MPN EU Issue 48 by MPN Magazine

EUROPEAN EDITION

MEDICAL PLASTICS news PUSH IT to the Accumold

talks ultra

-thin walle

d micro m

oulding

MED-TECH INNOVATION EXPO FULLY IMPLANTABLE HUMAN ORGANS THE BENEFITS OF CONNECTED HEALTH FOR MANUFACTURERS

ISSUE 48

May-Jun 2019

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CONTENTS May-Jun 2019, Issue 48

Regulars

Features

3 Comment Laura Hughes discusses why avoiding plastics isnâ&#x20AC;&#x2122;t the way forward

19 Time for transparency Sumitomo (SHI) Demag discuss its fully automated in mould decorating production cell which can be used by to issue medical devices with unique device identifications

6 News focus Plastic innovators win big at industry awards 8 Digital spy 16 Cover story Aaron Johnson, Accumold discusses ultra-thin walled micro moulding, electronics and the role of both within medical devices 42 06:2019

24 The end is in sight Medical Plastics News editor Laura Hughes spoke with Jeff Ross, CEO of Miromatrix Medical about the fully implantable human organs Miromatrix is creating

34 The perfect match Mark Turner, Medical Engineering Technologies discusses the relevance of chemical characterisation in medical device compatibility 37 A whole new world Avinent explains the possibilities its investment in the worldâ&#x20AC;&#x2122;s only full-colour, multi-material Stratasys J750 3D printer could provide within the medical sector

30 Better connected Kevin Deane, PhillipsMedisize explains why he believes connected health offers promising potential for manufacturers

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editor | laura hughes laura.hughes@rapidnews.com

EDITOR’S

Why avoiding plastics isn’t the way forward

publisher | duncan wood Medical Plastics News Europe Print Subscription – Qualifying Criteria UK & Europe – Free US/Canada – £249 ROW – £249 Medical Plastics News NA Print Subscription – Qualifying Criteria US/Canada – Free UK & Europe – £249 ROW – £249 FREE on iOS and Android devices Subscription enquiries to subscriptions@rapidnews.com Medical Plastics News is published by: Rapid Life Sciences Ltd, Carlton House, Sandpiper Way, Chester Business Park, Chester, CH4 9QE T: +44(0)1244 680222 F: +44(0)1244 671074 © 2019 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)

edical Plastics News focusses on plastics within the medical sector. However, the characteristics and processes associated with these plastics are equally as applicable within other areas where the material is used. The recycling of plastics within the medical field is a topic that has been widely discussed of late, as recycling rates are relatively low when compared with other sectors. A paper previously published in the British Medical Journal stated that less than 10% of total National Health Service (NHS) waste was recycled. Additionally, it was reported by the Press Association that the NHS used more than half a billion disposable cups across five years. These cups are mainly used for hot and cold drinks within hospitals, as well as dispensing medication. England’s chief medical officer, Sally Davies has previously called on the NHS to cut its pollutant footprint. Following the announcement of these figures, some hospitals have made pledges to reduce the use of disposable plastic cups. We as a society tend to follow government initiatives and live up to the expected social standards through recycling plastics at home and at work. There is no real reason why plastics used within the medical field should be treated any differently. Within a controlled, professional environment it seems odd to me that recycling rates here wouldn’t be higher than the rates achieved by the general public. Perhaps the NHS

and similar organisations should implement processes that require its employees to recycle more within the workplace. In contrast to the above, scope exists for other sectors to learn from the use of plastics within the medical field. At the recent Met Gala in New York, several celebrities wore garments that were created through a collaboration between designer Zac Posen and manufacturers Protolabs and GE Additive. Together, they had created garments for celebrities using 3D printing. The outfits they were able to design were glamorous and appropriate wear for the Met Gala, where looking fashionable is a necessity. The media coverage following these outfits is sure to bring attention to 3D printing. Hopefully, this will then stimulate interest in the technology amongst those who have not heard about it previously. As demonstrated by Posen, others within their own area of expertise may find a novel use for plastics and 3D printing, that is not currently in place in their field.

Plastics and their characteristics offer huge beneﬁts to the medical sector; therefore, strides must be taken to ensure that the material is utilised in the most efﬁcient and sustainable way.

We are making huge advances with the use of plastics and technology within the medical field. However, I strongly believe that there are still lessons to be learned from other sectors. I don’t believe that avoiding plastics where possible is the way forward. Plastics and their characteristics offer huge benefits to the medical sector; therefore, strides must be taken to ensure that the material is utilised in the most efficient and sustainable way.

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NEWS FOCUS

Plastic innovators win BIG at medtech awards ON 15 MAY 2019, THE MEDILINK UK HEALTHCARE BUSINESS AWARDS CELEBRATED THE BEST-IN-CLASS OF THE INDUSTRY’S TALENT. THE SELL-OUT GALA EVENING SHOWCASED A HOST OF POLYMER INNOVATIONS AMONG THE WINNERS.

he awards were presented by Adam Kay, award winning author of the hilarious bestseller This Is Going to Hurt - recollections from his days as a junior doctor. Adam provided postdinner entertainment to rapturous applause.

exceptional work being done in the UK and overseas to advance the healthcare sector. This year the awards have shone a spotlight on not only those suppliers serving the healthcare front line, but also the engineers and innovators working behind the scenes to set the pace of change.’’

Adam said: “It’s been an absolute pleasure and an honour to be invited along tonight to be part of this evening and to present awards to some wonderful companies doing crucial work, supporting through their innovation the healthcare and life sciences sector.” In total, 10 companies from across the UK and overseas were presented with either a Medilink UK or Med-Tech Innovation award. Nick Rodgers, vice-chair of Medilink UK commented: “The Medilink UK Healthcare Business Awards have been a raging success once again, congratulations to all of the award winners, runners up and finalists. It’s been fantastic to see so many people from across the industry coming together to celebrate the outstanding achievements and contributions to the Life Sciences sector.” Dave Gray, group editor, Med-Tech Innovation commented: ‘‘It’s been a privilege to learn about all of the

One of the firms celebrating a win was Paxman, which scooped the export achievement award for its scalp cooling technology for preventing hair loss in chemotherapy patients. Paxman’s cooling caps are made from high grade silicone material, designed to provide a close fit around the patient’s head. As coolant passes through the cold cap to extract heat from the patient’s scalp, inline temperature sensors ensure the cap maintains the scalp at an even, constant temperature. A neoprene cover is provided with the Paxman cap to assist in the efficiency and operation of the system. Paxman cold caps are attached to the scalp cooling system with quick release, non-drip plastic couplings. Once the treatment is finished, the cold cap can be disconnected from the cooling line and washed with soap and water or detergent ready for the next patient.

Meanwhile UK-based ES Precision was recognised with an engineering award for its laser perforating process which contributes to a better, more comfortable experience for amputees when wearing artificial limbs. Judges applauded the fact that the company has developed an efficient and effective way of manufacturing prosthetic silicone inserts by laser drilling. Finally, closing the night, the materials innovation award was given to Nova-BioRubber Green Technologies, which was chosen as a result of its green processing technologies for the production of hypoallergenic and sustainable biolatex, biorubber and inulin, designed to tackle latex allergy and satisfy growing rubber demand in a sustainable way. Judges said that the material could help deal with a significant problem in the healthcare world, and that a hypoallergenic and sustainable biolatex could make a huge positive impact on the industry.

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DIGITAL SPY

MEDTECH UPDATE

DIGITAL

www.HealthTechConnect.org.uk

spy DEVICE UPDATE

Wearable adrenaline could provide a potentially LIFE SAVING ALTERNATIVE

NEW RESOURCE LAUNCHED BY NICE

‘

tudents at Rice University are attempting to develop a cheaper, stylish and comfortable alternative device to the currently available adrenaline pens which are used in emergencies to treat allergic reactions. As current adrenaline pens are bulky, the students hope their idea will increase the chance of users bringing the device with them during their day-to-day life. The device is called, ‘Epiwear’ and has a spring-activated

injection system that is designed to deliver the same amount of adrenaline (0.3 millilitres) as currently available devices. Jacob Mattia, a bioengineering major who is developing the device alongside other students stated: “We’ve been focusing on the mechanism itself, but some of the ideas we’ve thought about are designing it with cool colours or integrating a watch to make it a dualpurpose device.”

©BRANDON MARTIN/RICE UNIVERSITY

ICE (The National Institute for Clinical Excellence) has announced a new resource named HealthTech Connect. The aim of this tool is to identify and support new health technologies. Companies can register online, and then enter and update information about their technology as it develops. HealthTech Connect will link the new technology with relevant assessment bodies such as NICE. As a result, companies will not have to provide the same or similar information separately. Meindert Boysen, director of the centre for health technology evaluation at NICE, said: “HealthTech Connect is a clear and simple point of entry

for companies developing health technologies, be it medical devices, diagnostics or digital health technologies, to access support and potential routes to national evaluation programmes.” Since the initial launch of the system in February, over 100 companies have registered to use HealthTech Connect, 13 technologies have been submitted, and one technology named Gynesonics’ Sonata System, has already been selected by NICE for an introductory briefing as a result of this technology. This resource is backed by NHS England and has been developed with NICE’s partner organisations. It is free to use.

DEVICE UPDATE

New high-resolution microscope ready for use

esearchers from the University of Connecticut and the University of Memphis have created a small and robust high-resolution microscope. They claim it is portable and inexpensive and able to detect conditions such as diabetes and malaria. The microscope is able to produce 3D images with twice the resolution of traditional digital holographic microscopy, which is typically performed in a laboratory. This use of 3D printing has enabled researchers to reduce the complexity of this system.

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Research team leader Bahram Javidi from the University of Connecticut said: “This new microscope doesn’t require any special staining or labels and could help increase access to low-cost medical diagnostic testing. “This would be especially beneficial in developing parts of the world where there is limited access to health care and few high-tech diagnostic facilities. “The entire system consists of 3D printed parts and commonly found optical components, making it inexpensive and easy to replicate.” The current system is ready to use for biomedical applications such as cell identification and disease diagnosis. The research has been published within the journal Optics Letters.

DIGITAL SPY

MEDTECH UPDATE

talking

POINT DRONE DELIVERS DONOR ORGAN R esearchers and aviation and engineering experts from multiple organisations have together developed a drone which was successfully able to deliver a donated kidney, which was then transplanted in to a patient. This drone was designed in order to maintain and monitor the organ during transit. The design consisted of a custom-made drone capable of carrying the additional weight of an organ, with cameras, trackers, and communications and safety systems for the flight over an urban, densely-populated area. Researchers believe that unmanned aircraft delivery has the potential to be the fastest, safest and least expensive method to transplant organs to those in need. Joseph Scalea, assistant professor of surgery at University of Maryland School of Medicine and one of the surgeons who performed the transplant

said: “Delivering an organ from a donor to a patient is a sacred duty with many moving parts. It is critical that we find ways of doing this better.” Charlie Alexander, chief executive of The Living Legacy Foundation of Maryland stated: “If we can prove that this works, then we can look at much greater distances of unmanned organ transport. This would minimise the need for multiple pilots and flight time and address safety issues we have in our field.” This research was conducted by the University of Maryland School of Medicine, the University of Maryland and the Living Legacy Foundation of Maryland, to develop what could potentially be a life-saving aviation system. Drones are already in use as a delivery method for medical products in Africa.

MEDTECH UPDATE

3D PRINTING REQUIRES highly functional bioinks

n order to 3D print tissues, organs and even entire body parts, scientists will have to create highly functional bioinks. These bioinks will need to be able to withstand being printed and then be able to survive within the human body. Researchers state that they have already developed a number of liquid bioinks that are made up of biopolymers, including gelatin and hyaluronic acid, an aqueous medium, and the living cells to be proliferated. They are deposited a layer at a time and in different sequences in order to create a hydrogel in the desired shape. When ultraviolet light is used, the molecules within the material are able to cross-link and create strong connections, leading to a change in the consistency of the material. As the

bioinks can be created with more or less of certain components, this can result in a large range of possibilities. This research was conducted at the Fraunhofer Institute for Interfacial Engineering and Biotechnology and the University of Stuttgart.

www.kaust.edu.sa/en

NEW PILL BOTTLES COULD IMPROVE PATIENT SAFETY Researchers at the King Abdullah University of Science and Technology have developed a pill bottle which aims to improve patient safety through the use of sensors. WHY IS THERE A NEED FOR THIS TECHNOLOGY? The researchers’ reason for this invention was to help tackle problems with prescription abuse. HOW DOES THIS WORK? Sensors are placed inside the lid of the pill bottle, and in the case of tampering, an overdose or unsafe storage conditions being detected the pill bottle sends a wireless alert to a cell phone via Bluetooth. The bottle lid that is able to use lightemitting diodes is 3D printed, enabling the number of pills that are dispensed to be counted. HAS THIS TYPE OF TECHNOLOGY BEEN USED BEFORE? Within hospitals wearable sensors are used to track things such as influenza outbreaks, however their usage is limited by the high costs associated with this technology. Researchers aim to make these pill bottles more affordable by creating the sensors from paper by drawing circuits with conductive ink. “Similar devices have been used in flat panel displays, but we’ve made them simple to build and easy to use by almost anyone,” states doctoral researcher Sherjeel Khan, who has been working on the product. 9

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INJECTION MOULDING

MARTIN MANKA, ARBURG SENIOR SALES MANAGER, MEDICAL DESCRIBES THE KEY ROLE ARBURG PLAYS IN PREVENTING THE FREEZE-CRACKING OF BLOOD-SAMPLE TUBES WITHIN THE TWO-COMPONENT WET-IN-WET MOULDING PROCESS.

he French Blood Donor Centre, and other institutions within Europe, the United States and Australia come to Jako Meditec, Szekszárd, Hungary, for tubes, closures and racks used to store blood samples. Their requirements are quite specific stating that each tube and the blood sample inside it must be uniquely identifiable, and the tubes must also withstand storage at -35⁰C for three years. To meet those demands, Jako worked with Arburg and a German mould maker to develop a unique two-component moulding process they refer to as wet-in-wet moulding. JAKO PRODUCES AROUND ONE MILLION TUBES A MONTH

The process yields transparent tubes made from polypropylene (PP) with a black PP base that can be laser marked with a unique data matrix (DM) code that meets the traceability requirement.

The first 8-cavity mould performed well, producing in excess of two million shots. Today, a moulding cell docked to a class 8 clean room is used to produce the tubes. The centrepiece of the cell is a 2,200-kN (245-ton) hydraulic allrounder 570 S, which is fitted with two size170 (3.7-oz) injection units and a 32-cavity mould.

However, Jako found they couldn’t use a rotary or sliding split mould which is the conventional approach to two component injection moulding, because injecting the two materials sequentially created a weld line that was prone to cracking during the thawing of the blood samples. This problem led to the development of the wet-in-wet process. Instead of injecting sequentially, explains Stephan Hauri, Jako project manager for plastic injection moulding, “both components are injected almost simultaneously into the mould. Here, they flow towards each other and fuse together when they meet.” This sophisticated innovation was jointly implemented with Arburg Hungary and the German mould manufacturer Polar-Form,” says Joachim Koch, who, along with his brother, Andreas Koch, founded Jako Group 20 years ago and formed Jako Meditec in 2015. The two share the title of managing director. Their father, senior partner Adam Koch came up with the idea for the wet-in-wet process and Jako also had the support of the Arburg application technology group during the development and implementation stages of the project. Joachim Koch states that the Arburg control system “operates with a precision down to a hundredth of a second during injection.” Such precision is necessary because the amount of clear and black material needs to be consistent so that the black section which gets the DM marking is the right size.

In the clean room, the tubes are stored temporarily until they are labelled, assembled, and inspected according to customer specifications. “For this purpose, we work with island solutions,” explains Hauri. In total, Jako operates five allrounders and around 20 moulds with between one and 32 cavities are in operation to produce the appropriate screw caps, thermoplastic rubber or elastomer (TPE) plugs and seven different rack types. Joachim Koch says Jako expects “to produce around 1.5 million tubes per month.” Andreas Koch concludes by saying, “the Arburg machines have been in continuous operation very reliably since the start of production and have proven extremely well suited to their task.”

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MTI EXPO

Let's talk about it LEANNE TAYLOR, HEAD OF CONTENT - PLASTICS, RAPID NEWS LED A HEALTHCARE DISCUSSION ON WOMEN IN PLASTICS ON THE HEALTHTECH STAGE AT THIS YEAR’S MED TECH INNOVATION EXPO.

he panel consisted of three women who were each introduced in turn by Taylor. They were: Dr Artemis Stamboulis, senior lecturer in biomaterials and nanomaterials, University of Birmingham Helena Flowers, owner and managing director, Andel Plastics Rebecca Smith, national territories manager, Connect2Cleanrooms Taylor began by asking each of the speakers how they had begun their careers within the medical plastics industry. Smith explained how she started her career in pharmaceutical sales, following completion of her biology degree. She described herself as having been very, “young and naïve” and highlighted how fortunate she had been to work for such a supportive pharmaceutical company. Smith spoke positively about seeing a successful woman within the business, and having the opportunity to learn from her. For the last eight years Smith has worked for Connect2Cleanrooms and mentioned how supportive the organisation is. Stamboulis described how she had initially completed a degree in polymer science and engineering to work for her family company. However, she mentioned how, “the boys in the company had some sort of priority”, and how they had been “considered to be better.” It was as a result of the lack of opportunities for Stamboulis within this company, that she decided to in her words to, “do something completely different.” She then went in to research following completion of her PhD. Flowers told how her story began similarly to Stamboulis’ as she also went in to a family business. However, Flowers mentioned how her mum had always said, “there is no such thing as a female job or a male job.” Unlike Stamboulis, Flowers remains in her family business having taken over the business in 2003, and now owning the business herself. Taylor asked about balancing a family and a career, and how employers could support women more with this. Stamboulis said how she believed if women have the motivation to do things then they will get them done. However, in order to do this women need flexibility from employers. Stamboulis also stated how some of her colleagues had made the decision not to have children so they could have a career. She asked, “is this really a choice?” Smith added that her organisation allows people to have the flexibility to do things like picking their children up from school. Smith thought she was lucky to work in an organisation that embraces this and believes that men and women in any organisation where there isn’t this type of flexibility should get in involved in making this the reality.

Flowers stated that this topic affects men as well as women, as men often have wives who have children, and therefore will face these challenges indirectly. Taylor then asked the women what they thought the advantages of having women within the workplace were. Smith commented: “Whatever race, sexual orientation, gender – we need to start to recognise the more diversity you have in an organisation, the better it is.” Stamboulis said, “there are some opportunities, but there are not enough.” Stamboulis thought that women needed to be encouraged to apply for more senior positions, and thinks that, “often women feel if I don’t get this job I have failed. Women can be afraid to challenge themselves.” She suggested job adverts need to be written in a different way. Flowers explained how she is attempting to recruit a female currently due to the different way they look at things. She is working on a job advert that she hopes will encourage women to apply. As the discussion came to a close the women gave their concluding remarks. Stamboulis stated, “I’m not interested in being in competition with men. I would like women to be confident and believe in themselves. We are equal.” Smith commented: “Don’t allow yourself to be a victim. Don’t sit there and think I’m not doing that because I’m a woman. You have to back yourself, then it is much easier to get others to back you.” Together Smith and Flowers agreed you have to, “be your own champion.”

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CASE STUDY

LIGHTNING SPEED MEDICAL PLASTICS NEWS EDITOR LAURA HUGHES RECENTLY ATTENDED THE INDUSTRY 4.0 SUMMIT AND EXPO IN MANCHESTER, UNITED KINGDOM. HERE, PROTOLABS HIGHLIGHTED HOW ITS ON-DEMAND MANUFACTURING OPTION ENABLED PARKER HANNIFIN TO REDUCE DEVELOPMENT TIME, RESPOND TO CUSTOMER FEEDBACK AND BRING INNOVATIVE PRODUCTS TO THE MARKET FASTER.

uring the Industry 4.0 Summit and Expo Anastasios Pantelis, an application engineer from digital manufacturing specialist organisation Protolabs presented a case study. This case was based on how Donald E. Washkewicz, the former CEO of the Parker Hannifin Corporation brought a robotic exoskeleton to life via digital manufacturing. It all started seven years ago when Parker Hannifin, a motion and control technology specialist investigated how to develop wearable robotic devices in the prosthetics and orthotics space. With the help of researchers at Vanderbilt University, Parker Hannifin worked to adapt robotics technology in order to increase mobility for patients with lower limb paralysis and to help these patients regain the ability to walk. This partnership between Parker Hannifin and Vanderbilt University led to the development of a wearable exoskeleton which consisted of a brace worn on the hips and legs that could be powered by motors, batteries, and other electronics. This exoskeleton named Indego was commercialised and licensed. The initial manufacturing process of the exoskeleton was determined to be suboptimal due to long delays when waiting for production quotes and also for parts to arrive. Protolabs however, aimed to relieve the company of these issues through methods such as offering the option of an interactive quoting system; something that was highlighted during the Industry 4.0 presentation. Ryan Farris, a coinventor of the technology whilst conducting his doctoral work at Vanderbilt University explained, “we primarily use Protolabs to test new ideas. For instance, as we consider a potential design improvement, we want the ability to create parts and see how they perform as quickly as possible.” An example is the component that serves as a light pipe for the device which requires a particularly quick turnaround. Farris explains the role of this part: “This little indicator is particularly important because this is how the user, the paraplegic, the stroke patient, or whoever is using the system knows what state they’re in, what mode they’re in, and what’s about to happen with the device.” Originally the part was manufactured with a moulded thermoplastic, but the motion of the assembly did not co-operate well with the rigid plastic-

like component. Therefore, a decision was made to manufacture this part with liquid silicone rubber (LSR), due to the flexible nature and durability of this material. Protolabs’ LSR moulding process meant they were able to quickly manufacture several components. Farris stated: “We have been very happy with the switch to a LSR part. The light transmission is excellent, the visibility of the indicator to the user is excellent, and we have not had any durability issues since the change.” Farris believes Protolabs’ moulding process allowed his team to save up to two months of time, but also acted as an example of the company’s strategic effort to listen to user feedback and rapidly implement product improvements. “Our aim is to be as fast as possible. When we have new developments, part of our competitive advantage is speed. When we have issues in the field, one of the things that we believe shows concern for our customers in a big way is our speed of response,” Farris explained. The on-demand manufacturing option provided by Protolabs enabled Parker Hannifin to reduce development time, respond to customer feedback and bring innovative products to the market faster. Additionally, Protolabs provided assistance to the development of the exoskeleton through its CNC machining and 3D printing capabilities.

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COVER STORY

AARON JOHNSON, ACCUMOLDâ&#x20AC;&#x2122;S VICE PRESIDENT OF MARKETING AND CUSTOMER STRATEGY, DISCUSSES ULTRA-THIN WALLED MICRO MOULDING, ELECTRONICS AND THE ROLE OF BOTH WITHIN MEDICAL DEVICES.

PUSH IT to the 16

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COVER STORY

ltra-thin walled micro moulding is becoming increasingly challenging as a result of trends within electronics such as wearables, and due to the pressing demand to improve patient care. Johnson provides a unique insight as to how this affects the manufacturers of small and micro injection moulded components. WHAT ARE THE CHALLENGES ASSOCIATED WITH ULTRA-THIN WALLED MICRO MOULDING? There are many challenges associated with ultra-thin walled micromoulding. The strong drive to reduce form factors means that design engineers are often looking towards wall thickness as an opportunity to gain space. As a result, this is putting a lot of pressure on component manufacturers and is pushing ultra-thin walled micro moulding to the extreme. One of the main challenges is the profound relationship between the geometry and the material selection, particularly with high aspect ratio wall sections. In these circumstances it can be hard to follow specific guidelines. An ultra-thin wall section e.g. about 75 microns thick over a high aspect ratio of more than 25:1, is achievable but is very material dependent. When you’re looking for material properties to match the geometry you’re after it can be very challenging. For example, polyetheretherketone is a commonly desired biocompatible resin but is not friendly to high aspect ratio ultra-thin moulding. Liquid crystal polymers (LCPs) on the other hand can perform very high aspect ratios but may not have the physical characteristics you’re after. It becomes more than just a simple guideline for aspect ratio and usually comes down to the experience of the micro moulder. WHAT ARE SOME ESSENTIAL APPLICATIONS OF ULTRA-THIN WALLED MICRO MOULDING? Wearable devices, micro surgical tools, diagnostics, transcatheter or endoscopic components are a few of the common medical devices looking to push the limits when it comes to ultra-thin walled micro moulding. Applications that are looking to do more in the same space, or more in less, are commonly looking to push the limits with their form factors. The more they can reduce the form, the more space they can have for other components, or the more they can reduce the overall footprint. WHAT IS THE BEST MATERIAL CHOICE FOR ULTRA-THIN WALLED MICRO MOULDING? LCP is probably one of the best performing materials when it comes to high aspect ratio ultra-thin walled micro moulding. Other materials including polyethylene, polypropylene, or polyoxymethylene are also very capable with these dimensions as well. In some situations, polymethyl methacrylate, polybutylene terephthalate or nylon could also be good choices. Each of these materials present their own advantages and limitations. The design plays a key factor in the success of a material for this purpose. WHICH ELEMENTS SHOULD MANUFACTURERS TEST WHEN USING ULTRA-THIN WALLED MICRO MOULDING? The structural and mechanical properties will need to be tested if they are important for the functionality of the part. Environmental testing is also very common, especially in high heat applications where material stability is important. Plastic parts that don’t have a lot of mass can sometimes behave unexpectedly, therefore a test is always recommended. WHAT ARE THE LATEST TRENDS FOR MEDICAL DEVICES? It is thought that medical devices will never stop looking to reduce their size. There is a high demand to produce more minimally invasive devices, and to find newer opportunities within patient care that can reach further into the body with less effort. The medical device market continues to push the limits of mechanical design with the hope of improving patient care. WHAT ARE WE SEEING IN NEW APPLICATIONS? Wearable applications are the latest trend within medical devices. It is thought that putting more care in to the hands of the patients often provides better data and more immediate feedback resulting in better care. Advancements in electronics, drug delivery, diagnostics, etc., have

all brought innovative products to market. Manufacturing processes like micro moulding have helped enable these technologies to provide the most value to the patients with the least amount of impact possible. WHAT IS IMPORTANT TO CONSIDER WHEN CHOOSING A MANUFACTURING PARTNER LIKE ACCUMOLD? Experience is the number one factor when choosing a manufacturing partner for micro moulding. Partners are required to build the tools, process the materials and produce high quality output, and this can be daunting. Secondarily, whenever interviewing a new potential partner their capability is not the only important factor. It is also very important to make sure that they are able to sustainably meet the scalability required, as a disruption in the supply chain can be extremely frustrating. It is very important to ensure your new partner is well equipped beyond the prototyping phase. WHY IS IT IMPORTANT TO CHOOSE A MANUFACTURING PARTNER THAT UNDERSTANDS TRENDS IN ELECTRONICS? As with any product or service keeping up with the needs of the customers is non-negotiable. It is important to understand that form factor reduction and pushing the limits with micro injection moulding could be key future solutions. Having a manufacturing partner that understands the trends in electronics enables the organisation to focus on the mechanical trends and the material science driving tomorrow’s products.

Putting more care in to the hands of the patient often provides better data and more immediate feedback resulting in better care.

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REGULATORY UPDATE

A FULLY AUTOMATED IN MOULD DECORATING (IMD) PRODUCTION CELL WHICH CAN BE USED BY TO ISSUE MEDICAL DEVICES WITH UNIQUE DEVICE IDENTIFICATIONS (UDIs) HAS BEEN PIONEERED BY MOULDING MACHINE SPECIALIST SUMITOMO (SHI) DEMAG.

n May 26th, 2020, the new EU Medical Device Regulations (MDR) which mean that every device or its packaging must be issued with a UDI will be enforced. The IMD production cell hopes to tackle what some in the industry perceive will be a challenging and costly undertaking. Designed predominantly for healthcare, automotive and aerospace manufacturing environments where quality control and traceability are critical, the advance hopes to represent a colossal change in how multiple components are individually issued with a unique identifier. This means that any potential quality defect, which might not be picked up for several months, or even years, can be tracked back to the very day and cycle it was manufactured to achieve item-level traceability and conduct root cause analyses on parts and components. Nigel Flowers, managing director at Sumitomo (SHI) Demag UK emphasises that authentication of individual components in high liability markets like healthcare requires a fingerprint style approach to traceability. Additionally, labels in the future will need to include two identifiers: A device identifier (DI) that identifies the labeller and the specific version or model of a device, plus a production identifier. This variable portion of the UDI needs to include the given lot or batch number, serial number, date of manufacture, expiry date, etc. Flowers explains, “real-time traceability is about being able to call up data and verify the exact settings used on the injection moulding machine when that individual plastic part was made. That’s where

connectivity to a Management Executive System (MES) is vital.” This represents another step towards the Smart Factory for tier 1 to 4 medical device injection moulders, offering heightened risk management, mitigation and containment, which enables organisations to respond accurately and rapidly with a targeted recall. To eliminate the risk of the wrong QR code being applied to the medical device component, Sumitomo (SHI) Demag deploys a highly dexterous 6-axis robot to remove each part from the mould. The robot holds the part during the entire time the QR code is etched on at the laser marking station, never releasing until the data has been scanned and stored in the holding data system. “What we have created is a fully automated plastic injection moulding and laser marking station that connects and communicates the code back to MES holding system where it reconciles up with the machine processing data. In addition to boosting traceability, this synchronised data gives production managers greater visibility on product cycle times and quality,” adds Flowers. Process data that’s recorded includes the exact production date and time, the injection and dosing time, melt cushion, injection pressure and temperature. This enhanced traceability aims to enable organisations to respond more effectively should a defective medical device part or component enter the value chain. Flowers comments, “it’s becoming increasingly imperative to limit operational risk exposures with targeted rather than mass recalls. Realtime traceability provides the means to limit recall exposure by improving end-to-end process transparency.”

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REGULATORY UPDATE

DAVID GWYN, GLOBAL SOLUTIONS ARCHITECT, AMPLEXOR PROVIDES PRACTICAL ADVICE ON REGULATORY UPDATES. GWYN BELIEVES THERE ARE STILL MANY LESSONS TO BE LEARNED.

hile the medical device industry often looks to distance itself from big pharma, it could learn a thing or two from across the divide when it comes to rigorous reporting standards. With medical device regulations (MDR) and equivalent international standards now being introduced, to increase traceability and improve patient safety, device producers have got a steep learning curve ahead. The regulatory climate for medical device manufacturers is on the brink of a major shift, intended to raise patient safety and make companies more accountable for tracking the impact of their products in the real world. The high-profile PIP breast implant scandal is among the cases

that have led to the formal steps being taken, first in Europe then globally in the coming years. The new regulatory requirements pose some fundamental challenges with echoes of where pharmaceutical companies were some 14 years ago – when European Mechanics Agency (EMA) and other regional authorities around the world began to usher through new information submission standards. HISTORY REPEATING ITSELF After a huge amount of pain and cost, drugs companies have come a long way – their most recent effort being to create a more definitive, consistent and reliable picture of their products from a regulatory perspective, in anticipation of new ISO IDMP requirements. Here, through an internationally harmonised approach to identifying and describing medicinal products, the industry aims to bolster pharmacovigilance activities, make it easier to locate and exchange product and substance information globally; promote reuse of data across different procedures and regulators; and generally streamline regulatory processes. Until now, medical device manufacturers have been mere observers of the developments. While quality and safety have always ranked highly for reputable players, efforts have largely been concentrated on the manufacturing shop floor in terms of product lifecycle information management. But this will need to change in the run-up to the European Commission’s new MDR, applicable from May 2020, and the equivalent in vitro diagnostic medical device regulation (IVDR), due for introduction in May 2022.

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REGULATORY UPDATE

One of the most critical areas of focus of these new regulations is postmarketing surveillance. Once the new regulations are active, device manufacturers will be expected to formally monitor the long-term safety of their products and provide evidence of their follow-up findings in periodic safety update reports.

regulatory documents ad infinitum. With strong, authenticated master data to draw on in support of multiple use cases, they were able to automate much of this work.

GATHERING EVIDENCE So, first off, companies need to be able to capture post-market safety data. MDR demands a detailed summary of safety and clinical performance information, which must be updated and reported at regular intervals with post-market clinic follow-up findings – a combination of formal studies, incoming feedback from patients and GPs, and potentially commentary captured via public online patient forums and social media platforms.

STAYING PREPARED Looking for broader efficiency gains will also serve medical device manufacturers well as they are required to provide better information directly to patients – for instance, online advice about the lifespan of a product, or guidelines about airport safety for users of pacemakers. That’s in addition to the immediate benefits of being able to call up a product’s status information in a couple of clicks, to verify where it is currently approved, or what has been the latest correspondence with a particular authority.

The new post-market surveillance requirements will apply to every category of medical device, too, creating a lot of work for manufacturers. The implications of falling short of authorities’ expectations could be significant, ranging from multi-million-dollar fines and products being taken off the market, to lasting reputational damage. The increased rigour won’t be confined to Europe, either. In the US, more than 1.7 million injuries and almost 83,000 deaths may have been linked to medical devices, based on reports to the FDA over a 10-year period. The International Medical Device Regulators Forum (IMDRF) has a keen interest in MDR and IVDR, too, which could result in countries in Asia and South as well as North America adopting their own variations on the requirements in the coming years. INSIGHTS FROM BIG PHARMA With little more than a year to go until the first new requirements come into force in Europe, there is a growing sense of urgency for medical device manufacturers to put in place strategies, processes and systems for managing all of their new reporting responsibilities. So what can they learn from their counterparts in the pharmaceutical sector, to save them from repeating early mistakes? The first takeaway is not to see the coming changes as a single event that manufacturers can plan for with a definitive, one-stop project. If pharma has learnt one lesson above all, it is that the global regulatory climate is continuously evolving, so trying to pin down all requirements up front, or waiting until all the final variables are known before getting going, is not a practical approach. Similarly, regulators’ hunger for information is seemingly insatiable, so selecting a series of best-of-breed applications that each handle a finite set of parameters, has been found to be be a false economy. When pharma companies did this, many ended up with 20 or more different systems from different vendors, all of which needed to be supported and updated, and many of which did not integrate and share data very easily with each other. This caused firms to fall back on manual processes and spreadsheets for managing all of the contributing information, reintroducing inefficiency, potentially introducing errors and undermining their considerable investments. LAYING FUTUREPROOF FOUNDATIONS Through more than a little pain, pharma companies have learnt that it is far more practical to create a more fluid, end-to-end information management capability which can be adapted to a range of different needs. The ideal many firms are now working towards is the creation of a single, complete, master set of data about their products and their evolving status – one that spans R&D, approvals, and post-marketing follow-up, and which can be applied as needed for each different use case.

Working towards a comprehensive, global master resource of product regulatory data offers medical device manufacturers a host of potential advantages, and a chance to skip to the point that many pharmaceutical companies are only just getting to now. With the first deadlines for the new regulatory compliance bearing down, medical device manufacturers now need to press ahead with their plans. One of the first discussions may need to be about moving extended product data management off the shop floor into a regulatory lifecycle/regulatory information management (RIM) environment, overseen by those tasked with matters of safety and compliance. Certainly, as post-marketing surveillance activities grow in prominence, the role of regulatory affairs teams will become more critical in the medical device sector, with a likelihood that relevant skills will be in high demand. It’s a further reason why manufacturers should start acting now.

Having a clear line of sight across a definitive single set of complete information offers companies all sorts of advantages, not least the scope to reduce repetitive data re-entry or document creation, and the opportunity to automate preliminary information checking and content building processes. In pharma, companies have been able to do away with huge teams of temporary staff who had been drafted in to review and edit

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INNOVATION IN IMPLANTS

THE END IS IN MEDICAL PLASTICS NEWS EDITOR LAURA HUGHES SPOKE WITH JEFF ROSS, CEO OF MIROMATRIX MEDICAL TO LEARN MORE ABOUT THE FULLY IMPLANTABLE HUMAN ORGANS MIROMATRIX IS CREATING, AND WHY THE ORGANISATION BELIEVES THAT THE TURNING POINT TO SOLVING ORGAN SHORTAGE IS IN SIGHT. COULD YOU TELL ME ABOUT THE FULLY IMPLANTABLE HUMAN ORGANS YOU ARE CREATING? At Miromatrix, our mission is to eliminate the organ transplant waiting list. The idea is to take a pig organ that was going to be discarded and perfusion decellularise it. The word decellularise means to remove all of the cells from the organ. This is achieved by cannulating the organ and perfusing a mild detergent through it, essentially washing the cells out. This will leave you with a perfect scaffold or matrix that still contains the key architecture. By starting with an existing organ, the method essentially preserves the blue print of an organ. After the pig cells are removed, we infuse the organ matrix with human cells in order to be able to create and reanimate that organ. WHAT SORT OF MATERIALS DO YOU USE FOR THESE IMPLANTS? Ultimately, our bioengineered organs will be comprised of a decellularised whole organ matrix derived from a pig and then recellularised with human cells. We are focused on ensuring the functioning of these implants. Therefore, currently we are infusing cells in to our liver construct and demonstrating the functionality of those. Later these cells will go in to longer-term implants to hopefully demonstrate that we can recover an animal. Our goal is to remove the animal’s native organ, replace it with our bioengineered organ, and have the animal survive. Once we achieve that, our next step will be human clinical studies. 24

HOW DOES THIS TECHNOLOGY DIFFER TO WHAT IS CURRENTLY AVAILABLE? This technology came out of the University of Minnesota, and their whole concept was focused on looking at how to advance regenerative medicine. Prior to their research, the idea of using a biologic and natural extracellular matrix wasn’t new. Previous technologies relied on immersion decellularisation, where they would take tissues and put them in to a solution. The decellularisation solution would essentially need to diffuse in, dissolve the cellular material, then diffuse back out. By this method, there was no way to decellularise complex tissues. This meant that you could do thin tissues, but the technology wasn’t suitable for whole organs. Perfusion decellularisation means instead of working from the outside in, we’re able to work from the inside out. We use that native vasculature to perfuse a solution in and through the whole organ or tissue to remove all the cellular material; this enables the decellularisation of complex tissues including whole organs. WHAT ARE SOME OF THE MAIN CHALLENGES THAT YOU HAVE FACED DURING THIS PROCESS? One of the first challenges was the ability to source the organ from any donor, for instance from a pig or from a human source. The natural thought would be to use human organs; however, the challenges with this are that you still have the issue of cadaveric organ sourcing and additionally, the organs that you can source are often damaged and/or diseased. We’ve learned that if the matrix is damaged or diseased, it then gets conferred on to the cells resulting in an inconsistent product. Therefore, a pig source would be perfect, especially with the medical device history of pig bowels and other tissues being successfully placed back in to humans. We then had to answer the key question about whether the scaffold would be immunogenic since we were decellularising the whole liver and placing it back inside the body. Instead of tackling the issue with a fully recellularised liver, we chose to start with a decellularised liver in order to derisk the ultimate approach. After careful research, sourcing pig livers and decellurarising those, we launched two products called Miromesh and Miroderm. We have positive data for thousands of patients who have been implanted with these products, and we have recently finished two prospective clinical trials on them. Most importantly, there has been no reported immune related issues with the implantation of Miromesh and Miroderm.

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INNOVATION IN IMPLANTS

YOUR GOAL IS TO ELIMINATE THE ORGAN TRANSPLANT WAITING LIST, DO YOU REALLY BELIEVE THIS IS SOMETHING THAT IS ACHIEVABLE? Absolutely, but in steps. Today, we’re focused on solving the urgent need of bridging the gap that exists between those who need life-saving organs and the shortage of them. That’s why our first product will be isolating primary cells for organs that were unsuitable for transplant.

Miromatrix Medical ©

We therefore believe that we have really been able to derisk our approach and demonstrate the ability to utilise a pig source, which allows us to have perfect quality control and utilise something that was in most areas being discarded. Our next big hurdle was one that has really plagued tissue engineering in general – how to revascularise the tissue. Tissue engineering was really good at demonstrating that you could take cells and the matrix and put them both together to create sheets of tissue. The challenge was however, that these sheets were really thin and translucent, meaning that although in theory it works it may not be clinically relevant.

Long term, the holy grail of what we are really working on is that secondary generation product. Some day we hope to isolate cells from a patient and create an organ specifically bioengineered just for them. This would mean that they would no longer require immunosuppression. If we can achieve that goal, we can eliminate the organ transplant waiting list. Miromatrix will be presenting their technology at the BIO International Convention in Philadelphia in June, following its Pipelines of Promise award.

For more complex diseases we need a thicker tissue, and the only way to get this is by having a vasculature which allows for the delivery of nutrients to those cells and the ability to take waste away. So now that we have derisked the matrix, the next step was to place endothelial cells (specifically human endothelial cells) back in to the liver matrix. The goal was to determine if we could revascularise or essential repave the vascular channels inside the decellularised organ. Right now, we are preparing to publish the results we believe demonstrate that we were successful and that we can revascularise the organ, place it back in to a large animal, and get sustained perfusion. WHEN DO YOU EXPECT THIS TO BE ROLLED OUT WITHIN PATIENTS? We are currently sourcing human livers and getting ready to source human kidneys that were deemed unsuitable for transplant. This means that although the organs are classed as high quality, they are not transplant candidates. In order to make them transplant viable, we’re isolating out human cells and seeding them on to our decellularised organ matrix. Our end goal is to have a completely human recelluarised organ whether that’s a liver, a kidney a lung, or a heart for transplantation.

Cell therapies are advancingat a rapid pace, and I would say it’s about two to two and a half years for our ﬁrst human implant.

We think that we are really making great progress by taking down those initial barriers and demonstrating early signs functionality. Based on our progress, we are targeting as early as 2021 for our first human clinical studies. A lot of people say, “this stuff is really cool, maybe my kids are going to see it.” I then tell them, “we are a lot closer than that.” Cell therapies are advancing at a rapid pace. We still have to take down hurdles such as obtaining agency approval, but we believe we are making good progress. WWW.MEDICALPLASTICSNEWS.COM

TUBING, CATHETERS & STENTS

A PERFECT FIT ACTEGA EXPLAINS WHY ITS PROVAMED THERMOPLASTIC ELASTOMERS (TPE) ARE IDEAL FOR ALL CONVENTIONAL INJECTION-MOULDING AND EXTRUSION PLANTS.

housands of tracheotomies and laryngectomies are carried out every year. These procedures lead to function loss of the upper airways, which could be anything from filtering, warming and moistening breathing air through to voice loss. Tracheostomy tubes and speaking aids are essential and the industry offers an extensive range of ultramodern tubes and aids which are optimally tailored to the demands and requirements of each individual patient. Although metal tubes are offered, these have thin walls and are rigid, with a larger inner volume than silicone and plastic tubes which feature thicker walls, minimally limit inner volume and are distinguished by a high degree of wearing comfort, and a comparatively lighter weight. Most tube wearers could benefit from tracheal tubes made from lightweight, soft plastic material as these lead to less irritation of the sensitive tracheal mucus membranes and less mechanical irritation of the tracheostoma. Additionally, plastic is advantageous compared to metal tubes, as metal cannot be inserted during radiotherapy due to reflections on the tracheostomy tubes possibly preventing the calculated radiation dose from being applied or causing uncontrolled radiation exposure. As in many areas of medical technology, most plasticbased tracheostomy tubes are manufactured from polyvinyl chloride (PVC). However, an increasing number of customers are requesting solutions from the manufacturers of medical technology which are free of PVC and plasticisers. All tubes in technical medical applications are obliged to comply with a wide variety of requirements as they are used in highly-sensitive areas where it is often a matter of

life and death. The material compound used must also be developed with care and display maximum quality, as the wrong material mix could result in fatal consequences. The material group, TPE possess good processability which makes them ideal for all conventional injection-moulding and extrusion plants. TPE also have very low emissions, good reusability and are cost effective. Additionally, they can be sterilised, conform with the Food and Drug Administration, International Standards Organisation and United States Pharmacopeia classes, whilst displaying very good sealing and adhesion properties. Actegaâ&#x20AC;&#x2122;s ProvaMed TPE are an example. These tracheostomy tubes are typically manufactured in extrusion or injectionmoulding processes, and their material properties need to be adapted accordingly. Extrusion requires exact setting of the material flow properties to the processing method while injection-moulding offers the possibility of manufacturing the tracheostomy tubes and neck flange in a single step. Multicomponent injection-moulding enables economic manufacturing of multiple components such as a connector made from a thermoplastic and the soft components made using TPE. This is particularly applicable when the materialâ&#x20AC;&#x2122;s adhesion properties need to comply with the connector material, therefore requiring optimisation. ProvaMed TPE display perfect adhesion to polystyrene and acrylonitrile butadiene styrene (ABS). The more diverse the types of tubes, the more extensive the areas of application and the more detailed the requirements. Another area of focus is represented by solvent bondability. Micro-tubes are often inserted through the neck flange in the case of transporting air to the cuff or for optional secretion removal, where the micro-tubes need to be bonded to the outer tubes. The ProvaMed portfolio provides some suitable solutions for this. Manufacture and printing are followed by sterilisation. TPE can display their particular advantages as only minimal changes in terms of mechanics and optics can be ascertained after sterilisation. The terms single-lumen tubes and mono-layer need some explanation. After all, lumen comes from the Latin and literally means light. Mono-layer, however, is actually a biological term and refers to a culture of single-layer cell layers based on individual cells. Nevertheless, the use of these terms within the context of medical tubes makes sense as lumen describes the cavity of an organ or vessel and, within the context of single-lumen tubes, represents the cavity in a tube. Mono-layer describes an individual layer in the corresponding tube. Single-lumen tubes and mono-layers are suitable for a range of applications. For transporting liquids and medication, they are used for infusions, enteral and parenteral feeding, and in urology and endoscopy. Their classic tube geometry can also be fitted with additional features. Multi-lumen or multi-chamber tubes represent key solutions for special areas of application in which air, material or liquids are transported and several functions can be carried out simultaneously in the same space such as suction and rinsing. They are used in acute dialysis, as central-venous catheters in urology, and as liquor drainage in the case of hydrocephaly. Multi-layer tubes make it possible to realise the most complex characteristics profiles. The advantages of a wide variety of materials can be combined with this manufacturing process. The areas of application here include infusion lines and filling tubes for bag systems, pressure lines for angiography, administration of medication in oncology and highly-flexible working channels with low sliding friction coefficients in endoscopy. WWW.MEDICALPLASTICSNEWS.COM

Thread-reinforcement involves reinforcing using wound or braided metal or polyamide (PA) threads in order to guarantee resistance to tube bending, bursting or vacuum. One example for medical technology is represented by respiration tubes. The range of materials available for manufacturing medical tubes is enormous, but not every material is suitable for all areas of application and not every material combination makes sense for the respective characteristics profile required. It always depends on the characteristics that are required for the application. Interactions between tube material and pharmaceutical substances or those produced naturally by the body which could impair the human organism must be prevented at all costs. There must be no interaction with the plastic, medication absorption must be avoided, the material must be entirely resistant to media and should also in certain cases be ultraviolet-stable in order to avoid embrittlement, deformation and opacity. Accordingly, liquid content remains visible enabling visual flow control. Tube systems in clinical applications should also display radiopaque strips in the tube wall to enable the position of the tube to be tracked in the body and the localisation of implanted drainage or surgical components using x-rays. Bacterial resistance should be increased in the form of antimicrobial coating. Buckling resistance is necessary to guarantee the free flow of substances through tubes. In the form of ProvaMed, Actega offers a TPE portfolio which is free of latex, silicone and phthalates displaying the requisite material qualifications in terms of normative, toxicological, biological and customised requirements. Materials can be adapted to a wide variety of requirement profiles outlined above and can also offer particularly good adhesive properties when bonded with thermoplastics such as polyethylene, polypropylene, polystyrene, ABS, polycarbonate and PA, which are also maintained even in the case of continuous media contact and increased temperatures.

TUBING, CATHETERS & STENTS

PINT-SIZED ROCEDURES

JOE ROWAN, PRESIDENT AND CEO OF USA AND EUROPE FOR JUNKOSHA, DISCUSSES THE IMPORTANCE OF INNOVATIONS SUCH AS PEELABLE HEAT SHRINK TUBING (PHST) TO TACKLE FUTURE CHALLENGES WITHIN THE MEDICAL TUBING SUPPLY CHAIN.

he future of the medical tubing sector is highly dynamic, not least because there are a variety of pressures on organisations within this space to provide solutions that are not only of the highest quality but also deliver cost savings throughout the product lifecycle. Take the catheter market as a prime example of these challenges. In the world of neurovascular and other complicated techniques, catheter manufacturers are being pushed for solutions that not only deliver complex procedures more efficiently but also provide cost savings at every turn. In what is a highly cost-conscious marketplace, PHST products that enable catheter manufacturers to advance efficiencies through streamlining their workflows is going from ‘nice to have’ to becoming a critical requirement. PHST CONTINUES TO SAVE VITAL TIME AND MONEY The PHST market is an exciting area to be in. Not only does it aim to address health care customers’ unmet needs, solutions including ultrasmall PHST also pave the way for progressively smaller catheter-based procedures - a continual requirement for medical device manufacturers. The reasons, aside from their desire to meet the health care sector’s needs, are because PHST ultimately reduces Total Cost of Ownership (TCO) for the catheter manufacturer. Since companies no longer have to use the process of skiving the heat shrink material from the catheter, PHST can help them produce the final product more rapidly with improved yields and lower inspection levels while being more ergonomically safe. In addition, as the health care sector continues to push for cost savings to be made all the while delivering excellent patient care, solutions such as Junkosha’s 2.5:1 PHST are a viable option. Providing the ability to rationalise processes in the manipulation of a catheter’s baseline materials by reflowing these quickly and efficiently, this solution can potentially act as a catalyst to provide cost savings for catheter manufacturers. APPLICATIONS According to Robert LaDuca, CEO of medical device tubing and catheter components manufacturer Duke Empirical, there are a number of applications where this new high ratio PHST technology will enable better processes and cost savings. These include tapered cardiovascular devices such as multi-lumen braid reinforced Peripherally Inserted Central Catheters (PICC), alongside a wide variety of next generation catheter designs that have varying diameters such as cardiac implant delivery systems where the implant is located in a distal segment of the catheter that is usually larger than the proximal portion of the shaft. In addition to enabling new processes for manufacturers in their development of innovative products, and the faster and more forceful recovery of the 2.5:1 PHST products can help reduce or eliminate air entrapment which can be an unwanted cause of bubbles and associated product defects such as fish eyes, voids, and insufficient strength of bonded layers.

WHAT NEXT FOR THIS MARKET? Into the future, numerous challenges face the medical tubing supply chain in the US and European markets including; stringent regulation, the need to make procedures less invasive and the enablement of a wider variety of operations across harder to reach parts of the body, increasing health care costs and the need to streamline workflows and processes - especially for catheter manufacturers. Although these various challenges differ around the world, they all require one thing - innovations that improve outcomes for patients and provide clinicians and other endusers with technologies that make their lives easier, reduce costs, and save time. For this reason, continuous innovation must be at the heart of the health care sector’s requirements. Without this, the unmet needs will continue to be just that: unmet.

Solutions including ultra-small PHST also pave the way for progressively smaller catheterbased procedures - a continual requirement for medical device manufacturers.

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DIGITAL HEALTH

BETTER CONNECTED KEVIN DEANE, VICE-PRESIDENT, INNOVATION, PHILLIPS-MEDISIZE EXPLAINS WHY HE BELIEVES CONNECTED HEALTH OFFERS PROMISING POTENTIAL FOR PHARMACEUTICAL COMPANIES AND DRUG DELIVERY DEVICE DEVELOPERS AND MANUFACTURERS.

FILLING THE DATA VOID As healthcare systems worldwide start to implement outcome-based reimbursement, the ability to measure medication effectiveness, and patient adherence plays an even more important role in managing and improving patient health. Unfortunately, little actual data exists that pinpoints when, or even if, patients take their medication, despite new prescription drug development costs estimated to be as high as $2.6 billion1. A range of research has demonstrated, though, that adherence rates are typically lower for patients with chronic conditions, and even clinical trials report average adherence rates of only 43 to 78 percent 2. Poor medication adherence is also the cause of 33 to 69 percent of all medication-related hospital admissions in the United States alone2 . Integrating connectivity into innovatively designed, patient-centric drug delivery devices can help fill this data void and support increased adherence by making it easier and simpler for people to take their medication on-time and as prescribed. Connectivity provides an efficient way to monitor patients’ adherence and condition, as well as to share both realtime and historical data with patients, clinical researchers, healthcare providers, caregivers and payers. THE CONNECTED HEALTH ECOSYSTEM The connected health ecosystem includes three primary components: 1. Connected devices - such as inhalers and injectors 2. Digital interfaces - including patient and caregiver apps, and dashboards for healthcare professionals 3. A cloud platform - enabling data integration with multiple sources including diagnostic devices, internet of things sensors and electronic health records in order to generate insightful analytics 30

Four years ago, Phillips-Medisize developed the first connected health system registered with the FDA for a specific drug. Since then, the number and popularity of connected health pilots has grown, but pharmaceutical companies sometimes struggle with how to scale the model, and extract and quantify the value created, which can impede additional investment. Recognising the increased interest and demonstrable benefits that connected systems provide, PhillipsMedisize decided to invest in developing a highly scalable platform to service the expanding market, rather than developing and maintaining one-off, application-specific solutions for each new project. THE BENEFITS The resulting cloud-based connected health platform provides a scalable medical device data system (MDDS) for pharmaceutical companies and drug delivery device developers. By reducing the risk, time and cost associated with developing connected health solutions, it helps accelerate time to market. Additional benefits include: • Comprehensive information-sharing and analytics capabilities: It connects pharma companies, clinical researchers, providers, patients and payers, sharing and displaying information from connected drug delivery devices, biosensors and regulated Mobile Medical Applications (SaMD/MMA). Dashboards can be customised quickly and easily at any point, which saves time and money, adds highvalue flexibility and streamlines connection with other supported external analytic systems. It also integrates medication, diagnostic and therapeutic data from multiple sources as well as supports global comparisons by normalising data across geographies. • Robust cybersecurity: A connected health platform can be deployed in a secure private cloud with a credible legacy of health data security, in a cloud hosting option selected by the pharmaceutical company, or in the company’s own data centre. In addition, cost-effective and secure collaborative environments are available for situations where crossindustry partners want the ability to share data. • Streamlined regulatory documentation: Full regulatory documentation services included with the connected health platform support premarket submissions for 510(K), combination products and CE mark to help lower project costs and speed time to clinical trial, regulatory approval and market, ahead of the competition. • Modular approach: Working with a manufacturing partner who can deliver connected health solutions that incorporate devices with embedded electronics and sensors also speeds the development process and keeps costs low, for both reusable and disposable drug delivery devices. Connected health platforms that come with a software development toolkit and defined, extensible application program interface, allow any device to be connected to the system. Pairing a configurable app with the connected health platform and deploying it across multiple products using a standard Bluetooth interface further supports a rapid, low-cost path to clinical trial and market. WWW.MEDICALPLASTICSNEWS.COM

DIGITAL HEALTH • Massive scalability: Building on a flexible, scalable platform rather than starting from scratch for each new drug makes it highly cost efficient to add or refine infrastructure for future projects. Because the price per user declines as the patient population increases, the costs for integrating connectivity for medications used to treat common chronic conditions also decrease. A CASE STUDY A leading pharmaceutical company recognised the need to update its current drug injection device in order to retain existing patients and attract new ones. The company’s drug had established safety and efficacy, but its injection device lagged in user friendliness. The company sought to use electronics to improve the injection experience but also wanted to help patients better manage their disease by offering seamless integration between the device and a patient app that could track injections and remind patients when and where to take them. Teaming with PhillipsMedisize, they developed and manufactured an innovative electromechanical autoinjector connected to the cloud, featuring: • Ergonomic design operated with one hand

• Secondary control functions hidden on the inside • A dashboard for healthcare professionals to easily monitor patients • Bluetooth connectivity that ensures data on injection time, volume and body location are synced with the patient app and dashboard • Personalised, localised messages and reminders for patients on their device and in the app The integrated system was introduced in countries worldwide after its initial launch in Europe. It has made injections more intuitive for patients, made it easier for caregivers and healthcare providers to coordinate and follow up on treatment, and helped the company retain its market position. MEETING MARKET NEEDS Only a few connected health solutions tied directly to medication have made it to market so far, even as healthcare becomes increasingly digital. The pace of development continues to accelerate as pharmaceutical companies and drug device developers and manufacturers seek to meet market needs. The opportunity to develop innovative connected health solutions using a secure cloudbased platform that provides a safe and scalable MDDS

helps reduce risk, cost and time to market. At the same time, by demonstrating a clear pathway to value creation, these cost models can bridge the gap between pilot and program and encourage additional investment in connected health. FOOTNOTES Sullivan, Thomas. A Tough Road: Cost to Develop One New Drug is $2.6 Billion; Approval Rate for Drugs Entering Clinical Development is Less Than 12%. Policy & Medicine. March 21, 2019. 2 Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-497.

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MTI EXPO

UNTIL NEXT TIME THIS YEAR THE MED-TECH INNOVATION EXPO TOOK PLACE IN THE NEW LOCATION OF THE NEC, BIRMINGHAM. THIS SECTOR-LEADING EVENT CONTAINED SOME EXCITING NEW FEATURES SUCH AS A THIRD CONFERENCE STAGE, SIGNALLING SIGNIFICANT GROWTH FOR THIS ANNUAL EVENT.

he Introducing Stage was a new forum for exhibitors to meet with delegates and demonstrate their technologies first-hand. Also new to the show floor was the Acceleration Zone, a forum for taking new ideas and organisations to the next level. Other additions included two new conference sessions: A global perspectives session as well as a panel discussion on the role of women in engineering. Med-Tech Innovation Expo is the UK’s only dedicated, standalone exhibition for medical device engineering and manufacturing. The event was complemented by the Med-Tech Innovation Conference organised in partnership with Medilink UK, as well as the Medilink UK Healthcare Business Awards.

Lohmann Technologies demonstrated how they are moving with the times. The evolution of modern textiles has increased rapidly over the last 30 years and these fabrics have new applications in the medical world, with the group demonstrating how textile bonding has evolved in the sector. Faulhaber raised the bar and showed their innovative winding technology and optimised design with the introduction of the Faulhaber BXT family of flat brushless DC motors, presented at Med-Tech Innovation Expo for the very first time in the UK. In all, more than 50 engaging and inspiring presentations took place across three stages, along with a wealth of exciting and educational show features. Visitors saw presentations from a wide range of major OEMs, government officials and industry experts. Tom Clutton-Brock, clinical director, MD-TEC said: “It was a great pleasure to be invited to the Med-Tech Expo meeting. I spoke on the Introducing Stage, which I must say was a packed audience. We had a great stream of people coming up to the stand to talk to us after.”

This year saw an expansion of the show floor to accommodate a record number of exhibitors nearing 300 from 14 countries. Initial data shows that this dynamic event connected almost 3,000 attendees across the two days from 34 different countries, with an exciting and diverse range of businesses, on hand to help them solve their medical design and manufacturing challenges.

In addition to the packed conference and seminar programme, visitors experienced a range of exciting show features. The Medilink UK Pavilion featured a range of Medilink member businesses, including Loughborough University, Piota and White Horse Plastics, an excellent platform to highlight their solutions to industry challenges.

Chris Philpott, business development manager, Boddingtons Plastics said: “Med-Tech gives us the opportunity to show and discuss the types of services that Boddingtons Plastics can offer to our customers. We’ve seen really good footfall and had several new leads for new devices. The show has been a great success for us and in fact we’ve booked for next year already.”

Duncan Wood, chief executive of Rapid News Group, owners of Med-Tech Innovation Expo said: “We are delighted with another significant step forward for this event as we work to create a defining event experience for the UK medtech sector. The two days contained many highlights, new products, new companies, world-class presentations and stunning applications. Whilst as organisers we have had superb feedback, we recognise we can’t do it without industry support, so we thank all our exhibitors, speakers, sponsors and partners for their efforts; they make the show.”

The event is fast becoming Europe’s go-to show for product launches, with a raft of companies bringing new and futuristic engineering solutions for healthcare OEMs and medtech startups to examine.

“It’s a good mix of exhibitors, we came to speak to a couple of clients and the conversations turned out very fruitful”, commented Robert Johnston, injection mould tooling expert, GSK.

The event also hosted the Medilink UK Healthcare Business Award Winners. Here, ten awards were presented to winners for both Medilink UK and Med-Tech Innovation categories. Judges rewarded companies for their contributions to the medtech and life science industry. Next year’s Med-Tech Innovation Expo will take place from 1st2nd April 2020 in the NEC, Birmingham, UK.

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EXTRACTABLES AND LEACHABLES

PERFECT MATCH MARK TURNER, MANAGING DIRECTOR OF MEDICAL ENGINEERING TECHNOLOGIES (MET) DISCUSSES THE NEW RELEVANCE OF CHEMICAL CHARACTERISATION IN MEDICAL DEVICE COMPATIBILITY.

CHANGES TO ISO 10993 In January 2018, seismic changes took place in the world of medical device toxicity assessment. The new edition of ISO 10993-11 added the requirement for a chemical knowledge of any device, whilst also requiring the driver to use this knowledge to understand the potential toxicity of the device. The potential toxicity then becomes, in its turn, the driver for risk assessment which may finally lead to a testing requirement. The toxicity end points have not changed, although there are some changes to the biocompatibility matrix. A short term, surface contact device still has the end points of cytotoxicity, sensitisation and irritation for which the risk versus benefit analysis must prove positive. A more invasive, permanent implant still has these end points plus sub-chronic, genotoxic and implant end points with the addition, now, of chronic toxicity and carcinogenicity. It is not always essential to use biological testing to show that there is acceptable toxicity for each of these end points, and it is stated in the standard that biological testing should not be the first resort. The approach should be data gathering and assessment first. Extractables and leachables2 along with other materials characterisation3 techniques will be required if all the chemicals and their abundance cannot be defined for a device. This information is not generally known because exactly what chemicals input materials come into contact with cannot be defined. There may be multiple chemicals in the production process and many of the specified materials may contain undeclared additives. This information is then fed into a toxicity risk analysis. Finally, toxicity testing is applied when the safety of a material or mixture of materials cannot be defined as safe from data available.

BIOCOMPATIBILITY MATRIX The ISO 10993-1 biocompatibility matrix provides a guide to the selection of information requirements, with chemical analysis now added to every category. MATERIAL CHARACTERISATION It is nearly always the case that it is not known exactly what materials a patient may be exposed to from the device and its supply chain. Because of this an investigation is needed. Material characterisation as described in ISO 10993-184 should be applied. Characterisation includes consideration of the chemical materials present and also morphology and the nature of the surfaces. The surface investigation may be concerned with features that encourage ingrowth or bacterial colonisation. There might be concerns with particular surface chemistry or catalytic properties of the surface. Methods of investigation could include electron microscopy, elemental analysis, infra-red spectroscopy or other techniques. The primary study will always be an investigation of materials released from the medical device in use – extractables and leachables, and particulate. The leachables are described in ISO 10993-175 as ‘released constituents that potentially contact the individual during clinical use’. The extractables include additional entities that can be forced out of the materials of construction, in the ISO 10993-17 definition ‘constituents that can be extracted in the laboratory’. The reason for

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Although, materials characterisation led by extractables and leachables is not the only route to obtain this information, it is the most likely method to ﬁnd unexpected materials. identifying and quantifying the extractables, in pharmaceutical container studies, is that there is a risk of them transferring into the formulation at some point during its storage. Similarly, the reason for examining extractables in medical devices is that they might become leachable at some point during the device’s lifetime. ISO 10993-126 gives us the extraction conditions (area to volume ratio, time and temperature, solvent polarity). The leachables concept transfers quite well to medical devices. This can be considered ‘in use’ or ‘simulated use’ leachables which likely to be delivered to a patient in use. Leachables can be taken from the device in question much as they have been traditionally in biological tests. The biggest difference in the leaching process is solvent changes between the two methods. Biological tests generally use cotton seed oil as the non-polar extract and water or saline as the polar extract. Whilst chemical analysis is generally carried out using hexane as an example non-polar solvent and water as polar, along with possibly a third solvent or mixed solvents. Extractables become more important for long term products. There may be substances that are released after a long delay that are not apparent in a 72 hour extract. Testing with more aggressive solvents, higher temperatures and longer soak times may be required. Here the concept of ‘simulated use’ leachables is introduced. Clearly it is not possible to wait for many years for the extractable to migrate into solution for analysis. Therefore, forced extraction is used, the strength of which (whilst being based in ISO 10993-12) can be adjusted according to the environment and duration of use. Hence, ’simulated use extract’. As we go up the invasiveness scale, we increase the strength of the solvents and consider increasing the extraction times and temperatures. ‘Consider’ because we are only interested in materials that will be present in use not degradation products produced in the extraction process by temperature or other processes not relevant to the ‘in use’ environment. There are specific tests for degradation products detailed in standards such as ISO 10993-137. TOXICOLOGICAL RISK ANALYSIS8 The analytical chemistry produces information identifying which materials are present and in what quantities. To be useful this information must be interpreted in terms of the toxicity end points given in the biocompatibility matrix. If no materials of concern are found or the patient contact is transient, then this can be quite a simple assessment. As more materials are identified and the patient contact becomes more intense the requirement for a toxicological risk analysis increases. This analysis is the domain of a registered toxicologist, who takes each material found and calculates the patient dose per 24 hours and over the product lifetime. A variety of information sources are then used to quantify the potential

toxicity of the materials individually and combined. There are several end points which are difficult to assess from published data (as used by the toxicologist), these include haemocompatibility and local effects such as implantation and irritation. CONCLUSION A knowledge of all chemicals released by a device in use is now required in ISO 10993, and this is listed in the testing matrix for every category of device. Although, materials characterisation led by extractables and leachables is not the only route to obtain this information, it is the most likely method to find unexpected materials. The vigour of application of chemical analysis should be tailored to the body contact and risk analysis for the device. Usually the chemical information, through a toxicological risk analysis, can be used to address all the toxicity end points without any need for animal testing. REFERENCES

1.ISO 10993-1:2018Biological evaluation of medical devices --Part 1: Evaluation and testing within a risk management process 2.https://www.met.uk.com/4dii-testing-and-analysis-ofextractables-and-leachables 3.https://www.met.uk.com/medical-device-testing-services/ biocompatibility/chemical-characterisation 4.ISO 10993-18:2005Biological evaluation of medical devices --Part 18: Chemical characterization of materials (under review) 5.ISO 10993-17:2002 Biological evaluation of medical devices --Part 17: Establishment of allowable limits for leachable substances (under review) 6.ISO 10993-12:2012 Biological evaluation of medical devices --Part 12: Sample preparation and reference materials. 7.ISO 10993-13:2010 Biological evaluation of medical devices --Part 13: Identiﬁcation and quantiﬁcation of degradation products from polymeric medical device 8.https://www.met.uk.com/medical-device-testing-services/ biocompatibility/toxicity-risk-assessment

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3D PRINTING

A WHOLE

NEW WORLD

AVINENT EXPLAINS THE POSSIBILITIES ITS INVESTMENT IN THE WORLD’S ONLY FULL-COLOUR, MULTI-MATERIAL STRATASYS J750 3D PRINTER COULD PROVIDE WITHIN THE MEDICAL SECTOR.

vinent, a Spanish scientific research and technological innovation company, has invested in a Stratasys J750 3D printer to increase its capability to produce 3D printed anatomical and dental models for customers within the medical sector. By using Stratasys’ J750 3D printer, the company plans to fill orders from public and private health centres, as well as hospitals requiring anatomical models used to simulate and effectively plan surgeries. FULL-COLOUR, MULTI-MATERIAL 3D PRINTED ANATOMICAL MODELS Avinent is based in Santpedor, Barcelona and provides digital health solutions for hospitals and clinics, through offering personalised implants and surgical guides in a variety of areas. The solutions offered include reconstructive surgery, orthognathic surgery, neurosurgery, as well as reproduction of body parts, such as the spinal column. The world’s only full colour, multimaterial 3D printer is expected to provide the accuracy and realism that is so crucial for medical practitioners. The J750’s unique capabilities will enable the company to produce high-resolution, multimaterial, colour models of a patient’s anatomy which is currently not possible with other 3D printing technologies. The ability to mimic a patient’s anatomy and offer a clear visual representation of the affected area, will ensure surgeons can provide an accurate prognosis and as a result identify the best course of treatment.

“In the past, we’ve tried several 3D printers, but we’ve been limited when requiring complex models that necessitate different textures, materials and colours,” explains Albert Giralt, CEO of Avinent. “The J750 is a big step forward for us. We’re now able to produce patient-specific models of exceptional realism, which will make the surgeon’s job much easier and ultimately improve patient care. The fact that we can now 3D print models using several different materials, textures and colours all in a single print means we can also drastically reduce cost and lead times during production.” Avinent states it is already seeing quantifiable benefits from this technology investment. For example, the company is now producing transparent 3D printed models of jaws that permit hospitals to show the localisation of nerves, and the team also recently 3D printed a highly-advanced transparent heart model with injected colours, using multiple materials and textures which enabled the surgeon to definitively outline a carcinoma growing in the affected organ. ULTRA-REALISTIC 3D PRINTED DENTAL MODELS 3D printing models that can combine hard and soft materials have increased the company’s ability to address more complex requests from customers. By using the Stratasys J750 3D printer Avinent is able to produce a wide range of models for dental practitioners such as creating the effect of gum using flexible materials, while mimicking the mandible or maxilla with nerves and teeth using more rigid materials. Giralt continues: “The new 3D printer will quickly take us to the next level of digital dentistry. Indeed, we can already now rapidly produce dental models with unrivalled realism, enabling dental practitioners to better visualise their patient’s mouth and teeth, and find the most effective solution to the specific problem. This is what medical professionals’ value, aiding pre-surgery simulations while improving the chances of success and overall patient care. The range of possibilities on the J750 are infinite, and its diverse applications will continue to grow.” WWW.MEDICALPLASTICSNEWS.COM

3D PRINTING

DOWN TO THE WIRE THIAGO BORGES, PROJECT MANAGER, MEDICAL DEVICE COMPETENCE CENTER, (MDCC), EVONIK BUSINESS LINE HEALTH CARE, EXPLAINS WHY EVONIK ARE READY TO SUPPORT THE STANDARD AND CUSTOM BIOMATERIAL AND TECHNOLOGY REQUIREMENTS OF CUSTOMERS FOR THE STREAMLINED DEVELOPMENT AND SCALE-UP OF ADVANCED, PERSONALISED BIORESORBABLE IMPLANT DEVICE APPLICATIONS.

dditive manufacturing, commonly referred to as 3D printing, is the process by which a digital model is converted into a three-dimensional physical model via the printing of consecutive layers of material.

preferred material for 3D printed medical device implants will remain difficult to achieve until innovations emerge that can address knowledge gaps such as the impact of various properties, like degradation during the printing process.

There are three main technologies that are most commonly considered for the 3D printing of medical device implants with polymers. Extrusion-based 3D printing which utilises standard pellets and is compliant with multiple materials has a limited print resolution with upfront investment costs, rivaling traditional extrusion equipment. Selective Laser Sintering (SLS), which utilises powder-based materials, For the last three decades, 3D allows companies to produce parts with excellent compressive strength, high printing has been earmarked as a transformational innovation that can resolution and the ability to create parts with complex geometries. However, the processes required to attain device parts at sufficient levels of quality can be highly disrupt existing practices across multiple industries. However, it has complex. only been in the last few that 3D printing has become a commercial Fused Deposition Modeling (FDM), which is also referred to as Fused Filament Fabrication (FFF), is another key 3D printing technology for the production of reality. medical implants. This printing process enables the continuous feeding of a filament-based material from a spool through a moving, heated extruder nozzle. Within the medical devices There are several advantages in the 3D printing of medical device applications industry, 3D printing technologies with FDM technologies; the equipment itself is less complex compared to SLS or have already begun to be utilised extrusion-based technologies, it is compliant for use with multiple types of polymer across a variety of market and other materials, and it is highly efficient. With a low melt residence time, parts segments. 3D printed devices with complex geometries are also easy to duplicate. show great potential to generate significant value-based health care To enable the commercial use of FDM technologies in the production of medical outcomes across these and other implant devices, it will be of critical importance to develop high molecular weight, application areas. For example, implantable, medical-grade filaments that can be manufactured in controlled the development of an implant environments. Such polymers must also be suitable to manufacture patient-specific device such as a facial plate with bioresorbable implants with acceptable part properties and be available in a range patient-specific geometries can of grades on quality spools that are suitable for higher resolution printing. These dramatically help to accelerate filament materials must also come from established, trusted suppliers with a record healing, reduce pain and minimise for safety, biocompatibility, performance and supply security to minimise regulatory wait times. For clinicians and and scale-up risk. payers, 3D printing technologies should also help to improve overall levels of productivity and patient RESOMER FILAMENTS satisfaction. In a search for answers to address such unmet market needs, Evonik has sought to combine its leadership position for biomaterials with new polymer–based 3D 3D-based innovations for printing competencies across various technologies including extrusion-based implantable medical devices printing, SLS and FDM. have to date been primarily based around the use of metallic For more than three decades, Evonik’s Resomer portfolio of materials. As bioresorbable, bioresorbable polymers has been utilised around the world by biocompatible polymers continue medical device companies to enhance various medical to replace traditional metallic implant devices and parenteral controlled release materials these outcomes drug products. More than 20 Resomer grades should only become even in various compositions such as Polylactide more pronounced. This is due (PLLA), Polylactide co-glycolide (PLGA), to incremental reductions in Polydioxanone (PDO) and manufacturing times, and lower polycaprolactone (PCL) are surgical costs such as eliminating available with a range the need for secondary surgery of degradation for implant removal. However, times and the widespread utilisation of bioresorbable polymers as a Evonik ©

Inherent Viscosities (IV). The portfolio aims to deliver breadth and versatility to match specific device requirements across multiple application areas. The company has leveraged this existing expertise in the design and synthesis of bioresorbable polymers to develop a new line of Resomer filaments that are suitable for the 3D printing of device parts with FDM technologies. Resomer filaments are ideal for high resolution 3D printing, with four different grades offered in a 1.75 mm diameter. These PLLA, PLGA, PCL, and PDO-based filament grades feature tight specifications including diameter size and processing temperatures. Degradation times can range from less than six months to greater than three years to match a range of application requirements. Resomer filaments feature mechanical properties and degradation rate profiles that can be precisely tailored to match the target application. As with other Resomer products, all filament grades undergo hydrolysis degradation in vivo and are eliminated through excretory pathways. APPLICATION AREA EXAMPLE The 3D printing of Cranial Maxillo Facial (CMF) plates for use in surgeries for congenital or acquired defects of the skull and facial region represents a significant application opportunity for the use of filament-based bioresorbable polymers and FDM technologies. With mechanical properties including strength, durability, flexibility and BEYOND the elimination of stress shielding all RESOMER required, such specialised materials FILAMENT and advanced processes can In addition to the be leveraged to rapidly development and supply and cost-effectively of Resomer filaments, Evonik create parts for also offers advanced application technology solutions to companies who are seeking to enhance the safety and performance of their bioresorbable implant devices. Evonikâ&#x20AC;&#x2122;s MDCC in the United States, and application laboratories in Germany and China try to provide customers with a broad range of application services for 3D printing technologies. Evonik also specialises in the development of customised polymers and filaments to match specific application requirements based on specific customer needs. SUMMARY While 3D-printing still represents a small fraction of the overall market, industry drivers including a shift to personalised health care, government incentives, reductions in manufacturing time and other technological advances are expected to make this segment increasingly visible and attractive for use over the coming decade. The convergence of modern 3D printing technologies, including FDM, with a new line of bioresorbable and biocompatible filamentbased polymers will enable the development of a new generation of 3D printed implants. These advances will help to improve patient care, accelerate availability of implants for surgeons, and also reduce costs across a broad range of application areas. Evonik is the only known supplier with a full portfolio of granule and filament options for bioresorbable polymers and is therefore well positioned to serve as a supplier and innovation partner for 3D printed device technologies.

A new line of Resomer filaments with a range of material choices and degradation properties that are designed for use across multiple application areas for high resolution printing with FDM technologies are now available for supply. Evonik has a global network of labs for application technology support, and high-quality Resomer production sites in the United States and Europe.

For more than three decades, Evonikâ&#x20AC;&#x2122;s Resomer portfolio of bioresorbable polymers has been utilised around the world by medical device companies.

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EVENTS

MedFit France 2019

MD&M East 2019

THE FAMOUS EUROPEAN PARTNERING EVENT IS EXPECTED TO ATTRACT AROUND 700 INTERNATIONAL PARTICIPANTS, ALONGSIDE 75 EXHIBITORS

MD&M EAST IS THE EAST COAST’S LARGEST MEDTECH EVENT, WHICH OFFERS PROFESSIONALS THE CHANCE TO SEE THE LATEST TECHNOLOGIES AND SOLUTIONS IN BIOCOMPATIBLE MATERIALS, COMPONENTS, ASSEMBLY, AND CONTRACT MANUFACTURING.

edFit France hopes to provide an environment for organisations of all sizes and experience levels to conduct tasks such as obtaining funding, facilitating market access or providing licensing opportunities. Within the show, there are five main activities taking place. These are: 1.Business convention: MedFit France are launching a platform that will enable users to send meeting requests. This platform will become available one month before the event. 2.Conferences and round table discussion: 60 experts will be speaking and providing a varied programme to attendees. 3.Exhibition: This will be located at the focal point of the event and offer networking opportunities. 4.Pitch sessions: There will be the chance to showcase your ideas to investors, providers and senior executives from within the industry. 5.Meet the experts sessions: 16 medtech experts will be available for pre-scheduled 30 minute meetings to discuss strategic needs and project advancement.

any of the major companies involved in medtech will be exhibiting at the event.

There will be a medtech showcase that will cover a wide range of topics including 3D printing and additive manufacturing, adhesives, automation, injection moulding, manufacturing equipment, medical device components, medical packaging and medical plastics. Three hubs will be on the expo floor, where shows will be offered on each topic throughout. The hubs consist of: • The medtech hub • Smart manufacturing and 3DP hub • The packaging hub The show is held alongside five others; East Pack, Atlantic Design and Manufacturing, Automation Technology Expo (ATX) East, PLASTEC East and Quality Expo. One expo pass will provide you access to all six of these trade shows.

Additionally, the event will host the prestigious Medical Design and Excellence Awards again this year. These awards will be presented to innovative companies within the medtech industry. The finalists will be announced in May, and the awards ceremony will take place on June 11th, 2019 in the Jacob K. Javits Convention Center, where the main event is taking place. MD&M East is taking place in the Jacob K. Javits Convention Center, New York, New York between June 11th and June 13th, 2019. There will be an app launched closer to the event which will be available on the Apple and Android app store. For now, though you can also stay up to date with the event on social media, by following the hashtag #AdvMfgExpo.

On the agenda there are four main tracks, with the main focus being on innovation. The tracks consist of: • Track 1 - Collaborate to innovate • Track 2 - Financing innovation • Track 3 - Market innovation • Track 4 - Digital innovation MedFit France 2019 is set to take place from June 25th to June 26th in Lille Grand Palais, Lille, France. You can follow the event focused on fostering innovation within medtech on social media with the hashtag #MedFit2019.

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Three highlights from the Med-Tech Innovation Expo 2019

Adam Kay, award winning author of the bestseller, ‘This Is Going to Hurt’, presented the 2019 Medilink UK Healthcare Business Awards in association with Med-Tech Innovation.

Professor Mike Hannay, managing director, East Midlands Academic Health Science Network (AHSN) discussed the role key AHSNs play within the industry and the NHS in the opening talk on the main stage.

Leanne Taylor, head of Content, Rapid News chaired a discussion on women in plastics. Dr Artemis Stamboulis from University of Birmingham, Helena Flowers from Andel Plastics, and Rebecca Smith from Connect2Cleanrooms, shared their perspectives on the topic.

06:2019 TECHNOLOGY WHICH AIMS TO HELP DIAGNOSE PARKINSON’S DISEASE BEGINS CLINICAL TRIALS

ritish start-up company Medopad have partnered with Tencent, a multinational company to create an Artificial Intelligence (AI) program which aims to enable doctors to diagnose Parkinson’s disease amongst patients. The medical trial is set to take place in London within a private clinic. It is thought to involve around 40 patients and take several months to complete. Fan Wei, head of Tencent’s medical AI Lab said: “We shared a lot of the same vision. Medopad is our main partnership.” Medopad currently have partnerships with several British

hospitals which use its technology to remotely monitor patients. They have developed a smartphone app that enables doctors to gather information about patients by setting tests patients can complete on their phones, and then collecting the data from the wearables. They have also been developing algorithms that can suggest diagnoses to doctors or alert them in the case of a patient deteriorating. In the future, both companies plan to target multiple sclerosis and psoriasis together.

TECHNOLOGY DEVELOPED FOR FASTER DIAGNOSIS OF INFECTIOUS DISEASES

iotangents, a Scottish veterinary diagnostics company, have developed technology which will provide vets with a method of testing cattle for fatal diseases on site and on the same day. This technology will offer farmers the advantage of early detection, and as a result the ability to isolate any infected animals quickly. This will enable farmers to limit the spread of infections amongst their cattle. Compared to current technology for infection detection, which takes seven days and takes place off-site within a lab this method could be an attractive option. Alan Hale, chief executive of Biotangents, said: “We already know that our diagnostic platform technology can have a real impact on identifying infectious diseases, quickly, in animals and that our patent pending design can be adapted for use in many other products and applications. “If we can successfully roll out our test internationally, we can realise an enormous market opportunity.”

CHECK OUT... THE LATEST EPISODE OF THE MEDTALK PODCAST The most recent episode sees regular contributor Reece Armstrong discuss the topic of in vitro fertilisation (IVF) with professor Simon Fishel, who has recently published a book titled, ‘Breakthrough Babies.’ Fishel highlights the highs and lows of his journey from being part of the world’s first dedicated IVF clinic to now running a fertility clinic group within the United Kingdom. Topics such as the adversity that was shown by peers, issues with regulatory bodies, the media involvement and lawsuits are all mentioned, alongside the positives where Fishel saw how IVF helped thousands of childless couples. You can listen to the latest episode on Soundcloud, iTunes and Spotify. 42

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Visit our Booth A61 Hall 13