the mandate to obtain informed consent, the failure to adequately document informed consent and the failure to maintain documents evidencing informed consent. We estimate that 95% of those observations would be eliminated with an e-consent format versus a paper format. These benefits would allow trials to meet and even exceed regulatory standards.

Finally, the system needs to comply with institutional review boards, quality assurance guidelines and regulatory standards. Such a system should prioritize risk reduction for regulatory audits and, therefore, incorporate tools including realtime enrollment statistics and traceable electronic signatures.

• Include a web dashboard of consent analytics at all sites; • De-identify consent information for sponsor review; • Ensure required signatures and manage consent amendments.

Conclusion Investing in e-consent is no longer a luxury. Compared to traditional methods, adopting a unified platform that enables e-consent can streamline studies, while saving time and reducing costs. The healthcare market is shifting to ensure products have a patientcentric approach, and that directive must include clinical trials. M Michael Tucker is senior product solutions specialist at Medidata.

What to consider when looking into digital enrollment process When transitioning to a digital enrollment process for clinical trials, there are several considerations. First, for e-consent to be successfully integrated into clinical trials, stakeholders need to ensure that it can be used on commercially available platforms, such as tablets and smartphones. Second, interactive tools, such as animation or touch screen navigation, provide an active learning experience that engages the patient, improving adherence and completion. Further,

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SOFTWARE

Connected medical devices: What are the pros and cons? What’s the holdup with getting connected medical devices on the market? Here are some potential answers. Abbas Dhilawala Galen Data

From increasing costs and an aging population, to the demand for affordable and personalized care, the healthcare industry is facing a variety of challenges. These challenges have opened the door for a new wave of low-cost technology to replace the outdated and struggling medical devices of the past. This new technology comes in the form of connected medical devices, which are not only a more affordable option but also significantly improve the quality of patient care. Medicare estimates $17 billion is spent each year on avoidable readmissions that can be mitigated with early intervention and better at-home care. With the world becoming more connected since the introduction of IoT and connected medical devices, this presents a unique opportunity to prevent some of these readmissions. So what’s the holdup? Some still have reservations and concerns when it comes to connected medical devices. What are the positives and negatives to this future path? Let’s take a look. Positive: diagnostic improvement Connected medical devices fall into an umbrella category referred to as the Internet of Medical Things (IoMT). The role of the IoMT is to allow medical devices to be connected to applications and the cloud where information is processed and stored. The applications then use this information to create the user interface. Connected medical devices directly benefit the patient and healthcare provider through the use of improved patient compliance, data collection that can lead to more personalized care, and most importantly the detection of device failures before they become serious. So how do these seemingly magical devices work? The answer lies in machine learning. Using machine learning techniques to comb through data and identify patterns in a patient’s health over a period of time, medical devices will be propelled into the future. This information helps identify new products and patterns of care. Connected medical devices also help with diagnostic services that may be too complex for a standalone medical device. As engineers and researchers collect data, diagnostic algorithms are improved over time, helping to quickly and efficiently provide the best possible care to patients.

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Positive: failure prediction One of the most important features of connected medical devices is that they have the ability to predict potential device failures before they become a lifethreatening scenario. For example, consider a heart pump manufacturer changing the type of lubricant used in pump bearings. The product may be the same, but any slight difference can cause an issue. Perhaps the operating temperature was different than the original lubricant, resulting in a higher wear pattern on the bearings, which would normally be undetected until the device failed. However, with a connected medical device, a notification would be issued to the physician and manufacturer, so the pump can be replaced before failing, which saves the patient’s life along with others whose pump contains the new lubricant. Along with early diagnosis and predictive abilities, connected medical devices also have the ability to track the effectiveness of patient care. This provides physicians with more comprehensive and frequent information about their patients, along with improved outcomes. Negative: cost and regulations While connected medical devices clearly have numerous benefits, including the ability to reduce long-term costs of patient care, the initial cost of developing and maintaining a connected solution is a major concern. Connectivity infrastructure either is the medical device itself, or an extension of the medical device. Either way, all regulatory requirements must be met. Creating products that fall into the connective category and meet all regulatory requirements is a tough process. This is also one that requires an extensive expertise in the space and a highly specific skill set, both of which are hard to come by, making device development and regulation a great expense. Negative: data privacy and cybersecurity There are more than 3.7 million medical devices in use. What if all of these devices were connected and someone managed to obtain sensitive medical or financial information from patients by interrupting the connectivity? Cybersecurity and data privacy are two of the largest concerns when considering adoption of connected medical

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devices. Connected devices are much more vulnerable to brute force, deliberate attacks as well as undirected malware. Cloud-integrated manufacturers are continually trying to prevent this possibility from occuring by listening to the FDA and other regulatory agencies that have issued guidelines on how to mitigate cybersecurity risks. In order to provide manufacturers with incentive to make changes, the FDA allows manufacturers, who have implemented mandated security updates on medical devices, to not repeat the entire regulatory approval process. Solutions Can these possibilities be managed and prevented? Absolutely. Thorough risk analysis should be performed to determine risk posed by connectivity threats since each medical device has a unique risk profile. Considerations:

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• • •

What kind of data is stored and transmitted? Does this data include private medical information? What is the potential harm if data is erased? What are the risks of connecting or not connecting a device?

Potential strategies: • • • • • •

Choose the right type and level of encryption; Create a list of cybersecurity procedures and guidelines; Use appropriate security controls for access to data; Train your workforce on good cybersecurity practices; Ensure good engineering by prioritizing secure design and coding; Track cybersecurity risks during product development;

• • • •

Limit the amount of data stored; Include cybersecurity verification and frequent reviews; Use the right type and level of encryption; Establish a post-market surveillance program and conduct assessments.

Connected medical devices provide a variety of benefits including automated alerts, remote monitoring, early diagnosis, lowered healthcare costs, and most importantly improved patient outcomes. When properly secured and maintained, these devices can be a very beneficial tool for improving patient health. In most cases, the benefits outweigh the risks. M Abbas Dhilawala is CTO of Galen Data (Houston). Dhilawala has more than 13 years of experience developing enterprise-grade software for the medical device industry.

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SOFTWARE

How to design for patient safety, data security and reliability Medical device creators are designing electronic devices with enhanced and sophisticated functionality, with most of the complexity contained within the software. Many new devices are also equipped to communicate with hospital networks, one another and the IoT (Internet of Things). Martin Nappi Green Hills Software

Designing life-critical software into the medical device and then connecting it to a hospital network or the expanding IoT introduces an elevated level of risk. It also broadens the potential attack surface of the device to would-be cyber attackers. Due mainly to the increasingly aggressive threat landscape, governing authorities like the FDA expect device manufacturers to take cybersecurity very seriously. To achieve approval to bring a Class III medical device to market, they expect manufacturers to conduct a threat assessment that includes an analysis of the potential for patient injury and mitigation of identified security risks. Manufacturers must provide an analysis of the likelihood and severity of patient harm balanced against other design considerations. Product developers are expected to incorporate device cybersecurity and perform risk-analysis at every phase of the development cycle. Operating systems like Windows, Linux, Android and many embedded real-time operating systems (RTOS) are not appropriate for use in life-critical devices. Basing a connected medical device design on a weak or vulnerable operating system framework may be suitable for some devices, but not for a Class III medical device or any device whose unauthorized breach or anomalous behavior could directly or indirectly cause a loss of life. These operating systems only protect against inadvertent or casual attempts to breach the device’s security. Furthermore, their immense base of program code has proven to contain thousands of vulnerabilities, according to the National Institute of Standards and Technologies. Using microkernel architecture Other industries, including avionics and automotive, have transitioned to using a software architecture based on partitioning or separating different software tasks into separate memory areas on the device. This high-integrity separationkernel or microkernel architecture uses microprocessor memory protection and hardware security to guarantee isolation of software components, monitor run-time operation and ensure each task has the resources required to run correctly. The underlying microkernel constantly monitors the overall system, detecting and isolating any unusual behavior caused by errant or malicious code.

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Critical tasks are partitioned separately from noncritical tasks, and information flows are validated. Digital certificates and keys are tied to the hardware root of trust to protect software and communications. Network connections may be enabled to specific tasks or to guested operating systems such as Windows or Linux, hosted in separate noncritical partitions so that coding errors and security breaches cannot affect critical functions of the device. Given the risks, external and independent software testing authorities should validate systems against stringent industry standards (e.g. RTCA DO-178B, ISO/IEC 15408, IEC 61508) with rigorous safeguards against failure conditions and strong resilience to defend against unauthorized access. It is reassuring to know that there have been separation kernel operating systems commercially available from multiple vendors for up to 20 years that are recognized by international authorities as meeting the highest levels of safety and security. Conclusion Historically, product security in the medtech industry was much less of a concern because many devices were not connected to networks, smartphones and tablets. But with the emergence of the IoT and the criminal element that comes with it, the top three priorities for device designers are now: • • •

Keeping the patients and clinicians safe; Keeping electronic health records secure; Keeping the device consistently operational and resistant to cyber attack.

Life-critical devices and our healthcare system need to be resistant to sophisticated, well-funded cyber-criminals, including terrorists or any criminal group with a reason to compromise our healthcare system. M Martin Nappi is VP of business development for the medical industry at Green Hills Software. He is a 30-year veteran of the embedded systems industry and is responsible for providing safe and secure software technology for medical devices and systems.

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STERILIZATION SERVICES

This sterilization innovation is enabling in-situ curable silicone A novel method to develop in-situ curable silicone relies on gaspermeable packaging and EtO sterilization. Heather Thompson Senior Editor

A silicone dispensing system takes a new approach to sterilization in order to achieve in-situ curable silicone. This dispensing system allows silicone to be sterilized in the uncured form, opening new possibilities for silicone-based medical devices. “Silicones are widely used in the medical device field in a variety of applications, and they do various jobs,” noted Julie Cameron, VP of business development and marketing at NuSil, an Avantor brand. The materials are often used for therapies in the fields of neurology, cardiology, orthopedics and gynecology, Cameron explained. “The innovative silicone dispensing system makes it possible for medical device manufacturers to create devices that will form in the body to the patient’s anatomy,” she said. There are various processes available to sterilize silicones. However, many of these processes have posed challenges in the past when it comes to sterilization of silicones in their uncured state. Gamma and electron beam sterilization can increase cross-linking, causing premature curing, Cameron explained. Dry heat and autoclave sterilization may be detrimental for heat- or moisture-sensitive formulation ingredients and packaging components. Nusil’s development harnesses ethylene oxide (EtO) and gaspermeable packaging. “EtO can permeate both the package and the silicone for proper sterilization, without significant effects to the raw material,” Cameron said. The ethylene oxide does not significantly change key silicone physical

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properties such as rheology, durometer, modulus, work time and cure rate. Once the sterilant gas is removed, the silicone is sterilized and ready for inclusion in the surgical kit. Permeable packaging is used in conjunction with addition cure, platinum catalyzed chemistry. Cameron noted that this cure system is desirable and accepted in the medtech industry because it has single-digit parts-per-million catalysts and no byproducts. Silicone-based implanted devices have multiple therapeutic applications. Depending on how it is used, each device has unique physical property requirements, such as firmness, cushioning ability or flexibility.

Image courtesy of Avantor

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STERILIZATION SERVICES

P E R A C E T I C A C I D S T E R I L I Z AT I O N ? VAPORIZED PERACETIC ACID (VPA) HAS BECOME A GAME-CHANGER IN MEDICAL DEVICE STERILIZATION, PROVIDING FOR A ROOM-TEMPERATURE PROCESS DESIGNED TO PRESERVE NEWER DEVICE MATERIALS AND COMPONENTS. Mason Schwartz | Revox Sterilization Solutions

Advances in medical device manufacturing have yielded products that are either heat-sensitive or easily degradable. Many materials that would otherwise be ideal for product design cannot withstand traditional sterilization methods such as steam, dry heat, hydrogen peroxide (VHP), ethylene oxide (EtO) or gamma/E-beam irradiation. This limits overall product innovation and, if not considered before product design, interferes with project progression, objectives, and product launch. Liquid or vapor Peracetic acid (PAA) is formed by the reaction of acetic acid and hydrogen peroxide (H2O2); these compounds exist in equilibrium and their eventual decomposition results in oxygen (O2), carbon dioxide (CO2) and water (H2O). The room-temperature VPA process greatly improves material compatibility over other sterilization methods such as hydrogen peroxide (VHP), ethylene oxide (EtO), and gamma/E-beam irradiation. Liquid peracetic acid (PAA) and vaporized peracetic acid (VPA) are highly biocidal sterilants that maintain efficacy in the presence of organic soil while removing surface contaminants. Through extensive testing of more than 100 materials, VPA has shown high material compatibility. For example, the VPA method can safely sterilize products that would normally be damaged by a liquid chemical, even copper, which is known to oxidize from liquid PAA. A product containing liquid copper was exposed to the VPA process in 10 repeated four-hour cycles, only showing a slight dulling of the original gloss. Tests

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have also been successfully conducted using multiple sterilization cycles on thermoplastics, thermosets, adhesives, batteries and bioabsorbables. Bioabsorbable implants such as internal drug delivery mechanisms, stents, vascular grafts and scaffolds for tissue engineering rank among the latest cuttingedge medical device categories in the world. They are also among the most heatand moisture-sensitive products. Sterilizing products like these requires a stable gaseous chemical agent that will not degrade the product. The ethylene oxide (EtO) process typically operates at 40 degrees Celsius, and hydrogen peroxide gas phase sterilizers range between 28 and 60 degrees Celsius, whereas VPA sterilization processes between 18 degrees to 30 degrees Celsius.

can be integrated directly into the onsite manufacturing process, reducing transportation and inventory costs associated with other contract sterilization methods. Sterilization process time can vary greatly, depending upon the product being sterilized and including the presterilization and post-sterilization aeration periods and external quality processes. Because it requires no pre- or postaeration, VPA can significantly reduce the overall process time and reduce inventory costs. It also provides the option to bring sterilization on-site, eliminating the inefficiencies associated with off-site sterilization. M

Other advantages VPAâ&#x20AC;&#x2122;s nontoxic, sterile processing solution leaves behind no harmful residuals, providing not only a safer work environment for employees but a safer product for patients. With VPA breaking down into carbon dioxide, oxygen and water, the VPA process is noncarcinogenic, nonexplosive/flammable, and requires no external ventilation. It

Mason Schwartz is R&D and operations director for Revox Sterilization Solutions. He oversaw the invention of the Revox VPA sterilization method for Cantel Medical and has worked with both the FDA and Revox customers to provide support through both PMA and 510(k) submissions. Image courtesy of Revox Sterilization Solutions

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“The silicone can be highly customized so that device makers are able to select the exact properties they need,” Cameron said. She noted that device makers often ask for properties such as elasticity, fatigue resistance and durometer to increase the functionality of a device. The material can also be tailored for radiopacity, and either insulative or conductive properties. Cameron said the new dispensing system could enable new therapies to be developed – ones that could not be done before because of the surrounding morphology. It serves as a means to provide an alternate

method of surgical implantation, where uncured, pre-sterilized silicone can be provided as a part of the surgical kit and formed within the body during the surgical procedure, resulting in a custom-fit device. M

THE INNOVATIVE SILICONE DISPENSING SYSTEM MAKES IT POSSIBLE FOR MEDICAL DEVICE MANUFACTURERS TO CREATE DEVICES THAT WILL FORM IN THE BODY TO THE PATIENT’S ANATOMY.

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TUBING

Vascular catheter construction: Reviewing the basics and what’s new Advances in catheter components are paving the way for improved, more sophisticated devices. A super-thin-walled PTFE catheter base liner presents new opportunities for smaller devices. MRI-compatible LCP braiding is stronger than previous non-metal braidings and rivals the strength of some stainless steel braidings. Kevin Bigham Zeus

Vascular catheters are paramount for non-invasive surgeries, serving as the working channels through which other devices or therapies are passed to treat blocked vessels and other vascular maladies. Tools such as atherectomy devices, stents, cameras, ultrasound and irrigation devices can be precisely placed in the treatment zone using catheters. Basic components While there are many variations, catheter construction principally involves five basic components – mandrel, base liner, braiding reinforcement, jacket and a fusing sleeve. These components provide opportunities to create clever and innovative refinements to improve catheter function, including design for ever-smaller vasculatures. Several recent developments in this area make it incumbent to review basic catheter construction and highlight a few of these latest innovations. Thinner and smaller The first component placed upon the mandrel during catheter construction is the base liner, typically a thinwalled tubing polymer extrusion that forms the interior

Image courtesy of Zeus

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wall of the finished catheter. PTFE is the preferred liner material because of its chemical inertness within the body and very low coefficient of friction. It also provides an extremely lubricious PTFE-PTFE interface between the liner and mandrel, enabling easy mandrel removal at the conclusion of construction. Most recently, extremely thin-walled PTFE liners have become available, fostering even smaller finished devices. The thinnest liners can be produced with wall thicknesses as low as 0.00075 in. (0.01905 mm). With the constant drive toward smaller devices, these super-thin-walled liners enable greater lumen potential than ever before while supporting microcatheter sizes that can reach the smallest vasculatures, even those bordering on neurovascular networks. MRI-compatible catheters Following the catheter base liner is a braiding to provide additional strength. The braiding is typically some form of stainless steel, nitinol or other biocompatible metal. Such braiding can take a variety of forms and pick counts to tailor mechanical properties of the device. However, magnetic resonance imaging (MRI) precludes the use of most metals used in catheter construction. Liquid crystal polymer (LCP) monofilament braiding, a newly developed alternative to metal, has taken on the challenge of MRI-compatibility. LCP possesses many beneficial properties for catheter braiding, including autoclavability, chemical resistance, mechanical properties that rival some stainless steel braidings, and diameters as small as 0.002 in. (0.051 mm). Above all, LCP is MRI-compatible: It is not metal. This extremely strong monofilament has been used in prototype catheters and has received highly favorable results. LCP also supports the construction of small devices because it may be produced with very small diameters. LCP monofilament opens the door for the first widely accepted, truly MRI-compatible catheters for minimally invasive procedures. M Kevin Bigham earned bachelor’s degrees in chemistry and biochemistry at the College of Charleston and a PhD in biomedical and pharmaceutical sciences at the Medical University of South Carolina. He has worked in manufacturing and research and is a technical writer for Zeus.

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TUBING

METAL TUBING FOR MEDICAL DEVICES?

MOST SMALL HANDHELD DEVICES USED F O R S U R G E RY I N C L U D E SOME TYPE OF TUBING T E C H N O L O G Y. T H E DESIGN ENGINEER U LT I M AT E LY M U S T DECIDE WHETHER D R AW N T U B I N G OR A ROLLED TUBE TECHNOLOGY WILL BEST SUIT A PA RT I C U L A R D E V I C E .

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Metal tubes are frequently used for the shafts of disposable and reusable medical instruments. The tubes can be manufactured from either drawn tubing or using a stamped and rolled technique. The following factors need to be considered when deciding which metal tube approach to use â&#x20AC;&#x201C; a drawn tubing or a rolled tube method. These factors include the size of the component being manufactured, tolerance and thickness of tubes, movement versus rigidity of the instrument, and the features required on the tube itself. Drawn tubing allows for greater

Jim Jock | Micro

control of tubing dimensions such as straightness or diameter consistency, particularly when tightly controlled dimensions are required throughout the whole length of the metal tube shaft. Drawn tubing is also more conducive to creating certain end features, such as flaring and flanging, expansions or reductions, and end sharpening. Not all drawn tubes have to be round. They can also have an octagon cross section, oval or D-shape, just to name a few. In manufacturing metal tubes, the rolled tube technology method is better suited for high-quantity

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orders such as those greater than 300,000 pieces. This method requires the use of a progressive stamping die and raw stock in coil form, usually stainless steel for surgical instruments. Features – such as holes, slots or windows – can be punched into the coil stock in the early flat blank stages of the stamping procedure. After these stamped features are completed in the stamping tool, a rolling

process begins, in which the flat stock material is finished into a tube shape. It is actually possible to stamp and roll a finished tube off a stamping power press in a few seconds, versus cutting drawn tubing stock to the correct length, cleaning it and putting secondary features in afterward. Using this rolled tube technology for metal tubes can significantly reduce component and subassembly costs when it is used to manufacture endoscopic subassemblies. Products that tend to fit into this category include scissors, graspers,

dissectors and tissue-holding forceps that support endoscopic procedures. Most small hand-held devices used for surgery include some type of tubing technology. In the design phase, the design engineer ultimately must make the choice between using drawn tubing or a rolled tube technology. Decisions are based on quantities, cost and the features necessary for the endproduct, all an integral part in bringing a new medical instrument to market. M Jim Jock joined Micro in 2001 to manage all corporate marketing activities. He has been involved with the metal stamping and manufacturing industry for more than 40 years.

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VALIDATION & TESTING

How to work with a third-party testing lab Clear communication is key to success when working with any test lab partner. Maintaining good communication and following these tips will help result in a positive testing experience for all. Kaitlin Bladl DDL

A minor misstep in product development and testing can have devastating consequences. While testing is unavoidable for most medical device companies, one option is to outsource testing to a third-party lab. As in any business relationship, good communication and knowing how the other party operates can make for a more productive relationship. Following are a dozen tips on working with a thirdparty testing lab. 1. Know the test standard When using an accepted standard, such as an ASTM or ISO standard, it is a worthwhile investment to purchase and understand the standard. This allows the device manufacturer and the test lab to speak the language of the standard and address any interpretational issues. 2. Organize samples and document what you send Sending clearly labeled samples saves time and prevents confusion. Documenting samples sent in an email or by another means also helps create a trail of information for verification. 3. Provide extra samples for setups Whenever possible, providing extra samples for test setups helps in the event there is a need to do any exploratory work and prevents the lab from having to unintentionally reduce the sample size in case any samples are inadvertently destroyed. 4. Donâ&#x20AC;&#x2122;t assume the test lab knows the product well Test labs do their best not to make any assumptions on the test samples they receive and should call the device manufacturer whenever there is any uncertainty. Be sure to tell the lab anything special it needs to know.

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5. Assign one point of contact Having one point of contact at the test lab and one at the device manufacturer makes communication easier for both parties, which provides a higher degree of clarity and reduces any chance for confusion. 6. Beware of scope creep It is not unusual for test results to differ from expectations. A common reaction is to try something different in hopes of getting a better result. It is also not unusual to secondguess a decision during the testing and want to try a variation of the original test. This often results in wasted efforts at a cost to the device manufacturer. 7. Read and understand the test labâ&#x20AC;&#x2122;s quote completely Assembling a test quote can be involved and detailed. While test labs do their best to capture everything discussed, realizing later on that something has been left out or misinterpreted can jeopardize the project. 8. Understand the order of testing If multiple tests are to be performed but not enough samples are supplied or available for each test, work with the lab to address the order of testing. There are two general routes to consider in this scenario. The first is to subject the samples to progressively more intense tests, while the second is to begin with the most robust test and work down from there. Selecting the method that makes the most sense depends upon several factors, such as intended use, expected operating conditions and expected performance.

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9. Don’t expect the test lab to diagnose unrelated problems If a device fails a test, a good test lab will only comment on the testing that was performed and offer insight on the details of the testing. You should not expect a lab to provide advice outside its area of expertise, because the manufacturer is truly the expert on its device. 10. Communicate special requests early Special requests are not a problem, but be sure to communicate them during the sales and quoting process to prevent delays to the project. 11. Have a clear objective for the testing A clearly stated objective for the testing helps everyone involved to understand the purpose of the testing and can prompt questions from the test lab that can lead to a more appropriate test method.

12. Prepare samples to the standard In an effort to save money, some manufacturers will prepare their own test samples. If not performed correctly, the testing may be compromised or have to be repeated. If a manufacturer chooses to prepare its own samples, a short discussion with the test lab might offer several best practices that make this route worthwhile. M

Product testing at DDL Image courtesy of DDL

Kaitlin Bladl is product & materials supervisor for DDL, a package, product and materials testing company for the medical device industry. She holds a bachelor’s degree in material science and engineering from the University of Minnesota.

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VALIDATION & TESTING

Understanding worst-case conditions in ISO 18562 testing For three decades, the ISO 10993 international standard series has provided the overarching guidance on evaluating medical devices for biocompatibility. The new international standard, ISO 18562, addresses gaps. Here’s what you need to know. Matthew Jorgensen Erin Bakes Robert Mueller Nelson Laboratories

Here’s an example of a gap in ISO 10993: When a gas is the carrier in an externally communicating device, the risk profile is different than if the carrier were a liquid, and liquids are the suggested matrices of ISO 10993. Consider a device with brass connectors. If tested by methods suggested by ISO 10993, the connector will be extracted in minimal essential media (MEM) fluid for a cytotoxicity test, and will certainly fail because MEM fluid will oxidize enough copper and zinc to be cytotoxic. The failed cytoxocity of a brass connector in a gas path is not meaningful, however, because air cannot dissolve metals to carry them to the patient. The new international standard, ISO 18562, addresses gaps such as these by recommending alternative test methods to evaluate the risks mentioned within the broader context of ISO 10993. Endpoints recommended by ISO 10993 Consider, for example, an oxygen concentrator, which enriches the oxygen concentration in air through the use of a synthetic zeolite material. The device’s materials have permanent, external communicating exposure to the patient (though none of the materials physically contact patient tissue). The following endpoints must be addressed, according to ISO 10993-1: • Cytotoxicity; • Sensitization; • Irritation; • Acute systemic toxicity; • Material-mediated pyrogenicity; • Subacute toxicity; • Genotoxicity; • Implantation; • Chronic toxicity; • Carcinogenicity. Addressing the endpoints recommended by ISO 10993 for devices like an oxygen concentrator is challenging using traditional methods. For example, how does one implant a complex machine into an animal? The relevance

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of toxic effects from a direct cell or liquid extraction of an oxygen concentrator is questionable when the toxic materials may not be transferred via a gas pathway. In an oxygen concentrator, zeolite is in the gas path and has a violent exothermic reaction with aqueous solutions. It is not surprising that this would kill cells, and at the same time, it is equally not surprising that this test would be irrelevant. ISO 18562 addresses the incompatibility between the methods of ISO 10993 and the goal of proving patient safety using a risk-based approach. The only way dry gas devices can communicate risk to the user is through the gas itself; therefore, analytical testing should focus on the gas with the aim of providing data of sufficient quality for toxicological risk assessment. Dry gas is expected to be capable of carrying volatile organic compounds (VOCs), particulates, and in special cases, inorganic gases. All of the toxicological risks related to these classes of devices are expected to be addressable by understanding VOCs, particulates, and (if applicable) inorganic gases. Testing worst-case conditions for VOCs and particulates Worst-case for VOCs must be viewed within the context of the laws of diffusion. The total amount of volatiles released by device materials is independent of the gas flow rate, being solely determined by the diffusion of the volatile through the device material. The rate of diffusion depends on the intrinsic properties of the material, the volatile compound and the temperature. Therefore, the worst-case temperature is the highest clinically relevant operating temperature for the device. The worst-case flow rate is the lowest that is clinically relevant, as this will result in the highest concentration of VOCs per volume of gas passed on to the patient. To understand worst-case conditions for particulates, consider their source. The primary source of particulate matter in gas-path devices is residual dust from the manufacturing and packaging processes. This particulate material is expected to blow out of the device during the first few seconds of operation. The friction of moving parts also generates residual dust.

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11/21/18 11:02 AM

Pre-clinical medical device testing under ISO 10993-1 and the MDR

A toxicologist using worst-case clinical conditions should measure and assess the biological risk of VOCs and particulates released by a device per ISO 18562. For VOCs measured in a dry gas path, these conditions are the maximum operating temperature with minimum relevant flow rate. For particulates, it is maximum flow rate to blow out residual dust. ISO 18562 offers a commonsense, risk-based approach to medical devices with external communicating gas path contact to patient tissue. To conduct a robust study, use sampling parameters that capture all possible clinical conditions in which the device could be used. Selecting a relevant high temperature and a low flow rate for VOCs and a high flow rate for particulates will help accomplish that goal. M Matthew Jorgensen is a chemistry and materials scientist. Erin Bakes is an associate extractables & leachables specialist. Robert Mueller is a chemistry project coordinator. They serve on the technical consulting team at Nelson Laboratories.

In today’s changing regulatory landscape, it’s more important than ever for medical device manufacturers to understand the nuances of pre-clinical device testing. Here are the implications of recent and pending regulatory updates, why extractables and leachables testing is more important than ever before, and how you can begin assembling the right team of testing experts to ensure your product portfolio complies. Sandi Schaible W u X i A p p Te c

With changes to ISO 10993-1 and the introduction of the Medical Device Regulation (MDR) in the European Union, chemical testing has become more important than ever to support a medical device’s safety for market. Medical device manufacturers can no longer rely on biocompatibility testing alone to obtain regulatory approval. ISO 10993-1 has placed added emphasis on the importance of developing a robust physical and chemical device profile, and the likelihood that an extractables and leachables (E/L) study will be necessary is high, especially for products with prolonged or long-term exposure and/or products that are in contact with circulating blood. Regulators will be looking for extraction conditions that demonstrate a device has been challenged. This means using aggressive solvents representing a wide range of polarities, elevated temperatures and extended timeframes. Equally important is ensuring that all chemicals from analytical equipment are identified. Unknown chemicals in a chemistry report mean the chemistry lab has not done their job. If study design and execution are not robust, and all chemicals have not been identified, be prepared to justify why and anticipate that repeat testing may be necessary. In order to keep existing devices in good regulatory standing and get new devices to market as seamlessly as possible within the guidelines of ISO 10993-1 and MDR, it’s crucial to dot your I’s and cross your T’s. Given the high volume of devices being evaluated and looming regulatory deadlines, one misstep could result in an avalanche of consequences. Preparing internally Before beginning work with a contract research organization (CRO), internal due diligence is necessary. Start with a review of all the testing data or materials data you have for your product. For materials data, include details on polymers, colorants, adhesives, additives and

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VALIDATION & TESTING

manufacturing aids. Using this data, you and your CRO team can determine if a gap analysis should be performed before testing begins. A gap analysis provides a comprehensive review of pre-existing data to identify what additional information is necessary to comply with current ISO 10993 standards and regulatory expectations. Partnering with a CRO Selecting a CRO with expertise in complete chemical characterization is critical. Full characterization of all chemicals is required for an accurate assessment of risk, and unknowns must be treated as worstcase scenarios, evaluated as if they are assumed to be genotoxic or carcinogenic constituents. Toxicologists should assess each chemical in an E/L report to establish a margin of safety and identify whether further testing or analysis is required to mitigate risk. The results from toxicological risk assessments should be used to guide which biological tests should be performed. Up until recently, CROs could get by with relying on biocompatibility testing. With ISO 10993-1 updates, this will no longer be the case. Beginning with biocompatibility testing is not best practice. Complete chemical characterization informs which biocompatibility tests should be conducted. Vetting CROs: Five questions to pose Before you sign an agreement with a CRO, there are some key questions you should ask to determine if they have the robust capabilities necessary to keep your company ahead of the curve in this changing regulatory climate. 1. Do you have the capabilities to conduct chemical characterization, toxicological risk assessments and biocompatibility testing in-house? 2. How often do you report unknowns? On average, what percentage of compounds in your reports are unknowns?

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3. Are your analytical methods sensitive enough to detect constituents at a level low enough to be properly evaluated in a risk assessment? 4. Can you demonstrate a longstanding track record of successful submissions to regulators? 5. What kind of post-submission regulatory and technical support will you provide?

Sandi Schaible is the senior director of analytical chemistry at WuXi AppTec, a global pharmaceutical and medical device company. She specializes in extractables and leachables studies. Sandi is a U.S. delegate and international delegate for ISO 10993 part 18 in chemical characterization. She is also a U.S. delegate for ISO 10993 part 13 and the particulates committee.

Also, because chemical libraries are not commercially available for all types of chemical testing, specifically liquid chromatography mass spectrometry (LCMS), it is important to work with a CRO that has a proven track record of complete identifications and that the identification is included in your study â&#x20AC;&#x201C; not an extra step with an additional expense. Recent and pending regulatory changes may seem daunting, but with thoughtful planning and partnership, you can avoid costly regulatory delays. While not a comprehensive roadmap to navigating ISO 10993-1 and MDR, these tips can get you started down the right path. M

Image courtesy of WuXi AppTec

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11/21/18 11:03 AM

DEVICE TALKS

How a teenage Gary Guthart, Intuitive Surgical’s CEO, got his start at NASA

Brad Perriello | Executive Editor |

Today Gary Guthart is best known as the CEO of Intuitive Surgical, the world’s leading medical robotics company. But robot-assisted surgery wasn’t Guthart’s first love, he told Medical Design & Outsourcing ahead of his keynote appearance at this year’s DeviceTalks West event next month. That honor goes to NASA (or, more properly, science). During his teenage years growing up in Sunnyvale, Calif., Guthart told us, he landed a job at the space agency that helped shape the course of his life. “I was a shy kid and a good math student. It turns out I had a knack for math,” Guthart recalled. “Then, my senior year of high school, a calculus teacher said, ‘Hey, I am going to sign you up for an internship.’ He actually signed me up without telling me. “I wound up in a human factors research lab run by a woman named Sandra Hart. I wrote software for evaluating the performance of combat pilots when under stress,” he said. Guthart never looked back, he added. “I decided, ‘I can’t believe I get paid to do this.’ I got to ride my bike onto, it was at that time a Naval base and a NASA base, so I had a little security clearance and rode through the little armed gates and got to watch experimental aircraft fly in and out of the base and meet shuttle pilots – and all as a teenager,” he said. “I thought, ‘I am in. That is it. I don’t care what else I am doing, but if I get paid to do this, this is the best job in the world.’ So that was my entry into science.”

After a nine-year stint in academia, during which Guthart earned a PhD in fluid mechanics, he landed at an applied research lab at Stanford Research Institute when a chance encounter at a basketball game put medical robotics on his radar. “While I was out at SRI, I would play basketball over lunch every lunchtime on the SRI basketball court. It was a good game, it was full, and I am standing on the sidelines (because I wasn’t a great basketball player) and I am starting with the person next to me, and he said, ‘Do you know anything about this kind of non-linear math, I am struggling with this surgical robot I am trying to make?’ That is how I ran into surgical robots,” he told us. M

‘I AM IN. THAT IS IT. I DON’T CARE WHAT ELSE I AM DOING, BUT IF I GET PAID TO DO THIS, THIS IS THE BEST JOB IN THE WORLD.’

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