N AMERIC AN EDITION
MEDICAL PLASTICS news Spotlight on innovation: Medtech’s brightest revealed
+ MD&M EAST PREVIEW FOCUS ON BIOABSORBABLE POLYMERS 3D PRINTING FOR HEALTHCARE
ISSUE 2
April/May/June 2017
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Work With The Experts™
CONTENTS MPN North America | Issue 2
Regulars
15 It’s in the bag Eastman Chemical Company outlines how a blood bag clinical trial supports DEHP replacement with DEHT
3 Comment 5 News focus
16 Breaking the mold Ultrasion, explains how ultrasonic molding has come of age
6 Digital spy 9 News focus 11 Opinion 32 Back to the future The medtech info you really need to know
Features 12 Leaders of the pack Lu Rahman looks at some of medtech companies making strides in the global market
19 Moving on up Trelleborg Sealing Solutions explains how it’s taking 2C LSR technology to the next level 20 Medtech takes a bite of the Big Apple As the global medtech sector descends on New York for MD&M East, we look at why you should be there
25 Ahead of the game Poly-Med, explains why 3D printing has huge medtech potential 26 Forming an attachment Techsil, explains how to choose the right adhesive when bonding elastomeric materials 28 Soak it up Evonik looks at the growth of bioabsorbable polymers 30 Little things mean a lot Ambionics develops breakthrough chold prosthetic using 3D printing 31 Taking shape Why thermoforming has a key role to play in medtech
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Innovative solutions. Engineered to your specific requirements. Realize your vision. Partner with the most innovative team in the industry. Visit our new web site at MicroLumen.com
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CREDITS
EDITOR’S
group editor | lu rahman
comment
deputy group editor | dave gray reporter | reece armstrong advertising | gaurav avasthi art | robert wood publisher | duncan wood
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Medical Plastics News is published by: Rapid Life Sciences Ltd, Carlton House, Sandpiper Way, Chester Business Park, Chester, CH4 9QE T: +44(0)1244 680222 F: +44(0)1244 671074 © 2017 Rapid Life Sciences Ltd While every attempt has been made to ensure that the information contained within this publication is accurate the publisher accepts no liability for information published in error, or for views expressed. All rights for Medical Plastics News are reserved. Reproduction in whole or in part without prior written permission from the publisher is strictly prohibited. ISSN No:
2047 - 4741 (Print) 2047 - 475X (Digital)
Make the connection W
With recent FDA guidance highlighting the need for medical device manufacturers to consider cybersecurity vulnerabilities across a product’s lifecycle, it’s obvious the issue needs to be considered at the start of a device’s life.
e don’t like it when things go wrong. We expect security as standard. From our bank accounts to online shopping, we put faith in our passwords, and hope they make the services we use as difficult to hack as possible. As the medical device sector becomes increasingly reliant on technology, the number of connected devices helping improve our health and well-being is growing at a considerable rate. Technical innovation has started its journey to transform the delivery of healthcare. Devices that administer medicine remotely, or send data to healthcare professionals are becoming part and parcel of the way global healthcare systems are operating. Artificial intelligence is helping us book appointments with our physicians and is even claiming to be able to triage patients faster than a real person. Add to this the way that cloud-based systems are being used to help SMEs deal with the challenges of medical device labelling, traceability and regulatory compliance, and the level at which technology has become ingrained in the medtech sector is evident. Amid this however, we have the issue of security. In everyday life, online security is part of the way we browse, shop and communicate. However, should the safety of a connected medical device be compromised,
the consequences can be far more serious than the loss of money from a bank account. At one end we have potential intellectual property theft, the cost of which can be extensive if a business decides to pursue legal cases should counterfeit products find their way into the market, for example. And at the other end we have the possibility that cyber attacks can cause serious injury, even death. A hacker only has to get lucky once to cause damage. Serious stuff. Cyber crime is big business. According to a report by OCISIA with BAE Systems, cybercrime is costing the UK economy alone around £27bn. The 2016 Ponemon Institute Cost of Cyber Crime Study estimates that every cyber crime case in the US costs a company over $15 million.
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Malware, ransomware, cybersecurity – they’re not exactly words to get excited over. The connected device sector is undeniably innovative, sexy and increasingly amazing. New technology can be jaw-dropping and there seems to be no limits to where it’s going next. But how much does security feature and at what stage? Many managing directors and CEOs, would be the first to admit that they don’t possess, or have the time to acquire, in-depth cyber-security knowledge and that unless something goes wrong it isn’t something that’s necessarily at the top of their agendas. Clearly things will have to change. As the medical device sector pushes ahead with machines that talk to each and communicate with the healthcare sector, experts also need to engage in communication. From cybersecurity experts to people leaving university armed with the know-how and skills to tackle this issue head-one, the expertise is there, waiting to be utilized. Making the connection – via devices and humans– is the first step towards ensuring things don’t go wrong.
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NEWS FOCUS
Under attack: HOW SAFE IS YOUR CONNECTED MEDICAL DEVICE? Lu Rahman examines the growing issue of cybersecurity and medical devices
T
he global connected health and wellness devices market is forecast to reach US$612.0 billion by 2024, according to a report by Grand View Research. As populations start to live longer, healthier lives, the demand for wearables has increased – and will continue if these figures are correct. In recent years patient monitoring has increased with healthcare organizations across the globe looking to improve the patient experience and ease the burden on hospital facilities. With increased technology comes increased risk. Devices and organizations are vulnerable. Via MPN’s sister site, DigitalHealthAge.com, we regularly report on data breaches in the healthcare sector. The UK’s National Health Service (NHS) is often under attack – according to a Freedom of Information study carried out by SentinelOne, almost a third of NHS Trusts have experienced an attack on data and systems. This could potentially put patients’ lives at risk. Tony Rowan is chief security officer at SentinelOne. He told DigitalHealthAge that: “Old school antivirus technology is powerless to halt virulent, mutating forms of malware like ransomware and a new, more dynamic approach to endpoint protection is needed.” Whether attacking a hospital or a device, all threats endanger lives. This has been recognised by the FDA which has produced guidelines for post-market cybersecurity risk management of connected medical devices. The 30-page document comes from a legitimate concern for medical devices that are already FDA approved, and the potential for them to be hacked. The document recommends that medical manufacturers should monitor, identify, and address cybersecurity vulnerabilities as part of their post-market management of medical devices and consider the product’s entire lifecycle when doing so.
Dr Anita Finnegan is CEO of Nova Leah, a company specializing in cyber security solutions for medical devices. She explained: “Increased connectivity of medical devices to hospital IT-networks provides significant benefits to patient care but also exposes both manufacturers, healthcare providers and patients to cybersecurity risks which can affect the safety of between 10 and 15 million connected devices currently being used by patients. “The newly published postmarket recommendations provide device manufacturers with a set of practices designed to assure the security of devices once in use. These include: Monitoring cybersecurity information to help identify and detect vulnerabilities; maintaining software life-cycle processes such as: monitoring third-party software components for new vulnerabilities; design verification and validation for software updates and patches; using threat modelling to help maintain the safety and performance of a device, and mitigating cybersecurity vulnerabilities early and before they are exploited.” Finnegan recommends that medical device manufacturers build in security controls during the product design phase and continually monitor devices to address future cybersecurity concerns. At the University of Arizona, electrical and computer engineer Roman Lysecky is looking at ways to develop technology to improve malware detection in pacemakers and other life-critical devices. "It used to be that we only had to worry about breaches of our computers and smartphones," said Roman Lysecky, associate professor in the University of Arizona Department of Electrical and Computer Engineering. "Industry analysts predict that by 2020, most of the 20 billion electronic devices
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on the market will be interconnected — and millions of these will be implantable medical devices. (IMDs)" These devices include pacemakers, insulin pumps and brain neurostimulators. Monitoring patients at home or remotely and transmitting data to healthcare professionals, makes this technology vulnerable. According to The University of Arizona, there are over 225,000 people in the US with implanted pacemakers. Should a hacker be successful, these individuals could suffer cardiac arrest. With this in mind, Lysecky is developing technology – using a prototype of a networkconnected pacemaker – where IMDs can detect malware and security breaches yet continue to function properly. So what next? Speaking at HIMSS2017, health data security expert Mac McMillan, CEO of CyngergisTek recommended: “I get a little irritated when people mention ransomware because people look at ransomware as if it's this big amorphous thing. It's actually just one type of attack, one type of malware that's out there. But because we had a large volume of ransomware attacks last year, all of a sudden we had people thinking they had to spend money on advanced malware technology to spot those things, to spot attachments to emails that could potentially have malware in them. “We always have had that. Why haven't we been doing that already? Just going after one thing is not going to solve this problem. We need to get back to the basics, like using two-factor authentication. Build a solid infrastructure. Do a good job in terms of security hygiene with respect to how you manage your environment, meaning keeping operating systems up-to-date, patching things regularly, configuring things smartly and employing technology in layers throughout the environment.
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INDUSTRY UPDATE
DIGITAL
www.tcd.ie
spy
Stop bugging me: PREVENTING INFECTION ON MEDICAL DEVICES
DIGITAL UPDATE
www.uwe.ac.uk Exoskeletons fits over doctor’s hands to aid surgery
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team of researchers led by the University of the West of England (UWE Bristol), UK, is developing a wearable robotic system for minimally invasive surgery, that will offer surgeons natural and dexterous movement as well as the ability to ‘sense’, ‘see’, control and safely navigate through the surgical environment. Minimally invasive surgery for some clinical applications is replacing the traditional ‘open access’ approach, and has been associated with patient benefits such as reduced blood loss, fewer infections and faster recovery. Led by professor Sanja Dogramadzi, Bristol Robotics Laboratory, the pan-EU research team identified a need for better tools in robotassisted minimally invasive surgery to support the surgeon’s performance.
The researchers will develop modern biomedical tools that mimic complex human dexterity and senses. These can be worn by the surgeon and transmit their movements to the closed surgical interface without restrictions. This will reduce the overall cognitive, manipulation and training demand. Three key pieces of hardware will be the starting points in developing the new surgical robotic system. Exoskeletons will fit over the surgeon’s hands, which will control the instruments inside the body – a newly developed surgical ‘gripper’ which mimics the thumb and two fingers of the hand. The instrument, which goes inside the body, will have haptic abilities, allowing the surgeon to ‘feel’ the tissues and organs inside the body, just like they do during conventional surgery.
M
icrobiologists from Trinity College Dublin have discovered how to prevent bacteria growing on medical devices such as hip replacements and heart valves that are implanted in the human body.
Their discovery is a step towards developing new preventative strategies that could have a direct impact on the recovery of patients following surgery. Medical devices are routinely used in modern medicine to prevent and treat illness and disease but their use is compromised when an accumulation of bacteria called “biofilms” attach to the device surface after it is implanted in the human body. Communities of these bacteria called ‘staphylococci’ grow on catheters, heart valves and artificial joints, and avoid being killed by antibiotics and the human immune system, which means healthcare professionals often have to remove and replace the medical devices. Each incident of biofilm infection costs the healthcare system €50,000 - €90,000. The research team – led by Dr Joan Geoghegan, assistant professor of Microbiology in Trinity’s School of Genetics and Microbiology is studying new ways to prevent medical device-related infection.
MATERIAL UPDATE
ww.covestro.com Cover story: Covestro reveals wound care textiles
C
ovestro’s Baymedix are new polyurethane raw materials for wound care. They are said to help with the healing process, come in several designs and can be used, for example, in absorbent foams manufactured from Baymedix FP, adhesives with skin contact made of Baymedix A and films based on the waterborne products Baymedix FD and CD. Recently, Covestro has focussed on material development textile coating applications in the medical environment. Ap p l i c a t i o n s i n c l u d e surgical wear, hospital bed linen, coatings for medical furniture, but also medical bandages.
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The company presented at INDEX17 where it showed new raw materials for sustainable, water-borne textile coatings with good haptics and enhanced stability towards disinfectants as well as for non-latex cohesive bandages for compression therapy and secondary fixation.
DIGITAL SPY
DIGITAL NEWS
www.stratasys.com
Stratasys takes bite out of dental market
T
he dental community is one of the fastest adopters of 3D printing technology, transforming highly manual processes in the shift towards digital dentistry
effectively keeping pace with growing segment requirements,” said R. Scott Rader, GM of Healthcare Solutions at Stratasys. “With the highest levels of throughput, Stratasys is shaping digital dentistry - again.”
Stratasys says its J700 Dental 3D printing solution, is a fast PolyJet-based 3D printer for the production of clear aligner molds. Driving scalable, on-demand production, the product aims to address increased demand for the fast production of 3D printed aligners as the industry incorporates new digital dentistry workflows.
talking
POINT
www.waseda.jp
WORKING FROM HOME
“The Stratasys J700 Dental 3D porinter is especially designed for orthodontic labs to achieve high throughput in production of clear aligners. It is custom-built to address demand for large scale capacity,
PRINT YOUR OWN WEARABLE TATTOO WITHOUT LEAVING THE HOUSE Japanese researchers claim to have used a household inkjet printer to create ultra thin stick-on elastomeric sheets that act as electronic devices yet feel like a tattoo. How thin? And why? According to the team at Waseda University the material is 750 nm, 120 times thinner than human hair, making it ultra-thin and flexible.
INNOVATON
www.uflexltd.com
FILM STAR: GAME CHANGER IN PHARMA PACKAGING
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he Films Business of Uflex team has come up with a special polyester film that obviates the problems posed by BON and PVC. PVC contains plasticizers with phthalates linked to health disorders that can damage the liver, kidneys, lungs and reproductive system. PVC film leaves high carbon footprint making it environmentally undesirable. BOPA (BON) is fraught with challenges such as high moisture absorption to the tune of 8-10% making its processing
difficult; leading to de-lamination and impairing the ability of the film to be chemically primed. Conventionally PVC and BOPA (BON) films have been used in cold formed pharma packaging industry. A typical alu–alu blister laminate comprises three layers ie.25 micron BOPA/ 60 micron soft aluminium foil / 60 micron PVC. Eliminating BOPA and PVC films in the cold formed alu-alu laminate blister pack for pharmaceuticals has been a daunting task for packaging experts. Uflex’s special polyester film is all set to replace the top and bottom substrates of the conventional cold formed alu– alu laminate to a whole new structure comprising 36 micron special polyester/ 50 micron soft aluminium foil/ 36 micron special polyester. This speciality film can be laminated on both sides of the aluminium foil without any problem.
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As the drive for both comfort for the wearer and ease of manufacture become increasingly important, the size of these products and the process required to create them, is hugely exciting. The researchers behind this development say that this development could help change the face of wearable electronics with objects such as wristwatches being no bigger than a sticking plaster! How did the Waseda team manage this new process? They came up with a method of joining electronic components without soldering, allowing thinner and more flexible elastomer films. Inkjet printing was then used to create conductive wiring. Don’t you need special conditions to do this? The team says that this can be carried out with a normal inkjet printer with no need for cleanroom conditions. Ok, so what happens? Conductive chips and LEDs are connected by sandwiching adhesive between two elastomeric nanosheets. This means there’s no need for chemical bonding by soldering or special conductive adhesives. Using a low-temperature processes, the Waseda team adds that the resulting ultrathin structures achieve better adhesion, without using substances such as tape or glue, better elasticity and comfort for skin-contact applications. The new system worked for several days on an artificial skin model. How exactly will this technology be used? Waseda University believes that uses for these products are expected to include human-machine interfaces and sensors in the form of electronic tattoos, improved tools for medicine, healthcare and sports training.
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NEWS FOCUS
FDA-CLEARED DEVICE ‘MA JOR INNOVATION’ IN DENTAL PROSTHETICS
Bite size: The Juvora dental disc, has received the US Food and Drug Administration 510(k) clearance for expanded indications
US FDA clears PEEK polymer CAD/CAM dental device for long-term implant borne prosthetics
T
he high performance polymer dental prosthetic device can potentially enable improved patient quality of life1 and efficiencies compared to metal.
Described as a major innovation in dental prosthetics for comfort, durability and precision, the Juvora dental disc, has received the US Food and Drug Administration 510(k) clearance for expanded indications. Indications for use in the United States now include the manufacture of full and partial removable dentures and implant overdentures, copings, su bstr uc ture s ( c e me nte d or uncemented), and frameworks for permanent and transitional anterior or posterior crowns and bridgework. Juvora implant prosthetic frameworks can be tailor-made to patients´ needs, using CAD/CAM workflows, and result in reduced treatment times and better treatment outcomes.
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What sets the Juvora dental disc apart are the outstanding properties of PEEK-Optima Natural
Following its successful CE mark approval in Europe and introduction onto the European dental market in 2012, the Juvora dental disc received initial FDA 510(k) clearance for purchase and use throughout the US in 2014. With this latest clearance, the FDA has cleared a CAD/ CAM device made of PEEK polymer for the manufacture of long-term implant-borne prosthetic frameworks, compatible for use with fixed rehabilitation systems including the All-On-42 treatment concept and, the Straumann Pro Arch3 system.
This alternative to metal prosthetic devices is made from PEEK-Optima high performance polymer. The biomaterial comes from Juvora´s parent company Invibio. It is said to offer a superior combination of strength, natural bone-like flex and toughness.
Improvement for dental prosthetics In addition to receiving endorsements from a growing number of dental labs and dental practitioners, the feedback from patients has been extremely positive. 99% of patients rated Juvora prosthetics high for comfort and 97% rated them high for overall satisfaction.4 "Patients have told us their Juvora prosthetics feel like having their natural teeth back. This is not to mention a reduction in weight, and superior comfort through tailored fit because the prosthetic has been made with precision through CAD/CAM workflows," noted Lynne Todd, head of Invibio Dental and Juvora. According to its maker, what sets the Juvora dental disc apart are the outstanding properties of PEEK-Optima Natural, the world’s first implantable PEEK polymer which is recognized within the spinal interbody fusion market. The feature-set of the biomaterial, and accordingly the Juvora dental disc, includes a bone-like modulus which gives the Juvora implant prosthetic
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framework the potential to react in a more natural way to the stresses and forces it encounters.5
A new era in precision design “Dentists in the US are now able to offer dental prosthetics that are not only more comfortable than those made from metal, but also more accurately and efficiently designed. Juvora dental prosthetics can be a compelling alternative to metal for long term fixed as well as removable implant prosthetic applications, such as frameworks and other superstructures – both for the dentist and for their patients," summarised Todd.
References: 1. B. Siewert (2017), PEEK in Dental Prosthetics (PEEK in der zahnärztlichen Prothetik Warum? Wann? Wie?), Podium Presentation, SSO Dental Meeting, 11 February 2017 2. The “All-On-4” treatment concept is a trademark and property of Nobel Biocare Services AG 3. The “Straumann” name is a trademark of Straumann Holding AG. 4. Patient feedback from 92 cases July 2013 – March 2015 5. Bone Regeneration Based on Tissue Engineering Conceptions —A 21st Century Perspective Jan Henkel, Maria A. Woodruff, Devakara R. Epari, Roland Steck, VaidaGlatt, Ian C. Dickinson, Peter F. M. Choong, Michael A. Schuetz & Dietmar W. Hutmacher, Bone Research (2013) 1, 216–248.
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2017 Calendar
2018 Calendar
BIOMEDevice Boston May 3–4, 2017
MD&M West February 6–8, 2018
MD&M East June 13–15, 2017
Advanced Design & Manufacturing Expo March 7–8, 2018
Boston Convention & Exhibition Center Boston, MA
Jacob K. Javits Convention Center New York, NY
Anaheim Convention Center Anaheim, CA
Huntington Convention Center of Cleveland Cleveland, OH
MD&M Minneapolis November 8–9, 2017
Minneapolis Convention Center Minneapolis, MN
BIOMEDevice San Jose December 6–7, 2017
The UBM co-located event model provides a large and diverse crossover audience under one roof, increased visibility for exhibiting companies, and access to more quality prospects in an expanded platform. Approximately 30% of MD&M exhibitor meetings are with attendees registered for colocated event brands.
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OPINION
The pace makers: M&A activity looking strong, says expert
P
redicting the future is a risk, fraught with difficulty, especially in the healthcare sector. A myriad of unforeseen factors can affect outcomes, even the most According to ruining conservative of forecasts.
Mark Bonifacio, Bonifacio Consulting Services, the rate of medtech M& A activity isn’t likely to slow down this year
Some prophecies have better odds than others. Consider, for example, the consolidation that has reshaped the medical device sector over the last few years. There are strong indicators that this industrywide consolidation will continue this year as existing platforms, new private equity players, and sector-related strategies all vie for assets. The only uncertainty is the pace at which this activity will occur. The mergers and acquisitions of medtech OEMs and contract manufacturers (CMs) last year progressed at a blistering pace, and it appears that rate could continue in 2017 barring any major political upheaval
or unforeseen chaos. The contract manufacturing (CM) market, in particular, seems poised to continue this rapid pace of consolidation. Medtech industry executive Bill Ellerkamp detailed much of the recent 2016 activity in the medical device outsourcing market in his article in the January/February issue of MPO. Since that time, KRG (PE backed) Vention Medical closed its deal for Lithotech Medical, an Israeli-based developer of complex nitinol wire-based technologies (Real time update: Vention was itself sold by KRG as two business units, one to PE Backed Medplast (DMS business) and the Advanced Technology piece of the business to publicly traded Nordson Corp). Ampersand Capital Partners made an undisclosed investment in Corpus Medical, a Silicon Valley-based contract development and manufacturing organisation focused on interventional medical devices, catheterbased delivery systems, and implants. Finally, Medtronic is reportedly shopping around the ($2.4B) medical supplies business it inherited with the blockbuster Covidien acquisition.
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The overall backdrop for these deals continues to remain strong. Historically low interest rates, deal leverage multiples, cash on private equity and strategic balance sheets, continued OEM consolidation, outside US suppliers and foreign investors looking for US beachheads are all contributing to this high demand. Unlike the auto, aerospace and consumer industries, the medtech CM industry is still a highly fragmented space (and relatively young, compared with these other manufacturing supply chains). Driving this consolidation is a need for some business sophistication for owner/operator, (‘mom and pop type operations’) and most importantly, there is extreme macroeconomic pressure to reduce healthcare costs across the globe (especially in the USA as our overall healthcare GDP spend approaches 18% of total GDP, almost 50% more than any other developed nation). All of this indicates we will see much more movement between the med device players in 2017. Stay tuned for the next deal announcement, you shouldn’t have to wait long.
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Leaders of the pack Innovation and medical plastic devices go hand in hand. Lu Rahman selects some of the sector’s stand-out companies.
I
t’s no secret that the medtech sector innovates with the best of them. As medical devices increase in functionality, as healthcare professionals demand more from medical products and as patients expect better usability and comfort, innovation does have to step up to the mark offering the above in a cost-effective, long-lasting design. Innovating successfully requires knowledge. With expertise in the medical plastics sector, Clariant understands the role that innovation plays alongside product development. But device developers face a double challenge, the company’s Stephen Duckworth told MPN, in that they need to, “develop products that are functional, compliant and easy to manage for medical professionals in clinical settings, but they also need to keep consumers/patients in mind.” He added: “These users select and rely on these products to monitor health status, manage chronic conditions, and dispense medications at home, in the workplace, or on the go, and they want devices that are attractive and easy to use.” Creating these type of products requires indepth know-how. Companies such as Clariant boast detailed knowledge of regulations plus an awareness of the need for materials to meet critical performance properties and at the same time meeting biocompatibility and toxicity standards.
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Beyond material selection and suitability, market knowledge – initiatives and legislation that will affect the on-going life of the product – is key. Product identification and anti-counterfeiting are becoming increasingly important. Aware of this, Clariant recently teamed up with SICPA, a trusted provider of global security solutions. The two companies have launched the Plastiward system, which uses proprietary covert taggant additives (produced by SICPA) that are compounded into various polymers at one of Clariant’s ISO13485-certified plants. The taggants then become an integral part of the plastic product or packaging and are readily detectable using SICPA’s proven deployment and monitoring platform. Once the tagged product enters the supply stream, the SICPA monitoring system is able to identify them at any point from factory to pharmacy.
Faking it Product counterfeiting is serious. Netstal has been looking at the problem and says it has devised a reliable and inexpensive solution with its partners. It recognises that counterfeit products pose a threat to people and to a company’s brand image. To overcome this problem, Dr Patrick Blessing, head of Netstal’s Medical Technology and Precision Parts business unit told MPN that by “using smart tools, it is possible to add both
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visible and invisible markings to products during the injection molding process”. Special devices can electronically detect markings invisible to the human eye – easily and inexpensively, said Netstal. For example, thanks to an integrated testing process, a laboratory machine can determine whether it has been stocked with original consumable materials or not. This also helps the work of customs agents to quickly identify counterfeit products.
Stess test On-going material research helps advance the medical plastics sector. Last year Sabic and PDI announced the results of a joint study on the environmental stress cracking resistance (ESCR) of Sabic’s materials used for medical device enclosures. The two companies evaluated how well Sabic’s thermoplastics withstand repeated exposure to PDI’s Super Sani-Cloth wipes, a surface disinfectant used in healthcare to prevent healthcare-associated infections (HAIs). The study revealed that several of Sabic’s product technologies – including LEXAN EXL polycarbonate (PC) resin, XYLEX (PC/ polyester blend) resin and VALOX polybutylene terephthalate (PBT) resin – deliver improved compatibility with PDI’s leading hospitalgrade disinfectant.
SPOTLIGHT ON INNOVATION
< Team effort: SABIC and PDI completed a joint study on the environmental stress cracking resistance (ESCR) of SABIC’s materials
Color show: A variety of drug delivery devices using color to make them more appealing >
Studies such as this are important for innovation to continue. “Sabic and PDI are committed to supporting the healthcare industry with information about compatibility between medical enclosure materials and commonly used disinfectants. Our joint study highlights the complex issue of environmental stress cracking, and provides valuable insights to help our customers make informed material selection decisions,” said Cathleen Hess, healthcare business leader for Sabic.
Press print The medical device sector watches closely the on-going research that helps drive the industry. Researchers from the Wyss Institute for Biologically Inspired Engineering at Harvard University and the Harvard John A. Paulson School of Engineering and Applied Sciences (SEAS) have made the first entirely 3D-printed organ-on-a-chip with integrated sensing.
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Clariant understands the role that innovation plays alongside product development.
Built by a fully automated, digital manufacturing p roc e d ure , the 3D-printed heart-on-achip can be fabricated with customizable size, shape and other physical properties, allowing researchers to easily collect reliable data for extended times in culture. This type of device offers potential for healthcare and may one day allow researchers to rapidly design organs-on-chips, also known
as microphysiological systems, that match the properties of a specific disease or even an individual patient’s cells.
reduce device cost, reduce device size, and have the potential to open up new capabilities for medical and consumer electronic devices.
“Our microfabrication approach opens new avenues for in vitro tissue engineering, toxicology and drug screening research,” said Kit Parker, professor of bioengineering and applied physics at SEAS.
Take the tube
Get your coat Many companies are continually looking at ways to improve the performance of medical devices. Jeff Hendricks Biotectix, explained how polymeric coatings can help do just that. Hendricks notes that one of the primary challenges facing next-generation cardiac and neuromodulation devices is electrode miniaturisation. Smaller electrodes are desirable to communicate with single neurons or small groups of cells, and to provide highly targeted stimulation in procedures such as deep brain stimulation, for example, while avoiding the side effects of collateral stimulation. However, as the electrode size decreases its ability to transport charge also declines, leading to high interfacial impedance. Conducting polymers are an excellent material choice for miniaturised electrodes because they can safely deliver the necessary charge without damaging the tissue for stimulation and reduce noise for higher quality recording. Biotectix’s conducting polymer coatings offer the possibility to improve the safety and performance of existing medical devices and to enable electrode and device size reductions by reducing impedance. These materials can also be used to create custom textile-based electrodes for consumer wearable and medical monitoring devices. Furthermore, they can help
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It’s always good to hear about the development of new devices. Cambridge Design Partnership (CDP) teamed up with King’s College London to develop a novel steerable catheter designed by King’s researchers. The catheter aims to improve the treatment of cardiac arrhythmia – a range of conditions which can lead to stroke or heart failure that affects 2 million people a year in the UK. The new steerable, micro-molded catheter enables targeted delivery of radio frequency energy to specific points in the heart tissue for corrective treatment. Compared with traditional catheters, the device has been designed to be quicker and easier to manoeuvre into the correct position, improving the accuracy of positioning and minimizing damage to healthy tissue, which should improve success rates of the treatment. Ma t t Br a d y, h e a d o f m e d ical t h er apy, Cambridge Design Partnership, said: “The steerable catheter is an extraordinary product, with innovative features that enable corrective treatment to be delivered to very specific areas of the heart. By enabling greater accuracy and quicker treatment time, we believe it is possible to preserve more healthy heart tissue, and increase the success of the treatment. It’s been hugely exciting to be involved in this joint project with King’s College London and use our expertise to bring such an innovative product one step closer to commercial use.”
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Xianbo Hu Ph.D., Principle Scientist “I am inspired to solve technical challenges, providing innovative solutions sets Vancive apart.”
Inspiration. Innovation. Dedication. Advanced Medical Adhesive Applications that Touch Lives With a relentless dedication to what’s next, the people within Vancive’s Core Business Segments see future possibilities. Offering scalable and inspired solutions for OEMs and Converters, Vancive Medical Technologies® responds to the unique needs and changing requirements of our customers. Dedicated professionals such as Xianbo Hu are agile, forward thinking, open to new ideas, and have a vision that helps customers and partners succeed. Download the Vancive™ Product Finder App Available on the App Store® and Google Play™
Visit us June 13 – 15 at MD&M East in New York — Stand #1174.
© 2016 Avery Dennison Corporation. All rights reserved. Avery Dennison, Vancive Medical Technologies, Vancive, and Design “V” Logo are trademarks of Avery Dennison Corporation. Android, Google Play, and the Google Play logo are trademarks of Google Inc. Apple and the Apple logo are trademarks of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc. MTR-MKT-000284-A
SPOTLIGHT ON INNOVATION
It’s in the bag E
astman Chemical Company has teamed with BloodCenter of Wisconsin (BCW) on a clinical trial evaluating a new plasticizer for blood bags. The aim of the trial was to evaluate the stability of red blood cells in di-2-ethylhexyl terephthalate (DEHT) plasticized containers compared with standard di-2-ethylhexyl phthalate (DEHP) plasticized containers. The trial expanded upon the use of DEHT as an alternative to DEHP for bags to store red blood cells in AS-1 and PAGGSM preservative solutions. This led to the conclusion that DEHT, a non-phthalate general-purpose plasticizer, is a viable alternative to DEHP. But why is an alternative needed at all? The trial was done proactively to preempt potential regulatory trends and consumer demands driving the industry toward nonphthalate alternatives to DEHP. Having been used to make PVC flexible for years, the inclusion of DEHP in blood bags has also been found to help minimize hemolysis, or the breakdown of red blood cells. However, the US. Food and Drug Administration (FDA) has stated that DEHP alternatives in medical devices for neonates and other at-risk populations should be considered, while France has introduced a ban on the use of DEHP in medical tubing for neonatal, pediatric, and maternity wards. In anticipation of the impact that these types of bans could have on the industry, Eastman was looking to expand its profile with a nonphthalate option that performed as well as DEHP for blood bag applications. “As we build out our portfolio of plasticizers, we want to be sure that all potential concerns are addressed without sacrificing function and performance. Blood bags are a great example of this. They are one of the most challenging applications in the plastics market because of storage and stability, but we’re seeing a demand for new options, so we had to develop
alternatives and prove their performance,” said Mark Brucks, Eastman market development manager. “This research proves that we have a practical alternative for those who have concerns around using DEHP in sensitive applications like blood bags.” The clinical trial results demonstrate that Eastman 168 SG non-phthalate plasticizer, a sensitivegrade DEHT, is a viable alternative for medical applications. Eastman 168 non-phthalate plasticizer was introduced to the market in 1975, and then, in 2013, an enhanced grade of the plasticizer was introduced for highly sensitive applications: Eastman 168 SG non-phthalate plasticizer. This alternative offers some of the same benefits of DEHP, including extension of storage, and helps meet both US and EU regulations while remaining cost-effective. The trial showed that hemolysis levels and red blood cell morphology remained the best with DEHP. However, all products tested well below the FDA requirement of 1.0% hemolysis and the EU requirement of 0.8% hemolysis at Day 42 of storage, showing similar performance. Although structurally and functionally similar to DEHP, DEHT is distinct from a metabolic and toxicological standpoint. DEHT is not a carcinogen, mutagen or reproductive toxicant, which makes the product ideal for medical applications. Specifically, the trial showed that after 189 days in storage, much longer than the 42-day standard, Eastman 168 SG nonphthalate plasticizer resulted in 72% lower plasticizer migration from the blood bags into the red blood cell solution than the DEHP bags. This means that the desired hemolysis results achieved with DEHP are similar with DEHT, but with lower migration of plasticizer into the red blood cell solution. The clinical trial findings were presented at the 2016 AABB Annual Meeting in Orlando,
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Florida, by Sharon Graminske, manager of applied research laboratory at BCW. Titled “In Vitro Evaluation of DEHT Plasticized PVC Blood Bags for Red Blood Cell Storage in AS-1 and PAGGSM Preservative Solutions,” Graminske’s presentation highlighted the trend driving the need for DEHP alternatives as well as the preliminary results supporting DEHP replacement with DEHT. “Our work with Eastman has provided valuable results that will benefit the blood banking industry,” said Kathleen Puca, BloodCenter medical director and principal investigator who oversaw the findings reported by Graminske. “The DEHT trial results offer new insight about a well-established plasticizer that has now been proven to have an even broader application within health care — providing safer blood products.”
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Next up, the trial work is being completed on plasma to validate performance.
The clinical trial results demonstrate that Eastman 168 SG nonphthalate plasticizer is a viable alternative for medical applications
“Eastman 168 SG is a proven, tested and toxicologically clean solution for the medical market,” said Brucks. “By working closely with BCW, we can extend the utility of Eastman 168 SG into this application, offering customers a cost-effective alternative that performs to standard so that they can confidently make the switch from DEHP when they are ready.”
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Little wonder: Its precision molding technology represents a new and innovative approach to micro plastic part manufacture, says Ultrasion
Breaking the mold
Enric Sirera, Ultrasion, explains how ultrasonic molding has come of age as the technology of choice for OEMs seeking to innovate and push the boundaries of product design
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edical device OEMs face numerous challenges, not least the development of smaller and smaller products and components with greater functionality. Miniaturisation of medical devices is driven by the requirement for less invasive interventions, and the pan-industrial push towards cheaper and lighter products. There are particular areas where continued requirements exist for efficacious parts that are as small as possible, for example in various in vivo diagnostic applications such as embedded sensors, in the development of intravascular ultrasound catheters, and for numerous micro-invasive technologies treating a variety of chronic medical conditions. Whether product designers are focused on such cutting edge developments, or are striving for miniaturization in other areas of medical product development, often there is a limit on product design parameters from the nature of (and availability of) cost-effective manufacturing alternatives.
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In the area of plastic medical device manufacture, OEMs have until recently been faced with using fabrication processes that are iterations of technologies that have been used for decades in larger scale plastic product manufacture. Plastic micro-injection molding technologies now exist that cater for the manufacture of smaller and more precise plastic parts, but they are still based upon the traditional screw, barrel, and heater-band technology that has been in existence for decades. The basic underlying process of plastic pellets being placed in a hopper, melted in a heated barrel, and then injected into the mold (often through a cold runner system) has remained the same. Injection molding on any level has inherent drawbacks in terms of material wastage, energy usage, and expensive tooling â&#x20AC;&#x201C; drawbacks that are exacerbated as the size of molding decreases. In recent years, an ultrasonic molding technology has become commercially available that addresses these drawbacks,
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INNOVATION but of critical importance to medical device OEMs, also opens up areas for innovation as it imparts advantageous characteristics in the melted plastic, allowing OEMs to design and manufacture longer, flatter, thinner, more feature-rich, and increasingly complex micro parts than has been possible before. When looking at ‘design for manufacture’ (which is a phrase often heard when discussing small plastic parts), ultrasonic molding allows the writing of a new chapter, as the limits of what is possible have changed.
The unique characteristics of ultrasonic molding Four years ago, Ultrasion introduced the first ultrasonic precision molding machine to industry. Since then, this ultrasonic molding has become the ‘go to’ technology for medical OEMs (and indeed OEMs in all sectors where precision and repeatability is key), when the parts required cannot be manufactured on traditional precision molding machines. In the area of precision molding, material degradation is perhaps the key issue for manufacturers of plastic parts. Material degradation is a product of residence time, and residence time is itself a product of the screw barrel and heater band configurations found on all traditional molding technologies. Ultrasion’s ultrasonic precision molding technology was primarily developed to overcome the problems associated with material degradation by eliminating residence time. To achieve this, the technology was built from the ground up without screws barrels and heater bands, and instead of the material being heated in advance of injection into the mold, it was melted in situ in the mold right by the gate, and only the amount of material needed per shot was processed. This reduces the thermal history of the plastics to milliseconds, dramatically reduces waste (as only the amount of material needed per shot is processed), and eliminates the need for ma te r ia l p urging. H a v i n g addressed the problems of material degradation, it was in addition found that processing polymers with ultrasonics led to other advantages.
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In the area of precision molding, material degradation is perhaps the key issue for manufacturers of plastic parts
Key among these was that melting through ultrasonics dramatically reduces the viscosity of the processed polymer. In most instances polymer melted by ultrasonics is almost the consistency of water, and this allows for much better flow through the mold using dramatically reduced molding pressures. Today, as the technology has evolved it is the advantages inherent in low pressure molding that is the key to success of ultrasonic precision molding. Ultrasion’s technology uses molding pressures of between 250 and 400 bar compared with the typical 2000-2500 bar used in traditional precision injection molding machines. The possibilities that this offers manufacturers of precision plastic parts are obvious. An array of over-molding and insert molding applications can be accommodated using ultrasonic molding that would be impossible on traditional molding
machines. In addition, through the use of vastly reduced molding pressures, manufacturers are able to mold around extremely delicate core pins, or tricky core pin configurations that would deflect or break under usual molding pressures. The advantages inherent in ultrasonic molding are best appreciated in the area of precision molding rather than large scale molding, and the company is in the process of expanding its ability to accommodate larger shot sizes, but it is unlikely that the process will be advantageous above about 20g shot sizes. It was never designed to make car bumpers!
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Four years ago, Ultrasion introduced the first ultrasonic precision molding machine to industry.
The first commercially produced machine on the ultrasonic molding platform was the Sonorus 1G which could accommodate a maximum shot weight of 2g. This machine was successfully sold to numerous OEMs throughout the United States, Europe, and the Far East. The demand from industry, however was for a machine that could accommodate slightly larger shot sizes, and so the company introduced the second version (the Sonorus S210 machine) at the 2016 K Show, which has a maximum shot weight capacity of 5g. Ultrasion provides quite a unique offering to customers. Each machine purchased can be designed to order, adapting the basic ultrasonic mouding platform to accommodate different shot size capability, different sonotrode sizes, different amplitudes, different frequencies etc… It is also process optimized to cater for specific materials used in specific applications if this information is shared by the customer. This ensures that the machine delivered is done so precisely manufactured for customer specifications. Increasing the shot weight that can be processed has made ultrasonic molding viable in a vastly increased number of applications from across all sectors of industry. Coupled with the fact that the technology can process all materials with equal ease, including tricky and high temperature melt grades of PEEK often used in medical applications, and it is easy to see why ultrasonic molding has made a name for itself and is a valued alternative to traditional molding technologies.
Summary Ultrasion’s precision molding technology represents a new and innovative approach to micro plastic part manufacture, and as an alternative to traditional precision injection molding technologies exhibits significant advantages in terms of the stimulation of innovation as it truly manufactures parts impossible on traditional molding machines. The nature of the process, and especially the reduced viscosity characteristics that ultrasonics can achieve as the melting agent, opens up the possibility of part design and part characteristics that have hitherto been unattainable. It is here that the interest that Ultrasion is attracting from OEMs across industry is focussed, most especially in the areas of medical devices and microfluidics.
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Setting the beat in medical technology, education, and innovation
Find your rhythm at this year’s event
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Find solutions to your challenges with innovative medical technologies and products Network with peers to discover insights and start collaborations Learn how to move your projects forward through education and training Experience the latest embedded systems technology with ESC running alongside this year’s event
May 3-4, 2017 Boston Convention & Exhibition Center Boston, MA
To learn more visit biomedeviceboston.com/mpn 34213_BIO_BOS17
INJECTION MOLDING
MOVING ON UP Trelleborg Sealing Solutions explains how it’s taking 2C LSR technology to the next level
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relleborg Sealing Solutions says it is revolutionizing the healthcare and medical market with its liquid silicone rubber (LSR) and two-component injection (2C) technology, which are said to produce innovative solutions for medical device manufacturers and endusers. The benefit to the device manufacturer is a hygienic, robust and cost-effective product design, often combining multiple components and functions into a single one, eliminating the risk and cost associated with a secondary assembly.
Helping healthcare Ursula Nollenberger, LSR components product director for Trelleborg Sealing Solutions, said: “LSR lends itself perfectly to medical applications because it is inert, very pure by nature and very versatile in its use, suiting it to a broad range of application conditions. It is also ideal for a large variety of medical grades whic h f a c ilita te s specification choices, making it a preferred choice within the healthcare sector.” 2C LSR technology
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Trelleborg’s 2C LSR technology allows medical device manufacturers much more latitude in their design solutions
Nolle nbe rge r continued: “One of our most outstanding capabilities is the simultaneous injection of LSR in combination with technical plastics, 2C LSR technology. One of the key advantages of this is the ability to mold several components into a highly complex single part. The simultaneous 2C LSR process is available in many hard-soft and soft-soft combinations,
including multi-color and multi-hardness options and is extremely efficient for high production volumes. “ We u s e h i g h l y advanced, sophisticated tools and process engineering to develop the most innovative solutions, combining two, three or more individual materials into one fully bonded, robust component.
Perfect answer: Trelleborg Sealing Solutions says its LSR and 2C technology produce innovative solutions for medical device manufacturers
“Trelleborg’s 2C LSR technology allows medical device manufacturers much more latitude in their design solutions, for example utilising space more effectively, saving or cutting out weight, or integrating extra functions. This groundbreaking technique offers a wealth of options for integration and miniaturization, resulting in better and more effective solutions in the long run.”
In life sciences applications it is particularly important to counter the prominent challenge of unwanted bacterial growth and inherent impurities either by way of inferior material properties or unsuitable production methods. 2C LSR technology enables more hygienic design solutions by eliminating, for example, dead space through the use of a customised 2C solution versus a classic O-Ring sealed package. LSR as a material, in combination with a hygienic product design including twocomponent solutions, produced in a fully automated closed-loop production process and in a controlled cleanroom environment, offers the purest available product in manufacturing. Working in collaboration with its customers, Trelleborg’s basic mode of operation provides
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the first concept stage all the way through to the end of the product life. To start with, Trelleborg’s design team currently work with the customer’s designers to either propose a black box solution or to value-engineer a customer’s concept or existing product.
Future plans Nollenberger revealed that Trelleborg plans to continue to push the boundaries and lead the way with continued investments in infrastructure and skill set at its global locations. “We continue to push forward with tool, process and automation technologies to let us produce ever smaller parts, down to micro and now even nano-gram weights, enabling the many ground-breaking and exciting technologies our customers are developing. Finding solutions to the so far thought impossible with LSR is what we thrive on. “We are proud to be one of the world’s leading developers, manufacturers and suppliers of high precision LSR and 2C parts and we intend to stay at the top.”
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Medtech takes a bite of Big Apple Keynote conversation with Apple co-founder Steve Wozniak along with spotlights on smart manufacturing and 3D printing make this medtech show a go-to event
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edtech moves fast. For 34 years, MD&M East has helped take medical devices from concept to market by uniting cutting-edge technology with the industry’s brightest minds. This year’s event is shaping up to be the best yet, with a fantastic keynote speaker, hot industry trends featured throughout the show floor, a three-day, two-track in-depth medtech conference, plus additional twoday innovation summits.
Organizers of MD&M East say they’re proud to feature Apple co-founder and icon of innovation Steve “Woz” Wozniak as the keynote speaker this year.
The event takes place on 13-15 June, Jacob K Javits Convention Center, New York.
Keynote Event: Conversation with Steve Wozniak Visionaries with big ideas backed by the brains to make them realities are the lifeblood of the advanced design and manufacturing industry. That’s why the organizers of MD&M East say they’re proud to feature Apple co-founder and icon of innovation Steve “Woz” Wozniak as the keynote speaker this year. The session promises to be a lively and thought-provoking discussion, complete with an opportunity for audience Q&A. Wozniak will cover topics at the intersection of his passions and trends in the advanced manufacturing industry, including innovation and creativity, robotics and automation, wearables, big data, the Internet of Things and more.
More about Wozniak A Silicon Valley icon and philanthropist for more than 30 years, Wozniak has helped shape the computing industry with his design of Apple’s first line of products the Apple I and II. He also influenced the popular Macintosh. In 1976, Wozniak and Steve Jobs founded Apple Computer Inc. with Wozniak’s Apple I personal computer. The following year, he introduced his Apple II personal computer, featuring a central processing unit, a keyboard, color graphics, and a floppy disk drive. The Apple II was integral in launching the personal computer industry.
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In 1981, he went back to UC Berkeley and finished his degree in electrical engineering/computer science. For his achievements at Apple, Wozniak was awarded the National Medal of Technology by the President of the United States in 1985, the highest honor bestowed on America’s leading innovators.
Through the years, Wozniak has been involved in various b u s i n e s s a n d philanthropic ventures, focusing primarily on computer capabilities in schools and stressing hands-on learning and encouraging creativity for students. Making significant investments of both his time and resources in education, he adopted the Los Gatos School District, providing students and teachers with hands-on teaching and donations of technology equipment. He founded the Electronic Frontier Foundation, and was the founding sponsor of the Tech Museum, Silicon Valley Ballet and Children’s Discovery Museum of San Jose. In 2014, he was awarded the Hoover Medal, a prestigious honor given for “outstanding extra-career services by engineers to humanity,” and was inducted into the IndustryWeek Manufacturing Hall of Fame.
In 2000, he was inducted into the Inventors Hall of Fame and was awarded the prestigious Heinz Award for Technology, The Economy and Employment for single-handedly designing the first personal computer and for then redirecting his lifelong passion for mathematics and electronics toward lighting the fires of excitement for education in grade school students and their teachers.
Wozniak is chief scientist at Primary Data and is a published author with the release of his New York Times best-selling autobiography, iWoz: From Computer Geek to Cult Icon by Norton Publishing. His television appearances include: ABC’s Dancing with the Stars and The Big Bang Theory, The Late Show with Stephen Colbert, Conan, and The Tonight Show Starring Jimmy Fallon.
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MD&M EAST
New focus for 2017: 3D Printing & smart manufacturing
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D printing's effect on the future of the medtech industry is a focus across this year's event, with a spotlight on materials, prototyping, and the finished product. The expo floor will host a dedicated 3D printing zone, featuring leading organizations making strides in this sector, while the two-day 3D Printing Innovation Summit is designed to give you the in-depth education you need to fully understand and apply the latest developments.
3D printing 3D printing has gone mainstream, widening the market for printer manufacturers, as well as material, software and service providers. The trend is currently at the forefront of the industry and will likely continue to be a major influence in the years ahead. For this reason 3D printing will be a key focal point throughout the New York event. From a dedicated area on the show floor featuring leading suppliers and technologies to the two-day 3D Printing Summit, the aim is to put this technology in the spotlight.
Why 3D printing? $26.7bn
industry by 2019
27%
compound annual growth rate (CAGR) in the industry globally
66.7%
of manufacturers are adopting 3D printing in some way, with 24.7% of companies planning to adopt 3D printing in the future
Smart manufacturing The smart manufacturing focus will give visitors the opportunity you to explore collaborative robots and robotics accessories on display from the world's leading suppliers. Free activities will connect visitors with the leading technologies and professionals building the factories of the future. There will also be the opportunity to attend the three-day, expert-led Smart Manufacturing Innovation Summit.
Technological advancements in connectivity and the shift to the digital enterprise are transforming the advanced design and manufacturing industry. From increased human-machine interaction and collaboration to real-time communication, cloud computing, and IOT to cyber-physical systems, and interconnectivity, the pace of change is rapid and exciting. A range of smart manufacturing elements â&#x20AC;&#x201C; industrial robots, collaborative robots, connectivity, software, sensors and much more â&#x20AC;&#x201C; are featured within ATX East and EastPack as well as the other advanced design and manufacturing co-located shows.
The smart manufacturing market $548.14bn
the worth of the global manufacturing market by the end of 2024, up from $159.05bn in 2015.
60.04%
CAGR In the global collaborative robot market alone by 2022, rocketing from $110million in 2015 to $3.3bn by 2022
$661.74bn
the predicted worth of the Internet of Things (IoT) market by 2012, growing from $157.05bn in 2016 and resulting in CAGR of 33.3%
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Source from a full spectrum of solutions MD&M East aims to be is the East Coast event that draws medtech’s top suppliers, giving visitors the opportunity to find the solutions needed to take projects from concept to market, and solve the toughest manufacturing challenges. Organisers of the event are inviting visitors to be the first to witness demos of technology yet to hit the market as well as being able to draw daily insight from free show floor activities and presentations focused on business development, improving patient outcomes, value
engineering, design thinking, speed to market, the Internet of Things, and more. Running alongside MD&M are five additional shows – Atlantic Design & Manufacturing, ATX East, EASTPack, PLASTEC East and Quality East – showcasing solutions spanning design engineering, automation and robotics, packaging, plastics and quality. With nearly one thousand manufacturing industry suppliers on one show floor, all sourcing needs can be covered with this event.
Make New Industry Connections
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n an increasingly digital world, face-to-face connections matter. In-person industry networking is designed to help you build relationships faster and more easily than on the phone. More than 9,000 industry professionals from leading companies such as Medtronic, Siemens, St. Jude Medical, 3M and many others will be there, providing access to the connections needed to advance projects – and your career – all in one place. Building a network of industry contacts can seem intimidating, not to mention time consuming! That’s why MD&M East is making it easy with a fast, fun, one-on-one speed networking activity. This allows you to get in front of professionals for five-minute sessions. From engineers and executives to suppliers and key decision makers, the opportunity is there to let you sit across the table from others looking to connect, learn and share. There’s no need to sign up for speed networking in advance, as seats are given on a first-come, firstserved basis, but the activity always fills to capacity, so organisers advise getting there early to reserve your spot!
Deepen Your Knowledge The MD&M conference is your key resource for staying ahead in the medtech marketplace, covering the latest medical technology and design. Your pass also includes access to the 3D Printing and Smart Manufacturing Innovation Summits, with unlimited track hopping across a total of 60 hours of in-depth educational content.
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MD&M EAST The 34th annual MD&M East conference Each year, the event offers an educational experience designed with the needs of the medical manufacturing professional in mind. Back for its 34th year, the conference is delivering two tracks of education to medtech professionals.
Track B: Product Development – This track tackles the latest advances in product development methodologies and strategies, design controls and value engineering, and is ideal for product development professionals in engineering, R&D, quality assurance/quality control, sourcing, manufacturing, regulatory, and design engineering.
Track A: Design – Covering topics ranging from user-centered design, disruptive design strategy and emerging technology, this track is tailored to medical device professionals working in design engineering, R&D, industrial design, and mechanical engineering.
Attendees can discover how to better define product development and design strategies, and join experts to investigate how products, processes, and people combine to help impact lives — and your bottom line.
Medical Design Excellence awards
The 3D Printing Innovation Summit
The Smart Manufacturing Innovation Summit
The MD&M East conference also features the Medical Design Excellence Awards (MDEAs). Since its inception in 1998, the mission of the MDEAs has been to recognize significant achievements in medical product design and engineering that improve the quality of healthcare delivery and accessibility. The event offers the chance to celebrate the achievements of the industry’s foremost innovators and gain inspiration during this prestigious annual event.
The two-day 3D Printing Innovation Summit brings together experts in this burgeoning field. Sessions will cover topics such as materials selection, making 3D printing costeffective, troubleshooting issues in additive manufacturing and lightweighting, overcoming challenges in end-user production, medical applications for 3D printing, and more. The summit includes a group tour of the show floor, stopping at some of the most innovative exhibitors’ booths for special presentations.
The two-day Smart Manufacturing Innovation Summit showcases experts and innovations in robotics, artificial intelligence, security, IOT and IIOT, big data, machine control, and more. The agenda was built through discussions with industry experts, past delegates and speakers. The summit includes a group tour of the show floor, giving delegates the chance to see new developments in collaborative robotics up close while hearing from the world’s most innovative suppliers.
Expo Floor Features Center Stage
Tech Theater
Curated Expo Tours
Center Stage is the base for all of the show action, every day. Free presentations, demos, and spotlights cover need-toknow topics to keep you competitive.
Innovative exhibitors showcase their latest products and services at Tech Theater. Ask questions, get answers, and discover new solutions you can engineer into your projects.
Join an expert guide for an exclusive tour of the show floor. Tours focus on a key theme, such as smart manufacturing or 3D printing, and give you an up-close look at the latest tech.
Expo Hours TUESDAY-WEDNESDAY, JUNE 13-14, 2017 10:00 a.m. - 4:00 p.m.
THURSDAY, JUNE 15, 2017 10:00 a.m. - 3:00 p.m.
On-site registration opens at 8:00 a.m. on June 13-14 and 8:30 a.m. on June 15
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WHEN SIZE IS KEY
PRECISION IN SILICONE Freudenberg Medical is your development partner for innovative precision components made of silicone and thermoplastics. With our unique technology and processing capabilities and our clear focus on medical, biotech, and pharmaceutical applications we pave the way for your innovations. With micro molding from Freudenberg Medical discover just how big small can be.
www.freudenbergmedical.com
3D PRINTING
Looking ahead: The full benefit of 3D printing lies in our ability to see and plan better, says M. Scott Taylor, Poly-Med.
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AHEAD OF THE GAME
ust the other day, as I was purchasing a new set of tires, I was reminded of the importance of quality in materials. While new features and technological advancements are obvious on recent cars (few of which are 3D Printing present on my 15-yearcommuter), the only Materials: old parts keeping 3,200 A Missing Link. pounds of steel firmly the road is the rubber M. Scott Taylor, to I was about to buy. The Poly-Med, decision to select a tire was not based explains why certain entirely on price. This 3D printing has critical product met a huge medtech variety of other specialty requirements including potential total lifetime value, safety profile, and manufacturer reputation. A closer look, and this checklist mirrors selection requirements we use for medical materials. I recently attended a talk by Dr. Frank Rybicki (The Ottawa Hospital), a major proponent of 3D printing applications in medicine. Dr. Rybicki is calling 3D printing the next revolutionary advancement in medtech, akin to the introduction of CT and MRI. Just like CT and MRI, 3D printing provides the ability to create and study, peel away confounding layers, and simplify the complex. A low-hanging fruit for this technology, similar to other imaging formats, is to create patientspecific anatomical models for pre-surgical planning and customized surgical guides. These are powerful, life-saving tools that improve outcomes.
And what if we could do more? The full benefit of 3D printing lies in our ability to see and plan better, and to also improve therapies through cutting edge
devices. Quality and speed of additive manufacturing continues to advance, creating a new need for a variety of materials to support implant applications. Permanent polymers, such as PEEK, have been adapted for use in 3D printing, except that few implant-grade bioresorbable materials have been introduced. An implanted device carries additional risks over a visualization or practice aide and requires full functionality, performing the designed task as well as or better than alternative products. In this way, 3D printing needs to be competitive with traditional manufacturing operations like injection molding, not just in terms of part performance but also with manufacturing considerations such as cycle times and process costs. Printer manufacturers are continually pushing the envelope by producing relatively inexpensive and faster printers that may be reasonably associated with a manufacturing process. Part performance though, relies just as much on the quality of material used to create the product. An excellent opportunity for applying advanced design capabilities with 3D printing includes the class of bioresorbable products. Benefits of bioresorbable devices are conceptually straightforward. These devices can provide structure for healing tissues when needed, and degrade to leave the body in a natural, pre-injury state with no need for further intervention. This is particularly of interest in pediatrics, where the patient is growing and permanent implants can be restrictive, causing complications after they are no longer needed. There are several case studies of successful applications in pediatrics, proving the utility and potential of 3D printing implants. Bioresorbable materials are relatively common in 3D printing – PLA is easily
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purchased from a variety of sources. These products likely do not meet the minimal requirements for medical-grade use as many are modified, containing additives to improve printing performance. To create a device that is intended for implantation, it is necessary to be more selective about the materials used to generate parts that are consistently both safe and effective. A first step towards supporting 3D printing of bioresorbable implants is creating more available materials. Having access to PLA that meets USP Class VI requirements is a start, and a good fit for orthopedic applications, though future availability of alternative materials with a variety of performance and degradation profiles will support development of more diverse indications. As we start to adopt 3D printing as a viable option to manufacture implanted products, there are best practices that can be applied to assure materials have the best chance of consistently meeting expectations. The promise of a revolution in patient care using 3D printing is being realized. Equipment is more accessible than ever, and by using the best materials we can maximize this benefit. Because using the right materials is where the rubber meets the road. 5 Best Practices for selecting bioresorbable 3D printing materials: • Supplier familiar with manufacturing, testing, and performance requirements of finished medical devices • ISO 13485 quality management system • Materials meets USP Class VI and other biocompatibility requirements • Materials provided with traceability and analytical data • Supplier willing and able to customize products for your application
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3D PRINTING
Jane Powell, Techsil, explains how to choose the right adhesive when bonding elastomeric materials in medical devices
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lastomeric is a term given to materials that elastically return to their original shape after deformation by compression or tension. Materials fitting this category are numerous and include rubbers, plastics and polymers; all differ in their polymer structure, polarity, and surface properties and that is why it is so difficult to stick these materials together. The growing number of design applications for elastomeric substrates has greatly increased the need for information on assembly techniques using these materials. Adhesives offer several benefits over mechanical fasteners for joining elastomeric materials. Unlike solvent bonds or ultrasonic welds, adhesives perform well with thermoset rubbers. In addition, adhesives distribute stress over a joint's entire bond area rather than in a single location. Unfortunately, the wide selection of elastomers and adhesives can make it difficult to identify the optimal combination for a given design.
What makes elastomeric materials so difficult to bond? Many modern elastomeric materials used in the medical field are formulated specifically for their resistance to harsh chemical and environmental conditions. As a result, these substrates also tend to be difficult to chemically bond. Often characterized by low surface energies, low porosity and non-polar surfaces, elastomeric materials feature no surface roughness onto which an adhesive can secure itself. In addition to this they are stretchy! So what properties are important to consider when choosing an adhesive to bond elastomeric materials? 1. Must the adhesive provide an elastic bond once cured to prevent stress cracking? 2. Does the adhesive need to withstand conventional sterilization methods with no deterioration in the properties of the bond? 3. If the bond will be in contact with water, heat or other environmental conditions will the adhesive be durable? 4. Does the bond need to be invisible? 5. Does the adhesive need to be viscous to fill a gap? 6. How is the adhesive going to be applied; by hand or fast speed automated process? 7. How big is the area to be bonded? 8. Will the adhesive need to bond to other substrates? 9. Does the adhesive need to have a particular bond strength, colour or cure speed?
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Although polyurethane, epoxy and hot-melt adhesives can be used; the main chemistries of adhesives for bonding elastomeric materials are: Cyanoacrylates: One-part, solvent free, rapid room temperature curing adhesives. They adhere to most substrates, are easy to dispense in automated systems and come in a range of viscosities. They exhibit strong shear and tensile strength. Whilst cyanoacrylates offer an easy bonding solution, they do have decisive drawbacks: They embrittle quickly and exhibit a very low impact and peel strength. They show poor durability on glass and poor solvent resistance. They are not good gap fillers, have low temperature resistance, the bond skins quickly and may stress crack some plastics. In addition, cyanoacrylates do not allow time to re-align the joints due to curing in seconds and cannot extend over large areas (they will bond the spreader or roller). RTV Silicone Adhesives: Solvent free, one-part systems which range in viscosity from self-leveling liquids to non-slumping pastes for gap filling. They cure to soft, flexible thermoset elastomers with excellent property retention over a wide temperature range. They adhere to a variety of substrates and there are UV cure formulations available to initiate cure. However, some can be slow to cure, so they are not always practical for small item assembly on a fast production line. They can have poor cohesive strength and a limited depth of cure. Light Curing Acrylics: Cure within seconds to form a tough thermoset polymer with excellent adhesion to a variety of substrates. The ability to cure â&#x20AC;&#x2DC;on demandâ&#x20AC;&#x2122; offers significant processing benefits. In addition, the range of viscosities and properties make light curing acrylics ideally suited for fast speed automated bonding processes. Other advantages include: Good environmental resistance; solvent-free; good gap filling; 1-part; invisible bond lines; rapid fixture and complete cure; the bond formed is elastic, so there is no stress cracking and they can be sterilized without losing integrity. Drawbacks are minimal: light must be able to reach the bond line for cure and light source equipment must be purchased. Because the final resins are thermoset plastics, light curing acrylics offer enhanced thermal, chemical and environmental resistance over Cyanoacrylate adhesives. Selecting the best adhesive for a given application involves more than selecting the adhesive which provides the highest bond strength. Other factors such as speed of cure, flexibility, environmental resistance, thermal resistance, suitability for automation and price will play a large role in determining the optimum adhesive system for a given application.
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InSpace syringe and device with biodegradable balloon (published with permission of OrthoSpace)
Soak it up
Bioabsorbable polymers have a range of uses in modern healthcare. Evonik looks at the growth of this material and its inclusion in life-saving products across the last 30 years
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n the medical device area, bioresorbable polymers have been successfully applied for the past 30 years. They are derived from lactide, glycolide, trimethylene carbonate, p-dioxanone and ε-caprolactone to produce a variety of bioresorbable products, and have broad application in the medical field due to their mechanical and thermal properties. This allows processing with common production technologies such as extrusion, injection molding and compression molding. Being bioresorbable, a second surgical intervention is not needed for removal. In addition, they aid in the healing process by gradually transferring weight load or facilitating tissue regeneration as the implant degrades.
In April 1966, Kulkarni et al.1 published the first significant report on the use of polylactic acid for medical purposes. The paper was the catalyst for the development of the polymer for human medicine after showing that polylactic acid (PLA) could be successfully implemented for sutures, vascular grafts and surgical implants. The study indicated that PLA was biodegradable, non-toxic, non-tissue reactive and would not be retained in any vital organs. The document explained that, through acidcatalysed homopolymerisation, a polymer resulted that could be cast into films, spun into fibers or used as coating. It also stated that the material would not elicit an immunological or inflammatory response and that degradation and elimination of the polymer was effected through the respiratory system. It was 20 years before the polymers became commercially available – the RESOMER brand of resorbable polymers was launched on the market in 1986 (first under the Boehringer Ingelheim label before its acquisition by Evonik in 2011). There was initial hesitancy of surgeons to use devices
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made from ‘plastics’ or to stray from conventional metal implants. Individual innovators led the way in working with biodegradable materials with some members of the surgical community requesting the development of biodegradable polymers with specific characteristics. This was the beginning of ‘on-demand’ polymer products, which still impacts the market today.
First lactide/glycolide polymer ventures In 1970 Davis & Geck launched the first bioresorbable sutures, Dexon. Due to their ability to reduce tissue drag, sutures derived from bioresorbable polymers are beneficial in the ophthalmic, cardiovascular and neurological application areas2.
Anterior cruciate ligament (ACL) screw Today metal screws are practically obsolete in the treatment of the anterior cruciate ligament (ACL) of the knee. Screws composed of bioabsorbable polymers have become widely implemented.
Bioresorbable pins
Biodegradable composites Several manufacturers have looked into combining biodegradable polymers with inorganic substances, such as derivatives of calcium phosphate. The benefits of such composites are two-fold: they can withstand higher loads and provide enhanced biocompatibility. Arthrex’s BioComposite interference screw is 30% biphasic calcium phosphate and 70% PLDLA. Smith & Nephew offers the Biosure HA family of interference screws. These are made of polylactic acid combined with hydroxyapatite (HA), a calcium phosphate material4. The company was the first to launch a composite implant in 2001, which was called the BioRCI-HA screw.
Cosmetic surgery The use of bioresorbable polymers has transformed cosmetic surgery. Today it is possible to undergo a ’thread lift’ using degradable threads to lift sections of the face. This fast, non-surgical and non-invasive procedure does not require anesthesia or a hospital stay.
Wraps
Bioresorbable pins to fixate tissue and ligaments have been used since 1985, although exhibited rapid degradation rates. With the use of polylactic acid (PLA) degradation could be extended3, sometimes up to several years. At that point, their application for slow-healing as well as fasthealing injuries could be justified.
Bioresorbable wraps and sheets are extremely thin, transparent foils that hold tissue masses in place and facilitate post-surgery healing. Composed of biocompatible material, they are metabolised by the body and do not need to be removed during a later surgical intervention.
A turning point in the field occurred with the patent of the Polypin from Biovision in 1994. This offered a new pin design using poly(L-lactide-coD,L-lactide) that was filled with an X-Ray contrast marker, enabling the implant to be exactly located in the body.
One of the first companies to develop bioresorbable wraps was MacroPore, with its MacroPore OS protective sheet. Today the product is manufactured by MAST Biosurgery under the brand names SurgiWrap, CardioWrap and OrthoWrap.
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BIOABSORBABLE POLYMERS
Stents In 1998, the first bioresorbable stents were placed in human coronary arteries during a successful clinical study with Igaki-Tamai stents from the Igaki Medical Planning Company5. This was a major breakthrough which led to more exploration into the use of bioresorbable stents. Another milestone occurred in 2011, when Abbott received a CE mark for the world’s first drugeluting bioresorbable vascular scaffold (BVS) for treating coronary constriction. The device, called ABSORB, completely dissolves in approximately two years6. Biodegradable stents allow blood vessels to reconstruct as the stent gradually disappears, offering a benefit over conventional stents.
Balloons For the treatment of rotator cuff damage, there are several options for treatment, starting with pain medication and physiotherapy, and progressing to surgical treatment, such as tendon repair and other options. To assist with extreme cases, it is today possible to insert a biodegradable balloon (spacer) that helps prevent friction between structures in the shoulder and prevent pain associated with this type of friction. The balloons are made of biodegradable polymer and are positioned between the humerus head and the acromion7. The InSpace was cleared for marketing in the EU (CE marked) in July 2010, and since then more than 10,000 surgeries have been performed using this device. The product is made of a copolymer of polylactide and ε-caprolactone that degrades over 12 months. Its aim is to decrease friction through cushioning, reducing pain and giving the shoulder time to rehabilitate through physiotherapy.
Combination products
techniques. One of those is the so-called bone welding technique, which has been applied by the KLS Martin Group with its SonicWeld Rx system. This is a novel way to perform osteosynthesis by combining resorbable implants with ultrasonic technology10. Through the energy generated by the ultrasound waves, the surface of the implant liquefies, enabling deeper penetration into the spongiosa, which results in stronger bonding than with conventional techniques.
Outlook – 3D printing and tissue engineering In the dental area, 3D printing has already been established to produce temporary tooth implants or customized models to train surgeons for complex operations. While these have not yet been produced with biodegradable polymers, there is ongoing evaluation into the development of patient-specific biodegradable implants consisting of PCL (polycaprolactone) and PLGA. Improvements in biocompatibility and osteointegration will need to be studied using inorganic fillers such as beta-TCP (tricalcium phosphate), hydroxyapatite or bioglass that can be added during the printing process. Currently, the largest challenge to patient-specific implants is time, especially where it concerns trauma patients. The implant needs to be designed, printed, sterilized and controlled before implantation can take place. There is, therefore, a great need to standardize materials, processes and supply chains. Research is also ongoing into implants that can improve cell adhesion and the growth and function of tissue. In the foreseeable future, implants will contain tissue that has been grown onto a biodegradable scaffold in an external bio-reactor. In this way, biodegradable medical devices can improve the healing process and outcome. The polymer scaffolds can be combined with extracellular matrices such as
collagen, oligosaccharides or other biologically active compounds. Scaffold design is an ongoing challenge, as the products need to provide enough support while but allow oxygen and nutrient supply to the tissue. To this end, biodegradable polymers such as polydioxanone and polyesteramide are being examined, as they show enhanced biocompatibility and mechanical properties. References: 1. R.K. Kulkarni et al., Polylactic Acid for Surgical Implants, U.S. Army Medical Biomechanical Research Laboratory, Walter Reed Army Medical Center, April 1966. 2. S. Fegade, “Biodegradable Polymers in Medical Applications,” plastemart.com, http://www.plastemart.com/ upload/Literature/paper_swapnil.asp 3. Y. Matsusue et. al., “In vitro and in vivo studies on bioabsorbable ultra-high strength poly (L-Iactide) rods,” Biomed Mater Res (1992): 26, 1553-1567. 4. “BIOSURE HA Interference Screw,” www.smith-nephew. com, accessed November 2016, http://www.smith-nephew. com/professional/products/sports-medicine1/knee-repair/ biosure-ha-interference-screw/ 5. “Igaki-Tamai Stent® Biodegradable Coronary Stent,” Kyoto Medical Planning, accessed November 2016, http://www. kyoto-mp.co.jp/en/igaki_tamai_stent.html 6. “Abbott Receives CE Mark Approval for World’s First Drug Eluting Bioresorbable Vascular Scaffold for Treatment of Coronary Artery Disease,” PR Newswire, (January 10, 2011), accessed November 2016, http://www.prnewswire. com/news-releases/abbott-receives-ce-mark-approval-forworlds-first-drug-eluting-bioresorbable-vascular-scaffoldfor-treatment-of-coronary-artery-disease-113197364.html 7. E. Savarese, R. Romeo, “New Solution for Massive, Irreparable Rotator Cuff Tears: The Subacromial “Biodegradable Spacer,” Arthroscopy Techniques (May 2012), accessed November 2016, https://www.ncbi.nlm. nih.gov/pmc/articles/PMC3678622/ 8. J. Arps, “Implantable Drug Delivery Devices – An Overview,” Medical Design Technology, July 2013, https://www. mdtmag.com/article/2013/07/implantable-drug-deliverydevices—-overview 9. bioretec, “CiproScrewTM,” accessed November 2016, http://www.bioretec.com/products/ciproscrew/ 10. KLS Martin Group, “SonicWeld Rx® Resorbable Osteosynthesis“, accessed November 2016, http://www. klsmartinnorthamerica.com/products/implants/cranial/ sonicweld-rxR-resorbable-osteosynthesis/sonicweld-rxRconcept/
Today, bioresorbable implants are available which contain an active pharmaceutical ingredient (API) that offers localised, controlled release directly to the affected area. The targeted location also makes it possible to lower the drug dose and therefore decrease potential side effects. This improves patient compliance as the drug is delivered without the need for the patient to remember to consume the medication8. One example of a combination product is the CiproScrew from Bioretec, which was launched in 2010. It contains the antibiotic ciprofloxacin and is used to prevent implant-related infections9 in cases of bone fractures, bone grafts, osteotomies, arthrodesis and osteochondral fractures.
Technological milestones Technologies for preparing biodegradable devices have been widely studied and proven. These include melt extrusion and injection molding. There are, however, advanced technologies which show substantial enhancements over common
InSpace positioning of the biodegradable balloon in the shoulder joint (published with permission of OrthoSpace)
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ORTHOPEDICS
LITTLE THINGS MEAN A LOT Ambionics develops breakthrough child prosthetic using 3D printing
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tratasys’ PolyJet 3D printing technology has enabled Ben Ryan, founder of Ambionics, to create a fully-functioning 3D printed hydraulic prosthetic for his two year old son, Sol.
Press print: Sol with his fully-functioning 3D printed hydraulic prosthetic arm, which enables him to move his thumb on his own
Researching infant development with prosthetics, Ryan has developed a prosthetic for infants to wear, enabling a more natural acceptance of prosthetic arms for young children. The customized design and production of the 3D printed hydraulic prosthetic has delivered cost savings of up to 76%, as well as time savings in design and production of 90%, compared with traditional methods of manufacture. This crucially permits
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prosthetics to be used at an earlier developmental stage.
To develop the design for the prosthetic, Ryan used Autodesk Fusion 360.
Sol was born with complications which resulted in the amputation of his lower left arm. Although able to keep approximately one inch of his lower arm, Sol would have to wait three years for a myoelectric prosthetic from the NHS in the UK, and one year before a cosmetic, non-functional prosthesis would be fitted. Ryan saw his son losing responsiveness and acceptance of his left arm, and decided to act.
“This is a very innovative and ambitious project and it’s been inspiring to work on it,” says Paul Sohi, a product design expert at Autodesk. “It is amazing that despite Ryan having no real background in product design, he’s effectively taught himself enough to create something that will not only help his own son Sol, but in Ambionics, potentially others facing the same challenges too.”
Carrying out research into infant development, Ryan saw that higher rejection rates occur when children are fit after the age of two years and that early fitting of functional devices correlates with continued prosthetic use throughout childhood. Another study also found that children fitted before two years of age tend to accept their powered prosthesis more than those fitted after two years. With this in mind, Ben designed a foam arm for his son and later a hydraulic prosthetic, enabling Sol to move his thumb on his own.
As well as its lightweight 3D printed design that weighs less than traditional myoelectric alternatives, the hydraulic prosthetic is body-powered and enables infants to grow accustomed to their ‘arm’ earlier than traditional fittings. The ability to operate without the need for any electronic devices or batteries is said to be unique to the Ambionics design and mitigates the risk of injury.
Ryan designed and created his 3D printed hydraulic prosthetic arm on the Stratasys Connex 3D printer. First practicing with prototypes of his design, he 3D-printed flexible actuators and a power-splitting unit (double acting helical bellow or DAHB) for the prosthetic. He says that the DAHB unit enables the wearer to open and close the thumb in manual mode or with assistive power (using compressed air or a hydraulic pump and reservoir), but the grip continues to operate manually in the event of power interruption.
While the NHS takes 11 weeks to convert the plaster cast of the arm into a wearable prosthetic, Ryan was able to produce the prosthetic in five days. With the flexibility to keep the scan on file, the digital copy allows replacement pro s t h e t i c s t o be e a s i l y pro du ced through 3D printing.
“The success of my patented DAHB mechanism draws on the advanced capabilities of the Stratasys Connex Printer – the ability to combine rigid and soft materials in a single print was vital to the success of the design,” explains Ryan. “We were fortunate enough to have access to this technology, which enabled us to 3D print a prototype arm so quickly and cost-effectively. In founding Ambionics, it’s now my goal to ensure that other limb deficient children like my son are not faced with the current constraints and delays of traditional prosthetic manufacture.”
Scan to wearable prosthetic in five days
“Essentially the entire prosthetic is 3D printed,” Ryan adds. “Only Stratasys’ strong rubber-like and dissolvable support 3D printing materials make production and use of the DAHB units possible. The internal cavities are complex and it would be impossible to remove the support material using mechanical means. The materials must also be strong yet flexible as they are used to transmit fluid pressure to operate the grip.” Having patented its DAHB technology inside the prosthetic, Ambionics is aiming to offer the service to healthcare providers worldwide and has started a Crowdfunding campaign to enable medical device usability trials.
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Shaping up
THERMOFORMING
Seán Egan, Nelipak Healthcare Packaging, examines the evolving role of thermoforming suppliers in medical packaging design
Team spirit: According to Seán Egan, Nelipak Healthcare, thermoformers are an extension of the customers’ packaging development team. Image: Nelipak Healthcare Packaging.
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he sterile medical packaging market continues to grow, with research published by MarketsandMarkets 1 projecting sales could increase by a Compound Annual Growth Rate of 5.72% over the next several years, bringing it to a $35.07 billion industry by 2020. Thermoforming represents one of the main manufacturing processes used in medical packaging production. Today’s medical device OEMs are looking to their thermoforming supplier to be more than just a manufacturer. Thermoformers become an extension of the customers’ packaging development team, taking on expanded roles in design, development and testing. Furthermore, OEMs expect thermoformers to not merely design around the product, but to fully understand how both the product and pack are to be used within the clinical environment. This increasingly results in device packaging not simply being a transport vehicle to get the device to the OR - but in many cases the pouch or tray may be used as part of the procedure. Design for manufacturing is another important consideration for the thermoformer in the package design process; having a pack that ticks all the boxes for the customer is no use if the product is difficult to manufacture. Prediction tools allow designers and tool makers to understand how a part will behave during manufacturing and amend accordingly to maximize production runs. On the OEM side, automation is increasingly being introduced into the manufacturing setting; the design team needs to take account of the requirements of the process balanced with the needs of the end user.
Thermoformers also need to understand how packaging influences the customers’ packing operations and supply chain. In addition to reducing the overall amount of plastic used, well-designed products have the ability to reduce labor and handling costs such as transportation, sterilization and storage through the supply chain. Reduction in overall footprint of the end pack should also lead to less plastic finding its way into the waste stream in situations where recycling is not practical, such as hospital waste with risk of contamination. Thermoformers and OEMs also need to work together to determine which materials should be used for packaging. The decision behind material selection is based on the product which is being packed, the sterilization method and material costs. Pricing can affect material choice if one or more materials can meet the same need for the pack, but where there is no alternative customers expect that package design will minimize the amount of material required to lower unit cost. In regards to packaging materials, healthcare device and pharma companies tend to be more conservative about change than other sectors of the market, largely due to the regulatory scrutiny they face. Healthcare rigid packaging predominately uses PETG, APET, HIPs and Barex materials. OEMs will generally favor these packaging formats and materials already proven in the market, which can limit their ability to innovate for evolving market needs. But new packaging formats or material combinations require validation and preparation of documentation for submission, which is both time consuming and costly to
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carry out. New materials need to address a critical market need in order to get quick acceptance, otherwise penetration of the market can be slow. Choosing a thermoformer who is experienced in navigating these challenges can open the door to expanded possibilities for next generation packaging. A thermoformer also must have an intricate understanding of the factors which impact seal integrity, which is critical to the product efficacy of healthcare packaging, as the seal maintains necessary sterile barriers. Seals must always remain intact under the strains of shipping and handling, yet peel open quickly and easily for the end-user in a surgical environment. Understanding and applying best practices during the heat sealing process and using custom built cleanroom sealing machines designed to the specifications of a medical device, pharmaceutical thermoformed blisters, or trays can result in better quality products that consistently have the necessary seal strengths and properties. Over the next few years, new medical device technology will emerge where packaging will play an even bigger part in the functionality and use of the device and have a larger role in educating home users in the device’s proper use. Choosing a thermoforming partner with the expertise, technical capabilities and industry knowledge to add value at the design and development stages will be critical for OEMs looking to keep up with the needs of their end users and capitalize on the opportunities of the growing healthcare packaging market. http://www.marketsandmarkets.com/Market-Reports/ regulatory-environment-impact-analysis-sterilepackaging-market-133232063.html
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CK A B E TO R U T THE FU Back to the Future is all about what’s big and what’s going to be big – the tech we like and you’ll be talking about. Lu Rahman selects some of the standout technology in recent weeks
Baby love
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e’re all big softies in the MPN office and a baby story really piques our interest so we loved hearing that 3D Hubs and Eindhoven’s University of Technology have developed a new neonatal training technique with help from 3D Hubs. Eindhoven’s University of Technology is home to PhD candidate and Healthcare Flagship Program participant, Mark Thielen, who is aiming to increase surgical and procedural success for neonatal patients. Using 3D printing and 3D Hubs, Thielen developed a training tool using printed lifelike newborn models with functional organs capable of intelligent sensor feedback. For surgeons and nurses, interacting with anatomical models is important to the success of surgeries and medical procedures. Within the neonatal field, it’s incredibly difficult to practice correctly with the current practice mannequins which lack the complexity and feel of a newborn patient. Thielen’s research is to develop mannequins which have all their major internal organs functioning and equipped with sensors to monitor key measurements such as pressure, stress and impact during trial procedures (eg CPR, intubation). Thielen’s research into the creation of hyper-realistic mannequins doesn’t stop at neonatal patients though, with there being potentially wider applications. He explained: “I believe that developing and advancing what we started here can aid medical research in a broader scope. We could potentially create realistic patient models of other body parts to strengthen medical training for emergency procedures and pregnancies.”
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While summer may be a little way off for us in the UK, we like to think our US readers are working under much more pleasant weather conditions. And for allergy sufferers the summer potentially brings more symptoms for those unfortunate enough to be affected.
The experiment showed that allergy sufferers had worse sleep and less activity than those without allergies. Allergy sufferers’ sleep could be disrupted four times more than those without allergies and had reduced activity during the day.
With most of us now owning a wearable of some sort, Sanofi has made use of these devices to carry out a social study on the sleep activity of allergy sufferers.
While the results may not be earthshattering, it’s interesting to see wearables being used for mainstream health. Good news for wearable device manufacturers as increasing numbers of drug companies see the benefit of data gathering using these handy little gadgets.
160 participants were split evenly between allergy suffers and nonsufferers tracked their sleep and activity using a wearable device for 30 days.
Vital signs 3D printing is vital to medical device markets and the healthcare industry could benefit from the use of 3D printing technology to customize medical devices and drugs, says market analyst Frost & Sullivan. Recent research by the group’s TechVision – 3D Printing for Healthcare Applications – has shown how a number of markets have shown interest in 3D printing in a drive towards more personalized healthcare. Frost & Sullivan TechVision research analyst Madhumitha Rangesa said: “Current products being developed using 3D printing are largely in applications areas such as medical implants, surgical guides, prosthetics, orthotics, orthodontics and anatomical models for surgery. Furthermore, a wealth of opportunities is opening up in future healthcare applications areas such as creation of bone structures, airway tracheal splints and medicine”.
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