MEDICAL PLASTICS news
+
3D printing Sterilisation Mergers & Aquisitions Cleanrooms
Scaling up PHILLIPS-MEDISIZE REVEALS THE SECRET OF ITS ASSEMBLY PROCESS ISSUE 25
July-August 2015
WWW.MEDICALPLASTICSNEWS.COM
“The best thing about the future is that it comes one day at a time.” Abraham Lincoln
“We only need one day.” Proto Labs
Get injection moulded parts in as fast as 24 hours. Time is of the essence when turning your product ideas into reality. At Proto Labs, we’ve built our reputation on providing designers and engineers with lightning-quick machined and moulded components for prototyping. Our new rapid liquid silicone rubber (LSR) moulding service can turn 3D CAD designs into functional components by the very next day … helping your business compete by lowering costs and speeding up your route to market. Call us on +44 (0)1952 683 047 or visit www.protolabs.co.uk to find out more.
To view our FREE whitepaper: Visit go.protolabs.co.uk/MPN815
CONTENTS July-August 2015, Issue 25
Regulars
Features
5 Comment Hacked off… The latest events in device cyber security
16 One direction Is a polymer pill the next big thing?
32 Business study The Douglas Group advises on M&As
18 Model answer Escatec, Stratasys and Zmorph highlight 3D printing expertise
35 Heart of the matter How Dassault Systemes living heart is helping device testing
23 Got it covered Whitford Corporation outlines the company’s ISO13485 work
36 Hey good looking Sterilisation: Sabic and Styrolution in focus
7 News analysis How an injectable polymer stops bleeding 8 Digital spy What’s going on in your industry 10 News profile 12 Speech therapy Nathan Doyle, Compounding Solutions exercises his vocal chords 14 Cover story Phillips-Medisize on its assembly and scalability process
25 Cleaning up Biocote outlines the importance of antimicrobials 28 Fighting talk Lu Rahman looks at recent criticisms levied at the catheter sector
46 Beady Eye MPN takes a look at Biocorp
WWW.MEDICALPLASTICSNEWS.COM
3
G ET
Y O U R
EXTRUSION PROJECT
DONE ([WHQVLYH YHUWLFDOO\ LQWHJUDWHG FDSDELOLWLHV 'HHS H[SHUWLVH LQ 37)( 3((. )(3 DQG RWKHU KLJK SHUIRUPDQFH PDWHULDOV KHDW VKULQN WXELQJ DQG PXOWL OXPHQ H[WUXVLRQ 'HFDGHV RI H[SHULHQFH :H DUH WKH H[SHUWV ZKHQ LW FRPHV WR DOO WKLQJV H[WUXVLRQ 2XU WHDP KDV ZKDW LW WDNHV WR LQVSLUH LQQRYDWLRQ IROORZ WKURXJK RQ HYHU\ GHWDLO DQG XOWLPDWHO\ JHW \RXU SURGXFW LQWR WKH PDUNHW
Work with the Experts™ /LPHULFN ,UHODQG | 3KRQH (PDLO RHPLQIR#WHOHÁ H[ FRP :HE ZZZ WHOHÁ H[PHGLFDORHP FRP 6RFLDO PHGLD )DFHERRN /LQNHG,Q DQG *RRJOH
/HW·V JHW WR ZRUN RQ \RXU SURMHFW 7HOHÁ H[ ,QFRUSRUDWHG $OO ULJKWV UHVHUYHG ´:RUN ZLWK WKH ([SHUWVµ LV D WUDGHPDUN RI 7HOHÁ H[ ,QFRUSRUDWHG
extrusions
catheters
components
medical devices
CREDITS group editor | lu rahman deputy group editor| dave gray
EDITOR’S
comment
editorial assisstant | emily hughes advertising | mandy o’brien art | sam hamlyn publisher | duncan wood
Medical Plastics News is available on free subscription to readers qualifying under the publisher’s terms of control. Those outside the criteria may subscribe at the following annual rates: UK: £80 Europe and rest of the world: £115 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 © 2015 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.
BPA Worldwide Membership
ISSN No: 2047 - 4741 (Print) 2047 - 475X (Digital)
Hacked off
With the news that the FDA has called for healthcare facilities to stop using Hospira’s Symbiq Infusion systems because of its ability to be hacked, it seems cyber security has become a key issue for medical device manufacturers.
Many device businesses are aware of the risk of cyber attacks pose on their products and have been working to counter vulnerabilities. However, with the news that the FDA is advising against the use of certain products, the story is taking a whole new turn. As we see an increase in medical devices such as IV pumps, insulin pumps and pacemakers being connected wirelessly to improve remote monitoring for doctors, this also means a potential increase in hackers. The FDA cited research from independent cyber security expert Billy Rios who concluded that patients could be at risk of remote attacks by someone accessing the hospital network. He highlighted the ease with which hackers could log in to a device without a username or password, allowing them to operate the device and change its settings. A high profile example of this in the US was former vice president Dick Cheney who found his pacemaker function had been disabled. A recent article in US publication, The Star Phoenix, quoted David Kleidermacher, chief security officer
at Blackberry. He said that currently it’s not illegal for device manufacturers to claim that the security of their product is as good as it can be, when this might not be the case. He is quoted as saying: “Can you imagine if it was legal for them to say that about safety? You can’t do that . . . But in the security world, they could say that and it would be absolutely legal. “That infusion pump manufacturer can make that claim. This is a problem.” While of course, this is a problem, it is one that needs to be addressed, not just highlighted. The rise in the digital health market has been well documented. In the UK, the NHS faces incredible strain as we see an increase in obesity-related illness such as diabetes, for example. The use of remote monitoring or drug administering devices eases burden for both the patient and the healthcare professional. Technological advancement is always welcome and we should be wary of pointing the finger at device manufacturers without entering into meaningful dialogue on the path the industry needs to take.
“
As we see an increase in medical devices such as IV pumps, insulin pumps and pacemakers being connected wirelessly to improve remote monitoring for doctors, this also means a potential increase in hackers.
Blackberry is apparently part of a group that is apparently looking in to security standards for medical devices and how to protect against cyber attack. It will be interesting to see the results of this and how medical device manufacturers can tap into their findings.
WWW.MEDICALPLASTICSNEWS.COM
5
Peel it off. Peel it ALL off. Introducing FluoroPEELZ™ Peelable Heat Shrink
One simple linear tear is all it takes. Groundbreaking FluoroPEELZ™ peelable heat shrink from Zeus offers medical device manufacturers a revolutionary way to increase yield and improve safety.
Request a sample today at www.ZeusFluoropeelz.co.uk
US +1 (803) 268-9500 | Europe +353 (0)74 9109700 Asia +86 13922204986 | Latin America +1 (803) 268-9500
www.zeusinc.com
NEWS ANALYSIS
A 3-D rendering of fibrin forming a blood clot, with PolySTAT (in blue) binding strands together William Walker/University of Washington
Injectable polymer stops trauma patients bleeding to death
M
ost military battlefield casualties die before ever reaching a surgical hospital. Of those soldiers who might potentially survive, most die from uncontrolled bleeding.
An injectable polymer from the University of Washington could prevent soldiers and trauma patients from bleeding to death
In some cases, there’s not much medics can do — a tourniquet won’t stop bleeding from a chest wound and clotting treatments that require refrigerated or frozen blood products aren’t always available in the field.
That’s why University of Washington researchers have developed a new injectable polymer that strengthens blood clots, called PolySTAT. Administered in a simple shot, the polymer finds any unseen or internal injuries and starts working immediately. The new polymer, described in a paper featured in Science Translational Medicine, could become a first line of defence in everything from battlefield injuries to rural car accidents to search and rescue missions deep in the mountains. It has been tested in rats and researchers say it could reach human trials in five years. In the initial study with rats, 100% of animals injected with PolySTAT survived a typically-lethal injury to the femoral artery. Only 20% of rats treated with a natural protein that helps blood clot survived. “Most of the patients who die from bleeding die quickly,” said co-author Dr Nathan White, an assistant professor of emergency medicine who teamed with University of Washington (UW) bioengineers and chemical engineers to develop the macromolecule. “This is something you could potentially put in a syringe inside a backpack and give right away to reduce blood loss and keep people alive long enough to make it to medical care,” he said. The UW team was inspired by factor XIII, a natural protein found in the body that helps strengthen blood clots.
and weaving a net,” said co-author Suzie Pun, the UW’s Robert J Rushmer Professor of Bioengineering. “The crosslinked net is much stronger.” But the synthetic PolySTAT offers greater protection against natural enzymes that dissolve blood clots. Those help during the healing process, but they work against doctors trying to keep patients from bleeding to death. The enzymes, which cut fibrin strands, don’t target the synthetic PolySTAT bonds that are now integrated into the clot. That helps keep the blood clots intact in the critical hours after an injury. “We were really testing how robust the clots were that formed,” said lead author Leslie Chan, a UW doctoral student in bioengineering. “The animals injected with PolySTAT bled much less, and 100% of them lived.” The synthetic polymer offers other advantages over conventional haemorrhaging treatments, said White, who also treats trauma patients at Harborview Medical Center. Blood products are expensive, need careful storage, and they can grow bacteria or carry infectious diseases, he said. Plus, the hundreds of proteins introduced into a patient’s body during a transfusion can have unintended consequences. After a traumatic injury, the body also begins to lose a protein that’s critical to forming fibrin. Once those levels drop below a certain threshold, existing treatments stop working and patients are more likely to die. In the study, researchers found PolySTAT worked to strengthen clots even in cases where those fibrin building blocks were critically low. The UW team also used a highly specific peptide that only binds to fibrin at the wound site. It does not bind to a precursor of fibrin that circulates throughout the body. That means PolySTAT shouldn’t form dangerous clots that can lead to a stroke or embolism.
Normally after an injury, platelets in the blood begin to congregate at the wound and form an initial barrier. Then a network of specialised fibres — called fibrin — start weaving themselves throughout the clot to reinforce it. If that scaffolding can’t withstand the pressure of blood pushing against it, the clot breaks apart and the patient keeps bleeding.
Though the polymer’s initial safety profile looks promising, researchers said, next steps include testing on larger animals and additional screening to find out if it binds to any other unintended substances. They also plan to investigate its potential for treating haemophilia and for integration into bandages.
Both PolySTAT and factor XIII strengthen clots by binding fibrin strands together and adding ‘cross-links’ that reinforce the latticework of that natural bandage. “It’s like the difference between twisting two ropes together
Other co-authors are Xu Wangc in UW emergency medicine, Hua Wei in UW bioengineering and Lilo Pozzo in UW chemical engineering.
WWW.MEDICALPLASTICSNEWS.COM
“
This is something you could potentially put in a syringe inside a backpack and give right away to reduce blood loss and keep people alive long enough to make it to medical care.
7
DIGITAL
DIGITAL BITESIZE
spy APPY TALKING
THIS ISSUE EDWARD CLIFFORD AT D3D INNOVATIONS PICKS OUT SOME OF HIS FAVOURITE APPS FOR BOTH WORK AND LEISURE Splashtop Streamer I use this remote desktop software to monitor my 3D prints remotely. It is very simple to setup and allows me to kill the print or hit the emergency stop if something goes wrong. I use it in combination with a webcam viewer to also get a live feed from my printer. All for free. Augment – 3D Augmented Reality Seeing and manipulating your 3D models in an augmented real world is fun but also a useful tool. You can place your model to get a real idea of what the outcome will look like. Measure & Sketch Ideal for anyone that needs to access their desktop on the move, Splashtop means you can get to your laptop via any mobile device. WhatsApp Instant messaging, video, photo, voice – all for free. This is especially useful when mobile phone signal is low or nonexistent. Sending photos to people on your contact list has never been easier and did I mention it was totally free. I use this app a lot since mobile phone coverage is not great in my factory but we do have strong wifi coverage. FTDI UART Terminal This great little app from FTDI allows you to connect your own hardware into your smart phone for direct terminal access. I find it useful for debugging software, setting up systems and controlling hardware. I would say this is a must have for many engineers and developers.
DIGITAL UPDATE
The human league What is human factors engineering? Human factors engineering is the latest way to describe ergonomics (old school speak). Basically it’s all about the relationship we have with a product. How does its physical form relate to the way we use it and is the design able to work in the way it’s intended?
One of the latest buzz phrases in the medical device space is human factors engineering. What is it? And what do you need to know? MPN offers a bitesize summary of this current hot topic …
Who needs to know about it? Who doesn’t need to know about it? Almost all medical
www.reportlinker.com
STYRENIC POLYMER TRENDS AND FORECAST
T
he Styrenic Polymers Market for Medical Applications - Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2014 – 2020 is now available The report analyses and forecasts the styrenic polymers market for medical applications on a global and regional level. The study provides historical data from 2013 along with forecast for the period from 2014 to 2020 based on volume and revenue.
8
The study provides a decisive view of the styrenic polymers market for medical applications by segmenting it by product type and regional demand. Product segments have been analysed based on current and future trends and the market has been estimated for a period from 2014 to 2020 in terms of volume and revenue. Regional segmentation includes the current and forecast demand for North America, Europe, Asia Pacific and Rest of the World. The segmentation also includes demand for individual product segments in all the regions. WWW.MEDICALPLASTICSNEWS.COM
device sectors should be aware of human factor engineering and what it means. Whether it’s diabetes, opthalmology, oncology, gynaecology or cardio-vascular surgical intervention, these sectors can benefit from human-centred priniciples. Why is it important for the medical device sector? Human factors engineering is a hot topic in the medical device sector. Companies such as Phillips-Medisize have invested considerable thought and time into this area of product development. Improvement and innovation is key with medical devices. Human factors engineering considers its interaction with the individual and the environment. In use how will it be unwrapped, handled, where will it be placed when not in use? Is scale-up important? How will this be achieved?
DIGITAL SPY
talking
DIGITAL NEWS
POINT Record year for UK life sciences UK life sciences is celebrating a record year for inward investment
According to the UKTI’s Life Sciences Organisation (LSO), the life sector is critical to the UK economy. It currently contributes £56 billion with 183,000 people working in the industry. The sector is underpinned by a long term industrial strategy and last year benefitted by a life science minister for the first time. The LSO works to bring high quality inward investment into the UK – from the earliest R&D collaborations through to clinical trials, commercial and manufacturing operations
and partnerships. It offers inward investors a bespoke service, tailoring support to the requirements of the client, whether they are making their first business inquiry and need to understand the UK landscape, or looking to connect with professional services, R&D opportunities, and supply chain partners. The LSO focuses on bringing value added investment to the UK, and recorded an increase of more than double the number of new jobs and financial investment compared with last year’s results.
Take two eggs...
Y
new recipe for antibacterial plastics
According to a study by the University of Georgia, bioplastics made from protein such a albumen and whey exhibit significant antibacterial properties. This could lead to their use in plastics used in medical applications such as wound healing dressings, sutures, catheter tubes and drug delivery.
For users of insulin pens, a device that means no more than one prick every three days is a welcome addition to the market What is it? According to Medirio its integrated insulin delivery is ‘revolutionary’. This product aims to allow every insulin pen user to manage insulin injections in an easier, discreet and more comfortable way.
DIGITAL BREAKTHROUGH
ou could be forgiven for thinking you’ve opened up a copy of Waitrose Food magazine ...
Point of interest
properties when blended with a traditional plasticiser such as glycerol. “It was found that it had complete inhibition, as in no bacteria would grow on the plastic once applied,” said Alex Jones, a doctoral student in the department of textiles, merchandising and interiors.“The bacteria wouldn’t be able to live on it.” The study appears in the online version of the Journal of Applied Polymer Science.
Why is it so significant? Medirio’s insulin device has been designed to be small, lightweight and discreet. Comfort has been built into the product so that the user needs no more than one prick every three days. The device should prove cost-effective and Medirio ensures users it is unable to be hacked. How it works The system comprises two devices, a hand-held controller and a disposable patch device. By contactlessly transferring the energy from the handheld unit to the patch device, Medirio says it has managed to develop a drug delivery system that is small and lightweight and yet apparently does much more compared with other insulin pens and syringes with no additional costs. While the disposable patch device rests on your body and under your clothes for about three days, the hand-held controller allows you to select the required insulin doses and deliver the medicament by simply placing it onto the patch device.
Researchers tested three non-traditional bioplastic materials—albumen, whey and soy proteins—as alternatives to conventional petroleum-based plastics that pose risks of contamination.
What the company says about it Medirio says this is a “medical device which significantly improves both efficiency and therapy control, together with a fresh new user experience which eases and simplifies the medication related action plan”.
In particular, albumen, a protein found in egg whites, demonstrated tremendous antibacterial
WWW.MEDICALPLASTICSNEWS.COM
9
NEWS PROFILE
Protecting hospital medical equipment FROM ATTACKS? by Adam Winn, Senior Manager, OPSWAT
T
he challenges in protecting hospitals from cyber attacks are similar to those faced in industrial control systems (ICS) and supervisory control and data acquisition (SCADA ) environments; the equipment used in hospitals is not user-serviceable and therefore often running out-of-date software or firmware. This creates a dangerous situation where the devices have vulnerabilities that can be exploited. Also, administrators are not likely to notice malware running on the device as long as nominal operation is maintained. The end goal of those infecting a medical device is to use it as an entry and pivot point in the network. Valuable patient records are not likely to be present on the medical devices but those devices often have some level of network connection to the systems that do contain patient records.
A recently profiled attack on hospitals was thought to be due to a technician visiting a compromised website on a PC with direct access to a picture archive and communication (PACS) system. The report details that the malware was detected but not before infecting the PACS system. Due to the nature of the system it could not be scanned for malware, let alone cleaned. It was then used as a pivot point to find a system with medical records that could be exfiltrated back to the attacker.
Deploy ransomware like Cryptolocker, effectively
Medical facilities share vulnerabilities with SCADA and ICS, so why shouldn’t they also share protection mechanisms? Critical infrastructure providers, especially power plants, often make use of air-gapped networks as a very effective defence mechanism. Using the above example, the PC with a web browser and internet access should not have also had access to PACS. This simple step would have stopped the infection from doing damage. If, for example, the technician needed to download something from the internet and transfer it to PACS then it would have to be transferred onto the air-gapped network.
Trigger system malfunctions
Sanitisation and cyber infections
What exactly is someone likely to do after getting a foothold on the network? Find patient records that can be used for
identify theft or blackmail
Steal research data for financial gain
crippling the facility unless a bribe is paid
Carry out a ‘hit’ on a specific patient
Real-world examples Billy Rios, a security researcher, recently went public with a vulnerability that affects drug pumps and could potentially be exploited to administer a fatal dose of medication to a patient. Rios notified the FDA about the vulnerability and saw no response so he went public to put pressure on the manufacturer to fix the issue. Faced with the reality that some medical equipment manufacturers do not invest in securing their devices from exploitation, the onus of security falls on the users of such equipment. This discovery shows a real-world example of how a cyber attack could affect a medical device and potentially endanger lives. This type of threat needs to be taken seriously. The real question is how can hospitals effectively protect devices such as these? It’s clear that installing antivirus software on medical equipment is impractical. Furthermore, healthcare IT is relatively helpless to patch the software and firmware running on these devices. So considering those vulnerabilities and the difficulty in remotely scanning these
10
devices, the best solution is to prevent malware from ever getting to these devices. Thankfully this challenge has already been solved in ICS and SCADA environments.
Hospitals and their staff are accustomed to preventing the spread of biological infections and they must now apply similar levels of prevention to preventing the spread of cyber infections. Defending against cyber infections, by comparison, is much easier. The medical industry isn’t alone in fighting this threat – they don’t have to invent new techniques for preventing infection, they simply need to adapt the proven strategies employed by other industries. Simply employing a network safety feature known as an air gap doesn’t guarantee security. The point of the air gap is to create a point through which data movement is carefully controlled. Additional measures must be employed to ensure that pathogens are not allowed access. In medicine these measures consist of removing foreign material with soap and water and disinfecting with various antimicrobial agents. It’s not practical to scan doctors and nurses for bacteria, so every surface is assumed to be contaminated until sufficiently cleaned and disinfected. The control point in a data flow is comparatively easier to maintain, as there are techniques for quickly finding infections on media moving through the air gap. For extra protection, any files deemed ‘clean’ can still be disinfected to completely eradicate the possibility of a threat doing undetected.
WWW.MEDICALPLASTICSNEWS.COM
THE ART OF PRODUCTION EFFICIENCY
100% production reliability means 100% production efficiency! That is an art. Especially in sensitive sectors such as medical technology or optics. What counts here is reliability, part precision, quality and cleanliness of the production environment. So why not place your trust in our experience? For a 100% perspective!
www.arburg.co.uk
SPEECH THERAPY
Name a business achievement you are most proud of?
I would say my current ongoing achievement of helping Compounding Solutions more than double its sales and size within the five years I have been working at the company.
VOCAL
&A
exercise
Who are you and what do you do?
I am Nathan Doyle, sales and marketing manager for Compounding Solutions, a specialty custom compounder for the medical market. I am in charge of a team of seven highly motivated sales individuals who have helped Compounding Solutions grow to become the best medical compounder in the industry!
How would you sum up your company?
Compounding Solutions is a custom specialty medical plastics compounder. Formed In 1999 our company was created with the medical device market at the forefront of our thinking and operations. We are not an industrial company that has backed itself into the medical marketplace. We are a group that made the initial commitment to high quality and tight manufacturing practices on day one. As new procedures emerge and older ones evolve the demand for innovative base line technologies within the device industry is growing rapidly.
12
What excites you about this industry?
I love the medical industry, the technological advancements coming out year after year in every facet of the industry are just astounding. This includes biocompatible materials, smaller and faster devices, new production processing (3D printing), new apps for mobile devices connecting us to better healthcare.
Where do you predict industry growth will come from over the next 12 months? With report R&D budgets the highest I have seen in the market place in five years, I predict the most growth will come from the cardiovascular device area, with significant growth coming from new PICC line technology and a new market segment neurostimulation.
Which medical plastic device do you wish you had invented and why?
It would have to the new style of heart valves coming out, such as the Boston Scientific Lotus Valve or the DirectFlow Medical TAVR system. Three of my family members have needed valve replacements and got older technology valves. These new systems are more minimally invasive procedure with longer lasting positive results.
WWW.MEDICALPLASTICSNEWS.COM
Brilliant performance | ENGEL medical
ENGEL medical Fully-electric machines impress with great performance. The ENGEL e-motion medical series combines best-of-class performance with maximum cleanliness. Optimised for clean room applications, the machine has an encapsulated barrel to minimize particle and heat load, along with encapsulated injection unit drives and an oil return unit on the toggle lever as standard features. The ENGEL e-motion medical is available as a continuous series with up to 500 tonnes clamping force.
Clean and precise. With ENGEL medical. Because it is about life.
ENGEL medical ENGEL AUSTRIA GmbH | Ludwig-Engel-StraĂ&#x;e 1 | A-4311 Schwertberg Tel. +43 50 620-0 | Fax +43 50 620-3009 | sales@engel.at | www.engelglobal.com
COVER STORY
I
Full scale
t is estimated that 80% of a product’s cost and quality is determined during the first 20% of the product development timeline. Whether the commercialisation strategy involves in-house manufacturing or the use of a contract manufacturing organisation (CMO), early integration of a strong design for manufacture (DFM) and design for assembly (DFA) philosophy is critical to the device quality, cost and risk during clinical builds and commercial launch.
Today’s medical device and pharma industry assembly concepts can be complex. Bill Welch, chief technology officer, Phillips-Medisize, outlines how the company’s assembly concept is tailored to customers’ needs and the philosophy behind its scalability process
A strong DFM/DFA philosophy ingrained within the product development process ensures manufacturing quality, cost, and risk objectives are met without losing sight of HFE and the enduser device needs. DFx refers to ”design for x”, in which “x” may be any desirable attribute. At the component level, DFM, or the more specific design for mouldability for injection moulded components, refers to ensuring the product design conforms to the guidelines for the manufacturing process to be used. This is especially critical in drug delivery devices, since plastics are the most common material for mechanical components. Component-level DFM forms the backbone of the assembly process – regardless of the planned level of automation – since the process capability at the component level is necessary to reduce variation in the assembly process. Similarly, DFA is done concurrently with product design – with quality, cost and risk of the assembly in mind. At the component level, this includes addition of features to make part handling, positioning, orientation and inclusion into the assembly or sub-assembly. Component-level DFA ensures a mistake-proofing plan is established, which is also necessary to reduce variation in the assembly process. Additional benefits are gained by concurrent DFM/DFA throughout the product development process – for example to reduce part count and eliminate high-risk assembly operations. Multimaterial or multishot, moulding is one approach to combing components that eliminate complex assembly operations and provide an elegant solution to design problems such as sealing to prevent moisture intrusion. Early DFM/DFA team collaboration can then evaluate the return on investment of the upfront mould tooling costs to reduce assembly equipment and labour costs, prior to finalising the design. While DFM/DFA must start at the component level to facilitate future scalability, the application of design for automated assembly (DFAA) is also applied concurrently by the DFM/DFA team. DFAA is the next level, designing assembly processes in which components are oriented, handled, assembled, and transported through an assembly process without manual intervention.
14
DFAA focuses solely on the automated assembly process, i.e, does not require human interaction DFAA application makes interim manual assembly processes to support builds prior to automation build and validation easier. A device that is easy to assemble manually will lend itself to automated assembly. Component-level DFA alone does not develop processes suitable for automated assembly DFAA requires specialised automation engineering involvement in the beginning phases of the development process to ensure automated assembly is taken into consideration in parallel with other DFx. We do not attach these as we do not have space left for more text. DFM/DFA needs to be an underlying philosophy truly integrated into the product development process.
Scalability to meet end-volume requirements Increasing volume and varying production on a single system platform? This is feasible! Scalability can develop the manufacturing scale from the initial low-volume methods to the desired end-state volumes. In the case of a specialised, niche drug delivery device this may mean progressing from low-volume, 3D-printed components assembled by skilled technicians to a “manumation” assembly process conducted by a trained operator. For commonly used drug delivery devices this typically means developing processes to support engineering builds, then clinical supply, and finally a fully automated or high speed automation process, supported by developmental, singlecavity tooling and incrementally higher multi-cavity tools. Flexibility, while related to scalability, has its own definition as it relates to two primary concepts: 1. The ability to re-use assembly equipment modules when progressing from one scale level to the next, to prove-out initial assembly concepts at lower scale and save time and cost by leveraging that same equipment 2. The ability to use all or most of an entire base flexible assembly line to produce multiple, similar devices. In the case of pens and auto-injectors this typically means matching up a device product platform with an assembly platform, with changes being primarily in the components presented to the line following a controlled line clearance and changeover process. DFM/DFA scalability considerations must be looked at with product development as part of a device manufacturing concept. This is a device-specific plan to scale component and assembly production capabilities to a desired endstate, typically with iterations for both components and assembly to meet engineering, clinical and commercial volume demand.
WWW.MEDICALPLASTICSNEWS.COM
COVER STORY Creating a roadmap A well-constructed device manufacturing concept will not only consider the volume, costs and timing of device needs but also the regulatory requirements, risks and geographic considerations with each iteration of the scale-up plan. It provides structured, modularly designed assembly lines which can be extended at any time allowing fast retooling times. Essentially, the device manufacturing concept provides the “roadmap” to progress from initial, limited control engineering builds to the validated end-stage scale, meeting all quality system and regulatory requirements. Core to the device manufacturing concept is a strong assembly systems foundation, starting with the earliest manual builds to ensure the manual process is feasible for scaling: Early manual builds need to establish the assembly sequence, fixturing, component orientation, and assembly operations that will be carried forward to subsequent scaling iterations Proper manual assembly is an enabler for higher level automation. Conversely, as mentioned above, a DFAA analysis may lead to a more robust manual assembly Collect and analyse reject / scrap data to reduce variation with each subsequent scaling iteration. It is imperative to ensure proof of concept has been achieved for each process before making further scaling investment The user requirements specification (URS) for a manual process needs to set the stage for the URS on the desired end-stage automation level. In some cases, it is helpful to draft the URS for the high volume automation first and ensure as much as possible can be learned from the manual process. In terms of flexibility, the re-use of assembly platform equipment is typically limited. For example, a core single-track
STEP CHANGE REQUIRED
assembly process cannot cost-effectively become a four-track system such as that used for a typical high volume pen but a single-track line platform may be scaled from manumation to semi-automation to full automation with upgrades to component feeding, orientation, assembly and inspection / test operations which maintain the single-track configuration. Equipment and tooling supplier selection is an important factor of the device manufacturing concept and consistent with DFM/DFA the suppliers should have early involvement. While the same suppliers can be used for all iterations of the same equipment and tooling, this is often not feasible or practical due to the technical focus, timing requirements or global support capabilities of the supplier. For example, a quick-turn tooling shop and local equipment builder may be necessary to maintain timelines for single-cavity moulds and manual assembly fixtures but they do not have highvolume capabilities or a global service network. In such cases it is imperative that the manufacturing unit or CMO possess the project management, tooling engineering, and automation engineering skills to develop suitable URS and ensure any lessons from initial stages are carried over to subsequent scaling iterations.
Summary Scalability for drug delivery devices begins with concurrent engineering via DFM/DFA and the development of a device manufacturing concept. Use of common definitions for classifications of tooling and assembly equipment can be used to align the team on the concept and enable the tooling and automation engineers to specify, via the URS, the process requirements and select the appropriate suppliers for each scaling iteration. This means the manufacturing unit or CMO must have the capabilities to provide effective DFM/DFA and development of a device manufacturing concept, as well as the capabilities for the project management and technical execution of the plan.
STEP CHANGE REQUIRED
SCALABLE PROCESS
PROTOTYPE PROCESS
DMC Classification
CLASS I
CLASS II
CLASS III
CLASS IV
CLASS V
Relative Description
Cam driven, multi-up, fully integrated, high speed automation. Human precense required for monitoring only. Self diagnostic with built in compliance and integrity checks.
Rotary Indexing Table or Integrated Linear System, with automated part feeding/conveyance. Single or multi-up capable. Fully automated work cell. Limited human interaction.
Scalable Manumation with multiple station and multiple operators.
Manumation with a single operator station.
Manual Operation that may include hand press, special tooling, and part fixtures.
Types of Use
Automated Production
Automated Production
Combination of Full / Semi-Automated
Semi-Automated
Manual Operation
QA Requirements
Automated Inspection & DAQ
Automated Inspection & DAQ
Some Automated Inspection, No DAQ
Manual Inspection
Manual Inspection
Product Handling
Automated Conveyance
Automated Conveyance
Conveyor or Robot
Conveyor / Manual Transfer
Manual Transfer
Capacity
~ 20MM EAU
~ 5MM EAU
~ 1MM EAU
~ 0.50MM EAU
~ 0.10MM EAU
Capability*
Established Global Provider
Established Global or Regional Assembly Line Provider
Established Regional Assembly Line Provider
Regional or Local Assembly Line Provider
Regional or Local Assembly Line Provider
Cycle Time
1 PPS
10 PPM
5 PPM
5 PPM
2 PPM
e.g. injection pens
e.g. safety syringes
e.g. filters
e.g. insulin pumps
e.g. IV-Sets
*Requires ASL Grading
Five levels or classifications of assembly In order to facilitate development of a manufacturing strategy, it is useful to leverage a high-level common language and terminology for tooling and assembly classifications. These ensure all team members can understand and agree in concept as to the initial, interim,
and final approaches to be taken to meet engineering, clinical and commercial volume requirements. The table above shows the five classes Phillips-Medisize uses to describe different levels and types of assembly, and examples of assembly lines.
WWW.MEDICALPLASTICSNEWS.COM
15
DRUG DELIVERY
T
One direction
his breakthrough pill could help end problems of patients failing to finish a course of medication, which can exacerbate illnesses and has contributed to the rise of antibiotic resistance bacteria.
Emily Hughes looks at how scientists in the US have designed a single pill made from a polymer gel that could deliver an entire treatment in a single dose
Robert Langer from the Massachusetts Institute of Technology (MIT), said: “Probably one of the biggest health problems in the world… [is] patient compliance – people forgetting to take their drugs. “As a consequence, there are many deaths, enormous amounts of hospitalisations, hundreds of billions of dollars in healthcare costs.”
Langer and his colleagues’ pill had to tackle two key issues. The device had to be able to survive the harsh environment of the stomach and slowly release its drug payload, but dissolve once it eventually passed through into the intestine. It also needed to be flexible enough to swallow and then unfold in the stomach to prevent its expulsion into the intestines. The team designed a supramolecular elastomer gel by combining poly(acryloyl 6-aminocaproic acid) and poly(methacrylic acid co-ethyl acrylate), a pharmaceuticalgrade polymer that resists digestion.
As a proof-of-concept, Langer and his colleagues embedded polycaprolactone (PCL) beads, as an example of slow drug release agent, into a ring of the elastomer gel and inserted the device into a standard 18mm gelatin capsule. When the capsule gets into the stomach the outer part dissolves and the elastomer opens up into a particular shape. The pill was successfully tested on a pig and in this case, the gel opened up into a 3.2cm ring within the pig’s stomach. The ring remains intact for up to seven days, before the gel component dissolves and the PCL beads can safely travel through the animal’s intestine.
The development of this elastic polymer may open the door for future developments in drug delivery.”
Gregor Fuhrmann from Imperial College London, UK, said: “I very much like the simple idea of creating an elastic polymer that is gastro-resistant but dissolves at intestinal pH. “The development of this elastic polymer may open the door for future developments in drug delivery.”Langer said: “It has the potential to change the way we take drugs. It’ll, I hope, save many, many lives.”
The gel can be cut to various sizes and recovers its shape quickly after being stretched to three times its original length.
16
“
WWW.MEDICALPLASTICSNEWS.COM
International exhibition and conference on additive technologies and tool making
Frankfurt am Main, 17 – 20 November 2015 formnext.com
Innovations. Impulses. Inspiration. The world’s leading companies in additive manufacturing technologies and highly specialized tool-making will show you their expertise at formnext powered by tct. Discover how additive technologies can be intelligently combined with conventional procedures in product development and production, and how you can use innovative processes to reduce your time to market even further. New potential across the entire manufacturing process is waiting to be discovered by you. We are looking forward to seeing you!
Where ideas take shape.
Get your free ticket here: formnext.com/tickets
For further information, call +49 711 61946-825 or write to formnext@mesago.com
3D PRINTING
Model answer As additive manufacturing continues to innovate and disrupt, Scott Rader, head of medical solutions at Stratasys, discusses the technology’s growing role within the healthcare industry
T
he medical industry is a field in which innovation and new technologies have a direct impact on improving processes, operation results and saving lives.
Started over 25 years ago, 3D printing – or additive manufacturing – can today produce parts across a range of industries and applications. From fully functional medical prototypes, such as a knee braces for improved design efficiencies, to manufacturing in-flight aerospace parts, right through to high-strength automotive components that can withstand the heat and endurance of high-speeds. This demonstrates the rapid advancement of additive manufacturing technology and its materials, offering companies significant advantages across the entire design and manufacturing process. As the healthcare industry takes larger and larger slices of the gross domestic product of countries, the question of cost will always be a factor associated with the obvious need to constantly increase innovation to improve efficiencies. In the medical field, 3D printing enables doctors to work faster, shorten patient theatre time and improve operation results. There have been many cases where patient diagnosis and treatments have been improved by 3D printing. The constant demand to improve efficiencies drives medical device manufacturers to produce products faster, more cost-effectively, with greater customisation and less intensive use of resources. Hospitals can test 3D printed medical device prototypes early in the process and feedback any required design iterations that can be made on-the-fly before final production. Subsequently, time-tomarket of new medical devices is dropping significantly, meaning more patients can benefit from these new innovations faster than before. In addition, we have seen a significant growth in the use of additive manufacturing during surgical planning and is fast-becoming an integral part of the process. Effectively performing and perfecting surgery on a 3D printed model prior to the actual procedure on the patient, not only can directly affect the amount of time patients spend on the operating table but can also significantly success rates. For example, using a physical 3D printed model of a cranium implant, surgeons can identify the exact size and shape required to repair the affected area prior to surgery and therefore reduce any unanticipated complications, something that is restricted by a CT scan.
18
Starting with the patient By its very nature, the healthcare industry is fast-paced and requires quick decisions to maintain patient care. Today, with increasing competition, hospitals are competing for patients. They look to market themselves as pioneers of innovation and early adopters of disruptive technologies that enable them to increase diagnosis, shorten usage of theatre time and reduce complications, while positively impacting patient care.
Improving healthcare More and more manufacturers of medical devices enjoy improved lead times using additive manufacturing technology. Users can produce multiple medical assembly tools that can be produced overnight compared to several days, or in some cases, even weeks if the tooling process is being outsourced via traditional production methods. With Stratasys additive manufacturing, users can produce manufacturing tools such as injection mould inserts. This allows In the medical a number of medical establishments to reach the early production stage for field, 3D printing clinical trials as well as a cost-effective enables doctors to way to produce expensive medical work faster, shorten devices. patient theatre
“
In certain cases, some of our own time and improve customers have reported dramatic lead operation results. time cuts by 95% and cost savings of up to 70%. An example of this is US design and product development company, Worrell, who accelerated its medical device development through the use of 3D printed injection moulds. Traditionally it would have taken four to six weeks to manufacture the tool in aluminium but with PolyJet 3D printing technology, Worrell dramatically slashed its lead times to two days for low-volume runs. The toughness and heat resistance of DigitalABS material has advanced the production of 3D printed injection moulds, as they are now able to withstand the rigours of an injection machine. Most significantly this enables companies like Worrell to quickly and cost-effectively produce medical device prototype parts in the final production material.
WWW.MEDICALPLASTICSNEWS.COM
3D PRINTING
Helping hand: University of Central Florida students developed a customised robotic arm for a six-year-old boy who was born without his right arm
Learning zone: 3D printing is not restricted to the operating table; a number of medical establishments are repurposing 3D printed models to train the next generation of doctors and surgeons
Personalised prosthetics As the application list continues to grow, the area of prosthetics is something that has been touched by the rapid advancement of 3D printing. The prosthetics themselves have been around for a long time and up until recently, were typically rudimentary in their design and functionality. Now, advances in 3D printing have heralded a new era of inexpensive yet sophisticated prosthetics. This increased availability has seen patients ask for customised options and has led to the explosion of personalised medical aids and prosthetics.
“
In certain cases, some of our own customers have reported dramatic lead time cuts by 95% and cost savings of up to 70%.
An example of this is at the University of Central Florida (UCF) where a number of engineering students developed a customised robotic arm for a six-year-old boy who was born without his right arm. UCF was able to 3D print and apply design iterations quickly to find the perfect solution for the patient. Thanks to the technology’s superfast turnaround time, the team produced a personalised prosthetic prototype bespoke to the child’s body before manufacturing the final, Ironman-inspired, robotic arm. Surgical guides As mentioned earlier, additive manufacturing allows surgeons to reduce unexpected risks by performing the procedure on 3D printed models of the affected area prior to surgery. By converting MRI scans of the patient into a 3D printed model, hospitals can pinpoint hidden problematic areas previously only raised by x-rays. Again, a brilliant example of this is of a two-year-old girl who was born with a severe abnormal facial condition known as frontonasal dysplasia. The abnormality caused her facial
features – specifically her nose which has no cartilage, and the space between her eyes – to widen, resulting in physical disfigurement and poor vision.
By using 3D printing technology to produce precise 3D printed models of her skull, quickly and cost-efficiently, the medical team was able to use the model to plan the exact operation and also discuss and explain the procedure to the little girl’s parents beforehand. Without a 3D printed surgical guide, the surgery would have traditionally taken around 24 hours. Thanks to the 3D printed replica, the ability to plan ahead meant that the operation was completed within 10 hours. With operating rooms costing at around 100 euros a minute, this is a prime example of the significant cost saving hospitals can enjoy by performing the surgery pre-theatre on a 3D printed model. More importantly, it reduces complications during the operation. 3D printing is not restricted to the operating table; a number of medical establishments are repurposing 3D printed models to train the next generation of doctors and surgeons on how to cope if things go wrong. For example, during kidney surgery, blood flow can only be stopped for 30 minutes, otherwise the kidney dies. Previously, surgeons would have to cut into the patient and use a tactical feel to locate the renal artery to ensure blood supply to the healthy portions of the kidneys wasn’t cut off. Now, surgeons can use a patient scan to create a 3D printed replica model, determine where the renal artery is and avoid this scenario. In some instances, we have seen hospitals manage to remove the tumour and cut the blood supply for only 21 minutes.
WWW.MEDICALPLASTICSNEWS.COM
19
3D PRINTING
The Printed Word 3D PRINTING CAN ACCELERATE TIME TO MARKET AND EXTEND THE WORKING LIFE OF MEDICAL DEVICES, SAYS MICHAEL WALSER, HEAD OF R&D, ESCATEC
3D
printing has now reached the point where it is having a significant impact on medical devices. Not only can it speed time to market but it can extend the working life of devices by enabling replacement parts to fabricated.
Until recently, 3D printing was a service that was mainly provided by third parties due to Plus points: 70-80% the expense of of 3D prototype the machines. printing is done in- As a contract design house we house at ESCATEC were spending which provides considerable sums several benefits says on outsourcing the company 3D printing of prototypes. Capital costs have now fallen to the point where we have found it to be is cost-effective to purchase a professional, fused deposition modelling (FDM) 3D printer for inhouse use.
“
Now 70-80% of 3D prototype printing is done in house which provides several benefits. Firstly, the capital cost is being quickly recouped from savings from not using a third party giving a rapid return on investment (ROI). Secondly, we can now produce rapid prototypes in minutes rather than several days so that we can test out a new design and quickly refine it. For example, checking that several parts, which are supposed to snap together, do actually fit as planned. When you are deep into the design of a new part, it is great to be able to touch and feel it and then see how it fits in with the rest of the design. We can now work on a design continuously rather than stopping and starting while we have to wait for the next version to be delivered in a couple of days. It has not only improved productivity but also creativity as designers can quickly and simply try out new designs on-the-fly in-house rather than going through the formal process of engaging an outside contractor every time. We have found that we can cut weeks off the time to design a new product, which can have a significant effect in reducing time-to-market for a customer’s project.
20
Thirdly, in addition to this design of experiment (DoE) verification, we can also show customers proof of concept (PoC) for designs along with variants. This makes the decision process on which design idea to go with much quicker as the customer can pick up and interact with the designs and easily select the best one to progress. Again, shortening the timeto-market for the customer and helping us to win pitches for new business. For our prototypes, ABSplus plastic is used, which is UL94 grade. However, various materials can be used in other 3D printers such as food grade materials, rubbers and opaque plastics. 3D printers can also print with one, two or three different type of materials to create complex objects with interlocked part made from different materials.
“
Speed star: ESCATEC says it has been able to cut weeks off the time to design a new product which can have a significant effect in reducing time-to-market for a customer’s project
This ability to create complex, multimaterial objects is important for an area that will grow in its significance in future – out of warrantee service and repairs. Medical devices are often expensive and therefore users expect them to last for many years of use. However, most manufacturers only provide a one-year warrantee. At ESCATEC, we are now starting to provide longer warrantees for customers should they be required because 3D printing now solves the biggest issue with multi-year warrantees – keeping a stock of spare parts plus the manufacturing tools and moulds. As we always retain the CAD files, it now becomes a simple matter of printing out a replacement part whenever it is required. This extends the working life of devices, reducing the total cost of ownership for the end customer.
WWW.MEDICALPLASTICSNEWS.COM
DIGITAL HEALTH
WWW.MEDICALPLASTICSNEWS.COM
21
3D PRINTING
Step on: Hospitals now have the ability to 3D print samples of certain body parts within hours from the time of examination of a patient
Printed word Z
ZMORPH EXPLAINS THE TECHNOLOGY BEHIND ITS 3D PRINTING TECHNOLOGY AND THE BENEFITS IT OFFERS FOR MEDICAL DEVICE APPLICATIONS
Morph is a multifunctional device with interchangeable toolheads that 3D prints and laser and CNC-cuts. Thanks to specially written software – Voxelizer – it enables the preparation of prints directly from MRI and CT medical scans. According to Zmorph, this functionality together with Zmorph devices, offers something special. A dual head extruder makes it possible to print complex geometry in multimaterial configuration. Files that are created from the scans, can be transferred to Voxelizer software and turned into instructions for the printer. This functionality can be very useful for surgeons who can then create medical prototypes such as models of bones and teeth or silicone moulds used for example in plastic surgery.
Changing lives The medical device sector is a fast growing area for 3D printing with the technology is helping to improve the health of many individuals. Recently we read about the man who saved his wife’s sight by manufacturing her tumour when his wife was misdiagnosed, Michael Balzer used this technology to save her from a complicated surgery. Those stories can show that 3D printing is not a technology from sci-fi movies anymore – it’s something changing our lives each day. Thanks to DICOM files, a virtual 3D picture of patient body or its part, it’s easy to diagnose broken bones or other kind of illness, find a solution and finally send it all over the world to print, without a lot of expenses. For example a team of Dutch surgeons from Utrecht, replaced the entire top portion of a 22 year–old woman’s skull with a customised printed implant made from plastic. Doctors and patients are using this technology in many ways. For example, the problem of traditional prosthetics was that the production process was long and expensive.
22
3D printing offers the opportunity of making simple replacement available for less. It is a great way to bring this kind of healthcare to areas of the world where it was impossible to buy traditional, expensive prosthetics before because of costs or lack of materials. The other way 3D printing can support medical device manufacture in poorer areas of the world is to 3D print cheap and simple medicine tools – for example to local hospitals in Haiti after the earthquakes.
Opportunities in medtech There are three main advantages of this technology in medical device manufacture – speed, cost and mobility. Hospitals now have the ability to 3D print samples of certain body parts within hours from the time of examination of a patient. This allows them to quickly have an exact replica of a part before surgery. They can carry out a group analysis of the body prior to surgery which can result in lowering the surgical risks. This speed and accuracy mix can be crucial in life-or-death surgeries. While the present applications of 3D printing are exciting, the future offers incredible potential as global research is examining possibilities and printing with new materials. Researchers from Harvard University are trying to bioprint fully functional blood vessels. In the future, thanks to 3D printing, we will be able to print chemical compounds at the molecular level. Organovo recently announced the commercial launch of its bioprinted liver assays which are able to function for more than 40 days. There is also a hope for burn victims – the Wake Forest School of Medicine in the US is working on a printer that can print skin straight onto the wounds. Cornell’s Lawrence Bonassar used 3D photos of human ears to fabricate ear moulds filled with cells suspended in collagen.
WWW.MEDICALPLASTICSNEWS.COM
ISO 13485
Got it covered F
ounded in 1969, Whitford Corporation’s early focus on solving problems for customers rather than merely selling coatings resulted in the company’s becoming the manufacturer of the world’s largest, most complete line of fluoropolymer coatings. Today, Whitford offers thousands Greg Lundell, of products from nine manufacturing Whitford facilities and operates in more than 50 Corporation, countries globally.
announces the creation of a new medical coatings group to be certified to ISO 13485
Always focusing on solving customers’ problems, Whitford’s emphasis on product development is an important core value. Along with the development of new products has come the development of new industry sectors served by its growing product portfolio.
“
underway. This includes new equipment for both the manufacture and quality control of products as well as office space for quality assurance and administrative personnel. Once complete, the group will be certified to the ISO 13485 standard. By implementing the stringent quality-system standards to achieve this certification, Whitford aims to ensure that the quality of its coating products is second to none. Medical-device companies searching for solutions that coatings can solve for them will be able to rest assured that Whitford understands the market, and will be a viable global supplier to the industry for years to come. Initially, the manufacture of coatings for medical devices will be relocated to the new facility following a full validation programme. The coating formulations will remain the same to ensure regulatory compliance for the end user. As the group becomes further established, co-development programmes will be initiated. We know there are certain coating specifications needed in the medical-device markets that are currently not available. Nitinol substrates, for instance, can’t withstand the high coating cure temperatures that traditional stainless steel substrates can; we’re looking to solve that, and make other improvements along the way.
Initially, Whitford focused on niches in Today, Whitford the industrial market, later moving to the offers thousands consumer market. Frying pans, irons, and of products from other household nonstick-coated items allowed Whitford to grow its business. nine manufacturing Specifications for more industrial applications facilities and came as a matter of course when companies operates in more realised coating critical parts would offer than 50 countries a variety of benefits over their uncoated counterparts. Corrosion resistance for parts in globally. contact with sea water, lubricity for fasteners and ease of cutting, release for moulds, and friction reduction in constant wear situations have all been the Currently, high-performance fluoropolymer coatings are cost and timesaving benefits offered by Whitford coatings. used on catheter guide wires, electrosurgical scalpel blades, stents, mandrels, needles and probes, biologic Along the way, the company’s high-performance coatings processing equipment, and a variety of other devices. As were sought out by the medical-device industry. Such devices, though highly specialised and often small and delicate, are susceptible to a number of extremes within the human body that mimic those faced in other industrial applications. Take the example of medical catheter guide wires, for instance. They are thin, flexible, and perform in relatively small spaces (blood vessels). In this example, lubricity prevents the wire from catching on vessel walls and ensures smooth catheter insertion. Another example is coated electrosurgical instrument tips. The release characteristics of non-stick coatings similar to those needed for industrial molds prevent tissue adhesion during operation. Coatings can also be used as a protective barrier on caps for drug and sample vials. Typically, vial caps are made of formed rubber or a rubber disk inside a plastic screw-cap. The rubber allows for proper seal formation, but are porous and can both leach components into the drug formulation and bind the drug they are meant to contain. Fluoropolymer non-stick coatings solve both of these problems. To provide maximum service to the medical-device market, Whitford Corporation recently decided to form a medical coatings group to be headquartered at the company’s worldwide headquarters in Elverson, Pennsylvania. This move should have both immediate and long-term effects on the medical coatings / device industry. Establishing the group has been an important project for the company over the past year. A dedicated manufacturing and QC facility was designed, and construction is currently
First choice: By implementing stringent quality-system standards, Whitford aims to ensure that the quality of its coating products is second to none
it evolves, the medical-device industry will require more coatings for an even wider application base, and Whitford plans on being a partner with device companies for their development. The future of our business includes biocompatibility and plastics class testing, generating information and data for customer device master files, regulatory support, and establishing full design control projects. It’s a different business model from supplying a coating for frying pans, but we can easily leverage our deep technical knowledge and second-to-none customer support in this venture. It’s a very exciting proposition for us and our customers.
WWW.MEDICALPLASTICSNEWS.COM
23
ISO 13485 at Innovative Polymer Compounds: ISO 13485 has been the cornerstone of the Quality System at IPC – Innovative Polymer Compounds - since we achieved certification to the standard just over 5 years ago. We used ISO 9001 standard as our initial Quality Management System when our plant opened, but from the outset ISO 13485 certification was our target. Unlike most compounders in Europe, IPC supplies into the medical device sector only. We do this from our custom built white room facility in Kilbeggan, Ireland. To this end, the additional disciplines inherent in the ISO 13485 standard with respect to both material control and traceability, as well as documentation control ensure that IPC can match the expectations of our customer base. Whether they are a multinational OEM, or 1st and 2nd tier supplier, ISO 13485 allows IPC to offer the robust quality system required. Documentation control under ISO 13485 allows IPC to provide each customer a comprehensive trail, to the original sales enquiry, project data, through TDS and MSDS, Production, COC and COA generation, to final packaging specification and bar coding / labelling. Material Control & Traceability is paramount to our customer base. From Supplier Documentation, Goods Inwards Inspection, Lot-to-Lot Traceability, Formulation, and Product Repeatability on our equipment, the standard ensures that all of the data the customer requires is complete and to hand. Sections of ISO 13485 which cover areas such as Sterilization, Software Validation, Implantables and Equipment Service focus on OEM’s and medical device producers themselves, and do not apply to the medical polymer compound products we produce for catheter, extrusion and injection moulding applications. In summary, ISO 13485 has been a major asset for IPC. It has delivered much in the way of new business, and gives existing and potential customers real confidence in the expertise that a robust Quality System such as ISO 13485 can bring to our company. The many successful customer audits – typically one per month, are a testament to the investment that Innovative Polymer Compounds has made in ISO 13485.
ANTIMICROBIALS
O
Cleaning up
bjects and surfaces within the hospital environment are known to harbour pathogenic bacteria or other microbes for extended periods of time the long term persistence of bacteria is a well understood problem. Bacteria such as Enterococcus spp. (including VRE another Biocote explains multi drug resistant pathogen Staphylococcus the need for aureus - including MRSA) are evidenced to antimicrobial survive for many months on hard surfaces. polymers in Gram negative species such as Actinobacteria, E.coli, Pseudomonas spp. and Klebsiella spp. a healthcare are also reported to survive for extended environment periods. A recent study conducted over a two year period showed equipment in three different wards displayed contamination levels of between 22% and 38%. More than 50% of the equipment sampled was highly contaminated, with P. aeruginosa repeatedly isolated from sinks, from the taps’ biofilm, and from the showers and bedside tables.
We can help product manufacturers develop an antimicrobial product by working with them to create a high performing antimicrobial product ready to take to market. The first stage in validating any associated claims for an antimicrobial product is having material which performs well in laboratory-based tests. Although these analysis requirements have stringent conditions and procedures by which the tested material and organisms are subjected, the question of how treated materials may perform in the ‘real world’ is a common one.
Germ warfare: Effective cleaning and disinfection as well as patient and staff awareness of infection control measures remains the primary method of action for control of environmental contamination
The company has published a series of case studies which address the concern of how antimicrobial surfaces behave in environments including, but not exclusive to, healthcare. A peer reviewed study, published in the Journal of Infection Prevention demonstrated a We can help product 95.8% reduction in bacteria between two wards, where ‘ward A’ contained BioCote manufacturers treated products and ‘Ward B’ contained develop an non treated products. BioCote has also antimicrobial performed a similar study in a care home, demonstrating a 94.8% reduction in total product by working microorganism counts when comparing with them to create a unit with and without BioCote treated a high performing products.
“
Effective cleaning and disinfection as well as patient and staff awareness of infection control measures remains the primary antimicrobial method of action for control of environmental product ready to BioCote has also demonstrated antiviral contamination. Working alongside these take to market. performance of treated surfaces, measures, integrated antimicrobial protection proving the ability of BioCote technology can provide an additional defence against the incorporated into a variety of substrates effects of contamination of items and surfaces both within such as polycarbonate and ABS to deactivate the Influenza the hospital environment and in any hygiene sensitive H1N1 virus by up to 99.99%. A further study demonstrates location generally. visually, via epifluorescence microscopy and molecular dyes, the ability of BioCote’s antimicrobial technology to inhibit biofilm formation of treated plastic.
Clean sweep: Integrated antimicrobial protection can provide an additional defence against the effects of contamination within the hospital environment. © Courtesy of Bioclad Antimicrobial Wall Cladding.
WWW.MEDICALPLASTICSNEWS.COM
25
CLEANROOMS
Pristine condition BUILDING AN EFFECTIVE CLEANROOM FACILITY – AN INSIDE-OUT APPROACH BY JOHN CHALLENGER, WH PARTNERSHIP
F
rom small start-up enterprises to established major international pharmaceutical companies and their supply chain, manufacturers and researchers require cleanroom facilities that will achieve quality and operational standards to meet the expectations of the regulatory bodies but most importantly work effectively and are value for money. Clients increasingly expect that facilities can be designed, built and qualified in extremely short timescales. These are all reasonable expectations but it is essential that both the client and the cleanroom contractor work closely to define the requirements prior to the start of any project.
compliance as that needed by the pharmaceutical industry. Clearly the quality of the cleanroom and its operating environment will depend on the product application and on the manufacturing standards imposed by the end user. Such standards can vary from simple clean manufacturing conditions that will prevent any plastic component from becoming contaminated to the use of aseptic conditions for products that will ultimately have direct internal patient contact.
sizing data are all prerequisites of being able to develop accurate room data sheets that will fundamentally describe each clean room and its operating requirements. So often, cleanrooms are developed without this fundamental data being in place which leads to failures in quality, purchaser disappointment and sometimes dispute. The other helpful element in the development of cleanrooms is the early involvement of the regulators, particularly when novel processes are to be carried out.
Definition and validation
Another significant factor affecting how the cleanroom might be designed and operated is the level of containment that barrier or isolation technology can provide. Many plastic moulding and filling machinery is legally required to be provided with safety guards or barriers that could be modified to create a specified environment in the critical manufacturing zone (the area immediately around any point of filling, moulding zone or through which any manufactured component is to pass). The way in which a cleanroom is specified will therefore depend on how the machine and its barrier are to operate and the potential contamination challenge from the surrounding area when in operation. The advantage of using barrier technology is that if it can be demonstrated that the critical manufacturing zone can be maintained throughout the manufacturing cycle then it may be possible to specify a lower environmental classification than would otherwise be required and reduce the capital and operating cost of the surrounding cleanroom. This type of isolation technology has been successfully operated since the 1980s and has demonstrated significant reduction in cleanroom operating costs.
For companies supplying medical plastics or products that involve the production of filled medicinal or healthcare products that use, for example Form Fill Seal machines, the way in which equipment is integrated into cleanrooms requires the same attention to detail and regulatory
The development of a manufacturing process-led user requirement brief or specification is essential to the development of a successful operating clean room. In this context the initial development of a materials/ process flow diagrams, adjacency diagrams and equipment list with
Inevitably for medical plastic products including polymeric packaging, particularly those which are either defined as medical devices or are used to contain parenteral, licensed or over-the-counter pharmaceuticals (OTC), appropriate levels of facility and product qualification needs to take place. The commissioning and validation of any cleanroom must be considered as part of the overall product quality control and assurance for the product and in order to adequately manage the process, it is first necessary to establish a thorough validation master plan (VMP). The production environment, cleanrooms and utility services that are critical to product quality will all need to be validated by undertaking installation qualification (IQ) and operational qualification (OQ). It should be noted that it is of considerable importance to establishing a reliable VMP that the user requirement brief, or in the case of the cleanrooms, a facility requirement specification has been thoroughly developed and approved by the company, relevant departments or person responsible for the overall product quality control. The extent of the validation procedure will depend on several factors, including the expectation of the specific regulatory body that will licence the facility and products, any involvement of major companies that may have their own extensive quality procedures and of course the type and use of the product being manufactured.
At WHP we recognise that integrating manufacturing plant and equipment into a cleanroom is fundamental to ensuring that the facilities will meet client expectations regarding time and cost. No matter whether a new cleanroom facility is to be installed in an existing or a bespoke host building, we adopt an ‘inside out’ approach, treating the cleanroom as part of the process or manufacturing plant design. There are very few companies in the UK, USA or mainland Europe that combine the full design and construction capabilities for both process plant and cleanrooms in a single organisation. This is surprising since integration of the two essential facets of clean production activities is paramount in the successful outcome of projects in the clean industry sectors. This approach to cleanroom design is not new and WHP was part of an association started in the 1980s adopting this methodology which was shown to deliver cost and time effective facilities.
26
WWW.MEDICALPLASTICSNEWS.COM
Clean sweep: WHP was involved in the construction of a cleanroom facility for TC BioPharm
Back to basics Generally speaking, clients and people working in facilities know what they want but not always how they want to achieve it. Our job is to listen to them, interpret what they say and advise on possible solutions. It is often found that three-dimensional space awareness and planning are not fully understood by the users. The design needs to be demonstrated effectively to enable them to understand not only how the operating and maintenance staff will interface with the manufacturing equipment but how the manufacturing equipment will interface with the cleanroom. This is a particularly important facet of design when large moulding machinery is to be installed which often requires reasonably frequent removal and installation of mould or change parts to meet the requirements of production campaigns. Of equal importance is the project management methodology adopted, particularly at the development stages of a project. WHP has found that a stage gate approach provides the technical and financial controls necessary to monitor each stage in the design or build process. This concept allows us to consider a range of options and choose the most suitable for each client or project. Recognising the need for the efficient transfer of information from the client or user, WHP has developed its own detailed check list of basic requirements to enable the full range of design parameters to be defined for the cleanrooms we are required to build. The following are some fundamental questions we ask: ■
Why do you need a cleanroom? do you manufacture your components and what are the critical concerns? ■ What environmental standards are required to ensure the repeatable and consistent products ■ How will the tooling and change parts be removed? ■ What are the heat gains from the equipment? ■ Is the space sufficient for the needs of the cleanroom, associated plant and equipment? ■ How
WWW.MEDICALPLASTICSNEWS.COM
Clean zone: The way a cleanroom is specified will depend on how the machine and its barrier are to operate and the potential contamination challenge from the surrounding area
■ Is
there enough headroom for installing ventilation and utility services? ■ Are all the interfaces fully understood?
Go with the flow Once the user requirement brief is properly established and linked with a full understanding of the manufacturing process and standards, the design can be started by developing the following: ■
Flow of raw material Flow of personnel ■ Flow of finished goods ■ Flow of waste product ■ Defining room environmental standards ■ Specifying room finishes ■ Sizing HVAC and utility services ■ Any future-proofing of the design so that is practical to expand the facility in a cost-effective, practical and timely manner ■
Once all of these operating features, location and essential services are agreed, designing a cost-effective facility which suits the client’s requirements and deliver the facility in a short timescale can become the focus. The success of this approach was demonstrated recently with a project for TC BioPharm in which a facility containing cleanrooms, quality control suites and development laboratories designed to support the manufacture of clinical grade product was constructed in just 12 weeks from start to finish and was granted a license to produce human cell therapy products by the Medicines Healthcare Products Regulatory Agency (MHRA). This was achieved by establishing a close working relationship with the client and taking the time to define the operational requirements of the facility.
27
CATHETERS
Fighting talk A
recent report on the BBC’s website column Scrubbing Up highlights the weaknesses in the urinary catheter market.
Recent controversy has brought the catheter sector into the spotlight. Lu Rahman looks at the criticisms being thrown at the industry and how it has hit back
Mandy Fader, professor of continence technology at the University of Southampton, said that in 80 years, catheter design had changed little adding that the industry was at fault of poor investment and weak regulation.
According to a recent report on the urinary catheter market by Transparency Market Research, the global urinary catheters market will reach US$2.37 billion in 2020 from US$1.66 billion in 2013. A range of factors is contributing to the growth of the market including an increase in urinary disorders and the growth of chronic disorders. Figures from the World Health Organisation (WHO) say that more than 200 million people globally suffer from a bladder control problem that requires a urinary catheter. In the UK alone 3-6 million people required a urinary catheter in 2013. According to the BBC, Professor Fader believes there is evidence that catheters are over-used but her main issues surround their design and the materials used. Instead of this medical device having what she says should be a ‘state-of-the-art’ design, she argues that the product hasn’t changed sufficiently in the last 80 years. Part of the problem for this she says, is weak regulation. She told the BBC: “Unlike with new drugs, manufacturers do not need to show that any changes they make to catheters actually work on patients.” Fader goes on to point the finger at catheter manufacturers saying that they need to invest more in new catheter design and materials that resist infection. According to the report she says that the devices have represented “easy money” due to high demand. However, she says that while this has been the case, the industry has lacked innovation and improvement. These comments didn’t meet with approval from the Urology Trade Association, which represents manufacturers of urology products including catheters. It rejects Faders’ claims that the sector lacks innovations and investment. The association has argued that Professor Fader’s assertions ignore continued investment by manufacturers, along with innovation to minimise the risks of infection and
28
improve the quality of intermittent catheters and people’s quality of life. The association has also expressed concern that Professor Fader’s claims might pre-judge research she is leading at the University of Southampton to assess the utility of single-use catheters, currently the standard products for patients, and catheters that can be washed and reused. Chris Whitehouse, chairman of the Urology Trade Association, said: “Professor Fader’s claims ignore substantial and continued innovation and investment in catheter products by industry, particularly over the last 20 years. Manufacturers continually talk with patients and healthcare professionals, and the development of catheters is led by what patients want and need. “The simple fact is that it is now possible to get catheters that are easier to use than ever before. Some are designed to look like consumer products to make them more discrete. For Professor Fader to then claim that innovation and investment isn’t taking place is quite clearly incorrect. These claims are particularly concerning given that she is undertaking research into catheters that could affect what products patients have access to in the future.”
“
The simple fact is that it is now possible to get catheters that are easier to use than ever before.
The Medicines and Healthcare products Regulatory Agency (MHRA) joined the debate and a spokesman for the agency was reported as saying that the MHRA has no evidence “to suggest that urinary catheter materials used in the UK do not meet the requirements of the Medical Device Directive.”
Innovation continues Clearly the debate remains but meanwhile those supplying healthcare with catheters and catheter-related products are continuing to innovate and make advances. Earlier this year NICE announced plans to recommend a technology to hold catheters in place and reduce infection risk. Draft guidance proposed the use of the 3M Tegaderm CHG IV securement dressing for catheters inserted into central veins and arteries. Tegaderm CHG dressing is a sterile transparent semi-permeable polyurethane adhesive dressing, with an integrated gel pad containing the antibacterial agent chlorhexidine gluconate (which is a widely used antiseptic and disinfectant). The draft
WWW.MEDICALPLASTICSNEWS.COM
-0. /CTOBER!D PDF
#
-
0-
9
#-
-9
#9
#-9
+
!
$!%##
"
p oly f lon We contract manufacture tubing components for medical device companies. Using novel heating methods we can create complex tip forms and micro-mouldings on the distal and proximal ends of thermoplastic medical tubing. Tight control of the heating process allows us to produce very closely toleranced tip geometries to the customer’s own design.
Get in touch with Polyflon: info@polyflon.co.uk +44(0)1785 859 054
WWW.MEDICALPLASTICSNEWS.COM
29
POLYMERS A VELOX PASSION
WE UNDERSTAND MEDICAL • Raw materials supplier • Small quantities just in time • Technical advice at design stage • Change management • Regulatory support • Customised polymer solutions CATHETER MATERIALS STENT COATING GRADES BALLOON SPECIALITIES
VELOX GmbH +49 (0)40 369 688 0 medical@velox.com
www.velox.com
30
WWW.MEDICALPLASTICSNEWS.COM
CATHETERS
“ guidance says that the Tegaderm CHG dressing should be considered for use in critically ill patients who need a central venous or arterial catheter in intensive care or high dependency units. The device manufacturer claims that the benefits of the Tegaderm CHG dressing include a 60% reduction in the incidence of catheter-related bloodstream infection in critical care patients with intravascular catheters, and reduced risk of death from this type of infection.
Cutting death rates
Our aim was to maximise usability in the hands of minimally trained birth assistants and lower the overall costs of the intervention, through reducing the medical professional’s, equipment and training required to safely and effectively use the device - to ultimately save lives.
Recently MPN reported on the Uterine Balloon Tamponade from the Cambridge Design Partnership which addresses the issue of Postpartum Haemorrhage (PPH). It is the leading single cause of maternal mortality and is thought to be responsible for approximately 57,000 deaths each year worldwide, nearly all of which occur in developing regions. Commercially available UBTs can cost as much as $200 each and need to be carefully inserted in theatre by trained clinicians. These factors prohibit their use in low resource areas, where currently a makeshift alternative assembled by tying a condom to a urinary catheter – the ‘condom catheter’ – is being trialled. Whilst this device is certainly cheaper, it still requires careful assembly, significant training and skill to be successful. The new UBT designed by Cambridge Design Partnership bridges the gap between the more expensive versions used in the West and the ‘condom catheter’. Its novel design combines features that make it intuitive and effective to use, to enable patient safety even in the hands of less experienced users – as well as ensuring cost effectiveness for manufacture. Lucy Sheldon, human centred design specialist, Cambridge Design Partnership said: “To be effective in low resource settings, medical products such as UBTs must be affordable and available; optimized for the intended conditions of distribution, storage, and use. To meet these needs we applied a human centred approach to the innovation process - combining expertise in human factors, risk management and interaction design - to the
development of our device. Our aim was to maximise usability in the hands of minimally trained birth assistants and lower the overall costs of the intervention, through reducing the medical professional’s, equipment and training required to safely and effectively use the device - to ultimately save lives.” Other innovation comes from Vygon (UK), the UK subsidiary of the specialist singleuse medical devices group, which recently announced that patients returning home from hospital with long-term catheters or receiving intravenous treatment can now buy online a disposable disinfection device, Curos Port Protector.
Curos Port Protector is a disposable, passive disinfection device. Studies have shown it reduces Central Line Associated Bloodstream Infections (CLABSI) and Catheter Related Bloodstream Infections (CRBSI) in hospitals. Its effectiveness was tested in vitro against Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli, Pseudomonas aeruginosa and Candida glabrata. The device has an integrated, disinfecting pad impregnated with 70% isopropyl alcohol, which cleans the IV or catheter access port, killing bacteria in three minutes – and providing ongoing protection for up to seven days. “Curos Port Protectors are a proven way of reducing infection risk for those patients who continue to receive treatment at home through intravenous needle-free devices and catheters,” said Brett Hughes, homecare manager at Vygon (UK). “A patient’s home is not as well-equipped as a hospital, Curos helps meet the challenges faced in providing quality healthcare in a domestic environment.” Allegations against the catheter industry are clearly unwelcome and the sector continues to innovate and push boundaries to help improve safety and infection issues. However, the conversation can be seen as a positive step to help boost product design and drive forward ideas and new ways of thinking. Already offering new and ground breaking devices and technology, the catheter industry has much to shout about and no doubt will continue to advance over the coming years.
WWW.MEDICALPLASTICSNEWS.COM
31
MERGERS & ACQUISITIONS
Business M Deborah Douglas is managing director of Douglas Group, a US merger and acquisition firm for mid-sized companies. She offers advice for companies involved in M&A activity
&A activity in plastic medical p r o d u c t manufacturing has been a key topic over recent years. There are companies in this segment that are competitively desirable and prognosis for growth is tremendous, with rapidly changing technology supporting steady development of new product and with increasing age and longevity of the population supporting market size.
Medical device manufacturers may experience calls from would-be buyers, probing potential interest in sale. The most successful sellers, however, aren’t the ones who respond personally to such inquiries. Premium acquisition pricing and terms come from a carefully managed competitive process. Buyers will pay the top premium when, and only when competitive process demands that they must. It is every buyer’s job to make acquisitions as cheaply as possible. In today’s marketplace the range of capable and ready buyers can make that a challenge. So, given the count of ready buyers and the heat in the marketplace, what can the potential seller do to ensure optimum results? First of all, have the selling process managed offsite, by professionals who know how it works. There are not enough hours in the day, for a private company seller to do it alone. It is impossible to keep it confidential if all of the related calls have to be done by an in-house owner. There are many capable intermediaries who do just seller representation. Find one you like. Consider a range of possible buyers. Sellers often think they know who the best buyers are likely to be. We have learned, over 23 years in this business, that they almost never are right. The ‘off-centre’ outside buyer will pay more than the obvious choice because he gets more when he makes an acquisition in a new area, that he couldn’t have penetrated without the buy. Consider multiple potential buyers but spend significant time only with the top few. A preliminary letter of interest with pricing and terms outlined should always be obtained before spending significant time on any one buyer.
32
WWW.MEDICALPLASTICSNEWS.COM
study
Resist or delay entering into an exclusive agreement with any one buyer. Buyers will often present a proposed letter of intent very quickly. That letter will provide that the seller agrees to talk to only the one buyer. Competition is gone from that point forward. Never enter into such a letter until you know what competitive buyers will pay, and until all substantive terms have been written, and agreed to with the buyer. Make sure final terms of any purchase agreement are clearly articulated with thorough understanding by both sides. Clean deals, without later dispute or litigation, come from very clear written agreements. Never accept an offer with less than 80% of the total cash you expect, unless the upside is huge and you’re personally comfortable that the risk is worth it. A large upside can be worth the risk but be sure that you understand that the cash at close is all that is guaranteed to be paid. Be sure the agreement for you to continue working is for a time period you can live with. Define duties that are to be yours and provide assurance that no move will be asked, if that’s important to you. If you hold real estate used by the company, any company sale agreement is not complete without clear articulation of the rental price and terms for the ongoing use of the property. Owners need to ensure that at some point in the future, that risk too can be eliminated. If you keep a minority interest in the sold enterprise, make sure there’s a binding agreement for your later buyout, at a firm formula price. Equity fund buyers are aggressive and commonplace in today’s M&A environment and they often want the seller to retain a portion. That can actually work wonderfully, for an exciting ‘second bite of the apple’ for the seller but if the enterprise could be held for many years, the seller needs protection.
“
Sellers who correctly manage the selling process may have the home run win of a lifetime in today’s acquisitive and competitive environment.
In the purchase agreement the seller will be required to make certain representations and warranties. Sellers need to carefully read and consider those representations, and they should make sure that any indemnification they must provide to buyers, regarding those representations, has a clear cap – not to exceed maybe 20% of the purchase price. Sellers who correctly manage the selling process may have the home run win of a lifetime in today’s acquisitive and competitive environment. The owner of a company gets one chance only to sell well. It is worth serious attention and hard work to do it right!
WWW.MEDICALPLASTICSNEWS.COM
33
NEC BIRMINGHAM, UK | 26-28 SEPTEMBER 2017
INJECTION MOULDING
EXTRUSION
ROTATIONAL MOULDING
BLOW MOULDING
RECYCLING
THERMOFORMING
M AT E R I A L S
VAC UUM FO RM IN G
DESIGN
FILM EXTRUSION
EXHIBIT NOW www.interplasuk.com 34
WWW.MEDICALPLASTICSNEWS.COM
DESIGN FOR LIFE
Heart of the matter Scientifically accurate 3D model accelerates device testing and research for treatment of heart disease
D
assauly Systèmes’ Living Heart Project offers a high-fidelity scientifically validated 3D simulator of a fourchamber human heart. With this model, device manufacturers, researchers and medical professionals will be able to perform virtual tests and visualise the heart’s response in ways that are not possible with traditional physical testing.
The Living Heart model offers a baseline healthy heart, which can be used to study congenital defects or heart disease by modifying the shape and tissue properties in an easy-to-use software editor. Medical devices can be inserted into the simulator to study their influence on cardiac function, validate their efficacy and predict reliability under a range of operating conditions. For example, coronary stents can be evaluated for optimal type, size and placement to achieve the best performance. “I had been aware of advances in simulation technology but prior to the Living Heart Project I was unaware that it could address the types of challenges I have as a practicing cardiologist and medical educator,” said Robert Schwengel, clinical assistant professor of medicine, Alpert Medical School, Brown University. “Having spent time with their 3D experiences, I believe a product like this could be very powerful in helping to educate my patients, students of medicine and current medical professionals, as well as lead to improved diagnostic capabilities and the personalisation of medical therapeutics.
Announced on 2014, the Living Heart Project leverages crowdsourcing of its 45 current members to build its models while protecting the intellectual property of each member. Members include regulatory science focused organisations such as the Food and Drug Administration (FDA) and the Medical Device Innovation Consortium (MDIC), as well as technology providers, cardiologists, medical device manufacturers and hospitals such as St Jude Medical and Mayo Clinic. This crowdsourcing approach has enabled the heart model to be independently tested and included in peer-reviewed scientific journals by project members and has helped Dassault Systèmes deliver the first iteration of the project’s commercial product on an accelerated schedule. This achievement demonstrates the effectiveness of the project’s approach and reaffirms the opportunity for simulation to address meaningful challenges in cardiovascular disease. “The availability of the first commercial, physics-based simulated heart marks a significant milestone for digital medical tools that will advance cardiovascular science and directly impact the quality of life of patients,” said Scott Berkey, CEO, Simulia, Dassault Systèmes. “The Living Heart Project is proof that our technology can potentially change the course of therapies through simulation of the human body. We will continue to collaborate with the biomedical community and our partners to provide technology and applications that will enhance the experience for heart patients everywhere.”
WWW.MEDICALPLASTICSNEWS.COM
35
STERILISATION
Sterilisation of medical tools and devices is an essential process for many medical procedures to prevent infections
Hey good looking S
STYROLUTION DISCUSSES THE COMBINATION OF STERILISATION AND AESTHETICS WITH STYRENICS
terilisation of medical tools and devices is an essential process that is required for many medical procedures to prevent infections and contamination. Several sterilisation procedures, such as steam sterilisation, EtO treatment, as well as beta and gamma irradiation, have been established in the industry to guarantee the complete removal of microorganisms, including bacterial and fungal spores from medical devices. While the complete removal and destruction of all living organisms is not always apparent to the naked eye, the aesthetics of a device can help create a sense of safety and cleanliness for both healthcare professionals and patients. As such, medical device manufacturers continue to seek out materials that balance sterilisation with aesthetic value and mechanical performance.
The taint of irradiation sterilisation
One of the most economic procedures for medical device sterilisation is the use of e-beam or gamma ray irradiation; and medical device manufacturers have a range of material options at their disposal for use in these sterilisation processes. However, not all materials are equally suited for these high energy treatments as they can result in a yellowing of the product or even the impairment of physical and mechanical properties.
While the yellowing tends to be temporary, depending on the material, the extent and duration of colour recovery differs significantly and can take up to several weeks (Figure 1). While additives or blue tints can be incorporated into the material to allow for colour correction over time, a poor colour compensation results in increased costs and logistical challenges due to prolonged inventory hold times for many manufacturers. Simply put – devices that are tinged yellow simply do not offer the aesthetic appeal or create the sense of confidence and cleanliness necessary for the healthcare industry.
Solutions for irradiation sterilisation Understanding the necessity of combining performance, sterilisation and aesthetics, Styrolution offers the healthcare industry two materials solutions, Zylar/Clearblend and Styrolux, which answer the challenges presented by other materials. Zylar/Clearblend is a clear, impact modified styrene acrylic copolymer that offers toughness, and chemical resistance to alcohols. As thermoplastic styrene-butadiene copolymer (SBC), Styrolux boasts high transparency, optical brilliance, impact resistance and ability to blend with other materials.
Medical service packages To meet the needs and demands of the medical industry, material solutions must also offer regulatory compliance in addition to aesthetics, performance and processability. Styrolution ensures its customers have the security and support necessary to guarantee compliance through medical service packages. These include a Full Service HD Package and an Essential HD Package. As medical device manufacturers continue to innovate in the healthcare industry, the use of materials that maintain their transparency and mechanical properties throughout irradiation sterilisation will continue to offer competitive advantages. By leveraging material solutions such as Zylar/Clearblend and Styrolux, and comprehensive medical service packages, manufacturers can develop medical devices with a clear and clean appearance that communicate the safety and sterilisation of the application, while reducing costs related to energy and inventory hold times.
Figure 1 Colour recovery of various materials after sterilisation with gamma irradiation. Styrolux and Zylar/Clearblend show a favourable low yellowing and hardly change in colour in dark storage. Natural PC shows strong yellowing with hardly any color correction. Styrolution’s Terlux shows a comparably better yellowing performance
36
WWW.MEDICALPLASTICSNEWS.COM
Permanent Antimicrobial Protection for medical plastics
Medically compliant polymers from Distrupol Be expertly guided to your polymer solution with Distrupol. To discover more about our medical range please contact us today. info@distrupol.com +44(0)1932 566033 www.distrupol.com
trusted by
+44 (0) 333 240 8308 www.biocote.com
THE ANTIMICROBIAL BRAND YOU CAN TRUST
7776 Distrupol MPN Advert 86x124 - Q3 2015.indd 1
22/07/2015 17:12
Medical Device Conference The Netherlands - Thursday 24th September
Synergy Health will be co-hosting an event with Anecto, Oliver Tolas, and DuPont. This one day conference will provide delegates with the opportunity to engage with industry experts on a range of subjects and an overview of all key elements of a product journey from concept to market.
WE TAKE CARE OF YOUR
For more information about the conference please email: assistance@synergyhealthplc.com
BOOK NOW!
medical device sterilisation needs Allowing you to take care of your customers
The relationship between manufacturers and sterilisation providers is an important element in assisting with the production and supply of products to customers. With over 30 years experience, Synergy Health, global supplier of outsourced sterilisation services is uniquely positioned to provide an experts’ insight into sterilisation technologies.
www.synergyhealthplc.com/sterilisation
assistance@synergyhealthplc.com MPN advert half page 2015.indd 1
WWW.MEDICALPLASTICSNEWS.COM
+44 8456 88 99 70 16/07/2015 13:58:11
37
STERILISATION
Performance parts Cathleen Hess, Sabic’s Innovative Plastics business looks at protecting staff and patients with high performance plastics
A
ccording to the World Health Organization (WHO), healthcare-associated infections (HCAIs) can result in prolonged hospital stays, create long-term disabilities, increase resistance to antimicrobials and generate high costs for patients and their families. To help combat this issue, the healthcare industry continues to prioritise efforts to help reduce the number of patients contracting infections while in the hospital or while administering healthcare in the home.
“
The WHO estimates that approximately 30% of patients in intensive care units (ICUs) in highincome countries are affected by at least one healthcareassociated infection.
The WHO estimates that approximately 30% of patients in intensive care units (ICUs) in highincome countries are affected by at least one healthcare-associated infection. In low and middle income countries, the frequency of ICU-acquired infections is at least two to three times higher and associated infection densities related to devices are up to 13 times higher, than in the USA. Newborns in developing countries are at an even higher risk of acquiring an HCAI with infection rates 3-20 times higher than in high-income countries.
High-touch medical devices, including electronic equipment encased in plastics, which are inadequately decontaminated can lead to the indirect transmission of pathogens. Regardless of region, there is no doubt that there is an urgent need for new solutions to be identified to help minimise the spread of HCAIs. Sabic’s Innovative Plastics business continues to develop materials with properties that can contribute to protecting both staff and patients from infection. Working closely with customers to understand their challenges has led to several key solutions, including materials with enhanced sterilisation performance,
38
materials with antimicrobial properties and materials that meet a wide range of chemical resistance requirements which can withstand more aggressive cleaning. The intensifying focus on the range of processes used to sterilise medical and dental equipment and devices continues to grow. Trends in the industry are pointing towards designing more inherent functional capabilities into reusable devices, meaning that they are more likely to contain sensitive electronics (vulnerable to heat and moisture) or other features which could require different sterilization options. Materials must now be able to withstand a number of different sterilisation processes which have the potential to degrade devices over time, diminishing their mechanical integrity, interfering with performance, or altering their aesthetics. Resin material technologies such as Sabic’s ULTEM HU1004 resin have evolved to help answer this need for enhanced protection and can be a significant factor prolonging the life of expensive medical and dental equipment by enabling it to better withstand intensive sterilization processes. Medical devices can be subjected to a variety of sterilisation processes, including gamma radiation, hydrogen peroxide gas sterilisation (a low temperature sterilisation process) and high temperature steam autoclave (up to 134°C). ULTEM HU1004 resin, a thermoplastic polyetherimide (PEI) material, has proven capabilities in each sterilisation environment. Sabic has worked closely with Indusbello, a medical device manufacturer in Brazil, to develop a differentiated solution using ULTEM HU1004 resin for sterilisation trays to help improve the safety of patients and clinician healthcare environments. Pre-assessed for biocompatibility per ISO 10993, this material can also provide flexibility in design, transparency, superior aesthetics and enhanced productivity through injection moulding.
WWW.MEDICALPLASTICSNEWS.COM
Team spirit: Sabic has worked closely with Indusbelloto develop a differentiated solution using ULTEM HU1004 resin for sterilisation trays
ammonium compound (QAC)-based disinfectants and alcohol-free / QAC-based disinfectants, which are commonly used disinfectants to help prevent the spread of infections. Designing healthcare applications with materials that can reduce the potential transfer of pathogens is another approach to help control the spread of infection. Sabic has developed a range of LNP antimicrobial thermoplastics compounds created with silver-based antimicrobial additives. The use of silver is key to the efficacy of these compounds, as silver is adaptable for diverse applications and is accepted as a broad-spectrum antimicrobial, with activity against multiple pathogens, including gram-positive and gram-negative bacteria, mould and fungus.
For opaque applications such as sterilisation tray bottoms where mechanical and physical property retention may be higher in priority than colour aesthetics, NORYL HNA055 resin offers impact resistance, dimensional stability, chemical resistance, hydrolytic stability and strong property retention after steam sterilisation at both 120°C and up to 134°C.
The antimicrobial portfolio comprises nine different grades across four product lines. Two levels of antimicrobial efficacy allow manufacturers to choose the solution that works best for their applications. When following ISO testing protocols under laboratory conditions (specifically the ISO test for MRSA), five of the ‘high effect’ antimicrobial LNP grades (used for high-touch applications) have a log reduction value greater than 4, representing a 99.99% reduction of pathogens. Four of the ‘low effect’ antimicrobial LNP grades (used for lowtouch applications) have a log reduction value of less than 4, representing a 99.0-99.99% reduction of pathogens. These compounds have the potential When following ISO to be used in a variety of medical device applications, testing protocols under such as monitoring and laboratory conditions imaging devices and other (specifically the ISO test device housings, as well as for MRSA), five of the surgical instruments, fluid and drug delivery products, and ‘high effect’ antimicrobial structural applications such as LNP grades (used for operating tables.
“
high-touch applications)
The repeated wipe down of medical have a log reduction In addition to the importance of minimising the spread of equipment with increasingly value greater than 4, infection in hospitals, the move aggressive disinfectants to prevent representing a 99.99% towards greater outpatient the spread of HCAIs is putting devices at risk for substantial wear reduction of pathogens. care and home administration of medication has created the and tear known as environmental need for improved safety in the stress cracking (ESC). ESC in medical home healthcare environment. devices as well as structural applications such as hospital bed components, can be related to Drug delivery device manufacturers are looking for many factors including polymer morphology, solutions that can make it easy and safe for patients chemical concentration and residual stress in to accurately administer their own medication. moulded components. Sabic’s range of engineered Sabic is helping the industry adapt to this trend with thermoplastics has been developed to help medical its new CYCOLOY HCX1640 resin, which meets device manufacturers meet challenging chemical standard healthcare regulations and can enable resistance requirements. Enhanced chemical the design of robust, light and attractive drug resistance performance test data which includes delivery devices, such as insulin pens. Our material results from an ESC resistance study, shows the technologies help manufacturers achieve thin walls performance of Sabic’s materials when repeatedly and dimensional stability, as well as improved weld exposed to aggressive disinfectants. The study looks line performance and impact resistance. These at compatibility of common flame resistant medical features enable the creation of complex designs enclosure materials tested with alcohol / quaternary that are capable of integrating an increased number of mechanical or electronic features.
Material world: Sabic’s CYCOLOY HCX1640 resin can enable the design of robust, light and attractive drug delivery devices, such as insulin pens
As the need for improved safety in hospital and home settings continues to rise, material innovators can play a significant role in developing new technologies to help create a clean and nonthreatening environment for patients and clinicians alike.
WWW.MEDICALPLASTICSNEWS.COM
39
BUYERSGUIDE Drug Delivery Devices
Bioabsorbable Polymers
Medipack AG (0041) 52 630 3636 Muhlentalstrasse 184-188, Schaffhausen, 8200, Switzerland
Foster Corporation (001) 860 928 4102 45 Ridge Road, Putnam, CT 06260
Catheters & Stents Formulance
(0033) 967 30 6463 Tour Oxygene, 10-12 boulevard Vivier Merle, 69393 Lyon Cedex, France
Interface Catheter Solutions (001) 949 448 7056 27721 La Paz Road, Laguna, Niguel, CA 92677 Microlumen (001) 813 886 1200 One Microlumen Way, Oldsmar, Florida, FL 34677, United States Teleflex Medical OEM (001) 847 596 3100 1425 Tri-State Parkway, Suite 120, Gurnee, Illinois 60031
Nemera (0033) (0)474 9505 46 20 Avenue de La Gare - B.P. 30, La Verpilliere, Cedex, 38292, France Schott
(0049) 6131 660 Hattenbergstrasse 10, Mainz, 55122, Germany
Extrusion Tubing Qosina (001) (631) 242-3000 150-Q Executive Drive, Edgewood, New York, NY 11717-8329
Injection Moulding Arburg (0049) 7446 330 P.O. Box 1109, Lossburg, 72286, Germany
Cleanroom Technology Engel Austria GmbH
(0043) 50 6200 Ludwig Engel Strasse 1, Schwertberg, A-4311, Austria
Medipack AG (0041) 52 630 3636 Muhlentalstrasse 184-188, Schaffhausen, 8200, Switzerland
Elastomers & Polymers
Carclo Technical Plastics UK
(0044) (0)208 685 5116 47 Wates Way, Mitcham, Surrey, CR4 4HR, United Kingdom
CI Medical Technologies (001) 724 537 9600 149 Devereux Drive, Latrobe, Pennsylvania, PA 15650, United States
EVERY SUCCESSFUL
MEDICAL DEVICE BEGINS WITH THE
RIGHT MATERIAL The leader in custom polymer technology for medical devices, implants and drug delivery applications Radiopaque · Low Friction · Antimicrobial Bioresorbable · Drug Eluding · Resin Distribution P 860.928.4102 • info@fostercomp.com
www.fostercomp.com
40
WWW.MEDICALPLASTICSNEWS.COM
Medical Plastic Parts
80149 Injection Site 13127 3-Way Stopcock
80375 Hemostasis Valve Y Connector
13148 Large-Bore Male Connector
80036 In-Line Flow Indicator
80137 Latex-Free Injection Site
11300 Vented Dust Cap
99921 Large Bore Female Connector
80330 FLO 30™ Tuohy Borst Adapter 12064 Slide Clamp
11158 Curved Dispensing Tip
65812 Non-Vented Universal Luer Lock Cap 99918 Closure Clamp
80393 Check Valve 33056 Non-Vented Luer Dispenser Tip Cap
11069 1-Way Stopcock 14038 Pinch Clamp
80184 Check Valve 65306 Vented Cap 99673 4-Way Stopcock
32309 Dilator
11079 Straight Dispensing Tip
80403 Tuohy Borst Adapter
12552 2 Channel Multi-Cavity Clip
12554 3 Channel Multi-Cavity Clip
12524 4 Channel Multi-Cavity Clip
12559 5 Channel Multi-Cavity Clip
12560 6 Channel Multi-Cavity Clip
C6011 Syringe
All trademarks and registered trademarks are the property of their respective owners
Qosina stocks thousands of OEM single-use components and offers excellent customer service including free samples, low minimums, and immediate delivery. Visit qosina.com to see over 5000 stock components, place orders and request a catalog. +1 631-242-3000
qosina.com
info@qosina.com
150-Q Executive Drive, Edgewood, NY 11717 USA
M1421.indd 1
7/16/2015 9:59:14 AM
WWW.MEDICALPLASTICSNEWS.COM
41
BUYERSGUIDE Injection Moulding
Metrology
Engel Austria GmbH
Sikora (0049) 421 48900 630 Bruchweide 2, Bremen, 28307, Germany
(0043) 50 6200 Ludwig Engel Strasse 1, Schwertberg, A-4311, Austria
Proto Labs Limited
Micro Moulding
(0044) (0)1952 683047 Halesfield 8, Telford, Shropshire, TF7 4QN, United Kingdom
Accumold
(001) 5159 645 741 1711 S.E. Oralabor Road, Ankeny, Iowa, IA 50021, United States
Qosina
(001) (631) 242-3000 150-Q Executive Drive, Edgewood, New York, NY 11717-8329
Ultrasion
(0034) 935 944 700 Valles Technology Park,Av. Universitat Autonoma, Cerdanyola del Valles, Barcelona, 23-08290, Spain
ISO13485 CI Medical Technologies (001) 724 537 9600 149 Devereux Drive, Latrobe, Pennsylvania, PA 15650, United States
Ophthalmics Nemera (0033) (0)474 9505 46 20 Avenue de La Gare - B.P. 30, La Verpilliere, Cedex, 38292, France
Innovative Polymer Compounds Ltd (IPC)
(00353) 57 933 3690 Unit 3, Midlands Gateway Business Park, Streamstown Road, Kilbeggan, Co. Westmeath, Ireland
Orthopaedics Materialise (0032) 16 396 291 Technologielaan 15, Leuven, 3001, Belgium
Metrology Hexagon Metrology
0870 446 2667 World Headquarters Office,Cedar House, 78 Portsmouth Road, Cobham, Surrey, KT11 1AN, United Kingdom
Nordson EFD (0033) 130 82 68 69 40 Rue des Vignobles, Chatou, 78400, France
Oxford Performance Materials
(001) 860 698 9300 30 South Satellite Road, South Windsor, CT 06074, United States
Packaging
Step 1 Blister sealing
Step 2
MRP System
Cutting of multi blister foil
MEDIPACK Rapid Packaging A simple system developed to save costs when packaging larger numbers of low cost components.
M
42
E
D
I
C
A
L
P
A
C
K
A
G
I
N
G
Result perfect individual blisters
MEDIPACK AG Mühlentalstr. 184 – 188 l CH-8200 Schaffhausen Phone +41 52 630 36 36 l info@medipack.ch www.medipack.com
WWW.MEDICALPLASTICSNEWS.COM
PEEK & High Performance Polymers
Advancing Device Design with PEEK-OPTIMA Polymers ÂŽ
` More than a decade of proven performance ` Use in over 5 million implanted devices globally ` Mechanical Strength & Durability
Visit Invibio.com to discover how we can help you bring your innovative devices to market more rapidly.
WWW.MEDICALPLASTICSNEWS.COM
43
BUYERSGUIDE
Orthopaedics
Sil-Pro (001) 763 972 9206 740 Seventh Street, South Delano, Minnesota, MN55328, United States Sunstar Degradable Solutions AG
(0041) 43 433 6200 Wagistrasse 23, CH-8952 Schlieren, Switzerland
Distrupol Limited
(0031) (0)78 6250150 Noordweg 3,Postbus 11, AA Zwijndrecht, 3330, Netherlands
Elasto UK Ltd
(0044) (0)161 654 6616 Don Street, Middleton, Manchester M24 2GG, United Kingdom
Invibio Ltd
Packaging Eastman Chemical B.V.
(0031) 10 2402 111 Fascinatio Boulevard 602-614, 2909 VA Capelle aan den IJssel, The Netherlands
Herrmann Ultraschalltechnik GmbH & Co.
(0049) 7248 79-729 Descostrasse 3-9, Karlsbad, D-76307, Germany
Nelipak Healthcare Packaging
(00353) 91 757 152 Unit 6D, Mervue Business Park, Galway, Ireland
PEEK & High Performance Polymers Foster Corporation
(001) 860 928 4102 45 Ridge Road, Putnam, CT 06260
Teleflex Medical OEM (001) 847 596 3100 1425 Tri-State Parkway, Suite 120, Gurnee, Illinois 60031 Zeus
(001) 803 268 9555 3737 Industrial Blvd., Orangeburg, South Carolina, SC 29118, United States
Polymers
Polymers
(0044) (0)1253 898000 Technology Centre, Hillhouse International, Thornton Cleveleys, Lancashire, FY5 4QD, United Kingdom
Melitek
(0045) 70 250 255 Hartvig Jensensvej 1, Nr. Alslev, DK-4840, Denmark
Polyurethanes DSM
(001) 510 809 1232 2810 7th Street, Berkeley, California, CA 94710, United States
Foster Corporation
(001) 860 928 4102 45 Ridge Road, Putnam, CT 06260 Formulance (0033) 967 30 6463 Tour Oxygene, 10-12 boulevard Vivier Merle, 69393 Lyon Cedex, France
Lubrizol Advanced Materials
(001) 216 447 6782 29400 Lakeland Boulevard, Wickliffe, Ohio, OH 44092, United States
Resorbable Implants
Your spe cialist for re sorbable implants Swiss
made
Degradable Solutions AG · A Company of the Sunstar Group Wagistrasse 23 · CH-8952 Schlieren · Tel.: +41 43 433 62 00 w w w.degradablesolutions.com · info.ds @ ch.sunstar.com
44
WWW.MEDICALPLASTICSNEWS.COM
Seals
TPE
Trelleborg Sealing Solutions Germany GmbH (0049) 711 786 40 Handwerkstrasse 5-7, DE-70565 Stuttgart, Germany
Sterilisation
Sterigenics
(001) 704 947 2505 2015 Spring Road,Suite 650, Oak Brook, Illinois, IL 60523, United States
Tubings Formulance (0033) 967 30 6463 Tour Oxygene, 10-12 boulevard Vivier Merle, 69393 Lyon Cedex, France
Microlumen (001) 813 886 1200 One Microlumen Way, Oldsmar, Florida, FL 34677, United States Polyflon (0044) (0)1785 859054 16 Raleigh Hall, Eccleshall, Stafford, ST21 6JL, United Kingdom Qosina (001) (631) 242-3000 150-Q Executive Drive, Edgewood, New York, NY 11717-8329
TPE for Medical Applications www.mediprene.com mediprene@elasto.se
Vention Medical
(001) 508 597 1701 261 Cedar Hill Street, Marlborough, Massachusetts, MA 01752, United States
Zeus (001) 803 268 9555 3737 Industrial Blvd., Orangeburg, South Carolina, SC 29118, United States
Ultrasonic Welding
Herrmann Ultraschall is a technology leader for machines, systems, and components for ultrasonic welding of plastics, packaging material, and nonwovens. Ultrasonic welding means joining without adhesives or screws, and without external heat supply. During this process, plastics are strategically melted by means of ultrasonic vibrations so that a cohesive or form-fit joint is produced. Being an economical production method with short cycle times, ultrasonic welding ensures a large degree of process control and repeatable quality results, and is implemented in many industries, such as automotive, medical engineering, packaging, hygiene, consumer, and electronics. Through their headquarters in Karlsbad and the Tech Centers and branch offices in Europe, the Americas, and Asia, the machine builder ensures global presence and local service for their customers. The product portfolio includes ultrasonic welding machines and modules for 20, 30, and 35 kHz.
For their customers, Herrmann Ultraschall assumes both the role of consultant and application problem solver with regards to the ultrasonic joining of plastic components, packaging and nonwoven products. For medical applications, these include membranes, adapters and connectors, fluid containers, surgical instruments, blood filters, disposable packaging, masks, wound dressings, and patches. Critical product and process requirements are realized with technology from Herrmann Ultraschall:
High strength Surfaces with impeccable visual appearance Reliable functionality of components Hermetic seal Prevention of particle flash Product safety due to cold sealing tools No adhesives or additives Statistical process monitoring Process data acquisition and analysis User authentification and audit trails Feasible for clean room applications
Herrmann Ultraschall GmbH & Co. KG, Descostraße 3–9, 76307 Karlsbad, Germany T: +49 7248 79-0 info@herrmannultraschall.com
WWW.MEDICALPLASTICSNEWS.COM
45
BEADY
eye
Keeping an eye on the next big thing can be hard. Each issue of MPN selects a company, service or technology that it thinks is the one to watch . . . Who are you and what do you do?
DELIVERY SERVICE
Biocorp specialises in the development and manufacturing of medical devices, including drug Eric Dessertenne, head of s m a r t business development and delivery devices. The company commercial operations, d e v e l o p s Biocorp, describes the innovative primary company’s advancement p a c k a g i n g safety in the medical device and a n d systems for the digital health sectors p ha r ma c e u t i c a l industry such as reconstitution sets, alternative to crimp caps and leading-edge passive safety systems for prefilled syringes. We also offer expertise in digital health: a device R&D team and a software R&D team work hand-inhand to develop highly integrated devices that help patients manage their treatment and improve their therapeutic compliance. Our most advanced smart delivery system yet is the DataPen, a reusable injection pen connected by Bluetooth to a dedicated smartphone app.
46
What projects have you been focused on recently?
Our R&D teams have recently focused their efforts on two devices: the DataPen and the NewGuard, a product combining the properties of a rigid needle shield with those of a passive safety system for syringes. The DataPen is the first injection pen directly connected to a smartphone app. This fully integrated system aims at helping patients administer their medication, manage their treatment and share essential data with their physicians or relatives. Lack of therapeutic compliance is a huge underserved issue that affects patients, payers and pharmaceutical companies. The DataPen is used for subcutaneous delivery and is compatible with standard 3ml cartridges. The proof-of-concept has been developed for insulin therapy in diabetes mellitus, as realtime management is extremely
important for this chronic condition. The software brings numerous advantages, such as data sharing, reminders, etc. The NewGuard device addresses issues affecting several stakeholders of the pharmaceutical industry. This system shields the needle to prevent needle stick injuries and contaminations, as required by regulatory authorities. In the US, the “Needlestick Safety and Prevention Act” was signed into law on November 6, 2000, to implement safer medical devices. In Europe, the two directives 89/391 and 2000/54 define risk management plans that healthcare providers have to implement in order to avoid accidental contaminations due to needles and sharp objects. Secondly, the NewGuard also provides a safety system that automatically locks the needle inside the rigid shield after the first injection. The World Health Organization recently published guidelines on the use of safety-engineered syringes for intramuscular, intradermal and subcutaneous injections in health care settings. This report was motivated by the alarming number of unsafe injections with the multiple use of the same syringes or needles on different patients, spreading deadly infectious diseases. Finally, the
WWW.MEDICALPLASTICSNEWS.COM
NewGuard combines these two functions while taking into account industrial processes and costs. Thanks to its size and shape, this device is compatible with nests. In consequence, manufacturing and assembly processes can be handled directly by glass manufacturers.
Describe your latest innovation?
Our latest innovation strengthens Biocorp’s position as the pioneer in connected drug delivery and is a new addition to our smart drug delivery devices range. This device is an add-on that fits on existing – and marketed - insulin pens to transfer patient data directly to a dedicated mobile app. This innovation brings many benefits to patients, physicians, pharmaceutical companies and payers.
What does it mean for the medical sector?
This latest innovation, along with the DataPen, underlines the increasing role that digital technologies play in the healthcare sector. During the last decade, numerous studies on health information technology have underlined the positive impact of eHealth and mHealth on the healthcare system and patients’ health). If medical mobile apps are efficiently integrated into treatments, they offer unprecedented opportunities to lower healthcare costs, improve treatment outcomes and enhance point-of-care delivery.
Plans for the future?
We plan to keep on developing new innovative devices for the pharmaceutical industry, both connected and non-connected. We are eager to continue contributing to the development of eHealth and mHealth technologies thanks to our two core competencies. We are considering new therapeutic areas for which we could adapt our platform technology.