MPN EU Issue 51

EUROPEAN EDITION

MEDICAL PLASTICS news +

WHY 3D PRINTING IS SUCH A HOT TOPIC DEVELOPING NEW PLASTIC MATERIALS COMPAMED 2019

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ORTUNITY

KNOCK KNOCK

When merger and acquisition due diligence teams come knocking ISSUE 51

Nov - Dec 2019

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Medical Solutions

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CONTENTS November/December 2019, Issue 51

Regulars

Features

5 Comment Laura Hughes discusses why Ireland is such a hotspot for medtech

11 Why are we still using plastic?

Teel Plastics discusses the main challenges associated with developing new plastic materials for the medical market

6 News focus How to optimise your chances of implant success 8 Digital spy 14 Cover story Ken Block Consulting explains how to cope when merger and acquisition due diligence teams come knocking 53 Events Why you should attend Compamed 54 12:2019

17 All of the lights Intertronics provides top tips for getting the best from your UV curing process 20 How medical plastics waste was turned into school shoes PVCMed Alliance explains why people should look to South Africa for inspiration on how to transform medical device waste into useful products 45 We’re going through changes Greenlight Guru explains the major regulatory changes which are coming soon for manufacturers of medical devices

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Adding Value to Your Vision

• Diagnostics • Surgical • Dental Care

• Respiratory • Drug Delivery

• Pharmaceutical

www.carclo-ctp.com 724-539-6989 sales@carclo-usa.com United States | United Kingdom | Czech Republic | India | China

editor | laura hughes laura.hughes@rapidnews.com

EDITOR’S

head of content | lu rahman advertising | sarah livingston sarah.livingston@rapidnews.com head of media sales life sciences & plastics | lisa montgomery head of studio & production | sam hamlyn graphic designer | matt clarke junior designer | ellie gaskell 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)

A whistle stop tour

of Ireland’s medtech industry

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arlier this month I was given the opportunity to tour some of Ireland’s medtech hotspots as part of a trip hosted by Enterprise Ireland - a government organisation which aims to develop and grow Irish enterprises across the global market. Ireland is often thought of as a medtech hub as it is home to 18 of the world’s top 25 medical device manufacturers as well as being the second largest country for exporting medical devices in Europe. This makes Ireland the perfect place to learn about medtech.

I travelled to Galway due to the large cluster of medtech companies and industry leaders in this area of Ireland. In case like I was, you are wondering why the medtech industry is so big in Galway, Paul Anglim, strategic development lead, BioInnovate, one of the world’s largest medical device hubs, explained there was multiple reasons for Galway’s medtech success. He explained how medtech started in the region, and a national networking event is hosted in Galway.

Anglim also mentioned the benefits the small community in Galway offers with connections ensured between organisations due to the fact that everyone knows everyone.

My first stop on the way to Galway from Dublin was at Irish Manufacturing Research

(IMR) - a company that launched after the crash 10 years ago with funding from Enterprise Ireland. The company’s vision is to enable advances in manufacturing in Ireland. IMR mentioned how they see something unique here in Ireland, where lots of competitors work together to keep the manufacturing process within Ireland.

Additionally, IMR has a STEM programme which works in primary and secondary schools and aims to change children’s reputations of manufacturing.

I think encouraging younger generations to be interested in the sector will only help to continue the success of medtech within Ireland.

Next I visited BioInnovate, a needs focused company.

Anglim recalled multiple success stories where BioInnovate had provided funding. One company was Embo medical, a medical device company who are developing the first true oneshot vascular embolisation device. BioInnovate also focuses its efforts on training people from industry. Anglim commented how anyone with an idea could approach the company and develop the idea regardless of their age and experience.

Across the road from BioInnovate is the Health Innovation Hub Ireland

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(HIHI) which works across the healthcare sector with Irish businesses in order to solve problems and improve patient care. The HIHI places a special emphasis on encouraging innovation through competitions. The 2019 Enterprise Ireland competitive start up competition was won

by Feeltect, a medical device company who produced an adjustable compression device for venous leg ulcers.

To conclude my trip, I headed to Med in Ireland where more than 800 delegates were attending the invite only event. The show began with keynote speeches followed by a panel discussion with industry leaders. Liam Kelly, chief executive officer at Teleflex, commented how demand for medical devices is inevitable for the next 30 years and how he believes it is a truly wonderful time for medical devices.

Demand for medical devices is inevitable for the next 30 years.

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NEWS FOCUS

How to optimise your chances of implant success RESEARCHERS DEVELOP NEW MEDICAL DEVICE TO OPTIMISE THE SUCCESS OF FUTURE MEDICAL IMPLANTS.

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esearchers from multiple institutions (Institute for Medical Engineering and Science (IMES) at MIT, the National University of Ireland Galway (NUI Galway) and AMBER, the SFI Research Centre for Advanced Materials and BioEngineering Research) claims to have discovered a way to enable longer-lasting and better-functioning implantable devices.

The research is focused around soft robotics which aim to tackle common issues experienced with implants.

Soft robotics are flexible devices that can be implanted into the body and are typically more comfortable than standard robotics for patients due to this property. However, following implantation of the soft robotics, often the body’s protection mechanism causes issues as the implant is recognised as foreign material and the cells react to protect the body as they would against a virus.

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One common reaction that can occur is fibrosis. Fibrosis is when a dense fibrous capsule surrounds the implanted device and impairs the function of the device. In some cases, this can result in the failure of the implant. Together, in an attempt to combat this issue, researchers have created a tiny, mechanically actuated soft robotics device which they claim is able to manipulate the environment at the interface between the device and the body, and as a result reduce the build-up of fibrous capsule. This therefore reduces the likelihood of rejection and increases the chance of implant success.

Talking about the research, Garry Duffy, AMBER principal investigator added: “We feel the ideas described in this paper could transform future medical devices and how they interact with the body.”

Ellen Roche, IMES core faculty member commented: “This study demonstrates how mechanical perturbations of an implant can modulate the host foreign body response. This has vast potential for a range of clinical applications.” This isn’t Roche’s first soft robotics device. She previously received international praise for her role in the creation of a soft robotic sleeve for patients with heart failure.

Soft robotics are steadily increasing in popularity within the medical sector and according to reports, J&J are currently working on a soft robotics platform.

Soft robotics have also been tested for their use as replacement muscles for disabled people, due to its flexibility.

Although currently the implantable medical market is estimated around $100 billion, there is huge pressure to find methods to optimise the success rates and patient outcomes associated with implantable medical devices. Soft robotics could be the solution.

W W W. M E D I C A L P L A S T I C S N E W S . C O M

Visit us at COMPAMED 2019 in Hall 8b, Stand P11 At Fluortek, we create medical tubing that exceeds performance requirements, creating custom solutions that turn challenges into solutions.

Serving the world’s leading medical device manufacturers, Fluortek specializes in the creation of extrusions engineered to custom requirements and unique applications.

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+1-610-559-9000

Fluortek, Inc. is ISO 13485:2016 Certified.

PTFE Tubing Fluorpolymer Tubing Thermoplastic Tubing Assembly & Secondary Operations Braid & Coil Reinforced Tubing Custom Material Compounding Multi-Lumen & Profile Tubing Heatshrink Tubing

DIGITAL SPY

DIGITAL

spy

MEDTECH UPDATE

www.tricare.mil/mtf/Walterreed

Trial claims to allow amputees to feel again through artificial limbs

MEDTECH UPDATE

N www.protolabs.co.uk

HOW TO MASTER DIGITAL MANUFACTURING

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igital manufacturer, Protolabs, have announced the launch of ‘Protolabs Insight’ a series comprising of weekly short videos. The videos will provide listeners with key information on how to master digital manufacturing.

Every Friday a new video will be posted

online which will cover how to design better parts for 3D printing, CNC machining or even injection moulding.

The series will aim to provide useful tips to save listeners both time and money.

You can subscribe to the series and view some of the videos online now on Protolabs’ website.

ew technology has allowed amputee Brian Tobias to feel through his artificial limb.

activity each day, whilst being much more comfortable than before and pain free.

Tobias was fitted with a prosthetic leg after losing his leg in a motorcycle accident five years ago.

His injuries following the accident subsequently derailed his career within the Navy.

The trial programme is currently available for anyone who is eligible for care within the military healthcare system.

Tobias heard about a clinical trial at Walter Reed in Bethesda where doctors were fusing a titanium implant into the bone and letting it heal. Three months later the rod is pulled out through the soft tissues and skin, and as a result the prosthetic limb is able to latch directly to the implant. The patient is able to feel and touch through their artificial limb as a result of the connection of the prosthesis to the bone.

Using this technology Tobias is able to complete an hour of physical

The videos will provide listeners with key information on how to master digital manufacturing.

DEVICE UPDATE

www.stevanatogroup.com & www.haselmeier.com

More options for diabetic patients D

eveloper and manufacturer Haselmeier has announced an agreement with Stevanato Group, a multinational company, to license Axis-D pen injector technology for diabetes. A version of the device is currently on the market and approved for use by the European Medical Agency (EMA), Food and Drug Administration (FDA) and other regulatory bodies. Additionally, the Axis-D Pen System is also available as a high quality plastic version.

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The Stevanato Group aims to use this technology to provide diabetic patients with a new pen injector which will be produced at one of Stevanato Group’s manufacturing facilities.

DIGITAL SPY

MEDTECH UPDATE

www.trimed3D.com

COMFORTABLE CASTS FOR BROKEN LIMBS

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edical solutions provider, TriMed, has announced the availability of Exiom’s innovative Xkelet casts and product line.

The orthosis system offers a 3D printed custom-fit cast that is able to optimise patient hygiene, functionality and comfort. Additionally, the Xkelet brace is able to fit on both children and adults and is available in a range of colours.

In order to create the 3D printed custom-fit cast a technician moves a scanner around the patient’s broken limb. This software is able to calculate the length, width, height and volume of the cast.

talking

POINT

The cast is then 3D printed with biocompatible materials and designed with an open lattice, so the cast is lightweight, waterproof and breathable. This allows the patient’s skin to receive proper air circulation.

Additionally, the features of the Xkelet brace prevent the loss of muscle tone that is often experienced with plaster casts.

POTENTIAL DELAYS TO EU MDR FOR CLASS I MEDICAL DEVICES MEDTECH UPDATE

www.telefonica.com

5G-enabled surgery

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elefónica, O2’s parent company, has demonstrated the first 5G-enabled remote surgery assistance system alongside a hospital in Malaga.

Using the technology, Telefónica broadcast live medical training sessions during the IV Advanced Digestive Endoscopy Conference. Without 5G this

would not have been possible.

Mercedes Fernández, innovation manager, Telefónica commented: “The operations organised at this conference are just an example of the numerous practical applications that 5G can have in healthcare.”

IN SUMMARY, WHAT IS EU MEDICAL DEVICE REGULATION (EU MDR)?

From 26th May 2020 MDR will come into effect in EU Member States. This regulation applies to all manufacturers selling medical devices within Europe and aims to provide greater protection of public health and safety.

WHAT ARE THE REASONS FOR THIS POTENTIAL DELAY? The European Commission (EC) initiated a corrigendum in May to amend or modify parts of the regulation. This would potentially allow a transitional period of four years for class I devices before the devices are required to meet the new regulation’s standards. This extra time to locate a Notified Body (NB) would probably be welcomed by organisations, as previously class I devices did not require review by a NB. WHICH DEVICES ARE AFFECTED? Class I devices are the lowest class of medical device, and typically have a simple design and provide minimal harm to the user. Examples of class I devices include surgical instruments and endoscopes.

Class I devices make up 40% of all medical devices.

IS THIS A DONE DEAL? No. The draft was initiated earlier this year by the EC, and all member states agreed to it. Now we are waiting to see if the European Parliament pass the corrigendum.

The corrigendum is anticipated to take place in November.

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Going further with Experience.

More than 70 years of experience speaks for itself. As a long-standing partner of local and global businesses alike, ENGEL delivers reliable solutions worldwide. Thirty years ago, our experience and passion for our work inspired us to make one of the most groundbreaking developments in our company’s history. At that time, we began to eliminate the use of tie bars, a move that represented a milestone in our industry.

Tie-bar-less technology ensures an accessible mould area, even greater precision and excellent mould protection. The concept has allowed us to give our customers long-lasting success – from 1989 until the present.

engelglobal.com/tie-bar-less

DEVELOPING NEW PLASTIC MATERIALS

Why are we still using plastic?

MPN EDITOR LAURA HUGHES SAT DOWN WITH CHRISTIAN HERRILD, DIRECTOR OF GROWTH STRATEGIES FOR MANUFACTURER TEEL PLASTICS, TO DISCUSS THE MAIN CHALLENGES AND CONSIDERATIONS ASSOCIATED WITH DEVELOPING NEW PLASTIC MATERIALS FOR THE MEDICAL MARKET. 2. WHY ARE WE TRYING TO FIND NEW PLASTIC MATERIALS, AND NOT SIMPLY USING ALTERNATIVES TO PLASTIC? Alternatives to plastic are just not viable for medical tubing, connectors, and bags. There is no other material family that is capable of providing the range of benefits plastic provides. Plastic is flexible and lightweight, as well as being durable and resilient. It can also be sterilised and manufactured in hygienic conditions.

There is a tendency to forget that legacy, non-plastic materials were used in the medical sector extensively for many years. These materials were gradually replaced with plastics because data and patient safety review showed plastics provided better clinical outcomes, usually at a lower price point, and also enhanced the quality of life for patients.

3. WHAT DO YOU THINK IS IMPORTANT FOR MANUFACTURERS TO BE AWARE OF TECHNICALLY WHEN DEVELOPING NEW PLASTIC MATERIALS? Manufacturers need to be aware of end uses for materials and targeted properties. Developing the process for manufacturing requires you to start with the end in mind.

4. HOW DO YOU THINK MANUFACTURERS CAN BEST DEVELOP NEW PLASTIC MATERIALS IN AN ENVIRONMENTALLY FRIENDLY WAY? Manufacturers should be aware of the environmental impact of their products and what the product life cycle is. There are advantages associated with having a product with a better end of life use or a product that is better for the environment in terms of production and processing.

1. WHY DO YOU THINK IT’S BECOMING INCREASINGLY IMPORTANT TO DEVELOP NEW PLASTIC MATERIALS FOR THE MEDICAL MARKET? It comes down to innovation. The medical sector has always been an innovative market, but the call is for purposeful innovation. There is a strong desire to move away from some materials, like flex- polyvinyl chloride (flex-PVC), that have issues associated with them. However, flex-PVC is still a useful material at a good price point with a strong, installed technical base.

A replacement material needs to be able to capitalise on that installed base of equipment and process and work with established connector materials whilst providing a competitive price point.

5. PLEASE TELL US A LITTLE BIT ABOUT STYROFLEX 4G80?

Styroflex is a styrene based thermoplastic elastomer. It is a block copolymer of styrene and butadiene, which gives it some unique properties. It was targeted to be able to run on the installed equipment base for PVC with little or no modification. It also maintains good clarity for use in intravenous tubing or infusion tubing for visualisation of bubbles. The material can be solvent bonded to a similar family of connectors as flex-PVC can.

6. WHAT ARE THE BENEFITS OF STYROFLEX COMPARED TO TRADITIONAL MATERIALS LIKE PVC? The material is as much as 20% less dense than PVC, so there is more yield of tubing per point of material. Compared to more traditional elastomers, the material is capable of being solvent bonded to conventional connectors, which gives it a unique cross section of capabilities.

There is no other material family that is capable of providing the range of benefits plastic provides.

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OVERSEAS BUSINESS

MOVING STATE SIDE PAUL BENTON, MANAGING DIRECTOR, INTERNATIONAL, ABHI EXPLAINS HOW THE ABHI US ACCELERATOR IS SUPPORTING COMPANIES TO GROW THEIR BUSINESS ACROSS THE POND. The Association of British HealthTech Industries (ABHI) is a UK industry association for health technology (HealthTech). With 300 members, daily activities see the association support companies on a number of critical issues, such as regulation, market access and government policy. Our industry is dominated by small and medium sized enterprises (SMEs), who have strong relationships with the UK’s NHS, the world’s largest single payer health system. Partnered to this, the UK has a powerful reputation for academic excellence, with strong research and development links.

As many of these businesses have achieved success in the UK, they are now looking for the right level of support to export their products and services to key strategic markets around the globe, with the US right at the top of this list.

Taking a state-by-state approach, ABHI has gradually expanded its programme across the US, leading a number of trade missions in recent years to develop a network of connections within local health systems that include clinical heads and c-suite leadership teams. Alongside that, ABHI has cultivated relationships with Chambers of Commerce, key business groups and leading technology companies.

This led in 2017 to the establishment of a physical presence at The Dell Medical School in Texas, where we believe is the ideal location for HealthTech companies to be based.

The Texas attitude to innovation is very open, with a real willingness to collaborate. With regional headquarters of some of the country’s largest healthcare providers located in the state, it makes sense to not only sell products, but conduct further research and development, and develop strategies for the clinical ecosystem that companies will find

themselves in. It also acts as the perfect springboard for accessing the wider US. Building on the significant network developed in Texas, ABHI has expanded its operations across the US - enabling deep connections to a network of institutions and hospital groups. At present, 16 UK companies are taking advantage of ABHI’s offer, which provides a platform for businesses to strengthen and grow their US activities by utilising ABHI’s advice, expertise and connections. From that initial cohort of 16 companies, 25 businesses have already pledged to use the programme in 2020, with this number expected to reach 30 by the end of the year.

Members of the programme benefit from the full use of ABHI’s dedicated workspace and office at the Dell Medical School in Austin, which provides access to their facilities and the support of senior faculty. The programme has already led to over 25 international research collaborations and new business generated for UK industry.

As Paul Benton, managing director, international, ABHI details: “When we first launched the initiative two years ago, the majority of our work was focused on Texas and its tremendous HealthTech capabilities. Building on these foundations, our expanded offer now delivers a springboard to other states, with numerous activities planned across the wider US over the coming year.”

Companies will also benefit from a nationwide programme of missions to key strategic regions, enabling more personal and lasting ties with the networks ABHI has cultivated over the years.

One company already committed to the 2020 cohort, is Bristol-based P3 Medical. Their sales manager Adrian Javes said: “As an SME looking to enter the American market for the first time, the ABHI US Accelerator has been integral to negotiating the complexities of GPO’s and hospital systems. The trade missions have been a fantastic opportunity to pitch our products to a level of hospital management that we would never be able to gain access to.”

Benton concludes: “Through the ABHI US Accelerator, this nationwide programme enables companies to de-risk their market entry and drive operations within the US. Added to this comes the support from a cohort of inmarket experts and access to ABHI’s highly developed US network. It is truly a comprehensive offer and one that I am delighted to see that companies are taking advantage of.”

The programme has already led to over 25 international research collaborations and new business generated for UK industry.

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KNOCK

COVER STORY

KENNETH L. BLOCK, PRESIDENT OF KEN BLOCK CONSULTING EXPLAINS HOW TO COPE WHEN MERGER AND ACQUISITION DUE DILIGENCE TEAMS COME KNOCKING.

MERGERS AND ACQUISITION LANDSCAPE Software is everywhere in medical devices today with the list growing every year. Examples include additive manufacturing (3D printing) systems which create patient-specific plastic and metal implants, Software as a Medical Device (SaMD) e.g., cloudhosted Artificial Intelligence (AI) algorithms which analyse medical images, software-driven electromechanical systems which provide surgical assistance, and providerprescribed device-interface tablets which improve post-surgical patient outcomes.

Whilst software helps to create new methods to assist users, new devices to benefit patients and new processes to manufacture devices, some of the medical technology companies employing software simultaneously emerge as excellent merger and acquisition opportunities. After successful product development and growth, many medical device companies with these products begin to position themselves as an acquisition target. On the other hand, some software-based medtech startups embed merger and acquisition opportunity exit plans into their corporate strategy from day one. Other industry players who are focused on their technology may find that they receive unplanned attention from an investment group or large multi-national corporation.

REGULATORY DUE DILIGENCE PROCESS Regardless of the path, my company’s recent consulting

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experience shows that many of these target companies are not ready for the harsh light of the EU/Food and Drug Administration (FDA) regulatory due diligence that usually occurs during the merger and acquisition process.

Knowledgeable buyers within the regulated medical device space must inevitably consider what liabilities may have been inherited due to any European/US (and other global market) compliance problems lurking within the target organisation before the deal is finalised. To consider this, buyers will often bring an entire regulatory team to the target company including software specialists, quality system specialists, submission/certification specialists and regulatory attorneys. My personal experience also shows that with deals above $100M, this focused due diligence team includes multiple regulatory attorneys from multiple firms, looking from different perspectives depending on their device experience. The primary job of this due diligence team is to scrub the target company’s established quality system, activities and decisions to find any lurking FDA/global compliance problems. The target company should expect that this due diligence activity will cover all regulated company and product aspects such as established procedures, staff training, design and production histories, device and process validations, technical files, FDA submissions, validity of CE Marks and IFUs, etc.

CASE STUDY Companies unprepared for tough regulatory scrutiny can have unwanted and very costly surprises discovered by that focused due diligence team. In one example, in which my company participated in the regulatory due diligence process, an orthopaedic company had their price lowered almost $2M due solely to the numerous EU/ FDA compliance problems discovered in the final weeks of the deal.

Unfortunately, this company had neither a strong internal audit system nor well-trained internal auditors. They acquired part of their product line (the portion with software) years before but had never conducted an internal audit of the acquired division (a strong testament to their weak internal audit program).

KNOCK

COVER STORY

Additionally, the company reduced the quality/regulatory staff as a cost-cutting measure approximately one year before the acquisition happened.

In this example, the relatively new CEO (brought on well after the staff reductions) was surprised at the true regulatory compliance state of the company because the required information submitted to management review had not indicated any type of compliance problem.

PROBLEM DISCOVERY What regulatory compliance problems exist in these target companies? And why do these problems serve as potential liabilities to the purchasing organisation? Firstly, every possible regulatory compliance problem that can exist in a global medical device company exists in these unprepared acquisition targets (e.g. ‘letters to file’ that should have been 510(k) submissions to FDA, product ‘experience’ reports from the field that were neither handled properly as complaints nor analysed for reportability to regulatory authorities, labeling that doesn’t match objective validation evidence, etc.) Secondly, when unsolved at deal closure, each of these compliance problems must eventually be addressed by the acquiring organisation through remediation that can sometimes delay the product/market timelines envisioned at the start of the merger and acquisition process. Fixing these situations and facing these delays can be expensive.

In the regrettable $2M example above, the CEO saw dozens of compliance issues emerge within several days of intense auditing by the talented merger and acquisition regulatory due diligence team. With trust in the company’s system and trust in the team’s capabilities, the CEO was blindsided by dozens of lastminute EU and FDA compliance discoveries. With no remaining time to resolve the issues, the best-faith approach was to negotiate the company value downward, allowing the merger and acquisition process to conclude.

With positive messages given to company executives, what method should have been used to discover possible regulatory compliance problems? From our experience with these unprepared merger and acquisition targets, the methods that clearly don’t work are relying on the existing internal team and any external regulatory resources involved in setting up and/or monitoring the company through the years. Logically, through internal quality audits, analysis of quality data and formal management review, the existing company team has already exhausted their chances to discover compliance problems. Likewise, with the financial and legal stakes so high, the target company’s CEO and board of directors gain no actionable value from a ‘customer-friendly’ regulatory assessment conducted by some long-term outsource partner.

ACTION PLAN Following the method below will increase the likelihood that a device company can be prepared for any merger and acquisition regulatory due diligence examination:

• Search for fresh regulatory assessment teams who can provide brutally honest feedback to the CEO / Board (as the merger and acquisition due diligence team will give to the buyer) • From that search, select the team with the deepest and most successful hands-on experience in all regulatory aspects encompassing the company and devices including software validation, quality systems, submissions and reporting (as the merger and acquisition due diligence team will be staffed) as well as experience with regulatory attorneys and the merger and acquisition due diligence process • Hire that tough skilled team at least six months before earnest merger and acquisition discussions begin The final point above then kicks off your internal merger and acquisition regulatory action plan. Before your company becomes the next potential medical device industry merger and acquisition target, hire the team now that may otherwise be hired by your buyer later. You want that independent team on your side ASAP, so that regulatory compliance issues can be identified and resolved prior to negotiating your company’s (higher) value.

Before your company becomes the next potential medical device industry merger and acquisition target, hire the team now that may otherwise be hired by your buyer later.

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I S N OW

We are excited about the addition of Bemis Europe Healthcare Packaging to the Nelipak family.

Meet us at Compamed in booth 8a/M01 to learn more about our enhanced capabilities and product offerings.

For more information, contact us: email: info@nelipak.com | phone: +353 91 757 152

www.nelipak.com www.bhp-europe.com

Nelipak® Corporate Office Cranston, RI, USA

Nelipak® Elsham, United Kingdom

Nelipak® Humacao, Puerto Rico

Nelipak® Clara, Ireland

Nelipak® Galway, Ireland

Nelipak® Phoenix, AZ, USA

Nelipak® Derry, Northern Ireland, UK

Nelipak® Heredia, Costa Rica

Nelipak® Venray, The Netherlands

Nelipak® Whitehall, PA, USA

ADHESIVES

All of the lights PETER SWANSON, MANAGING DIRECTOR AT ADHESIVES SPECIALIST INTERTRONICS, GIVES HIS TOP TIPS FOR GETTING THE BEST FROM YOUR ULTRAVIOLET (UV) CURING PROCESS.

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ince its introduction in the 1960s, UV curing technology has streamlined adhesive applications for medical devices. Over the last few years new UV curing technologies have been emerging, resulting in greater equipment choices and process considerations than ever before.

Typical applications for UV curing medical device adhesives include needles and cannulas, reservoirs, tube sets and catheter bonding. When an adhesive is required in a medical device assembly, manufacturers have a range of adhesives chemistries and cure options to choose from.

When assembling a medical device, it is critical that processes are reliable, consistent and are able to be validated. For bonding parts, UV light curing adhesives perform well against these criteria. This is because they are single part systems and come in a range of viscosities, facilitating precise, repeatable dispensing, both in quantity and location. Curing is fully completed in seconds and within a controlled process window

which means that immediate on-line quality assurance checks are possible.

Understanding and managing process variables is key for a robust procedure, as mandated by the industry.

The choice of adhesive is substrate dependent. For example, an adhesive which adheres well to PolyVinyl Chloride (PVC) may not adhere well to stainless steel. However, ensuring good adhesion to all of the substrates is particularly challenging in medical device manufacturing, possibly due to the use of less common plastics, such as PolyEther Ether Ketone (PEEK). A capable supplier will be familiar with industry-specific substrates and have appropriate adhesives for evaluation. In some cases, plasma surface treatment can be used to improve adhesion to low surface energy polymers.

Medical device manufacturers will want to consider selecting adhesives that pass ISO 10993 or USP class VI testing, which indicates that they are nontoxic. In addition, the adhesive will need to withstand the required sterilisation process (e.g. EtO - ethylene oxide). Intertronics supplies a wide range of ISO 10993-tested UV-curable adhesives that are able to withstand sterilisation.

Opting for a biocompatible adhesive will help the device to pass toxicity testing later on.

LAMP CHOICE UV curing lamps are usually based on two types of quite different technology.

Mercury arc lamps produce a broad spectrum of light and have been used successfully for decades, making them the predominant type of lamp for UV curing. However, despite their popularity, this type of lamp does have some drawbacks. They typically have a less than 2,000-hour bulb operational life; the intensity of the lamp degrades over time and is therefore a process variable which needs measurement and understanding. To guarantee a complete cure it is important to compensate for this. The bulb will need replacing before the output becomes inefficient.

Light Emitting Diode (LED) lamps are a more recent technology and, unlike mercury arc lamps, produce a narrow spectrum of light. When using a LED UV curing lamp, the output does not appreciably degrade over time, there are no bulbs to replace and there is no warm-up time required. One of the major

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ADHESIVES

equipment or materials supplier should be able to advise you.

THE PROCESS With most UV curing adhesives, curing starts with exposure to light and stops when the light is removed. The production process should ensure a full cure during the time of exposure.

If possible, all of the adhesive should be exposed in one dose of UV light, as multiple exposures could affect the integrity of the bond.

advantages over broad-spectrum lamps for medical applications is that LED UV lamps have a constant output, rather than one that decreases over time, removing a process variable and as a result increasing consistency.

LED lamps also emit a cooler light radiation than mercury arc lamps, are more electrically efficient and meet the increasingly stringent regulations regarding the use of mercury. However, LED lamps will not work optimally with all UV curing adhesives - this is because many of which are designed to cure with broad spectrum UV light.

When choosing a lamp, it’s important to remember that not all materials cure optimally with both types of lamp and a mismatch can result in non-optimal or poor bonds. Before taking advantage of LED UV curing technology, it’s important to remember that it is not a simple like-for-like replacement for a broad spectrum lamp. The spectral output of a curing lamp should be correctly matched with the material that is being cured.

CORRECT DOSE The key to success with UV curing is ensuring that the adhesive or other light curing material receives the correct dose of UV light. The dose depends on both the light intensity and time of exposure, as well as the appropriate wavelength for the material.

The correct dose can be achieved by carrying out testing before the final cure in order to understand the minimum dose needed for an application. From this, the user can then see how much energy is needed to achieve an optimal cure and can establish a curing process at the minimum dose, plus a recommended 25% safety factor.

Generally, Intertronics recommends a minimum curing intensity of around 50 mW/cm2. It is not recommended to use very low power UV lights for extended times as this is likely to result in non-optimal or incomplete curing for most industrial grade products, which may have a minimum activation energy level. Higher intensities should give a better cure and therefore a better performance in a shorter process time.

A radiometer can be used to measure light intensity and will give an output in either mW/cm2 or W/cm2. Radiometers with different spectral sensitivities are recommended for use with the different broad spectrum and LED curing lamps. Some radiometers can also measure dose. If you’re unsure which radiometer is suitable for your application, the technical staff at your UV

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UV light is hazardous. However, protecting operators is straightforward.

For manual, hand-held curing operations, a common sense approach would be to consider how you would look after yourself on a sunny day at the beach e.g. cover up exposed skin and protect eyes. A good supplier will deliver safety eyewear with each lamp and will help with any further Personal Protective Equipment (PPE) needed, as well as the risk assessment.

Training is recommended for everyone involved in the process. Additionally, a radiometer can also be used to check levels of UV light near the equipment, and to give colleagues better understanding of any hazard.

With new UV curing technologies entering the market regularly, there is even more potential for it to streamline manufacturing once the process is right. If you’re struggling to optimise your UV curing process, a specialist may be able to help.

With new UV curing technologies entering the market regularly, there is even more potential for it to streamline manufacturing, once the process is right.

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RECYCLING MEDICAL PLASTICS

HOW MEDICAL PLASTICS WASTE WAS TURNED INTO SCHOOL SHOES OLE GRØNDAHL HANSEN, PROJECT MANAGER OF PVCMED ALLIANCE EXPLAINS WHY PEOPLE SHOULD LOOK TO SOUTH AFRICA FOR INSPIRATION ON HOW TO TRANSFORM MEDICAL DEVICE WASTE INTO USEFUL PRODUCTS.

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hough plastic gets a lot of negative attention these days, even the most hardcore antiplastic crusaders agree that a modern healthcare system is inconceivable without plastics. No one has so far argued for plastic-free hospitals and a reintroduction of technically inferior medical devices of glass, rubber and metal that were used in the past.

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Yet the undisputed success of safe and affordable single-use medical devices should not lead us to the conclusion that our industry does not need to minimise the environmental impacts of our products. We can look to South Africa for inspiration - a place where environmental responsibility goes hand in hand with education and social and economic development.

PLASTIC WASTE PAVES THE WAY FOR SCHOOLING In Johannesburg, South Africa, a recycling project is currently underway which is a model example of how an immediate challenge regarding plastic and waste management can actually contribute to sustainable

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RECYCLING MEDICAL PLASTICS

WHY RECYCLE But what are the benefits if we decide to recycle medical devices in a more extensive way? The first thing that comes into the minds of people if you discuss this option is the contamination risk. The latest research has however shown that only a tiny fraction (around 3%) of the medical device is actually infectious e.g. an oxygen mask that has been used for only a few seconds on a patient who has broken their leg is no more risky to collect than a plastic bottle a patient has drank from and returned to the deposit system.

If nurses are asked to do the extra job of collecting medical devices for recycling, it is important that efforts are rewarded with socially beneficial products. This is obviously the case in this South African recycling scheme which allows poor children to go to school.

development. Here, a partnership of hospitals, schools, municipal authorities, non-governmental organisations and the plastics industry has developed a groundbreaking programme in which used medical equipment in hospitals is revitalised in the form of footwear for school children.

The project also demonstrates how partnerships can help create start-ups in the recycling sector. Additionally, recycling plastic offers a range of benefits such as improving the conditions for children in education, creating jobs, reducing climate impact and thus ensuring a green transition.

A number of key sustainable development goals are envisaged in the project.

As well as being a partnership (SDG 17), the project helps to achieve goal 4 on education, goal 8 on economic growth and goal 12 on responsible consumption and production. We can thus be inspired by the South African example of plastic and sustainable development.

HOW 20 INFUSION CONTAINERS WERE TRANSFORMED INTO A PAIR OF SHOES At the recent VinylPlus Sustainability Forum in Prague, I ran into Delanie Bezuidenhout of South Africa’s medical company Adcock Ingram. “In South Africa, we see some very special socio-economic circumstances compared to other parts of the world,” she told me. “As we considered which products we would develop from the medical waste, we looked at the community and noticed that about five million children in South Africa live in deep poverty.

Even basic necessities such as shoes are in short supply, which means that children cannot attend school, as school uniforms are required.”

“We thus found a product made exclusively of PolyVinyl Chloride (PVC), namely a school shoe. Our mission is to ensure that no children in South Africa should be absent from school due to a lack of footwear. Only 20 infusion containers are needed to produce a pair of shoes, so we are very prepared to collect as much as possible from the hospitals.”

Bezuidenhout emphasised that the shoes are recycled again and again: “The great thing about the shoes is that because they consist entirely of PVC, they are 100% recyclable. When the shoes get too small for the kids, they hand them over for recycling and then get a new pair of appropriate size.

This illustrates the circular community where several players in the value chain - from the international down to the local - collaborate and unite around recycling.”

Therefore, there is a great potential in recycling high-quality plastic medical equipment that can be used to make a wealth of socially beneficial products.

The benefits for the climate are clear - every time 1 kg of PVC is recycled, the climate is saved for 2 kg of carbon dioxide. For a recycling company, hospital plastic is also in great demand, since in addition to having a high-quality material, a secure supply is ensured. This is because a hospital knows exactly how much equipment is used per bed, which makes it possible to calculate the waste amounts.

The so-called recyclate can be used to produce many different products, but a hurdle will be to develop creative end products. For example, in order to motivate the South African nurses who are responsible for the sorting and collecting of used medical equipment, it has been crucial that the plastic waste they collect will be used for something sensible, which it clearly does in this case.

CONCLUSION The South African project shows us how through forming partnerships for plastic recycling we can create socially beneficial products and jobs whilst contributing to carbon dioxide reduction.

The benefits for the climate are clear - every time 1 kg of PVC is recycled, the climate is saved for 2 kg of carbon dioxide.

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BIOABSORBABLE POLYMERS

A winning combination MARTIN BINDL, GLOBAL DIRECTOR OF BIOMATERIALS AND CECILE BOUDOT, HEAD OF APPLICATION TECHNOLOGY FOR BIOMATERIALS, BOTH FROM THE HEALTHCARE BUSINESS LINE OF EVONIK, DISCUSSES ITS COMMERCIAL LINE OF PLA-PEG COPOLYMERS WHICH COMBINES MECHANICAL STRENGTH WITH RAPID DEGRADATION.

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he global market for implantable medical devices has been transformed in recent decades by the development of functional bioresorbable polymers with welldefined mechanical properties and precise degradation times.

Poly(lactic-co-glycolic acid) (PGLA) polymers are 100% biodegradable, can be fully metabolised by the body, and tailored to degrade over periods of up to four years. They have helped to transition markets away from metalbased-materials to reduce surgical costs associated with post-treatment implant removal and accelerate rates of patient healing.

Recent innovations including the development of osteoconductive composites that can match bone ingrowth, or filaments and powders that enable highresolution 3D printing of patient-specific parts are now beginning to make important contributions towards improving the safety, biocompatibility and performance of bioresorbable implantable medical devices across a range of application areas.

FINDING THE PERFECT COMBINATION Such therapeutic benefits have to date however been largely constrained to the orthopaedic and cardiovascular markets. Within the wound healing and paediatric markets in particular, conventional bioresorbable polymers have lacked the combination of high mechanical strength and the ability to degrade rapidly. While commonly used lactide-based polymers can achieve the desired mechanical strength based on monomer selection, monomer ratio and applied processing technology, their molecular weights influence degradation time. By comparison, other polymer compositions such as poly(dioxanone) (PDO), which are designed for rapid degradation within six months or less, are unsuitable for applications that require high mechanical strength due to their material properties, such as having a glass transition temperature that is below room temperature.

As a result, companies seeking to develop bioresorbable wound closure devices such as stomach or ligating clips and vascular closure devices have been forced to either utilise traditional metal-based materials or make compromises in the use of polymeric-based materials that may adversely affect functional performance. If a company chooses to compromise on degradation rates and prioritise mechanical strength, then device parts may remain in the body much longer than necessary, potentially increasing the risk of patient discomfort or the need for additional surgery. However, if companies prioritise rapid degradation over strength, then device parts may not perform as intended, potentially resulting in complications of the healing process or device failures with the consequences of increased patient pain or the need for follow-up surgery. For paediatric applications with accelerated bone regeneration, such as for cranio maxillo-facial (CMF) implants, imbalanced degradation times could significantly impair the ability of the device to match the natural healing process.

Evonik believes it has established a strong core competency in the production of highly pure polyethylene glycol (PEG) and poly (ethylene glycol) methyl ether (mPEG) substances that have a low polydispersity index (PDI) value and low diol content. These competencies have been leveraged

by Evonik to supply pharmaceutical-grade PEGs and mPEGs to a range of pharmaceutical companies.

Within the pharmaceutical market for complex parenteral drug products, the hydrophilic properties of PEGs have been successfully combined with the hydrophobic properties of PLA polymers to create di-block copolymers that can be utilised with

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BIOABSORBABLE POLYMERS

micelles and other nanoparticle-based formulations. By being able to control the extended release of active pharmaceutical ingredients (APIs), these copolymers can help to improve API solubility and the overall performance of parenteral drug products.

ADDRESSING THE UNMET NEED Until now, there has been no equivalent and commercially available PLA-PEG copolymers suitable for use in medical device implants. Evonik recognised that it was in a unique position to develop a new polymer class to address this unmet need within the medical device market. After several years of developing and testing, Evonik recently launched the world’s first and only known commercial platform of PLA-PEG copolymers for use with implantable medical devices.

By combining the hydrophobic properties of PLA polymers with the hydrophilic properties of PEG to increase water uptake, the new platform of triblock (PLA-PEG-PLA) copolymers is able to replicate the mechanical strength of standard, equivalent Resomer grades but degrade up to six times faster (as displayed in the chart).

By modifying various factors including PEG content and the composition and molecular weight of the polymer, Evonik has developed an initial range of four standard Resomer PLA-PEG grades that can address common application requirements. Featuring either 100% L-lactide or 70% L-lactide and 30% D,Llactide as the PLA component. Each grade provides well-defined mechanical strengths and degradation rates from 12 months to less than six months. PEG ratios for standard grades range between 1% and 4%, with the PEG segments having a molecular weight of 6000 dalton. A range of additional customisation options are available upon request, including the PEG to PLA weight ratio, the molar mass of each block, and monomer type and composition.

Like standard PLA polymers, Resomer PLA-PEG copolymers are made through ring opening polymerisation (ROP), which remains the most common method to combine various monomers for polymer synthesis. In reflection of the high quality of the products, they have a high level of purity due to their production under controlled cleanroom conditions that are compliant with “good manufacturing practice” (GMP) guidelines and ISO 13485 certification.

Polymer degradation for PLA-PEG copolymers takes place exclusively in the body, with materials converted into well-defined and biocompatible metabolites. Biodegradation of PLGA-based polymers occurs via the random cleavage of polymer chains through hydrolysis. Polymeric fragments are ultimately released as lactic acid and glycolic acid. These metabolites, which also occur naturally, are transformed into carbon dioxide and water via the Krebs cycle, and are eliminated from the body through the respiration system (Holland et al., 1986).

Biological degradation of other polymer families, such as PDO depends largely on the hydrolysis of ester linkages. The initial degradation is an abiotic degradation at the carboxyl end-groups formed by chain cleavage.

Evonik recently launched the world’s first and only known commercial platform of PLAPEG copolymers for use with implantable medical devices.

Chain cleavage is autocatalysed by hydrolytical carboxyl end-groups formation, which accelerates the hydrolytic reaction. In vivo studies have shown that unlike PGA and PLA, PDO is removed via urine suggesting other final degradation products than water and carbon dioxide.

When utilised in the form of a ligating clip, the main degradation product is 2-hydroxyacetic acid (Schaefer et al., 1982). PCL degradation starts similarly to PLA degradation with random chain scission by ester hydrolysis. However, the degradation rate is significantly lower. Intracellular degradation of PCL occurs once the molecular weight falls below 3000 (Woodward, 1985).

As shown in models with rodents, polymer fragments do not accumulate in the body and final products will be eliminated via the faeces (Sun et al., 2006).

Resomer PLA PEG copolymers are supplied as granular form and are designed to be easily processed on standard processing equipment without any changes to processing methods. Current data indicates a similar shelf life compared with the corresponding standard polymers.

Furthermore, Evonik can support customers in the processing of these new materials. The company’s application development laboratories and competence centres around the world also enable close collaboration between implant manufacturers and materials specialists.

Resomer PLA PEG copolymers replicate the mechanical strength of standard Resomer grades but can degrade up to six times faster

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HOW TO KEEP UP WITH MARKET DEMAND WOLFGANG MOERSCH, INTERNATIONAL MARKETING MANAGER FOR MANUFACTURER ZWICKROELL, EXPLAINS HOW MANUFACTURERS COULD REDUCE THE TESTING STEPS REQUIRED FOR AUTO-INJECTORS WHILST MAINTAINING ACCURACY.

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cross all pharma applications, the auto-injector market is one of the fastest growing sectors.

By 2020, global market volume of approximately US $2.5 billion (£1.9 billion) is expected, and auto-injectors represent the largest segment of this.

Strict regulations of these class II devices means that testing is a critical step for manufacturers to ensure both product quality and safety. Testing can be managed in-house or by a contract testing laboratory, for one or for many different product designs. Additionally, testing must support manufacturing protocols and industry regulations, whilst also focusing on accuracy and reducing time to market.

“Manufacturers need solutions that help them test complete device functionality on a single platform in an all-in-one test,” explains Erik Berndt, medical industry manager at ZwickRoell. “Market demand and growing expectations when it comes to time to market, mean our customers are operating in high-throughput environments where there is no margin for error. After all, patients everywhere are depending on reliable test results.”

The patients‘ dependency on these tests being both reliable and thorough is why pharma companies strive to achieve a high level of automation with auto-injector technology. The injection process is completely automated as the patient is able to simply remove the safety cap, position the injector, and inject the drug by the press of a button. Therefore, this means that all of the injector’s relevant functions must be checked before the production batch is released on to the market. “During our discussions with pharma companies, we identified a need for one testing system that could perform all standard tests,” says Berndt.

drug volume, including the last drops 5. Effective needle length 6. Safety function of the needle guard Other optional testing steps may also be conducted.

Zwick Roell created a solution which combines these six testing steps in to a two-column universal testing system with a safety device which incorporates non-contact sensors that are able to measure the injection time and the effective needle length by means of light barriers. Additionally, an integrated scale is able to measure the quantity of the administered drug.

This ZwickRoell solution is able to perform all of these test steps on just one specimen. As a result, this reduces the number of specimens required and increases throughput.

A typical market solution is a semi-automated testing machine that requires an operator to load the specimen, close the safety door, and start the test. From that point forward, all steps in the test sequence are able to be carried out automatically by the machine within just a few minutes per injector. ZwickRoell also offers a robot-driven fully automated testing system. “The roboTest specimen handling system removes the auto-injector from the storage magazine and inserts it into the testing machine. This solution removes the risk of operator error,” explains Berndt.

ZwickRoell’s fully automated solution is an efficient system that can measure up to 10 different parameters in one continuous process. ZwickRoell’s roboTest is controlled by automation software, AutoEdition 3, which directs the robot to remove the injectors one by one from the magazine, feed them into the machine, and start the test.

As the operator influence is minimised the results are thought to be accurate. Additionally, the process is significantly more efficient because of increased specimen throughput. The ZwickRoell testXpert III testing software, together with the expanded traceability option makes it possible to create documentation for the testing process that is complete and tamperproof.

Growth in market demand for auto-injectors is placing greater emphasis on throughput. Yet accurate test results are critical when it comes to patient health. This challenge has motivated manufacturers to seek solutions that streamline and automate the testing process without sacrificing accuracy, repeatability, reproducibility and traceability. The implementation of errorproofing mechanisms ensures consistency in testing programs, further elevates accuracy in measurement and supports excellence in manufacturing in alignment with stringent international standards and regulations.

The standard tests typically consist of: 1. Removal force of the safety cap 2. Activation force and displacement 3. Injection time 4. Determination of the administered

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UNDER THE N MA MAGNIFYING GLASS CALVIN JORY, PRODUCT MARKETING SPECIALIST, ULTRASONIC FLAW DETECTORS, FOR MEDICAL DEVICE MANUFACTURER, OLYMPUS, DESCRIBES HOW TO IMPROVE THE INSPECTION PROCESS FOR PLASTICS WITH GAGING TECHNOLOGY.

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lastic plays a major role in the medical device industry, where it has been used for more than 40 years. Advances in technology, growing populations, and a rise in infectious diseases have contributed to the increased use of pre-sterilised, disposable plastic medical products.

Yet inspecting these plastic products is challenging. Here, we’ll share some tips on how to improve the inspection process for plastic tubing and parts using ultrasonic and Hall effect thickness gaging technology.

recommend a 20 MHz focused immersion transducer, but depending on the material this may vary.

To efficiently transmit sound energy into a small-diameter part, you must focus the sound into a narrow beam. Beam focusing combined with an immersion setup provides good coupling on radiuses too small to measure with contact transducers. Focused immersion transducers use a contoured acoustic lens with a column of water to focus the sound beam for increased sensitivity. A desktop immersion-tank and probe fixture can also help ensure repeatable measurements. The tank and probe fixture create a steady column of water and help keep the test piece centered in the sound beam.

CHALLENGES OF INSPECTING PLASTIC MEDICAL TUBING The medical industry employs strict quality controls on manufactured plastic products, including extruded disposable medical tubing. Extruded tubing requires precise measurements for small diameter, thickness and concentricity tolerances. These products are used in minimally invasive surgery and examinations using miniaturised optics. Catheter tubes also have tight tolerances for wall thickness. In the past, manufacturers cut samples to inspect tubes and measured wall thickness using calipers. Now Ultrasonic Thickness (UT) gaging provides a fast, nondestructive alternative to inspect small-diameter tubing.

In ultrasonic testing, a transducer transmits sound energy into a test material and detects sound energy reflected from the part’s back wall or an internal defect. An UT gage measures time of flight and calculates the part thickness using a known sound velocity for the test material.

To create a consistent, low-flow water column, use an immersion tank with a bubbler nozzle which matches the application. A V-notch bubbler simplifies tubing concentricity checks, enabling you to rotate the tubing to quickly measure thickness around the circumference and slide the tubing over the probe to measure thickness along the part length.

INSPECTION PROCEDURE FOR PLASTIC TUBING The transducer and instrument setup for a tubing product are selected after initial testing of product samples. Using a transducer and a fixturing device, such as a bubbler, set the thickness gage to mode two.

Measurements are made between an interface echo that represents the test piece’s near surface and the first backwall echo, using a delay line or immersion transducer. This method is often used for measurements on sharp concave or convex radiuses in confined spaces with delay line or immersion transducers, as well as for in-line measurements of moving material with immersion transducers. Depending on the tube material, the minimum measurable wall thickness is typically 0.1 mm (0.004 inches) for diameters as small as 1.5 mm (0.060 inches).

Figure 1 shows a typical measurement of plastic tubing with an Olympus 38DL Plus gage. The first echo from the left represents the interface of the water and the tube, and the second echo represents the backwall, tube inner wall.

The gain and blanking parameters should be adjusted for optimum echo detection.

HOW TO AVOID COMMON ISSUES While you can simplify small-diameter tubing inspections by using proper equipment and calibrated instruments, measurement errors may still occur.

Here are three tips to avoid common issues:

EQUIPMENT AND SETUP FOR PLASTIC TUBING INSPECTIONS The appropriate transducer type, size, and frequency vary based on the application. For tubing with a diameter of less than 0.125 inches (3 mm), we

1. Increase initial gain When using an immersion setup, sometimes the interface echo is too small to reliably detect. This can happen when measuring plastics where the acoustic impedance is close to that of water. Increase the initial instrument gain to improve your chances of reliably detecting the interface echo.

2. Calibrate at the measurement temperature In-line immersion thickness measurements of tubing are often performed in a

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SILCONE GELS FOR ADVANCED WOUND CARE

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factory shortly after the tube has been extruded. However, sound velocity of plastic drops rapidly as temperature increases. So, you must calibrate your thickness gage to a sample at the measurement temperature.

3. Make final gain adjustments at the measurement temperature Attenuation of sound energy increases with temperature, especially for thicker samples. To account for changing signal amplitude, adjust instrument gain on a sample at the measurement temperature.

INSPECTION CHALLENGES Blow moulded and thermoformed plastic parts are commonly used for medical packaging and trays. Previous quality control methods involving cutting the plastic to measure the thickness with calipers introduced problems. This is because firstly, a burr is often left at the cut edge. If the operator measures over the burr, it’s not a true wall measurement.

Assuming the operator carefully avoids burrs, they are limited in where they can measure with mechanical devices due to poor access to tight corners. Operator variation is another problem, and calipers can cause errors when you hold them at an angle to the part. Thickness readings will also vary between operators when calipers are used on materials that can be compressed.

INSPECTION METHODS Two nondestructive inspection methods can reduce or eliminate these problems: 1. Use an UT gage • One advantage of an UT gage is that you only need access to one side of the material, enabling measurements of closed containers, large sheets, and other objects with limited access to both sides.

• Measurement accuracy depends on material sound velocity accuracy, so inaccuracies can occur if material sound velocity changes unpredictably.

Changes, such as substantial temperature shifts or density variations can also affect velocity. To avoid these errors, calibrate and measure at ambient temperature if possible. Otherwise, calibrate and measure at a known, constant position during manufacturing.

2. Use a Hall effect thickness gage • The Hall effect uses a magnetic field applied at right angles to a currentcarrying conductor. If a ferromagnetic target, such as a steel ball of known mass is placed in the magnetic field the induced voltage changes.

As the target moves away from the magnet, the magnetic field and the induced voltage change predictably. Plotted voltage changes can compare induced voltage to the distance of the target from the probe.

• To measure, place a Hall probe on one side of the product and place a ferromagnetic target on the other. The gage displays the distance between the target and the probe (wall thickness). This method has its advantages such as no couplant is used, measurement accuracy is independent of material velocity, and wall thickness in tight areas and thin samples can be measured.

• Additionally, it’s also easy to scan the probe around a part to verify thickness at several points or look for minimum thickness in an area. A limitation of this method, however, is that you must place a target ball inside the part. This therefore prevents its use on closed containers.

A Hall effect thickness gage can measure up to about 25 mm (1 inch). It can measure compressible materials, as long as you use the smallest ball possible to avoid compressing it. This gage is often in a production area and used by moulding equipment operators.

WHICH GAGING METHOD IS THE BEST? Many operators prefer using Hall effect gages like the Olympus Magna-Mike 8600 instrument when measuring small, thin-wall (less than 0.100 inches or

Figure 1: Plastic tubing, 2 mm (0.080 in.) diameter, 0.37 mm (0.014 inches) wall thickness

2.5 mm) parts with tight corners, and most blow moulders favour Hall effect gages since they must inspect parts with complex shapes, relatively thin and flexible walls and corners which are difficult to measure with other gages.

The optimal gaging method ultimately depends on the plastic part you’re measuring. It’s possible to quickly calibrate both gages in a few steps to produce accurate, repeatable results, and users often find operator technique is less of a factor with these methods than with mechanical gaging. Calibration data is stored with logged readings to provide a record of operator work. Both gages provide datalogging capabilities, therefore eliminating transcription errors.

The optimal gaging method ultimately depends on the plastic part you’re measuring.

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COMPONENTS AND ASSEMBLY

BRIDGING THE GAP DAVE SPLETT, VICE PRESIDENT OF BUSINESS DEVELOPMENT FOR MANUFACTURER INJECTECH, EXPLAINS HOW THE ISO 80369-7 LUER STANDARD COULD POTENTIALLY AFFECT ALL PLASTIC LUER USERS.

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he goal of ISO 80369 is to standardise connector use for common procedures. It aims to essentially move away from the luer connector as a standard interface for different devices in order to avoid misconnections which could result in injuries or death.

As many of us in the medical device industry have heard there is a new luer standard called ISO 80369-7.

This standard applies specifically to intravascular and hypodermic applications with the goal of standardising the luer taper and thread. However, the impact will most likely affect everyone that uses a plastic luer.

Many original equipment manufacturers are currently in the process of considering this change even though the “go live” date has been pushed back by the Food and Drug Administration (FDA). Whether you are a vascular company, a company that uses other manufacturers’ products, or are not included in the specific intravascular and hypodermic call out in the standard, there are some items you

may want to consider. The following outlines information regarding the relationship between the ISO 594 and new ISO 80369-7 standards.

ISO 594-2 The ISO 594-2:1998 standard references materials in the scope section. The requirements apply to rigid and semi-rigid materials, and as per the standard, metal and glass are considered rigid whilst many plastics are considered semirigid. The standard excludes a provision for flexible and elastomeric materials.

Section 3.2.2 of the ISO 594-2 standard states that for fittings using semi-rigid materials (e.g. most plastics) it is not possible to specify the fitting’s dimension accurately. The fitting should, however, pass the functional and performance requirements. Therefore, a bare minimum of dimensions must be met to connect to the female luer.

If a component manufacturer designed the male and female threads exactly to the ISO 594-2 dimensions a problem will occur. The thread profile combined with a softer material (such as nylon, polypropylene or highdensity polyethylene) easily allows the luer to be over-rotated resulting in a damaged thread and unsecure connection. This is why many component manufacturers state their luers “mate with” other luers designed to the standard. They therefore pass the performance requirements, but not all of the dimensional requirements. Depending on the end user, the luer can either be in compliance or not. Compliance to ISO 594-2 is truly subjective when considering plastic luers.

ISO 80369-7 The new ISO 80369-7 standard states that both dimensional and functional requirements must be met for compliance, as well as the semi-rigid and rigid dimensional requirements. Unlike ISO 594-2, the new standard adds a flexural modulus of 700 MPa or higher – any softer material cannot be used for compliance to this standard.

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COMPONENTS AND ASSEMBLY

ISO 80369-7 also states that by using modern test equipment and methods, it is now practical to define the dimensions with greater precision. This means that component manufacturers using plastic materials must now comply with the dimensional requirements.

ISO 594 COMPATIBILITY WITH ISO 80369-7 ISO 80369-7 used some of the requirements and parameters from ISO 594 where applicable. Therefore, if a luer complies with ISO 80369-7, it is backwards compatible to ISO 594. A plastic luer that only passes performance testing (ISO 594) will not be compatible with ISO 80369-7.

A POTENTIAL MISREPRESENTATION OF ISO 80369-7 COMPLIANCE Recently, the FDA has stated that it will accept the ISO 594-1, ISO 594-2 and ISO 80369-7 as options and will be recognised as consensus standards until ISO 80369-7 is re-released. This makes sense as the ISO 80369-7 standard is backwards compatible to ISO 594 as mentioned above. However, some companies may try to work this statement into design transfer activities.

Example case study 1. ISO 80369-7 is backwards compatible to ISO 594 2. Our luers pass the performance testing in ISO 594 3. Therefore, we can use section 3.2.2 in ISO 594-2 to exclude the dimensional requirements of ISO 80369-7 Please note: All dimensional and performance requirements in ISO 80369-7 must be met to claim compliance THE BENEFIT OF DIMENSIONAL COMPLIANCE There are several different designs of ISO 594 luers, and because the thread starts in different places this can result in potential luer to luer incompatibility.

To have a mating luer under ISO 594, the threads should meet the thread pitch, thread width and correct angles. Once you factor in different materials and clause 3.2.2, the waters become muddy quickly. As you can see from the pictures above, there is an interpretation issue. If the luer thread from one manufacturer has a thread that starts further back inside the male luer connector it will allow the luer tapers to engage, however, the locking function is compromised. Conversely, if the thread is too aggressive, it will not allow the luer tapers to correctly seal resulting in over rotation and a potential leak.

THE “T” DIMENSION The new luer standard specifies the “t” dimension for the male luer thread.

The “t” dimension measures from the end of the male luer to the first fully formed thread. This has the potential to be problematic as typically, the internal threads of a male luer taper down to the fitting’s wall and have a radius determined by the design. One may question where exactly the correct point is to measure the fully formed thread.

OUR SOLUTION Although the “t” dimension in ISO 80369-7 can be challenging to meet, it is an integral dimension that will help eliminate the potential of luer to luer incompatibility by standardising where the thread begins in relation to the end of the male luer.

Injectech has spent numerous hours refining tooling to meet the “t” dimension.

This has been confirmed through use of a computerised axial tomography scan by a third party which has certified that our ISO-80369-7 luers are in complete compliance with the standard.

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MOVING FORWARD It is absolutely necessary that medical device OEMs confirm that a component manufacturer’s claims of ISO 80369-7 compliance do in fact include all of the standard’s performance and dimensional requirements such as the “t” dimension when moving forward.

While we wait for the next revision of the ISO 80369-7 standard to be released, it would be beneficial to consider the following: 1. Eventually the standard will be enforced by the FDA. If your application falls into the end use scenarios specified in Table E.2 of the ISO 80369-7 standard, you should start considering component manufacturers and their ability to comply.

2. If your application does not fall into this group, understand that intravascular and hypodermic applications are the highest volume users of luers as evidenced by the title of ISO 80369-7. As component manufacturers adjust tooling to meet the new standard, the old ways of manufacturing ISO 594 luers to performance requirements only, will eventually be abandoned.

Although this standard is application specific, it has a far reaching effect on everyone in the medical device industry that uses a luer as a component part of their device.

Although this standard is application specific, it has a far reaching effect on everyone in the medical device industry that uses a luer as a component part of their device.

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3D PRINTING

LEARNING THE ROPES GARRETT HARMON, APPLICATION ENGINEER AT 3D PRINTING FIRM ESSENTIUM, EXPLAINS WHY CLINICIANS SHOULDN’T FEAR THE INTRODUCTION OF 3D PRINTING WITHIN ORTHOSIS AND PROSTHESIS.

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dvances in 3D printing machines, materials, and processes are putting new and powerful capabilities in the hands of Orthotic and Prosthetic (O&P) clinicians. With recent innovations in 3D printing platforms, O&P clinicians can seamlessly design and create bespoke devices that are lightweight, affordable, and comfortable for patients, more easily and efficiently than they can with traditional methods.

Patients around the world are pushing for more functional prosthetic devices which 3D printing can deliver. With 3D printing technology, O&P designers can make parts that interact fluidly with the human body while accurately mimicking natural human movement.

To turn this potential into reality, the now artisanal O&P industry must first embrace the change this technology offers. Inherently a bespoke industry, prosthetics are handcrafted by clinicians for each patient and clinicians often take great pride in the prostheses they make. However, the process can take days or weeks, often asking patients to wait before they’re outfitted with their prosthesis.

3D printing enables clinicians to quickly create prostheses that are not only fully customised to the wearer but costeffective as well. 3D printing expedites and empowers the bespoke nature of prosthetics,

giving clinicians a very capable tool to create unique limbs for individual patients, and do it in far less time.

BETTER MATERIALS Another key benefit of 3D printing is the introduction of exciting new materials to the O&P market, which will improve the fit and comfort of these devices.

This is vitally important as a poorly fitted prosthesis can cause considerable discomfort via bruising and sores. Additionally, if a prothesis is too heavy and cumbersome the patient’s mobility may be severely limited.

Many of the materials used in the O&P market today such as carbon fibre sheets are not the most comfortable. Silicon liners can be used as an alternative to provide a better fit and better comfort, however, this can increase the cost and wait time for a full prosthesis. 3D printing offers exciting alternatives to carbon fibre and silicon which will not only provide reliable strength but also long-lasting comfort.

Developing a comfortable, properly fitting prosthesis is not just a science, it is also an art. 3D printing has the power to take today’s bespoke, artisanal manufacturing process and transform it into a highly repeatable and consistent process, which ultimately results in more effective clinics and better patient outcomes.

INVOLVING CLINICIANS Given these many benefits, the O&P industry remains reluctant to fully embrace a 3D-printing manufacturing process. This reluctance, however, is understandable. As is the case with any new technology, a large learning curve and lack of trust can prevent adoption. To address this reluctance, the 3D printing industry has created solutions to make designing and printing devices more accessible and trustworthy as a manufacturing method.

Clinicians have many questions: How do I know what I’m designing on the computer is what I want? How do I know the machine is printing something as strong as what I can make by hand? 3D printing software is making it easier for clinicians to feel connected to the 3D printing manufacturing process. For example, when clinicians work by hand and want to change the shape of a prosthetic socket, they apply heat to the plastic and manipulate the material to better fit the limb in the device. To engage these clinicians more closely in the process, 3D printing software has features that enable them to mimic this action and adjust material in the software almost identically to how material would be adjusted while fitting or making a device.

Essentially, when a clinician sits down at their computer they see functions on the screen that match the functions they have been doing for years by hand. Better still, with 3D printing, an individual device can be adjusted with 0.1mm laser accuracy, ensuring that the final product is created exactly to the clinician’s design and the patient’s needs.

With 3D printing, it is also possible to take a specific set of conditions such as patient age, weight, activity level, etc. to determine the thickness, strength, and material needed in the prosthesis. This process enables clinicians to consistently design and reproduce strong devices based on proven materials and 3D printing processes. This repeatability allows for clinicians to gain trust in the technology to get strong, high-quality results every time.

3D printing will not replace clinicians. It’s not intended to. It’s intended to enable them to create prosthetics and orthotics faster, cheaper, and better than before, and to deliver prosthetics that are more accessible and affordable for many more people around the world. In this way, 3D printing has the power to deliver a happier and healthier life for millions of people.

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3D PRINTING

How to select the best fluids for 3D printing VENESIA HURTUBISE, TECHNICAL CHEMIST FOR MANUFACTURER MICROCARE MEDICAL, TALKS ABOUT HOW TO SELECT THE BEST FLUIDS FOR 3D PRINTING OPERATIONS.

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s the pressure to produce more complex biomedical parts increases, medical device manufacturing using 3D printing, a subset of additive manufacturing, is gaining widespread acceptance.

Initially 3D printing was considered by some manufacturers to be too slow and too expensive to be used on a large scale. However, recent advancements in both software and hardware technologies have lowered the costs and sped up the building process, making 3D printing a viable method for complex medical device manufacturing.

Historically, plastics were used to make the majority of 3D printed medical devices, and that trend continues.

Today over 80% of 3D printed parts are made using thermoplastic or thermoset polymers. Metals, ceramics and other composite materials comprise the other 20%. 3D printed polymer parts are manufactured using any variety of 3D printing methods including fused filament fabrication, selective laser sintering, stereolithography, digital light projector or material jetting processes. What all these methods have in common is that the parts are constructed in progressive layers by depositing or extruding polymers, one level at a time, until the parts reach their final shape.

Building the parts is just the beginning of the 3D printing process. Choosing the correct smoothing and cleaning fluid also plays a key role in the successful construction of 3D printed components. Since 3D parts are built progressively, layer-by-layer, the process sometimes leaves the parts with a stepped or terraced surface that requires smoothing to get a finished part.

In order for the smoothing to work without damaging the parts, it is necessary to understand the composition of the polymer parts. Finding the best smoothing fluid can often be a delicate balance between selecting one with a high enough solvency to effectively level out the parts, but not so strong that it damages them or compromises their structural integrity.

In addition to smoothing the parts, the fluid must also be effective at removing soils or particulate left behind from any additional processes. Any stray particulate like dust or shavings are typically non-soluble and will not dissolve in the cleaning fluid. Therefore, the particulate must be removed using displacement cleaning where the cleaning fluid gets under the particulate, dissipates any static charge and lifts it off the surface. The key to effective displacement cleaning is to use a dense, heavy fluid that floats the particles of dust and dirt off the substrate surfaces. Today’s modern fluids are typically 20% heavier than water and 50% heavier than alcohol, making them an ideal choice for displacement cleaning of 3D printed polymer devices.

An added advantage of using a chemical-based fluid for smoothing and cleaning 3D printed medical devices is that it creates a nonpyrogenic environment and can significantly reduce the risk of bioburden. Modern day cleaning fluids dry very quickly and completely therefore leaving no residues on parts after they exit the vapor degreaser. This process offers an easy way for engineers to validate bioburden issues out of the 3D printing process. The modern-day 3D printing post-processing fluids are also nonflammable and safe for use in heated machines, cold operations or in ambient temperatures.

Today, the medical device manufacturing industry is in a constant state of flux with new designs being developed daily. Post-processing using specialty fluids can help to make plastic 3D printing a viable option within the medical device industry. It is essential to work with a partner that has particular experience and expertise in specialty cleaning fluids for 3D printed polymers and vapour degreasing technologies. They can guide part designers through the postprocessing steps and recommend the fluids and methods that will work best.

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3D PRINTING

WHY IS 3D PRINTING SUCH A HOT TOPIC? MPN EDITOR LAURA HUGHES SAT DOWN WITH TWO OF THE INDUSTRY’S EXPERTS TO DISCUSS HOW 3D PRINTING IS TRANSFORMING PLASTICS MANUFACTURING.

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aura Hughes was joined by the following 3D printing experts:

• Elliot Street, co-founder and CEO of Inovus Medical, a medical device manufacturer • Simon van de Crommert, sales manager UK/Ireland/Benelux for 3D Systems, an organisation that engineers, manufactures and sells 3D printers

to partner with a company that possesses deep expertise in 3D printing to determine if the technology is appropriate for their business needs. If it is, then the appropriate solution can be developed beginning with the material, then the technology.

This is exactly the experience Inovus had with 3D Systems. They visited our stand at an exhibition, and Inovus was in need of a cost-effective lowvolume production method to help reduce the product development cycle and accelerate time to market. Having identified their application challenge, 3D Systems identified that SLS was the best solution for them as it produces strong functional nylon parts at a very competitive price compared to traditional technologies such as plastic injection moulding.

1. There is a real buzz around 3D printing within the medical field. Do you think medical device manufacturers are all now familiar with the term?

Street: I think the majority of manufacturers will be aware of the term 3D printing, but I do not feel there is a widespread understanding of the variations of the technology. There is still a lot of awareness to be gained of the variants of the technology and how the different types of 3D printing can be utilised for different aspects of device manufacture.

3. What are the main challenges surrounding 3D printing for manufacturers?

Street: Many of the medical devices manufactured are high volume, low value items, and as such the main challenge we see for widespread adoption of 3D printing in the medical device industry is the ability to scale 3D printing to facilitate high volume manufacturing.

van de Crommert: Plastic 3D printing has been embraced by a variety of industries since our own co-founder and CTO, Chuck Hull invented the technology more than 30 years ago.

From 3D Systems’ engagement with the medical community we’ve seen a keen interest in the technologies in medical device manufacturing, as well as patient-specific models, personalised surgical tools and instruments. We’ve also seen the adoption of plastic 3D printing in the dental industry.

While the process of certifying a workflow can be overwhelming, this is another area where selecting an experienced partner can help. 3D Systems has certified customer innovation centers where we collaborate with customers to tune applications and design workflows.

2. How can plastics manufacturers within the medical sector be encouraged to use 3D printing?

Street: Better education on the application of the various forms of 3D printing will highlight to many manufacturers how they can replace existing manufacturing techniques with 3D printing. Many manufacturers we speak to are not aware of the ability to use technology such as Selective Laser Sintering (SLS) printing for production level manufacturing.

van de Crommert: The biggest challenge we see medical device manufacturers experience is around certification. In many countries, for certain types of parts, the workflow and platform must undergo certification. As part of this workflow manufacturers must also use certified materials - ISO 10993-5 and -10 standards for biocompatibility (cytotoxicity, sensitisation and irritation), and USP class VI. This is important for all general medical applications as the parts come into contact with the skin and are required to meet requirements for biocompatibility, sterilisation and/or thermal resistance.

4. Do you think there are still many lessons to be learned about 3D printing?

Street: Yes. I feel the main lessons are around the application of the various types of 3D printing for different product types and for different stages of manufacturing. It was a steep learning curve for us when we were looking to adopt 3D printing as a frontline manufacturing technology and the answers on the best form of printing to use are not always immediately apparent. van de Crommert: While industrial manufacturing has been around for centuries, 3D printing has only been around for a few decades. This makes it a relatively young industry. We’ve seen tremendous advancements happen in materials, hardware and software over the years, and I believe this innovation will not slow any time soon. From 3D Systems’ perspective, the company was founded on a spirit of curiosity and a desire to innovate in order to help our customers with their business challenges. I think there are always opportunities to learn and grow and continue to help our customers maintain their competitive advantage.

van de Crommert: I believe the encouragement comes from seeing other manufacturers within the industry integrating the technology into their production workflow and realising the benefits. A manufacturer first needs 41

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TESTING AND INSPECTION

PACKAGE TESTING & VALIDATION UNDER ISO 11607 & MDR: WHAT YOU NEED TO KNOW BRITT JONES, MANAGER OF PACKAGE TESTING SERVICES FOR DEVICES, BIOLOGICS, AND COMBINATION PRODUCTS AT WUXI MEDICAL DEVICE TESTING EXPLAINS WHAT YOU NEED TO KNOW ABOUT PACKAGE TESTING AND VALIDATION.

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hanges to ISO 11607 parts one and two have left Medical Device Manufacturers (MDMs) wondering how new requirements will impact their business and efforts to prepare for the EU MDR. These regulatory changes add new requirements for package usability and sterile barrier systems and will use new terminology throughout the standard. With results aimed at improving care outcomes and patient safety, these changes establish consistency across global packaging and validation requirements. Here’s a rundown of what you can expect to see as these changes take effect in the coming months.

ISSUING INSTRUCTIONS: USABILITY REQUIREMENTS Changes to ISO 11607 place greater emphasis on the importance of usability evaluations because of the key role they play in package design.

New usability requirements aim to provide clinical staff with necessary instructions for use. Instructions must identify a clear location on the package to begin opening it, provide instructions on the opening technique, and describe how to present the product into the sterile field while preventing contamination or damage to the contents. Proper instructions for use are critical to infection prevention efforts and patient safety. MDMs will now be required to complete usability studies that prove the instructions are intuitive and effective.

PROTECTING PATIENTS: ESTABLISHING A STERILE BARRIER SYSTEM Regulators will be looking to see that your sterile barrier system’s configuration will remain intact and prevent the possibility of microbial contamination. Your packaging should guide clinicians on how to inspect package integrity before use to ensure contents are presented aseptically.

Product packaging should provide understandable steps for safe and proper use, so that the product remains sterile from the time the barrier is broken to when it’s presented into the sterile field.

WALKING THE TALK: STANDARDISING TERMINOLOGY Although syntax may seem trivial compared to other impending changes, creating consistency in the language used across documents will help set a benchmark for global standards.

HOW TO DETERMINE YOUR PACKAGE TESTING AND VALIDATION NEEDS While ISO 11607 updates align with expectations for MDR, implementation is where the regulatory bodies diverge. Package testing will be mandatory for compliance with ISO 11607, but this is still a grey area when it comes to MDR. As it currently stands, testing is not mandatory to meet the General Safety and Performance Requirements (GSPR) with sufficient justification for safety and compliance. The reality is many legacy devices either lack this information or have undergone packaging changes that prompt retesting. Risks of non-compliance include added costs for package redesign or retesting of products, package failure, patient safety issues or having to pull a product from market altogether.

Determining your needs for package testing and validation starts with conducting a thorough gap analysis. Remember, revalidation is required if you’ve made any changes to the packaging, materials or handling processes since the last testing of the product. To achieve ISO 11607 compliance, you will need to refer to ISO 16775 to decide which tests to perform, once associated risks in your packaging have been identified. As for MDR, many legacy products currently on the market will need more documentation than most companies have available after performing a gap analysis. Because of this, both MDR and ISO 11607 will require package integrity testing, in most cases.

SECURING A PARTNER Diligently vetting a potential Contract Research Organisation (CRO) partner is an important step to get you on the right testing path. Here’s some key things to consider: 1. Expansive accelerated aging: CROs need the capability of simulating a variety of environments that the device could be exposed to over the course of its life. This capability is particularly important in testing for accurate aging information. These manipulations should consider temperature, period of time, package types and materials.

2. In-house distribution testing: A CRO that can conduct complete performance validation testing in-house helps avoid hazards that can arise when multiple labs are involved.

3. Environmental conditioning: Exposing packages to freezing, tropical and dry conditions supports its ability to withstand various “worst-case” scenarios.

While aging testing helps establish a shelf-life, environmental conditioning ensures product stability during and after distribution.

With changes to ISO 11607 and MDR’s looming deadline on 26th May 2020, being organised and employing strategic partnerships is the way to earn regulatory approval.

WWW.MEDICALPLASTICSNEWS.COM

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REGULATORY UPDATE

We’re going through changes JON SPEER, FOUNDER AND VP OF QA/RA FOR SOFTWARE COMPANY GREENLIGHT GURU, EXPLAINS THE MAJOR REGULATORY CHANGES WHICH ARE COMING SOON FOR MANUFACTURERS OF MEDICAL DEVICES.

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etween the transition to ISO 13485:2016, the EU MDR and political instability, the past five years of regulatory changes in the medical device industry arguably represent more change than the industry has seen in 20 years.

While large, multinational manufacturers have the resources necessary to navigate these changes, small device makers - which make up 80% of the market, will likely be forced to make difficult decisions on the future commercialisation of their products in certain markets.

Let’s take a look at four of the largest changes facing the industry today: 1. ISO 13485:2016 AND THE PUSH FOR GLOBAL HARMONISATION OF QUALITY MANAGEMENT SYSTEM (QMS) STANDARDS ISO 13485:2016 introduced a long overdue shift in industry mentality towards quality management systems, shifting focus towards a risk-based approach to produce safe and effective medical devices. The standard also introduced the idea that medical device requirements should be less regionally governed and more globally harmonised.

While the 2016 version of the standard took more than a dozen years to update, don’t expect future updates to ISO 13485 to take nearly as long.

Working groups of the standard will initiate discussions in the latter half of 2019 to outline the next generation of the ISO 13485 standard.

The transition to the 2016 version of ISO13485 was painful for some organisations, as it required significant

changes in culture and systems, and engineering and quality teams would be well served to retain the lessons learned in the transition to avoid falling prey to “corporate amnesia” during future transition periods.

2. THE EU MDR COMPLIANCE DATE IS LOOMING If you are anything like me, you have May 26th, 2020 circled in red ink on your calendar. This is the deadline for full implementation of the European Union’s Medical Device Regulations (MDR 2017/745), upon which manufacturers actively marketing products in the EU must be fully compliant with these new regulations or cease operations until they are.

Compared to its predecessor, the Medical Device Directive (MDD), the EU MDR is less focused on the pre-approval stage of medical device manufacturing. Instead, the new regulations promote policies and procedures that elevate the manufacturer responsibilities throughout the lifecycle of their products. Securing a CE Mark, a symbol that indicates conformity with health, safety, and environmental protection standards for products sold in Europe, is no longer an end-state for device makers.

There are two key aspects worth noting: 1. The scarcity of Notified Bodies actively certified to serve the bandwidth from medical device companies requiring conformity assessments of products to receive CE Mark certifications 2. The cost of compliance - To date, only three organisations have secured licenses to act as a Notified Body under the new regulations, whereas under the MDD there were nearly 2,500 Notified Bodies. This is significant because as of the date of writing this, the current number of designated Notified Bodies will not have the capacity to address the entire EU market demand.

Going from 2,500 down to 20 entities is going to be a significant bottleneck for medical device companies seeking EU market presence.

One of the systems most impacted by the MDR is a device maker’s QMS. While ISO 13485:2016 certification still holds weight in the eyes of regulators, the MDR introduces additional QMS requirements including post-market surveillance, Periodic Safety Update Report (PSUR), incidents and Field Safety Corrective Actions (FSCA), and a dozen or so other items.

Due to the significant amount of new regulations that companies are expected to follow, many smaller-scale device makers will have to make difficult decisions as to whether the cost of compliance in the European market makes fiscal sense.

3. TAKING RISKS WITH RISK MANAGEMENT Plain and simple, ISO 14971 defines the international standards of risk management for medical devices. If the transition to ISO 13485:2016 wasn’t

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REGULATORY UPDATE

enough of a whirlwind for companies, the latest revision to ISO 14971:2012 is expected to be released in late 2019, bringing with it a new wave of changes for device makers to implement.

coming in the near future, I do not foresee MDSAP lagging behind for long.

Working groups are still finalising edits to the standard, but based on insights provided from group members, we can expect to see further clarifications on benefits and risk written into the guidelines. Risk has been well-defined in previous versions, however, benefits have not and it’s well overdue.

SUMMARY As consumer awareness of the medical device industry continues to increase and the demands for higher product quality grow louder, medical device manufacturers should expect regulatory changes to continue. The days of ten years or more passing between major updates to regulations are likely a thing of the past.

Unfortunately, some companies are experiencing the repercussions of falling behind on compliance, for example the transition to ISO 13485:2016.

This should serve as a cautionary tale for others to avoid falling behind on transitioning to the new ISO 14971 as soon as they are able. Device makers need to assign internal and external owners of risk management who will be responsible for implementing the necessary changes once the new version of ISO 14971 is released.

4. MEDICAL DEVICE SINGLE AUDIT PROGRAM (MDSAP) MOVES TOWARDS FURTHER HARMONISATION In 2012, the International Medical Device Regulators Forum (IMDRF) introduced a working group that would develop a framework for the MDSAP a global standard for medical device quality system compliance.

Under MDSAP, medical device companies may elect to undergo a single audit conducted by a recognised auditing organisation to qualify for selling their medical device in the program’s participating regions around the world, which includes Australia, Brazil, the United States, Canada, and Japan. Companies that choose to go via this route can avoid the high cost and effort associated with multiple market regulatory submissions and inspections or audits for their company.

MDSAP is a progressive push towards global harmonisation and has the potential to reduce the regulatory costs of audits and compliance for both device makers and regulators. After the close of the pilot program, both Canada and Australia have fully adopted the MDSAP program as their primary audit system.

However, MDSAP is based on the outdated guidelines from ISO 13485:2003, leading the European Union to pass on further participation in the MDSAP program. With an expected update to the current 2016 version of ISO 13485

Furthermore, the move towards regulatory global harmonisation will continue at a rapid pace as established best-practices become codified in law. In the past half-decade alone, we have witnessed many companies struggle to keep up with regulatory changes, which is likely due to a lack of dedicated initiatives within those organisations to proactively implement changes. As the pace of regulatory change shows no signs of slowing, and with many signs that it will likely increase, reactivity will no longer be an acceptable strategy.

The companies that will thrive in the coming decades will be the ones that recognise that their internal regulatory governance and QMS must be agile and patient-centric and make the necessary changes now to prepare for the regulations of the future.

The days of ten years or more passing between major updates to regulations are likely a thing of the past.

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YOUR MANUFACTURING PARTNER IN SINGLE-USE COMPONENTS AND ASSEMBLIES PVC-Free Tubing, Fittings, Quick Disconnect Solutions, and Single-Use Assemblies Eldon James Corporation manufactures and stocks over 6000 parts, 24 lines of proprietary PVC-free tubing, SeriesLock™ quick disconnect fittings and we can put them all together to build your custom assembly or choose from one of our catalog assemblies. Eldon James offers partnership manufacturing opportunities with a portfolio of capabilities that include: component design, extrusion, injection molding, formed tubing and assembly.

CHANGING THE WAY YOU CONNECT

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CATHETERS, TUBING & STENTS

FIVE FACTORS TO CONSIDER WHEN CHOOSING A COATED MANDREL THOMAS BARRETT, CEO OF APPLIED PLASTICS, A COATING SOLUTIONS SPECIALIST COMPANY, EXPLAINS HOW TO PICK THE PERFECT POLYTETRAFLUOROETHYLENE (PTFE)-COATED MANDREL.

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or any manufacturer developing advanced catheter components and devices, coated forming mandrels are as essential for increasing output, as resin and custom dies are for producing precise medical extrusions.

Mandrels are used in a variety of applications, ranging from catheter fuse welding and tipping operations to extrusion mandrels which are used for manufacturing catheter tubing that provides a smooth, slippery surface for faster production.

Coated mandrels are also commonly used as a catheter shaft manufacturing tool to: 1. Simplify removing the catheter 2. Limit shrinkage during the reflow process 3. Permit faster catheter production PTFE coated forming mandrels and catheter manufacturing have gone hand-in-hand for decades. For example, who remembers the days of calling forming mandrels “blockers” before what we now simply refer to as “coated mandrels?”

Over the years, coating options have grown in the medical device market to improve production processes in several different ways, and with so many material and coating options available today, choosing a coated mandrel to match your unique manufacturing needs can seem particularly daunting.

Therefore, here are five factors to consider when you’re choosing a coated mandrel, in order to make that decision much easier.

1. Work backwards Firstly, think about the end use application and what the primary goals of the device are. Whether you are manufacturing an advanced delivery system with multiple lumens or extruding over a multi-tapered mandrel, knowing how the end-product will be used will help you to identify the key characteristics required of the coated mandrel.

2. Make a list Write out all of the types and durometers of polymers which are needed to reach proximal and distal shaft performance requirements, such as kink resistance and steerability. It will also be important to understand how the reflow process operating temperatures may affect each polymer.

3. Test your options Now that you’ve identified the temperature ranges you can work with, you need to consider which mandrel substrate material to use. While there are material cost savings that can be gained when considering one material over another, you must consider what material characteristics and benefits each mandrel material would provide during production. It is helpful to

find a supplier who can provide multiple substrates of coated mandrels like stainless steel, nitinol and silver-plated copper. Then you can test each mandrel material to determine what’s best for your application and budget. The best way to make this decision is to put your options to the test.

4. Identify lubricity requirements Identifying lubricity requirements will help to ensure the coating process results in a longer mandrel lifetime during the manufacturing process. Pull wires and guide wires used in interventional procedures must navigate through the inner diameters of catheters seamlessly, making a high-quality lubricious coating like PTFE imperative. Other variations of PTFE fluoropolymer coatings, such as PTFE Natural, can provide performance benefits like achieving a 0.05 coefficient of friction to simplify catheter removal in fuse welding and tipping operations.

5. Key coating features to look for Lastly, whether you are designing a pull wire or a delivery system, always look for a quality coated mandrel which features a uniform, precise, non-flaking finish.

Key coating features: 1. Close tolerances 2. Abrasion resistant 3. Chemically inert 4. Chemical resistant 5. Bio compatibility 6. Corrosion resistant A lubricious coating, such as PTFE, becomes increasingly important to the catheter manufacturing process as complexity increases and French size decreases. Durability is also crucial to ensure safety and performance for any components included in the final device.

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for medical devices, pharmaceutical manufacturing and digital health.

Keep up to date with key developments that matter.

AVAILABLE IN PRINT, ONLINE AND DIGITAL FORMATS

ADVANCING HEALTHCARE

CONNECTING PHARMA

Advancing Medical Plastics

HEALTHTECH FOR HEALTHCARE

Intelligence for professionals involved in the design and production of Class I, II & III medical devices

Intelligence for the pharma and biopharma manufacturing supply chain – from clinical trial to mass production, regulations, and logistics and distribution

The essential information source for anyone involved in the design, manufacture and supply of plastic medical devices

Insight into technology to advance professionals in the medical, pharma and healthcare markets

www.med-technews.com @medtechonline

www.epmmagazine.com @EPM_Magazine

www.medicalplasticsnews.com @MPN_Magazine

www.digitalhealthage.com @digihealthnews

CATHETERS, TUBING & STENTS

Q&A MPN EDITOR LAURA HUGHES SAT DOWN WITH THOMAS BARRETT, THE NEWLY APPOINTED CEO OF APPLIED PLASTICS 1. WHAT DIFFERENCES WILL YOUR APPOINTMENT HAVE ON APPLIED PLASTICS AND ITS CUSTOMERS? Since joining Applied Plastics in June I’ve seen firsthand how great of a job Dave Ring and his team have done growing this company and continuously providing superior quality coated components to the largest original equipment manufacturers (OEM) for catheters over 60 years.

In recent months I’ve become more familiar with market demands and our customers’ highly engineered components and product specifications. We are committed to exceeding our customers’ quality and product requirements and plan to grow our capacity of advanced catheter components in 2020, including PTFE Natural mandrels and pull wires. Additionally, you can also look forward to exciting customer and engineering-focused updates to our website in 2020.

2. HOW WILL YOU ENSURE THE COMPANY STAYS UP TO DATE WITH THE LATEST TRENDS IN THE CATHETER MARKET? It’s no surprise the industry is moving towards smaller diameter devices focusing on more complex end therapies. Applied Plastics’ customers include the leading medical device OEM and contract manufacturers who are focused on high growth microcatheter segments, such as electrophysiology, neurovascular, peripheral vascular and transcatheter aortic valve replacement.

We partner with our customers in order to understand the end-use application, and then we incorporate our proprietary wire preparation and coating processes with our equipment which are able to meet the demands for tighter tolerances.

Additionally, since being acquired by Vance Street Capital in January 2019, Applied Plastics will be able to continue to invest in the business in order to help accelerate our strategic growth plans which are required for us to be a key supplier to the minimally invasive device market.

All of the above are key components to the manufacturing of medical devices used in vascular interventions.

We are continuously challenged by our OEM customers’ robust lubricity needs and tight tolerances, which enable catheter technologies delivering stents and balloons to seamlessly travel through the anatomy, increasing the probability of a successful procedure.

We meet these challenges by utilising our custom-built equipment and processes in order to deliver consistent, high quality components.

4. WHAT CHANGES DO YOU PREDICT FOR THE CATHETER MARKET? This is a really exciting time to be on the forefront of the development of life-saving systems and devices.

It will be fascinating to see how plastics manufacturers continue to improve manufacturing processes to hold tighter tolerances and thinwall thickness requirements from the innovative design engineers in the industry.

3. WHAT DO YOU THINK ARE CURRENTLY THE MAIN CHALLENGES WITHIN THE CATHETER MARKET FOR PLASTICS MANUFACTURERS? Applied Plastics provides manufacturing capabilities and the trademarked PTFE natural coating solutions to produce multiple parts such as: • Vital advanced catheter reflow components used in assemblies in the catheter manufacturing process • Pull wires and guidewires • Micro-extrusion mandrel spools

This is a really exciting time to be on the forefront of the development of life-saving systems and devices.

WWW.MEDICALPLASTICSNEWS.COM

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International exhibition and conference on the next generation of manufacturing technologies

Frankfurt, Germany, 19 – 22 November 2019 formnext.com

The entire world of additive manufacturing Design and software

R&D Metrology

Materials

Post-processing Services

Manufacturing solutions Pre-processing

Additive manufacturing surrounds a whole world of processes.

Instead of a world tour you only need one ticket – for Formnext!

Where ideas take shape.

Offical event hashtag #formnext

EVENTS

Why you should attend Compamed THE TRADE SHOW FOCUSES ON IMPROVING TEAM PLAY BETWEEN SUPPLIERS AND MANUFACTURERS.

DATE: 18TH – 21ST NOVEMBER 2019 TIME: 10:00 – 18:00 LOCATION: HALLS 8A AND 8B IN THE FAIR GROUND, DÜSSELDORF EXHIBITORS There is anticipated to be over 750 exhibitors from 40 countries. Exhibitors will include Bemis Healthcare Packaging, Boddingtons Plastics, Eldon James, Enterprise Ireland, Junkosha, Key Plastics, OraSure Technologies, Porex Technologies, Raumedic, Rose Plastic Medical Packaging, SaintGobain Performance Plastics, SteriPac, Stratasys and many more.

VISITORS The event attracts a large range of visitors. These include heads of research and development departments, production managers, engineers and technicians for research and development, technicians for production departments, technical procurement managers, medical technology exhibitors of MEDICA, packaging specialists, process engineers, design engineers and qualification and validation specialists.

Compamed expects visitors from 62 countries in the world.

KEY TOPICS Compamed runs parallel to MEDICA, which is planning to provide attendees with a chance to experience tomorrow’s healthcare market live.

Compamed hopes to build on previous years where the event has become a global hotspot for complex high-tech solutions in both microtechnology and nanotechnology.

The show will also aim to cover topics such as the manufacturing of components and finished products, manufacturing equipment, services, OEM equipment, electrical components, microtechnology, materials, adhesives, software and IT. FORUMS There will be two forums at Compamed: 1. The forum for developers and suppliers sponsored by DeviceMed i. Location: Hall 8b G40 ii. Key topics: Additive manufacturing, cyber security, regulatory affairs and medical innovations 2. The high-tech forum sponsored by IVAM i. Location: Hall 8a G40 ii. Key topics: New materials, production techniques, nanotechnology and microsystems technology There will be multiple presentations from industry experts taking place within each forum on every day of the event. The full timetable including speakers and topics is available on the event website.

KEEPING UP TO DATE: An app is available for the show. The app contains information to help you during the event, such as an interactive site map and hall plan, as well as a database of all of the exhibitors and product details. The app will also keep you up to date by providing information on trade fair and exhibitor news. The app is available in both English and German and is free of charge to download from the App Store or Google Play Store.

You can also follow the event’s multiple social media platforms to stay informed. The platforms are as follows:

www.youtube.com/user/medicatradefair www.facebook.com/compamedtradefair www.twitter.com/compamed www.linkedin.com/groups/4547526/profile

REGISTRATION AND TICKETS: Tickets are still available for the event and are cheaper to purchase in advance online. Reduced ticket prices are available in some cases such as for students and pensioners.

Your pre-purchased entrance ticket is also valid for free local transport to and from the Düsseldorf exhibition centre on the day of your visit, provided you remain within the area covered by VRR (2nd class, zone D). More information is available on your entrance ticket and on the website.

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Compamed presentations: Editor’s pick Every day during Compamed there will be multiple presentations in G40 in hall 8a and hall 8b.

The full timetable is available on the event website, but here are 3 sessions to look out for:

1

A pitching session with start-ups (Monday 18th November. 14:1014:30. Hall 8a, G40)

2

A current update on ISO 10993: past and future changes by Thor Rollins, Nelson Laboratories (Tuesday 19th November. 12:0012:30. Hall 8b, G40)

3

Material selection for next generation medical implants by Dr Jochen Ulmer, Euroflex (Thursday 21st November. 11:30-12:00. Hall 8b, G40)

12:2019 3D PRINTING ON THE BATTLEFIELD A

pilot program conducted by the US Military Academy West Point and the Uniformed Services University of the Health Sciences (USU) looked into the potential of 3D printing in desert deployment zones.

Program results displayed it was possible to 3D print and deploy medical devices to treat injured people on the battlefield.

Dr. Vincent Ho, principal investigator commented:

“We believe this programme has the potential to reduce logistical challenges and costs for transporting medical supplies to austere environments, which could also be applied to our special operations forces in remote locations.” Ho adds: “Instead of carrying tonnes of supplies, they could just print them using a, hopefully, more portable, light-weight version in the future that could fit in their pack.”

UNIVERSITY OFFERS SOLUTION FOR MEDICATION DELIVERY DURING NATURAL DISASTERS

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uring Storm Ophelia and Storm Emma, multiple diabetes patients were left isolated in their houses and unable to access their necessary medication from a local pharmacy or surgery. This prompted Professor Derek O’Keeffe, NUI Galway to begin the project.

This was the first attempt at delivering diabetes medication via a drone. EU regulations had to be ensured whilst ordering and dispensing the patients’ prescription medication. Additionally, as the drone was being designed for use in natural disasters, the device had a vertical take-

off and landing feature. This meant that the drone would still operate in situations where this is no infrastructure.

The positive results of the delivery of diabetic medication via the drone suggest that medical supply distribution by drones could play a key role within healthcare in the future.

Andrew Downes/xposure ©

CHECK OUT...

THE LATEST EPISODE OF THE MEDTALK PODCAST In our latest episode Ian Bolland, web content editor and Reece Armstrong, editor of our sister title European Pharmaceutical Manufacturer, speak to former health minister Sir Norman Lamb about his recent appointment to XenZone.

Lamb also discusses the availability of mental health services in the UK and why he believes young people can benefit from better mental healthcare.

You can listen to the latest episode on Soundcloud, iTunes and Spotify.

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