Boyd Trusted Innovation

• Decorative Protective Layer
  • Extend wear time, differentiate your brand, and embellish wearable aesthetics
• Housing Layer
  • Enhance breathability or waterproof to protect electrical components
• Cushioning Layer
  • Protect delicate electronic components and improve patient comfort
• PCBA with Backlit Switch Technology
  • Integrate flexible solutions advance functionality, connectivity, power, and brand differentiation
• Through-Hole Printed Flex Circuit
  • Use both sides of the flex circuit to maximize design flexibility and creativity
• Skin Contact Layer
  • Biocompatible adhesives improve wear time, patient comfort, and ease of removal
• Conductive Hydrogel
  • Improve reliable signal conductivity for both sensing or stimulating applications
• Delivery Liner
  • Design to maximize patient application efficiency, ease, and comfort

At every stage of life, converted tapes help improve the quality of life. From neonatal to geriatric care, medical adhesive tapes protect, heal and enhance the skin, secure medical devices, adhere body monitors, and dispense nutraceuticals.

At Boyd, our team collaborates with product engineers to bring designs to life by converting raw flexible materials into usable parts and stick-to-skin wearable products.

As a 3M Preferred Converter, Boyd has access to biocompatible medical materials that are gentle to the skin, easy to remove, and vary in wear times from minutes to weeks.

The Boyd engineers source the best materials for your application and designs for manufacturing by utilizing our state-of-the-art equipment in class 100 to 100k clean rooms in three continents to laminate multi layers die cut slit and print liners

With over 90 years of experience, trust Boyd to convert your ideas into reality

Contact us today to learn more.

I'm Fred Knox I'm the vice president of global medical sales for Boyd Corporation Boyd is a leading manufacturer in the disposable medical device industry, we offer converting services, precision die-cutting, medical grade adhesives and thermal management systems. Boyd offers innovative manufacturing technologies coupled with advanced material selection services we support the development of our customers products from the very beginning.

Beginning with material selection through process design and full-scale production. I'm Lane Shaver, I'm a field application engineer for Boyd corporation. Well Boyd has an extensive experience in material selection engineering R&D work and combined with world-class suppliers like 3M and our unique manufacturing abilities we're able to provide, high quality consistent parts meeting the tightest tolerances in the industry. I work very closely with the customers to provide an engineering process that provides them with the end product that they want and a product that we can produce, cost effectively and efficiently for them. In the medical industry it only takes one minor defect to be a problem so you don't want that minor defect to make it to the operating room to make it to the hospital so you've got 100% inspected so that every part your customer gets is of the highest quality so that they don't pass on your quality issues. Working in disposable medical devices it's important that you build long-lasting relationships with customers because you're working with them every day. Building strong relationships with our customers help them come to market quicker Boyd delivers a quality product on time with unparalleled customer service.

hello and welcome to this Boyd corporation and 3M webinar my name is katie and i will be your global spec moderator and now i would like to introduce today's presenters with us today is matt berdaul matt is the global channel manager with 3M medical solutions division also with us today is paul maciosi paul is a field application engineer with Boyd corporation to read more about either of our speakers please take a look at the speaker bio area to the right of the main presentation window matt and paul welcome to today's event and with that i'll pass things along to you to get us started so matt go right ahead everybody my name is maperdahl and it's my pleasure to be here with you today to present on the following topic the engineer's guide to wearables lessons learned from design mishaps wearable devices are a critical part of our healthcare landscape today and so i was very excited when our friends at Boyd corporation asked me to join them and collaborate on today's webinar first a little bit about myself I currently serve as the global converter channel manager within 3Ms medical materials and technologies business i have over 24 years of experience at 3M serving in multiple different functions and multiple different businesses within 3M and so during my time i've had the opportunity to

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to see the product development cycle and how it's executed both inside 3M as well as outside 3M with different customers and partners that we've collaborated with in the various businesses that i've worked in now let me touch on a couple key facts for 3M 3M is a very large corporation and many people know different different aspects of it but in totality we have sales in over 200 countries we're divided divided up into four business groups which i'll touch on in a minute we have over ninety six thousand three members globally and most importantly we have over a hundred and seventeen thousand patents that are held within the company and this fact truly speaks to our our core and our foundation as a technology and innovation company and that technology is one of our four key fundamental strengths that we leverage to bring products and solutions and innovations to the market every day on top of technology we are a manufacturing company we have strong roots and deep knowledge in the manufacturing space i mentioned our global footprint our global capabilities and then our 3M brand name is obviously very well respected in the industry

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now all of these fundamental strengths are critical to our success but really none of them matter if we don't put the customer first we have to be focused and are focused as a company on the end user and we put a lot of time and effort into gaining customer insights to help us create that customer inspired innovation and so when we think about 3M no matter what part of 3M or what business within 3M we're talking about the this vision these strengths these priorities and these values are what guide us in our efforts each and every day this slide gives you a visual of the four business groups that make up 3M now most people are aware and familiar with the consumer business group this is where brand name products such as post-it notes command adhesive strips and scotch tape reside but what's interesting about this business group is although it's typically the most well recognized it's actually the smallest of the four business groups shown here 3M has a significant president presence and product portfolio in the safety and industrial transportation and electronics and healthcare spaces and given the topic of today's discussion being wearables the healthcare space is where we'll focus so to give you a little more detail on the healthcare business group at 3M

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we're made up of five divisions shown here the medical solutions division is the largest division within the healthcare business group and has many well-known products that you would see in care settings around the world both in hospital and outside of hospital care settings products such as tegaderm advanced wound care dressings littmann stethoscopes and micropore securement tapes are just a few of the examples of the brand name products that 3M has in the market a little known fact about 3Ms healthcare business is 3M is actually in the top 20 globally in terms of medical device companies again oftentimes people think of post-it notes when they think of 3M they don't always think of health care but we do have a significant portfolio and a significant presence in the medical device space globally and with this position comes a broad and deep knowledge when it comes to quality regulatory medical device manufacturing and medical device product design experience it is from this foundation that much of the presentation that we share with you today is based in now a little bit more about the medical materials and technologies business that I'm part of so where we are different from the broader medical solutions division

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we do not bring branded 3M finished goods to the market but rather we are an oem materials and technologies component supplier to other medical device manufacturers so our mantra is improving lives by providing med device oems access to 3M science enabling breakthrough innovations in healthcare our four primary areas of focus within the medical materials technologies or med tech business as we like to call it are shown here on this slide given that today's topic is the wearable device topic we'll be focused on our body worn adhesives and medical device construction throughout the rest of our presentation and as a oem material supplier to medical device companies we've had the unique opportunity to work with numerous medical device companies during over the years these medical device companies have ranged from top 10 globally known medical device companies all the way down to small startups that are that are coming up with with new technology and breakthrough innovations in this space this experience coupled with our own product development and product design experience internally gives us a unique perspective on the device design process and really that's the hope of today is to help bring this breadth and depth of experience that we've garnered both internally and externally with partners and try to capture and highlight some of

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the key learnings and key mishaps that we've seen over the years and share those with you to help make your your process smoother and more efficient as you embark on your medical device design so now enough about 3M let's move into the meat of the presentation so as as part of our business we oftentimes publish white papers and different guides on various topics so the focus of today is is again predicated on our guide that we we published out there the engineer's guide to wearables and due to time we won't have the opportunity to go through the entire guide today but we will follow up after this webinar and make this guide available to all participants so that you can go through the entire guide and see all of the various lessons and steps and tips that we have shared now as mentioned at the beginning of this presentation wearables are a critical part of our healthcare landscape there are many healthcare trends out there today shown here on this slide and some key industry needs and key industry success enablers that all result in wearables being a critical solution that that med device companies are working to deliver to the market and because of this growing focus on wearables and growing development of

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various wearable devices to help address many healthcare needs out there we felt this guide was was critical to deliver to again help the advancement of these technologies and these products to bring the solutions to the end users in the market so let's dig into this topic further patient-centered care is becoming ubiquitous in the healthcare industry we're shifting from a doctor knows best culture to one in which patients seek multiple opinions highly tailored treatment options and ways to monitor their health themselves every day internet forums are frequented by people seeking ideas for how to manage their disease better overall patients and their caregivers are looking for convenience disease or health management that fits their lifestyle and the ability to connect with our providers privately and discreetly change in healthcare in the pace of medtech innovation is moving faster than ever like clinicians wearable device design engineers have an important role to play in healthcare today device manufacturers must continually evolve their offerings to keep pace wearable medical devices that help patients monitor and manage chronic illness are the conduit between a medical professional's treatment plan and the patient's ability to maintain an independent active lifestyle but in order to allow for such a routine wearables have to meet several requirements patients need devices that easily integrate into their daily lives and are personalized easy to use and comfortable with long lasting power we know that designing a device that checks all these boxes is no easy feat that's why we've compiled our knowledge

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from working with design engineers and device manufacturers around the world to develop this guide you will learn about an array of missteps your peers have encountered when bringing a wearable medical device to market and more importantly how to avoid them we'll discuss the importance of addressing system design how materials work together device manufacturability and how to keep the patient top of mind to help innovators like you get it right our goal is to help you innovate wearable technologies that improve people's quality of life and eliminate stressors the first step in this process is understanding users needs and then checking the boxes on those needs the first need is being life-proofed patients strive to live without constantly thinking about their illness as technology becomes smarter and more advanced patients expect devices to minimize the inconveniences of around-the-clock disease management in order for a device to do so successfully it needs to be built in a way that seamlessly integrates into the patient's everyday life devices should be water resistant and resilient after long wear times a slim profile that maintains flexibility and durability can help resist edge lift and improve aesthetics devices need to withstand the ins and outs of daily life including resisting the impact of bumps tugs and pulls materials and components that shield dampen and absorb energy can help with the life of the device the next key user need is comfort people look for comfort in everything from

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shoes to beds to cars wearables are no different excessive itching rubbing or irritation will not be tolerated pain associated with removal also needs to be minimal and time between wearable changes should be maximized materials can help improve comfort by being stretchy breathable and reducing moisture buildup poor system design can often lead to feeling uncomfortable whether it's with the device's size interface or breathability next key need is ease of use operating a device needs to be easy and intuitive if a user can't understand how to use a device and operate it without difficulty it doesn't matter how advanced the technology is when devices are straightforward users can adopt consistent and sustained use more quickly managing the number of buttons and confirmations for example is important and if the system is complexly complexly designed it could lead to non-compliance or the patient getting the wrong dose we recommend working with partners well-versed in user experience including a sophisticated converter that is able to consult on ease of production and usability next key need is personal personalization while some patients prefer a discrete device others want to proudly sport one that is bold and colorful regardless of the end of the spectrum they're on at the end of the day most patients want their device to be a reflection of who they are this can be challenging for device manufacturers looking for

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looking to produce on mass scale luckily workarounds are available for instance cover tapes can lend themselves well to mass production while offering a personalized touch final key need we'll touch on is long lasting power it's inconvenient and frustrating and can be dangerous for patients to have to frequently change or recharge their device it can mean going hours without the data critical to monitor their health devices with better power management may yield more consistent data and may cost less per unit to make and maintain over the device's lifetime defining these needs is a challenge in and of itself and then checking the boxes on these needs is a whole nother level of challenge and so what i want to do next is go through seven of the various lessons that we've documented to help provide you with some insight on some design mishaps and issues that we've run into or seen in the past we'll begin with lesson number one designing non-compatible or poorly integrated systems when designing your device it is important to consider the total system

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this encompasses the individual materials including the adhesives the design and the manufacturing process without doing so you could miss opportunities to optimize the manufacturability of your device a poorly integrated system can also result in a cascade of other problems that can affect comfort ease of use performance user adoption physical size and more for example choosing the right adhesive solution and partnering with a converter that has expertise with the materials you are considering during the design phase can present opportunities to optimize the stacking and layering of the materials you select which can improve their assembly and performance next lesson learned wrongly defining market needs it's too often that medical device companies over generalize their devices in an attempt to achieve what they think users want this becomes problematic when it results in an over or under designed device your innovation will have a greater chance of succeeding with strong data that drives healthcare decisions for starters identify the problem your device will help solve all key stakeholders need to have a deep understanding of the problem being solved and be unified in a vision that guides

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every decision this will help to save time avoid cost overruns and keep everyone on the same page going forward from there have discussions with those involved in conducting research to coordinate efforts you must understand what the end user really needs and wants out of the device performance before going into design make sure the research sufficiently backs up your decisions that address user preferences such as whether patients want a discreet device or one that can be personalized to match your style additional design nuances such as insights to make application and removal easier could improve the device and how well it's received by users research can also help determine and potentially navigate and use factors you can't control including a patient's culture overall health potential demographic issues and the environment in which they live keep in mind that initial research isn't an end-all be-all process it should be an ongoing effort that incorporates different types of input from quantitative to behavioral research check in with the research team regularly to find out what new information they've uncovered and what data reaffirms previous assumptions if any voice of customer data is available it should be mined for

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comments on challenges support issues technical requests and other feedback social media and user support groups also can provide valuable insights design and innovation are iterative processes and current data is essential to improve over time the unfortunate reality is that research can get expensive but having to make design changes late in development or creating a device that fails once it's in the market will also have a drastic if not worse consequences that affect time and budget it's in your best interest to make the investment on the front end rather than deal with negative repercussions down the road next lesson learned not taking skin seriously many of us like to believe skin is impervious but it's not skin is our primary barrier to the external world and is our first line of

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defense against infection and damage it's the body's largest organ and helps regulate many key functions such as body temperature and internal fluid balance it is like a conveyor belt for moisture and skin cells as they transition from the deeper levels of the dermis to the top layer of the stratum corneum we create new layers of skin as the old layers exfoliate every 10 to 20 days on average for an adult designing a device that will be worn on skin for extended periods of time needs to account for the nature of skin and limit potential damage that could occur during the device's lifetime too strong of an adhesive can injure skin upon device removal too weak of an adhesive can result in the device falling off increasing the cost of the patient and inadequate care if a replacement isn't available a device and adhesive design that does not account for breathability can unintentionally trap moisture that can cause irritation and maceration further injuring the skin make sure your design factors in all of these needs as early as possible to improve the experience

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and performance of the device throughout its where time it'll also improve patient compliance next lesson not incorporating the device's wear time into every decision when we advise on a project where time is always a top consideration all other decisions depend on it from what type of adhesive will be best for the application to the device's housing material if it's a stick to skin device wear time is even more important because the substrate skin is unlike any other in contrast to non-living substrates like metals or plastics skin moves breathes and completely regenerates itself regularly on top of that not all skin can tolerate the same level of external irritation despite age overall health and other uncontrollable variables skin needs to be able to function as normal particularly if a device will stay adhered for longer than a day or two it's a tall order but there are a few ways your design can accommodate skins needs for starters incorporate breathable backing and adhesive combinations wherever possible as they will allow moisture to move through the tape system

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moisture vapor transmission rate or mvtrs help indicate how breathable a tape system is however wearable devices on top of a tape system may alter moisture vapor transmission levels you should use a skirt or extended edge around the device rather than cutting the tape to the device's exact size doing this helps preserve the skin's ability to flex and move while maintaining a strong bond between the adhesive and skin it can also help reduce failures when the device is knocked against a doorway for example relatedly you can enable longer wear time if your device's layers are compatible with your intended user skin visol viso elastic elasticity how skin takes in and releases energy over time and in different temperatures when you don't consider visual elasticity this user skin may stretch as a response resulting in hyperelastic material performance beyond stick to skin applications wear time influences a wide variety of design

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decisions including power management material selection application and removal and overall durability when in doubt your material supplier should be able to help you make the right decision the next lesson is focused on using incompatible materials depending on the device's materials issues may not arise until after the device is manufactured and out the market this is troublesome because at this point it's too late to make cost-effective changes to proactively determine compatibility start with your substrate material the materials that are most commonly used for medical devices include polyethylene both in the ldpe and hdpe format silicone pvc polyester and polyurethane depending on which of these materials you use you are likely you are going to gain certain benefits benefits in terms of feel conformability ability to bond etc at the same time depending on which one of these materials you choose to use you're going to have some challenges that you'll need to deal with those include the inability to heat shrink whether or not they work well in in the converting process whether or not they have a tendency to migrate into other materials etc so if you take a look at the guide when

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you have a chance we outlined some of the compatibility and incompatibility topics that you need to consider when working with various which with various types of substrate materials but again the point here to know is whatever you do choose make sure that you investigate the material and you understand the pros and the cons and the benefits and challenges of working with each type of material and then with skin as a substrate the materials used in the device must meet biocompatibility requirements for country regulations and or industry standards such as iso 10993 and not be manufactured with materials of concern such as latex or animal derived materials discuss all materials you plan to use with your material supplier as early in the process as possible feedback from your material supplier will ensure you're headed in the right direction and reduce the likelihood of compatibility problems later in the scale-up process next lesson treating adhesive selection is a trivial exercise the mindset of tape as tape is a dangerous oversimplification when designing a wearable medical device from how from how an adhesive performs in different situations to how it interacts with other device materials adhesive influences the device's overall

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functionality and accuracy adhesion is part of a system so it's important to understand how each layer of the system contributes to the overall adhesion performance if adhesive selection isn't thought about early in the design process it can result in manufacturing issues device malfunctions and possibly harm to the user from manufacturing issues if a selected adhesive is very soft it can gum up equipment during converting and downline production processes leading to unforeseen added costs and delays due to unscheduled stops and cleaning additionally softer adhesives may require manufacturing equipment to run at slower speeds which adds to the run times and increases the overall cost of goods pre-coding and or pre-treating the converting dies with durable release surfaces protecting contact rollers with low adhesion wraps chilled rollers air blowers and using thread up designs that avoid contact with the adhesive surface can help avoid these issues partnering with a converter or third-party manufacturer that has expertise and is knowledgeable in working with your chosen materials can help ensure you are using the right adhesive for your design optimizing manufacturability and maximizing yield throughout there are also device malfunctions to consider a device that sticks to skin needs to stay adhered for its intended

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duration of wear in order to successfully fulfill its purpose if an insufficient adhesive is used the device can prematurely fall off this could potentially cause a missed reading or dose of a life-saving medication additionally an inappropriately selected adhesive that adheres components together can result in part shifting failures during or after sterilization or worse the device falling apart you also need to think about harm to the user skin is a sensitive substrate so it's important to choose the right adhesive system to avoid a potential medical adhesive related skin injury or marcy marcies can occur from improper skin preparation incorrect select adhesive selection and errors when the device is applied or removed improperly marcy ranges in severity from mechanical skin irritation to skin stripping and tension blisters once a patient experiences pain they may not want to use their device again or recommend it to others so make sure you consider the peel force to pain correlation some adhesives fall in a sweet spot offering less pain for a given level of removal force fortunately it's possible to avoid these outcomes by carefully and thoughtfully choosing the best adhesive for each application before embarking on the design processes or process consult with your material supplier on the substrate's unique characteristics the type of environment in which your device will be used the age range and general health of users location on the body and its intended where time the final lesson I'm going to touch on today is failing to foresee manufacturing process implications thinking through how a device will be manufactured early in the process can help you avoid redesigns delays cost overruns and issues during the scale up for

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commercialization process for example if a manufacturer selected a tape with a backing because of how it looked and felt without considering the technical specifications the misstep could be that the tape was selected without completing multiple internal wear studies and testing whether the backing was compatible with the desired bonding technique had the step been addressed earlier the manufacturer could have learned how to best select materials and avoided the headache and lost time as i mentioned at the beginning of my presentation my goal today was to share with you some of the lessons learned that we have documented in the engineer's guide to wearables i did not have the opportunity to share all of the lessons learned that we have in this guide and I'm sure there are many other lessons learned out there that various design engineers could share with you during my presentation I'm certain that you heard a couple key themes throughout one being material selection and that's where a partner such as 3M medical materials and technologies can help your company with that process we are materials experts and we can aid you and guide and help guide you through the process of selecting the right material for your device the other overriding theme that I'm sure

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you heard about was manufacturability and understanding how to connect and convert materials to deliver the end result that you are striving for and so this is a great point in the webinar to hand the reins over to board corporation who are the experts when it comes to converting materials and so when we think about any sort of device design i leave you on this slide a wearable is really an ecosystem there are multiple players that come together to create a wearable device that's going to meet the customers needs we're just one small part of it void is another part of it and obviously there are multiple other entities that come into play to create an effective and feature-rich wearable device so as i hand the webinar over to Boyd and they can talk to you about the manufacturability aspects of world devices i thank you for your time and please feel free to reach out to 3Medical materials and technologies should you have any materials solutions requests in the future thank you very much matt thank you so much for that great presentation I'm gonna pass things along now to paul to get us started with the second half of today's webinar paul go right ahead hello my name is paul maciosi I'm one of the medical field application engineers here at Boyd i've been working in the area of

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biosensors and wearables here for the last few years supporting our medical teams so I'm here to talk a little bit about some of the experiences that i've learned in regards to collaborating with our customers in in providing design assistance on these types of projects let me first try to provide a quick overview of who Boyd is we're a leading solution provider mainly focused in two areas thermal management and engineered materials solutions for thermal management we utilize a highly engineered system level approach to help our customers solve challenging thermal management system level problems our solutions can range from something as simple as a gap pad interface material connected to a heat sink to a fully integrated cooling system to help support these activities we have design centers at various locations around the globe where engineers are performing analytical modeling exercises such as computational fluid dynamics or finite element analysis to help our customers with these problems on the engineered material side these are converted parts from utilizing engineered materials using processes like rotary die cut or flatbed cutting metal stamping as well as extrusions of

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materials like plastics foam and rubber components uh our products are used in a wide array of different functions from bonding solutions to gaskets environmental sealing to electrical insulation and shielding applications to surface protection screen display enhancement noise and vibration control type solutions etc Boyd at a glance we're basically a billion dollar plus company in global revenue we have over 30 facilities worldwide over 300 degree engineers of our 6 000 global employees we're very diverse in terms of the markets we serve as you can see equally split between enterprise electronics consumer transportation industrial medical this map obviously shows the Boyd's global location or global footprint you can see that our main areas of focus north america the eu in the far east all of our sites are iso 9001 certified in many of the sites we have special certification depending on the market served specific to the medical industry our sites in gallatin tennessee, zika germany and wuxi china as well as chonburi thailand are all iso 1345 certified sites some of these are also fda registered locations we have two new sites that are applying for the iso 13485 certification grand rapids michigan and our newest site in juarez mexico

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let me spend a little time talking specifically about the solutions we offer for the medical industry this slide speaks to the wide breadth of products that Boyd offers in the medical space we provide products both on disposable and with various stick to skin applications dressings and advanced wound care products mainly products that are done completely on press on a rotary process to products like biosensors and medical wearables that combine converting as well as assembly we also play on the system level where we provide content into medical devices on the thermal side we are offering solutions for heat management things like heat sinks heat pipes liquid cooling plates heat exchangers convection cooling and so forth other types of content we supply to the system level devices could be things like environmental sealing screen enhancement dmi shielding noise vibration control type products

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the medical industry in general is facing increased design challenges as the demands of healthcare providers become more and more demanding specifically to biosensors and wearable devices from our voice of customer interactions what we've learned is most important to our customer obviously highly reliable high quality and low cost but also compliance to regulatory requirements but also the the ability to adapt new technologies into these devices and while making them smaller and lighter weight and easier to use for our engineered material solutions i think our value proposition to our medical customers is that Boyd is a very skilled and experienced converter we understand how to put together complex multi-layer products and on-press very efficiently cost effectively we can innovate in our process very well we have very good relationships with our raw material suppliers specifically in the areas stick to skin so we understand how to pick the right materials for these types of applications we have extensive clean room manufacturing our various sites uh experience with sterilized kitting and packaging and especially in our gallatin site you know where we've been working in the medical industry for decades

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i think we are very experienced with the healthcare industry and understand the medical customer very well our most traditional uh product offering in the medical wearables uh would be the skin stick to skin type dressing components that utilize the various different types of skin contact adhesives or the stimulating or sensing hydrogels or other types of hydrocolloid materials but for other smart wearable devices that are on the market today we offer other more traditional converted solutions for example the window box type display mounting systems that are used to bond the the displays light enhancement films environmental sealing gaskets or o-rings we also offer some internal components for like emi shielding or absorption and even thermal like heat spreader or insulating type components that go internal to the electronic device i wanted to share some of the lessons learned in our collaboration with our customers on new product development the first item i'll talk about is just having clearly defined roles and responsibilities and what i mean by that is you know we as the manufacturing partner our role is to help in the design process by making recommendations

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mainly in the area of design for manufacturing feedback trying to come up with an assembly process that makes it easier for us to make your part which will lead to lower cost we also make material recommendations but ultimately it's the customer's responsibility to own the design to validate the design and so that's what i mean by understanding what each party's role is in in this development process also an obvious thing is to state the product specifications from the start um and try to try to avoid uh having mission creep where new requirements come in at the later stages obviously we don't want to get halfway through a development activity where we find a new requirement that we didn't know about and it basically puts the project kind of in in peril to recover so just having those well defined up front is highly recommended likewise having realistic time estimates for the development project is is important oftentimes we underestimate the development time the complexity of the development process and even the time required to meet you know regulatory approvals so again it stresses the project when we don't

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set realistic expectations or milestones on timing cost obviously is going to be what's going to drive success or failure of any project along with meeting the performance requirements so being aware of what cost considerations are for a given design at the very early stages of the development process is really important we don't want to get to a point where we think we take out a more complicated design thinking that we're going to wave a magic wand and innovate a process that's going to save a lot of cost or we're going to make changes to the material later on to to save cost um you know firstly it's very difficult to to drive a lot of cost out of our process um you know more it would be much better to make design changes early on um that would have much bigger impact on cost and likewise with materials you know when we start changing materials and just on the basis of cost we're going to sacrifice quality and performance in doing so another comment i'll make is just trying to avoid or being aware of at least design requirements that might be at odds with each other an example I'm giving is like when we try to have long wear life but also we want to have water sealing performance of the skin contact materials we're choosing

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in general these skin contact materials are meant to be breathable um they you know that that helps increase the wear life we want to get any moisture that might be trapped against the skin out and pass through the adhesive and the backing materials so when we use materials that are watertight uh for sealing purposes that that may impact the wear life of the of the skin contact uh material itself so we may have to come up with other solutions or come up with a compromised solution that you know that meets both requirements simultaneously uh keep it simple it just simply means that you know obviously we want to look at different design iterations and permutations but you know we we need to be working towards converging towards the final design so we don't want the number of iterations to just you know go out of control where this becomes a science project and we're not moving closer to converging to a final solution and obviously validating the test not just at the end of the process but you know all the way through the development process is important

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um another thing i'll talk about is just the a lot of these materials that we use in these type of skin contact applications um you know the they do have shelf life limitations so understanding what that means for the design looking ahead to the mass production um are we going to be able to work with the shelf lifes on these materials given your volume projections and so forth you know we it may be that some of the things that um may change as a function of time aging aren't critical to the design uh we may be able to do system or finish part level aging studies to validate that we can go beyond the manufacturer's shelf life they typically the raw material suppliers are typically fairly conservative with their estimates on shelf life so this this may require additional testing to prove this out but you know again we we want to be cognizant of shelf life uh limitations of the materials we select and then lastly a similar along a similar line um minimum order quantity restrictions become really important these projects that we work on typically take a long time to ramp up the volume projections are usually low in the beginning usually take longer to reach maximum

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volumes so being aware of what the raw material suppliers minimum order quantity requirements are for a given material becomes really important in the mass production phase i wanted to offer two specific case study examples to help illustrate what we're talking about today so the first case study i'd like to talk about is on a cardiac monitoring biosensor device this is a wearable that is worn on the chest of a cardiac patient to monitor vital signs like ekg signal body temperature respiratory functions etc and securely broadcast that information to the cloud where doctors can remotely access this information it allows for patients to be released earlier than normal from the hospital because they can be monitored from home it's actually a device that's being considered for the current uh kobit 19 crisis where it may be a tool that's utilized to monitor patients that are not as severe in particular the respiratory function to be able to model those patients from home as opposed to taking up a hospital bed

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that could otherwise go to a more critical patient so this um as you can see the device itself is it's a it's a multi-layer construction rather intricate uh in the converting and in the assembly process um you know consists of a conductive electrode that senses the ekg signals from the body and the the other layers basically provide a seal around the electronics to protect so in this application the customer had a fully formed design that had already gone through regulatory approval so we weren't necessarily challenged to provide design feedback or even design for manufacturing input they what they were looking for is a manufacturing partner that would work with them through the many steps of qualification and develop for them a scalable customized assembly process that met their many needs

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we initially developed the process utilizing our one of our us sites to come up with the assembly process itself and to get qualified as an approved supplier and then we transferred this manufacturing process to our Thailand facility to meet their cost requirements for mass production so the process itself was very much a rigorous intricate assembly multiple steps um very much scalable for mass production as we could replicate these assembly lines um it challenged our manufacturing capabilities because we basically took on more of the some of the responsibilities the customer was doing um in particular there's an inline diagnostic check of the device that takes place while the part is actually being manufactured so we took on the responsibility to manage that that process uh which in essence does 100 functional check on every part the other critical aspect of this assembly was to utilize a single batch flow assembly process where it was very critical not to mix up components so we actually tailored our process to only manufacture on one component at a time through each step of the process so as a result we came up with a very

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you know customized solution that was very uh heavily controlled by process documentation uh documents that were we basically were very much welcomed the input of the customer to help create because it was critical to them to have that input so we don't normally you know allow access to so much detail in our assembly process but for this particular project this was a critical aspect to succeed the other value-added we offered was taking a look at their product overall and offering the ability to consolidate sourcing as we ended up providing some of the other raw material components or assembly sub-components to them in in the end in addition to doing the actual converting and assembly of the device we supplied some of the raw some of the components including a battery contact component on the electronic board as well as a molded rubber part and a the thermal form cover of the parts itself as well as a another converted component basically an attachment aid to help keep the part attached to the patient so in the end we provided a lot of content

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on this device as another value add to the customer the second case study that i wanted to talk about involved the project for a biosensor that basically was electrically stimulating device that is designed for memory enhancement improved focus this is an example of a project in which we were very much involved early in the product development cycle with the customer offering important design recommendations for the wearable device itself at the time we became engaged with this project they had a functional board design but had not yet designed the wearable patch component so we were very much involved in the selection of the materials the actual design of the patch itself how the how the these components were put together for ease of manufacturing and to hit their cost targets we supported the project at different steps along the way with rapid prototype samples or or small-scale production builds to allow the customer to validate the design and meet their product development milestones

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we were very much involved in terms of you know providing design for manufacturing feedback recommending ways components should go together making design changes to make it easier for us to assemble because we understood that that drove a lot of the cost of this device we also supported them in the material selection used not just again for ease of manufacturing but to meet their performance requirements also in the area of patient comfort in the selection of the skin contact component so we were able to help them select the right skin contact adhesive for this application this device was is worn for a short duration so there's no reason to have a long wear type time type skin contact material used more important is that there's just enough adhesion to keep the device fixed while making it easy to remove without discomfort for the patient so that concludes my portion of the presentation on an engineer's guide to

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medical wearables matt and paul thank you so much for that great presentation we do have some questions that have come in from our attendees so we are going to move into answering those in just a minute so gentlemen our first question does Boyd and 3M work with microfluidic devices and diagnostics as i mentioned in one of the slides discussing some of the current products we're supporting the current pandemic crisis with disposable microfluidic components and assemblies is an area that we are utilizing our precision converting capabilities not just in some of the precision cut components the cover films that are used to create the pcr cartridge for example but we're also looking into areas in which we can do some of the some assembly work applying these precision cut parts to the plastic component and offering a turnkey solution okay great thank you so much for that answer a reminder for all the attendees if you do have a question go ahead and place it into the q a window and click submit gentlemen our next question what is the longest wear time for an adhesive on skin this is a question that we get quite a

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bit and I'm going to give uh one of one of people's favorite answers to this question when it comes to length of wear time and how long of a where time can we achieve my answer is going to be it depends um you know as we talked talked briefly about in this paper and as you'll learn more about if you visit our science of skin website you know skin is a unique substrate and skin my skin is different than your skin is different than your neighbor's skin and so depending on you know age location of the body the physical environment that you're in um all of these factors make skin different and so there are things about your skin that we understand and again if we can put the build the right kind of picture of the environment in the specific application that you're working to achieve we can we can find solutions that will stick longer than others but kind of what's the holy grail and how long can i keep a wearable

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device on i get it really depends we have seen success uh certainly up to 14 days and you know i think we and others continue to challenge ourselves to find solutions that will adhere to the to the body for even longer um but again it depends on the hair growth uh you know how physically active are you are you know showering with the device on are you sweating with the device on um and those sorts of things but you know so again I'm gonna stick with my official answer if it depends i will say that we we do have applications that last up to 14 days and in some cases even longer than 14 days it just really depends on the device and the patient or individual that's wearing the device all right thank you our next question gentlemen does Boyd provide samples and or prototyping rapid prototyping and even small scale

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production builds is definitely an area that we support our customers it's a critical you know value add that we offer in these types of product development activities okay great thank you for that answer any attendees out there if you have a question go ahead and place it into the q a window and click submit if we don't have time for your question today we will get back to you following the webinar next question what is the best way to find the right medical adhesive for my wearable application you know if you've got a specific project that you're working on a couple options that you can use to to initiate your search um obviously first and foremost you can always reach out to your local 3M med tech rep or your local Boyd representative both the you know the 3M medtech team and the Boyd team work closely together day in and day out and so if you've got a specific project that you that you need some assistance on and

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finding the right medical adhesive reach out to either the Boyd or the 3M team and be more than happy to help guide you through that process if you're more of an independent learner and want to do some more research on your own i would direct you to our website findmyadhesive.com uh it's available in multiple languages and it's a great tool um really for any design engineer or really anybody because even i can use it and I'm a marketing guy it it guides you through a series of simple questions to get an understanding of the project you're working on and the type of challenge or you know adhesive challenge you're looking to solve and as it guides you through those questions the end result will be a group of potential products that should have the characteristics that you're looking for based on the questions that you've answered so if you go ahead and visit findmightadhesive.com and like i said go through the questions answer it it'll it'll kick out some options for you it won't give you the solution but it's a great way to get a few potential solutions that you may want to spend time investigating further

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great thank you so much for that information another question if we work with a company like Boyd or 3M who owns the design typically the type of design support that Boyd is offering is what i would call design for manufacturing feedback we're trying to highlight areas that are problematic in our manufacturing process or offering ways to improve the assembly to help save costs we may also make material recommendations that we think are suitable for your application but the ownership of the design clearly rests with the customer and that means that the customer is ultimately responsible for validating uh you know the design and determining the fitness for use of the recommendations we make all right thank you so much for that answer this is going to be our last question today we are running short on time if anyone out there does have a question go ahead and place it into the q a window and click submit we will get back to you following the webinar so gentlemen the last question for today does 3M have additional resources for wearable designs and stick to skin applications

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you know that's a great question because the information that i shared today is from one of the numerous white papers that the 3M med tech has put together over the last couple years so if you want to learn more about you know wearable design sticking to skin a couple places i can direct you to one would be under the if you if you go to our website www.3M.com backslash medtech and look under the body warn adhesive section there are some featured content there and that feature content includes the the engineers guide that we reviewed today as well as other white papers focused on perception science medical device design stick to skin and many topics and then specifically when it comes to learning about skin we have an entire website dedicated to the science of skin and that's at www.3M.com backslash science of skin and so i've included links on on this slide for that content and so if you want to visit those there's a plethora of information out there that can help you learn more about the topics we talked about today okay thank you so much for that last answer and we are going to wrap up things right now matt and paul i want to say thank you to both of you so much for such great presentations and for answering some of our attendees questions so thank you both and a huge thank you to our audience members for being part of this webinar event take care and we will speak with you soon.

My name is Mike Nagel, I'm the president CEO of Vomaris Innovations. We've been a Boyd customer for six-and-a-half years. Vomaris Innovations is a medical device company. We're located in Tempe, Arizona. Our flagship technology is biocompatible microcell, a battery technology. So being a unique technology and the next step that we have to take it is the technology has to be super easy to use, for the end-user. We originally went to Boyd. Being a small company, a med device company with sometimes limited resources, we wanted a company that was gonna offer us, you know, unparalleled customer service, some great accessibility, technical expertise, and really the ability to do world-class converting to our technology. With our recent design of our flexi FET device it was a very unique device and it's one size fits all for surgical incisions.

We had several designs that we originally came to Boyd with and what they were able to do on the front end is work with us and determine with us like what was gonna be the most easily manufactured product, what product we would be able to hit the easiest cost targets on, and really the recommendations for the best material for us to use to accomplish our goals. So they were invaluable during the entire process from concept to first manufacturing run.

I'd recommend Boyd for a lot of reasons but really the same things that make any relationship successful, dependability, reliability, and accessibility and the ability to work together and get us rapid designs back. The ability to grow with them in volume we don't have to worry that they don't have the capability when our product really reach another level of volume. They really have all that, all the technology we need right here with one-stop shopping.

Customer service is exceptional at Boyd. On the, anyone on my team whether it be manufacturing, finance production, anybody can get it can get a hold of a wanted Boyd, you know anytime they need or have a question. The other thing too is when we needed to come here, for maybe critical runs where we needed to physically see what would happen they could very rapidly get back to us scheduling manufacturing. So they're just again reliable, accessible, dependable that's the cornerstone of what makes Boyd so unique for us.

I'm Lane Shaver, I'm a field Application Engineer for Boyd Corporation.

Well, Boyd has an extensive experience in material selection, engineering, R&D work. In the marketplace today, the prototyping has to be really rapid, and it requires the ability to respond quickly, and be able to make samples for the customer quickly, and so we have various ways to do that; Through laser cutting, water jetting, CNC manufacturing, we can produce samples quickly for customers to get them into production as fast as possible.

So equipment like this is able to bring numerous materials together and register them so that we get an end product that meets a very tight tolerance and at the end of the machine we take it into the cleanroom and hand assemble it into a final part that gets sterilized.

Every part we manufacture is inspected by a camera or by humans and packed: manually packed or mechanically packed depending on how the part is produced.

In the medical industry, it only takes one minor defect to be a problem and so you want to make sure everything they get is a usable product that they don't have to worry about.

For engineering here at Boyd, we try to interact with the customers and help provide them engineering support.

I work very closely with the customers to provide an engineering process that provides them with the end product that they want and a product that we can produce cost effectively and efficiently for them.

Boyd Corporation- Medical Solutions- Face Shields

Boyd is proud to supply medical grade face shields used by frontline healthcare workers and now available for personal use. We have adjusted production lines to manufacture critically needed face shields and are projected to deliver more than 90 million face shields this year alone. Boyd Corporation Medical Solutions.