MPN EU Issue 52

EUROPEAN EDITION

MEDICAL PLASTICS news +

MAKING DRUG DELIVERY DEVICES CREATING TOOLS FOR SURGICAL TRAINING PHARMAPACK 2020

ARE YOU PREPARED? The May 2020 deadline for EU MDR is rapidly approaching

ISSUE 52

Jan - Feb 2020

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CONTENTS January/February 2020, Issue 52

Regulars

Features

5 Comment Laura Hughes discusses clinical trials for drugs and devices

20 Express delivery Lu Rahman speaks to Owen Mumford about the findings of its recent report

6 News focus A creative outlet for plastics waste 8 Digital spy 13 Digital health Ian Bolland examines the effect of sensor technology on the consumer wearable market 14 Cover story Laura Hughes provides a brief summary of EU MDR and shares the results of MPN’s recent survey 17 Therapy area focus: Oncology 39 Events What to expect at Pharmapack and MD&M West 42 02:2020

22 Trust me Orcha explains which femtech apps you can trust 24 Practice makes perfect Ian Bolland writes about his visit to Inovus Medical, St Helens 28 Spick & span Connect 2 Cleanrooms explores the clean manufacturing guidelines, trends and emerging technologies 33 Stick with it Eurobond Adhesives discusses medical device challenges 37 We’re all in this together Health Tech Alliance looks at the current state of healthtech within the NHS

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18.12.19 15:11

editor | laura hughes laura.hughes@rapidnews.com

EDITOR’S

head of content | lu rahman web content editor | ian bolland 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 © 2020 Rapid Life Sciences Ltd While every attempt has been made to ensure that the information contained within this publication is accurate the publisher accepts no liability for information published in error, or for views expressed. All rights for Medical Plastics News are reserved.

Reproduction in whole or in part without prior written permission from the publisher is strictly prohibited.

BPA Worldwide Membership ISSN No: 2047 - 4741 (Print) 2047 - 475X (Digital)

Are we nearly there yet?

G

etting a medical device to market is a time-consuming and challenging task. Following classification of the device, a Notified Body (NB) of any European state examines the application to ensure compliance with European regulations and awards the CE mark for the device to be marketed within Europe where possible.

However, gender bias often exists within clinical trials according to a scientific article published within the Pharmacy Practice journal. In fact, the National Women’s Health Network (NWHN), a consumer activists group, has long advocated for the greater participation of women and other key groups in clinical trials for all drugs and devices – particularly those which are to be marketed and used predominantly by women.

Previously women were excluded from clinical trials for reasons such as hormone fluctuations due to menstruation, as well as fears of including women who may become pregnant during clinical trials. However, we now know that the cells of men and women are very different and therefore reactions may differ for a drug or device within each gender.

In fact, it was only as recently as 1993 that the National Institute of Health (NIH) Revitalization Act was implemented. This regulation meant that women

and minorities must be included in any clinical research funded by the NIH. However, trials run by drug companies did not have to follow this regulation. Shortly after this, in 1998, the Food and Drug Administration (FDA) brought out a regulation stating that new drug applications must present safety and efficacy data by sex, and the demographics of participants in clinical trials must be included in innovative new annual drug reports.

With claims that even in a study testing for female Viagra, 23 out of 25 participants were men, it is probably no surprise that many drugs have been withdrawn from the market after finding out that they are more harmful to women than men.

We need to look as far back as animal research, where male animals are often used instead of female animals for testing drugs and devices.

A recent report by digital health company, Antidote, included results of findings from a survey of 4,000 patients and caregivers about their attitudes to clinical research. A key finding was that there is a real difference in the motivation between people of different races, regardless of their condition when choosing to volunteer for clinical research.

As described above with the female gender, there is a clear misrepresentation of different races within clinical research. A paper published in the Journal of the National

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15:11

Medical Association highlighted the importance of this, as research has shown that there are significant differences among racial and ethnic groups in the metabolism, clinical effectiveness and side effect profiles of drugs.

Although I believe we have come a long way, there is still a huge amount more to be done for clinical trial participants to be considered a true representative of our population. Raising awareness through talking out about the issue is the best way for those who have the opportunity to change this to take notice. After all, a more equal representation of clinical trial participants, will hopefully ensure a safer drug or device for everyone, and not just those who make up the majority of clinical trial subjects.

Many drugs have been withdrawn after finding out they are more harmful to women than men.

5

NEWS FOCUS

A work of art PLASTICS ARE COMMONLY USED WITHIN HEALTHCARE AND OUR HOSPITALS AND DISPOSED OF AFTER USE. HOWEVER, SOME NURSES HAVE FOUND A MORE CREATIVE OUTLET FOR THIS PLASTIC WASTE WHICH THEY HOPE BRINGS JOY AND HAPPINESS TO OTHERS.

T

ilda Shalof worked as a nurse within the intensive care unit at Toronto General Hospital for nearly three decades. Here, she began collecting clean plastic lids, tabs, pins, levers, screws, and connectors that she used every day, and which were clean and had not come into contact with patients. She claimed she was attracted to their vibrant colours and interesting shapes and thought they would be suitable as interesting sorting toys for her young sons, so she put these items into her pocket and took them home.

As Shalof’s children grew up, her collection at home began to build up and she found she had lots of bags of plastic pieces. Therefore, during the summer of 2015 alongside artists Vanessa Herman-Landau and Bradley Matson, Shalof started creating an artwork from these plastic pieces.

The final mural is four feet by nine feet and hangs on the wall of Toronto General Hospital, a part of University Health Network where Shalof used to work.

Shalof said how each piece of the artwork reminds her of moments she has experienced with patients, recalling how a yellow top from adrenaline which was used during cardiac arrest was featured within the mural. Talking about the creation, Shalof said: “Mindfulness is the key message in the mural. You may not

see value in these small pieces alone, however when you put many of them together with a helpful imagination you can turn these little fragments into something of value.”

Additionally, Shalof hopes it brings happiness to both staff and patients: “For families, it can be a cheerful, joyful thing to look at.” She added: “For nurses, I think it shows that all the little things that we do every day add up to big things for each person we treat. Any one of those pieces — the lids, the connectors — by themselves is meaningless. But all together you can create something with a lot of meaning for a patient.”

Shalof now continues to collect plastic bits whilst working within the interventional radiology department.

A second registered nurse, Beth Beaty, who works at Roper Hospital in South Carolina first began experimenting turning medical supplies into art when recuperating at home following her breast cancer diagnosis.

After one year, Beaty had created her first piece of art consisting of strings from patient belonging bags, a stethoscope and plastic caps from medications like antibiotics, flu shots, anticoagulants, insulin and morphine.

Her first painting was dedicated to Dr. Julia Haile, an infectious disease physician who passed away. This was because Haile was keen on the artwork idea of the piece and often asked Beaty for updates on her progress. Talking about the reason for the tribute to Haile, Beaty said: “She was always very encouraging and excited about it. I just thought it was a perfect tribute to her.”

Beaty explained: “I think part of what makes this cool is for nurses, we recognise all of these caps. For other people, it’s just a nice piece of art.

Everyone has a different appreciation for it. And I like being able to tell patients that their medicine cap will be used in a painting – it lights up their face and makes such a difference.”

These nurses are inspiring others to create artwork from medical plastics that would otherwise be disposed of, with many creations being shared on sites such as Pinterest.

I like being able to tell patients that their medicine cap will be used in a painting – it lights up their face and makes such a difference.

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04.12.19 12:30

DIGITAL SPY

DIGITAL

MEDTECH UPDATE

spy MEDTECH UPDATE

www.moon.ai and www.protolabs.co.uk

Trials set to begin for potentially lifesaving medical device

A

new medical device that could prevent worsening illness and loss of life is set to begin trials in Norwegian hospitals.

The trials are being made possible by manufacturing support from UK based custom prototype specialist, Protolabs.

The medical device – the Evo System, is able to monitor vital signs of hospital patients through an unobtrusive and cost-effective device which is fitted behind the ear. The device feeds real time data back to medical professionals who can then intervene when a patient’s health is deteriorating.

Moon Labs first protoyped the device using its own 3D printing technology.

After receiving the European Cool Idea Award, the organisation was able to upload its CAD designs in to Protolabs’ software to check the suitability for injection moulding.

Technicians at Protolabs also helped to provide advice on medical grade plastic.

The Evo System will be trialled in three hospitals in Norway, and Moon Labs hopes to gain CE marking so it can manufacture the technology by early 2021.

Moon Labs co-founder and product lead, Tord Asnes commented: “Without the support of the European Cool Idea Award, the cost of funding this next stage of development could have proven prohibitive for us.”

Bacteria-repelling plastic

B

https://pubs.acs.org/

acteria that cannot be killed with antibiotics are considered a real and important threat.

Bacteria form biofilms so they are able to adhere to surfaces as well as other bacteria.

Therefore, by reducing biofilm formation on surfaces the transfer and growth of pathogenic bacteria is reduced.

Scientists in Canada have conducted research focused around the concept that preventing bacteria from spreading is a suitable way to control it. Through combining both nanoscale engineering and chemistry, the scientists have created technology that even superbugs such as Methicillin-Resistant

Staphylococcus Aureus (MRSA) and Pseudomonas cannot sit on.

The results were achieved due to hierarchal structuring in the plastic wrap which makes it difficult for bacteria to attach as well as ensuring the material is waterproof.

The research was published in the American Chemical Society journal.

NEWS UPDATE

www.3m.co.uk & www.altariscap.com

3M SELLS DRUG DELIVERY BUSINESS

L

ife sciences company, 3M, has agreed to sell its drug delivery contract service unit to investment group, Altaris Capital Partners. The business reportedly achieves $380 million annually, however, sales were down about 11% in 2019.

Altaris Capital Partners is planning to pay around $650m for the group in a combination of cash, interestbearing security and 17% noncontrolling stake in the company created through divestiture.

delivery devices and inhalation contract manufacturing services.

This is not the first of its kind for Altaris Capital Partners who has previously made purchases within the pharmaceutical and manufacturing sectors. The acquisition is expected to be closed within the first half of 2020.

Michael Roman, CEO and chairman of 3M commented: “This transaction will allow us to focus more resources on our core healthcare The 3M unit being sold provides business as well as retain a share technologies such as in the value of the drug delivery metered dose business as it grows over inhalers, aerosol the coming nasal drug years.”

Moon Labs ©

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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

DIGITAL SPY

MEDTECH UPDATE

www.nesta.org.uk

talking

Could drones transport medical equipment in Britain?

F

our UK councils have partnered up in an attempt to conduct the first trials within the UK using Unmanned Aerial Vehicles (UAVs) to transport medical equipment between hospitals and GP surgeries.

Innovation foundation, Nesta, carried out research which claims this technology could save the UK public sector £1.1 billion and boost the economy by almost £7 billion.

Additionally, a study of five UK cities

POINT

showed that traffic congestion and long journey times were causing unnecessary delays to the NHS and emergency services.

Drones are currently used in other parts of the world to deliver blood; however, Britain’s airspace makes this process more difficult.

The bid to Department of Transport from Solent Transport – an organisation made up of four south coast authorities, must gain ethical approval to use drones for the transport of blood and chemotherapy kits.

WWW.NATURE.COM

NEW STUDY RESULTS SHOW PROMISE FOR AI IN BREAST CANCER DIAGNOSIS AND SCREENING

A

MEDTECH UPDATE

www.capnomask.com

ABHI US Accelerator programme helps manufacturer exhibit in the US

C

apnomask, a capnography mask made of soft transparent di (2-ethylhexyl) phthalate free polyvinyl chloride has been developed by UK manufacturer Mediplus.

material and vanilla scent also helps to ensure patient comfort and prevents post-operative nausea and vomiting which is a common complication after surgery and some anaesthetics.

The mask claims to provide a non-invasive method for accurate monitoring of the level of carbon dioxide in exhaled breath to properly assess a patient’s breathing. The mask also delivers oxygen during post-operative recovery.

mammogram uses low-energy X-rays to allow the human breast to be examined and is often used in breast cancer screening and diagnosis. However, according to the American Cancer Society, radiologists miss around 20% of breast cancers in mammograms and 50% of all of the women who are screened over a ten year period will receive a false positive result.

HOW ARE MAMMOGRAMS CURRENTLY READ? In the UK mammograms are read by two radiologists. In the case of a disagreement, a third is consulted.

WHAT DID THE STUDY PUBLISHED IN THE JOURNAL NATURE TEST? The research compared a computer which was created by Google’s Artificial Intelligence (AI) experts with healthcare professionals for screening mammograms.

WHAT WERE THE STUDY OUTCOMES? The study showed the AI system could identify cancers with a similar degree of accuracy to radiologists. It also showed that the number of false positive results, where tests are wrongly classified as normal, could be reduced by using AI.

The device includes a dual connector which is optimally positioned to ensure continuous capnography in patients under anaesthetic – a necessity according to the American Society of Anaesthesiologists (ASA). The soft

ARE THESE FINDINGS THE FIRST OF ITS KIND? No. Computer-Aided Detection (CAD) systems are used within mammography clinics.

However, CAD programs are typically trained to identify things human radiologists can see, whereas AI has the potential to train computers to spot cancers based on actual results of thousands of mammograms.

WHAT’S NEXT? More research is needed as well as the relevant regulatory approvals.

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2020 INDUSTRY FORECAST

LOOKING TO THE FUTURE OUR EDITOR LAURA HUGHES LOOKS TO THE YEAR AHEAD, AND SOME OF THE MAJOR CHALLENGES PLASTIC MATERIAL MANUFACTURERS MAY FACE WITHIN THE MEDICAL SECTOR.

A

t a time when society is so focused on sustainability and protecting our environment, excessive and non-recyclable packaging materials simply won’t cut it.

Well-known retailers such as Amazon have been criticised for this, resulting in the company taking extra measures to satisfy consumer demands.

Plastic faces extra challenges also as unlike other packaging materials it isn’t always recyclable. Plastics such as PolyEthylene Terephthalate (PET) which is used for single use clear plastic bottles and Low-Density PolyEthylene (LDPE) which is used in squeezable bottles will continue to be used without issues in the future as these plastics can be recycled.

Non-recyclable plastics, however, may experience a decline in the use of these materials whilst they are replaced with more sustainable plastic alternatives as these become available.

It is clear to me that the medical plastics market is still an exciting and growing industry to be in.

I think it will be really important to change some people’s perceptions on plastics. The material is sometimes thought of in a negative light. However, the material offers a huge range of advantages to our healthcare and lives that would not be possible without plastics. I don’t believe people realise how many and which plastics can actually be recycled and as we all become more knowledgeable on this, we will be able to recycle more and make more sensible choices, both healthcare professionals and non-healthcare professionals alike.

I also believe increasingly smaller devices will continue to be popular through 2020. A small size is advantageous for implants into areas such as the brain.

Additionally, as medical devices continue to be developed with wireless technology in mind, the devices are naturally developed to be smaller and more portable than previous medtech. With these wireless devices additional challenges present from a cybersecurity standpoint, and it is important for medical device manufacturers to consider the security of the devices during development, and not when they are on the market.

As 200,000 global trade visitors headed to last year’s well-known plastics trade fair, the K Show, and Grand View Research stated that the medical polymers market was predicted to grow at a compound annual growth rate of 8.4% through 2020, it is clear to me that the medical plastics market is still an exciting and growing industry to be in.

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DIGITAL HEALTH

WEB CONTENT EDITOR, IAN BOLLAND, EXAMINES HOW SENSOR TECHNOLOGY HAS BEEN AFFECTING THE CONSUMER WEARABLE MARKET.

Keep in touch F

ollowing the desire for technology and devices to be designed to be smaller, so is the want to become more connected. Life sciences and medical technology is no exception.

Early last year in our sister title, Med-Tech Innovation News – we featured Purdue University’s call for collaboration on wearable sensors – as the USbased institution developed a sticker-based sensor technology – as the developments of new sensors and wearables are leading to more innovative non-invasive devices.

Devices are becoming more and more connected – recently a multivital wearable sensor and Software Development Kit (SDK) in the form of a bandage sized patch from VivaLnk, a provider of connected healthcare solutions, received class II medical device classification, along with CE marking. Its size, lightweight and reusability all act as selling points, while the connectivity allows it various medical aspects of a user or patient.

As a result, new designs are being taken into account – including how they are powered. Jenax is one company that specialises in flexible batteries which can accommodate future designs – either leading to device manufacturers to drive new designs or following the trends that are desired as companies respond to their consumers.

On launching the product, VivaLnk’s CEO Jiang Li, said: “Our aim is to accelerate medical application development by providing the sensor platform so that the industry can rapidly innovate novel solutions while at the same time making it more accessible to patients around the world.”

The wearables market itself grew 15.9% in 2019 according to the International Data Corporation (IDC), and it might not slow down any time soon, with suggestions it could grow year-on-year by 7.9% until the end of 2023 – while internet of things spending could grow to $1.1 trillion by 2023.

But with that comes the safety element, as Jenax’s gel-polymer batteries have tried to accommodate the increasingly small and sometimes complex designs that come with medical devices. When it’s cut or punctured, the battery doesn’t leak – an innovation that is seemingly ahead of the curve when it came to factoring in a growing wearable. In a recent webinar they reflected on how to power a wearable in the same way as the would a solid battery – including using the battery itself as a wearable as the core of the design.

After developing non-flammable liquid electrolytes for flexible batteries, the director of Jenax, EJ Shin, said: “Liquid is the best conductor for ionic movement, which means it delivers the best battery performance. But because liquid can also be a tremendous fire hazard, many manufacturers try to use solid state electrolyte instead. They sacrifice efficiency and - in the case of wearables - comfort and usability, for safety.

“With this non-flammable electrolyte, we’re taking both to the next level, providing the peace of mind manufacturers and consumers need with the high performance they deserve.”

Aaron Johnson, vice president of marketing and customer strategy for injection moulding specialists, Accumold said: “From our perspective at Accumold miniaturisation has been a key contributor to the sensor market and in-turn, wearables. The technological timing for market adoption has finally allowed the desire or demand to be realised in a meaningful way. Sensors being the primary added value. Wearables as a category have been around for a time but never with the high degree of functionality that they have today. We see this trend only accelerating.”

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COVER STORY

ARE YOU PREPARED?

AS THE DEADLINE FOR EUROPEAN MEDICAL DEVICE REGULATION (EU MDR) IS RAPIDLY APPROACHING, OUR EDITOR LAURA HUGHES PROVIDES A BRIEF SUMMARY OF THE REGULATION AND SHARES THE RESULTS OF MPN’S RECENT SURVEY. WHAT IS EU MDR? EU MDR is scheduled to come into effect in EU Member States from 26th May 2020.

This regulation will apply to all manufacturers selling medical devices within Europe and aims to provide greater protection of public health and safety.

IS THERE POTENTIAL FOR EU MDR TO BE DELAYED? The United States issued a statement to the World Trade Organisation (WTO) in 2019 writing: “Our industry is worried about their continued access to the EU’s $125 billion USD medical device market, $20 billion USD of which is supplied by US products.”

However, the EU commented in July 2019: “There are no grounds for the time being to explore any amendment to the transitional periods.”

WHERE ARE WE NOW? To date the European Commission (EC) has designated nine Notified Bodies (NBs) against MDR. The EC previously predicted at least 20 NBs. The EU acknowledged that the final number of designated NBs could be “slightly lower” than originally anticipated. The US statement to the WTO explained how they do not believe this number is enough to, “ensure continued regulatory approvals by May 2020.”

Only one of the regulations that has been put forward has been adopted to date. This regulation involves the reprocessing of single-use medical devices.

Additionally, the EC’s draft standardisation has been heavily criticised. The US statement addressed the issue to the WTO stating: “Industry maintains that the product standards necessary for compliance with MDR cannot be completed before the deadline.”

COMMENTS Lots of key industry figures have shared their views on the topic.

Reiner Thiem, head of regulatory affairs, Raumedic “We have intensively worked over the last three years to gain an understanding of the new regulatory landscape.”

Peter Rose, managing director - Europe at Maetrics, a life sciences consultancy firm: “Three year transition periods are well established in our industry, but never have I seen a transition period being used to get the system ready.”

MPN CONDUCTED A SURVEY ON PEOPLE SELLING MEDICAL DEVICES WITHIN EUROPE. THE RESULTS OF THE SURVEY ARE DISPLAYED BELOW. The survey was completed by people from the following countries:

Q Did you use any consultancy service as part of your preparation?

50% 40% 10%

N/A

2%

2% 2%

2%

2% France

15%

Spain UK

Canada

USA

14

2%

32%

YES NO

2%

Germany

39%

Poland Ireland

Greece

Unknown

COVER STORY

Q On a scale of 1-5, (1 being not ready at all, and 5 being ready to go right now) how prepared are you and your business for the new EU MDR?

9.52%

26.19%

40.48%

19.05%

4.76%

1

2

3

4

5

Q Which class of medical device is your company primarily a manufacturer of?

28%

55%

12%

5%

Q Do you think the implementation of EU MDR will have a detrimental effect on patient outcomes?

To date the European Commission (EC) has designated nine Notified Bodies (NBs)against MDR. The EC previously predicted at least 20 NBs.

Q What do you think are the most challenging aspects of these new regulations?

Class II medical devices

Class III medical devices

No response

60%

40%

35.71% Unsure

11.9%

Q When did you start making preparations for EU MDR?

Within the last 6 months

9.52%

Within the last 3 months

0.00%

Within the last month

11.90%

Not started

Scott Whittaker, president and CEO, AdvaMed “We are now in the critical period of transitioning to the new system, which needs to be completed by May 2020 (and May 2022 for IVDs). Industry is concerned that while we are prepared, key elements of the new EU regulatory system will not be ready sufficiently ahead of these deadlines to enable industry to comply with the new rules in time. In particular, we believe the capacity of the “NBs” (approval bodies) will not be adequate to allow for the re-certification of tens of thousands of existing and new products ahead of the May 2020 MDR implementation deadline. Appropriate and urgent action by European institutions will be essential to ensuring continued access to existing life-saving and life-improving medical devices and diagnostics that hospitals, doctors, patients and families rely on every day.”

Sandi Schaible, senior director of analytical chemistry and regulatory toxicology, WuXi Medical Device Testing “The year of MDR is here. And device manufacturers are under more pressure than ever before. With so many questions about NBs, whether Europe will delay implementation, and EUDAMED, the uncertainty and stress is palpable.

Device manufacturers, you are not alone. We’re in this together. But don’t sit idle and risk having your devices pulled from market. If you’re behind, it’s time to lean more heavily on laboratory testing partners, if they have capacity.

Put your foot on the gas and approach partnerships with transparency. Being forthcoming with details and giving your lab partners visibility to forecasts, intervals, and timelines will help you make up for lost ground in these final months before the 26th May 2020 deadline.”

WWW.MEDICALPLASTICSNEWS.COM

14.29% Required documentation

4.76%

Available resources

19.05% Clinical data for existing products

14.29% Q Do you believe the guidance for EU MDR is clear enough?

33.33%

S

23.81%

O

Within the last 12 months

N

54.76%

Notified bodies

YE

Class I medical devices

66.67% 15

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ONCOLOGY

Therapy FOCUS A cool idea SCALP COOLING TECHNOLOGY PROVIDER, PAXMAN, EXPLAINS HOW ITS INNOVATION AIMS TO HELP PATIENTS MAINTAIN A SENSE A NORMALITY WHILST RECEIVING CHEMOTHERAPY. WHO ARE PAXMAN? Founded in 1997, Paxman Coolers design and manufacture the Paxman Scalp Cooling System – a hair loss prevention system for cancer patients undergoing chemotherapy.

Hair loss is consistently ranked as one of the most feared and common side effects of chemotherapy treatment, and the damage that chemotherapy causes to the hair follicle can be alleviated by using scalp cooling treatment - also known as the ‘cold cap’. The cold cap which is manufactured from high grade silicone material works by reducing the temperature of the scalp by a few degrees immediately before, during and after the administration of the toxic chemotherapy drugs.

3D-printed cooling caps, along with important biological hair follicle research as well as developing innovative scalp cooling-related treatments. Initially, the Centre will focus its efforts on three key projects: • Development of a novel, environmentally friendly ecosystem for 3D-printed individual cooling caps ready for mass production and ultimately a perfect cap fit.

• Biological research using the most clinically-relevant in vitro models: Cultivated human hair follicles.

Paxman has enabled scalp cooling to be available for chemotherapy patients worldwide. The company’s aim is that every applicable cancer patient, no matter where in the world nor their financial position, has the opportunity to maintain a sense of normality by keeping their hair through chemotherapy treatment.

HOW SUCCESSFUL IS SCALP COOLING? In recent years the success rate for patients using scalp cooling has been around 50 percent (on average), with significant variations experienced between different types of chemotherapy.

A key factor in improving efficacy is Paxman’s research and development collaboration with the University of Huddersfield in the UK. The collaboration was formalised in 2019 with the Paxman Scalp Cooling Research Centre, a multidisciplinary research group that constitutes the world’s first research and development centre in scalp cooling.

HOW TO IMPROVE SCALP COOLING EFFICACY The target for improved scalp cooling efficacy has always underpinned Paxman’s company-wide strategy and continues to form a major part of the company’s research, development and innovation strategies. The launch of the 4th generation Paxman Scalp Cooling system in 2018 saw a complete re-design of the silicone cooling cap. The fit of the cooling cap is critical for successful hair retention outcomes for patients. Extensive research by academics at the University of Huddersfield into varying cultural differences in head sizes and shapes led to the latest 3D printing technology being used to produce the optimum shape and fit for the cooling caps. The Knowledge Transfer Partnership (KTP) for this most recent project was judged “outstanding” by the Technology Strategy Board.

• Development of a topical product with the potential to substantially enhance the effect of scalp cooling. The enhancement effect of the product has already been proven in initial in vitro tests.

Continuous innovation is vital to ensure that the personal cooling caps ensure a high level of comfort for patients, as well as enabling them to practice their cap fitting in the comfort of their own home, maintain good hygiene and remove the nursing burden.

Paxman ©

CHASING ZERO HAIR LOSS: THE 80/20 VISION The 80/20 vision means that around 80 percent of patients using scalp cooling shall be able to keep most of their hair. In 2012 the benchmark for scalp cooling efficacy was 48% whilst in 2019 we saw a significant uplift in successful scalp cooling outcomes to over 56%. Paxman’s research and development programme allows the company to continuously refine the efficacy and user-friendliness of its scalp cooling system. The collaboration with the multidisciplinary research team at the University of Huddersfield brings together crucial industry expertise and know-how.

The Paxman Scalp Cooling Research Centre, the world’s first multidisciplinary research centre focused on scalp cooling will continue developing individual WWW.MEDICALPLASTICSNEWS.COM

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MAKING DRUG DELIVERY DEVICES

Five ways to optimally manufacture drug delivery devices BILL WELCH, CHIEF TECHNOLOGY OFFICER, PHILLIPS-MEDISIZE LISTS FIVE BEST PRACTICES THAT CAN HELP ACCELERATE TIME TO MARKET AND OPTIMISE RETURN ON INVESTMENT. 1. TAKE A TEAM APPROACH Pull together a combination of stakeholders, including design, marketing, finance, procurement and manufacturing, in the earliest stages of development. That way, you can work with front-end innovators to identify and refine the concepts that deliver the best features and usability for patients, caregivers and healthcare professionals, and also plan for the manufacturing and commercial realities that influence marketplace success. To maximise return on investment, it is critical to balance desirable design features with the cost of goods, production time, manufacturing complexity and scalability.

2. UNDERSTAND PATIENT NEEDS Patients have varied medication delivery preferences and dosing needs. For example, patients in paediatrics, geriatrics and oncology often require highly flexible oral dosing based on age, weight and other variables, and may find it difficult to swallow normal-sized tablets and/ or capsules. As a result, mini-tablets often offer a viable option, given their size and flexibility for adjusting dosing.

To provide patients and caregivers with reliable methods to administer mini-tablets in variable quantities, Phillips-Medisize is commercialising an innovative, low-cost mini-tablet dispenser which mounts directly on a standard Ø38mm tablet bottle neck.

This makes it easy to safely and accurately dispense the exact number of minitablets needed per dose, without requiring a new or different bottle. Users of this device simply shake the mini-tablets into the preset dispenser dosing disk, rotate the lid and pour the mini-tablets onto a spoon, food or other option.

3. INTEGRATE MOULDING DESIGN EARLY In plastics manufacturing, the moulding design is typically added after the parts are designed for the mechanical application. However, for drug delivery devices, integrating moulding requirements early in the process is critical to addressing shrink, sink and multiple other factors caused by heating, forming and cooling. The resulting changes can affect the mechanical design and necessitate future adjustments to the overall device design in order to avoid moulding parts with unmanageable tolerances and quality issues. Meeting established plastics design standards, tolerance expectations and tooling design increases the overall design effectiveness, in turn reducing variability and furthering compliance with global regulatory requirements for product manufacturing.

4. DEVELOP CONNECTED DEVICES ON AN INTEGRATED PLATFORM Adding connectivity to drug delivery devices presents unique challenges along with numerous benefits. Developing these innovative products on an integrated core platform can accelerate time to market by using proven designs, existing infrastructure and repeatable manufacturing processes.

Phillips-Medisize has created a scalable connected health platform that combines plastics components, electronic components, sensor technologies and software, and features a modular approach that is easily customised to multiple therapeutic areas.

5. CHOOSE YOUR DEVELOPMENT PARTNER WISELY Innovative partnerships that consider the entire opportunity lifecycle, facilitating a smooth flow through each stage, offer distinct advantages. These include increased production speed and reduced cost, as well as reduced risk once the product reaches the market. With the emerging trend of outcome-based reimbursement, combination products must continue to find ways to improve the entire therapy solution. Design development and user considerations, while important to consider, are merely aspects of the greater value proposition provided through design thinking and the committed implementation of device strategy.

These best practices provide a strong foundation for successfully developing, manufacturing and bringing drug delivery devices – both mechanical and connected – to market, quickly and cost-effectively.

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DRUG DELIVERY

DELIVERY HEAD OF CONTENT, LU RAHMAN, SPEAKS TO MEDICAL DEVICE MANUFACTURER, OWEN MUMFORD, ABOUT THE FINDINGS OF ITS RECENT REPORT SCOPING THE NEAR-TERM COMPETITIVE BIOSIMILARS MARKET IN THE USA AND EUROPE, AND ITS IMPACT ON DRUG DELIVERY DEVICE DESIGN.

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he available market for biosimilar manufacturers seeking to compete with original reference biologics coming off patent between late 2018 and 2023 in the USA and Europe, is considerable. However, says Owen Mumford, even where clinicians encourage the use of biosimilars for the patient, there remain some key considerations to overcome. This includes clinical confidence in the biosimilar; competitive pricing of drugs through greater competition; and patient confidence in the drug delivery device.

Owen Mumford’s study reveals the size of the near-term opportunity in competitive biosimilars markets for biologics coming off patent 2018-2023 and offers evidence that device design is a key differentiator in addressing patient adoption.

In Europe, the estimated market opportunity for this five year cohort of patent expiries (factoring in competitive discounts and based on 50% market share) for biosimilar manufacturers is $3.12 billion per year based on current revenues; the equivalent market opportunity in the USA comes to $5.24 billion per year.

Molecular size and viscosity create issues around the volume of drug being delivered, as well as potentially causing pain upon administration. We are seeing an increase in self-administration across the globe. As a result, precision dosing, ease of use, comfort, and convenience – all reliant on drug delivery device design – have become key in ensuring patient adherence.

Familiarity and comfort with a particular delivery device also has to be taken into account as it can hinder switching from treatment despite the advice of healthcare professionals.

George I’ons, head of product strategy and insights, Owen Mumford Pharmaceutical Services says: “This latest paper highlights some important issues concerning the key role of design for ‘combination products’ where delivery device and drug are seen as single entity by regulators. This highlights the supporting role of device design in ensuring that drugs, especially newly booming biosimilars, enter the market competitively.”

LR: Why is device design for biosimilars so important in relation to patient adoption and what are the main considerations in drug delivery design for biosimilars compared with other drugs?

GI: The device component is increasingly seen as integral to the therapy as a whole with biologics rather than a secondary consideration, especially since the design of the delivery device may have an impact on patient adherence.

Testament to this is the position the Food and Drug Administration (FDA) has taken by creating a specific category for approval of combination products i.e. the device and drug.

To maximise on this opportunity, biosimilar manufacturers need to think seriously about drug delivery.

Biologics and biosimilars present specific challenges with respect to formulation development due to the nature of the molecular structure as these types of treatments are typically administered subcutaneously. Typical considerations are the trade-offs between medication volume, viscosity and injection frequency, and delivery time. Higher viscosity formulations may allow less frequent dosing for the patient but increase the complexity of device design. Higher volume injections may mean looking at different options in prefilled syringe and autoinjector design or even considering wearables as alternatives. Injection time, ease of use, lack of pain and needle protection are all key drivers for increased patient acceptance.

It is now widely accepted that the design of a drug delivery device – typically an auto-injector or prefilled syringe device – is a crucial consideration.

When switching to a new biosimilar, patients may experience difficulties if they are using a different device that is too unfamiliar. On the other hand, improvements in design and ease of use may be a persuasive factor.

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LR: How can drug delivery designers and manufacturers seize upon the opportunities available in this market?

GI: A key element in device design is a thorough and robust Human Factors (HF) program. The HF process will test user acceptance of a new device and importantly determine the level of risk associated with each step in its use.

Results from formative HF studies can provide key insights as to how device design can be modified to create more user-centric product features. Also important for device manufacturers is the ability to be able to offer flexibility in design so that different sizes and configurations of primary containers can be accommodated to allow for varying drug volumes and viscosities. With low volumes typical of biologics, the device also needs to ensure that the full dose is delivered to the patient and that the residual volume in the device is as low as possible. Another key consideration is the requirement to ensure that device designs comply with sharps injury prevention regulations and incorporate safety features that prevent needlestick injury and reuse. With many pharma companies creating different doses and formulations of the same molecule, as part of lifecycle management, the ability to have a platform device that can be used for all these variations with minimal design changes is a key factor.

the requirement for employers to provide safety devices designed to prevent needlestick injury. These regulations apply to the employees regardless of the place of work and so cover acute and home settings. The US FDA has a specific combination product approval process for drug and device combinations. This has yet to be established in Europe and as such in this market the device still requires a CE mark for approval; however, the process will change with the introduction of the Medical Device Regulation (Regulation (EU) 2017/745) in May 2020. For Europe the drug is also regulated separately and a Marketing Authorisation Application (MAA) is reviewed and granted by the European Medicines Agency.

LR: Is it important for device companies to collaborate with drug manufacturers and how easy is this process?

GI: The collaboration between pharma and device manufacturers is essential to developing and bringing a successful combination product to market. This relationship is key throughout the drug development process with horizon scanning for devices often taking place well before initiation of clinical studies. Most large pharma companies employ dedicated device teams who work closely with other internal departments such as formulation chemistry, clinical, sales and marketing as well as creating a close working relationship with the device suppliers. Smaller pharma companies without device teams often need additional technical support and guidance throughout the process so good collaboration whether large or small - is central to a smooth launch.

LR: You highlight self-administration devices - how important is this market and what are the future opportunities?

GI: We’re seeing self-administration become increasingly important across the world. There are many drivers of this trend: In particular, self-administration helps to ease the burden on hospitals and makes treatment more convenient for patients. This is creating opportunities for manufacturers to favour the production of devices which prioritise ease of use and safety features. There is a growing demand for pre-filled syringes while safety-engineered devices can be seen to dominate the pre-filled market, with three in every four devices offering safety mechanisms. If we look at the market data for safety syringes specifically, an analysis of a range of key research sources reveals that the global pre-filled syringes market was estimated to be worth over $772 million in 2018, rising to some $1.137 billion in 2023: This amounts to a significant growth rate of 8.1%.

Precision dosing, ease of use, comfort, and convenience – all reliant on drug delivery device design – have become key in ensuring patient adherence.

LR: Are there any differences between the US and UK markets?

GI: Approval of biosimilars is far more progressed in Europe compared with the US with over 60 approved by the European Medicines Agency to date compared to 25 approved in the US by the FDA. Both US and EU markets have well established regulations in place concerning

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FEMTECH

Trust me

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WITH ONLY 15% OF FEMTECH APPS MEETING QUALITY THRESHOLDS, WHICH ONES CAN BE TRUSTED? KATE GILDING, MARKETING MANAGER FOR THE ORGANISATION FOR THE REVIEW OF CARE AND HEALTH APPS (ORCHA) EXPLAINS HOW TO IDENTIFY WHICH FEMTECH APPS YOU CAN TRUST. and identify your ovulation by analysing basal body temperature. Backed by scientific research, the app is the first digital method of birth control available in both the USA and Europe. Natural Cycles achieved an ORCHA Score of 84% on iOS and Android, making it the highest scoring pregnancy app on ORCHA’s App Library.

here has been a huge rise in the number of apps that address women’s health. From periodtracking apps, pregnancy and nursing care, women’s sexual wellness, to reproductive health, it’s the most searched for category on Google and is attracting the attention of Venture Capital investment.

The ORCHA has reviewed hundreds of femtech apps in order to provide transparency for patients and healthcare professionals alike in terms of the apps that are safest and most clinically assured. Each app featured on our App Library receives an ORCHA Score, which provides clarity on which femtech apps are the best, and which should be used with caution.

We’ve reviewed over 200 of the femtech market’s most downloaded apps, looking at 260 criteria across three main components. These components were data security, clinical assurance and user experience. They were chosen to uncover the strengths and weaknesses of the sector and spot the stand-out apps. Our analysis found that more than 85% of the apps do not meet our quality threshold of 65% and have areas that need addressing, primarily around clinical assurance.

Given this proportion of low-quality apps, combined with the increased consumer demand and lack of regulation in app stores, we believe ORCHA’s App Library is of vital importance for enabling populations and healthcare professionals to discover the femtech apps that do stand out as being safe and trustworthy.

Mush – This app empowers women to build local friendships with other mums, share advice and find support from an understanding community.

Mush creates opportunities for mums to socialise, bridging the gap between appointments with healthcare professionals, and provides support for those who don’t have family networks nearby. Mush scored 83% in their ORCHA review on both iOS and Android.

Mum & Baby – Developed in partnership between families and maternity staff from NHS trusts in North West London, Mum & Baby can provide support from the start of pregnancy to early parenthood. The app allows you to understand your choices for maternity care in North West London, and make personalised plans for your care during pregnancy, birth and beyond. Mum & Baby achieved an ORCHA Score of 82% on Android and 81% on iOS. Ovia Pregnancy Tracker – Ovia allows you to track your baby’s development and your own wellbeing as the pregnancy progresses. It includes a customisable health tracker, a calendar for organisation, a community of mums and expectant mums, and over 2000 pregnancy articles and tips. The app achieved an ORCHA Score of 80% on iOS and 79% on Android.

Breast Start – This app provides evidence-based information from NHS professionals about all aspects of breastfeeding. It also allows you to find support locally and nationally, including giving advice on local breastfeedingfriendly places. Breast Start achieved an ORCHA Score of 76% on Android.

It’s exciting to see the surge in apps available on the femtech market but worrying that so many of these apps remain unregulated and exist without clinical assurance. Digital health solutions can be a great aid during pregnancy and can address multiple women’s health concerns, so platforms such as ORCHA are necessary to overcome the inherent uncertainty of app stores by introducing transparency as to which healthcare apps can be trusted.

Here, we explore five of the topscoring femtech apps reviewed by ORCHA, which can be useful before, during and after pregnancy: Natural Cycles – This app can be used as a fertility tracker, or, in the USA and Europe as a method of birth control. Natural Cycles uses a smart algorithm to learn your cycle

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SURGERY

Practice makes perfect WEB CONTENT EDITOR, IAN BOLLAND WRITES ABOUT HIS RECENT VISIT TO ST HELENS TO LEARN HOW MANUFACTURER INOVUS MEDICAL CREATES USEFUL TOOLS TO AID SURGICAL TRAINING.

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eginning with simply a sheet of plastic and a heat gun, the team at Inovus Medical has come a long way since the development of its first laparoscopic simulator.

The St Helens-based team is expanding, with much of its manufacturing done in house. While it builds its own simulators to allow junior doctors and surgeons to practice procedures using digital aspects, augmented reality and virtual reality, it has also started to develop its own electronics and materials behind the use of medical devices. This year alone has seen £1 million investment going towards another augmented reality system.

Elliot Street, Inovus CEO and cofounder, worked as a junior doctor in the early years of the business. His co-founder, Jordan Van Flute, had only just graduated. Addressing how the company began, Street said: “What we wanted to do first was answer an unmet need which needed to be answered. We wanted to answer it affordably and we set up a company where we had to really hustle, and noone would hear of us apart from the exact end users using the kit.

“All we were going to do in those first five years was developing really good kit in front of the people who need to buy it.” The “kit” Street refers to was at first just a plaster box with a webcam in. Street realised when he began his surgical training how there was a “real lack of access to good quality, affordable laparoscopic trainers,” and this is how the idea was created.

Talking about the industry, Street said: “We’re vertically integrated in the processes of manufacturing, we’re vertically integrated in the process of design and product development, but we’re also vertically integrated in the actual products themselves and the portfolios.”

As well as the digital simulators, Inovus also manufactures original materials in-house. “Our haptics are real haptics, you don’t need sensors because we’re putting in models that feel like real tissue,” Street added. “The thing that’s giving you all that haptic feedback is a real, tangible model and then we build a digital environment around that.”

Street explained that a major driver of the idea was the desire to allow trainees to perform a virtual procedure in the most realistic way – repeatedly stating his desire for products to be affordable, accessible and functional. Simulators have been developed for multiple purposes including those that can be taken home, and those that are designed for use in an institutional setting.

The materials developed in-house allow Inovus to try and make procedures like appendix surgery and ectopic pregnancies as realistic as possible – the latter specifically having its own mass that can be removed from the model. Polyps and lesions are among the ‘dummy scenarios’ that have been manufactured for surgical practice from silicone material.

The simulators therefore conjure up a mixture of the digital environment and reality. To take it as close to reality as possible, with some of them 3D printed in their entirety like the Bozzini Hysteroscopy Simulators and Sellick Cricoid Pressure Trainers.

Talking about the materials Inovus is developing in-house, Street commented: “Some materials we have are proprietary to us and we spent a long time developing those materials, which allow us to perform electric surgery, use energy devices in theatre on them and they react like real tissue.”

Elliot Street, CEO and co-founder, Inovus

Inovus’ first device was made by bending a piece of plastic with a heat gun around the side of a fridge, and then drilling some holes in to it. Street and Van Flute took photos of the product and shared the images on their self-coded website. Every time they sold something, they constantly reinvested the money, using it to initially buy a safer method of bending plastic and later, more kit.

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SURGERY

Inovus is putting newly developed materials into its first products to be used – where it looks as if surgeons are cutting through real tissue, attached to an energy device. Street explained: “The first time I put the energy device through it’s probably the most excited I’ve been and there’s lots of exciting stuff that goes on under this roof.

“For me, that’s a game changer. I don’t say these things lightly because prior to this I wouldn’t say that. I’d say that’s a really sensible solution for an unmet need but now we’re developing technologies on the material side, on the way we utilise other technologies like 3D printing, and on the software side which are truly game-changing for the industry.”

Street explained using the company’s own blend of materials has allowed them to manufacture tissue which can be of real benefit to surgeons. He commented: “The materials we use range right through from a whole myriad from different types of silicones – our proprietary soft tissues to our acrylic plastics which we heat and fabricate here right through to the stuff we 3D print such as nylon.

For medical device companies as well, we’re offering them a product that shows their product in the best light.

“Everyone uses silicone for soft tissue. The great thing about silicones is when you get your mix right you can create tissues which give you tension when you’re holding them in a medical device or instrument which actually feels like a real tissue.

“With our appendix model, one surgeon I trained with said, ‘how on earth have you managed to make that feel like an appendix?’ Imagine his surprise the next time I see him when he’s cutting through this tissue, he can use an energy device and it behaves like real tissue.

That for me is not only a value added to training surgeons, but also they’re now able to perform procedures super-realistically and they can use the real instruments.”

However, it’s not just surgeons who can benefit from this technology. Street concluded: “For medical device companies as well, we’re offering them a product that shows their product in the best light so when they want to go and demo their product, they’re able to use non-animal by-products so they don’t sully their kit.

“Training surgeons are also able to practice in a safe, controlled environment away from the patients but on a material that’s behaving like a real tissue behaves.”

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CLEANROOMS

How clean is your cleanroom?

TIM RUSSELL, BUSINESS DIRECTOR-CONTROLLED ENVIRONMENTS AT TSI INCORPORATED IN CONJUNCTION WITH PMT (GB) EXPLAINS THE CASE FOR A FACILITY MONITORING SYSTEM IN A CLEANROOM ENVIRONMENT.

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any facilities choose to install facility monitoring systems to monitor particle counts and other environmental parameters.

There are multiple benefits associated with use, and it makes great business sense, however, the advantages to a business are not always fully understood.

These benefits include: • Reduced waste • Improved yield • Improved quality • Increased profits While there are some organisations that choose to install a facility monitoring system just because regulatory guidance states one should be installed and used, many, given the choice, would choose not to. Initial capital and ongoing maintenance costs seem expensive, the mountains of data that will require analysis seems daunting, and alert and action level excursions often leads to time consuming root cause investigations. Plus, there are also necessary considerations around the maintenance, calibration and validation overhead involved.

WHY DO REGULATIONS EXPECT A MONITORING SYSTEM TO BE INSTALLED? 1. Risk reduction A facility monitoring system improves probability of hazard detection, leading to a reduction in risk. Product quality is impacted if too many airborne particles find their way into the product, compromising patient safety.

Only when deploying and correctly positioning monitoring probes to frequently collect data, is there a chance of detecting particles. If there are no particle monitoring probes installed close to critical processing locations, the probability of detecting particles entering the process is zero.

and a better understanding of the manufacturing process. This increased knowledge leads to recognising when the process is drifting out of control before it’s too late and means a less segregated product, less product waste and fewer interruptions during manufacturing without compromising patient safety.

2. Monitoring makes great business sense Today, monitoring systems are already being used to support energy saving initiatives. There are significant energy savings to be made when setting back air change rates and air velocities whilst being safe in the knowledge that environmental conditions have not been compromised.

Continuous particle monitoring in a facility means the exact time of a particle excursion is known and immediately notified to end users. This supports timely root cause investigations and minimises how much of the batch is segregated – saving a significant amount of money.

The availability of Alternative Microbiological Methods (AMMs), such as continuous laser induced florescence particle counting, means there is also an option for immediate understanding of the microbiological quality of the air surrounding the process. This could possibly lead to intervention free manufacturing and supports Real Time Release Testing (RTRT).

Smart factories of the future will have fully interoperable systems where data is seamlessly exchanged between multiple platforms. Sharing and centralising facility monitoring system data transforms it into holistic information that aids decision making. This holistic information could predict that an excursion is likely, enabling proactive steps to be taken to positively impact yield and significantly save on manufacturing costs.

Smart factories of the future will have fully interoperable systems where data is seamlessly exchanged between multiple platforms.

Turning critical data into information is key. This can be conducted through real-time data presentation, reports and alarm notifications. The ability to do this results in increased knowledge

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Corpora

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CLEANROOMS

ROWIN VOS, GENERAL MANAGER BV AT CONNECT 2 CLEANROOMS, A CLEANROOM DESIGN AND MANUFACTURE SPECIALIST, EXPLORES THE CLEAN MANUFACTURING GUIDELINES, TRENDS AND EMERGING TECHNOLOGIES TO PROVIDE CLARITY TO MANUFACTURERS.

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Spick & span

urope’s current Medical Device Directive (MDD, 90/385/EEC) on active implantable medical devices states that, “devices must be designed and manufactured in such a way that, when implanted under the conditions and for the purposes laid down, their use does not compromise the clinical condition or the safety of patients.”

instance, if the implant is made of one solid polymer and can be autoclaved or gamma-sterilised, the required manufacturing conditions are relatively easy to specify.

The clear message here is on patient safety; however medical device manufacturers often struggle with the fact that the directive is not prescriptive enough in terms of the environment. Instead, some feel it leaves ambiguity over which clean manufacturing standard is applicable to their production environment specification and which guideline they should follow to mitigate risk.

LIMITATIONS OF APPLICABLE GUIDELINES Typically, medical device manufacturing is conducted in ISO 14644-1:2015 classified cleanrooms, ranging from ISO 5 to 8, with final packaging usually conducted in an ISO 7 or 8 environment. This cleanroom standard however, does not provide specific instructions for medical device processes, and even ISO 13485 focuses mainly on the quality management systems throughout the life cycle of a medical device.

This leaves manufacturers with quite a few questions to answer. What part of the product do we need to protect at what stage of manufacturing?

Does it need post-processing and will the material or object withstand the conditions required? Does it need to be manufactured aseptically? How should it be packed and under which conditions?

But what if your active medical device is a polylactic acid-based absorbable implant? Sensitivity to hydrolysis and molecular weight reduction may not permit autoclaving or radiating. Post-sterilising the outer surface would also not be effective as, over time, the human body will be exposed to the core and the 3D printed inner layers of the object, including any potential contamination trapped in there during the manufacturing process. Trapped organisms could potentially be pathogenic or the core could be sterile, but still endotoxin-laden. So is ISO 5 sufficient, or should the manufacturing environment be scaled up to EU GMP A or B? EXPLORING NEW STERILE TECHNIQUES The question over sterile production and techniques has triggered researchers to start experimenting and exploring emerging technologies. It has recently been documented that 3D printing could be intrinsically sterile because of the temperature and pressure applied during manufacturing, such as in the article titled, ‘On the intrinsic sterility of 3D printing’ by Neches et al., 2016.

In more than twenty incubations, the researchers found only two contaminated parts. Although the experiment was based on a limited amount of incubations and a rather wide spectrum of manufacturing conditions was applied, the researchers suggest that the printing process does indeed produce functionally sterile parts.

Most of their experimental manufacturing conditions included the use of biosafety cabinets, including ultraviolet light, and aseptic preparation and decontamination of the printing area and substrate, and therefore, in essence, they were set up in line with EU GMP A particle and microbial manufacturing guidelines.

From a clean manufacturing perspective, it was interesting to observe that the contamination on the parts was found to be common skin associated microflora, potentially indicating a post-processing handling error. Considering the latter, the results indicate that not only the technical (particulate) aspects of ISO 5 should be considered, but rather the whole chain of processing and handling activities should be defined in Standard Operating Procedures (SOPs) according to EU GMP aseptic processing.

What is needed in practice requires a thorough evaluation through risk assessments of the intended use, the class of the medical device, and its manufacturing materials. For

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CLEANROOMS

Q&A ROWIN VOS, GENERAL MANAGER BV, CONNECT 2 CLEANROOMS PROVIDED MEDICAL PLASTICS NEWS EDITOR LAURA HUGHES WITH HIS EXPERT OPINION ON CLEANROOMS REGULATIONS. WHAT IS THE DIFFERENCE BETWEEN ISO AND GMP? In both guidelines, particle contamination is used for the classification of the environment, both at rest and in operation. One of the main differences between the ISO classification and the EU GMP grades is the addition of microbiological limits of the room in operation. When following EU GMP guidelines, the principles of Quality Risk Management (QRM) should be applied to ensure that microbial, particulate and pyrogen contamination associated with microbes is prevented in the final product, or at least reduced as far as possible. In practice that also means that the facility, equipment and process design must be optimised, qualified and validated according to Annex 15 of the EU GMP. IS IT THEN SUFFICIENT TO BUILD AN ENVELOPE WHERE ALL EXPOSED SURFACES ARE SMOOTH AND IMPERVIOUS, WITHOUT UNCLEANABLE RECESSES, AS DETAILED IN EU GMP ANNEX 1?

No, that is not sufficient to provide complete product protection, as the case studies by Neches have shown. Personnel must have appropriate skills, training and attitudes, with a specific focus on the principles involved in the protection of the product during the aseptic manufacturing and packaging process. Also, the processes and monitoring systems must be designed, commissioned, qualified and monitored by personnel with appropriate process, engineering and microbiological knowledge.

In essence, all activities should be managed in accordance with QRM principles that provide a proactive means of identifying, scientifically evaluating and controlling potential risks to quality (GMP draft Annex 1, December 2017).

YOU MENTIONED THE DIFFICULTIES THAT APPLY TO TERMINAL STERILISATION OF POLYLACTIC ACID, POLYGLYCOLIC ACID AND POLY(LACTIC-CO-GLYCOLIC ACID) IMPLANTS, BUT UNDER STRICTLY CONTROLLED CONDITIONS IT CAN BE DONE. HOW DOES THAT AFFECT THE MANUFACTURING CONDITIONS? In general, there are two primary routes of manufacturing sterile products: • One leads to terminal sterilisation • The other is based on pure aseptic manufacturing to completely prevent contamination and maintain sterility from start to finish.

• In fact, a third hybrid option could be to apply a minimum level of thermal or radiation post-processing to improve the sterility assurance level of an aseptically manufactured device.

to validate the outcome to a sterility assurance Level of 106. Although in practice, that is not very likely to work, as that case would be hard to validate.

Validation depends on repeatable results, time after time, which is difficult to do without strict process control.

Industrial pharmaceutical manufacturing sets out new sets of rules. Compare that to a situation where a patient could be expected to freshly prepare and reconstitute lyophilised drugs by aspirating saline from a pre-sterilised container, breaking an ampoule, adding the water, aspirating the solution in the syringe again and injecting intramuscularly. All of that would usually be done standing at the kitchen worktop.

The manufacturer who delivers that same syringe in a “ready to use” format will have to build a full EU GMP suite from grade D, cascading all the way down to grade A for sterile filling the syringes.

We have to bear in mind that the Medical Device Directive stipulates that devices must be manufactured in such a way that their use does not compromise the safety of patients. That is all encompassing.

Connect 2 Cleanrooms ©

But even in the case of terminal sterilisation, the manufacturing objectives are to control and minimise the particulates and bioburden in the product throughout the non-sterile processing stages. That’s why we refer to a “controlled” environment. The envelope, equipment and pre and postmanufacturing processes all need to be governed by Standard Operating Procedures (SOPs) in order to create that “controlled” environment.

SOME MANUFACTURERS MAY ARGUE THAT THE CONTAMINATION RISK IS FAR-FETCHED. WOULD YOU AGREE? Yes, to some extent I tend to agree, but it is still up to them to assess their risks, based on their materials, process and intended use. Another way of looking at it would be to develop a process of minimal measures and

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PEEK & HIGH PERFORMANCE POLYMERS

The next generation JOHN DEVINE, MEDICAL BUSINESS DIRECTOR AT INVIBIO BIOMATERIAL SOLUTIONS, A SUBSIDIARY OF VICTREX, SPOKE WITH MPN TO EXPLAIN THE ACCELERATING ROLE OF BOTH NON-IMPLANTABLE AND IMPLANTABLE GRADES OF POLYETHER ETHER KETONE (PEEK) POLYMERS. What are the major trends you anticipate for drug-delivery devices within the future?

We see a key trend towards connected drug-delivery devices or e-devices, such as insulin pumps which are used in the treatment of diabetes. E-devices have smaller dimensions compared to non-e-devices and are miniaturised to precise tolerances, resulting in reduced weight and easier use. When complex electronic components must be embedded, they too are designed to be compact with the lowest possible wall thickness.

Is there a place for PEEK within the future of the medical sector?

Based on properties such as PEEK’s low moisture absorption and stability as a dielectric, PEEK has a long history of use in numerous applications. Polymer solutions provider, Victrex Group has acquired knowledge in design synergies and cross-applications, which allows us to address both the design and manufacturing challenges of these devices.

Can you expand on the properties of implantable PEEK and how these can benefit applications?

Invibio’s PEEK-OPTIMA is biocompatible, which is an absolute requirement for implantable applications. PEEK is inherently radiolucent, so medical imaging by X-ray, computerised tomography scan and magnetic resonance imaging, are artefact-free and therefore facilitate analysis and diagnosis with unobstructed views. Furthermore, it can be sterilised using standard processes such as gamma and e-beam radiation and steam sterilisation.

In terms of mechanics, given that the polymer can be processed by injection moulding or machining, very small parts with accurate dimensions and tight tolerances can be produced and assembled, making it a competitive option for drug-delivery applications. PEEK is also chemically inert, and this stability allows it to be in contact with aggressive chemicals or drugs without interactions, whether PEEK is present in the form of packaging or as a conduit. If mechanical strength is required, then PEEK parts can be designed to meet this key engineering requirement. Some companies are focused on subcutaneous drug delivery devices to make it easier for patients and this trend may require materials which are known to be safe for long-term implantation. (1) PEEK polymer is available in a wide range of forms for use in different manufacturing processes in order to deliver patient value. Victrex ©

PEEK has the potential to drive cost savings for the manufacturer.

What are the main benefits of using PEEK for non-implantable applications?

For non-implantable Victrex PEEK, the potential range of applications is quite broad and includes injection-pen/autoinjector and wearable segments. For these devices, the solutions must be reliable and safe as well as accurately dispense the right amount of drug at the right location at the right time. The requirement to be patient-friendly and low cost is important for these types of applications in order to address any treatment adherence challenges.

PEEK can play a key role thanks to its high mechanical strength, where it exhibits stiffness, along with impact and fatigue resistance, and a low frictional ratio. Additionally, it is chemically stable at both high and low temperatures, remaining non-leachable and non-extractable.

In terms of processability, it can be machined and injected to precisely accurate dimensions and tolerances.

One beneficial consequence could be the opportunity to reduce the number of parts and components that comprise the device.

Conclusion PEEK has many attractive properties for the medical sector, and the choice of PEEK can help to reduce the number of parts by integrating functionality, reducing the size and weight of devices, and streamlining the manufacturing processes. As a result, PEEK has the potential to drive cost savings for the manufacturer.

References 1) Sci Transl Med. 2017 Aug 30;9(405). pii: eaaf9166. doi: 10.1126/ scitranslmed.aaf9166.Subcutaneous drug delivery: An evolving enterprise

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ADHESIVES

STICK WITH IT SIMON DEARING, MANAGING DIRECTOR OF MANUFACTURER EUROBOND ADHESIVES DISCUSSES SOME OF THE CHALLENGES MEDICAL DEVICES PRESENT MANUFACTURERS WITH. THE CHALLENGE Medical devices present manufacturers with a unique challenge. As well as being health-compatible, the materials used within these devices must allow high-precision production and permanent joining as well as withstanding various sterilisation methods. It is particularly important to consider all of these factors when choosing which adhesives to use for the assembly of medical devices.

ADHESIVES Medical grade adhesives can be used to bond medical products such as syringes, dialysis filters, blood bags and tube connections. These medical products are usually made from a range of synthetic materials such as plastics that are hard to bond e.g. PolyEther Ether Ketone (PEEK), PolyEthylene (PE) and PolyPropylene (PP). On the other hand, common plastics such as PolyVinyl Chloride (PVC) and Acrylonitrile Butadiene Styrene (ABS) are well suited to bonding.

DISPOSABLE MEDICAL PRODUCTS Disposable medical products are often produced in large quantities. It’s important for adhesives to possess mechanical bond strength, as well as being able to be rapidly cured. When adhesives have both of these properties high volume production can be ensured.

For transparent and UltraViolet (UV)-permeable materials, UV-curing medical grade adhesives can be used. For UV-impermeable substrates we recommend Light Emitting Diode (LED) curing, and for visual quality inspection, fluorescent versions of medical grade adhesives are also available. One such product is Vitralit UV 4802 which has been developed

by German adhesives manufacturer Panacol and is supplied to UK businesses via Eurobond Adhesives.

REUSABLE MEDICAL PRODUCTS For reusable medical products, durability and the ability to withstand frequent sterilisation play a vital role. Cured acrylate adhesives have a high resistance to sterilisation by autoclaving, gamma radiation and ethylene oxide. These sterilisation methods therefore have no measurable negative impact on Panacol’s medical grade adhesives.

Additionally, electron-beam sterilisation has even been shown to improve the adhesion of some medical grade adhesives of the Vitralit series. This is thought to be due to an increase in the degree of polymerisation of these products.

EXAMPLES Eurobond Adhesives supply USP class VI and ISO

10993 medical grade adhesives to manufacturers of medical disposable devices. These organisations use the adhesives Euorbond Adhesives supply to manufacture many disposable items.

Vitralit UV 4802 is a one-component acrylic system that cures very fast when exposed to light. Eurobond claim the system demonstrates excellent adhesion to many plastics such as PEEK, PolyEthylene Naphthalate (PEN) and Thermoplastic PolyUrethane (TPU). These plastics are all typically hard to bond with conventional adhesives. This adhesive also adheres very well to ceramics and glass. Tests have shown that the adhesive is highly resistant to heat and is able to keep its soft and flexible characteristics even after being exposed to temperatures of 150°C for seven days. As a result of its high flexibility the adhesive is perfectly suited for bonding thin and bendable PEEK plastic materials.

Vitralit UV 4802 is pink in colour and cures within seconds under a UV or visible light source. Both high pressure gas discharge lamps and LED curing systems are suitable for curing the adhesive. Once cured, the adhesive fluoresces which enables inspection of the bond line under black light.

For reusable medical products, durability and the ability to withstand frequent sterilisation play a vital role.

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ADVANCING HEALTHCARE THROUGH INNOVATION

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Get your coat OUR EDITOR LAURA HUGHES SAT DOWN WITH ARJUN LUTHRA, COMMERCIAL DIRECTOR, BIOINTERACTIONS, TO FIND OUT MORE ABOUT THE COMPANY AND FUTURE SECTOR PREDICTIONS. 1. Please tell me about your organisation, BioInteractions BioInteractions innovates high-performance, biocompatible coating technologies for the medical device industry. We have spent over 25 years in the industry tackling the variety of biocompatible challenges seen by medical device manufacturers. Our range of products aims to provide innovative and effective solutions to improve antithrombogenicity, device related infections and tissue damage at the device-body interface.

We have also improved our ability to support our customers’ developments through our commitment to care services. We are able to provide an optimised coating process for a specific device, in-house testing procedures and to provide supporting data and experience with regulatory submissions.

2. Which materials are you able to coat?

Our technology works on a wide range of substrates and we have multiple techniques to improve the interaction between the substrate and the coating.

Our application techniques enable us to coat a wider range of materials in order to ensure a consistent coating applied to the device to give long-term efficacy on the device.

3. You have developed a new antimicrobial which doesn’t release toxins into the body. How does this coating work?

AvertPlus Antimicrobial is a non-leaching coating that eliminates bacteria and helps to reduce biofilm formation. The coating targets a broad spectrum of bacteria, without harming the patient’s cells.

The coating works by using a combination of components to provide a contact-kill mechanism. This multi-faceted approach significantly reduces the ability of bacteria to remain on the surface and colonise. This gives the coating significant advantages over alternatives for tackling device related infections.

4. Please can you tell me more about the antithrombogenic coating you have developed which is able to mimic the endothelial layer?

The Astute Antithrombogenic Coating is a non-leaching coating that actively improves the haemocompatibility of a device by mimicking the natural endothelial layer. Astute enables a device to perform its intended function by preventing formation of a thrombus and reduces the risks of further complications from occurring in a patient.

6. In the next five years, what are the key changes you predict within the coatings sector?

The medical device regulations have been through significant changes recently. Therefore, the technologies will follow suit and have to catch up with these new regulations. This will take a significant amount of time but will also help to improve the overall quality of innovations and medical devices available.

In addition to this, there is a clear intent to introduce computer software and systems into more therapies. This will certainly change the way we are able to provide the therapies and the amount of data we are able to receive.

This will in turn improve the therapies available to patients.

BioInteractions are committed to innovating and maintaining the highest standards for our customers in order to help provide innovative and effective medical devices for patients.

7. Which events can our readers find you at this year?

We are exhibiting at the MD&M West 2020 show (Booth: 1425) and the MD&M East 2020 show (Booth: 733).

Astute Antithrombogenic coating uses a multi-faceted approach to prevent thrombus formation and helps the device maintain its position for therapy. The coating interrupts the blood cascade mechanism as well as preventing blood components from interacting and depositing onto the surface. This innovative approach provides superior haemocompatibility to the surface and reduces significant risks of the device to improve the patient’s well-being.

5. What do you think are the main challenges when developing coatings for manufacturers?

Our customers face a variety of challenges whilst they are developing their final product for the market. A significant change in the industry has come from the regulatory changes, such as MDR. This has had a significant impact on the way devices are being regulated and has impacted the pathways certain devices are able to take. BioInteractions have followed these changes closely and are able to assist our customers with their regulatory submission.

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OPINION

We’re all in this together WHAT POTENTIAL DOES THE HEALTHTECH SECTOR HOLD FOR THE NHS IN 2020? KRITTIKA BHATTACHARYA, PUBLIC AFFAIRS OFFICER, HEALTH TECH ALLIANCE, EXPLAINS HER THOUGHTS.

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s we enter a new year, following a turbulent few months of political infighting and election battles, one thing has been made abundantly clear – that the NHS and its values remain deeply important to the electorate, across the country. As services struggle under winter pressures, stretched budgets and an ageing population, polls showed that healthcare was the most important issue to voters at this election, ahead of Brexit.

We, the Health Tech Alliance believe that the UK’s thriving healthtech sector holds enormous potential in alleviating pressures on clinical staff, enabling greater self-care among patients and reducing bed days – all of which benefit both patient outcomes and easing the immense burden on the NHS. It is therefore our mission to ensure that patients can access the wealth of cost-effective and transformative innovation that are being produced by alleviating the market access and reimbursement obstacles that currently affect companies of all sizes.

The Alliance is an informal coalition of healthtech companies, seeking to do this by working collaboratively and problem-solving with the various health service bodies. Chaired by Dame Barbara Hakin – former deputy chief executive of NHS England - the alliance has engaged regularly with key stakeholders from within NICE, NHS England, NHS Digital, NIHR, the Academic Health Science Networks and government and civil service.

Members benefit from regular, intimate working groups where they can engage directly with stakeholders across the health system, share best practice with industry peers and explore opportunities for further collaboration with leading market access experts and other members.

Why this focus on collaboration, rather than competition? Well, the Alliance has found that utilising the expertise of our industry members to develop constructive ideas and clear evidence of the benefits of technologies to the NHS and the wider society, engenders a more productive response from the health service. While these efforts may not produce an immediate level of reimbursement, they can lead to a cultural shift that allows key decisionmakers to see innovation as part of the solution to pressing issues facing the NHS, rather than a luxury to be invested in down-the-line.

It is clear too, that as policy moves in a positive direction, a unified voice is required from the sector. The refreshed Accelerated Access Collaborative, the introduction of the Long-Term Plan and its commitment of a medtech funding mandate all demonstrate high-level ambition but as we enter

a new decade the health service and industry must work to implement these measures efficiently and effectively.

Wider changes will also present opportunities and challenges for industry – the advent of Integrated Care Systems and the impact of leaving the EU on medical device regulations are just two issues where it is fundamental that the voice of companies is heard when informing decisions. The Alliance regularly engages with government departments, health bodies and parliamentarians to ensure that the voice of healthtech is considered on behalf of our members.

The challenges that the UK’s health service face are widespread but through collective, constructive and collaborative dialogue, innovative technologies have a positive impact and - most importantly significantly enhance patient outcomes.

It is clear too, that as policy moves in a positive direction, a unified voice is required from the sector.

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EXHIBITION & CONFERENCE 5 & 6 FEBRUARY 2020 PARIS EXPO, PORTE DE VERSAILLES – HALL 7.2

Pharma’s dedicated packaging and drug delivery event

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Innovation Gallery | Pharmapack Awards Innovation Tours | Pharmapack Start-up Hub

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Networking Areas & Events Match & Meet Programme

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GET YOUR FREE* TICKET AT WWW.PHARMAPACKEUROPE.COM * Free registration available until 26 January 2020

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Pharmapack:

EVENTS

What you need to know A TRADE SHOW DEDICATED TO PACKAGING AND DRUG DELIVERY.

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he event is taking place from 5th to 6th February 2020 in hall 7.2 of the Paris Expo.

At the show, 5,500 attendees from 75 different countries will have the opportunity to network with more than 400 exhibitors, as well as access to multiple educational opportunities.

Attendees can also visit the Start-Up Hub which will be a dedicated area for companies looking to develop and expand new technologies within the pharmaceutical packaging, labelling, drug delivery device design and engineering fields. Here, there will also be a stage for start-ups to pitch their ideas during a start-up pitching competition.

LEARNING OPPORTUNITIES Alongside the exhibition there will also be three methods for visitors to ensure their industry knowledge is up to date: Conference • There will be expert speakers from hospitals, research institutes, health regulatory bodies, pharma/ biopharmaceutical companies, veterinary companies, packaging/ drug-device developers and startups. Speakers will discuss current market trends as well as provide an overview on regulatory changes in both the EU and US markets and the impact on packaging and drug device developments.

Guido Heinen key account manager medical, Hexpol

Workshops • Packaging suppliers, medical device suppliers, testing services and consulting companies will show attendees how to overcome challenges and problems.

Learning Lab • There will be two days of live presentations on the exhibition floor from exhibitors about their products and services.

Thomas Kostadinov marketing manager healthcare EMEA, Covestro

PHARMAPACK AWARDS Each year alongside the show the Pharmapack Awards takes place.

There are two main categories - Health Product and Exhibitor Innovations which aim to celebrate the latest innovations from packaging. The awards ceremony will take place on the first day of the show from 17:4519:00 in the Learning Lab. INNOVATIONS If you are interested in taking a look at some products which have recently been launched, then the Innovation Gallery is also worth a visit.

Additionally, from this area you can take part in free innovation tours led by industry experts.

Simon Poulter products director, Baltimore Innovations

“We’re looking forward to meeting contacts new and existing at Pharmapack 2020. At the show we’ll present the latest developments in the Mediprene family of TPEs at Hall 7.2, stand J26. Among the highlights will be several Mediprene TPE grades for solvent bonding applications. These TPE compounds achieve high bond strength when applying solvents such as cyclohexanone. They are available in hardnesses from 60 Shore A to 45 Shore D and can be further expanded based on application requirements. They are transparent, and the tubing grades also offer good kink resistance properties”.

“We are pleased to introduce two new product families: Low-Friction Makrolon polycarbonate, which enables lower device deployment forces while offering dimensional consistency and Makrolon glass-filled polycarbonate, for medical devices that demand superior and lasting strength. Both product families are biocompatible and are available globally. After a successful premiere in 2019, we are happy to return to Paris and welcome existing and new partners to our booth K46 to see how we are envisioning a brighter world for patients everywhere.”

“Baltimore Innovations will be launching their new Prontopacker desiccant dispenser at Pharmapack 2020. The machine takes current industry standards to the next level and compliments all the major bottling and flow-wrap production lines. This new highspeed unit has been developed over the past four years and Baltimore are so confident of its performance, that they are guaranteeing problem-free operation, backed-up by local servicing. Visitors will get the opportunity to see the Prontopacker live in-action on stand D42. Come along and have a look!”

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16:49

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MD&M West 2020: The 35th annual event IN FEBRUARY 20,000 ENGINEERS AND EXECUTIVES WILL COME TOGETHER FOR THIS WELL-KNOWN EVENT. WHAT IS MD&M WEST? MD&M West claims to be the largest medical design and manufacturing event in the world. This year’s show will be the 35th annual event.

WHEN IS THE EVENT? MD&M West is taking place in the Anaheim Convention Center, Anaheim, California between 11th and 13th February 2020.

WHY SHOULD I ATTEND? The show will provide attendees with a three-day conference covering topics such as medtech, 3D printing and smart manufacturing. There will also be the opportunity to talk to suppliers and industry experts on their booths.

Industry experts and well-known organisations will be exhibiting at the event.

These include but are not limited to 3D systems, Accumold, Americhem, Avery Dennison Medical, Canon, Caplugs, Covestro, DuPont Medical Packaging, Fluortek, Injectech, Junkosha, MicroLumen, MTD Micro Molding, Nelipak, Nelson Laboratories, Protolabs, Qosina, Raumedic, Schottli, Shawpak and ZwickRoell.

SOCIAL MEDIA Keep up to date with the event on social media by following #AdvMfgExpo aswell as: @MDM_Events www.facebook.com/mdmtradeshows/ https://www.linkedin.com/company/3993086 For more information, please take a look at the event website.

The conference programme consists of new formats for 2020 including Lightning Workshops and Tech Talk panels, as well as the opportunity to network with industry experts.

Two new features will also be introduced this year. The first is the MD&M Innovation Lab. Here, endproduct technologies will be displayed on the show floor. Companies who will be showcasing products includes AstraZeneca. Elvie, United Orthopedic Corporation and 3B Medical.

The second new feature for 2020 will be the Medtech Wall. The idea is that show visitors will be able to witness 40 years of medtech innovation on this wall. This feature is to celebrate the 35th anniversary of MD&M West as well as the 40th anniversary of Medical Device and Diagnostic Industry.

TRACK: MD&M Conference: Advancements in medical plastics for medtech TITLE: Material innovations for medical devices and pharmaceutical applications TOPIC: The presentation will provide an overview of the selection criteria for materials for medical devices.

SPEAKER: Vipul Davé (Johnson & Johnson) DATE: Tuesday 11th February TIME: 10:45-11:45 LOCATION: 210C TRACK: MD&M Conference: Advancements in medical plastics for medtech TITLE: Panel of industry experts: Sustainability, environmental responsibility and the medical device community TOPIC: Are single use medical devices the answer? This session aims to answer this question and discuss how the industry can alleviate pressures on the environment.

SPEAKERS: Len Czuba (Czuba Enterprises), Frank Pokrop (Quidel), Vipul Davé (Johnson & Johnson), Rob Chase (NewGen Surgical) and Nick Packet (DuPont) DATE: Tuesday 11th February TIME: 13:15-15:00 LOCATION: 210C

This year there will be three conference tracks running alongside the exhibition: 1. Medical Design & Manufacturing West Conference 2. 3D Printing Innovation Summit Medical TRACK: MD&M Conference: Keeping up and staying compliant with global 3. Smart Manufacturing Innovation and FDA regulations Summit TITLE: The impact of IVDR requirements on manufacturers and strategies TOPIC: How to cope with challenges ahead of the2022 compliance date There are also four additional trade SPEAKER: Jon Goveia (Abbott) shows taking place next to MD&M DATE: Tuesday 11th February West. These shows are West Pack, TIME: 15:15-16:00 Automation Technology West, Design LOCATION: 210D & Manufacturing Pacific and Plastec West.

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What to attend at Pharmapack: Editor’s pick 1

Workshop: Impact of Medical Device Regulation on Drug/ Device Combinations - are the market players ready? Date: 05/02/2020. Time: 09:10-09:50.

Location: Rooms 725-727.

2

Workshop: Polycarbonate Innovations for Next Generation Drug Delivery Devices. Date: 05/02/2020. Time: 14:00-14:40.

Location: Rooms 725-727.

3

Learning Lab: On-Demand Packaging including preserialisation. Date: 05/02/2020.

Time: 11:30-12:00. Location: Stand L30.

02:2020 IT’S HOW YOU PACKAGE IT

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edical device manufacturers should ensure packaging solutions exceed mandatory EU legislation to safeguard quality standards and maintain a contaminant-free environment according to packaging systems and machines specialist, Ulma Packaging.

The Sheffield-based machinery provider is recommending companies implement practices from Part 11 of Title 21 of the US Code of Federal Regulations to ensure quality.

Ulma Packaging ©

Dave Berriman, technical manager at ULMA Packaging UK said: “By utilising packaging machinery with software that can keep hold of important control system data, such as ULMA’s range of thermoforming machines, medical product manufacturers can enjoy peace of mind that their packages are sealed without leaks and can be opened without coming into contact with foreign particles.”

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pecialty chemical company, Clariant has agreed to sell its Masterbatches business for approximately USD 1.6 billion to PolyOne, a global provider of specialised polymer materials and services.

Hariolf Kottmann, executive chairman of Clariant commented: “This announcement is a significant milestone on our path to focusing on businesses with above-market growth, higher profitability and stronger cash

generation.”

All proceeds from the intended divestments of Clariant’s non-core businesses will be used to invest in innovations and technological applications within the core business areas, in order to strengthen Clariant’s balance sheet and to return capital to shareholders.

The transaction is anticipated to be completed by the third quarter of 2020.

CHECK OUT...

HAVE YOU LISTENED TO OUR PODCAST YET? The MedTalk Podcast brings together the editor of Medical Plastics News alongside the editors of our sister titles Med-Tech Innovation and European Pharmaceutical Manufacturer.

Episodes aim to provide a light-hearted take on the latest news in the medical technology, digital health and pharma industries.

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

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