NORTH AMERIC AN EDITION
MEDICAL PLASTICS news +
EU MDR MD&M WEST 2020 INDUSTRY FORECAST
It's a mystery THE MYSTERIES OF THE 2018/19 EDITION OF BIOCOMPATIBILITY STANDARD ISO 10993
ISSUE 13
Jan/Feb/Mar 2020
WWW.MEDICALPLASTICSNEWS.COM
ADVANCING MEDICAL PLASTICS
You expect precision.
We
deliver.
C C C
contract manufacturing injection molding medical devices
Our manufacturing includes cleanroom environments, automation, and assembly services, delivering total value solutions that reduce investment and improve cost.
care lo United States •
technical plastics www.carclo-ctp.com 724-539-6989 sales@carclo-usa.com
United Kingdom • Czech Republic •
India
• China
CONTENTS MPN North America | Issue 13 | Jan/Feb/Mar 2020
Regulars
Features
3 Comment Laura Hughes discusses why the medical sector should embrace artificial intelligence 4 News focus 6 Digital spy 9 Greenlight Guru True Quality Roadshow What you can expect from the roadshow and the company over the year ahead 10 Opinion Aaron Johnson, Accumold explains the key to micro molding success
12 Cover story Medical Engineering Technologies explores the mysteries of the 2018/19 edition of ISO 10993 and chemical characterization 15 Therapy area focus: Cardiology 33 Events What to expect at MD&M West and BIOMEDevice Boston 36 Back to the future
16 European Medical Device Regulation - Are you ready? Laura Hughes provides a brief summary of the regulation and shares the results of MPN’s recent survey 22 Bringing 3D printed medical models to life Stratasys explores how 3D printing could transform medical device testing for manufacturers 25 A test of character Nelson Labs explains why chemical characterization is still considered the strongest way to assess patient risk 29 The future looks bright Junkosha predicts smaller catheter solutions in 2020
WWW.MEDICALPLASTICSNEWS.COM
1
Visit the Schöttli Booth at PLASTEC West 3982 February 11–13, 2020
CREDITS editor | laura hughes laura.hughes@rapidnews.com
EDITOR’S
comment
head of content | lu rahman web content editor | ian bolland advertising | sarah livingston sarah.livingston@rapidnews.com head of media sales plastics & life sciences | lisa montgomery head of studio & production | sam hamlyn graphic design | matt clarke junior designer | ellie gaskell publisher | duncan wood Medical Plastics News NA Print subscription - qualifying criteria US/Canada – Free UK & Europe – £249 ROW – £249 Medical Plastics News Europe Print subscription - qualifying criteria UK & Europe – Free US/Canada – £249 ROW – £249 FREE on iOS and Android devices Subscription enquiries to subscriptions@rapidnews.com 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 © 2020 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: 2632 - 3818 (Print) 2632 - 3826 (Digital)
Time to embrace change
E
very year we see increasingly more advances with robots and technology, however, what should be seen as a huge gain for the medical sector is often feared by those who are afraid of change, and think robots have the potential to take away their jobs, will cost lots for the company, or affect the control of certain processes. If you have ever called an emergency helpline or visited a GP surgery, then you will know that these professionals are applying common sense, empathy, intelligence and years of training when addressing your concerns – some of these factors being very difficult to instil in a machine. In 2018, the Food and Drug Administration (FDA) approved the IDx-DR device by IDx Technologies for diabetic retinopathy diagnosis - the first approval of its kind. The system works by taking an image of the patient’s eye, and then uploading the images to a server for analysis. In the case the software provides a positive diagnosis, the patient is then referred to a human who is an eye specialist. The initial system can be operated by anyone and does not require a specialist. Another example is Aerobit’s smart inhaler which is able to track medication use and record each time an inhaler is taken by an asthma patient. The device is able to provide reminders and alerts to the patient; However, the doctor still plays an important role in tracking the treatment progress and compliance for that patient. Jane Rendall, managing director of Sectra UK and Ireland, commented on the UK’s healthcare system – the NHS’ unused data sets: “The NHS has practically unused archives of millions of diagnostic images that could become one of the most powerful clinical datasets in the world if artificial intelligence is used effectively.” Interestingly, a report by KPMG, a global network of professional firms who provide audit, tax and advisory services had the following key findings: • 60% of US life science CEOs see artificial intelligence creating more jobs than it eliminates • Most life science companies have made investments in artificial intelligence in some form WWW.MEDICALPLASTICSNEWS.COM
• 2 5% of US CEOs surveyed said they have already achieved significant returns from artificial intelligence investments A recent study published in the Nature journal also concluded that in the UK, where mammograms are typically read by two radiologists during screening, artificial intelligence could lower the workload for the second reader by 88%. I believe artificial intelligence has the potential to transform the way we work within healthcare. Removing the need for a skilled healthcare professional saves money and time which can be better used elsewhere. Additionally, machines are tireless and can be programed to have an extremely low possibility of error. A report by the Association of American Medical Colleges indicated a projected shortfall of nearly 105,000 physicians by 2030; artificial intelligence has the potential to ease this burden, but only if we allow it.
I believe artificial intelligence has the potential to transform the way we work within healthcare. 3
NEWS FOCUS
New research claims to push the limits of fundamental chemistry RESEARCHERS ARE BELIEVED TO HAVE DEVELOPED A NEW TYPE OF MATERIAL FROM A POLYMER WHICH ACTS SIMILARLY TO HUMAN MUSCLES. Stimuli-responsive hydrogels are a class of soft materials that are able to change their mechanical properties when certain external triggers are applied. Researchers from Jonathan Barnes’ lab have developed a new type of artificial molecular muscle from a polymer that is able to change color and contract when exposed to blue light. Barnes began working with hydrogels because he wanted to develop a material that could change shape and size just like our muscles do when they expand and contract. Barnes recalled: “A lot of people said we would never get the amount of contraction we were hoping for…but it actually worked better than we ever imagined.” This research built on a study previously published in the journal, ACS Applied Materials & Interfaces, which Barnes was involved in. The more recent research focused on developing soft, biocompatible materials that could sustain heavy loads so in the future these materials could be suitable for applications such as prosthetics or transplantable organs. Faheem Amir, lead author on the paper and a postdoctoral researcher in Barnes’ lab said: “Cells within living systems face a 3D environment, yet most of the studies that are done on cells are done on 2D materials.” Therefore, this research addresses a current technology gap. These
This is pushing way beyond fundamental chemistry, and even beyond Washington University, to build collaborations all around the country and even the world.
4
hydrogels provide the opportunity to bring cells into a 3D system and identify how they behave under different conditions. Additional research has also been conducted to improve the speed of the reaction and method of activation. This is because previously hydrogels had to be submersed into a chemical reducing solution, however, this new material is able to respond to visible light by using a photocatalyst in the hydrogel network. Barnes’ lab has partnered with the Washington University School of Medicine (WUSM) in order to obtain the relevant materials. Barnes concluded: “We took this idea that no one thought would work to the point where we’re actually showing biomedical relevance with these materials. This is pushing way beyond fundamental chemistry, and even beyond Washington University, to build collaborations all around the country and even the world.” The results of this hydrogel research offer a wide range of opportunities for future medical applications all around the world.
WWW.MEDICALPLASTICSNEWS.COM
CYROLITE速 has been working in hospitals and
Lipid-resistant, BPA-free, and highly transparent: CYROLITE速 acrylics are the reliable invisible helpers in hospitals and labs.
labs for more than 40 years. Thanks to their excellent properties, our high-performance acrylics are perfect for use in a wide range of medical devices. CYROLITE速 is highly transparent and easily processed into intricate parts. It can be reliably sterilized using most common methods and is BPA- and DEHP-free. This has impressed both patients and healthcare professionals alike: CYROLITE速 meets the requirements of USP Class VI, ISO 10993-1, and REACH. You can find more details at www.cyrolite.com.
DIGITAL
spy
www.placon.com Manufacturer wins WorldStar award for medical tray
REGULATORY UPDATE
www.senate.gov
Stephen Hahn confirmed as FDA commissioner
A
Senate vote result of 72-18 sees Stephen Hahn named the next Food and Drug Administration (FDA) commissioner. His appointment follows a much higher number of votes compared to previous commissioner Gottlieb who was only confirmed by the Senate 57-42. Hahn is a well-regarded radiation oncologist who previously served as the chief medical officer at the University of Texas MD Anderson Cancer Center. Scott Whitaker, CEO of AdvaMed commented on the announcement: “During the confirmation process, Dr. Hahn
6
MEDTECH UPDATE
demonstrated his deep understanding of the agency’s mission to protect and promote the public health and the role of innovation in improving patient care.” Both Whitaker and Mark Leahey, CEO of the Medical Device Manufacturers Association, mentioned how they looked forward to working with Hahn to ensure timely patient access to new medical devices. Health and Human Services secretary Alex Azar called Hahn a "superbly qualified leader" who will help expedite the administration's public health agenda.
P
lacon, a manufacturer and designer has been presented with the WorldStar award for its Orthofix medical tray. The awards aim to recognize the continuous advancement of packaging design and technology, and the medical tray was part of the medical and pharmaceutical category.
The Orthofix tray has features to suspend a set of medical device screws. The screws are coated with hydroxyapatite to prevent the abrasion or rubbing off of the critical coating that is required on each screw to ensure proper medical operating room usage. Dan Mohs, Placon’s chairman
and CEO described receiving the award as “wonderful recognition.”
MEDTECH UPDATE
www.bostonscientific.com
World’s first disposable duodenoscope receives FDA clearance
M
edical device company, Boston Scientific, has received 510(k) clearance for its single-use duodenoscope for endoscopic retrograde cholangiopancreatography procedures. The duodenoscope – Exalt Model D scope, claims to be the first and only FDA-cleared disposable
duodenoscope on the market. The device was granted breakthrough device designation from the FDA in order to provide patients and healthcare providers with rapid access. Single-use duodenoscopes are needed because reusable duodenoscopes have recently
WWW.MEDICALPLASTICSNEWS.COM
been criticized for outbreaks of bacterial infections. Singleuse duodenoscopes avoid the cleaning and sterilization issues associated with the reusable devices. Boston Scientific is planning a limited market release of the device within the United States in the first quarter of 2020.
DIGITAL SPY
MEDTECH UPDATE
www.reportconsultant.com
Plastics company named as a key player in anesthesia monitoring device market
P
hillips Plastics has been named as a key company within the anesthesia monitoring device market report written by Report Consultant. The report provides an evaluation of the anesthesia monitoring device market for 2019, as well as future
projections for the sector. Report Consultant claims that North America has the largest market for anesthesia monitoring devices as a result of increasing awareness of patient safety amongst patients and physicians.
talking
POINT
www.fda.gov
FDA responds to fears of nationwide shortages
NEWS UPDATE
www.jnj.com
JOHNSON & JOHNSON LOSES COURT CASE OVER SURGICAL MESH
D
uring a case within Australian federal court, Johnson & Johnson have been described as “negligent” over the vaginal mesh implant. The surgical mesh has been used for the repair of pelvic organ prolapse as well as for stress urinary incontinence, however, its use has been widely reported due to a significant number of women reporting negative experiences with the device. The Australian federal court ruled in favor of hundreds of women who suffered pain following the vaginal mesh implant. During the case Judge Anna Katzmann
explained how there was “overwhelming” evidence showing the medical device creator Ethicon, who is owned by Johnson & Johnson, was “negligent.” Speaking about the verdict, manufacturer Ethicon said: “Ethicon believes that the
company acted ethically and responsibly in the research, development and supply of these products.” The company is currently considering options to appeal the court decision. Compensation will be awarded by Katzmann in February.
What are the reasons behind the potential nationwide shortages? Two medtech sterilization plants have been closed, and another facility is currently in talks about potentially shutting down. Why are the facilities being shut down? The reason for the closures is because the Environmental Protection Agency (EPA) considers the levels of Ethylene Oxide (EO), which is a carcinogen, to be too high at these facilities. Why is this important for manufacturers? According to the FDA, 50% of all devices which are sold within the United States and require sterilization, are sterilized using EO. EO is a popular sterilization method due to its penetration properties and ability to leave products undamaged during the process. What does the FDA advise? The organization are identifying alternative sterilization methods and ways to reduce the amount of EO needed to sterilize devices. “The FDA will continue in our steadfast commitment to develop solutions to avoid potential device shortages and encourage new, innovative ways to sterilize medical devices while reducing adverse impacts on the environment and on the public health,” said the FDA in a statement issued on the topic. The full statement can be read on the FDA website.
7
The world of ENGEL Efficient. Reliable. Innovative. As one of the world’s leading companies in the field of plastics machine manufacturing, we offer our customers integrated system solutions. This means: injection moulding technology from a single source. Machine, automation, process, training and service are all perfectly integrated with ENGEL. And we always look to the future. Innovation and the latest technologies offer our customers a decisive competitive advantage. be the first.
www.engelglobal.com
GREENLIGHT GURU TRUE QUALITY ROADSHOW
ON THE ROAD AGAIN SOFTWARE COMPANY, GREENLIGHT GURU, EXPLAINS MORE ABOUT THE COMPANY’S TRUE QUALITY ROADSHOW AND WHAT TO EXPECT IN THE YEAR AHEAD. WHO IS GREENLIGHT GURU? Greenlight Guru is the only quality management software designed specifically for the medical device industry.
development engineer – then this roadshow is of huge relevance to you.
The company provides design control, risk and quality management software for organizations to ensure traceability is maintained throughout the entire device lifecycle. This software is used across a range of classes of medical devices in more than 600 cities across 50 countries and six continents.
PLANS FOR 2020 The organization is planning to host eight shows as part of the roadshow in total during 2020 including its first international event in Dublin, Ireland. The schedule is listed below.
WHAT IS THE GREENLIGHT GURU TRUE QUALITY ROADSHOW? The roadshow provides you with the opportunity to connect with medical device professionals within your area. Each event follows a similar format: • NETWORKING The evening begins with a networking reception where attendees are given the opportunity to talk to the city’s top medical device quality, regulatory and engineering professionals. • PANEL There will be a panel discussion where key topics, personal industry stories and thoughts on the medical device industry will be covered. • FIRESIDE CHAT To conclude the event, there will be a live recording of the Global Medical Device Podcast. This interactive session will include Jon Speer, the founder and vice president of quality and regulatory affairs, Greenlight Guru, along with a key, local figure within the industry. The roadshow was launched in 2019 and visited eight cities throughout the year including: Atlanta, Boston, Houston, Indianapolis, Minneapolis, Orange County, San Diego and San Francisco. Speaking ahead of the roadshow launch in 2019, Speer described the roadshow as a result of the company’s, “determined focus on education, redefining best practices, and keeping you ahead of the ever changing regulations.” Speer added: “The True Quality Roadshow aims to become a leading destination for the exchange of best practices, venues for networking and career growth and the celebration of industry embracing true quality.” If you are a medical device industry executive, quality professional, regulatory affairs professional, clinical affairs professional or a research and
• • • • • • • •
February 2020: San Jose February 2020: Houston March 2020: New York City April 2020: Boston April 2020: Dublin May 2020: Minneapolis June 2020: San Francisco July 2020: Chicago
Members of the team at Greenlight Guru will also be at the following events throughout the year: • M D&M West 2020 (Anaheim, February) • Emerging Medtech Summit (California, February) • MedTech Strategist (Dublin, April) • Medical Alley Annual Dinner (Minnesota, April) • FDA/Xavier Medcon Conference (Ohio, May) • MedTech Innovator Summit (California, June) • WSGR Medical Device Conference (California, June) • Xavier Health AI Summit (Ohio, August) • RAPS Regulatory Conference (Texas, September)
WWW.MEDICALPLASTICSNEWS.COM
9
PINION THE KEY TO SUCCESS AARON JOHNSON, VICE PRESIDENT OF MARKETING AND CUSTOMER STRATEGY FOR INJECTION MOLDING SPECIALISTS ACCUMOLD, EXPLAINS THE KEY TO MICRO MOLDING SUCCESS.
A
ccumold works at the precision and micro end of the spectrum when it comes to molding, and as such has a unique perspective, not just concerning the requirements that medical device Original Equipment Manufacturers (OEMs) have when pushing for part or feature miniaturization, but also on the vital questions that medical customers must ask of their shortlisted micro molding partners. When choosing which micro molder to work with, the lines of engagement are different from the typical job shop relationship manufacturers have with conventional molders. The critical nature and complexity of the micro products that medical device OEMs rely on means that a chosen micro molder should from the get-go be viewed as a strategic partner in the entire product development process.
As such, one key question that medical OEMs must ask of a micro molder is the extent to which they are truly vertically integrated. The ability to truly provide design and material assistance, micro tool fabrication, micro molding, metrology, automation and assembly under one roof not only mitigates risk associated non-adherence to tight tolerances and accuracy requirements, but also exhibits the ability to be able to support and control a product development program from end-to-end. Control is central to success as this removes the headaches of dealing with multiple vendors and streamlines the entire product development process. It is often best to visit your chosen partner to see the facilities for yourself, as there are cases where claims of in-house capabilities are not always the case in reality. Beyond locating a micro molder that insists on a strategic partner relationship (with all that this implies in terms of the quality, speed, and cost-effectiveness of outcomes), it is also useful to question and assess the size and longevity of your chosen micro molder. There is no substitute for experience, and this comes through a long association with micro molding and micro product development. Also, there will come a time when you need to scale up to high volume mass manufacture, so you need to locate a micro molding partner that has the physical space and infrastructure in place to cater for your medium- and long-term needs. The safety critical nature of many medical devices requires absolute accuracy and the creation of cutting-edge and innovative micro molded products. To enable this, it is vital that medical OEMs thoroughly interrogate the inherent capabilities that their chosen micro molder has. Customers should certainly be quite forensic in their interrogation of the extent and experience their chosen partner has in the fabrication of micro tools, as well as assessing the extent and quality of their molding facilities, and also assess the metrology capabilities in-house, because as is often said in the micro manufacturing arena, “if you cannot measure it you cannot make it.� Your chosen micro molding partner should also have extensive experience in terms of automation and assembly, but such capabilities can only be motivated optimally for medical OEMs if the team driving them show the passion and experience necessary to manufacture seemingly impossible and innovative micro products. Ask your micro molder how collaboratively they work internally and also with you, as the key to micro molding success is collaboration and transparency. Your chosen micro molder should have a solutions-oriented focus and a demonstrable reputation in the medical device industry for high quality, timely, and cost-effective results.
10
WWW.MEDICALPLASTICSNEWS.COM
The shawpak is a revolutionary machine offering a thermoforming solution to your medical packaging needs that is totally unique
IDEAL FOR INTEGRATION INTO ROBOTIC CELLS AN OPTIMUM SINGLE-PIECE FLOW SYSTEM
SEE MORE AT
WEST PACK 2020 Booth 4929, 11-13th Feb 2020
shawpak USA Inc. Lusk II, Suite D108, 6440 Lusk Boulevard, San Diego, California 92121, USA T +1 201-961-4740 | F +1 201-891-1412 W www.shawpak.co.uk | E sales@shawpak.co.uk
T
here have been a series of earthquakes in medical device regulation recently. Not only has the world been turned upside down by the new Medical Device Regulation (MDR)1 - the key European regulation system, but the overarching biocompatibility standard ISO 10993-12 has had revolutionary changes. When it comes to assessing the biocompatibility of a device, the new edition of the toxicity standard radically increases the emphasis on chemical knowledge (chemical characterization) of the device or drug delivery product. This has been added to the biocompatibility matrix3 as the first requirement for every category of device. The standard calls for a risk based process in this assessment using chemical characterization as the key input. This characterization includes all the chemical data that can be found relating to the device. It should encompass components, molding materials, any additives, processing materials, packaging materials, labels, inks and every other material involved in making the device. This information would ideally include toxicity information for each material (this can often be found in the literature if the material supplier does not have the data). Also, it is important to consider the chemical formula and quantities of all component materials, health and safety data as well as any other data and test results. Other information (which is not necessarily chemical) also needs to be considered e.g. particle release and materials of biological origin. Chemical characterization is a combination of information obtained by reviewing information sources including: • The input materials (specification, Material Safety Data Sheet (MSDS) and safety testing) • Processing (heating, contact with other materials, other stresses) • The storage conditions • Sources of contamination • The effects of sterilization • Any information obtained from chemical testing The same information is required on any possible contamination. Examples of contamination are:
12
It's a mystery THE MYSTERIES OF THE 2018/19 EDITION OF BIOCOMPATIBILITY STANDARD ISO 10993
MARK TURNER, MANAGING DIRECTOR OF MEDICAL ENGINEERING TECHNOLOGIES (MET), A UK-BASED TESTING FACILITY, EXPLORES THE MYSTERIES OF THE 2018/19 EDITION OF ISO 10993 AND CHEMICAL CHARACTERIZATION. • Unreacted monomers (also catalysts, activators and inhibitors) • Degradation products • By-products from processing or interactions between materials (especially in sterilization conditions) • Processing lubricants • Legion other possibilities (intended or unintended) Once the chemical data has been gathered, a view can be taken on whether it is adequate to demonstrate safety. If all the input materials have good data and it can be rationalized that no new hazards would be introduced during processing, sterilization and storage, further work might be limited to the risk analysis. Possible scenarios for this are that the materials are used in another product which already has full testing in place, or that the input materials individually have data that addresses all the toxicity endpoints and the production, the sterilization and all other processing parameters are exactly the same as other products in a range. WWW.MEDICALPLASTICSNEWS.COM
COVER STORY
CASE STUDY We explore an example of chemical characterization for a wound dressing which offers up to 3 days of contact. COMPONENT MATERIALS These all have evidence of safety for up to 24 hours of use and include spun bond polyester contact layer, hydrogel absorber, a polyurethane cover, adhesives and a polythene release liner. HAZARDS The hazards identified in production included: • Injection process for the hydrogel allows contact with metal and rubber materials • Silicone oil is used in an adjacent process • Cutting and laminating machine has lubrication • Contamination may also come from cleaning fluids • Possible metal and rubber particle generation • The adhesive can overheat (and possibly degrade) during application RESULTS The toxicologist concluded that the chemical characterization is incomplete because we do not know the quantities or nature of contaminants from production. The biocompatibility test matrix adds implant and sub-chronic risks to those indicated for 24 hours contact. At this point, a chemical analysis was required to identify and quantify the full range of materials that could be made available to the patient. An ‘extractables and leachables’ analysis or in the case of a medical device a ‘simulated use leachables analysis’ should be conducted. The analytical chemistry tools available are very powerful and can easily find chemicals in the dressing that would never be released to the patient. Extraction and analytical techniques should be selected to find everything that could migrate in use, but not include chemicals that will not be released when the product is used. This additional data now completes the chemical characterization of the dressing and allows the toxicological risk analysis to progress.
A trained person can conduct this gap analysis, identifying areas of missing information and areas of concern. If the gap analysis identifies information is missing, chemical analysis of extractable materials will be required. Biological testing should only be applied when chemical information gathering (and any chemical testing) delivers inconclusive results. A toxicologist is required to assess the implications of any toxicity information, or its absence. This toxicological risk analysis can conclude whether or not the device is safe to use or if biological testing is required to confirm some aspect of safety. Hence, biological testing is the ‘gold standard’ but also the ‘last resort’.
CONCLUSION In conclusion the chemical characterization of a device is now required in ISO 10993 and this is listed in the testing matrix for every category of device. Leachables analysis is not the only route to obtaining this information, but it is the most likely method to find unexpected materials. The vigour of application of chemical analysis should be tailored to the body contact and risk analysis for the device. The chemical characterization, through a toxicological risk analysis, is used to address the toxicity end points required for the body contact involved. REFERENCES
1. E uropean Medical Device Regulation. https:// eur-lex.europa.eu/ legal-content/EN/ TXT/PDF/?uri=CELEX:32017R0745 2. ISO 10993-1:2018 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process 3. Biocompatibility matrix extracted from ISO 10993-1. https://met.uk.com/medical-device-testing-services/ biocompatibility
WWW.MEDICALPLASTICSNEWS.COM
13
Medical Solutions
Complete solution provider, from concept to full scale production C, ACA A Annaahheeimim, ter | | 0 2 9 0 1 2 0 , 3 2 1-,1 onnCCenetenr FeFebb. .51-7 enntitio v n n o o C C eim AnAanhaehim
9
35 2 h t o o B
Global Turnkey Solution Provider With over 75 years of experience in product development, advanced polymer processing, including assemblies and various post-processes, we offer you unique and reliable services.
Customer Solutions
Facts & Figures
• • • • • • • • • •
• • • • • •
Anesthesia & respiratory devices Cardiovascular devices Diabetes care devices Drug delivery devices In vitro diagnostics Laboratory Nephrology & urology devices Ophthalmic devices Ostomy devices Primary plastic packaging
Robust Design.
Developed to save time & cost.
Founded 1938 in Sweden Over 1400 employees 12 production sites worldwide Technical design centers in EU and US 90 000 m² production area 500+ moulding machines (IM thermoplastics & silicones, IBM, EBM) • 70+ assembly lines
www.nolato.com
CARDIOLOGY
Therapy FOCUS Around-the-clock monitoring OUR EDITOR LAURA HUGHES CAUGHT UP WITH AMNON BLANCA, HEAD OF BUSINESS DEVELOPMENT, CARDIACSENSE TO LEARN MORE ABOUT THE COMPANY AND ITS FUTURE PLANS.
C
ardiacSense are an organization aiming to improve the quality of life and reduce hospitalization for people through monitoring 24 hours a day, every day.
My first interaction with the company was ahead of this year’s Medica trade fair, when I received the news that CardiacSense were launching its commercial watch at the event. Blanca explained how the company had previously attended Medica, however, CardiacSense had exhibited on a small stand offered by Israeli’s trade mission department. 2019 was the first time CardiacSense had hired a full-sized booth at the trade show. Blanca explained how during Medica the company optimized the opportunity to explore collaboration opportunities, to meet potential customers and to view the latest industry developments. I asked Blanca to provide me with more information on the device launched at the event. THE FEATURES The device has three main sensors: 1. PhotoPlethysmoGraphy (PPG) This is optical technology which monitors the patient for 24 hours a day, every day. The sensor is able to detect any present heart arrhythmias, as well as measure vital signs such as heart rate, respiratory rate and oxygen saturation over the wrist. In the case of the PPG sensor detecting an arrhythmia, the watch will vibrate and issue a visual alert. The patient should then place two fingers from the opposite hand on the crown of the watch for the ElectroCardioGram (ECG) signal. 2. ECG The physician will receive a strip of the ECG signal as well as the relevant PPG signal. 3. Blood Pressure (BP) measurement This is placed over the radial artery and provides absolute and continuous blood pressure readings. Both the PPG sensor and BP sensor were developed in-house and are patent protected.
DESIGN As the watch is for medical use, and many of the users will be elderly people, there was a specific emphasis on using non-irritative and medical grade materials. Blanca explained how, “the body of the watch is plastic Macroblend M525 and the band is medical silicone.” PATENT APPROVALS The company are currently awaiting patent approvals which Blanca describes as the “stone corners of our special sensors that are providing the outstanding accuracy levels we have reached.” CE AND FOOD AND DRUG ADMINISTRATION (FDA) APPROVALS I was informed that CardiacSense will soon be submitting both CE and FDA approvals for A-Fib detection using its PPG and/or ECG following the completion of a clinical trial which is currently underway. CardiacSense will be exhibiting at HIMSS 2020 from 9th to 13th March 2020 in Orlando, Florida, USA. CardiacSense ©
Talking about this watch, Blanca emphasized how the company feels this device meets an unmet need within the market, claiming that there is currently, “no solution in the market for long-term (over 28 days) and continuous detection of heart arrhythmias that is not invasive.” For BP measurement, CardiacSense has also developed a new sensor that uses several technologies in order to measure absolute BP over the wrist. CardiacSense has a patent pending for this technology. DEVELOPMENT When developing the device, Blanca informed me of the four key features CardiacSense focused on: 1. Need 2. Accuracy 3. Robustness of the solution 4. Ease of use WWW.MEDICALPLASTICSNEWS.COM
15
SERVING MEDICAL DEVICE COMPANIES WORLDWIDE
European Medical Device Regulation - ARE YOU READY? AS THE DEADLINE FOR EUROPEAN MEDICAL DEVICE REGULATION (EU MDR) IS RAPIDLY APPROACHING, OUR EDITOR LAURA HUGHES PROVIDES A BRIEF SUMMARY OF THE REGULATION AND SHARES THE RESULTS OF MPN’S RECENT SURVEY. WHAT IS EU MDR? EU MDR is scheduled to come into effect in EU Member States from 26th May 2020. This regulation will apply to all manufacturers selling medical devices within Europe and aims to provide greater protection of public health and safety. IS THERE POTENTIAL FOR EU MDR TO BE DELAYED? The United States issued a statement to the World Trade Organisation (WTO) in 2019 writing: “Our industry is worried about their continued access to the EU’s $125 billion USD medical device market, $20 billion USD of which is supplied by US products.” However, the EU commented in July 2019: “There are no grounds for the time being to explore any amendment to the transitional periods.” WHERE ARE WE NOW? To date the European Commission (EC) has designated nine Notified Bodies (NBs) against MDR. The EC previously predicted at least 20 NBs. The EU acknowledged that the final number of designated NBs could be “slightly lower” than originally anticipated. The US statement to the WTO explained how they do not believe this number is enough to, “ensure continued regulatory approvals by May 2020.” Only one of the regulations that has been put forward has been adopted to date. This regulation involves the reprocessing of single-use medical devices. Additionally, the EC’s draft standardization has been heavily criticized. The US statement addressed the issue to the WTO stating: “Industry maintains that the product standards necessary for compliance with MDR cannot be completed before the deadline.” COMMENTS Lots of key industry figures have shared their views on the topic. REINER THIEM, HEAD OF REGULATORY AFFAIRS, RAUMEDIC “We have intensively worked over the last three years to gain an understanding of the new regulatory landscape.” PETER ROSE, MANAGING DIRECTOR - EUROPE AT MAETRICS, A LIFE SCIENCES CONSULTANCY FIRM: “Industry is increasingly becoming concerned about the timetable for the EU MDR." He added: "Three year transition periods are well established in our industry, but never have I seen a transition period being used to get the system ready.” SCOTT WHITTAKER, PRESIDENT AND CEO, ADVAMED “The medtech industry supports the new EU regulations’ objectives to ensure the highest level of patient safety, timely access to innovation, and the trust of all stakeholders. We are now in the critical period of transitioning to the new system, which needs to be completed by May 2020 (and
16
May 2022 for IVDs). Industry is concerned that while we are prepared, key elements of the new EU regulatory system will not be ready sufficiently ahead of these deadlines to enable industry to comply with the new rules in time. In particular, we believe the capacity of the NBs (approval bodies) will not be adequate to allow for the recertification of tens of thousands of existing and new products ahead of the May 2020 MDR implementation deadline. Appropriate and urgent action by European institutions will be essential to ensuring continued access to existing life-saving and life-improving medical devices and diagnostics that hospitals, doctors, patients and families rely on every day.” SANDI SCHAIBLE, SENIOR DIRECTOR OF ANALYTICAL CHEMISTRY AND REGULATORY TOXICOLOGY, WUXI MEDICAL DEVICE TESTING “The year of MDR is here. And device manufacturers are under more pressure than ever before. With so many questions about NBs, whether Europe will delay implementation, and EUDAMED, the uncertainty and stress is palpable. Device manufacturers, you are not alone. We’re in this together. But don’t sit idle and risk having your devices pulled from market. If you’re behind, it’s time to lean more heavily on laboratory testing partners, if they have capacity. Put your foot on the gas and approach partnerships with transparency. Being forthcoming with details and giving your lab partners visibility to forecasts, intervals, and timelines will help you make up for lost ground in these final months before the 26th May 2020 deadline.”
WWW.MEDICALPLASTICSNEWS.COM
www.kenblockconsulting.com MPN conducted a survey on people selling medical devices within Europe. The results of the survey are displayed below. Q On a scale of 1-5, (1 being not ready at all, and 5 being ready to go right now) how prepared are you and your business for the new EU MDR?
9.52%
26.19%
40.48%
19.05%
4.76%
1
2
3
4
5
Q Which class of medical device is your company primarily a manufacturer of? 28%
55%
12%
5%
Q Do you think the implementation of EU MDR will have a detrimental effect on patient outcomes?
Q What do you think are the most challenging aspects of these new regulations?
35.71% Unsure
11.9% Notified bodies
14.29% Required documentation
4.76%
Available resources
19.05% Class I medical devices
Class II medical devices
Class III medical devices
No response
60%
40%
Clinical data for existing products
14.29% Q Did you use any consultancy service as part of your preparation?
Q When did you start making preparations for EU MDR? 54.76%
Within the last 12 months
23.81%
Within the last 6 months
9.52%
Within the last 3 months
0.00%
Within the last month
11.90%
Not started
50% 40% 10%
YES NO N/A
The survey was completed by people from the following countries:
2%
2%
2%
32%
2%
Q Do you believe the guidance for EU MDR is clear enough?
2%
33.33%
2% France
39%
Poland Ireland
N
UK
Germany
S
Spain
O
15%
YE
2%
Canada
USA
Greece
Unknown
WWW.MEDICALPLASTICSNEWS.COM
66.67% 17
momentive.com
SELF-LUBRICATING LSR FOR HEALTH CARE APPLICATIONS Momentive´s family of liquid silicone rubber materials (LSR) enable health care device designers and equipment manufacturers to introduce improved material features for critical applications such as needle-free access valves, o-rings, stoppers, seals and assembled parts. The Silopren* LSR 46x5 SL product family can provide enhanced lubricity for specialized applications requiring a high-slip surface not achievable via traditional silicone molded parts.
momentive.com/healthcare Visit us at MD&M West 2020
BOOTH #2449 Before purchasing or using any Momentive products, please visit www.momentive.com/salesdisclaimer to view our full product and sales disclaimer. *Silopren, Momentive and the Momentive logo are trademarks of Momentive Performance Materials Inc.
INJECTION MOLDING
Injection molding excellence: How to transform your business
WHAT IS MOLDING EXCELLENCE, AND HOW CAN IT TRANSFORM YOUR BUSINESS? MATTHEW THERRIEN AND SCOTT MOLNAR, DIRECTORS, STRATEGIC BUSINESS SOLUTIONS, RJG ANSWERS THESE QUESTIONS. “There’s no such thing as perfection. But, in striving for perfection, we can achieve excellence” – Vince Lombardi. Whether it is in sports or business, there has to be a common goal and a drive to get there, - that keeps the momentum going. It is an infinite contest which never ends. Standardizing injection molding processes on a global scale can be overwhelming and seem a near impossible feat, but it is vital to the growth and success of companies wanting to ensure that only quality parts get to their customers and their customers’ customers. It is also important to reduce liability, comply with product specification requirements and be ISO compliant. This method of streamlining training, technology, and methodologies is referred to as molding excellence. WHAT IS MOLDING EXCELLENCE? Molding excellence is when an effective core team (champions) develops the fundamental competencies that encompass the high-level execution of foundational training, technology and best practices. The ultimate goal is to implement total best practices across the operation—assuring interoperability and flawless execution.
Success in business is a continuous measurable (quantifiable) process of improvement for long term sustainability based on an applied knowledge-based (data) management strategy. Sustainability is based on proper leadership and coaching to build the bench for succession planning. Filling one spot does not solve the problem, this only means you are starting from scratch again. The highest level of performance (quality) that you can expect from your process is determined by the minimum standards that you have established and maintained. Collaboration between the Original Equipment Manufacturer (OEM) and Contract Manufacturer (CM) is essential to establish a continuous improvement partnership. During the process of planning, doing, checking and adjusting it is important to remember to be disciplined and stick to the science, data and physics of molding. ISO 13485-2016 expands on the necessity for continuous improvement as opposed to achieving one-time compliance. It requires global collaboration around applications and projects from start to finish and 100% traceability of every part. Exercise effective documentation demonstrating the objective evidence that provides an auditable path back to the origin of the process development - that is replicable. PART PROCESS: A NEW APPROACH Putting foundational knowledge in place is a major step to instill a molding excellence culture. With a greater understanding of what it
WWW.MEDICALPLASTICSNEWS.COM
19
INJECTION MOLDING
takes to achieve standardization, OEMs and molders can take a collaborative approach using practical methods to develop a part process (as opposed to a machine process) for a given mold.
MOLDING EXCELLENCE IMPLEMENTATION In any organization, the end goal of molding excellence requires the commitment and dedication from the top down. It is vital to assign the right people who have the wherewithal not to sidetrack the objectives and deliverables. The strength of a cross functional team is displayed when if one person goes down, another can step in.
This alternative application uses Machine Independent Variables (MIV) that allow you to move a mold from machine to machine without needing to revalidate the part. As you can imagine, this saves an enormous amount of time and money. MIV provide a unique opportunity for seamless transfer into production and the flexibility to move between capable machines.
There are different levels of execution and implementation. Internally, it may take 100% “re-thinking” of how a part is procured and goes through its product life cycle in a medical device assembly. Are all of the suppliers in your approved vendor list fluent in scientific injection molding principles and putting them to practice? Can they demonstrate and provide the evidence that it is woven into their manufacturing culture?
The benefits of utilizing the MIV methodology as an integrated part of the culture includes operational excellence, improved financial performance, improved part quality, faster tool launches, optimal part designs, global consistency, mold transferability, supplier flexibility, cost reduction, and market share growth. A FUNDAMENTAL WAY TO PROCURE INJECTION MOLDED PARTS As always, the due diligence for part quality assurance starts at the beginning. Take a practical approach, keep it simple, and measure what matters. To achieve this, it takes full commitment from the entire team - you’re either all in or it’s not going to happen. And it doesn’t happen overnight. The part design, along with material considerations are key elements that directly impacts the design of the mold. This drives the required machine specifications that will satisfy the development of a robust and sustainable part process.
As an OEM, addressing the “knowledge gap” does not only pertain to your supply chain, but it is also about looking in the mirror and acknowledging the internal needs of the business as well. Anyone who touches the part at any point from concept to end of life e.g. marketing, design, product managers, program managers, supplier quality engineers will benefit from building a well-rounded understanding of the product life cycle. When the behavioral changes become a norm and are instilled in your culture, they can then be extended to the external supply chain. We find that what works best is a collaborative experiential learning experience between the OEM and the CM. This allows for shared ownership of the end results - the team owns it and is accountable to themselves to deliver. This interoperability between OEM and CM can even be executed globally. REALIZED VALUE OEMs and suppliers that practice these methods and use the available technology have a higher success rate because there is a vested partnership in sustainability. These values include: • Common language: Across all departments • Process development: More consistent method • Stabilized Production: Repeatable and transferable • Measurable: Increased confidence through verification • Increased profitability: Better use of resources and time • Global flexibility: Risk mitigation and contingency planning There is a continued effort by the Medical OEM Consortium to facilitate the methods to achieve these objectives and deliverables.
RJG ©
From a plastics point of view, a strategy based on the four plastic variables makes molding simple RJG ©
20
WWW.MEDICALPLASTICSNEWS.COM
• NEW CONCEPTS • SINGLE LUMEN TUBING • MULTI-LUMEN TUBING
Years
• BUMP TUBING • RIBBON EXTRUSIONS
redefining the limits of extrusion technology...
1989–2019
• CO-EXTRUSIONS • MICRO-EXTRUSIONS • PROFILE EXTRUSIONS • COATED WIRE • TRI-EXTRUSIONS • MULTI-LAYERED EXTRUSIONS • FULLY ENCAPSULATED STRIPES
For 30 years, Microspec has specialized in advanced medical extrusion services world wide, extruding most thermoplastic elastomers, 1989–2019 including fluoropolymers, engineering resins, and custom compounds. The precision medical parts we extrude are among the smallest and most complex in the industry, with some of the tightest tolerances. Contact Microspec with your extrusion challenge – We’ll turn it into reality.
• OVER-EXTRUSIONS • BALLOON TUBING • INTERMITTENT/MULTIDUROMETER EXTRUSIONS
Microspec Corporation
327 Jaffrey Rd. • Peterborough, NH 03458 USA • +1 603-924-4300 www.microspecorporation.com info@microspecorporation.com
Where you need us, when you need us Sterigenics® is the global leader in sterilization solutions with more than 90 years of deep expertise and operations that span 45 facilities in 13 countries. We work with you from product conception to commercialization, helping to ensure the safety of your Medical Device Product and Process. Safeguarding Global Health® - with every product we sterilize. Visit us at Booth #3135
RADIATION STERILIZATION – WHAT IS THE IDEAL DOSE RANGE SPECIFICATION FOR MY PRODUCT?
sterigenics.com
Michael Flanagan | February 12, 1:30 PM | Tech Theater Booth #637 Sterigenics® is a registered trademark of Sterigenics U.S., LLC. All rights reserved. © January 2020, AC105.0129(1/20)
3D PRINTING
Bringing 3D printed medical models to life SCOTT DRIKAKIS, HEALTHCARE SEGMENT LEADER - AMERICAS, STRATASYS, EXPLORES HOW 3D PRINTING COULD ENABLE MEDICAL DEVICE MANUFACTURERS TO OVERCOME CURRENT LIMITATIONS, IMPROVE CLINICAL VALIDATION AND CHANGE THE GAME OF MEDICAL DEVICE TESTING.
T
he use of 3D printing in healthcare is not a new phenomenon. Those who keenly pay attention to technology developments within the sector will be unsurprised to hear of its use. In recent years, Stratasys has worked with customers across the world to improve patient care and communication, accelerate clinical validation and increase innovation. In Europe, hospitals such as CHU Bordeaux and Guy’s and St Thomas’ have utilized the very latest in advanced, multimaterial 3D printing to create patient-specific 3D medical models to help plan complex procedures. Equally, customers such as Nidek Technologies have been able to dramatically accelerate clinical trials when incorporating 3D printing into the device testing process.
Despite these incredible advances, 3D printing has had its limitations in terms of organ realism and biomechanical functionality and, to date, has not offered a testing method which covers all problem areas. This means that many medical device manufacturers are still also reliant on traditional testing methods. These predominantly involve the use of human cadavers, animals or virtual modeling. However, as with the current 3D printing solutions available, each of these methods comes with their own distinct limitations. These can range from ethical concerns to lengthy and costly development processes. As a result, medical institutions are continuing to push for technological advancements to overcome such issues. To help make this a realization, it is essential to create a solution that can directly target the specific drawbacks that each of the traditional methods of testing have, as well as overcome the current limitations of 3D printing itself. The recently launched J750 Digital Anatomy 3D printer claims to address all of these issues. Through using advanced new materials and software, this printer can replicate the actual feel, responsiveness and biomechanics of human anatomy. For all medical device testing, an accurate clinical scenario is a necessity. It is extremely difficult for any of the current methods of testing to create these. Human cadavers are sometimes difficult to obtain and are always highly processed. While medical device manufacturers might sometimes be able to target the correct pathology for testing, the cadaver lacks that ‘live tissue feel’. With animal testing, the correct pathology can only be approximated and their use can often raise ethical concerns. On the other hand, when customers turn to virtual modelling, any attempt at life-likeness is extremely difficult as touch and depth perception are instantly lost. With 3D printing, although patient-specific scenarios can be recreated, that ‘realworld’ life-likeness has not been possible to date. Launched in tandem with the new Digital Anatomy 3D printer, a selection of new materials can emulate real-life clinical scenarios better than ever before. Initially, this technology is best suited for cardiac, vascular and orthopedic applications. For example, with the new TissueMatrix material, these models can effectively simulate functions such as tear resistance, cutting resistance, suture pull force and valve regurgitation. With GelMatrix and Agilus materials, aimed at vascular procedures, it can accurately replicate burst pressure, guide wire insertion force, and aneurysm burst pressure. Finally, BoneMatrix can simulate native bone properties for tapping, reaming, spinal alignment and sawing applications. All of these materials are being clinically tested and validated by third parties, and more specific anatomies are expected to be added to this 3D printer’s repertoire every year. Medtronic recently published their validation testing on the Digital Anatomy printer, materials and software. Although advanced material capabilities are essential, crucially, this new solution includes a software in which specific anatomies, not materials, are chosen. On-demand, users can generate the microstructures required, all the way down to individual bone densities, or patient-specific irregularities.
22
WWW.MEDICALPLASTICSNEWS.COM
To reproduce such specificities in silicone modelling, or to look for an animal or human cadaver where the pathology is as close as possible to the patient specific requirements, often creates substantial delays in product development cycles. Medical device manufacturers can use Digital Anatomy models to improve design throughout the product life cycle by performing design verification and validation, competitive comparisons and failure analysis. With the Digital Anatomy 3D printer, turnaround times and product development cycles can be reduced by up to 70%. Of course, the testing of medical devices requires significant financial and logistical investment too. Human cadavers and animal studies require controlled environments, both of which are expensive to maintain. The Digital Anatomy 3D printer eliminates the need for a controlled environment. The testing of medical devices, and any further clinician training required post commercialization, can all happen in a no-risk environment. We expect the return on investment to be far shorter than people expect, often under 18 months. As part of the development and testing of this machine, we’ve worked closely with the Jacob’s Institute (JI), a New York medical innovation center focused on accelerating device development in vascular medicine and Medtronic, one of the world’s largest medical device companies. The JI has regularly turned to 3D printing to recreate patient-specific anatomies and test its devices, but one key issue that previously arose was the inability to replicate live-tissue feel and biomechanical realism. For surgeons such as Dr Addan Siddiqui, chief medical officer at the JI, the biomechanical realism and live-tissue feel of the new Digital Anatomy materials offer the tactile feedback that was not available before. The institute reports unprecedented levels of realism in the 3D models created, which is enabling them to study new devices in actual clinical situations in order to establish their effectiveness, long before they are introduced to patients. Every day, we are seeing medical institutions improve clinical care with 3D printing. Initially, we expect the Digital Anatomy 3D printer to help
our medical device customers advance clinical validation, improve design verification and improve product and field training practices. Academic medical centers and pediatric hospitals can now train future surgeons on complex and rare procedures on demand in whatever environment is readily available to them. We also expect users to continue to advance surgical procedures by utilizing this solution for surgical planning. For us, we are always committed to improving patient care across the world and we know that partnering with our customers is the best way to accomplish this.
Academic medical centers and pediatric hospitals can now train future surgeons on complex and rare procedures on demand in whatever environment is readily available to them.
WWW.MEDICALPLASTICSNEWS.COM
23
Helping engineers find the right medical adhesive EPOXIES SILICONES UV/LED CURING SYSTEMS
FAR Certified
NASA
UL Rated
Low Outgassing Approved
154 Hobart St., Hackensack, NJ 07601, USA ∙ +1.201.343.8983 ∙ main@masterbond.com www.masterbond.com
Need to Steer Your Design Fast? Try these innovative off-the-shelf solutions from the leader in Steerable Catheters and Custom Medical Extrusions!
We Solve Regulatory & Quality System Problems!
RISK MANAGEMENT
Visit our online store at www.dukeextrusion.com for the largest selection of medical tubing and catheter products available anywhere! Many materials and products ship in as little as 24 hours with sizes ranging from 2Fr to 32Fr.
REGULATORY STRATEGY
FDA INSPECTIONS ON-SITE TRAINING
Y
Investigational device for R&D use only. This device has not been cleared by the FDA.
DukeExtrusion.com | (831) 420-1104 | DukeEmpirical.com
BRINGING INNOVATION TO LIFE!
FDA compliance issues? Validation backlogs? 510(k) challenges? Audit pressures? SUPPLIER AUDITS
PROCESS VALIDATIONS
MDSAP GAP ANALYSIS AUDITS
510(K) APPLICATIONS
M&A DUE DILIGENCE SOFTWARE VALIDATIONS
FDA/ISO GAP ANALYSIS AUDITS
WARNING LETTER RESOLUTION
QUALITY SYSTEM COMPLIANCE
Tokyo ™
CAPA
Dallas
Paris
info@kenblockconsulting.com
TESTING & INSPECTION
A test of character ALTHOUGH CHEMICAL CHARACTERIZATION IS NOT A FOOL-PROOF TECHNIQUE, CHRISTOPHER POHL, ASSOCIATE TOXICOLOGIST, NELSON LABS EXPLAINS WHY THIS METHOD IS STILL CONSIDERED TO BE THE BEST AND STRONGEST WAY TO ASSESS PATIENT RISK.
E
veryone is very familiar with the phrase when buying a house: All that really matters are three things - location, location, and location. This same principle applies to extractables and leachables chemistry analysis – the three things that truly matter are identification, identification, and identification. The greatest growth in the past ten years in demonstrating the safety of medical devices and container closure systems for drugs has been using analytical chemistry to determine what chemicals can leach from the device and what the patient is exposed to during its intended use. The use of analytical chemistry can significantly improve the safety of medical devices by allowing for the assessment of long-term endpoints which are very difficult to assess using traditional animal models. That being said, analytical chemistry is only as good as the identification of the compounds that are detected. If, for instance, the compounds cannot be identified, the hazards posed by the chemicals cannot be known. Also, if compounds are misidentified, it could cost the company thousands of dollars in mitigating hazards that are not real, or even worse, luring the company into thinking that a device does not pose a hazard when in fact there is a significant risk introduced to the patient. These examples are not just theoretical; many of these have been experienced recently in the medical industry. For example, a medical device manufacturer was testing a new device. Their first step to determine if the device was safe was to perform an extractables and leachables study followed by a toxicological risk assessment. When the analytical chemistry was completed, there was a set of compounds tentatively identified as tetrachlorodibenzo-p-dioxin. P-dioxin is a carcinogen, a mutagen and a teratogen and is not acceptable to have in a medical device at any level. Detecting this compound was controversial, as it was not known how it got onto the finished device. To have a compound like p-dioxin being detected during verification could potentially scrap the entire project, and so additional identification work was deemed necessary to confirm the
identity of the chemical compound. The additional work, however, cost in excess of ten thousand dollars and it took two to three months for the actual identification to be confirmed. In the end, it turned out that the substance was not p-dioxin, but was identified as chlorobenzoic acid instead, which has a much higher tolerable exposure. On the flip side, as indicated above, there have been cases where a compound was identified as non-hazardous when, in actuality, it is hazardous. This is the most dangerous of situations, as this is the scenario where patients, clinicians, and caregivers can be exposed to toxic and even carcinogenic chemicals without even knowing about it. In some instances, this can occur when chemicals are lower than the detectable limit of the analytical test. Through being aware of possible hindrances, chemical characterization is still the best and strongest option to assess risks to patients and the people that we are trying to help during their time of need when conducted correctly. Chemistry plays a crucial role in helping to characterize and mitigate the biocompatibility, systemic toxicity and carcinogenicity risks that would be difficult to detect and identify otherwise.
Through being aware of possible hindrances, chemical characterization is still the best and strongest option to assess risks to patients and the people that we are trying to help during their time of need when conducted correctly. WWW.MEDICALPLASTICSNEWS.COM
25
TESTING & INSPECTION
Tackling hurdles DR RICHARD PADBURY, SENIOR TECHNOLOGY CONSULTANT AT LUCIDEON, DISCUSSES IMPORTANT CONSIDERATIONS AND CHALLENGES FOR MANUFACTURERS DEVELOPING BIOABSORBABLE STENTS (BAS). BAS – GOING NOWHERE? BAS hold a lot of promise as an alternative to Bare Metal Stents (BMS) and Drug Eluting Stents (DES), however, structural and mechanical concerns have meant that adoption of BAS has been slower than anticipated. Nevertheless, recent studies from patient trials, using Abbott’s Absorb BAS, have shown promising results in peripheral vascular applications, giving BAS technology a fresh perspective. WHY BIOABSORBABLE? In the coronary market, BAS were initially designed to reduce the long-term complications associated with BMS such as late-stage thrombosis. A further drawback of BMS is that the materials are typically incompatible with the vascular environment, which leads to an increased risk of inflammation and restenosis. This is overcome via the application of BAS because the degradation by-products are eliminated by the body during resorption, as the artery wall naturally heals. Although these drawbacks can be overcome by DES (which release anti-proliferation drugs from biopolymer coatings), the stent still remains.
There is a continuous need to improve long-term patient outcomes, which can be achieved with bioabsorbable materials due to their inherent capability to safely support tissues as they heal and repair, before leaving the body over a controlled length of time. Because of these properties, bioabsorbable materials have also been developed for applications beyond the cardiovascular world, including orthopedic devices such as pins and screws, ligament and tendon repair, surgical applications ranging from tissue reconstruction and augmentation patches to sutures and wound closure devices and emerging applications such as scaffolds for tissue engineering. Despite these exciting advances, bioabsorbable devices provide a platform to highlight the general challenges of optimizing polymer process-structureproperties and medical device design. All factors must come together to deliver a break-through performance.
TESTING & INSPECTION
WHAT’S THE CHALLENGE? Polymers are characteristically different from their metallic or ceramic counterparts because of their unique viscoelastic behavior. This leads to distinct mechanical properties that depend on time, temperature and thermal transitions which determine whether the polymer acts like a flexible, rubbery material or a brittle glass. PolyLactic Acid (PLA), a common bioabsorbable polymer used in many of the applications mentioned, has a glass transition temperature (Tg) of 60-65°C. This leads to brittle behavior at physiological temperature (37°C) which means PLA devices can easily be damaged during processing, handling or during surgical deployment. Polymers also have vastly different microstructures across different polymer chemistries, which range from purely amorphous to semi-crystalline. Discrete variations in polymer chain orientation and crystallinity can form from the surface of the device to its core. These fluctuations can be attributed to thermal and mechanical strains that occur during processing and even after surgical deployment. For bioabsorbable materials, this can lead to non-uniform degradation and a decrease in structural integrity which could promote larger deformations and medical device failure. WHAT CAN BE DONE TO OVERCOME THESE CHALLENGES? Despite their viscoelastic behavior and complex microstructures, polymers are attractive materials because of their tunability. They can be subtly modified by changing a few molecules or blending and copolymerizing with other monomers. For example, the same PLA can be copolymerized with PolyCaproLactone (PCL) to form a block copolymer with a much lower Tg compared to PLA alone. With a greater understanding of microstructure, it is also possible to modify processes to enhance molecular orientation, eliminate microstructural irregularities and enhance the overall properties of the polymer. Additives can also be blended into the polymer in different forms, e.g. fibers and particles, which can serve a range of multifunctional attributes, from providing additional mechanical strength, to radiopacity so that devices can be visualized during surgery. However, it is important to note that when we improve one aspect of a polymer it can be at the cost of another, either in terms of mechanical performance, degradation time or biocompatibility. I AM HAVING DIFFICULTIES DURING MANUFACTURING, WHAT SHOULD I DO? Here at Lucideon, we are frequently asked this question and, as materials science experts, we understand the complex processes researchers and engineers will need to go through to understand their challenges and overcome them. Lucideon works closely with partners to test and characterize a wide range of medical devices and materials and have seen first-hand the complexities of bioabsorbable technologies. Most medical devices go through numerous process steps during highthroughput manufacturing. Every manufacturing step has its own unique set of process conditions which increases the chance of picking up contamination, defects and changes in morphology and microstructure. When failures do occur, the root cause can be confounded by the multiple process steps, and corrective actions become more difficult to prescribe. Nevertheless, there are numerous thermal, mechanical and chemical methods validated for medical devices. But it is important to acknowledge that material structures and failure modes vary across different applications and that the resolution of the analytical instrument is an important consideration when characterizing failed devices. WHAT ARE SOME OF THE MOST IMPORTANT CONSIDERATIONS? In general, when a medical device fails during or sometime after manufacturing, the goal is to compare the failed material to a previously
known ‘good’ state or a highly controlled standard with no thermal or mechanical history. In order to extract the most reliable information it is important to consider sample size, sample preparation and handling, and choice of analytical method. With sample size, assessing whether you have sufficient availability of samples for analysis ensures the question posed stands the best chance of being answered. This includes appropriate sample sizes from various stages of manufacture, as well as failed components, as this is often crucial towards systematically ruling out various factors and failure modes. With sample preparation and handling, one of the most important risks is unintentionally contaminating the failed material, which can unwittingly impact its characteristics and risk an erroneous diagnosis. Finally, with choice of analytical method, the suitability of different characterization methods, whether they are chemical, mechanical, thermal or image based techniques, depends on the type and number of analytes being investigated and if they can measure at the appropriate length scales or concentration ranges. So bioabsorbable medical devices might not be ready to take the market by storm yet, but the hurdles to overcome are nothing new to polymer scientists. With successful trials from Absorb, a bioresorbable vascular scaffold and the numerous benefits to be gained from bioabsorbable medical devices, we are sure the discussion around them isn’t going away anytime soon.
So, bioabsorbable medical devices might not be ready to take the market by storm yet, but the hurdles to overcome are nothing new to polymer scientists.
WWW.MEDICALPLASTICSNEWS.COM
27
POLYMER PROCESSING SOLUTIONS FOR
MEDICAL TUBING.
TAILORED TO YOUR EXACT NEEDS.
VISIT US AT BOOTH 4024
What are your tubing system needs? Tighter tolerances? Higher line speeds? Complex parts? Material issues? Whatever it might be, Davis-Standard will work with you to engineer and supply the precise extrusion system for all of your medical needs. Incorporating the latest extrusion, controls, tooling and screw technology, our sophisticated lab lines can support your medical tubing applications and product development such as microbore catheter tubing, multilumen tubing, bump tubing, and much more. davis-standard.com tel
+1 860-599-1010
Innovative solutions. Engineered to your specific requirements. Realize your vision. Partner with the most innovative team in the industry. MicroLumen.com 28
2020 INDUSTRY FORECAST
JOE ROWAN, PRESIDENT AND CEO OF USA AND EUROPE FOR MATERIALS SPECIALIST JUNKOSHA EXPLAINS WHY MEDICAL DEVICE INNOVATIONS WILL PAVE THE WAY TOWARDS SMALLER, COST-EFFECTIVE, CATHETER SOLUTIONS IN 2020.
The future looks bright
I
n the world of neurovascular interventions and other complicated procedures, catheter manufacturers are being pushed for solutions that not only deliver complex treatments more efficiently but also provide cost savings at every turn. In what is becoming a highly cost-conscious marketplace, solutions including Peelable Heat Shrink Tubing (PHST) products that enable catheter manufacturers to advance efficiencies through streamlining their workflows and Multi-Filar active catheter solutions that provide increased signals into formerly inaccessible areas of the body, will go from being nice-to-have to becoming critical requirements in the future. PHST SAVES VITAL TIME AND MONEY The PHST market is an exciting area. As we head into 2020, newer innovations are adding to PHST’s wider capabilities, for example, Junkosha’s 2.5:1 PHST solution, which has been designed to equip catheter manufacturers with the highest shrink ratio currently possible in peelable fluorinated ethylene propylene. This solution enables catheter manufacturers to save time and money through a reduced number of shrink processes. Additionally, thanks to PHST’s 'take-up', it allows the use of cost-effective, lower tolerance, baseline materials in the manufacturing process, and enables the ability to reflow these easily into a single smooth construct. This results in a reduced total cost of ownership for the catheter manufacturer, which in turn increases the margin available.
Although these various challenges differ around the world, they all require one thing – innovations. These are needed to not only improve patient outcomes but to provide clinicians and other end users with technologies that make their lives easier, reduce costs and save them time. For this reason, continuous innovation must be at the heart of the healthcare sector’s requirements. Without this, the unmet needs will continue to be just that, unmet.
MULTI-FILAR SOLUTION PROVIDES BRIGHT FUTURE FOR ACTIVE CATHETERS Using precision engineered PTFE lamination technology, a new fine wire and cable solution within Junkosha’s Multi-Filar active catheter solution provides multiple signals through an ultra-small shaft, enabling a new generation of small, flexible and intelligent catheters to effectively push back the boundaries of current medical procedures. Single strand configurations are joined into a multi-filar assembly that can be utilized in electrophysiology catheters for applying pacing and recording protocols from inside the heart, ablation and balloon ablation catheters for atrial fibrillation as well as cardiac mapping. The Multi-Filar technique also allows for easier assembly of the signal or power wires into the final medical device, making the manufacturing process simpler and more cost-effective. WHAT NEXT FOR THIS BURGEONING MARKET? As we head into 2020, there are numerous challenges the medical tubing and catheter markets face every day in the US and European markets, including: • Stringent regulation across all levels of healthcare. • The need to not only make procedures less invasive for patients but also that can enable a wider variety of operations across harder to reach parts of the body. • The increasing cost of healthcare, especially in the US and Europe, which places a huge strain on those looking to innovate and provide the best possible outcomes across the sector. • The need to streamline workflows and processes, especially for catheter manufacturers, to enable vital cost savings and a reduction in total cost of ownership.
WWW.MEDICALPLASTICSNEWS.COM
29
EXTRUSION
The best approach GLEN GUILLEMETTE, PRESIDENT OF GUILL TOOL & ENGINEERING, EXPLAINS HOW MANUFACTURERS CAN OPTIMIZE THE EXTRUSION PROCESS.
CLEANLINESS IS CRITICAL Clean parts, especially with sealing and locating surfaces, are key to product performance and successful end products. These surfaces receive the most care and attention during manufacturing and are the control surfaces that ensure uniformity throughout the tubing. Remember, precision-machined alignments are affected by even a speck of dirt measuring only a few thousandths of an inch. A human hair is about 0.003” (0.08 mm), and since there are many such surfaces in a quality tool, cleanliness is critical. It is also critical to check the tools for any deformities. Burrs, scratches and scrapes are usually a result of careless handling and/or storage of equipment.
TOOLING MAINTENANCE In order to optimize extrusion efficiency, quality and overall productivity for medical tubing applications, tooling maintenance is necessary. The use of a dedicated work cart exclusively reserved and equipped for extruder head maintenance is also recommended. This cart, along with a supply of spare components and hardware is easily justified, especially when examining the potential cost savings that result from well-maintained tools. It is really important to realize that any misalignment of the tools may be exaggerated in the final product output. Therefore, machining tolerances are held extremely close on today’s multi-lumen and multi-layer medical tubing by utilizing relevant production equipment and processes.
Guill Tool & Engineering ©
KEY FACTORS TO CONSIDER DURING THE PROCESS 1. Maintain a clean, organized work area with soft and clean renewable work surfaces 2. Use a vise with soft jaws e.g. copper 3. Use special equipment e.g. tip removal tools 4. Standard tools include wrenches and soft-faced hammers 5. Maintain a supply of soft and clean rags 6. Use cleaning solutions in a spray bottle 7. Use spare parts as suggested by your tooling supplier, which are properly organized and stored 8. Keep your equipment’s repair/maintenance manual handy 9. Have a small surface plate in order to provide a true flat surface 10. Use a set of appropriate gauge and tip pins for initial tool location adjustment 11. Make sure you have all the proper lifting aids available, including overhead hoists and hydraulic lifts. In most situations, the head and tooling will still be at elevated temperatures, therefore lined gloves are needed during handling.
EXTRUSION
CASE STUDY In this example, with an improperly centered tool, a calculated out-oftolerance area of 0.059 in2 (38 mm2) was derived. When the two surface areas were compared, the calculated material waste was 11.8% of the finished product. The formula is % wall = min. wall thickness, max. wall thickness X 100. Alternatively, if the % wall can be increased from 80% to 95%, savings of about 12% of total cost can result. Savings will vary depending on the designs. USEFUL TIPS FOR THE PROCEDURE • Clean your equipment while it is still hot as the residue is easier to remove. It helps to remove and clean one piece of tooling at a time in order to maintain elevated temperatures. • When cleaning a dual compound crosshead (plastic and rubber), clean the plastic tooling first and the rubber second. • Never use steel tools such as scrapers or screwdrivers because these can scratch and mar the tooling. • Do not use open flames because this generates excessive heat especially in thin sections. This can affect hardness, concentricity and tolerances of components. • Recommended cleaning tools and materials include: • Brass pliers to grip material and aid in pulling. • Brass scrapers that are available in different widths for cleaning flat exposed surfaces. • Brass bristle tube brushes that are available in diameters from 1/16” to 1” in 1 /16” increments (ideal for cleaning holes and recesses). • Brass rods - Different diameter rods are good for pushing material out of flow holes. • Copper gauze for cleaning and polishing exposed round or conical surfaces. • Copper knives for removing residue from recesses and other hard-to-reach areas. Also, polishing compound restores polished surfaces. • Compressed air which is more effective for releasing plastic but also aids in rubber removal. Be careful not to force debris into recesses with compressed air. • Cleaning solutions may be useful, so remember to use fresh, clean rags (used rags often have metal chips embedded in them, which may scratch polished surfaces). • Cleaning oven should be used only for plastic. It is vital to follow manufacturer’s recommendations. If no temperatures are specified do not exceed 850 degrees F (454 degrees C). Also, do not quench tooling to cool, as this could affect tooling hardness, concentricity and tolerances. • Purging compounds - several are offered to purge the extruder screw/barrel of residual polymer and rubber compounds.
HOW TO MAKE TOOL CLEANING EASIER The quickest way to remove the die is to employ the pressure of the extruder to push it out. Clean the body by using an air compressor and brass pliers so that the material cools down which increases the melt strength, making it into one-lump versus an elastic, gummy-like substance that is harder to remove. Clean the body feed port using compressed air and brass pliers to simultaneously cool and remove the excess residue from the feed ports. This procedure is followed by brushing with a round brass brush that polishes the surface. The flow area of the 2” (51 mm) flange adapter should be cleaned by carefully using a brass brush. Most manufacturers recommend using a hand polishing stone to remove the offending burr. Follow stoning with a light application of 600-grit emery cloth if necessary but avoid rounding edges that are intended to be sharp. Flat sealing surfaces can also be cleaned using a stone, followed by a 600-grit emery cloth. Place the cloth on a clean, flat surface, preferably a surface plate, then apply friction in a circular hand motion until the area is clean and even. The parts in question should all be hardened steel alloys and will not be adversely affected using these methods. Inconel, Monel and Hastalloy are typically not heattreated, requiring special care and handling to avoid any damage. REASSEMBLY: THE FINAL STEP OF THE PROCESS Working from your dedicated tool cart, follow the manufacturer’s instructions for reassembly.
WWW.MEDICALPLASTICSNEWS.COM
31
JOIN
NORTH AMERICA’S LARGEST ANNUAL MEDTECH EVENT 20,000+ Industry Professionals 1,900+ Leading Suppliers
FEBRUARY 11-13, 2020 // ANAHEIM, CA A N A HE I M C O N V E N T I O N C ENTER
4726_MDM_W20
REGISTER NOW at MDMWest.com/INVITE Use promo code INVITE for free expo registration and $100 off conference pricing
TUBING, CATHETERS & EVENTS STENTS
What’s on at MD&M West? ARE YOU THINKING ABOUT JOINING 20,000 ENGINEERS AND EXECUTIVES AT THE EVENT THIS FEBRUARY? IT’S NOT TOO LATE TO REGISTER FOR THIS WELL-KNOWN EVENT. WHAT IS MD&M WEST? MD&M West claims to be the largest medical design and manufacturing event in the world. This year’s show will be the 35th annual event. WHEN IS THE EVENT? MD&M West is taking place in the Anaheim Convention Center, Anaheim, California between 11th and 13th February 2020.
Manufacturing Pacific and Plastec West. Industry experts and well-known organizations will be exhibiting at the event. These include but are not limited to 3D systems, Accumold, Americhem, Avery Dennison Medical, Canon, Caplugs, Covestro, DuPont Medical Packaging, Fluortek, Injectech, Junkosha, MicroLumen, MTD Micro Molding, Nelipak, Nelson Laboratories, Protolabs, Qosina, Raumedic, Shottli, Shawpak and ZwickRoell. SOCIAL MEDIA Keep up to date with the event on social media by following #BIOMEDevice aswell as: @MDM_Events www.facebook.com/mdmtradeshows/ https://www.linkedin.com/company/3993086
WHY SHOULD I ATTEND? The show will provide attendees with a three-day conference covering topics such as medtech, 3D printing and smart manufacturing. There will also be the opportunity to talk to suppliers and industry experts on their booths. The conference program consists of new formats for 2020 including Lightning Workshops and Tech Talk panels, as well as the opportunity to network with industry experts. This year there will be three conference tracks: 1. Medical Design & Manufacturing West Conference • This track will explore emerging technologies of the digital health boom, look at advancements in medical plastics for medtech as well as the impact of recent changes to the quality standard. 2. 3D Printing Innovation Summit • Material trends will be discussed, as well as how to choose the right tools and materials to support your design strategy. 3. Smart Manufacturing Innovation Summit • Topics such as artificial intelligence, Internet of Things and the smartMedical factory will be discussed within this track. Alongside MD&M West, there is also four additional trade shows. These shows are West Pack, Automation Technology West, Design &
TRACK: MD&M Conference: Advancements in medical plastics for medtech TITLE: Panel of industry experts: Sustainability, environmental responsibility and the medical device community TOPIC: Are single use medical devices the answer? This session aims to answer this question and discuss how the industry can alleviate pressures on the environment. SPEAKERS: Len Czuba (Czuba Enterprises), Frank Pokrop (Sotero Wireless), Vipul Davé (Johnson & Johnson), Rob Chase (NewGen Surgical) and Nick Packet (DuPont) DATE: Tuesday 11th February TIME: 13:15-15:00 LOCATION: 210C TRACK: MD&M Conference: Advancements in medical plastics for medtech TITLE: Material innovations for medical devices and pharmaceutical applications TOPIC: The presentation will provide an overview of the selection criteria for materials for medical devices. SPEAKER: Vipul Davé (Johnson & Johnson) DATE: Tuesday 11th February TIME: 10:45-11:45 LOCATION: 210C TRACK: Keeping up and staying compliant with global and FDA regulations TITLE: The impact of IVDR requirements on manufacturers and strategies TOPIC: How to cope with challenges as a result of the IVDR requirements will be covered ahead of the compliance date in May 2022. SPEAKER: Jon Goveia (Abbott) DATE: Tuesday 11th February TIME: 15:15-16:00 BOOTH NUMBER: 210D
WWW.MEDICALPLASTICSNEWS.COM
33
JOIN
NORTH AMERICA’S LARGEST ANNUAL MEDTECH EVENT 20,000+ Industry Professionals 1,900+ Leading Suppliers
FEBRUARY 11-13, 2020 // ANAHEIM, CA ANAHEIM CONVENTION CENTER
4726_MDM_W20
REGISTER NOW at MDMWest.com/INVITE 372211_MDM_MN18
Use promo code INVITE for free expo registration and $100 off conference pricing
EVENTS
What’s on at BIOMEDevice Boston 2020? A CHANCE TO SEE HOW MEDICAL DEVICES REACH THE FINAL STAGE OF DEVELOPMENT.
F
or one ticket, alongside BIOMEDevice Boston, there is also another expo – Design & Manufacturing New England which attendees can access. BIOMEDevice Boston will focus on medtech research, development and products as well as experience to help attendees remain up to date with the industry. The Design & Manufacturing New England event will include the latest design software, rapid prototyping, 3D printing and sensors.
technologies and answer any questions from the audience. The engineering theater will provide attendees with the chance to gain a deeper perspective on sensors, robotics, aerospace and defense. During the expo, attendees can also network with 3,300 industry peers and over 375 suppliers. SOCIAL MEDIA Keep up to date with the event on social media by following #BIOMEDevice aswell as: @MDM_Events www.facebook.com/mdmtradeshows/ https://www.linkedin.com/company/3993086 Please refer to the event website for more information.
Visitors can also attend the BIOMEDevice conference with their expo tickets which runs parallel to the event. The conference consists of two tracks running alongside the center stage: 1. PRODUCT DEVELOPMENT • In this track topics such as the miniaturization of medical devices, user-centered design, EU MDR, IVDR and cybersecurity will be covered. 2. RESEARCH AND DEVELOPMENT • This track will include how to optimize research funding, the use of robotics within medtech, solving research and development challenges and what to do when you have an idea for a medical device. 3. CENTER STAGE • This stage will feature a keynote speaker on each day as well as a mixture of panel discussions, live demonstrations and talks. On the expo floor there will be plenty going on to keep visitors entertained. The center stage will see experts within the industry providing insights on major topics and developments within the sector. There will also be a tech theater and an engineering theater. In the tech theater exhibitors will present live demonstrations of their
IN BRIEF DATE: 6th to 7th May 2020 SHOW TIME: 10:00-16:00 CONFERENCE TIME: 08:30-16:00 LOCATION: Boston Convention & Exhibition Center, Boston, MA PARKING: Available on site TRANSPORT: The event is an eight minute taxi ride from Logan International Airport and a 15 minute walk from South Station – one of Boston’s major transportation hubs.
There will be a booth bar crawl taking place on Wednesday 15th February. All participating companies who are welcoming attendees for beer, wine and networking are listed on the event website.
WWW.MEDICALPLASTICSNEWS.COM
35
Five things to look out for at MD&M West 2020 1
MD&M INNOVATION LAB: The lab,
which is new to the show this year, will explore endproduct technology from start-ups, universities and exhibitors.
2
DESIGN DOME:
Here, attendees will be able to partake in prototyping workshops led by industry leaders.
3
3D PRINTING NETWORKING BREAKFAST:
On Thursday morning there is the opportunity to enjoy breakfast whilst learning more about 3D printing.
MEDICAL DEVICE OFFERS PROMISE FOR NICU AND BEYOND
C
urrently, depending on the number of newborn babies and how often they feed, a nurse can spend hours each day holding a syringe above an incubator whilst milk or liquid formula drains into the baby via a stomach tube. Therefore, the news of a gravity feed syringe holder which is able to simplify the feeding of newborn babies is likely to be welcomed. The device has been announced by non-profit, community-based health system, MedStar Health, and is suitable for newborn babies who are
36
4
spending their early days in special, temperature-controlled incubators whilst being cared for in the Neonatal Intensive Care Unit (NICU). The device can hold four different sizes of syringes and was designed to be suspended from the top of the incubator or attached to an intravenous pole - thus expanding its use outside the NICU. The innovation was submitted by registered nurse, Tiffany Morris to MedStar Institute for Innovation. The organization, realizing the device’s potential, then selected the product for further development. The device is currently being piloted at MedStar Franklin Square and is the subject of a patent application. It was recently awarded the Cool Ideas Award which is sponsored by Cleveland Clinic Innovations and Protolabs.
SPEED NETWORKING:
A previously popular show feature will return to allow visitors to discuss engineering topics with new connections.
5
CAREER ZONE: The
perfect opportunity to network with companies who are currently hiring. A list of all participating companies is on the event website.
Partnership formed to recycle medical device
T
wo organizations have joined forces to ensure a migraine device can be recycled. Bio-medical technology company, Theranica Bioelectronics has partnered with California Electronic Asset Recovery (CEAR) in order to recycle its smartphonecontrolled prescribed wearable, Nerivio which is used for the acute treatment of migraine. Nerivio is the first smartphonecontrolled migraine wearable to receive De Novo authorization from the Food and Drug Administration (FDA). The device is a non-invasive prescribed wearable which is made up of a lithium metal battery, circuit board and plastics - highly recyclable components. Each device can be used for up to 12 migraine treatments before a replacement is required. A connected smartphone
WWW.MEDICALPLASTICSNEWS.COM
application is able to keep track of therapies and alert the user as they approach the final dose. After the final dose, users can send the used Nerivio unit to the CEAR facility. Here, the battery will be removed and automated technologies within the facility will be used to separate the remaining components for reuse. The drug-free, non-invasive and digitally connected prescribed wearable is already available in more than 100 participating headache clinics across the United States.
Visit us at Booth #367