Medical Design & Outsourcing - NOVEMBER 2019

www.medicaldesignandoutsourcing.com NOVEMBER 2019

2019

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Medical Design & OUTSOURCING

USP Class VI Approved Silicone

medicaldesignandoutsourcing.com ∞ November 2019 ∞ Vol5 No6

E D I T O R I A L EDITORIAL Executive Editor Chris Newmarker cnewmarker@wtwhmedia.com @newmarker Managing Editor Nancy Crotti ncrotti@wtwhmedia.com Senior Editor Danielle Kirsh dkirsh@wtwhmedia.com Assistant Editor Sean Whooley swhooley@wtwhmedia.com Editorial Director DeviceTalks Tom Salemi tsalemi@wtwhmedia.com

VP Lifesciences Mary Ann Cooke mcooke@wtwhmedia.com 781.710.4659

S T A F F

DESIGN & PRODUCTION SERVICES VP of Creative Services Mark Rook mrook@wtwhmedia.com @wtwh_graphics Art Director Matthew Claney mclaney@wtwhmedia.com @wtwh_designer Graphic Designer Allison Washko awashko@wtwhmedia.com @wtwh_allison Graphic Designer Mariel Evans mevans@wtwhmedia.com @wtwh_mariel

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HERE’S WHAT WE SEE

What's keeping you up at night?

V

isiting many of the big medical device companies around Minneapolis-St. Paul this year, I frequently asked a question a previous boss liked to use with sources: What’s keeping you up at night?

There were the usual complaints of difficult contract manufacturers or the need to stay on top of potential innovations. But there were two specific items I heard about constantly: worries about the future of ethylene oxide sterilization and the scramble to make the upcoming May 2020 deadline to comply with the European Union’s new Medical Device Regulation (MDR).

Medical Design & Outsourcing has you covered on both of those issues in this year’s Medical Device Handbook.

My colleague Nancy Crotti has been churning out multiple stories a week for MDO about medtech’s EtO crisis. In the Handbook’s sterilization services section, she summarizes where things are currently for medtech’s mostused sterilization method.

“While the FDA has sought input on ethylene oxide alternatives, the EPA holds the power to control its use,” Nancy said.

The Handbook also has a number of articles about the MDR: • The MDR’s Direct Part Marking (DPM) requirements challenge manufacturers of small-part and orthopedic devices to use the entirety of a part’s complex surface geometry for labeling, according to Dwalin DeBoer at Mack Molding.

• Medical device companies need to strategically shift their business models in order to succeed under the EU regulatory reforms, said David Novotny and Angela Brown at Icon.

• Joseph Tokos at WuXi Medical Device Testing explains how device companies need to make the most of their lab testing partnerships as they prepare for the MDR. Whether medical device developers are new to, say, catheters, motion control components or tubing, the roughly 50 articles in this issue should help them dip their toes into these areas. Our goal is to provide useful information, versus marketing pitches, from the medical device designers, outsourcers and consultants serving our community.

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Wrapping up this issue’s editorial, I’d like to note the end of an era at WTWH Media’s Life Sciences business, as executive editor Brad Perriello moves on to new opportunities.

Brad co-founded MassDevice with Brian Johnson, who is now president of the Massachusetts Medical Device Industry Council (MassMEDIC).

Since 2009, MassDevice has been the online journal of the medical device industry, with hourto-hour coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.

Brad and Brian’s recipe for success at MassDevice was simple: Produce solid daily journalism for an industry that needs it. As the new executive editor, I am honored to continue in their footsteps as we produce news and insights that matter in the medical and life science industries.

We are also fortunate to be part of a hardworking and innovative company, Cleveland-based WTWH Media, which over a dozen years has grown into a business with tens of millions of dollars in annual revenue.

Additionally, we have promoted veteran business journalist Nancy Crotti to managing editor of Medical Design & Outsourcing and Danielle Kirsh to senior editor.

And we welcome Sean Whooley to our team as assistant editor. Tom Salemi, previously content director for The MedTech Conference, joins us as editorial director for DeviceTalks.

Expect even more great coverage from our medical device team in the future.

Chris Newmarker | Executive Editor | Medical Design & Outsourcing | cnewmarker@wtwhme di a .c o m |

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CONTENTS

medicaldesignandoutsourcing.com ∞ November 2019 ∞ Vol5 No6

• • • • • THE MEDICAL DEVICE HANDBOOK

INSIDE

the Medical Device Handbook 6

HERE’S WHAT WE SEE

44

MACHINING

How LaserSwiss can solve

What’s keeping you up at night?

engineering challenges

12

48

Developing catheters and

Making wearables and

CATHETERS

MANUFACTURING

minimally invasive surgical

microfluidics manufacturable;

devices

Solving tough automation challenges; The case for

16

CONSULTING

90

REGULATORY, REIMBURSEMENT, STANDARDS AND IP

Medtech product liability and IP;

Succeeding under the EU’s MDR; Specification developers

96

SOFTWARE

single-source medical device

Safety and security; Software

manufacturing; Ultrasonic plastic

prototypes feeding your quality

welding; Thermoelectric coolers;

system; Cloud-based product

Understanding both feasibility

EU MDR and labeling; Going

design tools

and usability

paperless; Speeding a device to market; Avoid medtech

20

packaging blunders

DESIGN SERVICES User needs and product

requirements; Extended reality; Medical device miniaturization;

66

MATERIALS

Aluminum anodizing; A

Design pitfalls around

hydrophilic coating for vascular

miniaturization

catheter innovation; Kolsterising

30

72

DRUG DELIVERY

Connected health optimizing patient and provider experience

MOLDING

Considerations for rubber medical parts; Reel-to-reel insert molding; Thermoplastics for

34

ELECTRICAL COMPONENTS

Smaller is better – but also

trickier; Have the right sensor for your medical IoT job

38

Microhydraulics

40

HIGH PERFORMANCE POLYMERS

STERILIZATION SERVICES

The fate of ethylene oxide

sterilization

104

TUBING

Geometric transition extrusion

108

VALIDATION AND TESTING

medical device injection molding;

Medical device package

High-consistency rubber versus

validation; Making sure an active

liquid silicone rubber

implantable device will pass

80

MOTION CONTROL COMPONENTS Titanium alloy springs; Ironless

FLUID POWER COMPONENTS

102

linear motors and MRIs; Lowspeed precision velocity control

86

RAPID MANUFACTURING

FDM printers; Binder jetting and

debinding

regulatory muster; Succeeding at medtech package validation; Biocompatibility sample preparation; Getting the most out of your lab partnership ahead of the EU’s MDR

116

DEVICETALKS

After 20 years at Boston Scientific, here’s what this medtech R&D leader has learned

120

AD INDEX

High-consistency rubber;

Transparent ABS resin versus polycarbonate

8

Medical Design & Outsourcing

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CATHETERS

How to develop catheters and minimally invasive surgical devices Developing innovative catheters and minimally invasive surgical devices is hard.

These strategies spur inventive solutions and unlock the path to success.

Don Baumgarten Product Creation Studio

M

inimally invasive surgery (MIS) offers compelling benefits compared to traditional open surgery, such as faster patient recovery, reduced risk of infection and lower healthcare costs. To improve MIS capabilities, medical device companies are continually working to advance catheter and device technologies and bring new products to market.

Developing those innovative products is a formidable task. By their very nature, MIS devices have small working elements, which greatly complicates development. The miniaturization of mechanisms, electrical modules and diverse technologies is technically difficult work.

Engineering teams can quickly find themselves facing seemingly impossible challenges. Here are a few strategies to make inventive breakthroughs possible in these difficult development efforts: Generate a wide variety of solution options An engineering team can encounter numerous technical challenges when developing new features and functional capabilities for MIS devices. A common pitfall is to quickly focus on the first clever idea proposed to solve a new problem. Rarely will the first good idea turn out to be the fastest to develop and have the best performance and lowest manufacturing cost. Worse, the development team can hit a dead end if the concept turns out not to meet functional requirements or if the manufacturing cost is too high.

It’s better to generate a wide variety of solution concepts for significant technical challenges because the expected development time, level of performance and manufacturing cost can vary greatly among concepts. The team will also have options if a favored idea doesn’t pan out, and might actually discover a concept with the potential to work better than others for a lower manufactured cost.

How can a team generate such an ingenious idea? Effective brainstorming sessions stimulate team creativity and often produce inventive ideas not previously considered. Use these sessions when substantial technical problems arise. The

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Minimally invasive knee surgery

iStock photo courtesy of Product Creation Studio

time needed to conduct a brainstorming session is minor compared to overall development time, and this type of focus is often the key to generating creative, breakthrough ideas.

Investigate multiple concepts After creating and assessing a variety of concepts, it can be tempting to commit to a favorite idea before it’s actually been proven to work. Selecting a single concept too early adds substantial risk to the development effort because technical designs don’t always function as expected. Even promising concepts can ultimately fail.

The unusual physical characteristics of MIS devices and unique surgical applications make the performance level of technical concepts hard to predict. A concept can perform much better or worse than expected. The more novel the concept, the less predictable the outcome.

With that in mind, it’s best to investigate several leading concepts to give the team options if a preferred concept is not viable.

Building and testing proof-of-concept prototypes for the best ideas enables the team to make informed comparisons of functional performance, development risk and manufacturing cost before choosing a single concept.

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CATHETERS

Use large-scale prototypes The unique development challenges presented by catheters and MIS devices often necessitate a relatively high number of prototype design-build-test cycles to achieve the desired function. Building prototypes at actual size (1:1 scale) can be time-consuming and expensive because the unique components, such as catheter sheaths and minuscule parts, must be ordered from highly specialized suppliers.

The cost and schedule needed for design iterations can become untenable.

It often works well to conduct initial design iterations using large-scale prototypes. Iterations can be much faster and less expensive at 2:1, 5:1, or 10:1 scale because components can generally be fabricated using standard machining and manufacturing processes or 3D printing or by modifying off-the-shelf components. The goal is to solve as many functional issues as possible at the larger scale to minimize the number of design iterations needed at actual size.

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Catheter sheaths and other highly specific components can be approximated at larger scale, although some properties of those components cannot be readily duplicated. Even with those limitations, the quick learning made possible by largescale prototypes is extremely valuable.

Be strategic to be innovative Teams must overcome numerous technical challenges to bring new catheters and minimally invasive devices to market.

Using deliberate strategies to tackle these difficult development efforts can enable your team to make the breakthroughs needed for project success.

Don Baumgarten is director of mechanical engineering for Product Creation Studio. He has participated in the design and manufacture of medical devices for startups to Fortune 500 companies, including Philips, Boston Scientific, GoPro, Pathway Technologies and Intellectual Ventures.

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CONSULTING

Why you need to understand both feasibility and usability Innovative medtech requires an understanding of feasibility and usability.

In other words, you need to figure out “fusability.”

Jeff Champagne MPR Associates

C

reating a new disruptive medtech product is never easy. Whether as part of a large multinational or a two-person startup, from the beginning, the odds are stacked against your success. How can you improve your probability of a positive outcome?

The key is to find ways to reduce your risk of failure. Try looking at the development as process as opposed to a result, a voyage as opposed to a destination. A risk-based approach to the process looks at all the things that could possibly go wrong, ranks those risks and then develops a plan of action to ensure that those things never happen. An objective of this plan is to prove “fusability.” This convergence of feasibility and usability helps to reduce risk while compartmentalizing the challenges.

Breaking it down into the key components, fusibility includes a number of dimensions: •

16

Market feasibility – What is the unmet need and is there a viable market for the product?

The solution to the unmet need must provide compelling value for the relevant stakeholders. Are there incumbent players or technologies that stand to be disrupted and might put up barriers?

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•

•

•

•

Clinical feasibility – Has the product been proven to improve outcomes and lower costs? Does its use fit within the framework for current healthcare delivery? Does it fit within (or better yet, improve) the workflow/ workload for clinicians?

Technical feasibility – Have the necessary technology solutions been proven? If not, what are the risks associated with development of those solutions?

Commercial feasibility – Has the business model been defined with a clear path to revenue? Is there a clear path for reimbursement? Who is the customer and how is the device purchased?

Organizational feasibility – Does the team have the skills and experience to win? Investors don’t care where your MBA is from or how many PhDs or MDs you have on your team. Having a team member who has been all the way through the gauntlet, successfully launched and had an exit is sacrosanct. The entrepreneur is “the jockey” and the technology is “the horse.” You can’t win if either is faulty

Answering these key questions requires identifying all stakeholders and what they value, de-risking technical “big rocks” and understanding the requirements for the ideal product construct.

This is an iterative process, and finding the best solution to an unmet need is as much about poking holes in all of the assumptions baked into your plan as it is about the technical engineering of a solution. It’s important to start with the end in mind but recognize that there are many ways to solve the problem, and as new information is learned, the concept will need to adapt. There is a reason the NSF iCorps program makes would-be entrepreneurs interview hundreds of people. Many seemingly disparate points of view must be considered before a winning product can be ideated never mind realized.

Here are some useful tips to keep in mind about developing a medtech product:

www.medicaldesignandoutsourcing.com

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CONSULTING

Don’t fall in love too fast No matter what you do, make sure you resist the urge to fall in love with your product too soon. The blindness this infatuation creates can be impenetrable to objective critique.

You’ll have plenty of time to admire your creation when it’s on the market. First make sure that you have created the right product.

Develop a ‘vertical slice’ When it comes to engineering emerging technologies, most of what we see as new is simply a convergence of existing technologies with some new enabling piece of the puzzle. But just because something works well in some scenarios does not mean that it will converge as planned.

Try thinking of a proof of concept demonstration as developing a “vertical slice.” According to Craig Mauch, our director of product design, a vertical slice is the integration of all the functioning components of a system acting as a system to accomplish a task. It may not look like the final product but it is critical to proving that

each component of the solution can work together. The vertical slice provides early feedback and avoids “surprises” later on that often occur when this advice is not heeded.

Most people consider the technical specs on off the shelf components as tried and true. But when operating as part of a larger system they may not be up to the task. One example of this could be power consumption for a component.

Under normal circumstances specs may represent actual performance but when daisy chained together with constraints and less than optimal conditions, performance could be skewed.

Ignore human factors and usability at your own peril The human factors aspects of a product should never be an afterthought. For a medical device, applying usability engineering principles to reduce the risk of use error is a required part of the process, but it is not sufficient to create a great product. Developers need to have

empathy for the user which means having an appreciation for their capabilities and limitations based on their education, backgrounds, working environments, stress level, medical condition, etc.

The sooner you can get physical prototypes into prospective users’ hands the better, as you often discover unexpected results in the ways people interact with things. This should an iterative process that is done early and often so that user feedback can be incorporated as the design evolves.

When done effectively, the usability process also answers some of the feasibility questions and yields products that fit seamlessly into the life of key stakeholders, are easily adopted by all stakeholders and provide value to each, solving pains and providing gains, all while outperforming the status quo.

Keep these concepts top of mind in each approach and you’ll surely increase your chances of success.

Jeff Champagne is director of business development at MPR Associates.

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DESIGN SERVICES

Connecting the dots: User needs and product requirements Using the tools of design discovery can help your company capture user needs and build better products.

Bill Welch Tr i p l e R i n g Te c h n o l o g i e s

A

ll product development teams have one thing in common: the desire to just get started. Especially when coupled with pressure from investors and management, it’s very tempting to shortcut design inputs and let the development teams start on something. It’s not hard to imagine how this leads to problems later. Typically, when teams are rushed, issues that could have been identified early are discovered later in the process, when design and engineering changes are extraordinarily costly.

One of the most important starting exercises for any development effort is to identify and create a list of user needs. These documents provide important insights into product requirements and help to identify potential problems early-on.

It’s a good idea to start with marketing requirements and these key documents: • • •

List of actors and roles.

Workflow analysis.

Journey map.

Together, these documents provide a clear framework for analysis and a roadmap that enforces discipline in the process. If done correctly, the benefits include: • • •

Image courtesy of Triple Ring Technologies

20

Making sure user needs are properly represented in product requirements.

Identifying gaps in the marketing requirements document.

Providing a foundation for user experience (UX) designers.

Imagine you have been asked to develop a handheld diagnostic device that will be used by surgeons in the operating room.

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The company’s engineering team will probably already have made assumptions about how the product will be used. The company may have also hired a design firm to create product renderings. Jumping the gun on both of these activities tends to integrate early assumptions and may lead a team off course.

Before development begins, it is important to take a step back and reevaluate all of these assumptions. User needs should come from the user — through site visits, focus groups, voiceof-customer surveys, customer interviews, user studies and recorded observations.

Here are four processes that are especially important: 1. Market requirements The market requirements document (MRD) will have different names in various organizations, but the core principles are the same: Why does the product exist, and what features and cost targets are needed so it can be successful? A product manager or someone in a business role usually writes the MRD, which can range from one to 50 or more pages. It should include: • Key product features.

• Target sales price.

• Approximate sales volume per year and product lifetime.

• Sales method.

• Target customers.

The MRD should focus on highlevel features that might be seen in a brochure. Avoid constraining the team with how the features will be implemented, and leave out specifications. The developers will figure out how a feature will be implemented, or how a cost target will be met.

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2. Actors and roles Next, focus on the users by creating the list of “actors” (users) and “roles” (how they use the product).

This is a comprehensive list of every person who will ever be in contact with the product. The more comprehensive, the better. Because our fictitious handheld device is used in the OR, it will have a long list of actors. Include the surgeon, patient and the full OR staff. If needed, add a salesperson for the demo mode. Also consider the assemblers in the factory, service and repair staff, the hospital’s biomedical engineer and central processing staff, etc. Next to each one, include a brief description of their role.

3. Workflow analysis Diagramming workflow is a crucial step and can take the form of a flowchart or a narrative text document. Describe every step of each user’s interaction with the product.

For example, during a recent workflow exercise, our team was focusing on the surgeon’s workflow within the sterile field. The original design of the device we were provided included a button that the surgeon or nurse could press to interact with the device during surgery. We determined through

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workflow analysis that it was possible to eliminate the button and replace it with an IMU (inertial measurement unit) or motion detector. This insight resulted in several significant benefits: reducing product cost and complexity, potentially reducing user errors, eliminating an ingress point and improving the user experience.

The act of writing down the steps in a workflow analysis will produce insights and discoveries that can improve the product and identify potential issues early.

4. Journey map The journey map documents the physical movement of the device and its accessories through the usage environments. Typically, a journey map is a single page diagram with a line that connects locations where interactions happen with a device. If the product is a one-time-use device, the journey map is likely to be a straight line, beginning on the left with the initial interaction point, flowing through to the right, where the product is moved to the point of use and ultimately disposed of.

In the case of our fictitious handheld device used in the OR, assuming the device is durable and designed for repeated uses, the journey map will include a loop in which the product will flow from central storage to the OR, to processing where it’s cleaned, then back to central storage. If a durable device also requires an accompanying sterile disposable component, the journey map will be a combination of a straight line (disposable) and a loop (durable), meeting in the OR. Just as with the workflow analysis, the journey map will uncover new insights that will lead to a solid list of product requirements. For example, if a durable device needs to be cleaned and sterilized in central processing, the method and chemicals used in cleaning will need to be considered. This often affects the mechanical construction of a product housing, including parting-line location as well as determining which ingress protection (IP) rating is needed.

Key take-aways 4.875”

It’s very common for companies to want to skip these “soft” processes and just get to work on making a new device. Even for teams within large companies, there is pressure to go fast and show results. What’s equally common is development teams becoming victims of feature creep, or to getting stuck along the way because they try to fill in the blanks after getting started, especially in the validation stage.

It’s going to save money in the long run to invest the time up front to fully understand and properly capture what your users really need. Connect the dots between user needs and requirements as early as possible.

Bill Welch is director of product design for Triple Ring Technologies.

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How XR is boosting medical device product development The medical device industry is increasingly adopting ideas and technologies from the consumer market. Extended reality (XR) is a key contributor to this evolution.

Jason McGovern Kaleidoscope Innovation

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efinitions of current technologies are evolving, but extended reality (XR) can be described as an umbrella term used to broadly describe technologies including virtual reality (VR), augmented reality (AR) and mixed reality (MR).

How XR can benefit medical device development Extended reality can be used throughout the medical device development process, ultimately speeding up the creation and testing of the product.

Additionally, XR can contribute to more flexibility in collaboration. It allows for teams in different physical locations to still build and work together.

Further, XR in the medical device development process can also help enable more efficient user feedback during research and testing.

For example, virtual store simulations are an efficient way to gather user feedback in the consumer market. Historically, shelf space layouts were tested through actually building physical shelves. Working in the physical space takes time to move the various products to different places on the shelves between tests, and it also takes users’ time to wait while items are moved. On the other hand, with the virtual store layout, users can walk through a totally different layout within seconds.

This same principle is true in medical device development. For instance, virtual feedback can inform changes to the ergonomics of a device and the surgical suite in a more efficient way before testing in the physical space.

How XR can benefit end-users Training When it comes to medical devices, virtual procedural training could help improve overall performance and speed.

Extended reality provides opportunities for students, young physicians, etc. to participate in more practice scenarios than would normally be the case. Certain procedures or opportunities are extremely difficult to set up and execute. With the “magic” of XR, these rare offerings are now available with a click of a button. Practice is crucial to perfecting medical procedures, and XR is one way for clinicians to refine their technique. www.medicaldesignandoutsourcing.com

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Photo by Stella Jacob on Unsplash

Patient experience Beyond device development and training, XR can be used to benefit the patient’s experience by pulling from the consumer and gaming industry’s focus on XR as an entertainment vehicle.

Hospitals could adopt VR entertainment as a playful distraction for children undergoing a stressful procedure. Virtual reality is already being explored for use in psychiatric care, such as the treatment of phobias, and for an analgesic effect.

Another way to enhance the patient experience is to draw from what Disney is doing in its theme parks. The Happiest Place on Earth is using AR to engage families while they wait in line for rides. Now imagine applying that to a pediatric hospital setting where families are waiting in the lobby.

And there are still more ways that XR could be incorporated into the user’s experience. For instance, physicians could virtually walk the patient through what a procedure would entail using XR visuals, as opposed to simply explaining it with “doctor jargon” and trying to translate that into layman’s terms.

XR watch-outs While there are numerous reasons to start implementing XR as part of the medical device design process, there are also some watch-outs.

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to be developed). That’s why product development teams should also have access to wet labs, as medical device development can benefit from the advantages offered in both virtual and real-world environments.

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The perfect time Now is the time for medical device companies to invest in XR — both to help in the development process and to incorporate XR into the end user’s experience. Ten years ago this technology was gimmicky, five years ago it was expensive and inaccessible, and now it is on the cusp of transforming the medical landscape.

Imagine where the technology will be five years from today and how the medical industry could change, adapt and grow with it.

Jason McGovern leads the software development team at Kaleidoscope Innovation, where he manages his team’s production of immersive VR and AR experiences as well as other interactive products for clients. Prior to joining Kaleidoscope, Jason worked for The Walt Disney Co. in its Disney Interactive division and for Jakks Pacific as a lead producer on its video games and interactive toy products.

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Medical device miniaturization: How to think of human scale Shrinking medical technologies could improve patient quality of life.

But don’t overlook the challenges that come with medical device miniaturization.

Mike Johnson, Jason Phillips and Mark Burchnall Stress Engineering Services (SES)

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ailure analysis projects of miniaturized medical devices provide an important lesson: Design solutions need to be customized for the application.

Datasheets and other vendor literature may not provide the accurate picture of a component’s material properties at a miniaturized scale. Material properties of components may change as the size of components approaches the grain structure size and require custom processing to get to the final component construction. Custom component-level bench tests need to be completed to fully understand that component’s performance against its intended requirements. We’ve often seen such challenges in sealing, assembly features, electrical components and mechanical manipulation components in miniaturized assemblies.

Sterilization techniques, sustained loading/strain, or manufacturing conditions can also affect medical device components in a miniaturized assembly.

At SES’s Force-4 medical device product development group — where we work — we’ve found the best solution is for the design process to begin with discovery and focus on the human context of the miniaturized device.

Our clients often ask us to make their products as small as possible so that they are better able to interact Photo courtesy of istockphoto.com with patients and

improve quality of life during use. Our approach to medical device miniaturization at Force-4 starts with understanding the environmental requirements that our clients are trying to achieve as well as empathy for user experience. (Are they a consumer, user, patient or caregiver?)

Often the driving reason for miniaturization is the interest of achieving a better human interfacing device. Whether the device is worn or in the skilled hands of a surgeon, the interaction of human and machine is critical to the design vision. Force-4, through Human Performance Research (in partnership with the AFRL, WPAFB, Human Performance Directorate), has developed design strategies that guide miniaturization and its human integration vision.

Miniaturization and human integration tend to occur on a continuum of four stages: •

•

•

•

Component integration — making a device fit to human scale, either wearable for transport or able to be grasped for manipulation. (Smart watches, backpack heart-pump, CF vests) Streamlining —the evolution of a device to become even further integrated into the human form factor with less bulk, greater mobility and more dexterity. (Insulin pumps, multi-feature handheld surgical devices, eyewear with built-in headphones) Hybridizing — taking advantage of a closer and less easily separable connection to the body, which speeds information to the senses, heightening performance. (Artificial pancreas, implanted chips, ocular implants, exoskeletons, prosthetics) Remote integration — furthering capability with accessible features and functionality untethered to direct human-centered form factor. (Robotic surgery, UAVs, IOT sensors)

When planning a miniaturization strategy, it is important to consider the level of needed integration and think of form factor with an eye toward some degree of elasticity. Namely, how can form change and remain effective in the event it needs to be somewhat larger or altered in geometry? The ultimate solution could amount to a combination of the above strategies.

Additionally, the ability to manufacture the device often comes into effect. Miniaturization 26

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can significantly challenge traditional methods of manufacturing and automation. It is important to pull in manufacturing expertise during the design process to ensure planning and early technology selection. That includes considerations of challenges such as material handling for assembly and final packaging. Issues typically resolved later in the project need to be well thought out early on with experienced personnel to ensure design outcomes are necessary. At Force-4, we focus on our systems engineering to ensure we have collaborated concurrently throughout the design.

There are also final considerations associated with cost. One needs to consider the total cost of the device, regardless of the product lifecycle, if a viable product is being taken to market.

In summary, design for miniaturization is driven by the need for devices more highly in-tune with the human form and surrounding

environment; this progress will always challenge manufacturing and necessary automation. For Force-4, the challenges around medical device miniaturization mean thinking inside-out and outsidein — and understanding the implied micro-to-macro relationship of a device’s interaction with the user. Force-4, as a subsidiary of Stress Engineering Services, now completes full product development, sustaining engineering and equipment development as it continues to leverage SES’s strong history in failure analysis and physicsbased predictive design analysis. We merge vision for the human scale and the technical foresight to achieve the supporting miniaturization goals.

Mike Johnson is director of product development, Jason Phillips is manager of industrial design, and Mark Burchnall is senior associate engineer at the Force-4 subsidiary of Stress Engineering Services (SES).

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Medtronic’s Micra leadless pacing system is an excellent example of miniaturization to the benefit of patients, according to David Fink at Ximedica.

Image courtesy of Medtronic

Medical device miniaturization: Here are the design pitfalls you need to avoid When it comes to medical device miniaturization, the usual design risks still apply.

David Fink Ximedica

T

he rapid increase of miniaturization in medical device development is undeniable as medtech companies seek new ways to improve patient outcomes and overall healthcare quality.

A broad array of technology advances in consumer electronics, semiconductors, sensors and material science has driven the creation of the new miniature devices and systems, and the results have been extraordinary. Here are just a few:

more important than ever. The negative impact that design can play in device errors by users is well documented. Regulators globally are increasingly focusing on it, and medical device creators have increasingly realized that they need to change their product development processes.

Here are three areas of medical device product development that especially need improvement now that devices are undergoing miniaturization:

•

1. Not taking human-centered engineering into account Human-centered engineering and all its components of human factors, usability and risk assessment must now be embedded in the device development process — ideally from early concept development through the various phases of development.

The size may be much smaller, have greater functionality and markedly reduce the cost of a potential treatment. But if it does not consider the end-user, the risk of adoption and use error increases. Ideally, at the inception of the development program, the design team will be including not only the technical and manufacturing challenges of miniaturization but who will be using the product, how will it be used and where.

Think of what’s going on in the wearable devices field. Consider that many of these wearables will target an aging population. Older users may face problems of dexterity and peripheral neuropathy.

•

Medtronic’s Micra leadless pacing system is an excellent example of miniaturization to the benefit of patients, both in the treatment and delivery/ placement of that treatment. Running leads to the heart has been an Achilles’ heel for pacemaker systems; shrinking the pacemakers and placing them inside the heart appears to be the answer.

Wearables used to monitor health and wellness are another segment of devices that miniaturization is transforming. Smaller and more capable wearable sensor systems integrated into an effective connected health system could immeasurably improve healthcare.

While miniaturization and all that comes with it is a vital factor in new device development, it cannot ignore crucial aspects of form. Simply put, device miniaturization is not insulated from the usual design risks. In fact, it’s making attention to them 28

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MEDICAL

They may not be able to understand and interact with a user interface.

Knowing those issues early in the miniaturization development process could inform concepts that could be tested in formative studies with potential users. The results could enable adjustments resulting in an optimal interface and user experience.

It may be as easy as a more effective clasp mechanism for a wrist band for those with dexterity challenges or a simplified delivery system for an adhesive-backed miniature device.

2. Rushing toward ‘solutions’ Development teams often rush to potential design solutions early in a program based on experience or incomplete research at the risk of creating a significant use error that may or may not be identified later in the project. The adage of pay me now or pay me more later applies here as the expense in time and budget to remediate that error can be crippling. Too many innovative development programs fall prey to the drivers of a tight schedule to launch when in fact an early and objective assessment of risks to successful outcome can support prompt and effective corrections. Consider this issue in the context of timing in which early successful intervention may be an investment in weeks or months against discovering a significant use error late in the development cycle. Late-cycle design corrections can take months or years depending on the degree of change. Include the added cost in that discussion and significant compromises are often the result at the expense of a solid user-centered design.

3. Not doing the early work Discipline in documenting who will use the product — and it is frequently more than one use group — the anticipated steps (flow) of how the product or like-product may be used and the environment it will be used in is a high priority. In the overall timeline of a development project, this does not need to be a daunting task.

There are great tools available such as contextual inquiry of users and observational research of users in their anticipated use environment.

Executed well and objectively, these www.medicaldesignandoutsourcing.com

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activities frequently uncover unmet user needs that translate to a more effective miniature design. For example, observing targeted users in their environment frequently identifies workarounds with existing products that are not identified in an interview or discussion. Those can be translated into user needs with a resulting design that can avoid a significant user error. More importantly, that improvement leads to greater product acceptance and postlaunch revenue.

Design outfits and other outside companies that specialize in this area can be very helpful, especially if they conduct this activity from an unbiased view. These early activities are often viewed as too costly or too time-consuming. In reality, the early work, when done well, creates a solid foundation of understanding of who, how and where the product will be used.

That foundation informs much of the miniaturization concepting, design and verification activities that follow, including solid design decisions grounded in an understanding of end-use.

Identifying and correcting use errors early saves time and cost as opposed to later stages of verification or even post-launch.

The impact of miniaturization on device design will fuel dramatic improvements in the quality and cost of healthcare, to the benefit of patients globally. That impact will be accentuated with an effective, efficient and disciplined human-centered engineering practice woven into the miniaturization development process.

David Fink is VP of strategic development at Ximedica. Fink has more than 40 years of successful new product development experience in the medical device industry, ranging from early-phase research, strategy and business development through detailed design to commercial launch.

Prior experience includes more than 20 years at Covidien/Kendall, most recently serving as director of R&D, managing multiple development groups in the fields of cardiology, radiology, respiratory care and advanced wound care.

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Medical Design & Outsourcing

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DRUG DELIVERY

How connected health can optimize patient and provider experience Connected drug-delivery devices provide quantitative data on medication uses that may improve patient engagement and support the move toward value-based payments.

Iain Simpson Phillips-Medisize

H

ealthcare has become increasingly digitalized in the past decade, with the widespread adoption of electronic health records (EHR), connected devices in hospitals and laboratories, and smartphones and tablets to support healthcare professionals. At the same time, prescription medication — especially for patients with chronic diseases — is increasingly being taken at home rather than in the hospital, underscoring the need to explore and expand mobile digitalization to monitor adherence.

Fortunately, the widespread availability of lowcost connectivity such as Bluetooth and near-universal access to mobile technologies such as smartphones have opened the door to new opportunities in this arena. With smartphones already integral to most patients’ lives across the globe, the logical next step is to use them as tools to support both medication adherence and disease management.

A belief in the potential of connectivity to improve medication adherence through better usability, medication reminders, remote patient support and other features that support behavioral change has driven the development of connected drug-delivery devices. But, as the healthcare industry continues its march toward a value-based payment model in lieu of a volume-based one, the landscape is set to change.

Aligning patient, provider and pharma company needs with the healthcare reimbursement process is critical and probably best accomplished by shifting the focus from adherence alone to improving outcomes. But adherence is only one part of the story. A poor outcome for a therapeutic intervention could be a result of non-adherence and/or non-response. A step beyond value-based healthcare is recognizing that all patients are not the same, so prescribing the same dose to all may not be optimal. We need to move toward precision or personalized medicine, where treatment is tailored to individual needs.

Supporting outcomes-based payment In addition to providing a better patient experience, connected drug-delivery devices

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can generate reliable data in near-real time, allowing providers, payers and pharma companies to understand what works and what doesn’t. Healthcare providers can use medication usage data collected directly from devices and integrated with electronic patient reported outcomes (ePROs) and digital biomarkers to understand medication performance under real-world conditions as well as monitor treatment performance on

Phillips-Medisize brought to market a fully electronic auto-injector designed to track injection history and share treatment information with healthcare providers.

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individual and cohort levels. These data can also be integrated into EHRs, which help aggregate diagnostic data, prescriptions, treatment adherence and outcome measurements. These digital advantages provide a two-fold benefit: the ability to accurately support outcomesbased payment and to deliver more responsive, personalized healthcare.

Looking toward the future, smartphoneconnected tracking will monitor patient activity,

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sleep and other behavior to further quantify medication efficacy. In addition to supporting reimbursement in today’s value-based environment, these data can help healthcare providers better tailor and improve the effectiveness of their patient treatment plans.

Creating a win-win opportunity Trailblazers who are willing to invest in the development of innovative, connected drug-delivery devices have a unique opportunity to create a win-win situation for all stakeholders. As with any development project, the right partner is key.

Choose an end-to-end manufacturing partner who has an established track record in helping pharma and drug-delivery device companies speed time to market by streamlining design and production; who understands the unique regulatory requirements of the local market; and who offers a scalable connected-

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health platform that enables secure information-sharing and analytics and the flexibility to accommodate multiple therapeutic areas.

Evidence increasingly demonstrates that patients who use connected drug-delivery devices have high levels of medication adherence and persistence longer-term. Consistently high adherence adds value, since medications cannot help patients who don’t take them. Connected drugdelivery devices can play a critical role in reliably capturing real-world data on medication use.

These data can support better decision-making, more effective use of relatively expensive resources and improved reimbursement. When combined with patient-reported outcomes and digital biomarker data from wearable biosensors, they have powerful potential to improve outcomes and quality of life for patients living with chronic disease.

Iain Simpson is a director of front-end innovation at Phillips-Medisize. He has more than 25 years of experience in multi-disciplinary technology and product development, with an increasing emphasis on the use of devices and digital technologies.

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ELECTRICAL COMPONENTS

Smaller may be better, but can also be trickier and more expensive The trend toward shrinking technology has some high-level implications for the design and development of regulated medical devices.

Bill Betten Betten Systems Solutions

T

he shrinking of technology has certainly affected the world of consumer devices very directly, providing enhanced capabilities at relatively low prices.

Typical advantages include the ability to put more functionality into a smaller package, lower power, lower manufacturing cost and improved reliability.

While smaller technology has clearly benefited the consumer marketplace, it can translate differently into the regulated medical device world.

As in consumer products, shrinking the electronics gives medtech manufacturers the ability to pack new or improved features into a smaller volume. Capabilities and product performance will likely always remain a driver for integration, whether it be on a printed circuit board or an application-specific integrated circuit (ASIC).

must be able to dissipate the heat generated by electronics, making materials selection and cooling a critical concern, particularly for an implantable device. While materials selection is always driven by biocompatibility issues if in contact with the body, the need to address thermal management affects the packaging design as well.

Integration does improve reliability. Integrated circuits, interfaces and connections are common points of failure in discrete circuits, but they can be reduced to a metal layer deposited via a batch process with corresponding higher reliability.

However, as technology nodes continue to shrink, the defects inherent in the underlying silicon material can result in both short- and long-term failures.

Because medical devices put a premium on reliability and longevity, these factors can be important.

Balancing costs with volume The cost of integrating is lower as well, driven typically by the ability to make many circuits in one batch process. However, the upfront non-recurring engineering costs for developing an integrated circuit are quite high compared to PC boards with discrete components. While there are strategies for mitigating the upfront costs, design costs can reach $1 million and a mask set can cost in the $500,000 to $1 million range, depending on the process node selected. These costs can be easily amortized if spread over the millions of components for consumer devices but prove a challenge for the relatively low volumes of most medical devices unless the item is single-use.

The MEMS factor While much of this discussion has focused on the more traditional integrated circuit, another family of small devices, microelectromechanical systems (MEMS), is playing an increasing role in medical

Other considerations Developing a custom chip in medical devices is most often driven by other attributes (size, power, performance, etc.) with cost less likely to be the driver. Size can be a critical concern, particularly for a wearable or implantable device in which space is at a premium.

Shrinking the electronics typically also lowers power consumption. However, it also makes the ultimate packaging smaller, which may result in a thermal management issue. Medical devices 34

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Facing the challenges While advantages such as size, power, features, performance and perhaps manufacturing cost exist, so do challenges for medical device integration. Sterilization of devices, particularly with gamma radiation, can be an issue. Design and testing of integrated circuits reside in the arena of specialists, because cuts, jumpers and probing do not work at the nanometer scale, making device verification and troubleshooting problematic.

Developing a test process for an integrated circuit might easily cost as much as the initial design of the circuit because of the need for wafer, device and package-part testing.

Finally, even with all of the technological advances of the last few decades, certain things just don’t scale. Chief among these are energy sources. While battery chemistries have certainly improved (as have design techniques for energy usage), energy densities are such that the primary solution in products ranging from cell phones to laptops to pacemakers is to increase battery size for more power for the given application. In fact, pacemakers are typically explanted and replaced after 10 years to ensure continued operation. In addition, the antennas required for communication follow the laws of physics, needing to be of a certain size in order to transmit and receive information at their specific frequencies.

‘Technology of the small’ Technology has affected all aspects of our lives and the evolution of the “technology of the small” will certainly continue into the medical device arena, making possible new diagnostic, monitoring and treatment capabilities, subject to the considerations noted above. Even if we don’t fulfill the vision of sending a team into the body of a comatose patient using a miniaturized submarine to remove a blood clot in the brain (as in Isaac Asimov’s 1966 classic, Fantastic Voyage), it is indeed possible that a remote-controlled miniature “drone” may one day indeed do that or even destroy cancer cells. Stay tuned as science fiction becomes reality.

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devices. MEMS can be defined as miniaturized mechanical and electromechanical elements (i.e. devices and structures) that are made using the techniques of microfabrication.

MEMS devices can vary from relatively simple structures having no moving elements to extremely complex electromechanical systems with multiple moving elements. While the functional elements of MEMS are miniaturized structures, sensors, actuators and microelectronics, the most common elements today are the microsensors and microactuators. In medical devices, the promise of compact or unique sensors may be realized through the integration of MEMS structures with traditional integrated circuits.

Explore our full product range online or contact us with your application requirements.

Bill Betten is the president of Betten Systems Solutions, a product development realization consulting organization based in Minneapolis-St. Paul. Betten uses his years of experience in the medical industry to advance device developments in the medical and life sciences industries, helping clients to develop innovative medical devices and adapt to a changing environment. Betten most recently served as director of business solutions for Devicix/Nortech Systems, a contract design and manufacturing firm. He has also served as VP of business solutions at Logic PD, medical technology director at TechInsights, VP of engineering at Nonin Medical, and in a variety of technology and product development roles at various high-tech firms, including Honeywell and 3M. 36

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11/21/19 5:01 PM

How to have the right sensor for your medical IoT job If the Internet of Medical Things (IoMT) is truly to become a reality, sensors will be an important part of the equation.

Chris Newmarker Executive Editor

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oth doctors and the people they treat already have access to a vast amount of health data, a situation unheard of a decade ago. But the data can’t be trusted if the sensors aren’t accurate, reliable and sturdy enough to withstand different environments and unpredictable scenarios, according to Jen Gilburg, senior director of strategy for sensor solutions at TE Connectivity.

Medical Design & Outsourcing recently reached out to Gilburg for some answers on the role sensors have to play in the evolution of IoMT. MDO: How new is the idea of an Internet of Medical Things? Tells us a bit about the history. How close are we to seeing it become a reality?

Gilburg: We can say at least since 2007 the term has been around, but it really has gained focus around 2010. … Additionally, as we looked to take some costs out of healthcare and as more of the IoT infrastructure (from SDKs to cloud services) became available, the Internet of Medical Things idea has really taken hold.

By 2015, the FDA had cleared over 100 mobile apps for medical use which provides an example of the steady pace IoMT has been evolving.

With our aging population, increased rates of diabetes, asthma and other chronic diseases, IoMT has a lot of utility in remote patient monitoring and telemedicine. Many use cases are in production today including applications for heart, blood pressure, EKG monitoring and glucose monitoring.

MDO: How does the move toward IoMT affect the type of sensors TE Connectivity needs to supply?

Gilburg: TE Connectivity (TE) has a broad portfolio of sensors targeting healthcare applications. For example, TE provides temperature and pressure sensors for minimally invasive catheters that can be used in applications that measure pressure from a pulmonary artery, and through the OEMs solution, feed data back to a mobile device for constant home monitoring. We also provide sensor technology in fitness trackers … used more broadly in preventative healthcare. www.medicaldesignandoutsourcing.com

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MDO: What are the top technical challenges that need to be addressed when it comes to IoMT and sensors?

Gilburg: The top technical challenge is ensuring the device is secure, meaning, a rogue application cannot take control of the sensor for nefarious purposes and/or ensuring the data coming to and form the sensor has not been corrupted by a malicious attack. Standards for communication and authentication need to be considered, as well.

Additionally, the packaging of the sensor needs to be ruggedized to maintain integrity when exposed to harsh fluids or conditions. Lastly, there are regulatory, compliance and liability hurdles.

MDO: What are the top things that medical device creators need to consider when selecting a sensor for an IoMT purpose?

Gilburg: When selecting a sensor for an IoMT application, one of the main considerations is confirming the sensor can maintain calibration over the duration of the use case (e.g. ranges do not ‘float’ and become inaccurate). Another consideration is ensuring your sensor vendor has a broad array of sensor types for the variety of use cases you would like to develop including different ranges within the sensor (e.g. ultra-low pressure, low pressure, medium pressure, etc.). The sensor packaging also needs to be able to withstand the harsh conditions (bodily fluids, temperature fluctuations, etc.) of respective use cases.

MDO: How might the IoMT transform healthcare? Why is it important?

Gilburg: Early stories have shown that active management of chronic diseases via many of the IoMT monitoring applications, coupled with sensors, have been successful. Additionally, AI can reduce admittance rates, which in turn reduces costs, and improve clinical outcomes. According to Forbes, the medical IoT market is estimated to be a $117 billion market by next year.

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FLUID POWER COMPONENTS

What is microhydraulics and where is it used?

Microhydraulics enables significant force from a minimal power source within a tiny space — ideal for medical orthotic and prosthetic equipment, exoskeletons and more.

Bar flange mount safety screens from The Lee Co.

Ken Korane Contributing E d i t o r, Fluid Power World

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luid power systems are noted for their high power density — permitting high force and torque output from relatively small components when compared to electromechanical systems. Microhydraulics enables a significant amount of force from a minimal power source within a very restricted space envelope. Thus, it can provide a straightforward solution to problems that are often beyond the limits of traditional mechanical options.

In many cases, these systems are ideally suited for wide-ranging applications like medical orthotic and prosthetic equipment, human-assist lifts, exoskeletons, hand tools, rescue robots, aircraft and missiles, race cars and oceanographic instrumentation.

Engineers might be tempted to simply downsize typical commercial components when the need arises to control motion and force in very small powered systems. However, the reality is a bit more complex because scaling laws are not intuitive, according to researchers Jicheng Xia and William Durfee of the University of Minnesota.

For example, they note that in a cylinder, force is proportional to area (L2) while weight is proportional to volume (L3). On the other hand, the thickness and weight of a cylinder wall required to contain a fixed pressure goes down with bore size. Thus, the final weight of a hydraulic system at small scale cannot be determined by

Medical Design & Outsourcing

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proportionally scaling a large system.

Also, the fundamentals associated with pressure-driven flow dictates that high pressures are required to permit high flow rates through micro-sized channels. In laminar-flow conditions, an order-of-magnitude decrease in the hydraulic diameter of a channel increases by two orders of magnitude the pressure difference required to maintain a constant average flow velocity.

Another critical barrier for increased hydraulic power density at reasonable efficiency is the seals. Surface effects such as friction drag of seals and viscous drag of gaps become significant in small bores and that impacts overall efficiency. Too tight and friction dominates; too loose and the pressurized fluid will leak past the seal. Cost and power consumption are also important considerations.

Fortunately, a number of manufacturers have designed or re-engineered hydraulic components to work on a “miniature” scale.

As one example, Bieri Hydraulik, a unit of Hydac International based in Liebefeld, Switzerland, makes six standard versions of Type AKP micro-axial piston pumps designed with three or five pistons. For instance, the 5-piston Size AKP36 pump measures only 1.4 in. (36 mm) in diameter by 3.9 in. (99 mm) long. It features a displacement of 0.36 cm3/rev with 250 bar maximum pressure and 4,000 rpm max speed.

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The Size AKP103 measures 1.9 in. (50 mm) in diameter x 3.8 in. (98 mm) long. It has 3 pistons, displacement of 0.1 cm3/ rev, 500 bar max rated pressure, and runs at speeds to 5,000 rpm. A 5-piston version offers a displacement of 0.3 cm3/rev.

These quiet-running units reportedly offer high volumetric efficiency even at a minimum speed of 100 rpm. They are valve-controlled on the pressure and suction side, so are not suitable as motors. The small units are used in offshore and oil and gas applications, in metering systems, and general hydraulics systems with small displacements.

Hydro Leduc (Azerailles, France) offers a complete range of fixed and variable displacement micro-pumps; micro-motors (speeds from 350 to 6,500 rpm); check, pressure-relief, solenoid and pilot valves; and complete micro-power packs for operating in widely varied working environments.

For example, its PB32 fixed displacement micro-pump has a body diameter of only 1.28 in. (32 mm) with displacement as small as 0.0007 in.3, maximum speed of 5,000 rpm continuous and 6,000 peak, and maximum pressure of 4,350 psi continuous and 5,075 psi peak.

A slightly larger PB33 HP version has a 0.0027 in.3 displacement and a maximum continuous pressure rating of 13,050 psi and max peak of 14,500 psi (1,000 bar).

The Lee Co. (Westbrook, Conn.) makes an array of miniature, highperformance fluid control components, including Lee Plug expansion plugs, solenoid valves, flow restrictors, safety screens, relief and check valves and shuttle valves. The company’s flow controls, to cite one typical product, offer metered flow in one direction and free flow in the opposite direction. It’s also called a one-way restrictor. In the smallest size, the diameter is only 0.18 in., yet the nominal system pressure rating is up to 3,000 psi. Other similarsize products include poppet-style check valves that can flow one GPM at 25 psid and have a nominal system pressure rating up to 4,000 psi; and pressure relief valves that have cracking pressures from 20 to 100 psid and, in some versions handle nominal system pressures up to 5,000 psi. Some miniature check valve and restrictor models can even handle system pressures up to 8,000 psi.

Likewise, safety screens as small as 0.13 in. diameter help protect orifices,

relief valves and other sensitive hydraulic components. Critical components are often relatively immune to low levels of small-size contaminants, but a single large particle can cause sudden failure — possibly with catastrophic effects. While filters maintain fluid cleanliness during operation, safety screens provide an added level of protection. The units come with hole sizes from 0.0008 in. to 0.062 in., and high-pressure versions won’t burst or collapse at pressures of 7,500 psid, even if fully clogged.

SFC Koenig (North Haven, Conn.) offers a range of plugs, flow controls, check valves and related components.

The Expander plugs, for instance, reportedly seal drilled holes with excellent reliability. They come in sizes from 0.093 to 0.875 in. and are rated to 6,500 psi (450 bar) for push-type units and 7,200 psi (500 bar) for pull versions.

The company’s stainless-steel Restrictor units provide precise flow control in fluid systems and are available in sizes as small as 0.093 in. (4 mm) in expander and threaded styles, and handle pressures to 2,900 psi (200 bar). Orifice can be specified to achieve desired flow

This article originally ran on our WTWH Media sister site Fluid Power World on June 24, 2019.

An assortment of microhydraulics components from The Lee Co.

www.medicaldesignandoutsourcing.com

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rates. Check valves, 0.216 in. (5.5 mm) diameter, handle forward or reverse flow, have a cracking pressure of 2 to 29 psi (0.14 to 2 bar) and maximum working pressure of 4,352 psi (280 bar).

Takako Industries, a member of the KYB Group based in Kyoto, Japan, claims to make the world’s smallest axial-piston pump.

The square shape TFH-040 unit measures only 1.18 in. (30 mm) wide by 3.0 in. (77 mm) long and is rated for a maximum working pressure of about 2,030 psi (140 bar).

Displacement is 0.4 cc/rev, input speed is to 2,000 rpm, with a flow rate of 0.8 lpm.

The unit is part of a family of micropumps which feature a hybrid drive system that combines the benefits of hydraulics with the controllability of an ac-servomotor and inverter to satisfy a broad range of specifications with a small-volume pump. Typical applications, according to the company, include a pump for valve controls, mold switching equipment for forming machines, hydraulic clamps and crimping presses.

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Medical Design & Outsourcing

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HIGH PERFORMANCE POLYMERS

High-consistency rubber adds shape to medtech manufacturing High-consistency rubber (HCR) offers medical device manufacturers an established biocompatibility pedigree, broad processing parameter ranges and excellent physical properties.

High-consistency rubber (HCR) is a high-molecularweight polymer combined with silica, producing a material that can be molded, extruded or calendered into a useful component.

Image courtesy of NuSil

Brian Reilly NuSil

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H

igh-consistency rubber silicone (HCR) has long been used by the medical device industry. From tubing and balloons to sheeting and molded parts, HCRs are comprised of a high molecular-weight polymer combined with silica. The result is a versatile silicone that has a clay-like consistency in its uncured form.

Along with versatility, HCRs have a proven history of use in numerous approved implantable and non-implantable applications. These silicone elastomers were first used in the 1960s for implantable devices like hydrocephalus shunts. Since then, HCR use has expanded into a wide range of medical applications because of the material’s established biocompatibility, broad processing parameter ranges and excellent physical properties.

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Curing versatility Part of HCR’s versatility stems from its ability to use different curing systems. Options like peroxide- and platinum-catalyzed solutions offer device manufacturers different advantages depending on the application.

A key advantage to a peroxide-catalyzed system is that the curing mechanism is not activated until the HCR is exposed to heat, providing a very long work period that is ideal for a molding or extrusion process. This curing system creates unique elastomeric properties that can be useful in manufacturing balloons or similar applications where “tension set” is important.

For platinum-catalyzed HCRs, the cure chemistry is designed to accommodate faster cure times and increased throughput without corrosive byproducts. Platinum-catalyzed, addition-cured HCRs typically yield much higher physical properties than traditional peroxide-catalyzed HCRs, also making them ideal for applications that use molded or extruded components.

Processing versatility HCRs offer broad processing parameters, so manufacturers considering a silicone should be aware that different end-use applications require different fabrication methods. For example, extrusion is the most efficient production method for silicone tubing that will be incorporated into a medical device. Once the processing method is established, consider additional requirements, such as: What properties should the tube have? Does it need to be stiff and rigid or soft and flexible? These and other factors can help determine whether it requires a peroxide-cure or platinum-cure system. An experienced HCR supplier can guide manufacturers through the process of choosing the most appropriate silicone and fabrication method.

Three considerations for using HCRs The versatility of these silicone elastomers makes them well-suited for a variety of medical device applications. Here are three factors to consider when choosing an HCR:

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HIGH PERFORMANCE POLYMERS •

•

•

LOW STRESS. SMOOTH. GENTLE. STEADY. CALM. The new KNF FP 400 combines the advantages of diaphragm liquid-pump technology with pulsation levels comparable to gear pumps. It’s self-priming, has run-dry ability and provides a long, maintenance-free lifetime under continuous-operation conditions.

The pump produces low-stress, smooth pulsation of 150 mbar, with much lower levels achievable. It delivers gentle, low-shear flow of up to 5 L/min at 15 psi, with steady, linear control between 10% and 100% of nominal flow.

The FP 400 is perfect for clinical diagnostic instrument tasks such as liquid recirculation, supply/replenishment, mixing /agitating processes, and temperature management loops.

Learn more at knfusa.com/FP400

Final considerations for HCR selection Silicone suppliers with deep expertise in providing HCRs for medical devices offer significant advantages to manufacturers.

For example, suppliers who already have established relationships with regulatory bodies can more efficiently and more effectively help meet essential guidelines.

Another key consideration is whether the supplier has a robust quality system, including ISO 9001 certification, knowledge of ISO 13485 requirements for medical devices and experience with FDA master file submissions.

A silicone supplier with this expertise can provide support throughout the design and regulatory submission process to help medical device manufacturers save time and money as well as move devices to market faster.

Brian Reilly is business development director of biomaterials for NuSil, part of Avantor. He holds a B.S. in biological sciences from California Polytechnic State University-San Luis Obispo.

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Integration/interaction with other materials: One of HCR’s advantages is the ability to incorporate additives, such as colorants or active pharmaceutical ingredients (APIs), into the pre-cured formulation. Manufacturers using additives or other materials within the device should consider how they will interact with the silicone and the molding process. Additives may be temperaturesensitive and can also adversely interact with formulary components, resulting in an incomplete cure. Consider partnering with a silicone supplier that can customize solutions to address these challenges before they arise.

Avoiding cross-contamination: Be mindful of other chemicals that are used in the manufacturing process.

Some chemicals may negatively affect platinum-cured HCRs in their uncured state, causing a partial or incomplete cure.

Manufacturers can prevent contamination by implementing clean manufacturing practices, like using dedicated instruments such as spatulas for subdividing HCR and cleaning all surfaces between uses.

Flexibility in HCRs: Medical devices and fabrication processes vary widely, so it’s essential to work with a silicone partner that uses innovative solutions that provide greater manufacturing process flexibility. For example, a provider using an optimization system can help device engineers optimize process requirements, such as work time and cure profile.

Medical Design & Outsourcing

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Image from Toray Industries

How Toray Industries' Toyolac ABS resin compares with polycarbonate Toray officials think the resin could be ideal for any sort of connector in a fluid application requiring resistance to lipids and oils.

Nancy Crotti Managing Editor

T

oray Industries (New York) is touting its Toyolac transparent ABS resin as a less expensive alternative to polycarbonate.

Newly available in the U.S. but used worldwide for several years in demanding medical applications, Toyolac is an FDA Drug Master Fileregistered material that has several advantages over polycarbonate, according to Minneapolisbased Toray consultant Aron Yngve.

“Toyolac compares very well to clear polycarbonate,” Yngve said. “It also has scratch resistance with structural strength and chemical resistance that fits many polycarbonate applications.

With its injection moldability, solvent adhesive, gluing and printability properties, designers and molders will find Toyolac useful for future product development.”

Toyolac can be molded at much lower cylinder temperatures than polycarbonate (210° C to 260° C, versus 280° C to about 310° C for polycarbonate). Mold cooling is at 80° C. In spiralflow testing, Toyolac flow can reach 270 mm, whereas polycarbonate flow gets to about 100 mm before stopping.

“You can get more cavities than you can with polycarbonate,” Yngve said. “It flows easier and further at low temperatures, which translates into an enormous reduction in your cost to mold it. Depending on the component, you can get almost twice as many parts as you would with polycarbonate in the same time cycle.”

As an ABS resin, Toyolac is not as strong as polycarbonate, but many medical applications do not require such strength, according to Yngve. It may be ideal for any sort of connector in a fluid application and is resistant to lipids and oils. www.medicaldesignandoutsourcing.com

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“This is great for fittings, filter housings and other applications that require transparency and have direct circulating-blood contact as well as drug-infusion applications,” he said.

Although translucent ABS has been available for quite some time, transparent medical-grade ABS has not. Achieving that level of transparency in this resin was the biggest challenge for Toray engineers, who adjusted the refractive index of its components to make Toyolac.

Toyolac can transmit light nearly as well as polycarbonate, Yngve added. Polycarbonate rates at about 90% clear for light transmission and Toyolac comes in at 87%. Even transparent materials can have some haze to them, and the haze on polycarbonate is 1%, while Toyolac’s haze is 3%, he noted.

“What design engineering and manufacturing people really want is a clear plastic that is capable of competing with polycarbonate but yet is inexpensive as a straight polymer when you purchase it,” Yngve said.

“Most importantly, it is hugely easier to process.

It takes less heat to mold and less water to cool it, it flows better so you can get more cavities in the same size press. These factors combine to make a very significant cost savings.”

Toyolac may be sterilized using ethylene oxide or gamma radiation, but cannot be autoclaved. It is USP Class 6 tested and meets ISO 10993 for biocompatibility. Specific tests include –4 for blood interactions, –5 for in vitro cytoxicity, –10 for irritation & skin sensitization and –11 for systemic cytotoxicity. It also is USP 88 biological reactivity tested (USP Plastic Class VI).

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MACHINING

How LaserSwiss can solve manufacturers' engineering challenges Medtech companies can improve output quality and repeatability using the single-pass operation offered by LaserSwiss manufacturing.

Joe Lovotti and Damian Zyjeski Okay Industries

L

aserSwiss combines the precision of Swiss turning with a fully-integrated laser-cutting system to deliver efficiency and lower costs. While the low cycle times of laser processing provide accuracy and high-yield production, machining processes are sometimes required, due to part design or to improve manufacturability.

For some manufacturers, this may mean moving a laser-cut part onto a new piece of equipment, increasing part handling, quality processes and production time. Machining processes typically have higher cycle times, which only increase with movement from machine-tomachine. Combining two proven manufacturing methods into a single-pass operation means output, quality and repeatability can be improved.

Here are some tips on how OEM’s can use LaserSwiss manufacturing processes to solve complex engineering challenges.

Image from Okay Industries

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Consider LaserSwiss before disregarding a design LaserSwiss can efficiently produce components that require intricacy, tight geometries, fine or angular cuts or a high-degree of bendability. For example, this method can be used to manufacture tubes with diameters from 2.0 mm (.080 in.) to 12.7 mm (½ in.), wall thicknesses down to .05 mm (.002 in.) and laser-cut widths as small as 0.05 mm.

LaserSwiss combines fully integrated laser cutting with machining operations that include turning, milling, tapping, drilling, thread whirling, grooving, sawing and chamfering.

While some parts can be produced using solid stock, most components are tubular, often designed as single-use medical instruments or robotic surgical instruments.

LaserSwiss is particularly well-suited to manufacturing a wide range of medical device components. The level of feature complexity that LaserSwiss provides has revolutionized the manufacturing process, giving greater flexibility for engineers to design and manufacture parts that were not practical before.

Optimize processes for cost efficiency Laser cutting is not only highly accurate, it’s fast. In some operations, machining a part may take up to eight seconds, compared to one second for laser. However, machining operations are often necessary in part production.

The combination of laser cutting and machining capabilities means the optimal production process can be used to make a component quickly, without moving from machine-to-machine. Integrated quality checks can be performed on the LaserSwiss, increasing efficiency without compromising the integrity, delicacy or the precision required for surgical and medical components.

An examination of the ratio of laser cuts versus machining passes is an important part of the analysis. If there is a need for 50 laser cuts and only one machined cut, LaserSwiss

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MACHINING

might not be cost-effective. Finding the optimal fit of machining and laser features that makes a part right for LaserSwiss typically requires analysis by your manufacturing partner’s engineering team.

Partner with LaserSwiss engineers to identify design possibilities The manufacturing process that a customer has in mind might be simplified. Having a collaborative engineering team with expertise in advanced laser processing, machining and other manufacturing operations helps customers identify which operations or design modifications can lower costs and increase manufacturability.

Design and functionality options such as assembly tabs on a device or ramp features for component removal may be efficiently produced while the part itself is manufactured. It’s also

possible with LaserSwiss and the help of a skilled engineering team to simplify an assembly or combine two parts into one, saving both time and money.

LaserSwiss engineers may be able to identify process and cost-saving options that OEMs might not have considered.

Joe Lovotti is director of laser technology at Okay Industries. Working in the medical device and implant industry since 1980, he helped pioneer the industrial use of lasers and worked as a consultant in the development of LaserSwiss technology.

Look for a manufacturing partner with dedicated prototyping Having a team of experts who can develop a laser process or machining process that can produce complex patterning, bendable components or intricate design using quick-turn prototyping can be a crucial step before production. Combining separately developed laser and machining processes on the LaserSwiss can make prototyping more efficient. Testing out design and manufacturability before production can streamline operations, control costs and optimize the performance of medical components.

Damian Zyjeski is CNC product development manager at Okay Industries and brings 20 years of engineering and management experience to his role.

The Best Components Begin with the Best Material

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MANUFACTURING

Making wearables and microfluidics manufacturable: What you need to know Here’s why medical device creators need to design wearables and microfluidics for manufacturability and scalability to achieve the optimal performance patients and providers rely on.

David Franta and Matt Berdahl 3M Medical Materials and Te c h n o l o g i e s

Image courtesy of 3M

P

oint-of-care, microfluidic and wearable medical devices play a key role in enabling positive care outcomes and simplifying care management — changing patients’ quality of life for the better. In order for these devices to achieve peak performance and produce accurate measurements and reliable readings, design engineers need to particularly focus on three elements of the development process. Thoughtfully considering materials, manufacturing processes and scalability according to the application are critical steps in bringing the device to life.

From prototype to product, materials matter To demonstrate a mass-produced device’s ability to function reliably, it’s important to use the same materials in the prototype that will also be used in the end product. If you use different materials for the prototype and finished device, it could yield unexpected results at various phases in development, throwing a wrench in the overall plan.

Some of the most common materials used in device design include glass, PMMA, polycarbonate, polystyrene, COP or COC, PDMS, metal, flexible web and paper. Glass typically has the best chemical resistance, but it’s fragile and is not the easiest material to work with in mass production. Considering all of the tradeoffs based

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on your product and its unique application is crucial. For microfluidic devices, polymeric films and sheets are popular because they enable a scalable manufacturing process.

It is also important to consider compatibility and temperature conditions. If the polymer materials used in your device are not compatible with each other, it can affect diagnostic integrity.

In addition, note the polymer material’s thermaltransition properties if the device will be exposed to extreme temperatures or hostile environments during storage. Hostile environments, pressures or chemical reactivity and other harsh conditions may require resilient and versatile materials.

Plan ahead for manufacturing While it may sound obvious, manufacturing processes influence other design decisions you will have to make before the device gets to the production floor. There are a variety of manufacturing methods used to produce medical devices. While some use chemicals such as strong acids, others require thermal operations for fabrication. These processes can have a huge impact on material properties. Some common methods include etching, lasering, casting, molding, roll-toroll hot embossing and planar processing. Below is a short summary of each process to keep in mind before selecting one for your project.

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MANUFACTURING

Small- to large-volume processes • Roll-to-roll processing: This method is compatible with an array of materials.

During this process, each material layer is cut individually. First, the device is designed as a CAD file.

Then, the geometry is cut, the inner portion is cleaned, and the layers of the device are bonded together.

Keep in mind, this process’ accuracy depends upon your chosen cutting method, materials, layer registration and layer thickness.

Large volume processes • Hot embossing: This is a process commonly used for replicating products since it is typically easy to tool-up for and execute. This is a preferred process for replicating microstructures, as the tooling is fairly simple.

• Injection molding: Molding is often used for microreplication and microscale thermoplastic replication.

While it may have faster cycle times, it requires more expensive, intricate tooling and larger investments in order to execute effectively.

• Other planar processing: Other types of planar processing can be used on silicon or glass materials. Processes may involve chemical etching, dry etching and powder blasting.

Others processes Casting (small volume): Casting is the process of creating a device by pouring (casting) PDMS into a mold of the product.

Laser (small to medium volumes): This process uses noncontact micromachining systems. Laser systems may be reprogrammed to produce varied patterns, making them ideal for the design and development phase of the microfluidic biosensor.

Powder blasting: Powder blasting creates fluidic channels by mechanically removing part of the structure’s material with a particle jet machine.

Etching: There are several types of etching. Dry etching can create deep, high-density, high-aspectratio structures in glass and silicon substrates. Similarly, wet etching can create useful features but uses chemicals like hydrofluoric acid to create channel structures in glass and silicon substrates. Feature fidelity and edge sharpness should be evaluated when using etching processes.

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Make it scalable from the beginning Scalability of the prototype affects material selection, end-user, environment and manufacturing process decisions, which is why you need to consider it early in device development.

There are three main stages that comprise the scaling process. During the first stage of scaling, materials and individual components are joined to create a working assay. Once this step is complete, the product’s robustness, including sensitivity, selectivity, specificity and reproducibility, is evaluated and compared to laboratory performance.

This evaluation will inform whether design improvements are necessary to mitigate any design issues or manufacturing variations that arise.

The second stage of scaling may use higher-speed replication processes to produce the desired batch/volume of devices, while still meeting the critical design parameters identified. In the final stage of scaling, you should be able to produce the volume of devices needed to meet your forecasted yearly-use volumes — perhaps 10,000 devices or more in the span of a few months. Depending on the production goals you set for your product, a clear manufacturing path must be laid out before beginning production in order to achieve the desired target volumes.

Since mass-manufacturing medical devices is an iterative and multi-step process, making thoughtful decisions on material selection, manufacturing techniques, scalability and development parameters will help ensure device development and production go smoothly. If you decide change is necessary later in the design and development phases, you will likely run into setbacks, such as added costs and time delays. Visit FindMyAdhesive. com and answer a series of projectspecific questions

to get started down the right path. Be sure to engage your material supplier early on to solicit recommendations — and pay attention to these considerations to ensure your solution is scalable and successful, from concept through commercialization.

David Franta is microfluidics global business manager at 3M Medical Materials and Technologies. Franta received a BS in materials science from the University of Minnesota, Twin Cities. He has more than 25 years of experience at 3M in product and process development, business management, strategic product platform creation and Lean Six Sigma operations. His experience has involved new technology creation in biomedical sensors, biotechnology solutions and medical adhesives.

Matt Berdahl is global marketing manager for pressure-sensitive adhesives and tapes at 3M Medical Materials and Technologies. Berdahl received his BA in operations management as well as his MBA from the University of St. Thomas in St. Paul, Minn. Matt has 23 years of experience at 3M in a variety of roles including the supply chain, procurement, Lean Six Sigma, sales, marketing and business operations. His business experience has involved tapes and adhesives used in the industrial, consumer, transportation safety and medical markets.

Image courtesy of 3M

www.medicaldesignandoutsourcing.com

11/21/19 5:18 PM

4 steps to solving tough automation challenges As more dynamic automation systems take a larger role in the development of medical products, engineers need to learn how to design for repeatability and reliability.

Brian Ballweg and Bill Stube Plexus

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hether to bring a medical product to life or make sure processes in the lab run smoothly, the use of dynamic automation systems continues to increase. In a field like medical device and equipment design, it’s imperative that all systems function flawlessly.

It can often take years to gain the expertise to navigate difficult automation challenges. The goal, however, remains the same: automation that ensures both repeatability and reliability.

Repeatability is the ability to perform a task the same way every time. For instance, the introduction of robots makes repeating the same motion consistently a reality. Reliability is determined by how well an action or motion can be performed throughout the life cycle of a system.

A concrete example of this can be seen in a robot that is grabbing microscope slides to scan for cancerous cells. That robot must be able to repeat the exact motion every time. It must always make the same motion, with the same amount of pressure, without error or slide damage for the life cycle of the product.

Designing and building an automation system with reliability and repeatability at its center comes down to four steps: 1. Define the use cases The first step in developing an automation system is identifying the stakeholders, determining their hierarchy and understanding their interdependencies.

The goal, then, becomes understanding the context in which the product will be used.

Questions to ask during this stage may include: • • • •

What are the user’s needs and product constraints?

What components are necessary to make the product run smoothly through the process?

In what ways are the device users interacting with the system?

Who is purchasing the solution?

Once this analysis is done, it becomes important to synthesize that information to meet the needs of multiple stakeholder groups in a way that allows the system to function best. www.medicaldesignandoutsourcing.com

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Image from Plexus

2. Make it work Determining early concept feasibility is, essentially, understanding how to make the automation system function the way that it should. In most automation systems, this can be characterized as creating equivalency to human motion while optimizing system variance, aligning to key business considerations and evaluating and reducing key technical and business risks. For the robot picking up slides, determining early concept feasibility could include understanding the ranges of motion and care in handling that will be necessary for the machine to function like a lab technician.

Engineers who determine early concept feasibility will build on the information that was gained when the use cases were defined and understand how to proceed with creating the system.

3. Simulation and prototyping Simulation and prototyping of an automation system are about understanding how the system will actually function before final commercialization and manufacturing. This step is driven by observing the system in use and evaluating its function. Some companies will choose to use simulation software to complete this step; others will gather the materials and build a working prototype.

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MANUFACTURING

Instead of choosing one method or the other, the strategic route is to view simulation and prototyping as collaborative steps. First, employ simulation software to gather data quickly, then follow up the simulation with a working prototype to prove feasibility and confirm the data from the simulation.

4. Execute for precision Once an automation solution is in place for a product or process, dedicate the time to research and correct every issue that arises. For a robot picking slides, executing for precision could include continually optimizing the motion flow of the arm. If something gets stuck, for instance, physically manipulating it to get it back on track is only a quick fix. Every fault, big or small, must be noted. To keep a system repeatable and reliable through its life cycle, each

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fault must be investigated for the root cause and solved before the system is ready to function in the market.

The types of problems that will involve automation vary from company to company. Some need to carry objects hundreds of feet and some need to move nanometers. While both ends of this motion spectrum and everything in between has its own complications, each one depends on repeatability and reliability. By making these two tenets the pillars of an automated medical device system, companies will be putting themselves in the best position to succeed.

Bill Stube is director of engineering operations for life sciences at Plexus, with 15 years of experience in engineering, system architecture and project management of complex product development projects from initial concept and architecture through production manufacture.

Brian Ballweg is a senior principal engineer at Plexus with 26 years of experience in mechatronic product development and commercialization in healthcare/ life sciences, communications, industrial, commercial and aerospace/defense.

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Image by Cytonn Photography on Unsplash

Here's the case for single-source medical device manufacturing

Companies that outsource medical device manufacturing can either divide the production work among several providers or unify the effort from a single source. Both tactics have advantages, but the use of multiple suppliers can have expensive downsides.

Thomas Black B. Braun Medical

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edical device manufacturers have a wealth of resources available to handle outsourcing production needs. Experts-forhire can address everything from design and engineering to assembly and legal/regulatory reviews. There are advantages to adopting this business model, including partnerships with service providers who are adept at their manufacturing specialty.

However, more often than not, the decision to use multiple suppliers on a medical device can have a variety of unintended consequences. These drawbacks can delay a project timeline, increase costs, lower finished quality and create undue workload and stress for the internal project team.

A vertically integrated, single-source contract manufacturer has many benefits.

Reduce supplier audits and validation Consolidating design and engineering functions with manufacturing provides significant synergies.

The design team will lean heavily toward materials and components from suppliers who have already been audited and are part of the company’s existing supply chain. Similarly, engineers will generally design devices with pre-validated components and materials from these suppliers, eliminating the time and expense required with the validation process.

Prepare for a long product life cycle An integrated contract manufacturer can deliver benefits over a longer product life cycle. For example, a contract manufacturer that also provides sustaining engineering capabilities will be better able to address improvements, enhancements and changes to the product as feedback returns from the field.

Likewise, the longer an integrated team works on a medical device from design through production and sterilization, the more institutional knowledge they can provide. A vertically integrated contract manufacturer acts as a full extension of the customer’s team to provide critical insight and history about everything from material selection to engineering.

Minimize variability Engineers intimately familiar with their manufacturing processes understand how to design to make the most of their equipment and processes while minimizing manufacturing variability. Smart design can imbue a product with a standard of quality from the outset.

Planning in this way can accommodate requirements for functionality (the ability to sterilize a valve or tube, for example), clarity in documentation and quality-control metrics.

Which model works best?

Of course, there is no one model that works best for every company. Some might opt for an approach akin to selecting a group of “all stars” to play together on the same field or court. However, judging from the lackluster level of teamwork evidenced in such sporting events, that direction might not be ideal for something as critical as a medical device.

As the design, production and distribution of medical devices becomes increasingly complicated and regulated, there is tremendous value in consolidating resources with a single contract manufacturer that can provide an integrated team to steward a product from conception through many years of production. The long-term benefits in terms of timeto-market, overall quality, thoroughness of documentation and accountability will typically outweigh any perceived short-term benefits of a multiple-source approach.

Reduce management time Working with an integrated contract manufacturer eliminates the need to manage multiple vendors and the time associated with that management. One project manager is responsible for the entire timeline from the earliest design stages through assembly and sterilization.

Thomas Black is VP of the OEM and international sales divisions of B. Braun Medical, where he has spent the past 36 years of his career. He is a graduate of the UCLA Anderson School of Management and the University of South Carolina–Columbia, where he obtained a BS in finance.

www.medicaldesignandoutsourcing.com

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A single-stream supply chain also alleviates managerial concern for accountability. With an integrated manufacturer, there’s no question about who is responsible for resolving an issue. As one client has expressed, he likes having “one throat to choke.”

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How to plan for ultrasonic plastic welding success in medtech manufacturing By thinking through the ultrasonic welding process, you can avoid the pitfalls and maximize results.

To m H o o v e r Emerson

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ltrasonic plastic welding is an effective, repeatable and reliable joining method for a range of medical-grade polymers. It is used in an ever-increasing number of medical applications worldwide, in the manufacture of everything from analytical and drug-delivery devices to surgical instruments, filters, and consumables — even disposable medical apparel.

Cannula, luers, & fillings.

Image from Emerson

Part design Avoid design pitfalls by engaging early with application experts about the details of part design. Among the most critical aspects of design for ultrasonically welded parts are part geometry and joint style. For example, if hermetic sealing is essential for the performance of a medical product, consider use of tongue-and-groove joints rather than chisel-step or other joints. Adding texturing or “energy directors” on part surfaces further enhances joint reliability and manufactured part quality.

Material compatibility Ultrasonic welding works extremely well with many medical-grade thermoplastics, but some are incompatible with the process. Once you’ve selected material types for a part design, ensure that your supply chain can manufacture parts consistently.

Should a material be adapted or changed, weld parameter changes or even equipment changes may be required.

Because weld quality and strength tie closely to part design and materials, realize that even small changes can have significant impact on the joining process. However, once you “dial in” a process with the right ultrasonic welding equipment and weld parameters, you should enjoy outstanding repeatability and process control. Welded joints immediately bond into a cohesive assembly — no curing or setup time is required.

Like any other joining or product assembly technology, it is essential to get the basics right to avoid potential pitfalls or unexpected difficulties. Fortunately, the potential pitfalls of this still-growing technology are well understood and can be easily avoided by thinking ahead and working closely with your ultrasonics supplier to “accentuate the positives” in five areas: • • • • • 54

Part design, geometry, joint style and surface finish.

Material compatibility.

Actuation technology.

Adaptability.

Global resources and support.

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Actuation technology Next, select the right actuation technology based on your application needs, production targets and budget. This selection is especially important for medical device applications that rely on the use of delicate or miniaturized plastic parts, electronic components or other components with significant regulatory and traceability requirements.

The pneumatic actuation technology used on conventional ultrasonic welders relies on relatively high levels of downforce to actuate the welding process and can be too much for thin-walled or delicate parts. These parts need a technology that offers much more sensitive resolution at low levels of actuation and weld force.

www.medicaldesignandoutsourcing.com

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Modularity and adaptability To keep pace with evolving production requirements, choose a welder that offers modularity and adaptability. Emphasize modular systems available with short lead times that can be set up rapidly, then manually operated on a benchtop or fully automated when increased production speeds are required.

Demand easy and intuitive controls that can establish and maintain consistent process quality, automatically adjust to manage minor variations, capture event logs and weld history for 21 CFR Part 11 compliance, and store required part and device traceability data.

Medical Device Manufacturing From Concept To Market

Support Finally, look for global support, including advice and recommendations that help shape your medical product designs, reduce labor costs for training and production, minimize downtime and maintenance requirements, and enable you to adapt when the supply chain, vendors or manufacturing requirements change.

Though ultrasonic welding is a powerful and adaptable joining technology, it’s not ideal for every medical application. However, by accentuating the positives of product design, materials, actuation technology, adaptability and support, manufacturers can make the smartest choices about when and how to apply ultrasonic welding to produce attractive, innovative and high-quality medical devices and products.

We are vertically integrated to provide you with all the services and capabilities essential for complete medical device contract manufacturing.

• Clean Room Assembly • Custom Tubing Solutions • MIM (Metal Injection Molding) • Precision Machining • Insert/Injection Molding • Precision Metal Stamping

Tom Hoover has been a senior medical market manager for assembly technologies at Emerson since 2010.

He has experience in all aspects of medical device product development and regulatory compliance.

Contact us today to discuss your next project: sales@micro-co.com

Visit us at BIOMEDevice San Jose, Booth #629 11 • 2019

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MICRO 140 Belmont Drive, Somerset, NJ 08873 USA • Tel: 732 302 0800 • www.micro-co.com

11/21/19 5:19 PM

MANUFACTURING

Thermoelectric coolers for medtech: What you need to know Active cooling solutions keep medical equipment below maximum operating temperature to ensure proper performance.

You can tailor them to yield a more optimal solution.

Image from Laird Thermal Systems

Andrew Dereka Laird Thermal Systems

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hermoelectric coolers are active solid-state heat pumps that use the Peltier effect to move heat away from sensitive electronics. Also referred to as Peltier coolers, these devices are a more efficient alternative to compressor-based cooling systems for a wide range of medical applications.

Designed with size, efficiency, a low power requirement and continuous reliable operation in mind, thermoelectric coolers enable medical OEMs to meet thermal design challenges, including thermal stability and precise temperature control. With the ability to cool well below ambient temperatures, thermoelectric coolers protect medical electronics from heat generated by medical products including lasers, imaging equipment, sample storage chambers and thermal cycling equipment for DNA amplification.

How they work During operation, DC current flows through the thermoelectric cooler to create heat transfer and a temperature differential across the module. One side of the thermoelectric cooler is cold, while the other side is hot. Heat absorption and heat dissipation mechanisms, usually fans or heat sinks, are connected to the thermoelectric cooler. The cold side heat sink absorbs heat from inside the cabinet, while the hot side heat sink rejects heat to the ambient environment.

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A standard single-stage thermoelectric cooler can achieve temperature differentials of up to 70°C and transfer heat at a rate of up to 350 W. Colder temperatures can be achieved, down to -100°C, by using a multistage thermoelectric cooler in a vacuum environment. Thermoelectric coolers are also environmentally friendly, as they do not require refrigerants to dissipate heat.

When the polarity on the thermoelectric cooler is reversed, the device can also provide heat with temperature control, which is a requirement in a number of medical applications such as reagent storage. This also eliminates the need for a resistive heater that would be used in traditional compressorbased systems, resulting in lower costs.

Thermoelectric cooler assemblies At their core, thermoelectric cooler assemblies consist of an array of thermoelectric coolers, a heat exchanger and a fan. Thermoelectric cooler assemblies offer a cooling capacity spectrum from approximately 10 W to 500 W and use multiple heat-transfer mechanisms, including air-to-air (convection), liquid-to-air (re-circulating liquid) or direct-toair (conduction) methods. These assemblies remove the passive heat load generated by the ambient environment in order to stabilize the temperature of sensitive components used in medical equipment.

www.medicaldesignandoutsourcing.com

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The most commonly used type of thermoelectric cooler assembly is the air-to-air configuration, which uses fans to increase the air exchange between the hot and cold sides to maximize heat transfer.

Precise temperature control When combined with an advanced bi-directional temperature controller, thermoelectric cooler assemblies can deliver temperature control to within ±0.5°C. Temperature controllers can turn on the thermoelectric cooler assembly to cool once the upper-temperature limit has been reached and turn off a few degrees below the temperature set point. Similarly, the controller can turn on and provide heat once the low-temperature limit has been reached and turn off a few degrees above this limit. A hysteresis setting is used in conjunction with the temperature limit set points to set the desired degree range for the application.

Temperature controllers may also provide monitoring and alarm functions,

including identification of a problematic fan, over-temperature thermostat and temperature sensor failure, all of which are critical to maximizing the amount of time medical equipment can operate. These controllers require minimal programming and can be easily integrated with a thermoelectric cooler assembly. They may also lower operational noise, as fan speeds can be reduced once the specified temperature has been reached.

Advantages Thermoelectric coolers and assemblies offer several advantages when compared to alternative cooling technologies, including: • • • • •

Compact size.

Solid-state construction providing robust reliability with few moving parts.

Ability to heat and cool for precise temperature control.

Use no hazardous CFC refrigerants.

Can be mounted in most any orientation.

• • •

Reduce development time.

Reduce operating cost.

Offer options for customization.

Thermoelectric coolers and assemblies in combination with temperature controllers are ideal for medical thermal management applications that require active cooling to below ambient temperatures and have cooling capacity requirements of up to 500 W. Peltier devices provide precise temperature control in an efficient and compact form factor, all at a lower total cost-of-ownership.

Andrew Dereka is product director at Laird Thermal Systems. He has 18 years of experience in engineering, sales and product management.

MEDICAL DEVICEwww.arthurgrussell.com ASSEMBLY Manufacturing_11-19_Vs4-CN-FINAL.indd 57

11/21/19 5:20 PM

MANUFACTURING

How EU MDR will affect labeling on small medical devices The EU’s new Medical Device Regulation includes Direct Part Marking requirements that challenge manufacturers of small-part and orthopedic devices to use the entirety of a part’s complex surface geometry for labeling.

Dwalin DeBoer Mack Molding

This process validation engineer programs a laser to mark a surgical instrument.

Image from Mack Molding

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U MDR is the newest set of regulations governing companies that produce and/ or distribute medical devices within the European Union. It aims to increase medical device safety and effectiveness, address weaknesses identified by manufacturers and to account for rapidly changing technological developments in the industry.

Beginning in May 2020 EU MDR replaces 1992’s Medical Device Directive (MDD).

Marking requirements While these new regulations encompass much more than part marking, this aspect has proven to be no small undertaking. In many ways, the EU MDR DPM is similar to FDA’s Unique Device Identification (UDI) system; however, there are differences, such as the MDR’s 2D barcode requirement.

Many medical devices, including smaller ones used in orthopedic applications, have limited area for part markings. The increased amount of information that is required on each device coupled with often-complex shapes and limited space for these markings has created a challenge for OEMs and manufacturers. Adding to the urgency is the fact that parts with the CE Mark will not be granted immediate compliance to the MDR standards.

In order to maintain the CE Mark, these products must be reviewed against and meet all of its requirements.

Embracing lasers Advancements in laser technology do more than make UDIs legible. They can make 2D-printable barcodes and other markings on curved and articulating surfaces and in several different planes, maximizing the amount of surface area used for marking purposes. In some cases, these machines also check the work by

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inspecting the recently marked barcode for readability, sharpness and other parameters. This report can subsequently be printed and added to the DHR. Some laser-marking equipment can even locate the part and appropriately orient it for marking, eliminating the need for holding fixtures. Current technology has increased in speed and is able to print several surfaces in one set-up.

These new laser-marking devices can also handle several different kinds of plastics, metals and even paper, offering versatility in printable materials. The uses vary from catheters to surgical instruments to paper serial tags for non-medical products. It is important, however, to understand the power of the laser being used. When marking stainless steel, it is essential to not use a highheat, deep burn as the part cannot be passivated in the field and will ultimately succumb to rust. Using a focus adjustment that reduces the concentrated laser beam to a less excited state can produce a high-contrast engraving with low heat penetration.

Laser marking also offers near-unlimited resolution.

Images can be smaller than the head of a pin, so small as to be imperceptible to the human eye but legible under a microscope.

Because laser marking changes the surface of the part — as opposed to an ink that would be adhered to the part — it produces a permanent and professional result.

Laser marking is typically faster than other processes such as pad printing, while avoiding complications from wet ink such as solvent pop, and providing significantly improved abrasion resistance. Additionally, laser marking allows for serialization in applications where this is necessary, indexing with a variable that will sequentially serialize parts, making each unique.

EU MDR goes into effect in little more than six months. Laser marking’s speed, versatility and other efficiencies set it apart in its ability to meet the regulation’s requirements for existing and new parts in a timely manner. Whether the part is a metal sterilization tray or a plastic imprint trial, the resulting image is crisp, clean and sharp through a process that is highly repeatable and accurate.

Dwalin DeBoer is a business unit director for Mack Medical/Mack Molding (Arlington, Vt.), working with medical device customers on reusable and disposable applications.

www.medicaldesignandoutsourcing.com

11/22/19 2:45 PM

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.

To learn more, call 586.263.5100 or visit teampti.com Prototype | Design | Engineering | 3D CAD Modeling | Tooling | Molding | Manufacturing | Cleanroom Molding

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MANUFACTURING

How going paperless can improve manufacturing speed and accuracy A manufacturer that eliminates paper from its shop floor can save time and money while reducing errors.

John O’Kelly Newcastle Systems

Image from Newcastle Systems

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Benefits of going paperless • Reduced motion — Walking back and forth endlessly from product to printer impedes efficiency in the manufacturing process. In many cases, the wasted steps occur when associates on the floor walk to a static printer or computer, since most do not have direct access to vital information needed to accurately compete their job. The shift to paperless processing reduces motion and cuts down on steps, vastly improving productivity.

Companies that have already embraced a paperless shop floor have seen a 75% reduction in overtime, 90% reduction in labeling errors and a savings of up to $7,500 in labor costs per user.

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Improved accuracy and tracking — Errors are common when associates need to look at multiple pieces of paper to track and complete their tasks.

Changes are quite common in medical device manufacturing, and paperless techniques make it easy to update important data accurately.

Real-time data — The ability to continuously monitor real-time data enables workers to view, analyze and make decisions using the most accurate statistics possible, thus improving decision-making

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across the company. When paper is the primary information source on the floor, employees are often working with outdated information. Gathering data is time-consuming and takes a lot of work.

Automation is key to improved efficiency.

s competition and regulation in medical device manufacturing increase, speed and accuracy take on even more importance.

Paperless operations streamline the approach by reducing errors and speeding up delivery.

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The benefits are clear, but how do you implement a paperless methodology within your manufacturing facility? Here are a few solutions to consider.

How to go paperless • Mobile power — Because of medical device manufacturing regulation requirements, work instructions and the device history records (DHR) must follow the staff member and manufactured product at all stages of production. Introducing mobile-powered work stations, equipped with a laptop, printer and a radio frequency (RF) scanner, gives staff the flexibility to move with and/or around the product. This reduces wasted motion and the need for a paper trail, which can be costly when it comes to efficiency and accuracy.

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Software — When combined with a mobilepowered workstation, enterprise resource planning (ERP) and manufacturing execution system (MES) software help reduce the use of paper and the risk of errors while also decreasing part lead time.

Medical and clinical device manufacturer Cogmedix recently embarked upon a company-wide process improvement initiative that included the shift to paperless

www.medicaldesignandoutsourcing.com

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processing. Derek Fournier, scaled product launch manager at the company, said that under Cogmedix’s previous ERP system, technicians were walking to static computer stations to log in and out of work orders.

“The disruptions would escalate at lunchtime and end-of-day as lines would tend to form with multiple associates looking to transact their work orders,” Fournier said. “Also, for associates who were running higher-volume production with multiple work orders in a day, that required them to remove themselves from the production cell every time a work order was completed and started.”

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EAGLE STAINLESS Tube & Fabrication, Inc.

With the advanced technology and the expertise to deliver stainless steel exactly as you want it.

RF scanning and paperless picking — Combined with ERP software, RF scanning enables staff members to reduce their paper trail and complete their tasks in a timely manner. RF scanning allows staff to book production output directly, giving all staff members an easy way to track everything that leaves the floor — a huge efficiency benefit when tracking output stats and projects’ status. Implementing RF scanning also reduces the time needed to complete inventory checks and gives everyone on the floor a clear understanding of inventory. Paperwork with tasks and lists cut into productivity, while RF scanning gives correct picking assignments faster, adding a layer of efficiency and accuracy.

Extensive tubing inventory - Eagle stocks stainless, copper, brass and aluminum in metric, hypodermic and fractional tubing in an extensive assortment of grades.

Cut-to-length tubing - Eagle can cut and de-burr any diameter in quantities from 1 piece to millions from lengths of .040” and longer with a standard tolerance of ±.005 on diameters of less than 1”. Closer tolerances are met quite often.

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

For Cogmedix, the integration of mobility and elimination of paper have dramatically improved the manufacturing process.

“Now, we can maximize our resources, get cells up and running faster and be more productive using strategic computers, printers and scanners,” Fournier said.

The medical device manufacturing industry is fiercely competitive. Everyone is looking to be faster and more accurate, meaning that even the smallest improvements in efficiency, such as going paperless, can give you a leg-up on the competition. The transition doesn’t happen overnight; it takes time. However, the result is a more competent manufacturing process and an improved bottom line.

CNC Machining Centers - enable machining some of the most intricate parts imaginable.

Working in diameters from .030” to 2”, we’re ready to meet your most demanding requirements.

Wire EDM & Laser Machining enables Eagle to produce some of the mosdt exotic parts imaginable.

John O’Kelly is the founder and CEO of Newcastle Systems, a workplace mobility solutions company partnering with many of the world’s leading companies to enhance worker productivity, operational efficiency and organizational profitability.

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Assembly - Custom tube drawing and assembly of multiple parts to achieve a single component.

End reduction Bulging Flaring

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End Forming - Robotic machine centers speed production and reduces cost.

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11/21/19 5:21 PM

MANUFACTURING

How to speed your device to market Developing a device from pre-clinical work through clinical trials and the regulatory process can take years and millions of dollars. Several factors can help a company to maintain a steady pace without breaking the bottom line.

M a t t Va l e g o RBC Medical Innovations

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wo of the most significant challenges in medical device manufacturing are getting the product to market faster than the competition and meeting high client demands. Larger original equipment manufacturers (OEMs) that sell medical devices to institutions, such as hospitals and clinics, can expedite speed to market by working with clinicians to quickly identify unmet needs and indications for use. However, converting this feedback quickly into a deployable device can be a challenge.

Oncology tumor ablation, chronic pain treatments, vessel sealing and renal denervation are a few examples of minimally invasive surgical therapies that employ radio frequency generator-based treatments. For these clinical areas of development, it is more important than ever to quickly identify new markets to maintain a competitive growth strategy. This speed to market helps companies compete and stay innovative while lowering the total cost of owning their capital equipment by using common components across multiple verticals.

The equipment itself is a significant component to the overall system cost. Typically, manufacturing equipment is very purpose-built, and changing or updating it requires extensive redesign and testing.

A more configurable platform that allows for adding features or performing maintenance updates could lower the cost of ownership. In some cases, features may be added without changing equipment software.

Taking this a step further, new technology is available that allows a client to introduce new therapies without updating generator software. Those therapies include connecting a new multi-electrode catheter to perform an enhanced ablation treatment. Introducing a unique catheter with a different control algorithm can expands the original device’s applications.

The technology behind these innovations involves using an encrypted communication protocol and framework that are pre-programmed into the ablation generator and enabled by the probes that plug into them. The probe tells the generator what to do, allowing it to perform new functions and use new features without ever having to update its software.

These platforms offer highly customized RF energy for novel and unique therapies.

While most general-purpose RF energy platforms have a variety of settings, they cannot be highly customized. This technology allows the customer

Medical Design & Outsourcing

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Image from RBC Medical Innovations

the flexibility to create unique therapies and user experiences in a fraction of the time it would take to create custom settings from scratch.

This solution also alleviates a major logistical pain point, as updating software on capital equipment deployed in the field is very time-consuming and costly.

Field representatives must go out to each center, or the center’s direct employees must be trained to perform software updates. Additionally, records must be generated that work was completed, and transferred back to the manufacturer for record-keeping — another time-consuming process.

Smaller firms and startups can also use an RF development platform to customize their algorithms in order to get to clinical trials faster. Startups can save money and reduce their risk of missing investor and clinical milestones. A developmental platform can also allow small firms and startups to expand their bench research and try things they would have otherwise been unable to due to constraints of off-the-shelf generators.

For example, they can experiment rapidly to figure out a catheter/probe design and energy combination that will produce the desired lesion, which in turn produces the desired clinical effect.

A customizable development platform may also allow a company to build the first device on a commercial-ready system, rather than developing the market-ready product after the clinical concept is proven.

Matt Valego is VP of sales & marketing for RBC Medical Innovations. He has more than 20 years of experience in medical sales, marketing and business development.

www.medicaldesignandoutsourcing.com

11/21/19 5:21 PM

Expanding the universe of motion MICROMO is now FAULHABER MICROMO

WE CREATE MOTION

As a member of the FAULHABER Group since its inception, FAULHABER MICROMO’s long-standing partnership and coordination with FAULHABER Drive Systems is now amplified. Reorganized as a united, fully-integrated part of FAULHABER Drive Systems, FAULHABER MICROMO now has expanded design and engineering capabilities, providing improved customer support, faster lead times on products, and additional motion control expertise for OEMs in the North American market.

FAULHABER MICROMO · Clearwater, FL USA 800-807-9166 · www.faulhaberUSA.com

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11/21/19 3:33 PM

MANUFACTURING

3 tips to avoid common medtech packaging blunders A medical device packaging expert reveals three common packaging mistakes and how to avoid them.

Mike Hafner Viant

Mike Hafner is packaging engineering manager at Viant.

Image courtesy of Viant

P

ackaging engineers likely get more than their share of flak during the holidays when family members unwrap hard-to-open packages. They have also seen their share of packaging challenges at work. Here are three common packaging mishaps as well as three tips for avoiding them: •

•

•

The home-run approach, which is easy to spot.

The device is surrounded in foam as a lastminute method of protecting the sterile barrier.

That indicates that the core team likely ran into some unexpected package performance issues, ran short on time, and had to find a workable (but less efficient) solution to get their product out the door.

Shoehorning a new device into an existing packaging system without evaluating and assessing risk may seem like a good idea.

Using existing package systems can effectively shorten a timeline. The problem comes when you identify new design criteria beyond what the package system was originally designed for. This can lead to hybrid designs that require additional time to implement, time that may not be built into the project timeline.

The domino effect occurs when design engineers are so focused on all the devicerelated details that they haven’t considered how product design changes can affect packaging.

Even small tweaks, such as increased diameters or changes in materials, edge profiles or surface treatments, can mean that a snap-fit package no longer performs as intended, or a pouch no longer comes together for an effective seal.

Packaging missteps like these can cost your team in terms of both money and time. Here are three suggestions for avoiding them.

Allow enough time for design and development Leaving packaging and labeling to the end of the project often results in suboptimal packaging at best, and cost overruns, delayed product launches and lost revenue at worst. A new package system may take more than six months to develop. Be sure to include time for working through design phases, component lead times, build durations and test durations.

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Work closely with the core team A packaging engineer should have a seat at the table at the earliest stages of product design, as a core team member or at least working closely with the core team. As the device changes throughout its lifecycle, so should the packaging design change to accommodate the product. This will ensure that you’re taking packaging needs into account at each step up until launch, and in some cases, beyond launch.

Understand the design inputs While protecting the device and maintaining sterility will always be critical, package design inputs and criteria shouldn’t stop there. Make sure you thoroughly capture all the requirements throughout the entire lifecycle. For example: •

How will the device be loaded into the package during manufacturing?

• How will the device be sterilized?

• What is its intended shelf life?

• Does the device have environmental limitations?

• Does it have features you must isolate or protect?

• How will the end-user remove the device from the package while maintaining an aseptic technique?

If all this talk of what can go wrong with packaging makes you break out in a cold sweat, don’t worry. An experienced partner can take the entire process off your shoulders. Look for a manufacturing partner with true end-to-end solutions, including packaging engineering.

This partner can develop packaging for manufacturing customers, allowing them to streamline their supply chains and avoid costly packaging mistakes.

While your device packaging may not be featured in an “unboxing video” on YouTube, it’s important to keep in mind that the packaging will always be the first thing your customer sees.

Mike Hafner manages a team of degreed packaging engineers supporting a wide range of devices throughout the product lifecycle. With 15 years of medical device industry experience, he has led packaging efforts for numerous product launches and has implemented dozens of new package systems.

www.medicaldesignandoutsourcing.com

11/21/19 5:21 PM

NEW GENERATION

You’ve never seen

a solenoid valve like this before.

TM

High Flow, Low Power, Low Leakage Across an Extensive Cycle Life The Lee Company is excited to announce a new generation of versatile and innovative 3-port solenoid valves. In a miniature 10mm package, the genvi™ solenoid valve platform features high flow capacity, low leakage and ultra-low power consumption. Designed using innovative manufacturing techniques, this new valve offers not only unmatched reliability, but also an economical price point suitable for molecular diagnostics, respiratory therapy, compression therapy, environmental monitors, breath analyzers and other applications where performance and reliability are paramount.

When designing portable or stationary instruments, OEMs are often challenged with meeting aggressive size, power, and weight limitations, all without sacrificing the remaining elements of system-level performance.

Each subcomponent is therefore pushed to offer improved performance within a smaller footprint.

Featuring high flow and low power consumption, genvi solenoid valves are the solution. An extremely tight leakage rating reduces compressor demand and further underscores the valve’s ability to provide consistent long-term operation across an extensive cycle life.

Custom valve solutions, supported by The Lee Company’s Innovation in Miniature engineering experience in microfluidics, are also available ® to meet specific application requirements.

The Lee Company

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COMPAMED, Hall 8a/K09 and BIOMEDevice, Booth #633 or TheLeeCo.com/genvi W E S T B R O O K

Genvi_MedicalDesign&OutsourcingNOV2019.indd 1 TheLeeCo 11-19.indd 56

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10/16/19 11/21/19 11:22 4:17 AM PM

MATERIALS

ALUMINUM ANODIZING? Neel Patel

|

V P, F l o r i d a A n o d i z e S y s t e m & Te c h n o l o g i e s ( F A S T )

Aluminum anodizing is the electrochemical passivation process by which the surface layer of an aluminum substrate is converted into an aluminum oxide layer. While a natural oxide layer can be found on aluminum, this layer is often uneven, thin and offers poor protection. The controlled application of an electrical charge in an acidic electrolytic bath results in a very regular and uniform layer that has increased durability, as well as wear and corrosion resistance. Additionally, these anodic layers can undergo secondary processing to incorporate various functional materials such as colorants or lubricants.

There are numerous processes and standards that apply to aluminum anodizing, the most common find their origins from the defense, aerospace and automotive industries. In the U.S., the most often cited anodizing specification is the U.S. Defense specification MIL-A-8625 which defines three types of aluminum anodizing Type I – Chromic acid anodizing, Type II – Sulfuric acid anodizing and Type III – Sulfuric acid hard anodizing, with Type II and Type III being the most often utilized.

How are anodic coatings applied?

The anodizing processes involve submerging the aluminum component into an acid electrolytic bath and then passing an electrical charge through the medium. A cathode is located on the outside of the tank, while the aluminum serves as an anode (hence the term anodizing). As the current moves through the bath, oxygen ions are released from the acid electrolyte and join with the aluminum substrate producing the aluminum oxide layer. It is important to note that, unlike a paint or plating process, the anodic layer is fully integrated into the underlying substrate, actually forming into and out of the substrate at the same time.

What you should look for in an anodic coating?

People often misinterpret the terminology of anodizing, especially in regard to the phrase “hardcoat.” While on the face of it, the word hard would seem to indicate some form of strength or wear resistance, in this instance, hardcoat is more accurately referring to the thickness of the anodic layer.

The specification from which the term is derived, MIL-A-8625, does not even mention any hardness characteristics for either Type II or Type III anodizes. In fact, the hardness of the aluminum oxide of both types would be equivalent, though the difference in thickness of the hardcoat does significantly alter the surface appearance of the substrate.

This, in turn, leads to what is the ideal anodic coating for medical devices. As stated earlier, the most common anodizing specifications in the U.S. come from the aerospace and defense

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Image from Florida Anodize System & Technologies

industries. The needs of these industries are far different than those of medical and surgical devices. For example, the mechanical considerations of the aerospace, defense and automotive industries necessitate abrasion resistance and so a hardcoat anodize would be appropriate. However, for the medical and surgical industries, abrasion resistance is not as high a concern as chemical resiliency as would be needed for sterilization systems.

So, first and foremost, it would be imperative that a medical anodize be durable enough to withstand at least 50 cycles (and preferably more) of ethylene oxide, hydrogen peroxide or high alkaline cleaner. This would require it to have a non-leaching colorant that does not fade, peel or blister after repeat sterilization processing.

Additionally, besides thickness considerations or chemical resiliency, a good medical anodize should also have a smooth and even finish with no localized discoloration, and colors should not appear dull or muddled (unless that is the desired appearance). Rather, for easy identification and human factors considerations in the medical setting, the anodic coatings should have a vibrant, easily identifiable and lustrous finish.

Finally, as human factors assessments in medical device design are becoming ever more stringent, a medical anodize should be available in a multitude of colors to assist operators in making an easy distinction between device types or control surfaces. While black or clear finishes are available, a palette of non-leachable, sterilization resistant colors enables medical device manufacturers to effectively utilize color as a human factors modality.

In summary, a medical-grade anodize should be: • • • •

an even and consistent finish. be available in a multitude of non-leaching colors. be aesthetically pleasing. resistant to the harsh chemical environments of sterilization systems.

www.medicaldesignandoutsourcing.com

11/22/19 1:05 PM

I know that my outsource decisions can impact his outcome.

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Viant 9-19.indd 56

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VIANTMEDICAL.COM info@viantmedical.com ©2019 Viant. All rights reserved.

11/21/19 4:19 PM

MATERIALS

W H AT I S A L U M I N U M A N O D I Z I N G ?

What to look for in an anodizing provider Anodizing providers are located in almost every corner of the United States. However, in the medical device industry, the cost of non-quality is exceptionally severe, and so manufacturers must be vigilant in their selection of an anodizing provider.

When selecting a vendor, a few important things to consider include: •

Medical industry experience – Most anodizing is performed for the aerospace and defense industries, so selecting an anodizing company not just experienced, but with specialization in medical devices can drastically impact the finished quality of the anodic coating. Acceptable machining oils, manufacturing standards, etc. are all industry-specific, so processing medical equipment in chemical baths used for other industries can lead to bath contamination and nonconforming material.

•

•

(CONTINUED)

Medical industry compliance - When all components are critical-to-quality, it is important that a vendor understands the regulatory requirements of the medical device sector and have an industry-specific audited Quality Management System such as ISO 13485.

Validated and scalable production – The consistency and quality of the finished anodic coating must be measured and validated at a level acceptable for scalable production. When selecting a vendor, it is appropriate to ask about a company’s QC pass percentage, particularly as in the medical device industry the costs associated with noncomplying/nonconforming materials returns can be both financially significant, and also a regulatory complication. A QC pass rate of 98% or greater is usually a signal of a high-quality medical-grade anodic process.

Neel Patel is a VP at Florida Anodize System & Technologies (FAST) in Sanford, Fla.

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Materials_11-19_Vs6.indd 68

11/22/19 9:41 AM

Could Biocoat's hydrophilic coating promote vascular catheter innovation?

Biocoat officials say their Hydak coatings deliver competitive durability and lubricity — and they’re made out of a naturally occurring substance.

Chris Newmarker Executive Editor

e

s.

on

65

B

iocoat (Horsham, Pa.) this year has been touting internal studies in which its Hydak coatings demonstrated durability and lubricity that matched or exceeded other hydrophilic coatings, additives, PTFE and silicone.

Better yet, Hydak offers extremely low particulate counts, according to the company. Plus, it’s made out of something that’s already in the human body: hyaluronic acid (HA), a naturally occurring polysaccharide.

Biocoat applies its Hydak coatings using a thermal heat curing system in which it places coated items in an oven for a predetermined time. The controlled heating accelerates drying of the solvent and any necessary chemical reactions taking place within the coating, enabling a better surface bond and durability, according to Biocoat. The consistent and uniform bonding from the thermal heating system means that it’s possible to coat both the inner and outer diameter of a catheter device.

Biocoat officials acknowledge that the high levels of lubricity and durability that hydrophilic coatings offer are not always required for some procedures and devices. However, they argue that premium performance will greatly benefit catheter procedures designed to treat life or death cases, such as in cardiovascular and neurovascular applications.

“Could you get a neurovascular catheter from your groin to your brain using one of those additives or Teflon? Absolutely. Is it going to be more difficult for the doctor? Yes. Is it probably going to be more difficult for the patient to recover? Yes,” Bob Hergenrother, senior director of R&D at Biocoat, told Medical Design & Outsourcing.

Here are the four main variables that Hergenrother suggests evaluating when it comes to deciding what type of lubricious coating to use in a catheter application: www.medicaldesignandoutsourcing.com

Materials_11-19_Vs6.indd 69

1. Particulates Government regulators are scrutinizing, in fact demanding, particulate data from medical device companies. The count of foreign materials left in the body after a device is used is extremely important when it comes to patient safety, Hergenrother said.

2. Friction Doctors performing procedures that include a catheter consider “low friction” as a must-have because it directly impacts ease of use, according to Hergenrother. It also serves to reduce patient discomfort and may improve healing, with shortened procedure times.

3. Durability When it comes to catheter-based cardiovascular or neurovascular procedures, there can be many twists and turns on the route to the targeted area of interest, so a coating needs to maintain consistent lubricity while remaining durable throughout the procedure, Hergenrother said. In theory, the more durable the coating, the less particulates generated.

4. Pricing Biocoat officials acknowledged that hydrophilic coatings may be more expensive than other lubricious materials. However, they say the overall performance and safety profile that hydrophilic coatings offer justify the higher pricing model. The difference in overall performance can be seen in the following chart, which shows the overall performance of the different types of lubricious materials.

In this chart, the Biocoat R&D team tested several types of lubricious coatings that are typically used to minimize friction on interventional medical devices. The tested coatings include Biocoat’s Hydak hydrophilic coating, extrusion additives, silicone oils and polytetrafluoroethylene (PTFE).

To complete this test, the Biocoat R&D team performed a pinch test and recorded the results after testing cycles 1-3 and after cycle 30 to determine the initial friction and overall durability of the coating material. The materials coated with Biocoat’s Hydak coatings had significantly better lubricity and durability counts than any of the other tested materials, according to the company.

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Medical Design & Outsourcing

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MATERIALS

KOLSTERISING?

Kolsterising is a low temperature, thermo-chemical, diffusionbased surface hardening technology that is used to enhance the inherently poor mechanical and tribological properties of austenitic stainless steels, according to Derek Dandy, a medical market development engineer at Bodycote. It can be used on stainless steels, cobalt and nickel-based alloys, offering hardness and improved mechanical and wear properties without corrosion resistance loss.

Because of its diffusion characteristics, kolsterising is ideal for medical devices that require corrosion, wear and fatigue resistance. It can eliminate delamination and metal debris, as well as galling in stainless steel alloys to improve wear resistance and fatigue strength.

This process allows for the use of more common materials, such as 316L, to achieve the performance of

Danielle Kirsh

|

Senior Editor

materials like 465 and Nitronic. Kolsterising also offers consistent diffusion depth, increased abrasive wear and cavitation erosion resistance, elimination of galling and fretting, and scratch resistance. It also does not affect magnetic properties of metal alloys.

The enhancements are accomplished by adding large concentrations of carbon atoms which form high compressive stresses at the surface. The compressive stresses along with occupation of the interstitial sites by the carbon atoms cause a significant increase in the surface hardness of the material, which improve mechanical and tribological properties. Also, because no phase change takes place, the final part’s dimensions, surface finish, and corrosion resistance are maintained.

For more information, visit Bodycote’s website at bodycote.com/s3p

Better Together

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11/22/19 8:54 AM

TRACO POWER North America, Inc. http://us.tracopower.com salesusa@tracopower.com +1 (408) 916-4570

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TPP15-J

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2.82 x 1.14 x 0.85”

TPP 30A-D

30

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2.74 x 1.36 x 0.95”

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TracoPower 11-19.indd 56

11/21/19 4:18 PM

MOLDING

Image from Apple Rubber Products

4 considerations before designing a rubber medical part Knowing the requirements of everyone involved in developing a molded rubber medical part during the design phase can speed the process right through production.

J o h n Tr a n q u i l l i Apple Rubber Products

W

hen designing a medical rubber part, designers should not only think about the functionality of the part but also about other compliance requirements. This can help to remedy the common disconnect among the design engineer, purchasing agent and quality-compliance engineer.

Design engineers want to get the part that will work in their assembly. Purchasing agents want to make sure they can meet the timetable and get the most cost-effective part. Quality engineers need all the documentation to satisfy quality standards and information to pass regulatory reviews.

Using the right material With new material regulations being introduced, making sure you have the right material is critical.

EU MDR (European Union Medical Device Regulation) is changing the requirements for materials used in medical devices.

Many design engineers use common rubber sealing material in prototype concept work. It’s the easiest to get and they may believe all rubber materials are the same. Before the product goes to market, a company’s regulatory department may find the material unacceptable or needing a high level of testing to determine if the material is qualified for use.

Letting a rubber molder know the material is going to be used in a medical device will allow the molder to select the correct material. This will help streamline compliance and may eliminate future

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testing if the material is already tested. Medicalgrade rubbers typically have been tested to FDA USP Class VI or ISO 10993.

Formulators also try to eliminate substances that are found on restricted-use lists, such as REACH, Prop 65 or EU MDR. Rubber compounds are typically made up of 20 or so individual ingredients, compared with plastic compounds that might only have three or fewer. Formulating medical rubbers requires an extensive review of these ingredients, including the purity level of each.

Rubber tolerance Many standard title blocks have the same tolerance callout. These callouts are typically used in metal forming. High-precision lathes can cut metal to very high precision so tolerance is very low. A typical callout on three places is +/- .005 in.

This may work for small rubber parts, but in most cases, this is too low for rubber. The ingredients in a rubber formulation are mixed at a given tolerance. This can cause variations in the amount of shrinkage from batch to batch.

In addition, molds are heated. The tolerance on a mold temperature profile can also cause shrinkage variations.

The combination of this tolerance stackup causes a higher degree of required dimensional tolerance. The Association of Rubber Products Manufacturers (ARPM) provides a standardized rubber tolerance guide based on the level of

www.medicaldesignandoutsourcing.com

11/22/19 9:02 AM

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MOLDING

precision. High precision would be A1, through commercial products at A3. Of course, the higher the precision, typically the higher the cost. Assuring the correct tolerance on a rubber part print will assure the part is quoted appropriately.

Surface finish Unlike metal and plastic, which allow for a roughness tester to measure the peaks and valleys of surface imperfections, rubber is deformed when being tested by most devices. You can’t get a good measurement of roughness on a finished rubber part. A molder will most likely reject your addition of roughness specifications to prints. To get a specific texture on a part, the mold is textured.

Since the molds are made from hardened steel, a measurement could be made on the tooling, if required.

Designers tend to put highly polished values on rubber goods. This could lead to problems. Highly polished flat surfaces will stick together during

Molding_11-19-Vs6-CN-FINAL.indd 74

transport and customers will get a bag of stuck-together parts. Take the example of flat gaskets. If the mold is polished, the flat gaskets will stack up and will have to be peeled apart before use.

Another example is polished O-rings.

When using automated assembly systems, most use a vibratory bowl feeder. These can cause the O-rings to form columns and stop the feeding system. In both cases, a textured finish will help prevent this and should not affect sealing, because the rubber is going to deform into your sealing mating components.

Quality documents Typically before medical devices go to market, a full regulatory review is completed. This can cause long delays when the requirements are not known in the pre-production phase and can postpone the market launch. Rubber molders need to know the required documentation before approving

prototype or production tooling. Design engineers may want to have their quality department contact the molder to relay this information. This will allow the molder to properly quote the required workload.

It also allows them to assure no schedule conflicts. Standard first-article inspection reports are common when new tooling is purchased. Full IQ/PQ/OQ process validations can require many hours to complete, especially if there is a largecavity tooling like a small O-ring tool.

With a little work during the design phase, rubber medical parts can have smooth sailing right through production.

Rubber molders want to make sure a customer gets the part they want, but also want to make sure the correct paperwork is supplied.

John Tranquilli is a rubber chemist and materials manager at Apple Rubber Products, where he has worked for 23 years. Tranquili holds a B.S. in chemical engineering from the University at Buffalo.

11/22/19 9:02 AM

REEL-TO-REEL MOLDING? Armand Pagano

|

Weiss-Aug Co.

A reel-to-reel method for electronics manufacturing eliminates waste and error to reduce costs. Here’s how.

Reel-to-reel insert molding can prove a more efficient process for design engineers when it comes to lowering assembly costs. The process is best suited for products that require dimensional stability and need to function in harsh environments, such as drug-delivery device parts and components.

How it works Reel-to-reel insert over-molding combines two technologies: stamping and molding.

In the reel-to-reel process, stamped components or frames arrive from the stamper in continuous form on a disposable cardboard, Masonite, plastic or other type of reel.

The base material of the stamped frame can be any material.

Copper or nickel-based alloys are the most common.

The perforated, continuous strip resembles a movie film.

Perforations, known as pilot holes, advance the coiled sheet and locate the metal strip in the progressive die. The accuracy of the relationship between the mold’s cavity and the pilot hole guarantees that the plastic detail always remains in the right place. The pilot hole also helps ensure the correct alignment of components in any subsequent manufacturing operation, such as forming, bending, soldering, welding or assembly.

Technicians mount the stamped, reeled-up frame onto a pay-out reel (uncoiled), which feeds into the molding machine.

Like the feeding motion in the die, the frame advances through the mold after each molding cycle. Here, the feeding unit on the punch press is usually mounted on the beginning of the progressive die and pushes the strips through the die.

This arrangement is opposite in the molding process, where the feeding unit mounts at the end of the mold and the strip is pulled through the mold. Molding can take place in a horizontal or vertical molding machine. Following the molding process, the frame rolls back onto a reel, and the part is ready for any secondary operation or shipment to the customer.

Reel improvements The reel-to-reel system saves money by eliminating waste and reducing processing hours, as well as the need for additional equipment and staff. It also enables improved designs and lower up-front costs.

Because the device developer receives a continually molded and oriented product, less sophisticated assembly tooling is required.

It decreases up-front tooling costs compared with

shuttle or rotary molding. Reel-to-reel requires only one “A” and one “B” side mold, whereas rotary or shuttle molding can require multiple “B” sides. Further, the process employs vertical molding, which is lower in cost for hourly machine rates and part costs because the press is less expensive and has a smaller footprint.

Reel-to-reel also offers savings in terms of reducing operating needs and material waste. No operators are required to place stamped inserts into the mold cavity or assemble them into load bars. And the single continuous frame eliminates the need (and cost) of a robot or other delivery system.

The continuous, unattended operation ensures consistent, repeatable cycle times, with a high-quality product result.

Flash and mold damage are practically eliminated because components are automatically placed accurately. Medical device parts can be expensive and can be made from expensive alloys, such as gold, for plating. The process doesn’t waste gold in the stamped contact area of electronic components.

Finished parts fit onto a single reel, ensuring an economical, safe way to package and transport components.

Higher output gives the engineer greater latitude in designing a product, especially when two strips are fed into a mold.

The tolerances achievable in reel-to-reel are the same as for any other type of insert molding and are limited only by the resin selected (as far as plastic part dimensions are concerned) and whether the blank tolerances of the strip can be maintained. Typically, the thinner the metal used, the greater the accuracy between plastic and metal. For some liquid crystal polymer resins, the accuracy can be in the .01mm range.

Best practices While reel-to-reel offers significant savings and flexibility, it is important to consider a few design and operation matters.

Keep in mind that the part needs to fit the application.

Otherwise, the process will require more metal to make the same part. The geometry of the part should also fit the process, because the carrier strip may not allow movements for undercut features.

Be sure to monitor the strip position during the cycle. The tool can be damaged if the strip position goes over a shutoff. Likewise, have a process in place to monitor part quality coming out of the tool, particularly if a secondary process is in line and the parts are high-value. A technician must be able to stop and fix an issue before making a ton of scrap.

With these simple requirements, reel-to-reel can offer a variety of advantages for medical devices.

www.medicaldesignandoutsourcing.com

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MOLDING

These common thermoplastics are ideal for medical device injection molding The properties of certain polymers make them good choices for a variety of medical devices.

Raj Singh BMP

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electing the correct medical-grade plastic for a medical device or component is a critical decision in manufacturing the perfect part.

Polymers have long been considered to have a significant advantage over metals for medical applications.

That’s because the isotonic saline solution that comprises the body’s extracellular fluid is extremely hostile to metals but is not normally associated with the degradation of many synthetic high-molecular-weight polymers.

Polymers are typically classified into three groups.

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Injection molding manufacturing equipment

Image from BMP Medical

Thermoplastics — linear or branched polymers that can be melted and molded using conventional techniques. If reheated, wax can be molded into a different shape.

Thermosets — cross-linked polymers that are normally rigid and intractable.

They consist of a 3D molecular network and cannot be re-melted. They degrade rather than melt upon heating.

Elastomers — rubbers that can be stretched to extension and will spring back when the stress is released.

By weight, thermoplastics represent 90% of all plastic used worldwide. Unlike most thermoset plastics, thermoplastics may be processed without any serious losses of properties. Here are some of the most common thermoplastics used in medical device injection molding: Polyethylene Also called polythene, polyethylene can be formulated in high or low densities. It is cost-effective, impact- and corrosion-resistant, absorbs little water and retains its overall performance and structural integrity after frequent sterilization cycles. A porous synthetic polymer, polyethylene is biologically inert, does not degrade in the body and is often used in medical implants.

Polypropylene Polypropylene is a white, mechanically rugged material with a high chemical resistance. It is resistant to stress, cracking, impact and fatigue and has a high melting point.

Polypropylene is commonly used to manufacture disposable syringes, membranes for membrane oxygenators, connectors, finger-joint prostheses, nonabsorbable sutures, reusable plastic containers, pharmacy prescription bottles and clear bags. www.medicaldesignandoutsourcing.com

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Polymethyl methacrylate Polymethyl methacrylate (PMMA) is a synthetic resin that offers transparency, toughness, rigidity and an almost perfect transmission of visible light. An ideal substitute for glass, it can keep a beam of light reflected within its surfaces and is frequently made into optical fibers for telecommunication and endoscopy.

Polyvinyl chloride Polyvinyl chloride (PVC) is produced in two general forms, as a rigid or unplasticized polymer (RPVC), and as a flexible plastic. Flexible PVC is commonly used in areas where a sterile environment is a priority, and in some cases as a replacement for rubber. PVC is dense, inexpensive and readily available.

Rigid PVC is very hard and has extremely good tensile strength.

PVC is commonly used to manufacture disposable devices for hemodialysis or hemoperfusion, as well as tubing, cardiac catheters, blood bags and artificial limb materials.

Polyamide Polyamide, or nylon, is a synthetic thermoplastic polymer that is often used as a substitute for low-strength metals because of its strength, inflexible nature, temperature resilience and chemical compatibility.

Polyamide is good for CNC machining, injection molding and 3D printing. It can be conditioned or combined with other materials to improve its overall strength and is a good option for parts that see a lot of wear and tear. It resists most chemicals but can be tricky to mold and is expensive.

Acrylonitrile butadiene styrene (ABS) ABS is commonly used in part production and 3D-print manufacturing for OEMs. Its impact- and heat resistance and rigidity make it a good engineering plastic, or a substitute for metals in structural parts. It can be injection-molded, blowmolded, or extruded, melted and reshaped, and sterilized by gamma radiation or ethylene oxide (EtO).

Common uses are non-absorbable sutures, tendon prostheses, drug-delivery systems and tracheal tubes.

Polycarbonate Polycarbonate is naturally transparent and offers good UV protection. It is a good alternative to glass, relatively shatterproof., and medical grades can be sterilized using steam at 120 °C, gamma radiation or EtO. Polycarbonate is lightweight, offers chemical-, electrical-, heat- and impact-resistance, stability and high performance.

Raj Singh is technical manager for BMP Medical.

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MOLDING

High-consistency rubber versus liquid silicone rubber for medical device components Here’s how high-consistency rubber and liquid silicone rubber compare when it comes to making medical device components, according to ProMed, which primarily works with the two types of silicone.

Chris Newmarker Executive Editor

Curtis Hodgin, a block project engineer at ProMed, shows off a video of silicone mixing processes during a 30thanniversary tour of the company's Plymouth, Minn. headquarters in October.

Image by executive editor Chris Newmarker

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roMed (Plymouth, Minn.) has decades of experience providing the medical device industry with implantable silicone components and assemblies. Its 30th-anniversary celebration at its Plymouth headquarters in October included tours with some good basic primers of the company’s manufacturing processes, which have expanded over the years to include assembly, micro-molding of highly engineered plastics and combination products.

Here’s how ProMed engineers described high-consistency rubber (HCR) and liquid silicone rubber (LSR) — two types of silicone that the company frequently works with. (Note that silicone comes with two parts — one with the catalyst and the other with the crosslinker.)

What is high-consistency rubber?

Also called gum stock because of its “gummy” consistency, HCR has a higher viscosity compared to LSR. It comes partially vulcanized in sheets and bricks and is an older technology primarily used before the development of LSR. HCR’s higher viscosity makes it more difficult to process, with mixing techniques primarly limited to cooled roll mills, according to Curtis Hodgin, block project engineer at ProMed. The manufacturing techniques are also different when it comes to HCR. ProMed manufactures HCR using transfer- and injection-type presses. Sean McDermid, new product development engineer at ProMed, noted that it is typically compression-molded.

HCR injection molding or transfer molding, Hodgin explained, is generally more complex than LSR injection molding. “Depending on part geometry, high shear conditions can be exhibited in the tool. These shear conditions tend to create variable shrink rates, which can lead to a more complex tool design,” Hodgin told Medical Design & Outsourcing.

What is liquid silicone rubber?

LSR has a lower viscosity than HCR. A newer technology, it comes in sealed buckets. LSRs are

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typically injection-molded and generally have a longer pot life when compared to HCR. “Because of the lower viscosity of LSR, this is the preferred material for manufacturing silicone parts at ProMed. LSR’s lower viscosity allows additives to be added more efficiently when compared to HCR materials,” Hodgin said.

ProMed mixes LSR in two ways, contact- and non-contact mixing. The company can mix in a wide variety of additives, including: • • •

Restricted and non-restricted colorants; Powdered additives including PTFE (Teflon), barium, desiccant and tungsten; Pharmaceuticals such as steroids and hormones.

“Because of LSR’s lower viscosity, the shrink rates and high shear conditions that are exhibited when processing HCR are greatly reduced, making complex geometries more achievable,” Hodgin said. “Parts can be produced more rapidly as LSR is almost always run on an injection-style press.”

How do the two compare?

LSR is easier to manufacture and better intended for use on complex geometries, according to McDermid. HCR can reach better overall properties. LSR, meanwhile, offers a larger variety of material choices.

“Generally, in ProMed’s experience, LSR is preferred by the vast majority of our customers.

Typically, the costs associated with HCR are higher when compared to LSR,” Hodgin said.

Anything else worth noting?

The shrink rate of silicone can affect a project.

Variables include durometer, additive, material flow and gate/vent. ProMed engineers also noted that new mixing technologies are opening the door for high-speed and high-volume mixing processes.

“LSR molding is a technology that is growing,” McDermid said. “The industry seems to be constantly coming up with innovative ideas for new manufacturing techniques and abilities.”

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MOTION CONTROL COMPONENTS

5 reasons to use titanium alloy springs The properties of titanium may make it cost-effective for manufacturing springs for medical devices.

Titanium micro compression springs and extension springs for medical applications Image from Newcomb Spring

2. Reduced spatial requirements Due to titanium’s lower torsional modulus, a titanium spring will require fewer coils than a steel spring to produce a similar load, even when using the same wire diameter. Similarly, a titanium spring can achieve a spring rate (the amount of force required to deflect a spring) with fewer active coils than a similar stainless steel spring.

This often reduces a spring’s free-height, saving space as well as weight. These spatial benefits can be substantial, especially when designing micro-size assemblies.

Stress limitations must always be taken into consideration. In some cases, it may be necessary to increase the wire size to keep the stress in check.

Space savings can be demonstrated using the following formula, in which:

Cricket Rumsey Newcomb Spring

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n surgical components, implantables and other medical devices, springs play a variety of critical roles. Selecting the right spring material can often yield notable improvements in performance, lifespan and cost.

Titanium alloy springs provide critical benefits compared to stainless steels or other materials in many medical applications. A careful cost-benefit analysis can help to ensure the best material is selected.

Here are five potential benefits of titanium allow springs: 1. Corrosion resistance and material stability Titanium provides remarkable corrosion resistance.

This, along with its non-magnetic properties, makes it ideal for many medical and dental applications. While stainless steel had been the material of choice in the past, more and more parts are being designed to take advantage of this very light, strong, non-magnetic material with its excellent corrosion resistance.

Titanium components are often recognized for their biocompatibility, and typically remain static once implanted. Some think of titanium as a material with the same characteristics of bone.

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n – active coils G – modulus in torsion d – wire size R – rate D – mean diameter n = (G * d ^4) / (8 * R * D ^3) Modulus in torsion for 302 stainless steel: 10 x 10^6 (design reference only) Modulus in torsion for titanium: 5.6 x 10^6 (design reference only) In this calculation, a titanium spring would require half of the active coils compared to a stainless steel spring with the same dimensional values.

3. Lightweight Reducing the weight of surgical tools, equipment and implantables has become increasingly important. Titanium instruments are much lighter than similar stainless steel instruments and retain their strength even after being subjected to cyclic loading. Titanium is recognized as having one of the highest metal strength-to-weight ratios.

4. Process-tolerant Medical parts are often exposed to a variety of environmental changes as they move through forming, assembly, cleaning and shipping.

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MOTION CONTROL COMPONENTS

A component may undergo several cleaning and inspection processes before packaging. When put into use, these same parts can be exposed to harsh sanitizing agents as well as bodily fluids. Titanium’s stability from initial forming to final implantation can be critical in a spring’s performance. The complete process — from material specification to packaging design — should be detailed in advance.

5. The cost of titanium is dropping Often, the biggest concern when specifying titanium is cost. While material prices depend on a metal’s purity, titanium typically costs five to seven times more than stainless steel. However, given the relatively small size of most medical applications, as well as the performance benefits over the life of the product, the initial cost of titanium is often negated.

Modern CNC machining also holds tight tolerances, reducing errors and waste, and computerized processes have decreased set-up times. Ongoing improvements in

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forming technology make using higher-cost materials, like titanium, more attractive.

Recent advancements also produce titanium wire more cost-effectively. While many high-volume manufacturing runs still specify other types of material, the transition to titanium is increasingly common.

Spring expertise To confirm parts will perform as expected, designers should always consult a spring engineer to review material and component specifications. Leading spring manufacturers regularly produce components from titanium, with efficient processes that minimize scrap and part handling and meet strict compliance requirements. Always rely on the expertise of a spring engineer before finalizing material selection.

Cricket Rumsey is general manager of Newcomb Spring’s facility in Dallas, Texas.

He brings more than 23 years of spring design and production expertise to his role.

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How ironless linear motors can improve MRI performance MRI system designers are increasingly using ironless linear motors for patient moving systems, according to Parker officials. Here’s why.

Chris Newmarker Executive Editor

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arker Hannifin Corp. (Mayfield Heights, Ohio) has provided motors for MRI systems for about 15 years. Officials there say system designers are increasingly turning to ironless (also called aircore) linear motors such as Parker’s I-Force ironless linear motors in order to properly move people into the right position for a scan.

“It’s certainly becoming more popular because it provides smoother motion. It’s quieter, it’s stiffer. Where customers are doing that, it’s because it can improve the imaging process,” Brian C. Handerhan, a business development manager at Parker, recently told Medical Design & Outsourcing.

In the world of permanent magnet linear motors, there are two major types, iron core and ironless. Here’s how the two compare — and why ironless is the choice for MRI system designers: Iron core linear motor The iron core motor is designed with two parts, a forcer made of iron laminations with windings, and a magnet track, which consists of a steel bar with magnets fastened to it at regularly spaced intervals.

“The iron laminations focus the flux very well onto a line of magnets below it. This produces the highest force density motor out there because the flux coupling is very tight because of the iron elements that direct the force,” said James Monnich, an engineering manager at Parker Hannifin.

The downside, according to Monnich, is that iron core forcers are heavy because they’re filled with iron and copper. And because of the iron in the forcer, there’s attractiveness to the magnetic track.

“The attractive force can be as much as 10 times that of the continuous thrust force capability of the motor. This attractive force must be supported by the linear

Parker Hannifin Corp. officials say there’s increased interest in using ironless linear motors, such as the I-Force ironless linear motor shown here, to move people into the correct position for an MRI scan.

Image courtesy of Parker

www.medicaldesignandoutsourcing.com

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bearings, causing larger bearings to be required,” Monnich said Iron core linear motors are popular workhorses in industrial settings, according to Monnich. But they aren’t ideal right outside an MRI, for obvious reasons: There’s a lot of ferrous metals in them, and magnetic fields radiate out of them.

Ironless linear motor While the iron core linear motor has one row of magnets, an ironless or aircore motor has two rows of magnets that are parallel to each other, according to Monnich. “Magnets on the right, magnets on the left. Opposite poles, north and south. That produces a magnetic flux strength between those two magnets.”

The forcer is made simply of formed coils that are made into a structure using epoxy and other nonferrous materials. This forcer is placed between the two rows of magnets and when current flows through the coils force is produced.

Since there is no ferrous materials in the forcer, there is no attractive force with the magnets. The downside is that an ironless motor has 5/8 the force of an iron core motor of the equivalent cross-sectional size, Monnich said. But increasing the size of the forcer can produce high-thrust force motors. Parker has ironless motors that can produce 200 to 300 lb of force continuously, with intermitted forces over 600 lb, so the motors can still easily move a patient if sized properly.

“It’s smooth, it doesn’t have attractive force, and the magnetic field is more encapsulated,” Monnich said of ironless motors.

Ironless motors also address challenges with cogging that one sees in iron core motors, where there’s a bump in force going from one magnet to the next.

“There are little techniques to minimize that. You can reduce it quite a bit, but it’s still there,” Monnich said of cogging in iron core motors. “With an ironless or aircore motor, there’s no cogging whatsoever.”

The properties of ironless linear motors make them a good fit for MRI systems, Handerhan said. “Generally, if a manufacturer is selecting a linear motor as the drive train, they’re looking for something that’s quieter than a mechanical drive train, something that’s going to provide smoother motion than a mechanical drive train, and something that’s going to be stiffer than a mechanical drive train. All of those are going to play into better imaging.”

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MOTION CONTROL COMPONENTS

4 steps to precisely control motor velocity at low speed Low-speed precision velocity control is all in the filtering.

Chuck Lewin Performance Motion Devices

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number of medical devices such as peristaltic pumps, syringe controllers and robotic catheter controllers need precise velocity control at low speeds. The key to success is having the right information from the motor and feeding it to the right control algorithm.

The most popular control method for positioning motion control is the PID (proportional, integral, derivative) servo loop. But as those who have used it will tell you, the resultant motion at low speed eventually becomes a series of digital starts and stops rather than a smooth velocity.

Other control techniques can do better, but in all cases the velocity controller is only as good as the information that is fed to it, as the following how-to guide shows.

Here is a sequence of steps to control low-speed motion.

1. Switch to a velocity loop Many low-speed applications will benefit from switching to a control loop that explicitly measures the velocity and then executes a loop that compares the desired velocity with the measured velocity. The difference between these two is the velocity error, and after being passed through a PI (proportional, integral) filter, the resultant output value is fed to a current loop where it

controls the physical torque generated by the motor.

The velocity loop can use an analog tachometer signal as feedback, but it’s more common nowadays to use a position encoder and calculate the velocity by successive subtraction of the position read.

There is also a fancier technique that can be used at low speed called 1/T period measurement.

This scheme measures the time interval between the arrival of similar encoder output signals (for example, successive falling edges of the quadrature A signal) and from this measured time interval calculates the velocity.

While not without its limitations, 1/T can only be used in conjunction with a velocity loop and represents another reason to switch to this control approach.

2. Slow the loop rate down Particularly if the measured velocity comes from subtraction of successive positions, you want to give as much time as possible between reads. This will increase the accuracy and reduce the choppiness of the measured velocity.

While modern servo controllers offer loop rates up to 10 kHz and beyond, it is rare that the velocity loop needs to run at more than 1 kHz. With some experimentation, you can find the servo rate that gets you the best velocity estimation but is still fast enough to stably control the motor.

Image from Performance Motion Devices

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3. Filter your way to success Dramatic improvements in the smoothness of the velocity control can be achieved by filtering the velocity estimation, often using a bi-quad filter programmed for a low-pass filtering function. The digital outputs of position encoders are by their nature a series of tiny steps, so filtering can significantly smooth things out and mimic analog-velocity sensors.

Depending on your application, another useful filter type is the deadband filter. This type of filter is especially good at reducing hunting when the command velocity is near zero, which can be important to reduce noise and motor heating.

4. Connect to a higher-level loop If your application only requires velocity control, congratulations, you’re done!

Many applications, however, operate the velocity loop within a higher-order loop such as a position loop or a loop for pressure or temperature control. Respirators, temperature controllers and reactor-process controls are all examples of applications in which an outer loop measures a desired quantity and then continually commands a motor (usually acting as a turbine or centripetal pump) to spin at the speed that will achieve the desired measured quantity.

In these systems the output of the higher-order loop becomes the input command to the velocity loop. If this is the case, once again you should consider filtering that command to smooth the velocity profile.

Conclusion Performance Motion Devices (PMD) and others provide velocityand torque-control integrated circuits that combine all of these motor-control features into a single package.

But even a well-tuned and well-filtered velocity loop cannot defy the laws of physics. When all else fails, higher encoder resolutions will make it easier to create smoother low-speed motion.

Also, be mindful that successive subtraction of positions may bring out non-linearities in the encoder output that would be unimportant in a position-control application. Resolution is not the same thing as accuracy, so in the velocity control application, how evenly the resolvable encoder counts are spaced out has a direct impact on the quality of the motor velocity control.

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Image from Kaleidoscope Innovation

RAPID MANUFACTURING

AN FDM PRINTER AND HOW DOES IT WORK? P u l k i t Ve r m a

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Kaleidoscope Innovation

What is an FDM printer?

An FDM (fused deposition modeling) printer is a 3D printer that is often used in early concept development and prototyping for medical device design. FDM refers to how the 3D model is formed. The material (molten plastic) is deposited by a three-axis system in single layers, and multiple layers fuse together to form the 3D model.

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ABS, a common household plastic, offers good strength and thermal characteristics, but requires good ventilation, as it emits strong odors. It requires a heated build platform to avoid warping.

PLA offers great surface quality, is one of the easiest materials to print and is also biodegradable but lacks impact strength.

How does an FDM printer work?

The process begins with a 3D CAD (computer-aided design) model. Slicing software divides the digital model into numerous slices (layers) and outputs a G-code file for the printer. The FDM printer heats solid plastic filament and melts and extrudes it from a nozzle — layer upon layer — onto a build tray to form the 3D object. Each layer can be 0.1mm to 0.5mm thick, based on the desired resolution.

Higher-grade FDM printers can print engineering and higher-performance materials including nylon, TPU (thermoplastic polyurethane) and PET (polyethylene terephthalate) or PETG (polyethylene terephthalate glycol).

Frequently used in disposable plastic bottles, PET can be used for pieces that come in contact with food and it does not release odors when printing.

What are the most common materials used in FDM printers?

The two most common materials in FDM printing are ABS (acrylonitrile butadiene styrene) and PLA (polylactic acid).

Both are inexpensive and available in a variety of colors.

How are FDM printers used?

Medical device designers and engineers often use FDM printers in early-concept exploration and medium-fidelity prototyping stages.

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W H AT I S A N F D M P R I N T E R A N D H O W D O E S I T W O R K ?

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Early-concept exploration stage: FDM printing allows users to easily print multiple concepts to examine the form and fit of the actual piece before pursuing detailed features.

Medium-fidelity prototyping stage: For testing or for prototypes that resemble actual production parts, users often print at medium fidelity. This resolution uses thin 0.1 mm layers. This option is ideal for obtaining feedback on feel and performance.

What are the advantages and disadvantages of FDM printers?

Advantages: The most significant advantage that FDM printers offer is the low cost to purchase and operate. Because they are popular in the consumer market, low-end FDM printer models start at $150. FDM printers are easy to operate and offer fast concept-to-prototype lead time.

Disadvantages: FDM printers do not offer the high quality, dimensional accuracy or reliable operation that some other 3D

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printers offer. Reliability can be an issue with failed parts or clogs in flowing plastic. FDM is not the best choice for printing parts that need to be close to perfection.

What size 3D models do FDM printers build?

In general, the average-size FDM printer can print models approximately 120 mm x 120 mm x 200 mm, while some printers can print as large as 500 mm x 500 mm x 500 mm.

Pulkit Verma is a design engineer at Kaleidoscope Innovation in Cincinnati, with a focus on product design. Before earning his master’s degree in mechanical engineering, Verma studied product design and intellectual property rights. He has experience working at a law firm in New Delhi, India, where he provided technology-focused legal support to global clients.

Binder jetting and debinding: Here's what you need to know Binder jetting is a fast, affordable method of metal 3D printing. The right debinding fluids can harmlessly remove wax binders from metal 3D-printed parts before they’re sintered.

Ve n e s i a H u r t u b i s e MicroCare Medical

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D printing, a subset of additive manufacturing, has been in use since the 1970s. Originally limited to hobbyists to create plastic toys and figurines, the process intrigued medical device manufacturers, who recognized 3D printing’s potential.

By the 1980s, medtech manufacturers were using 3D printing to create patient-specific devices. Today, hearing aids, orthodontics, contact lenses, artificial joints and prosthetic devices are 3D-printed and custom-made for each individual patient and their unique anatomy.

How is binder jetting used in 3D-printed medtech?

Historically, plastics were used to make the majority of 3D-printed medical devices and today, more than 80% of 3D-printed parts are still made using thermoplastic or thermoset polymers. Metals, ceramics and other composite materials comprise the other 20%.

However, metal 3D printing is rapidly moving to the forefront of medical device design. Metal 3D-printed parts are built much like plastic 3D parts, except that a metal powder feedstock is used instead of polymer or plastic for added strength and durability.

A variety of metal powders, including stainless steel, low-alloy steels, carbon steels, nickel alloys, tool steels and tungsten alloys are used to build small, precise and detailed geometries for all types of medical devices as well as complex surgical instruments. www.medicaldesignandoutsourcing.com

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Metal binder jetting — A quick overview A number of methods may be used to make metal 3D-printed parts. Some, like selective laser melting (SLM) and electron beam melting (EBM), are advanced processes that require a significant investment in specialized equipment, complex safety procedures and very skilled operators. Binder jetting (BDJ) by comparison is faster and more affordable. It does not use lasers or electron beams to build parts, making it safer and easier to use with minimal training.

Binder jetting builds three-dimensional parts from a computer-aided design (CAD) file. Nozzles on the 3D printer head place an ultrafine layer of the metal powder on a build platform following a path determined by the CAD file. Then a liquid wax bonding agent, typically paraffin wax, carnauba wax or specialty polyethylene wax, is applied to bind the particles together. The print head continues to deposit alternating layers of the powdered material and the binding material, layer by layer, to form a “green” part.

Once the “green” parts are built, most of the wax binding agent is removed. Then the parts are placed in an oven and sintered at a very high heat to render their final, solid-mass state. The resulting high-quality, dense metal parts have excellent dimensional repeatability and can be post-processed using standard metal finishing techniques such as grinding, cutting or coating.

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RAPID MANUFACTURING

Choosing the right debinding fluids and methods Using metal binder jetting may seem straightforward, but it is important to get the details right for the best possible end product. This includes choosing the best fluids and methods for removing the wax binders from the parts.

The binding agents serve the important purpose of holding the “green” parts together, but they must be partially removed before the parts can be exposed to the high heat required for sintering. It is a balance of selectively removing enough of the binder from the “green” parts to allow fast sintering at a very high heat, but not so much that the fragile parts will lose their dimensional accuracy or fall apart during the process.

One successful combination for removing binder is a debinding fluid plus a vapor degreaser. Debinding fluid vapors flow around the parts inside the vapor degreaser to dissolve the binding waxes. The lower viscosity of the debinding fluid allows it to penetrate the pores, blind holes and internal channels of the parts to effectively remove just

the right amount of wax binders. After the debind cycle, the parts are cool and dry enough to be immediately placed into the sintering oven.

New, sustainable debinding fluid blends have been formulated without the use of solvents such as n-propyl bromide (nPB) or trichloroethylene (TCE), which may cause health and environmental problems. Most have a low global warming potential (GWP) and offer long-term compliance with global environmental regulations.

Companies looking for help with metal binder jetting and debinding should consult with a critical cleaning partner that specializes in vapor degreaser debinding. They can recommend the best debinding fluids and methods for any application.

Venesia Hurtubise is a technical chemist at MicroCare Medical, where she researches, develops and tests cleaning-related products that are used daily in medical and precision-cleaning applications. She holds an MS in Green Chemistry from Imperial College London.

Complex surgical instruments can be made using metal 3D printing.

Image from MicroCare Medical

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11/21/19 3:30 PM

REGULATORY, REIMBURSEMENT, STANDARDS AND IP

Medtech product liability and IP: Here's where it's going Medtech is rapidly changing. Here’s how Greenberg Traurig experts think the shift will affect liability and IP protection.

Chris Newmarker Executive Editor

G

reenberg Traurig is one of the largest law practices in the United States, with 2,100 attorneys serving clients in 41 offices in the U.S., Europe, Latin America, the Middle East and Asia.

Medical Design & Outsourcing recently sought insights from some of the top lawyers at GT who are involved in medical device products liability and intellectual property: Ginger Pigott, Michael R. Goodman and patent attorney Roman Fayerberg.

MDO: Medtech companies are increasingly packaging sensors, software and other digital features into their devices. How is going digital shifting the way device companies protect their intellectual property? What kind of new liability challenges is it creating?

Pigott/Goodman: The inclusion of software, digital features, data sharing and remote access are all at the forefront of medical device technology and associated therapies. They also introduce new liabilities. For example, is there a possibility that the software will depart from its intended use? Can an implanted sensortransmitter withstand the body’s own defenses?

Are these products secure from evolving outside threats and to what extent might the software developer or device manufacturer be liable?

We are also seeing non-traditional companies competing in this space with devices that blend the practical with the medical. More and more apps and fitness devices incorporate health data or tracking.

And, with the advent of 3D printing, tech companies are entering into the medical device space. But if there is a software error when designing a product from a 3D printer, for determining liability, it is unclear whether the software is also the product or just the medical device. It may simply depend on whether the state considers a product “tangible.”

These are a few examples that may challenge some of the traditional legal defenses that have protected prescription medical devices.

Fayerberg: With respect to the intellectual property protection, medtech companies will need to be more strategic in the way they protect their intellectual property. Protection of the digital features introduces additional considerations that do

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not arise when protecting more traditional medical devices. In particular, some digital features, mobile apps or software may not be eligible for patent protection. Accordingly, medtech companies will need to carefully consider which digital features of their devices can be protected with patents, and which other options are available to them to protect their intellectual property, including trade secrets. Medtech companies will also need to ensure that their patent counsel are experienced in both traditional medical devices and software patents.

MDO: Robotic surgery appears to be the hot new area in medtech, with almost every major medical device company seeking to do something in the field. What is your perspective on the trend?

Pigott/Goodman: Robotic surgery and the use of such systems continues to develop and the trend is on the upswing. Such innovation has not and will not eliminate adverse outcomes, however. Technology and its assistance in performing surgery — as well as its ability to document the procedure and preserve such evidence means that we have more information when evaluating “what went wrong.” The question becomes, though, when the something does not go as expected or desired, who is responsible? Just a few years ago, it was a doctor and a scalpel (or other tools). Now, it is a doctor, his or her tools and a robotic tool that has both hardware and software (not to mention maintenance requirements). What has not yet changed is that the doctor still controls the surgery. Though the technology is improving, it is becoming more complicated with more peripherals that can go wrong and frankly, the investigation on an injury is much more nuanced and complicated.

That said, robotic surgery gives surgeons a significant advantage in both accuracy and, in many cases, speed of surgery.

Fayerberg: We are seeing an increase in the number of issued patents and filed applications for robotic surgery. The patent claims can be directed to the overall system or to the individual tools. On the other hand, as some of the earlier, broader patents are expiring, we expect to see new robotic companies emerging. In addition to the surgical robots, we are seeing an increase

www.medicaldesignandoutsourcing.com

11/22/19 9:47 AM

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REGULATORY, REIMBURSEMENT, STANDARDS AND IP

in the patenting activity related to the robotic principles for use in assistive and therapy devices, such as exosuits for stroke victims.

MDO: When you look at the way things were five years ago and the way they are now, what’s the major difference — and what is your top piece of advice based on the difference?

Pigott: Five years in medical device innovation has become a lifetime as such new technologies and uses are coming quicker than ever. While the increasing pace of development itself is not particularly new, the speed — combined with types of competitors in this space, scope and access by larger areas of the world, and the expectations for what technology can do — have all made things more complicated than ever in terms of how to prepare for claims. My advice from the litigation side is that success will always bring litigation and success

followed by any reasonable challenges — e.g. field actions, recalls, newly discovered potential adverse effects — is going to bring litigation even faster. Keeping that in mind, careful consideration of pathway to market choices, such as regulatory clearance versus approval, characterization and classification of the device, and even simple record keeping and communication can all go into protection or greater risk.

Risk may not be able to be eliminated, but it can be significantly reduced and mitigated by smart and organized companies with an eye toward the day that not only the FDA (or other country equivalent) shows up for an audit, but the day when the inevitable adverse event turns into litigation.

Fayerberg: With respect to the intellectual property, as the competition increases, it is more important than ever to have a cohesive patent strategy. An effective, strategic patent portfolio is designed with both offensive and

defensive considerations, and should include patents with varying scope of protection.

Ginger Pigott (Los Angeles) is vice chair of Greenberg Traurig’s Pharmaceutical, Medical Device & Health Care Litigation Practice and focuses her practice on products liability litigation with an emphasis on the defense of complex medical device and pharmaceutical products.

Michael R. Goodman (Denver) is a Greenberg Traurig attorney and registered patent agent advising clients in the medical device, pharmaceutical, biotechnology, food and dietary supplement industries on FDA regulatory compliance and products liability matters.

Roman Fayerberg (Boston) is a registered patent attorney at Greenberg Traurig. He focuses his practice on the development and management of strategic patent portfolios and counseling clients on patent issues.

How medtech companies can succeed under the EU's MDR For many devices, the cost of compliance with EU MDR and IVDR will be high and will require significant expertise. Manufacturers should immediately begin developing a strategic business model that will prepare them for success under the new reforms.

David Novotny and Angela Brown Icon

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he transition to the new European Union (EU) medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) represents one of the most disruptive transformations occurring in the medical device industry, touching every aspect of product development, production, distribution and monitoring.

These regulations, which set forth more stringent safety and data requirements for devices distributed in the EU, are expected to greatly increase the complexity of keeping existing products on the market and introducing new ones.

The cost of complying with such stringent requirements will be high, requiring manufacturers to allocate a substantial budget annually for the next three years. Moreover, the transition is likely to cause hundreds, if not thousands, of products to leave the EU market.

Despite the challenges that these changes present, they may also introduce an opportunity for early movers to gain an edge over competitors who are slower to

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comply. To achieve success under MDR and IVDR, companies will have to generate and implement a strategic business plan.

A new business model Until the new regulations go into effect, medical devices already on the market are considered safe by default.

But with the deadlines approaching (May 2020 for MDR and May 2022 for IVDR), thousands of medical devices currently on the EU market will need to be recertified.

Companies will have to submit vast amounts of clinical data in addition to implementing comprehensive postmarket surveillance assessments and reporting.

Also, there is concern for the shortage of notified bodies (NBs), the entities needed to certify devices.

MDR requires the European Commission to designate NBs to certify specific categories of medical devices.

The influx of submissions will cause increased workloads that can overwhelm notified bodies, particularly for IVDs, creating backlogs that may delay product reviews.

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Photo by Sara Kurfeß on Unsplash

Early movers may have the chance to gain market share over slower competitors that are unable to comply before the deadlines. In fact, this phenomenon is officially underway as of September 2019, when Biotronik became the first company to land MDR certification for a high-risk device. To follow this precedent, companies will need to create a comprehensive business plan that prepares them for success.

Why launch new products outside the EU? MDR and IVDR significantly shift the global regulatory landscape. Historically, gaining a CE mark has been easier than obtaining FDA approval, yet the strict new data requirements and added steps of NBs and regulatory review may make pursuing approval in the U.S. quicker and easier. A single language, large patient populations, less-restrictive data-protection laws, robust IT infrastructure

•

•

and central institutional review further contribute to study efficiency in the US. Similarly, countries in the Asia-Pacific and Latin American regions may be more attractive for some devices, particularly in regenerative medicine.

C-suite involvement C-suite executives may play a critical role in preparing your business for success under MDR and IVDR. To engage them effectively, companies should consider involving upper management in the following processes:

Cost assessment — Allocation of significant funds will be necessary to comply with the new regulations. This suggests that the chief financial officer (CFO) and chief operations officer (COO) should take the lead.

Product triage — For many low-volume products, the added cost of MDR and IVDR will not be worth the expense, which may

•

lead manufacturers to trim their offerings in Europe. This will have operational and strategic implications, suggesting a need for the involvement of the CFO, COO and CEO. Market entry strategy — Because the European clinical evidence requirements could end up being more stringent than U.S. requirements, U.S. market entry could potentially be more profitable, calling for a comprehensive market entry strategy.

With the first deadline quickly approaching in May 2020, manufacturers should immediately begin developing a strategic business model that will prepare them for success under the new reforms.

David Novotny is general manager and global head of medical device and diagnostic research services for Icon. He has more than18 years of experience within the medical device, diagnostic, biotech and clinical industries.

Angela Brown is director of regulatory affairs for Icon’s medical device and diagnostics research unit. She has more than 20 years of regulatory affairs and quality assurance experience in the medical device industry, specializing in international regulatory affairs, working with universities, start-up and bluechip companies.

A S P E C I F I C AT I O N D E V E L O P E R ?

A S P E C I F I C AT I O N D E V E L O P E R C A N C O N C E N T R AT E O N D E V E L O P I N G A P R O D U C T I D E A , O B TA I N I N G I N T E L L E C T U A L P R O P E RT Y P R O T E C T I O N A N D C R E AT I N G A S A L E S P L A N — A N D L E AV E T H E M A N U FA C T U R I N G T O O T H E R S .

Jim Medsker

|

Keystone Solutions Group

The FDA defines a specification developer as an entity that develops a specification for a device that is distributed under that company’s name, although it performs no manufacturing. The definition also includes companies that arrange for the manufacturing of devices labeled with another establishment’s name by a contract manufacturer.

Many startup and early-stage companies fall within the definition of a specification developer. It is quite common for an early-stage company to own the intellectual property and the sales channel for its new idea and outsource all of the remaining activities, such as manufacturing, sterilization, packaging, etc. While virtually all aspects of the product development and manufacturing

processes can be outsourced, the specification developer remains ultimately accountable for the safety and efficacy of the product.

An entrepreneur or startup company can decide to operate as a “virtual” company and forgo the bricks-and-mortar model, but the company must create and maintain a basic quality management system (QMS) and establish contractual agreements with partners in order to meet the requirements of a specification developer.

What the FDA wants The FDA requires a specification developer to meet certain quality system requirements. While this article is not meant to

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W H AT I S A S P E C I F I C AT I O N D E V E L O P E R ? be an exhaustive review of all requirements, it is intended to shed light on the subject and add some definition to the often-used phase.

The FDA provides guidance documents to help those who are developing new products or commercializing a medical device understand how to properly document, manufacture and market their medical devices and meet FDA requirements. These guidance documents, definitions and regulations create a pathway for ensuring the specific steps are followed and the proper documentation is in place.

A company that chooses the specification developer route has fewer quality management system requirements to meet than a medtech manufacturer. Here’s what it does have to do: •

•

Photo by Helloquence on Unsplash

If you are an entrepreneur, a startup company or an established company looking to simplify your internal infrastructure, operating as a specification developer is often a great path to consider.

How it works So, what’s involved and what does it look like? First and foremost, do your homework and review the information provided by the FDA regarding the requirements of a specification developer. Second, unless you have the resources in-house, seek the advice of a regulatory consultant to determine what the QMS, supplier quality agreements and other requirements are for your enterprise.

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(CONTINUED)

Create and maintain a basic QMS that meets the FDA requirements of a specification developer.

This QMS includes a number of standard operating procedures and documents such as a quality manual, management responsibility, design controls, corrective and preventative actions, device master record, complaint files and others. The specification developer QMS typically is not required to include procedures that are executed and maintained by a contract manufacturer, such as manufacturing assembly procedures, environmental procedures, equipment qualification records, etc.

Develop and maintain one or more supplier quality agreements (SQAs). An effective SQA defines the roles and responsibilities of the specification developer and its key suppliers. It helps “draw the line,” so to speak, and determine which party is responsible for a given activity. While SQAs often vary in scope and the demarcation of responsibilities can be fine-tuned, both the specification developer and the supplier must meet the regulations that apply to each enterprise.

Advantages The specification developer route offers a number of advantages, depending on your goals. It allows companies to focus on their strengths and not get bogged down with operating a device-development or manufacturing operation.

Many companies have created a medical device idea, attained intellectual property around it and want to sell the product without the burden of an extensive manufacturing infrastructure. This model also allows companies to use a broad range of expertise available through outsourcing to experts in materials and manufacturing processes.

Jim Medsker is president of Keystone Solutions Group.

He has more than 20 years of experience in product development, startups and operations in the medical, automotive, aerospace and industrial markets.

www.medicaldesignandoutsourcing.com

11/22/19 9:47 AM

S O LU T I O N S FO R M E D I CA L

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How to ensure safety and security when using mobile devices in healthcare The emergence of medical IoT and widespread use of wireless technology throughout healthcare have changed the cybersecurity landscape.

Martin Nappi Green Hills Software

S

mart mobile devices have become a significant part of the healthcare infrastructure, and their widespread use has led to rapid growth in the development of medical software applications. Smartphones, tablets and laptops provide caregivers with direct access to all types of medical systems and data, improving their efficiency and helping them care for more patients.

For medical staff, mobile devices make collaborating and exchanging patient data more efficient and allow clinicians to engage patients through secure text messaging, patient portals and telemedicine. These technology-enabled forms of patient engagement boost patient satisfaction, loyalty and health outcomes.

Some hospitals employ a Bring-Your-OwnDevice (BYOD) policy, allowing doctors, nurses and other staff members to use personal mobile devices to access and engage with systems that store patient health information. Some healthcare systems enable providers to monitor and control life-critical medical devices from these devices, too.

Expect vulnerabilities Smartphones, tablets and laptops generally run versions of Microsoft Windows, Apple iOS or Android operating systems, which only protect against inadvertent or casual attempts to breach a device’s security.

These operating systems are comprised of millions of lines of program code and are frequently

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SOFTWARE

proven to contain numerous vulnerabilities. Some are caused by software coding errors that may allow a cyber-criminal to install malware, seize operation of the device or use it as a portal to gain access to other resources on its network. Hundreds of these vulnerabilities are listed on the National Institute for Standards and Technology’s (NIST) national vulnerability database.

Historically, product security in the medtech industry was much less of a concern because most medical devices were not connected to networks or wirelessly to computers, smartphones, and tablets. But with the emergence of the medical IoT and widespread use of wireless technology throughout healthcare, everything has changed.

Hospital-based efforts Some of the hospitals that have created mobile apps have gone to great lengths to institute extensive cybersecurity for their BYOD programs, allowing doctors, nurses and other caregivers to use personal mobile devices to access internal systems and manage patients. They have employed a comprehensive defense-in-depth security strategy to prevent unauthorized access to their networks or patient information. These may include: • • • • •

User authentication.

Role-based access control.

Encrypted communication.

Virtual private networks.

Over-the-air updates and installations.

www.medicaldesignandoutsourcing.com

11/22/19 9:52 AM

Quality goes up.

Headaches go down.

That changes everything.

Quality isn't just a box you check. It’s not limited to a process or even a department. It’s the ultimate differentiator. The MasterControl Platform helps you digitize, automate and connect critical processes, documents and data so you can improve quality across your entire product life cycle.

Explore how quality changes everything at www.mastercontrol.com

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SOFTWARE

Unfortunately, a sophisticated hacker could still penetrate a healthcare worker’s phone and create an exploit that breaches the hospital system when the worker logs in.

2.

Stop that hacker As the market changes and security becomes critical, connected devices will become more widespread than today. If we really want to stop that sophisticated hacker, we have to take several different approaches, some of which may not be practical in the short term.

1.

Introduce new smartphones, tablets and laptops with a different software architecture, designed from the outset to completely isolate patient and life-critical data from all other data and then only allow secure and encrypted connection with similarly architected computing and networks.

These devices do exist and have been deployed by the U.S. armed forces, U.S. intelligence agencies and law enforcement.

3.

Ensure that all new patient lifecritical devices such as insulin pumps and pacemakers are designed from the inside-out with an industry-proven separation kernel architecture that securely isolates the safety-critical software components from the connectivity, user interface and general computing components on the device. All information flows are validated, and digital encryption keys are tied to the hardware root of trust to protect software and communications. For decades, separation kernel-based products, extensively certified for both safety and security, have been controlling the flight and guidance systems in airliners, jet fighters, industrial and automotive systems.

Where insecure networked equipment, such as PACS systems, medical robotics or hospital pharmacy computing exists and are not due for short-term replacement,

4.

a “black box” can been inserted at the equipment connection.

This internally uses the separation kernel with network isolation and control software to protect against malicious attacks.

Importantly, if none of the above are implemented, devices that could kill a patient if accessed by a hacker should be disconnected from the network until they are secured.

When our healthcare system implements this proven approach to safety and security in its mobile devices and equipment, we will see a far more robust and protected computing environment.

Martin Nappi is VP of business development for the medical industry at Green Hills Software. He is a 30year veteran of the embedded systems industry and is responsible for providing safe and secure software technology for medical devices and systems.

How software prototypes can feed your quality system Achieving regulatory compliance with a new medical device means more than checking boxes.

M i l t o n Ya r b e r r y Boston UX & ICS

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n medical device development, quality management achieved through design controls can often be viewed as an “add-on” activity intended to check the regulatory boxes for the FDA. This practice happens at startups whose founders are new to regulatory compliance, but also at Fortune 500 companies with storied medical device legacies.

While the circumstances might differ, the result is similar: Product risks are managed outside of a quality system, usually at the end and at disproportionate cost.

In such scenarios, prototyping early in the product development cycle typically happens as a means to get a jump on the project schedule and handle visible technical risks. As the prototype becomes more substantial, the line between the prototype and production code becomes ever less distinct. Fleshing out features gets priority over analysis and evolution of the prototype. Then, as an afterthought, the focus becomes “How do we check the boxes to make this compliant?”

This very natural evolution of work results in a quality system that adds no value. By contrast, correctly designed prototypes can feed and shorten development

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under design controls by reducing product evolution and cementing the product vision internally.

Iterate on key product issues The prototyping phase is an opportunity to work on important product issues until reaching a clear and decisive vision. Giving short shrift to the study and revise steps in a build/study/revise cycle can introduce uncertainty later in the development process and cause disruptive change. Developing a high-fidelity prototype that leaves zero room for interpretation provides a direct path to product realization: “Make it exactly like this.”

This dynamic is especially true in the area of user experience (UX) design. Due to concerns about user error, the FDA released final guidance in 2016 on following appropriate human factors and usability engineering processes to improve the safety and efficacy of new devices.

“User error is still considered to be a nonconformity because human factors and other similar tools should have been considered during the design phase of the device,” the agency said.

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Companies that develop a highfidelity prototype and do formative testing may avoid the problems associated with discovering user errors during late-stage testing. A high-fidelity user interface (UI) prototype not only reduces bumps in testing at the end of development, but it may feed each step of the design process.

Develop a refined prototype A well-reviewed and refined UI prototype acts as a strong precursor to a cornerstone of design controls — the product requirement document (PRD).

Feature interactions, operational modes, error states and safety features can all be uprooted and iterated with a fraction of the resources normally required under design controls. A UI prototype also accelerates the engineering and testing by providing precursors for design documents and test cases.

Get comfortable with the idea that, at this point, you’re not developing software for the final product. You’re eliminating risks and unifying the product vision across your organization. This has strategic value beyond getting a jump on development.

The good news is that there is a range of rapid-prototyping tools and product frameworks available that enable fast and inexpensive prototyping. The best ones will have been applied in other medical devices, which makes them good candidates to accelerate development under design controls.

Milton Yarberry is the director of medical programs at Boston UX and Integrated Computer Solutions (ICS). He has more than 15 years of experience working with large and small medical device and IVD manufacturers.

Image from Boston UX and Integrated Computer Systems

Why medical device companies should explore cloud-based product design tools The move to cloud-based product development tools represents a transformational change, including for medical device creators.

Darren Garnick Onshape

N

early every manufactured product in the world today begins its life as a 3D computer model. Computer-aided design, better known as CAD, is used to improve the quality of existing products as well as create brand new ones from scratch. The industry as a whole moved from 2D drafting to 3D solid modeling in the late 1980s and early 1990s, giving designers and manufacturers a more efficient and faster way to make design changes — and a more accurate way to visualize products in a real-world context.

At the same time, the CAD industry experienced another major platform shift, migrating from cost-prohibitive proprietary computer systems (CAD companies controlled both the hardware and www.medicaldesignandoutsourcing.com

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German biotech startup BellaSeno designs the external structure of its 3D-printed breast implants with cloud-based CAD tools.

Image courtesy of BellaSeno

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software) to far more affordable Windows PCs. This was the “democratization of CAD,” making the technology available to startups and smaller companies that previously could not access it.

Three decades later, we are again experiencing a transformative change in the world of product design — the move to cloud-based product development tools. Although most industries moved their business-critical tools online years ago — e.g. HR software, CRM, accounting, marketing, etc. — most hardware engineers have been stuck using an installed file-based CAD system tied to a single work computer.

commercially released Onshape in 2015.)

But thousands of companies have already deployed them.

Here are a few examples of medical device companies designing products in the cloud: •

Loop Medical (Lausanne, Switzerland) is developing a new “painless” and minimally invasive device to extract blood from the capillaries just below the skin versus conventional methods that collect blood from the vein. “Onshape’s workflow is really smooth and it’s much easier to share our work and move on to the next task,” said founder Arthur

Formulatrix, which develops laboratory automation technology for pharmaceutical R&D, is using cloud CAD to enable real-time collaboration between its design teams in the United States and Indonesia. Pictured here is a component of a refrigerated machine that uses a robotic microscope to rapidly analyze thousands of protein crystals much faster than the human eye..

Screenshot courtesy of Formulatrix

Late adopters or not, product development teams are now finding the advantages of cloud-based design tools hard to ignore. By using a CAD and data management system built on a cloud database architecture, multiple engineers can now simultaneously work on the same CAD model and share their progress with project managers or external partners in real time, versus emailing static files back and forth and waiting for feedback. Teams can instantly access their work on any computer, tablet or phone anytime without the restrictions of software licenses tied to specific hardware. In short, cloud CAD allows companies to spend less time worrying about IT issues and more time on innovation.

Fully cloud-based design tools are relatively new to the market. (We 100

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Queval. “As the CEO, I can always see the status of a design and comment or address problems in real-time.”

•

BellaSeno (Leipzig, Germany) is seeking to develop a safer alternative to silicone breast implants using a bioresorbable polymer already used in FDA-approved and CE-marked products for other medical procedures.

“We’re developing more than 150 different implant sizes and profiles to choose from that fit every possible body type,” said biomedical engineer Sara Lucarotti. “Using Onshape’s configurations feature, I was able to plug in all the measurements and automatically generate 150 CAD models in less than an hour.”

•

Formulatrix (Bedford, Mass.) develops laboratory automation solutions for pharmaceutical companies and academic research institutions.

The company is using Onshape for designing a robotic microscope that more rapidly analyzes the structure of protein crystals that are critical for disease research. “We were impressed with the collaborative capabilities of a cloud-based CAD program,” said Heinrich Köchling, director of worldwide engineering. “We spend a lot of time with our team in Indonesia on video conference calls, and the ability to have multiple people on different sides of the world work simultaneously on our designs is very powerful.”

• Thinklabs Medical (Centennial, Colo.) has developed a digital stethoscope that amplifies heartbeat sounds more than 100 times the audio levels generated by traditional hollow-tube stethoscopes. “3D printing liberates the design of our products, and Onshape in many ways liberates our production people to be very creative,” said CEO Clive Smith. “We’re no longer tied to one computer. Everyone can just pick any computer and work when they need to. Onshape makes our production process much more efficient.”

While many of the comparisons between different file-based product development software weigh specific CAD features and functionality, cloudbased Onshape also has a heavy focus on improving processes. A comprehensive edit history allows CAD users to revert to any prior stage of a design, encouraging teams to take creative risks. In addition, there are regular automatic software updates — bug fixes, new features and enhancements — released every three weeks in the cloud. Unlike with file-based CAD and data management systems, the cloud upgrades require no installations, have no software incompatibility issues and result in zero downtime.

Darren Garnick is the content director for Onshape, a cloud-based product development software company based in Cambridge, Mass.

www.medicaldesignandoutsourcing.com

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STERILIZATION SERVICES

Federal agencies will control the fate of medtech's most-used sterilization method While the FDA has sought input on ethylene oxide alternatives, the EPA holds the power to control its use.

Nancy Crotti Managing Editor

Ethylene oxide

Image from Sterigenics

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he fate of the medical device industry’s most widely used sterilization process lies in the hands of the Environmental Protection Agency. The EPA has been giving the medtech industry mixed signals about the gas used to sterilize billions of devices annually.

The agency said it might seek to cut industrial emissions of ethylene oxide (EtO) by 93% nationwide. While that proposal doesn’t affect medtech directly, it may not bode well for an industry that relies on the gas that the EPA considers a carcinogen to sterilize about half of the devices it produces annually.

The February shutdown of a major Sterigenics EtO plant in Willowbrook, Ill. prompted the first in a series of FDA warnings about possible device shortages. Two other shutdowns followed in Georgia (one has since reopened), but state and local scrutiny of EtO emissions and public outcry may lead to what one industry advocate called a “rolling effect” of plant shutdowns and device shortages nationwide.

EtO sterilization works at low temperatures — between 90°F and 135°F — making it a viable option for devices made of multiple components and materials, including plastics, polymers, metals and glass, as well as coatings, bonds and packaging from damage. It can also penetrate

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different types of device packaging, enabling sterilizers to process truckloads’ worth of devices simultaneously.

The EPA is due to come out with proposed rules regarding commercial EtO operations in May 2020. Meanwhile, the FDA is seeking public input on alternatives to EtO and on methods to reduce emissions. The agency has been mum about response to its pleas, issued in July. Medtech advocates argue that, even if a viable alternative surfaces, it would take years and significant investments to institute, including the time to validate the new method for each device it would sterilize.

Some medtech manufacturers such as Becton Dickinson (BD), and Medline Industries sterilize their devices in-house, but many smaller firms rely on contract sterilizers such as Sterigenics.

The EPA sent medtech a potentially more positive signal in early November about how it measures EtO levels in the environment. The agency said it is working on updating how it characterizes air concentrations of the gas while it reviews the national emissions standards for EtO commercial sterilization operations.

Medtech industry trade group AdvaMed praised the EPA for reconsidering how it characterizes air concentrations of EtO. Specifically, the agency said it has begun to “examine the

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question of whether ethylene oxide is present more broadly in the air in the U.S., and if so, at what levels” — a step AdvaMed has been advocating for months.

The EPA has begun to analyze air quality samples from a subset of existing, longstanding monitoring stations that are not focused on specific industrial sources of EtO to determine whether the gas was present in the air.

The results confirmed the presence of ethylene oxide, with six-month averages ranging from about 0.2 to about 0.4 micrograms per cubic meter.

“We believe that there is no immediate, short-term risk from the levels of ethylene oxide found in these limited air monitoring data,” the agency said. “There is a need to better understand low levels of ethylene oxide over a longer-term period. EPA will continue to collect information from its existing air monitoring networks and share data as it becomes available.”

The agency also added EtO to the list of air toxins to be routinely monitored at all 34 monitoring sites, which are located in urban and rural areas.

“As part of EPA’s ongoing effort to protect people and the environment, yesterday’s preliminary test results show that EtO is present and safe at background levels,” AdvaMed said at the time. “Those levels are safe whether a sterilization facility is present or not. That’s an important finding, and we appreciate EPA’s commitment to doing further research here.

“EPA’s data shows that ambient air levels of EtO are far higher than the proposed standard that some have used as justification to shutter sterilization facilities,” the trade group added. “This demonstrates that the standard is not a reliable or useful gauge for determining appropriate emission levels of EtO. As we continue to study EtO’s presence in our atmosphere, it’s important to remember that leading toxicologists

and epidemiologists confirm that the communities surrounding these facilities are safe. We look forward to working with EPA, FDA and other stakeholders to find a reasonable solution to the issue of EtO use that will allow for the continued safe and responsible sterilization of needed medical devices.”

The EPA is accepting comments on its proposal and will hold public hearings in early December in Washington, D.C. and Houston, Texas.

The agency said it will seek input on several topics, including possible approaches to calculate and control fugitive EtO emissions; potential improvements to EtO monitoring technologies; and process differences between types of sterilization facilities.

The EPA will also seek information from several commercial sterilization companies on facility characteristics, control devices, work practices and costs for emission reductions.

When it comes to precision manufacturing of medical components and assemblies, close is not good enough. Steven Kmiec, our Director of Manufacturing, agrees. Steven and his team are dedicated to finding the

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Steven Kmiec Director of Manufacturing

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245 New Park Drive Berlin, CT 06037 Tel (860) 225-8707

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How geometric transition extrusion can reduce medical tubing risk Complex extrusions open up design, quality and performance possibilities for medical tubing products, such as catheters, wound drains and hemodialysis tubing.

Dan Sanchez Tr e l l e b o r g Healthcare & Medical

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any medical tubing designers are increasingly looking to geometric transition extrusions manufactured of high-consistency rubber (HCR) silicone. This process reduces the total cost of ownership for the original equipment manufacturer while improving part quality and greatly enhancing the types of devices being sought by healthcare providers.

Silicone is a proven material of choice for medical devices because of its purity and biocompatibility. It is also highly customizable,

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allowing it to be optimized for a wide range of devices that require radiopacity, conductivity and physical properties such as high tensile strength.

HCR silicone’s unique green strength — the strength of rubber in its unvulcanized state — allows for highly complex geometries in continuous extrusion processes, setting it apart from other types of polymers, such as polyurethanes, thermoplastics and room-temperature vulcanizing (RTV) silicones. Used with a geometric transition extrusion process, such as Trelleborg’s GeoTrans, HCR extrusions can change cross-sections

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dramatically, opening up new possibilities in a wide range of medical devices, including wound drains, catheters and hemodialysis tubing.

Device examples With geometric transition extrusion, tool components can be moved during the extrusion process to change tubing geometry. For example, a tube can transition from single to multiple lumens or split from a multi-lumen tube into two or three single lumen tubes. Extruding different geometries in one process eliminates assembled joints that may be weak or create internal misalignments in which fluids can become turbulent or stagnate. This, in turn, reduces labor costs and improves the overall quality of the product.

Additional examples of geometric transitions include: • A multiple-lumen tube can have one or more lumen stops and restarts, eliminating the need for secondary

operations, such as backfilling a lumen after filling a catheter balloon.

• Instead of a wound drain comprising three separate pieces — an extruded tube, a complex cross-section extrusion, and a molded hub as a connecting piece — the drain can be created as a single extrusion with two or more distinct geometric crosssections and a smooth, integrated transition where the hub had been.

• Off-ratio bump tubing for applications requiring a variable outer diameter with either a constant or variable inner diameter may be created with very short transitions (fractions of an inch).

Design considerations The first aspect for consideration in the design of geometric transition extrusion is the hardness required. Although HCR silicones are available from approximately 20 Shore A to 80 Shore A, the extremes of the hardness spectrum are challenging for highly technical extrusions.

The ideal target for GeoTrans extrusions is between 50 Shore A and 70 Shore A. The green properties of HCR silicone materials are ideal to facilitate the control of the material and forming of geometries in the critical transition areas. There is also greater availability of suitable materials from silicone suppliers in this hardness range.

Size, combined with the expected cross-sections, is the second consideration. The GeoTrans extrusion process has been used to manufacture products between 7 Fr and 24 Fr (on the catheter scale). This size range is ideal to minimize initial and maintenance costs.

Reducing the complexity of the crosssections also speeds time to market.

The third design consideration is tolerance targets. Transitioning from one cross-section to another creates pressure differentials within the raw silicone as it flows, causing variations in size due to tapering along the length of the tube.

Therefore, with complex extrusions,

Innovative solutions engineered to your specific requirements.

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one section can be manufactured to very tight tolerances and the others would need to have more flexibility in dimensional tolerances.

To eliminate further tolerance and measurement correlation issues, it’s important to define where the extrusion will be cut for dimensional inspection. Close collaboration between designer and manufacturer is critical to ensure that the final specifications and tolerances support design for manufacturability.

Benefits The benefits of geometric transition extrusion include reduced processing time and cost, lower risk of mechanical failure, less validation cost, fewer regulatory issues and overall improvement to performance and quality.

The tooling costs for this process are considerably higher than for traditional extrusion. Despite this, for some devices, the total cost of ownership is reduced by eliminating one or more components, secondary processes and/or assembly steps.

Device designers and manufacturers are increasingly inclined to pursue a solution

with this method because the strength improvement dramatically enhances the device’s longevity and robustness. For example, eliminating secondary bonds can greatly increase a device’s ability to withstand cycle loading, reducing the risk of failure and increasing device life expectancy.

Processing time can be significantly reduced when devices are redesigned to take advantage of this technology. Although running a simple extrusion is faster A bifurcated GeoTrans extrusion Image courtesy of Trelleborg Healthcare & Medical than running a geometric transition extrusion, assembly time is often cut in half. For instance, the production volume of many long-term implants does not justify complex, automated assembly. However, a redesign to include a geometric transition can eliminate the need for manual assembly of a portion of the device. Additionally, the design validation process may be significantly shorter, with fewer components and assembly processes.

An excellent example is bifurcated tubing, which traditionally has four components: a two-lumen tube extruded and cut to length, two single-lumen tubes extruded and cut to length, and a molded hub. In the past, each of these pieces had to be bonded together in a secondary step, after which each bond and secondary process step had to be tested. In contrast, using geometric transitioning, one extrusion process can produce the bifurcation, cut the extrusion to length, and stack complex extrusions in bundles, minimizing the secondary processes required during the final device assembly.

Reducing the risk that a device will run afoul of a U.S. or international regulation is top of mind for designers these days. The more components and secondary processes involved with a design, the greater the risk. Thus, medical device manufacturers are seeing benefits from partnering closely with component suppliers to identify how sophisticated technologies like GeoTrans can contribute to risk mitigation.

Indeed, the redesign of catheters, drains and tubing often comes from a collaboration between the manufacturer and a component supplier experienced in geometric transitioning, with a variety of devices being evaluated to see whether this method could be used to eliminate components.

Dan Sanchez is a product manager at Trelleborg Healthcare & Medical. He has been working closely with customers on GeoTrans projects for 21 years. For more information on GeoTrans, visit www.tss.trelleborg.com/healthcare.

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10 things to do before your next medical device package validation

Scott Levy DDL

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Before a medical device package validation, it’s important to do your homework and understand what needs to be done.

1. Understand the regulatory requirements (FDA, EU, etc.).

In general, regulators expect you to prove that your packaging system ensures sterility maintenance of that device and to confirm the consistency of your processes.

4. Perform a risk assessment of the medical device you are packaging.

Determine the specified attribute data for your package, identify all potential failure modes that could cause (or result from) an out-ofspecification package, and then determine the sample size needed to catch those failures. The chosen sample size and resulting confidence level will depend upon the overall risk assessment (Failure Mode Effects Analysis, or FMEA) that the medical device manufacturer puts in place for any given device.

2. Read and familiarize yourself with ISO 11607 so you understand your validation responsibilities.

To obtain a CE Mark for marketing your medical device in the EU, you must comply with ISO 11607. The FDA also recognizes ISO 11607 as a consensus standard, so if you are in conformance with it for your CE Mark, you will have a much easier time complying with FDA regulations.

5. Talk to your suppliers and service providers.

Your vendors have a lot of knowledge. Get as much data as possible from material providers, thermoformers, package converters and machinery providers. Finally, work with a qualified and knowledgeable test laboratory that understands the regulatory requirements and can further guide you to assure you meet specific regulatory requirements.

3. Get your package professionals involved early in the product design process.

Packaging professionals should be working with colleagues in regulatory, product development and quality as early as possible during medical device development. Also, during product design verification, conduct feasibility testing to understand the product and package interactions.

6. Write your packaging protocol and establish clear acceptance criteria.

Your protocol should have the following: a purpose, a scope, a reference section listing all standards and test procedures, descriptions of all materials and equipment, all attribute data, a sequence of events or a flow chart of what will transpire, and a summary of the chosen

efore you set out to validate a medical device package design or process, you have to do your homework. Here are 10 points to consider before beginning any package validation effort:

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Image courtesy of DDL

VALIDATION AND TESTING

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sample size and acceptance criteria. It is important to document everything, as the protocol can help you manage your processes with outside vendors.

7. Know your worst cases.

Review your product families to define all worst-case scenarios. It is a hard question to answer, but you are looking for what potentially can cause the most adverse effects to the package.

8. Understand the differences between package seal strength and whole package integrity.

You cannot solely test packages for seal strength, as you also need to test for whole package integrity, using a method such as ASTM F2096 (Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization [Bubble Test]). You should also consider the microbial barrier properties of the materials selected for their sterile barrier system.

Stability testing and package performance are also important. Stability testing looks at the effects of aging on seal strength and package integrity and helps you determine a shelf life, whereas performance testing looks at the effects of handling and distribution on seal strength and package integrity. Separating these evaluations allows you to identify the causes of seal failure or compromised integrity.

9. Do a gap analysis of the test standards that you have previously used versus what is current.

When any new standard is released, do a gap analysis to address whether the new standard affects an older validation and if you are still in compliance. A gap analysis is also necessary if there is a change in packaging materials or processes.

10. Make sound, technical, sciencebased justifications if needed.

If making a justification, you need to take a look at all factors for a particular

justification and make it science-based and defendable. Too many times, organizations are trying to meet a timeline and use loose justifications in order to meet that timeline. When in doubt, use your supplier’s knowledge as a sounding board.

In the end, medical device professionals need to understand what they are putting into packages. If you do your homework with materials and processes and understand what you need to do before validation, you will build a successful validation program.

Scott Levy is the lead packaging engineer at DDL, a third-party testing laboratory that serves the medical device industry. With more than 24 years of testing experience, Levy specializes in helping medical device manufactures comply with ISO 11607 and other industry standards.

How to make sure an active implantable device will pass regulatory muster Want to speed up your medical device’s time to market? Consider the numerous required standards and tests throughout the production process.

Bill Stearns Intertek

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ctive implantable medical devices (AIMDs) are complex products subject to rigorous regulatory standards. Most AIMDs include non-implantable supporting equipment, such as control and communication equipment, battery packs, implant kits, software applications, etc.

Both require evaluation to regulatory standards.

Many devices also have electromagnetic compatibility (EMC) and wireless capabilities to consider. With a lengthy list of potential standards and tests, it’s important to know the requirements for a given product and consider them throughout the production process to get a compliant, marketable device to the industry.

Implantable components ISO 14708 applies to the implantable device. It has seven parts; each outlines requirements for specific

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devices. All AIMDs must comply with Part 1, general requirements for basic safety and obligations for product marking and information/documentation. Parts 2-7 supplement or modify Part 1, taking priority. They are: • • • •

•

Part 2, requirements for cardiac pacemakers.

Part 3, requirements for implantable neurostimulators; aligns with ISO 14708-1:2014.

Part 4, requirements for implantable infusion pumps; covers safety requirements illustrated via type-testing of samples.

Part 5, which applies to circulatory support devices, excluding intra-aortic balloon pumps, external corporeal perfusion devices and cardiomyoplasty; specifies type tests, animal studies and clinical evaluation requirements.

Part 6, requirements for AIMDs intended to treat tachyarrhythmia, including implantable defibrillators.

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Image by Glenn GarstensPeters on Unsplash

•

Part 7, requirements for cochlear implant systems; includes type-test specifications.

Non-implantable elements Non-implantable supporting equipment must be evaluated to specifications for electrical safety and performance found in IEC 60601 and IEC 62304. They are: •

• •

•

•

•

IEC 60601-1, the general requirements for basic safety and essential performance of medical electrical equipment.

IEC 60601-1-2, EMC requirements to ensure safety and performance in proximity to other electrical products.

IEC 60601-1-6, the general requirements for safety and performance of medical electrical equipment. Collateral standard IEC 62366 covers the application of usability engineering to medical devices.

IEC 60601-1-11, which includes requirements for equipment and systems used in home-healthcare environments.

IEC 60601-1-12, which covers equipment intended for use in an emergency medical services environment.

IEC 62304, which specifies lifecycle requirements for development of software used in medical devices; includes provisions for risk management, maintenance and configuration.

Some AIMDs require specialized active equipment only used during the implant process. This equipment is also subject to the requirements of IEC 60601-1 and should be evaluated.

EMC and wireless considerations Many AIMDs use wireless interfaces expected to maintain basic safety and essential performance without interfering with other electronics in their vicinity or the intended electromagnetic (EM) environment. Devices must maintain EM equilibrium when performing their designed functions.

Clause 27 of ISO14708/EN45502 outlines EMC evaluations to determine the effects of EMI on an AIMD. They confirm that implantable components exposed to EM fields do not experience unacceptable risk such as damage, heating or local increase of induced electrical current density. These assessments verify that the AIMD maintains basic safety and continues to provide essential performance, placing an emphasis on EMC risk management and analysis.

Each aspect of the AIMD that might affect performance when exposed to EMI should be tested in a scenario critical for patient outcome, based on risk. The standard expects and requires disclosure, explanation and justification for any unintended behavioral responses, which should be temporary and end with testing. Test labs must make accurate notes on behavioral responses www.medicaldesignandoutsourcing.com

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during testing. Permanent changes in performance due to these tests, outside of specification, are prohibited.

AIMDs using wireless technologies such as Bluetooth, WiFi, wireless induction charging and RFID chips must meet requirements regarding coexistence, security and functionality. The most common sources for wireless standards are the International Electrical Commission (IEC) and the International Special Committee on Radio Interference (CISPR). Regulations cover output power, effective radiated power, occupied bandwidth, power spectral density, spurious emissions, frequency stability and specific absorption rate (SAR).

These standards ensure the AIMD’s safety and performance as it interacts with other devices and functions within the body.

Best practices A design review early in the process is critical when developing AIMDs. Reviewing the product, its intended use, potential user, environment and evaluation requirements can prevent costly mistakes by addressing and resolving them early. This can save costly redesigns and additional testing later, allowing you to avoid delays to market.

Given the number of tests to be done, conducting all evaluations simultaneously has several advantages, including time and cost savings, allowing economies of scale around risk management, software and usability. Reports can be streamlined, referencing each other without having to duplicate efforts. A single report package with all necessary information can be made and reviewed for a potentially faster product launch.

It is important to know which standards apply to a given product and to prepare for testing from the beginning. It’s also essential to complete evaluations in a timely, cost-effective manner to help bring these devices to markets across the globe.

Bill Stearns is a senior engineer on Intertek’s medical device team, serving as team lead for electrical safety of active implantable medical devices. He has more than 30 years of electrical engineering experience, with more than a decade focused on regulatory and compliance needs.

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How to succeed at medtech package validations

Image from Millstone Medical Outsourcing

Ben White Millstone Medical Outsourcing

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he medical device manufacturing industry has never been more competitive. Rapid growth in the aging population worldwide and technological advancement have driven fast-paced product development as companies vie for market share.

This pressure makes time to market critical. Precious market share often goes to the manufacturers that can develop and launch products fastest without sacrificing quality or patient safety. Successfully navigating the demands of package design and validation often proves the crux of product development.

Without a clear understanding of the package validation process, the risk for manufacturers escalates.

That risk is multifaceted, including the danger of being out of compliance as well as the possibility of costly timeto-market delays that can imperil profits. Ever-increasing regulatory oversight and tightening global standards add complexity to an already complicated process.

The package validation process: An overview Package validation safeguards patient safety, ensuring medical devices arrive at the operating room ready to be placed into patients’ bodies with an effective aseptic transfer. The process entails creating a sterile package and ensuring its integrity despite the stresses of the transportation process. Establishing a package validation process is mandatory for compliance with regulations imposed by oversight bodies and the global standards that cover packaging, including the ISO 11607 standard, Parts 1 and 2.

The traditional custom package validation process can be broken down into three phases, as defined by the ISO 11607 standard of a validated packaging system:

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•

• •

Understanding the nuances of package validation and testing is a high-stakes endeavor for manufacturers.

Package design, which involves selecting materials and a sterile barrier system (SBS) that considers the product, user and anticipated process. Usability evaluation takes place to demonstrate that the sterile contents can be aseptically removed from the sterile barrier system for presentation.

Process validation, which includes qualification, validation and proof of stability of the SBS materials and seals.

Performance and stability validation, which covers testing the integrity of the packaging and its sterile barrier for the stresses of distribution and aging.

Process validation is further broken down into installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ), which together are intended to objectively demonstrate the mitigation of patient risk.

Because package design and validation can be complex, with many variables and opportunities for error or delay, typical timelines for completed validation can vary from as few as six months to as long as 18 months or more. It’s easy to see how unanticipated delays or difficulties can threaten a manufacturer’s ability to realize R&D investment or first-to-market advantage.

Common mistakes and problems Many manufacturers encounter common pitfalls in the package validation process. These can range from conceptual mistakes to functional errors. Here are some of the most common: •

The most common mistake also has the greatest potential to upend the product launch process.

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potential to upend the product launch process. Manufacturers often fail to consider package design until late in the product development process, which can add months to the launch timeline.

Best practice is to consider package design from the very earliest days of product development.

•

•

Another common package validation mistake concerns package design. The package’s sterile barrier system must be able to withstand the distribution stresses that can occur between the warehouse and the operating room. Comprehensive testing must consider all nuances of the device’s journey, including the stresses of air and truck travel.

The third common package validation error involves package stability.

Manufacturers must determine the length of a product’s shelf life and ensure the package can maintain a sterile barrier for the duration of this shelf life. To speed the package validation process, manufacturers sometimes subject packaging materials to aggressively accelerated aging stresses. Failure can set the package validation process back repeatedly, so it’s important to understand the ideal aging parameters for time-related package stability validation.

Manufacturers also have options to reduce risk and cut time to market in the package validation process. Engaging a partner with expertise can reduce risk, provide key knowledge of the regulatory landscape and its tightening compliance demands, and speed time

to market while upholding patient safety. In addition, the recent rise of an array of robust pre-validated packaging solutions for particular medical device product lines — including spine and orthopedics — can cut time to market by as much as 50% while preserving quality and patient safety.

Medical device product development comes with great risk and even greater potential reward, especially in improving patient lives and outcomes. Success in the high-stakes package validation process hinges on understanding and executing all aspects of a complex, risky process to ensure the utmost in safety and quality with faster time to market.

Ben White is engineering manager of business development for Millstone Medical Outsourcing.

Risk management in biocompatibility sample preparation Having a device tested for biocompatibility can involve several steps, and preparation is key.

Christopher Parker To x i k o n

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he core tenets of risk management revolve around identifying all potential risks, determining their significance and creating a plan for handling each one. In device development, the risks can be tremendous and range from choices of safe materials and qualified vendors to cybersecurity.

Plan ahead One risk in device development is the assessment of a device’s biocompatibility. How a device will perform in biocompatibility evaluations — whether they be risk assessment, chemical characterization or biocompatibility testing — may vary, but that performance is better suited for success with as much forethought as possible.

Each activity related to the biological safety of a iStock photo provided by Toxikon device should be driven by www.medicaldesignandoutsourcing.com

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a biological evaluation plan. Understanding the intended use of your device allows for proper classification to identify the correct endpoints for evaluation, explain its chemical characterization, predict how a device may perform in testing and how to handle any positive results.

Getting started The first step in any evaluation program is sample preparation. The most important considerations include: • • • • • • •

Special instructions for preparation.

Determination of the surface area.

Selection of extraction conditions.

Will the test article be cut or tested intact?

Does the test article degrade or absorb water?

Ensure the preparation procedure can capture all byproducts if the test article is curing in-situ.

Possible effects of any accessories on the physical and chemical properties of the device’s materials.

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applied to the test system (IV dosing, for instance) and it must be incubated in various vehicles in order to create a surrogate dose.

A medical device, or the extract vehicle thereof, can change during extraction. If this happens, the first and biggest thing to consider is whether the same effect can happen during clinical use. If it can, what’s the impact to device function and associated patient safety? Here are the most common post-extraction changes that are observed: • • • • • • •

Rusting.

Dissolution or degradation.

Extract can become turbid.

Particulate formation.

Test article or extract color change.

Changes in pH. Bilayer formation.

How to address them If any of these items are identified as

possibilities or are observed in testing, there’s a multi-step process that should be followed. First, assess why the change occurred. Then determine if it can happen in clinical use and whether it would affect patient/clinician safety as well as device performance.

For instance, if a metal clip begins to rust during a 50° C extraction over 72 hours, but it only touches the intact skin of a patient for less than an hour during normal use, the rusting probably won’t happen clinically and has a small impact.

A study of physical changes to a device during a shorter extraction period may help with the assessment and mitigation.

Here’s a list of items to consider: • •

Is one of the device components a “bad actor”?

Were the extraction conditions appropriate?

• • •

Did the sterilization process cause an untoward material change?

Were manufacturing aids left behind or was the device not completely clean?

Did shipping conditions affect the device (a warm and moist vs. cool and dry environment)?

Thinking about how a device may react in the different test systems, whether it’s the extraction process or being directly applied to a plate of cells, can help you prepare for these situations.

Christopher Parker is associate department head of in vivo biocompatibility at Toxikon. Since joining the company in 2007, he has worked closely with medical device manufacturers to develop their testing programs and support their regulatory product submissions.

Getting the most out of your lab partnership ahead of the EU's MDR Here are some insider tips to avoid costly testing and submission delays as you prepare for the MDR. J o s e p h To k o s WuXi Medical D e v i c e Te s t i n g

M

edical device manufacturers have a lot to keep track of these days. Between ongoing device development and preparing for the European Union’s impending Medical Device Regulation (MDR), it’s more important than ever to maximize every partnership.

Outsourcing device testing to laboratories or contract research organizations (CROs) offers much needed relief to manufacturers and an opportunity to enhance MDR preparation efficiency. Here are a few insider tips to make the most of your relationship with your testing partner: Don’t hold back on the details Your testing partners need to ask a lot of questions about your device to be able to design a concrete test plan and provide an accurate quote. It may seem like they’re asking for too much information before you even sign a contract, but these fine details can make or break a test plan. Failure to thoroughly detail device materials, for example, can lead to flaws in the extraction plan, such as the wrong solvent, equipment, temperature or extraction time. Complete and accurate dimensions are important because the extraction ratio will depend on wall thickness. Surface area information is also important because testing partners need to know whether the device must be cut into pieces for testing and the implications of doing so.

Providing all of the information upfront will save time and help prevent delays, denied submissions due to

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inadequate results and increased costs when studies aren’t designed properly.

Before requesting a quote, gather detailed information on the following: • • • • • •

Purpose, category and patient contact time.

Size, thickness and surface area.

Materials, colorants, pigments, adhesives, additives, polymers and manufacturing aids.

Procedures used to manufacture and sterilize the device.

Parts and composition.

Existing data from previous testing.

Read up on regulations Understanding how new regulations and standards apply to your devices will empower you to educate your internal team and instill a sense of urgency to collaborate with your testing partner. Making an effort to keep abreast of the latest on MDR will allow you to have more productive and timely conversations about your test plans.

If you don’t have the bandwidth to dig into testing requirements — after all, that’s part of why manufacturers work with outside resources — you’ll at least want to check in with each person or department involved in device development. Design engineers and material suppliers, for example, will help you understand the intricacies of the device’s design, materials and parts.

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Image courtesy of WuXi Medical Device Testing

It’s also important to note that patient contact time and in vivo testing methods will be under heightened scrutiny. Devices with shorter patient contact time are now going to be held to the same standards as those with longer patient contact time. This means the current data packages on even Class I devices may be incomplete moving forward. If the duration of patient contact is shorter than 30 days, be sure to ask your testing partner if you have remaining gaps in your submission that will require new testing. Also, take this opportunity to evaluate all of your options with existing in vivo device data or product family grouping data to minimize in vivo testing.

Learn from others’ mistakes Sometimes, even the best intentions can’t guarantee a smooth testing experience.

Beyond looking into what the regulations require and providing thorough product information, there are a few pitfalls that can lead to incorrect testing parameters, delays and added costs.

One common mistake is providing

outdated information from a previous design. Start each device information request from scratch instead of copying and pasting from a previous form; then, investigate any gaps. This forces you to consider all the details carefully, which reduces the risk of an improperly designed test plan. Getting it right the first time reduces the risk of needing additional device samples (test article) and repeating tests.

It’s critical to provide truly representative test article of the devices produced by manufacturing.

Using a prototype, for example, could yield inaccurate results and put your submission’s approval at risk because prototypes may be made of different materials or employ a different manufacturing process.

Another easily avoidable mistake is failing to describe any device changes in detail. Your testing partner can better address risks of your updated, next-gen device if they have a good understanding of what prompted the updates. Whether you addressed patient safety concerns or

made updates to improve user experience, communicating the reasoning behind any device changes allows a lab to tailor the study.

Finally, don’t misunderstand the role of chemical characterization. While biocompatibility testing is important, chemical characterization is what identifies risks you didn’t even know exist.

There’s a lot to consider from a regulatory standpoint right now, and you need to maximize on every partnership to keep pace. Device manufacturers and labs alike are facing capacity constraints. If you provide a forecast to your partner and inform them of what samples they can expect and when, they may be able to reserve testing space and adjust capacity to better meet your needs. For more tips on how to prepare for MDR, read “Countdown to MDR: Do you know your options?,” “Pre-clinical medical device testing under ISO 10993-1 and the MDR” and “What you need to know about reusable devices and Europe’s MDR.” Joseph Tokos is the technical director of chemistry at WuXi Medical Device Testing.

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DEVICETALKS

Sarah Faulkner (left), then DeviceTalks program manager, interviewed Boston Scientific corporate research VP David Knapp (right) at DeviceTalks Minnesota in September.

Image by WTWH Media videographer manager Brad Voyten

After 20 years at Boston Scientific, here's what this medtech R&D leader has learned David Knapp, VP of corporate research at Boston Scientific, has spent 20 years developing devices that cut across divisions at the medtech giant. At DeviceTalks Minnesota 2019, he gave attendees an insider’s view of what he’s learned about device development and healthcare.

Sarah Faulkner Contributor

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n his 20 years at Boston Scientific, David Knapp has learned a lot about how to develop a medical device. His approach to identifying an unmet clinical need that could be tackled by a new technological therapy is welldefined: it all starts with empathy.

“There are people who have a pair of eyes that I don’t have, that see things that I don’t see.

And those are the kinds of people we try and put in these kinds of roles where they’re observing procedures. Ethnography is a huge part of this, but it can’t be the only thing. Really [we need] a deep understanding of physiology, disease state,” he said in an interview at DeviceTalks Minnesota 2019.

“The other thing I’ll say is that it’s incredibly important to me to prioritize needs based on multiple criteria. The three questions I think about

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are ‘will it work?’, ‘can you prove it?’ and ‘is there a business case around this to add value to the healthcare system?’ And if you can bring those three questions together and put a team around those, then you’ve got something.”

The shift to value-based healthcare For years, analysts and major players in the healthcare industry have spoken about the impending shift to value-based healthcare. And most would agree that the industry has a long way to go as it moves away from a fee-for-service model. To effectively transition to value-based healthcare, Knapp acknowledged that it will require cooperation between all of the various players: payers, industry, providers and regulators.

“The reality is that everything we do involves all of those stakeholders. It is absolutely the case

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[Minnesota] is just an oasis of talent.

It's an oasis of ideas and creativity.

Whether you're talking about strategic companies, many of which are essentially based here one way or another, or whether you're talking about startups, this is the place to be. that going forward we’re going to need to engage them in this story,” he said.

“But the good news is that we’ve been doing this for a long time.”

He pointed out that after Boston Scientific acquired Guidant in 2006, the company went from having predominantly traditional mechanical devices to also selling active implantable devices.

“Because those active implantables have sensors in them, we were now in a world where we had data over time being collected from the patients that were using those devices,” Knapp explained. “What we realized was that this was an opportunity for us to really dig deep, analyze the data and understand how we might be able to address the disease of these patients better.”

Boston Scientific crafted an algorithm that interprets data from multiple sensors embedded within its defibrillators. That AI produces an index for each patient, which is then sent to a physician and (based on the doctor’s preferences) the doctor can receive an alert when things change beyond a certain threshold, according to Knapp.

“Oftentimes that happens before a patient is feeling sick. That’s really important, because if they’re waiting until they’re feeling sick and they go to urgent care, or they go to an emergency room or a heart failure clinic, by then it may be too late to change something. This is an opportunity for a physician to intervene earlier and make a difference,” he said.

“That is the kind of thing that is going to really add value in the future for devices. If you think about what that does and telegraph in the future where appropriate, devices are increasingly going to have those capabilities. To be able to sense, to be able to collect data, and who does that better than the companies that are creating implants that are right there where the action is?”

Moving from acute to preventive care As VP of corporate research at Boston Scientific, Knapp has a unique role — he works on technology platforms that cut

across multiple divisions at the medtech titan. His job gives him a high-level perspective on the issues that are shaping how healthcare is delivered and how patients are cared for around the world.

One thing Knapp is thinking about a lot these days is the world’s aging population.

“At some point along the line here, the number of people over the age of 65 begins to be much greater than the number of younger people that are here.

The burden for the healthcare system goes way up and costs go way up, so... patients are demanding better solutions and solutions that are more personalized and proctored for them,” he said.

In order to make the shift to valuebased healthcare and address the industry’s problems of the future, medtech companies need to start thinking about engaging in preventive care, according to Knapp.

“If I think about the history of Boston Scientific, we have been playing in a space of acute treatment. Something needs attention and we have a plethora of devices that can address that. Increasingly we’re going to be needing to think about the broad continuum of care and then how do we essentially diagnose and understand that there is disease sooner, maybe even before the patient is seeing any clinical symptoms,” Knapp said. “And then once we do intervene, how do we keep them healthy and [help them to] stay out of the hospital.”

Another issue that Knapp highlighted at DeviceTalks Minnesota 2019 was the ever-growing need for technologies that are suited to the requirements of individual countries and populations.

“Disease and disease treatment is not evenly distributed in the world.

There’s an underserved community and I think it’s the job of companies like Boston Scientific to address that,” he said. www.medicaldesignandoutsourcing.com

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Knapp pointed out that when started at Boston Scientific 20 years ago, the company was largely focused on addressing the U.S. market. But over the last decade, according to Knapp, Boston Scientific has started to increase its global footprint, with presences in places like Shanghai, Ireland, Costa Rica and India.

Minnesota: ‘an oasis of talent’ It’s no secret that Boston Scientific regularly invests in or purchases companies with interesting technology earlier this year it closed a $465 million deal to buy spinal implant developer Vertiflex. The company also partnered with Mayo Clinic this year to open an accelerator named Motion Medical.

Boston Scientific has also worked with Medical Alley, the University of Minnesota and Mayo Clinic in the Twin Cities on a project known as the gBETA Medtech Accelerator.

“That has been eye-opening for me in terms of bringing entrepreneurs to the fore and really encouraging them to step up. These are companies that are already formed and it’s just about accelerating them. It’s seven weeks of being able to have all the resources through those organizations,” he explained. “And believe me, they take advantage of it.”

Knapp said that as far as talent and technology goes, Minnesota is “ground zero for medtech.”

“This is just an oasis of talent. It’s an oasis of ideas and creativity.

Whether you’re talking about strategic companies, many of which are essentially based here one way or another, or whether you’re talking about startups, this is the place to be,” he said.

To the young startups looking to engage Boston Scientific, Knapp shared some advice.

“Just understand the stage that you’re at and what you’re looking for. And understand that we have over 32,000 employees in the company. It’s a big company. Sometimes it can take time to find the right people, but they’re there,” he said. “So be persistent, have the grit to not just expect that your very first touch point is going to be the answer. Even at a company like ours, it takes a couple of phone calls.”

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CONGRATULATIONS PRESENTED BY

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A D VA N CED MATERIA L S Medical Design & Outsourcing is excited to release the

CA B L ES CO N TRA CT MA N U FA CTU RIN G

winners of our annual

CO U PL IN G S

Leadership in Medical Technology program. Since we announced the nominees in our January 2019 issue and online, our user community has voted on what companies they feel best exemplify medical

D ESIG N SERVI CES D I G I TA L MA N U FA CTU RI N G EL ECTRI CA L FA STEN I N G & JO I N IN G

technology leadership in 12 categories. We are happy to celebrate the winners here.

F L U I D PO W ER MA CH I N IN G MO TI O N CO N TRO L PRO D U CT D EVEL O PMEN T

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Sponsorship opportunities are available for future DeviceTalks programs.

For more information, contact Mary Ann Cooke. 781.710.4659 | maryann@massdevice.com

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15.and Extent and Nature of Circulation Outside Sales Through Dealers and Carriers, Street Vendors, Counter the Mail) (3) Sales, and Other Paid or Requested Distribution Outside USPS®

11,607

9,589

9,529

0

0

Average No. Copies Each No. Copies of Single Issue Published Issue During Preceding Nearest to Filing Date 12 Months

a. Total Number of Copies (Net press run) (4) Requested Copies Distributed by Other Mail Classes Through the USPS (e.g. First-Class Mail®)

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11,605

Total Distribution (Sum 15cPrint and e) b.

Total Requested andofPaid Copies (15c) + Requested/Paid Electronic copies (16a)

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PS Form 3526-R, September 2007 (Page 2 of 3) i. Percent Paid and/or Requested Circulation (15c divided by foftimes 100) X I certify that 50% all my distributed copies (electronic and print) are legitimate requests or paid copies.

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Master Bond.....................................................5 MasterControl................................................97 maxon......................................cover/corner, 81 Medbio, Inc....................................................70 Memory Protection Devices.........................25 MICRO Medical.............................................55 MicroCare Corp.............................................52 Microlumen..........................................104, 105 MW Industries - LaVezzi Precision................47 MW Medical Solutions..................................49 New England Wire Technologies & New England Tubing Technologies......107 NextPhase........................................................3 Nitto Kohki USA...............................................5 NSK Precision.................................................95 Okay Industries............................................103 PTI Engineered Plastics.................................59 Renishaw.........................................................45 Resonetics.................................................... IFC Rotor Clip Company, Inc. ...........................101 Schneider Electric Motion USA....................35 Smalley Steel Ring.........................................91 Smart Products USA, Inc.................................1 Solenoid Solutions, Inc..................................29 Spartan Scientific...........................................82 Spectrum Plastics Group.................................4 STEUTE Meditech, Inc...................................21 Tegra Medical..............................................IBC Teleflex Medical OEM...................................13 The Arthur G. Russell Co., Inc.......................57 The Lee Company.........................................65 TRACO POWER North America...................71 Viant................................................................67

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