MPN NA Issue 12

NORTH AMERIC AN EDITION

MEDICAL PLASTICS news

LET’S STICK

HOW SOFT-SKIN ADHESIVES ARE SUPPORTING THE WEARABLES TREND

TOgether +

SECURING MEDICAL DEVICES KEEPING UP WITH REGULATORY REQUIREMENTS FITNESS TRACKERS

ISSUE 12

Oct/Nov/Dec 2019

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ADVANCING MEDICAL PLASTICS

CONTENTS MPN North America | Issue 12 | Oct/Nov/Dec 2019

Regulars

Features

3 Comment Laura Hughes looks at the potential role fitness trackers and smartwatches could play within the medical sector

9 Joining the dots Emerson talks about how to choose the right technology for medical devices

5 News focus 6 Digital spy 12 Cover story DuPont discusses how the rising popularity of medical wearable technologies poses challenges for device designers 40 Back to the future

15 Through the fog ConvaTec explains how manufacturers can ensure compliance with regulatory requirements 22 Mergers and acquisitions: What you need to know Ken Block Consulting describes how to complete an optimal merger and acquisition process

28 Why you should hire a medical device security engineer Cynerio writes about how to ensure patient safety is always top of the agenda 39 MD&M Minneapolis, BIOMEDevice San Jose and Compamed More information about these key industry events which are taking place in the final quarter of 2019

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CREDITS

EDITOR’S

editor | laura hughes laura.hughes@rapidnews.com

comment

head of content | lu rahman advertising | sarah livingston sarah.livingston@rapidnews.com head of media sales plastics & life sciences | lisa montgomery head of studio & production | sam hamlyn graphic design | matt clarke junior designer | ellie gaskell publisher | duncan wood Medical Plastics News NA Print subscription - qualifying criteria US/Canada – Free UK & Europe – £249 ROW – £249 Medical Plastics News Europe Print subscription - qualifying criteria UK & Europe – Free US/Canada – £249 ROW – £249 FREE on iOS and Android devices Subscription enquiries to subscriptions@rapidnews.com Medical Plastics News is published by: Rapid Life Sciences Ltd, Carlton House, Sandpiper Way, Chester Business Park, Chester, CH4 9QE T: +44(0)1244 680222 F: +44(0)1244 671074 © 2019 Rapid Life Sciences Ltd While every attempt has been made to ensure that the information contained within this publication is accurate the publisher accepts no liability for information published in error, or for views expressed. All rights for Medical Plastics News are reserved. Reproduction in whole or in part without prior written permission from the publisher is strictly prohibited.

ISSN No: 2632 - 3818 (Print) 2632 - 3826 (Digital)

Could fitness trackers and smartwatches be used as medical devices?

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hen I typed the words ‘fitness tracker’ and ‘smartwatch’ into Google, I was immediately inundated with the various types of devices and flooded with articles claiming to tell me which device is the best on the market. Reports suggest that 16% of adults in America now own a smartwatch; but do these devices actually have any value within the medical sector?

The validity of fitness trackers as medical devices was tested in a study conducted by sports reporter, Eric Chemi.

He exercised whilst wearing multiple fitness trackers and compared measurements such as distance, heart rate and steps. Chemi found that the results recorded by each device varied considerably. The necessity for such devices was also put into question by the results of a trial published in The Journal of the American Medical Association, which concluded that these devices may not offer any advantages over standard behavioral weight loss approaches.

However, on the other hand in the UK, the NHS could be seen as promoting wearable fitness gadgets, by having a section on its website dedicated to health and fitness trackers.

Additionally, the Food and Drug Administration has announced its plans to speed up the approval process for companies such as Apple and Fitbit. I feel this implies the industry’s approval of such devices, conflicting with the conclusions of previously mentioned studies.

In our digital spy section on page 6, I mention how Fitbit has announced plans to launch a personal coaching product in 2020 to help users managing chronic conditions like diabetes.

Additionally, Apple’s smartwatch has hit the headlines for its fall detection feature which has reportedly saved the lives of multiple users. The feature works by detecting the user’s fall and location, and then contacting emergency services as well as the user’s emergency contacts. It seems like the manufacturers of these devices are working hard to increase their value to both the user and society.

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I find currently published information regarding these devices to be inconsistent. As a user of a fitness tracker myself, there is no doubt in my mind that such devices could play a key role in the improvement of our general health and wellbeing on a recreational level. However, for these trackers to be regarded as trusted medical devices amongst physicians, there must be greater standardization of this technology to ensure accurate data is consistently collected across all platforms. The end goal would be for physicians to be able to trust fitness trackers and smartwatches to the same extent as current medical device monitors used in professional settings. To achieve this, there needs to be a shift change by the manufacturers to produce devices intended for this purpose.

“

The end goal would be for physicians to be able to trust fitness trackers and smartwatches to the same extent as current medical device monitors.

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United States

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NEWS FOCUS

From shattered Olympic dreams to CEO HOW SINEAD MILLER, CEO AND CO-FOUNDER OF BIOMEDICAL DEVICE COMPANY, PATH EX IS HELPING DIAGNOSE AND TREAT SEPSIS.

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s the daughter of a former superbike racer, it isn’t surprising that Miller grew up interested in racing, focusing her attention on road cycling during her teenage years. On a full cycling scholarship Miller attended Marian University, Indiana, whilst joining the U.S. national team and representing her country in races all around the world. Every race was a step towards a spot for Miller in the 2012 Olympic Games.

However, on 1st September 2010 Miller’s dreams were shattered. When competing during the three-day Ladies Tour of Holland (now known as the Boels Rental Ladies Tour), Miller careened into a parked car at around 30 miles an hour.

Due to the speed of the collision all of the impact went towards Miller’s face resulting in shattered front teeth, nose and jaw, a fractured C3 and C5 vertebrae, as well as brain injury.

Miller was motivated by her trauma and decided to pursue a career in neuroengineering. After achieving both a B.S. in chemistry from Marian University, and then a B.S. in biomedical engineering from Purdue University, Miller went on to graduate school at Vanderbilt University. It was here, whilst working on her doctorate that Miller began focusing on research around the use of iron core nanoparticles to magnetically extract bacteria from blood.

This research led Miller to focus on sepsis, a life threating condition.

According to the Centers for Disease Control and Prevention, atleast 1.7 million American adults are affected each year by a sepsis, and this infection goes on to result in nearly 270,000 deaths.

Commenting on her research Miller said: “It’s the biggest killer in our hospitals right now.” She added: “I had this idea for a device that doesn’t use nanoparticles but uses kind of a similar technique to bind bacteria and pull them out of blood. I used the knowledge that I had to fabricate this device that was for cleaning blood, pulling bacteria out. And it worked.”

In 2017, Miller partnered with Alex Wieseler to start a biomedical device company named, PATH EX, which is part of TMC Innovation Institute’s accelerator program.

The device Miller developed is able to fit in the palm of a hand and diagnose bacterial infections within the blood by capturing and removing pathogens and their associated toxins. The device is able to take a five-milliliter blood sample from a patient suspected of having sepsis or a bacterial infection, separate the bacteria from the clean blood and provide doctors with the opportunity to test the bacteria straight away.

Miller concluded: “I wanted to make some impact in the healthcare space to help people like me.”

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DIGITAL SPY

MEDTECH UPDATE

DIGITAL

spy DEVICE UPDATE

www.fitbit.com

Fitbit launches a paid premium service

HOW TO DEAL WITH MOISTURE IN HEARING INSTRUMENTS WWW.REDUX.COM

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edux has launched a drying system for hearing instruments that are impacted by moisture. By the push of a button, the device is able to restore hearing instruments to their peak operational state in around 14 minutes.

The device is available for both audiology

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round 14 million adults subscribe to mobile wellness services, spending on average $174 per year across a variety of apps. Therefore, consumer fitness brand, Fitbit, who has more than 27 million active users may experience high demand with its premium service.

The premium service will cost users $9.99 per month or $79.99 annually.

In return for this payment, users will be provided with personalized wellness reports including health data trends and analyses of activity, heart rate, sleep and weight fluctuations.

Users will be able to share their information with healthcare professionals such as their physician by exporting their wearable data from the Fitbit app’s dashboard.

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Fitbit previously launched Fitbit Coach which allows users to stream personalized video workouts on a phone or computer or launch a workout anytime right from their wrist.

Fitbit will provide all Premium subscribers with complimentary access to Coach, and current Coach subscribers will automatically be upgraded to Premium for no additional cost.

Fitbit CEO James Park commented: “The launch of Premium also marks an important milestone as we expand our business beyond devices.”

Fitbit plans to launch a personal coaching product in 2020 for users managing chronic conditions like diabetes.

and hearing care professionals and works by using a vacuum to lower the evaporation point of water in order to remove all of the liquid from within hearing aids. This method ensures complete moisture removal at a controlled and safe temperature and works for both traditionally

MEDTECH UPDATE

3D printer developed which mimics cleanroom environment WWW.KUMOVIS.COM

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edtech manufacturer, Kumovis has developed a 3D printer to enable medical technicians to efficiently produce implants and other products using additive manufacturing that is adapted to the industry’s needs.

Kumovis’ R1 3D printer has integrated temperature control

and filter systems so users can create a cleanroom environment within the build chamber, and as a result of this meet the requirements for manufacturing patient-adapted medical products.

This feature ensures any defects caused by foreign particles in the component can be avoided.

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powered and rechargeable hearing aids.

Redux is partnering with audiologists to implement a membership program that provides patients with regular access to technology at their local hearing care provider.

DIGITAL SPY

talking

MEDTECH UPDATE

POINT

Drug testing on animals: The end is in sight www.onlinelibrary.wiley.com /journal/15214095

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ioprinting is a process which enables scientists to artificially create organs which can then be used to repair damaged tissue, replace organs and perform drug and other medical tests. Similar to 3D printing, the object is built layer by layer in a timeconsuming process which can take days and doesn’t allow objects to be made with free form shapes.

However, new research published in Advanced Materials, details a new optical technique that can create

complex tissue structures within a few seconds. The research was conducted by researchers at EPFL and University Medical Centre Utrecht. The technique used is called volumetric bioprinting and works by creating tissues with a laser.

The technique is thought to be suitable for mass fabrication and personalized implants. Additionally, it will also be useful in drug testing as it will effectively eliminate the use of animals.

MEDTECH UPDATE

The world’s first polymer heart valve transplant WWW.CSIRO.AU AND WWW.FOLDAX.COM

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ifePolymer, a biopolymer heart valve which was designed in Australia has been successfully implanted into a patient. This research was a joint project between CSIRO and medical device manufacturer Foldax.

LifePolymer is manufactured to be used in critical surgical procedures.

The valve uses a proprietary CSIRO polymer which could pump blood effectively for decades without calcification, risk of clotting, or damage to red blood cells. The polymer valve

also claims to be able to act against aortic valve disease.

“Tria heart valves are revolutionizing the industry as the first and only biopolymer heart valve platform using LifePolymer material, eliminating the use of animal tissue,” Ken Charhut, executive chairman of Foldax commented. “What makes this so different from other heart valves is that we were able to design the valve to mimic the native valve.”

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DO YOU WANT TO LEARN MORE ABOUT POROUS POLYMERS?

P

olymer solutions provider, Porex announces it’s new monthly webinar series. Avi Robbins, VP of global product development and R&D for Porex explains more about this announcement.

1. WHY DID POREX DECIDE TO LAUNCH FREE MONTHLY WEBINARS FOR ENGINEERS? When we launched our new website at the beginning of the year, we created an “Ask an Engineer” feature where engineers could talk to our expert engineers. The popularity of this made us realize that there is an appetite for knowledge about porous polymers.

2. ARE YOU THE FIRST MANUFACTURER TO DO THIS? As far as we know, we’re the first to launch a series for engineers focused solely on the science of porous polymers.

3. WHAT TOPICS ARE CURRENTLY SCHEDULED? • Passport to performance: Maximizing device capabilities with sintered particles • Stronger together: Bonded fiber for fluid management • Redefining the capabilities of foam with opencell technology • Decoding your venting needs: Which materials work best?

• Wicking workshop: Tips and tricks for better function 4. CAN THESE WEBINARS BE WATCHED ONLINE AFTER THE LIVE EVENT? The episodes will be recorded and made available at www.porex.com/webinars

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JOINING TECHNOLOGIES

JOINING THE DOTS DIDIER PERRET, GLOBAL BUSINESS DEVELOPMENT MANAGER, MEDICAL SEGMENT, EMERSON, TALKS ABOUT HOW TO CHOOSE THE RIGHT TECHNOLOGY FOR MEDICAL DEVICES.

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ew challenges are presenting that demand new designs, new features, new capabilities, greater complexity and higher standards as a result of the fast-growing medical device industry. Many medical devices are too complex to mold as single pieces, and so optimal assembly methods are essential for the successful delivery of reliable products. In order to select an assembly method and supplier for your assembly needs it is imperative to examine and compare all the options to understand the advantages and limitations of each process, and to leverage assembly system providers that can offer the greatest technical expertise for your application.

The best way to get the optimal process for your application is to go into the decision-making process with a ‘process-neutral’ mindset. Working with suppliers that can help you explore a range of assembly technology is often the best way to achieve the benefits of reduced time to market, lower costs, and improved product reliability.

A WIDE RANGE OF TECHNOLOGIES TO CONSIDER Many joining technologies exist for medical device applications, ranging from fasteners to adhesives to various forms of plastic welding.

Plastic welding methods are popular because they can join a range of thermoformed plastic assemblies while eliminating the biocompatibility concerns associated with chemical solvents and adhesives, and the design complexities of incorporating mechanical fasteners.

In addition to traditional welding with heated plates, there are a variety of plastic welding approaches available, including ultrasonic welding, vibration welding, spin welding, and ‘clean’ methods with laser, infrared, and ‘pulse staking.’ ‘Clean’ welding methods are specially designed to produce plastic welds with a minimum of flash and particulates - a critical factor for success in any medical device or product application, and for many applications, utilizing a combination of techniques provides the best solution. In nearly all cases, clean plastic joining methods integrate easily into high-volume part production and automation processes, thanks to rapid process cycles, data-

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driven quality assurance, and high energy-efficiency.

APPLICATION EXAMPLES Ultrasonic welding Ultrasonic plastic welding is an extremely cost-effective and popular technique whose benefits include speed, no consumables, minimal or no setup time, low cost of capital equipment, and easy integration into automation. It utilizes a series of components to deliver mechanical vibration and force to the parts, which generates heat at the interface of the mating surfaces, melting the plastic and creating a strong bond.

In medical devices, reliable, repeatable, high-precision, and perfectly clean joining processes are typical requirements. As medical devices and their component parts continue to miniaturize, device makers face the challenge of joining thinner, lighter, and more intricate plastic components that may also contain embedded electronics.

Successful welding processes therefore demand an increasingly difficult balance of precision positioning, low trigger force, and exceptional control over the weld

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component (transmissive part) and absorbing it in the second component (the absorptive part). This absorption results in heating and melting of the component interface, and the parts are joined with the application of a controlled clamp force.

Laser welding is a gentle and clean joining process that enables welding of complex geometries and materials that are difficult to bond with other techniques. Laser welding can ensure attractive, reliable hermetic sealing in a single step that only takes a few seconds.

The new Branson GLX-Micro Laser Welder can control clamping forces as low as 1N, enabling repeatable, flash-free welding of small parts and complex geometries without the risk of deflection, bending, or cracking essential components. Its cleanroom-ready design and customizable data outputs were developed to meet the needs of medical device manufacturers.

Emerson ©

that conventional ultrasonic welders cannot provide.

To meet this challenge, Emerson recently introduced the Branson GSX ultrasonic welding platform.

This new product incorporates an advanced electro-mechanical actuation system (patents pending) that combines software, servo controls, and a proprietary ‘dynamic follow-through’ feature that can provide instantaneous weld adjustments based on real-time feedback. With it, the Branson GSX platform provides control and position accuracy, and delivers and controls ultra-low weld actuation forces. This enables consistency across multiple welders in the same line, with post-weld tolerances and part variabilities measured in microns.

Thanks to technical advances like this, ultrasonic welding continues to provide significant advantages for assembly of wearable and implantable medical devices, minimally invasive surgical instruments, as well as catheters, cannulas, luers, and trocars and other important medical products.

Laser technology Laser welding of plastics is an innovative welding technique based on the principle of passing laser energy through one plastic

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Infrared technology Clean Infrared Technology (CIT) can be used for clean joining of small, medium, and large parts. Precise plasticization occurs using noncontact heat input by medium-wave, metal-foil emitters that emit the same wavelength spectrum as the absorption range of most common thermoplastics. During the CIT process, the two-part halves to be joined are held in position a few millimeters from the metal-foil-emitter platen that follows the contoured profile of the weld seam. The platen uniformly preheats the weld area without damaging pre-assembled inner parts.

Once plasticization has occurred, the platen is removed, and the halves are brought together under pressure and allowed to re-solidify, producing a clean, clear, weld that is virtually particle-free.

Vibration and clean vibration technology Vibration has been used for many years to weld large parts. Clean vibration technology combines infrared and vibration processes. An infrared source preheats the part surfaces to minimize particle generation during the subsequent vibration welding process. This approach produces clean, highstrength joints with low residual stresses, low material-specific friction, and shorter welding times.

The major application benefit of clean vibration joining lies in its ability to join large (up to 1500 mm long and 700 mm wide) and intricately shaped plastic parts. The process works with multi-plane and curved surfaces and is capable of sealing even internal cross ribs in parts to create separate fluid compartments. This technology is typically used to assemble large two-part systems such as patient monitors, infusion pumps, or fluid collection vessels.

Clean vibration processes often are set up to weld multiple assemblies at one time as part of automated production.

Key considerations for process selection 1. Material 2. Part geometry 3. The complexity of the part and weld profile 4. Wall thickness and internal walls 5. Production volumes 6. Capital equipment cost For new or modified medical devices, all parameters should be evaluated with a ‘process-neutral’ approach to ensure the appropriate joining technique is chosen.

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COVER STORY

LET’S STICK TOGETHER STEPHANIE STEICHEN, TECHNICAL SERVICE AND DEVELOPMENT SPECIALIST, DUPONT EXPLAINS HOW THE RISING POPULARITY OF MEDICAL WEARABLE TECHNOLOGIES POSES INTERESTING AND SOMETIMES FORMIDABLE CHALLENGES TO DEVICE DESIGNERS.

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he device attachment can often be overlooked as a critical parameter in overall device performance, function, and user experience. Although devices can be attached by clips, belts, or clothing, the comfort, ease, and flexibility provided by adhesive securement is typically preferable. The selection of an adhesive, therefore, is an additional important factor to consider early in the design of a wearable medical device.

Silicone adhesives have unique material properties and versatile chemistry that enables their use in medical device attachment. When compared to alternative adhesive offerings, silicones provide the necessary adhesion to securely affix dressings and devices with a non-sensitizing, non-irritating, highly breathable, and skin-friendly formulation. There are two primary families of non-bonding silicone adhesives: Soft Skin Adhesives (SSAs) and Pressure Sensitive Adhesives (PSAs).

DuPont ©

Within each adhesive family there is a wide range of available adhesion levels and additional properties that can be tailored for the needs of a given application.

The selection of an appropriate adhesive requires considering and understanding several critical parameters which will affect the performance of the adhesive and the wear of the device. These parameters can be broadly classified into two categories: Unmodifiable and modifiable.

UNMODIFIABLE PARAMETERS Skin physiology – The interaction between the adhesive and the substrate it is adhering to is critical. The skin is a dynamic and highly variable substrate which provides a challenging surface upon which to adhere.

The composition of the skin can vary significantly between individuals and also between different locations on the body. Factors such as hair density, oil/sebum production, sweat glands/production, and moisture levels will modify the skin’s surface and affect the interaction with the adhesive. These surface irregularities may potentially disrupt the non-covalent bonding of the adhesive to the skin and negatively impact wear.

This variability can be further amplified by disease state. Numerous diseases affect the health, integrity and overall condition of the skin. The presence of wounded skin can complicate wear, as it may modify the mechanical properties of the skin, introduce extraneous biologic fluids, and prevent aggressive solutions that could further injure the area.

User type – The age, activity level, and general health of a device user can have drastic effects upon the wear of an adhesive/device. A healthy and active user will inherently place more demands upon the adhesive than someone bed ridden. These adhesives are not covalently bound to the surface of the skin and instead rely on a combination of intermolecular interactions to remain adhered. There is a limit, therefore, of how much force these bonds can withstand before adhesive failure occurs. Movement of the skin under the adhesive is unavoidable, but the amount and frequency will impact the wear duration.

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COVER STORY

Application/use - In certain use cases, the location of the medical device cannot be adjusted. For example, an ostomy pouch must be repeatedly placed over the stoma, which stays in the same location. This prevents the designer or user from adjusting the device to a more comfortable position unperturbed by clothing and free of other surface irregularities or contaminants.

Although the above parameters provide a challenging set of conditions to work around, between the adhesive selection and device design, the designer has a host of modifiable parameters with which to adjust wear and device performance.

MODIFIABLE PARAMETERS Adhesive design: Chemistry and rheological properties – The chemistry and rheological properties of the adhesive control its propensity and subsequent ability to interact with the surface of the skin – a relatively non-polar and hydrophobic substrate. The chemistry dictates the types of intermolecular interactions, e.g. hydrogen bonding, van der Waals forces, etc. that can occur, while the rheological properties facilitate the intimate contact required for these interactions to occur. It is thought that PSA adhesion is driven by moieties containing hydrogen bonding acceptor and donor sites being placed in intimate contact with the contours of the skin by way of its flowable, thermoplastic nature. SSAs, although thermoset, allow for the same intimate contact due to their soft, gel-like structure. Based on the desired application, the base and cure chemistries can be carefully selected to obtain the distinct adhesive families, e.g. thermoplastic or thermoset, and to further refine the desired material properties, e.g. cohesion, adhesion, softness, etc., which can impact wear. Although complex, a robust adhesive design is an important consideration that can significantly improve overall device performance.

Permeability – The adhesive’s permeability to gas and moisture will affect both wear and user comfort. An occlusive dressing has the potential to cause irritation and could, if severe enough, have a deleterious effect on skin integrity and health. While silicones are highly permeable to gases, they are less permeable to liquid water due to their hydrophobicity. In regions of the body with higher moisture, such as the armpit, on active users, or in humid climates, the wear can be negatively impacted due to moisture accumulation under the dressing. The introduction of perforations in the silicone dressing can mitigate these effects and improve wear.

Modifiable parameters

Unmodifiable parameters

Material properties

Skin physiology

- Chemistry - Softness/rheology - Permeability

- Inherent variability Age Sex Location on body

- Condition

Healthy vs. disease Intact vs. broken

Dressing design

Participant type

- Surface area - Weight - Location - Adhesive thickness

- Age - Activity level - General health Application/use

- Device location - Attachment duration

The selection of an appropriate adhesive requires considering and understanding several critical parameters which will affect the performance of the adhesive and the wear of the device.

Device design – The device design includes the selection of the adhesive, but also its overall construction. An increase in adhesive surface area, an increase in adhesive thickness (for SSAs), and a decrease in device weight should all increase device wear. By maximizing the ratio of adhesive surface area to device weight, one should theoretically improve wear. However, the thicker the silicone adhesive, the lower the permeability and the more occlusive the attachment, which could negatively impact wear and user comfort. The occlusivity of the device component itself should also be a consideration.

The location of device attachment is also critical. Large surfaces with flatter contours, such as the chest and abdomen, that are less likely to be accidentally perturbed will provide the most desirable surfaces for wear. If surfaces with more substantial curves, such as the arms, are utilized, the device must be flexible enough to conform to the contours or be designed to otherwise accommodate the contours. This is to ensure the intimate contact required for good adhesion and wear.

The wear of a device on the skin is a complex interaction that is affected to varying degrees by numerous modifiable and unmodifiable parameters. A balance must be struck in every device design between these two classes to maximize wear, user comfort, and device performance.

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REGULATORY UPDATE

THROUGH THE FOG MEDICAL PLASTICS NEWS EDITOR LAURA HUGHES SAT DOWN WITH BEAU ROLLINS, GLOBAL DIRECTOR OF QUALITY SERVICES FOR CONVATEC, TO BETTER UNDERSTAND ISO 10993-1:2018 AND LEARN ABOUT HOW MEDICAL DEVICE MANUFACTURERS CAN ENSURE COMPLIANCE WITH REGULATORY REQUIREMENTS.

1. PUT SIMPLY, WHAT IS ISO 10993-1:2018?

If I had to summarize the new ISO 10993-1:2018 in just a few words, it would be “risk based evaluation.”

The standard has evolved from a list of tests that anyone could pick up and follow, to one that now requires the evaluator to be trained and knowledgeable in biological evaluations. Due to the shift to using a risk-based approach, what used to be a straightforward document has now evolved in to a detailed and robust risk based evaluation.

2. WHAT ARE THE MAIN CHANGES MANUFACTURERS NEED TO BE AWARE OF FOR ISO 10993-1:2018?

The most noticeable change is to Annex A. Other key changes are new device exposure categories, emphasis on the requirements of the author for the biological evaluation, and on material and chemical characterization.

Additionally, a new category, transitory, has been introduced to allow for devices like needles and lancets that are in contact for less than one minute, to be evaluated and accepted without testing unless they use coatings or lubricants that could be left behind. The terminology for ‘permanent’ device has also now changed to ‘long-term’ – combatting a misconception that only permanent implants belonged in that category.

3. DO YOU HAVE ANY TIPS FOR HELPING MANUFACTURERS COMPLY WITH ISO 10993-1:2018?

For FDA submissions that are new or complex, do a pre-sub. Ensure that your biological evaluation protocol is in line with their expectations and identified risks. For EU regulators, we’re on the precipice of European Medical Device Regulations (EUMDR) which will change the European tech files, but if you are in doubt, talk to your regulatory body and propose a change review to allow them to look over your plan (like a pre-sub), but be warned, with MDR and new requirements, many regulatory bodies can take six months or more to do this. If you want to go straight to submission, I recommend finding a good consultant who understands these changes and a laboratory that understands the analytical requirements that are coming out hopefully later this year in the new 10993-18.

4. WHAT DO THESE CHANGES MEAN FOR THE MANUFACTURERS OF MEDICAL DEVICES? For most, it’s probably a new approach for your biological evaluations, a new employee or consultant to perform or review the evaluation, and a new test

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for medical devices, pharmaceutical manufacturing and digital health.

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REGULATORY UPDATE

that is not cheap. The analytical testing can be used to mitigate the risks for various toxicities and therefore can mitigate those costs for higher risk devices, but for the low risk devices, this is a new test and expense that adds to the approval hurdles. I think it’s fair to say that most manufactures are not set up for this level of baseline evaluation.

In industry, we are also seeing regulatory bodies and governments rejecting biological evaluations due to the authors or reviewers not carrying sufficient experience or education to perform these evaluations. In the past most organizations had these evaluations performed by research and development engineers, quality engineers, sterilization engineers, or even regulatory specialists, and now if their curriculum vitaes do not reflect the necessary skills or competency, their biological evaluations are being rejected. To combat this, manufacturers are bringing on biocompatibility skilled individuals to conduct reviews. The struggle organizations are finding is that since there is not a certification or course established to accredit individuals for biocompatibility, the supply of experts out there is rather thin.

5. WHAT DO YOU BELIEVE ARE THE CURRENT BIOCOMPATIBILITY CHALLENGES FACING MEDICAL DEVICE MANUFACTURERS? In one word, resources, which leads to a supply and demand issue. We are deficient on the information available from our suppliers, and the laboratories (particularly the extractables and leachables sector) are dealing with new methods and a shortage of scientists/equipment which leads to capacity constraints. The methods and requirements are not detailed in standards or have been generally established so that the results we receive vary (this was recently proven in an inter-lab comparison performed by J&J and presented at SOT) and are extremely expensive.

The biocompatibility field has developed into being a full time, specialized position and with MDR here, most companies find themselves lacking the biocompatibility systems and specialists. Even many of the consulting firms out there are struggling to provide competent biocompatibility consultants.

6. HOW CAN YOU AND OTHER LEADERS IN THE INDUSTRY HELP MEDICAL DEVICE MANUFACTURERS TO BETTER UNDERSTAND THESE REGULATORY REQUIREMENTS? There has been a noticeable increase and push for biocompatibility specific conferences around the globe where ISO members and industry experts can present changes and explain the standards and various ways to assess the biocompatibility of a device.

and Nelson laboratories generally holds biocompatibility specific discussions at the various medical device tradeshows and webinars.

There are opportunities out there for the readers to attend and learn more.

BEAU ROLLINS GLOBAL DIRECTOR OF QUALITY SERVICES FOR CONVATEC ISO DELEGATE FOR IRRITATION/ SENSITIZATION, IMPLANTATION, AND ABSORBABLE MATERIALS AAMI US REPRESENTATIVE FOR IRRITATION/SENSITIZATION, SYSTEMIC TOXICITY, GENOTOXICITY, INDUSTRIAL EO STERILIZATION, AND MICROBIAL METHODS PART OF THE ISO ROUND ROBIN GROUP THAT RECENTLY VALIDATED THE IN-VITRO IRRITATION METHOD WHICH HAS BEEN ADDED AND UNDER FINAL REVIEW THIS YEAR FOR A NEW ISO STANDARD, ISO 10993-23

I will be speaking in Chicago at the biocompatibility conference in October and San Diego at the Q1 productions conference in December. There is also a NAMSA sponsored biocompatibility conference in Minneapolis this year

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STERILIZATION

JACK CHAN, GLOBAL MARKETING DIRECTOR - MEDICAL, POREX, HIGHLIGHTS THE POTENTIAL STERILIZATION CHALLENGES MEDICAL DEVICE MANUFACTURERS MAY FACE AS A RESULT OF THE RAPIDLY INCREASING DEMAND FOR CLEAN AND SAFE DEVICES.

Squeaky clean S

terilization is essential to ensure that safe, ready to use devices perform as designed. It is a critical step in the manufacturing process and a medical device is simply not complete without it. Therefore, sterilization needs to be addressed in both the design and material selection phase.

Although manufacturers have always known the importance of sterilization, recent events have driven greater attention to the issue. For one, the Environmental Protection Agency shut down two major Ethylene Oxide (EtO) contract sterilization facilities earlier this year due to high levels of EtO in the air. This is because long-term and occupational exposure to EtO can irritate the eyes, nose, skin, throat and lungs, potentially increasing the risk of cancer. This has caused concern due to a potential shortage of sterilized medical devices and a heightened the demand for clean and safe devices.

Following the closure of the sterilization facilities, the Food and Drug Administration (FDA) issued two public innovation challenges to explore alternatives for using

EtO with new sterilization methods and technologies that are effective and environmentally safe. It is equally important to ensure that the medical device’s packaging is designed to protect the medical device and maintain sterility, as well as being able to be validated.

Additionally, as the medical device market continues to grow to meet the demand of the aging population, increasing access to healthcare and rising expectations of innovative devices will dictate a greater need for sterilization. Manufacturers may struggle to manage the increasing sterilization capacity, and it may become impossible to ensure devices are sterile. Microbes cannot be detected by the naked eye and manufacturers cannot ensure that a sterilized medical device that has been transported and stored is still sterile.

It is vital for manufacturers to certify that they are up to date with sterilization standards from the FDA. Manufacturers can also utilize materials in their devices that have been third-party tested and validated as containing virtually no material additives, contaminates or heavy metals that can cause interferences in clinical, analytical and blood transfusion testing, like the certified Pure Porex product lineup.

To provide a solution for these issues and address mounting concerns of potentially life-threatening healthcare-associated infections in China, Porex worked with medical device manufacturer Guangdong Xianfeng Medical Technology to improve the autoclave sterilization process for surgical equipment used within healthcare environments.

Porex provided Xianfeng with a robust, reusable filter that would serve a dual purpose in the medial container: •T o function as a vent to allow pressure equalization during the sterilization process • To serve as a barrier to bacteria during subsequent storage Equipped with a Porex Virtek polytetrafluoroethylene solution, the Xianfeng containers can properly sterilize surgical instruments and maintain sterility until use in surgery.

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CASE STUDY

How to reduce time, error and costs for surgeons RUI SOARES, SENIOR RESEARCHER AND MANAGER OF INNOVATION AND INTELLIGENCE AREA AT CENTIMFE FROM ENGINEERING & TOOLING CLUSTER IN PORTUGAL, PRESENTS A CASE STUDY ON THE ADVANCED TECHNOLOGICAL APPROACHES FOR THE DEVELOPMENT OF MEDICAL DEVICES.

T

he technologies related with product development and advanced manufacturing have experienced a huge evolution in recent years and these technological advances are changing the healthcare industry.

Tooling and plastics industries are globally recognized as being technologically very advanced, both in terms of the equipment used and people skills. Therefore, it is no surprise that the adoption of these technologies has been a norm in its companies for many years.

The integration of technologies for the acquisition and manipulation of medical images like Computed Tomography (CT) and Magnetic Resonance (MR), Computer Aided Design and Simulation (CAD/ CAE) with 3D Printing (3DP) and Advanced High Speed Milling (HSM) systems makes it possible to build physical models that reproduce anatomical structures which can leverage many advantages for medical applications. Such models are useful, for example,

Figure 2: Importing of DICOM files from skull. CENTIMFE ©

Figure 4: Mold for production of customized implant. CENTIMFE ©

at the educational level, helping in the elaboration of complex surgical procedures, treatment planning, visualization of some specific anatomical structure, diagnostics, implant design, design of medical instruments and other applications.

These technologies can also be applied to the manufacturing of medical devices and customized implants that can be used in surgery and various pathological situations such as the repair of bone defects (such as those caused by bone loss) or the anatomical correction of bone structures being highly advantageous, as it can enable medicine to restore not only the function but also the shape of a damaged bone structure.

CASE STUDY Figure 1 represents a case study developed within the Portuguese Engineering and Tooling Cluster involving a physical model of a fractured skull manufactured by 3D printing and a customized pre-surgical implant that allows the surgeon to plan surgery and reduce time, error and costs.

The personalization contributes to the aesthetic and functional outcome of the implant, since it considers the anatomy of the patient.

Virtual 3D models were produced from 2D DICOM images (Figure 2) generated by CT and/or MR of the defective skull. Both defective part and the model for repairment were reconstructed digitally in CAD (Figure 3), converted to STL format and afterwards manufactured using 3D printing technology.

The manufacture of the repairment implant was made using an aluminum mold (Figure 4) produced by HSM from the related 3D model geometry. This mold was then used during the chirurgical repairing procedure for injecting bone cement to quickly produce the repairing implant. This approach allows the surgeons to have control on the manufacture of the final customized implant and the use of a commonly known material in the medical field. The final dimensions of the implant and its assembly achieved very good results, indicating the efficiency of the technologies and methodology used.

Figure 1: 3D printed physical Figure 3: CAD geometries from skull, model of a fractured skull mold and implant. CENTIMFE © and customized pre-surgical implant. CENTIMFE ©

All medical devices and models are unique, and the characteristics of each one should be carefully considered when selecting the manufacturing system.

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MERGERS AND ACQUISITIONS

Mergers and acquisitions: What you need to know

KENNETH L. BLOCK, PRESIDENT OF KEN BLOCK CONSULTING, EXPLAINS HOW YOUR ORGANIZATION CAN ENSURE AN OPTIMAL MERGER AND ACQUISITION PROCESS. MERGERS AND ACQUISITION LANDSCAPE Software is everywhere in medical devices today with the list growing every year. Examples include additive manufacturing (3D printing) systems which create patientspecific plastic and metal implants, Software as a Medical Device (SaMD) e.g., cloud-hosted Artificial Intelligence (AI) algorithms which analyze medical images, softwaredriven electro-mechanical systems which provide surgical assistance, and provider-prescribed deviceinterface tablets which improve post-surgical patient outcomes.

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

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

Knowledgeable buyers within the regulated medical device space must inevitably consider what liabilities may have been inherited due to any FDA (and other global market) compliance problems lurking within the target organization before the deal is finalized. To consider this, buyers will often bring an entire regulatory team to the target company including software specialists, quality system specialists, submission/certification specialists and regulatory attorneys. My personal experience also shows that with deals above $100M, this focused due diligence team includes multiple regulatory attorneys from multiple firms, looking from different perspectives depending on their device experience. The primary job of this due diligence team is to scrub the target company’s established quality system, activities and decisions to find any lurking FDA/global compliance problems. The target company should expect that this due diligence activity will cover all regulated company and product aspects such as established procedures, training, design and production history, validations, submissions (as well as decisions not to conduct a regulatory submission including ‘letters to file’), FDA registrations and device listings, validity of CE Marks and IFUs, etc.

CASE STUDY Companies unprepared for that regulatory scrutiny can have unwanted and very costly surprises discovered by that focused due diligence team. In one example, in which my company participated in the regulatory due diligence process, an orthopedic company had their price

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

22

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MERGERS AND ACQUISITIONS

lowered almost $2M due solely to the numerous FDA compliance problems discovered in the final weeks of the deal.

Unfortunately, this company had neither a strong internal audit system nor well-trained internal auditors. They acquired part of their product line (the portion with software) years before but had never conducted an internal audit of the acquired division (a strong testament to their weak internal audit program). Additionally, the company reduced the quality/regulatory staff as a cost-cutting measure approximately one year before the acquisition happened.

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

PROBLEM DISCOVERY What regulatory compliance problems exist in these target companies?

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

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

With positive messages given to company executives, what method should have been used to discover possible FDA (and other) compliance problems? From our experience with these unprepared merger and acquisition targets, the methods that clearly don’t work are relying on the existing internal team and

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any external regulatory resources involved in setting up and/or monitoring the company through the years. Logically, through internal quality audits, analysis of quality data and formal management review, the existing company team has already exhausted their chances to discover compliance problems.

Likewise, with the financial and legal stakes so high, the target company’s CEO and board of directors gain no actionable value from a ‘customerfriendly’ regulatory assessment conducted by some long-term outsource partner.

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

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EU MDR

A manufacturer’s guide for EU MDR SANDI SCHAIBLE, SENIOR DIRECTOR OF ANALYTICAL CHEMISTRY AND REGULATORY TOXICOLOGY AND SHERRY PARKER, SENIOR DIRECTOR OF REGULATORY TOXICOLOGY, BOTH FROM MEDICAL DEVICE COMPANY WUXI APPTEC, TALK THROUGH WHAT MANUFACTURERS NEED TO KNOW ABOUT THE EU MEDICAL DEVICE REGULATION (MDR).

F

rom 26th May 2020 MDR will come in to effect in EU Member States.

This regulation will apply to all manufacturers who are selling medical devices within Europe.

HOW EU MDR AFFECTS MEDICAL DEVICE MANUFACTURERS With recent updates to ISO 10993-1 and the MDR on track to replace Europe’s current Medical Device Directive (MDD), medical device manufacturers have to develop and execute action plans for necessary testing as soon as possible. These new and updated regulations place increased emphasis on the roles that robust data and complete evaluations play in supporting medical device safety.

If manufacturers don’t pursue gap analyses, conduct required chemical characterization and biological testing, assemble submissions, and move forward with registering devices under MDR, they have two other choices.

One option is to end the life of the device in Europe, and the other option is to develop the next generation under MDR and extend the current product life under MDD. KEY FINDINGS FROM THE NEW KPMG/RAPS SURVEY A recent KPMG/RAPS survey of more than 200 medical device industry leaders found that the majority (73%) don’t anticipate they will be fully compliant with MDR by the deadline, and almost half of respondents said they will likely discontinue or withdraw devices from the market because of the regulation.

What’s most striking about the KPMG/RAPS survey is how far behind the industry is. Just over a quarter of those surveyed plan to be fully compliant by the deadline, and 46% plan to leverage MDR’s transitional provisions to continue selling in Europe through 2024, while working on their compliance programs. Additionally, 66% have yet to plan for a systematic, long-term process to remain compliant moving forward.

Organizations are investing heavily in the initial compliance efforts, with 36% estimating more than $5 million in expenditures, but few are considering how to make these efforts sustainable. With the stricter requirements of maintaining a CE mark under MDR, manufacturers must

begin planning for sustainable success, if they want to continue selling their devices in Europe. As the report states: “It is possible to manage the additional workload that sustainability will require if organizations start planning now for the two to five years after application of the regulation.” This isn’t just about meeting a one-time deadline.

It’s about adhering to stricter guidelines for patient safety in an ongoing capacity.

Another telling result from the survey is the recurring theme of a lack of guidance. Manufacturers are struggling to wrap their heads around the new regulations, and the clock is ticking. This is one reason it’s so important to allocate internal resources to managing MDR compliance, but now is also a great time to enlist partnerships with others in the industry that can help educate around what exactly will be audited.

POTENTIAL DELAYS Many manufacturers are hoping Europe will delay implementation – but don’t count on it! Even if manufacturers are starting late there’s still time to catch up,

Sandi Schaible, senior director of analytical chemistry and regulatory toxicology, WuXi medical device testing

Sherry Parker, senior director of regulatory toxicology, WuXi medical device testing

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but they’ll have to kick it into high gear. Those that sit idle are at risk of lengthy regulatory delays, added costs, and having their devices pulled from the EU market. The May 26th 2020 deadline is fast approaching, and it’s not likely that Europe will grant an extension on MDR. HOW TO PREPARE If manufacturers haven’t started planning for MDR, the first step is to rationalize product portfolios.

A common challenge in the rationalization process is a lack of clinical experience reports, particularly for legacy products.

Unearthing relevant documents presents a time-consuming obstacle, involving diving into literature or

This isn’t just about meeting a one-time deadline. It’s about adhering to stricter guidelines for patient safety in an ongoing capacity.

seeking input to satisfy reporting requirements. This extra work is one reason older products should be prioritized in the rationalization process.

Manufacturers should also remember to focus on products that have the highest market demand and return on investment.

Before partnering with a laboratory testing facility or Contract Research Organization (CRO), it is important to assemble an internal multi-disciplinary team of specialists. Since MDR is multifaceted, the team should include experts from quality, product, regulatory affairs and engineering departments to ensure that nothing is overlooked. Together, they can conduct a gap analysis on product lines and identify any missing or outdated information in technical files. To comply with the new requirements, notified bodies will not accept historic product data or performance reviews alone which is why it’s important to do this work before approaching a testing partner.

Once all of the necessary product information and technical file data has been gathered, it is time to develop a biological evaluation test plan. Many manufacturers opt to outsource their regulatory testing needs to a CRO or lab to accelerate the process and get devices in front of regulators before competitors. Being transparent and forthcoming with details, as well as giving lab partners visibility to forecasts, intervals, and timelines will set the manufacturer and lab up for success.

REGULATORY GUIDANCE Various organizations are conducting research and compiling insights in surveys, whitepapers, articles, webinars, etc. and KPMG and RAPS are great examples of industry thought leaders doing this. CROs and laboratory testing facilities are also good resources.

Not only is it important to stay on top of regulatory changes, it’s critical to understand how regulations are being interpreted by regulators.

Manufacturers should choose a testing partner that spends time watching and interacting with regulators to understand their expectations on how testing is conducted. CROs or labs with international delegation on ISO committees and that collaborate with ISO by writing standards, participating in round robins, or offering other technical expertise can help manufacturers understand what regulators want on a deeper level.

The bottom line is that the industry impact of MDR is huge.

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CYBERSECURITY

WHY YOU SHOULD HIRE A MEDICAL DEVICE SECURITY ENGINEER LEON LERMAN, CYNERIO CO-FOUNDER AND CEO EXPLAINS WHY HAVING ONE SINGLE PERSON ULTIMATELY RESPONSIBLE FOR SECURING MEDICAL DEVICES ENSURES PATIENT SAFETY IS ALWAYS AT THE TOP OF THE AGENDA.

T

he number of vulnerabilities, ransomware cases and cyberattacks being identified on healthcare organizations is on the rise, and therefore protecting medical devices is becoming a high priority. Today, even basic everyday attacks on hospitals that aren’t specifically targeting medical devices can threaten patient safety due to the vulnerable nature of the devices used within these organizations that were not built with security in mind.

However, securing medical devices

30 28

is complicated. It requires collaboration between experts who understand enterprise security and biomedical engineering, as well as being familiar with medical devices. Hospitals often don’t have full visibility into all of the devices on the network and therefore devices are often hidden and as a result can’t be managed. Additionally, practitioners who are already stretched to the limit providing patient care are often unaware of security procedures or are reluctant to slow down patient treatments by following them. For example, caregivers often share passwords because looking up a forgotten password takes up valuable time. According to a Ponemon Institute study the vast majority (80%) of device makers and healthcare delivery organizations rate the level of difficulty in securing medical devices as “very high.”

By appointing a Medical Device Security Engineer (MDSE) hospitals can have one person ultimately responsible for protecting medical devices.

An MDSE should have a background in both biomedical devices and

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CYBERSECURITY

enterprise cybersecurity and is responsible for interfacing with the different departments within the healthcare organization to define, communicate, and enforce medical device security policies. Because there are new recommended policies, new medical devices and new tools to discover and manage being introduced all of the time, the duties of an MDSE are constantly evolving. Based on the current realities though, here are some duties that everyone can agree on.

1 .Educate: Perhaps the most important duty for the MDSE is to raise awareness of the potential risk and convince all the stakeholders to get on board including caregivers, biomed technicians, procurement and IT. An MDSE needs to be an excellent communicator who understands the unique perspective of every person involved in order to convince them to change their habits to be more security aware. Sample duties include educating procurement to avoid those devices with a high security risk, convincing doctors that they need to give up on their favorite products because they are not secure, informing suppliers that obsolete operating systems with vulnerabilities are no longer tolerated, and fostering collaboration between biomed and IT departments to share medical device knowledge and expertise.

2. Keep a complete and current inventory: Managing the enormous inventory of medical devices in circulation, such as glucometers and intravenous pumps is no small task, especially as their numbers are growing and more devices are being connected to the network. An MDSE needs to ensure that the medical organization has full visibility for all devices, even those added to the network by vendors on a trial basis. It’s very important to understand where the medical devices are and what their role is in medical workflows and clinical processes. This understanding really helps the security professionals to understand the importance of the device, prioritize the risk accordingly and apply the right controls to properly protect the assets and their communications without interrupting hospital operations.

3. Do a risk assessment: Each device on the network needs to have the relative risk assessed. This assessment needs to take into account not only the device itself but also the wider ecosystem which connects to the device - including gateways, interface engines, terminal servers, workstations etc.

Devices’ characteristics that the MDSE needs to know include if patient information is stored on the device, if treatment decisions are based on data generated by the device, the level of authentication used, if the device connects directly to the vendor’s network to do upgrades and maintenance, if the device can be patched when a security vulnerability is identified, and if communications over the hospital’s internal network are encrypted. This includes properly prioritizing the risks and deciding on a proper action plan to perform remediation.

4. Adhere to industry standards: An MDSE needs to be aware of technical standards at the industry level and have a full understanding of the regulatory landscape. This includes knowing Food and Drug Administration (FDA) and Office of Civil Rights (OCR) best practices and manufacturer disclosure policies. This also includes keeping up to date with The Medical Device Innovation, Safety and Security Consortium (MDISS) which provides coordinated information and analysis to support timely response activities and of course HIPAA (Health Insurance Portability and Accountability Act of 1996) privacy and security rules.

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5. Implement preventive measures: The MDSE needs to take all preventive measures necessary to respond to all known device vulnerabilities. Patches should be applied when available, and compensating controls should be put into place to limit devices’ exposure – this includes access control lists and network micro segmentation. All controls should be continuously evaluated to ensure that they continue to lower the organization’s risk over time.

An MDSE has a lot to do to pack into a single position, but there are tools that can help minimize mundane tasks and improve efficiency. Monitoring tools can automatically identify and classify devices on the network and assist with risk assessments.

Clinical workflows and device communications can be modeled, and device behavior can be monitored so that suspicious behavior can be identified, and the appropriate personnel can be alerted.

Having one single person ultimately responsible for securing medical devices ensures that patient safety is always at the top of the agenda.

By being equipped with the necessary tools, having the right security and biomedical knowledge and support from management, an MDSE can make securing medical devices a reality.

Having one single person ultimately responsible for securing medical devices ensures that patient safety is always at the top of the agenda.

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CYBERSECURITY

A recipe for disaster?

CHRIS HARVEY, DIRECTOR OF RECALL SOLUTIONS, STERICYCLE, EXPLAINS HIS THOUGHTS ON CYBERSECURITY WITHIN THE MEDICAL PLASTICS INDUSTRY.

A

s the medical plastics industry becomes increasingly digitalized with processes such as Artificial Intelligence (AI) and Industry 4.0, it is essential that manufacturers are able to implement these digital changes with sufficient security measures in place. For the benefit of both consumers and medical device manufacturers we’re hopeful companies will be able to do this, as if they cannot, the litigation and reputational losses could be substantial over the next decade.

Additionally, because this is a relatively new area for many medical plastics manufacturers, most are not yet equipped to implement the right security measures. However, I believe that they are aware of the issue and are moving quickly to correct any weaknesses in their systems.

Given the size and importance of the industry, you can expect the companies to invest in the resources to make the necessary technological changes in processes and equipment.

In order to stay up to date with cybersecurity measures, first and foremost, manufacturers must accept the fact that cybersecurity is a battle with no end. The Food and Drug Administration (FDA) provides guidance and Memoranda of Understanding that can help guide the industry, but companies

must not limit their understanding and security measures to what regulators recommend or require. Collaboration within the industry and across related industries is the best way to stay up to date with the latest risks and threats and take appropriate steps to protect against them.

Manufacturers need to be honest and forthcoming with patients when it comes to data security and privacy. In no other situation is this communication more important than when a vulnerability is identified, and a product needs to be recalled. In these cases, telling patients exactly what is at risk and what the company is doing to prevent such an incident in the future is paramount.

I believe regulations are only part of the solution, and it is important that manufacturers do not rely on regulatory agencies to be their sole source of information. We need to think about cybersecurity less in terms of regulatory compliance and more about entering a new battle every day. Cybersecurity is a moving target, and the fact is that we don’t know what the next big threat is – and neither do regulators. It’s a reality that makes it difficult for anyone to stay ahead of the curve.

Product recalls have remained steady over recent quarters, with no real surprises about the cumulative impact of these events. But what was remarkable was that software issues were the top cause of medical device recalls, accounting for 46 recalls. When we really stop to think about what that means, we can’t help but realize the risks facing patients, doctors, and device companies who increasingly rely on AI and data collection to inform medical decisions and treatment options. If the software that is used to operate a device is inadequate, how can we be sure that it is protected from cybersecurity vulnerabilities?

Add to that the fact that companies have only recently been laser-focused on mitigating cyber threats associated with medical devices. It’s a recipe for disaster.

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INJECTION & MICROMOLDING

PERFECT

MEDICAL PLASTICS NEWS EDITOR LAURA HUGHES SAT DOWN WITH PATRICK HANEY, RESEARCH AND DEVELOPMENT ENGINEER, MTD MICRO MOLDING, TO FIND OUT WHAT MANUFACTURERS NEED TO KNOW ABOUT INJECTION AND MICROMOLDING.

1. WHAT ARE THE MAIN DIFFERENCES BETWEEN MICROMOLDING AND CONVENTIONAL INJECTION MOLDING? Micromolding has many aspects that differ from conventional injection molding. These differences may vary from the way that the processor may optimize molding parameters, to the subtle differences that molding different material types may present.

Typically, conventional process parameters are compartmentalized and optimized in stages. Most molders would think of the fill/pack/hold/cool molding cycle to be as fundamental as elementary grade mathematics.

However, influences from thermodynamics and ultra-high shearing mechanics make compartmentalizing the molding process a lot more difficult in micromolding. The shot’s small volume surrounded by so much relative tool steel forces a micromolder to invent creative ways to ensure that each processing parameter is set with not only part quality in mind, but also material preservation.

In short, micromolding requires an unprecedented attention to detail that is not typically required in more conventional molding settings.

2. WHAT DO YOU THINK ARE THE KEY THINGS MANUFACTURERS INVOLVED IN THE INJECTION AND MICROMOLDING OF PLASTICS NEED TO KNOW? It is really important for manufacturers to understand the differences between micromolding and macromolding.

Micromolding is a thermal form-change method for creating very small, three-dimensional, components having smaller features and dimensional tolerances. Micromolding is not a slightly altered version of macromolding, made to fit the microworld. The materials used in micromolding behave very differently in the microworld, requiring specialized expertise and technologies.

The micromolding world is governed by principles of scalability which state that as the physical size of an object is reduced, the volume and surface

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area are also reduced, but not linearly with the size. Therefore, the same materials used in macromolding applications yield far different results when scaled to micromolding applications.

Plastics in general do not scale linearly. This is in terms of properties and material behavior such as flow or any type of non-Newtonian behavior. In a conventional molding world those characteristics are more or less understood and systematically manipulated. But in the microworld, predictable non-Newtonian behavior rarely occurs. This idea applies to more than dimensional or mechanical things like strength or shrink - it also influences things from the way material processes to the macromolecule behavior.

Design, processing, polymer science, shear sensitivity, crystallinity, flow dynamics, etc. often behave in ways the conventional molding world would label as unexpected.

3. WHICH FACTORS MUST BE CONSIDERED BY MANUFACTURERS WHEN MICROMOLDING PLASTICS FOR MEDICAL AND DRUG DELIVERY DEVICES? You need to think about manipulating material differently in micro than you would in a macro environment. For example, it is important to consider: 1. Optimizing velocity conventionally This can be done in micromolding, but if we go through the steps in the conventional way, the results will say our optimized velocity

INJECTION & MICROMOLDING

PRECISION is extremely high which can be detrimental to materials, due to the high shear exposure. So, we need to come up with other ways to optimize injection velocity in the microworld in order to ensure a robust process and maintain material integrity.

2. Widely understood decoupled molding process The latter half of this technique is primarily based off of gate freeze time in the macro world. In micro, gate freeze is nearly instantaneous so parameters cannot be optimized based on something like gate freeze time. The micromolding process does not give an operator the data to even determine those parameters conventionally. This, however, is not to say that those parameters cannot be optimized for a micro process. Rather, it means that we must think critically about the capabilities of the micro process and determine new ways to scientifically optimize those parameters based off of what is best for the material integrity and application.

Additionally, medical microinjection molding requires much more specialized equipment than traditional microinjection molding.

In conventional injection molding machines, the screw performs four basic actions: Melt, feed, convey and inject the polymer. MTD’s advanced medical micromolding machines utilize a screw-overplunger design, where the screw only melts, feeds, and conveys the polymer into the plunger cavity.

As you can see in the table, this has several advantages, but the most basic are that we can control residence time at high heats, and we do not shear all of the material in the barrel. The advantages lead to very tangible results for our customers such as cost savings from reduced material usage, and faster product development timeframes.

4. WHAT DO YOU BELIEVE ARE THE MAIN CHALLENGES ASSOCIATED WITH MICROMOLDING PLASTICS? In micromolding, it is extremely important to realize that this is not just scaled down macromolding. A processor not only needs to understand the basics of how to optimize a molding process, but also how each decision effects things like part functionality, material morphology, degradation mechanics, and flow characteristics.

The key to success lies in understanding every possible avenue of your polymer, and how you may manipulate and control those avenues to shape them into a fully functional world class product.

5. HOW DO YOU SEE THE INDUSTRY EVOLVING IN THE FUTURE? Specifically, with bioabsorbable resins, these materials will be tailored to perform specific functions because we are considering the polymer science aspect of things too. Also, things like customized molar ratios and optimized crystallinity are going to lead the way to allow bioabsorbable materials to have the ability to break down at a very precise tissue regeneration rate.

In the future, electronics will incorporate micromolding technology more and more. We are already seeing this today. As technology becomes increasingly more digital, the micromedical device industry will continue that trend, which will in turn require powerful electronics to be incorporated into plastic implants and devices.

ADVANCED MEDICAL MICROMOLDING

CONVENTIONAL INJECTION MOLDING

Optimized runner systems

Long/larger runners

[Unrecoverable] minimal material waste, by volume

Increased material waste

Violent molding process (fast, high Less-violent molding process temp, high shear rates) Tight/stringent process windows

More latitude in process window development

Macromolding guidelines do not apply

Macromolding guidelines do apply

Without end of arm tooling (EOAT), Robotic part removal does not robots, and cameras, there is a always add value high risk of mold and cell damage Tightly married tooling and molding processes – key to success

Less shear sensitivity

No material regrind option

Material regrind is common

Good fit for engineering/exotic/ bioabsorbable materials

Bad fit for engineering/exotic/ bioabsorbable materials – normal material waste too expensive to justify

Highly complex detail achievable

Highly complex detail not achievable

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Global Excellence in Delivery Device Testing EMC Testing Packaging Validation Medical Device Testing Extractables & Leachables Chemical Characterisation Combination Device Testing

Medical Engineering Technologies Unit 16, Holmestone Road, Dover, Kent, CT17 0UF, UK

www.met.uk.com t +44 (0)845 458 8924 e solutions@met.uk.com

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TESTING AND INSPECTION

AMY B. MILLER, DIRECTOR, LAB SERVICES, PMO AND SUPPLY CHAIN AND DANIEL L. BANTZ, TECHNOLOGY MANAGER, PERFORMANCE AND PACKAGING, LABS, BOTH FROM WEST PHARMACEUTICAL SERVICES, EXPLAINS THE IMPORTANCE OF TESTING AND INSPECTING WITHIN LABORATORIES.

The perfect pair T

he development of new drugs, especially combination therapies, is a complex venture associated with in-depth analysis and difficult decisions prior to commercialization. Many factors need to be considered when packaging drugs for ease of use by patients, so that they meet the highest quality standards, and are safe for use.

As combination products become more prevalent, as well as the need for scientific data to support regulatory requirements for pharmaceutical manufacturers, the challenge of using traditional glass or engineered polymers (plastics for combination products) remains similar. Regardless of the material, it is critical to understand the compatibility and performance of the primary packaging system with both the drug product and the delivery systems for successful development and commercialization of the drug product. At West, we implement efforts to attempt to help customers keep costs lean, product development efficient, risks low, and regulatory approval seamless.

We believe that the drug chooses the primary packaging, and in many cases a polymer-based system is the right choice. For example, a drug product may be sensitive to silicone oil, requiring use of a polymer syringe instead of a glass syringe, or a drug product may require storage at cryogenic temperatures and require the use of a polymer vial instead of a glass vial. At the outset of drug product development, it is critical to consider the suitability of the planned packaging/delivery system so the right choice can be made. In order to ensure this, a well-planned testing strategy is needed, comprising evaluation of extractables/leachables, particles, container closure integrity, and system performance.

Extractables/leachables: Through gross compatibility studies utilizing exaggerated conditions, it can be determined early on if any extractables from polymer containers sand elastomer stoppers/plungers can leach into the drug products effecting safety and efficacy. Once that is determined, utilizing the data collected from the compatibility study, a formal development program for extractables and leachables can be implemented based on United States Pharmacopeia (USP) Chapters <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems, <1664> Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems, and ICH Q3D Guideline for Elemental Impurities.

Particles: Understanding particle load from polymer container and elastomer stopper/plunger is needed as particles affect efficacy and patient safety. Utilizing USP (USP <787> Subvisible Particulate Matter in Therapeutic Protein Injection; USP <788> Particulate Matter in Injections; and USP <789> Particulate Matter in Ophthalmics) visible and subvisible particle loads can be determined. Typical methods are membrane microscopy, Light Microscopy Image Analysis (LM/IA), and Light Obscuration (LO). When possible, particles should be identified through techniques such as optical microscopy and Scanning Electron Microscopy with Energy Dispersive x-ray Spectroscopy (SEM/EDS). This is especially important for controlling particles by identifying their source.

Container Closure Integrity (CCI): A pharmaceutical manufacturer must determine the Maximum Allowable Leakage Limit (MALL) for the drug product in order to evaluate CCI of the packaging/ delivery system. USP <1207> Package Integrity Evaluation â&#x20AC;&#x201C; Sterile Products defines MALL as the greatest leak rate (or leak size) tolerable for a given packaging/delivery system that poses no risk to drug product safety and quality over shelf life.

USP <1207> provides guidance on how to evaluate CCI such as deterministic methods, which are strongly endorsed compared to probabilistic methods. Deterministic methods are tracer

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TESTING AND INSPECTION

Daikyo Crystal Zenith 2mL vial, 13 mm stopper, and 13 mm Flip-Off seal. West Pharmaceutical Services ©

gas leak detection (frequently with helium), high voltage leak detection, vacuum decay, and frequently modulated spectroscopy headspace analysis (frequently with oxygen). These methods must be developed and validated for the specific system. It must be demonstrated that the packaging/delivery system meets the MALL for the drug product. MALL varies with each drug product and system.

System performance: To understand performance and functionality (essential in design verification testing), testing should be based on established guidelines and standards, such as ISO standards. An excellent example is ISO 11040 Prefilled Syringes — Part 8: Requirements and Test Methods for Finished Prefilled Syringes. It includes tests such as Deliverable/Residual Volume, Tip Cap Pull-Off Forces and Torques, Liquid Leakage Beyond the Plunger, and other methods useful in evaluating performance. ISO 11040 also includes pharmaceutical requirement tests such as drug-container interaction, biological requirements and particles.

In many cases, especially when novel devices such as new combination products are being evaluated it is necessary to create custom testing strategies and methods. These should be in alignment with established guidelines and standards such as ISO 11040-8, and those that are FDA recognized consensus standards. It is emphasized that the test methods employed, custom or not, require validation in order to be used for stability and release testing. This is especially true for combination products. In fact, utilizing a testing approach as here described is not just a best practice, but an expected practice.

When developing a testing strategy, other factors may need to be considered such as those particular to the specific drug product. It may be necessary to employ a contract laboratory, and it is necessary to ensure the laboratory is GMP and FDA compliant and ISO certified. Depending on the drug product, the laboratory may need a DEA license. The laboratory should also have proper facilities/equipment and, more importantly, scientific staff capable of both developing and executing a testing program that successfully navigates regulatory requirements.

Creating a comprehensive testing strategy, from initial compatibility through stability and release is essential, regardless of the drug product, types of materials, systems and devices chosen. The right contract testing partner is necessary to accomplish this and ensure the availability of scientific data that helps ensure optimized results to patients, as well as fast regulatory approval and delivery to market occurs.

Utilizing a testing approach is not just a best practice, but an expected practice.

The SmartDose Gen I. 3.5 mL drug delivery platform.

West Pharmaceutical Services ©

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MINNEAPOLIS

THE BIGGEST

MEDTECH EVENT IN THE MIDWEST! 5,000 Industry Professionals 500+ Top-Level Suppliers

OCTOBER 23-24, 2019 // MINNEAPOLIS, MN M I N N E A P O L I S C O N V EN T I O N C EN T ER

REGISTER NOW at MDMminn.com/INVITE 372211_MDM_MN18

Use promo code INVITE for a free expo registration WWW.MEDICALPLASTICSNEWS.COM

EVENTS

MD&M Minneapolis THE 25TH MD&M AIMS TO CONNECT ATTENDEES WITH INNOVATORS IN MEDTECH AND PROVIDE ACCESS TO INDUSTRY LEADERS. DATE: 23rd - 24th October 2019 LOCATION: Minneapolis Convention Center EXHIBITORS: A large number of well-known exhibitors will be present at the show including Accumold, Arburg, Canon U.S.A, Davis-Standard, Engel and NuSil. KEY TOPICS: The conference will cover emerging technologies, materials and coatings, usercentered design, artificial intelligence, sensor technologies, usability testing, automation and scaling up and slimming down.

EXTRA INFORMATION: Five for One - MD&M allows attendees access to five events with one pass: MD&M Minneapolis, MinnPack, ATX, Design & Manufacturing and PLASTEC Mobile app - To keep up to date with information before and during the event you can download the event app for free on to your device Fun extras - The event also features a booth bar crawl on the first day and a pizza party on the second day of the event

BIOMEDevice San Jose THE EVENT HOPES TO EMPOWER MEDICAL DEVICE DESIGNERS, ENGINEERS, AND EXECUTIVES TO REACH THE NEXT STAGE OF THEIR MEDTECH PROJECTS. DATE: 4th - 5th December 2019 LOCATION: San Jose Convention Center EXHIBITORS: Some of the industry specialists that will be in attendance include B. Braun, Emerson, Fluortek, Microspec, Nelson Laboratories and Phillips-Medisize.

KEY TOPICS: The agenda includes artificial intelligence, minimally invasive surgery, robotic surgery, sensors, digital health, wearables, in vitro diagnostic devices, virtual reality and augmented reality.

EXTRA INFORMATION: Why Silicon Valley?

• Northern California leads the nation in life sciences venture capital investments with a total of $5.3 billion •T he region is top for venture financing within the medical device market with $1.4 billion •W ith 82,000+ employed people within life sciences, the Bay Area is the nation’s leading employer for the sector

Compamed A TRADE SHOW WHICH FOCUSES ON IMPROVING TEAM PLAY BETWEEN SUPPLIERS AND MANUFACTURERS. DATE: 18th – 21st November 2019 LOCATION: Fair ground Düsseldorf EXHIBITORS: 784 specialists from their field will be present from 37 different nations, with the largest number of representatives from host country Germany, closely followed by China.

KEY TOPICS: This year the focus will be on innovative materials, forward-looking components and new services. Topics such as the manufacturing of components and finished products, manufacturing equipment, OEM equipment, microtechnology, materials, adhesives, software and IT will also be discussed during the trade show.

EXTRA INFORMATION: •M EDICA: Compamed runs parallel to MEDICA, which is planning to provide attendees with a chance to experience tomorrow’s healthcare market live •T op tip: Free shuttle buses are available from the car parks at the venue

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A WEARABLE DISPLAY FOR SURGEONS: A LIVE DEMO DATE: Wednesday 4th December TIME: 13:10-13:40 LOCATION: Booth 641, San Jose Convention Center INFORMATION: Attendees of the live demonstration taking place during BIOMEDevice

San Jose will be able to listen to how HMDmd’s CEO John R Lyon and senior vice president Allen Newman worked with surgeons to develop a device for surgeon’s to wear when performing surgical procedures.

The device consists of a medicalgrade head-mounted wearable display that uses 3D and high-

NO MORE LEAKS R esearchers at the University of Birmingham have developed a new method for 3D printing soft materials.

The technique is called Suspended Layer Additive Manufacturing (SLAM) and works by using a polymer-based hydrogel in which the particles have been manipulated to create a selfhealing gel. To help create a 3D shape, liquids or gels can be injected daily and built up in layers. This

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process avoids sagging and leaks which often occur with other methods.

Additionally, SLAM could also be used to create objects which are made from two or more different materials meaning this method would be suitable for creating complex soft tissue types, or for drug delivery devices where different rates of release can be required.

SLAM could offer huge benefits when manufacturing artificial medical implants.

resolution organic light-emitting diodes. The technology aims to prevent surgeons struggling to operate comfortably due to having to move in order to look at a screen. Newman and Lyon will discuss how the device was developed as well as how the device could be used clinically during their demonstration.

Sensor developed to reduce hospital superbugs

A

sensor which is able to constantly sample patients’ antibiotic levels has been developed by researchers at Imperial College, London.

The sensors are the size of a small plaster with tiny needles on the underside which are even thinner than a human hair.

As a result of their small size the needles are able to sample body fluids by flowing between cells, and the needles can be coated with enzymes in order to tune a reaction to different drugs.

The sensors are able to display how the patient reacts to the antibiotic they have received, and as the needles are able to sample fluids 200

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times a second, this method is much faster than existing methods and provides the opportunity for adverse reactions to be spotted quickly.

This isn’t the first use of micro-needle sensors which have been used to monitor blood sugar levels previously.

However, this is the first time the sensors have been used to monitor antibiotic use.

More work is needed to make the technology reliable enough for clinical use, but this technology is showing promise in helping to reduce drugresistant infections, manage serious infections and save the National Health Service money.