Pharmapack 2019

Highlights Connected Devices,

Adherence Packaging
Connected devices offer unprecedented promise in the ability to improve patient
adherence as well as track product storage conditions and link patients with the
healthcare ecosystem.
By Keren Sookne, Director of Editorial Content
 Pharmapack 2019 Highlights Connected Devices, Adherence Packaging

With an exhibition, innovation gallery, awards and learn-

ing opportunities, Pharmapack Europe, held Feb. 6-7 in Par-
is, offered the latest in pharmaceutical packaging and drug
delivery systems. Here are a few key takeaways:

Connected devices
In 2019, despite the fact that connected drug delivery de-
vices are available and that adherence monitoring is pos-
sible and could drive demand, the adoption rate of these
products is slow. According to Merck’s David Braun, this is
due to a number of factors including complicated user in-
terfaces, high product costs, lack of patient awareness/pro-
Dr. Giana Carli Lorenzini, Postdoctoral Research Fellow in the Department of
motion in the health system and lack of a proper ecosystem Design Sciences at Lund University.

around the devices.

Braun also pointed out that adherence reminders have to
get smart. “If we don’t use artificial intelligence, the patient
will receive a reminder when they are busy, such as when
they’re driving the kids to school,” he said. Merck partnered
with Medisafe, and developed an app that can send the pa-
tient adherence reminders at the “right time,” such as a few
minutes after they arrive home.
He added, “We want to boost adherence and create val-
ue. When data is sent to a mobile phone, what about the
stakeholders… will the physician have time to look at this
alert? Is there support in the healthcare system to observe
non-adherence and trigger the patient to take their dose?” Dr. Alex Cole, Chief Scientist Aurora/Strategic Marketing Analyst at CPI.

If the insurance company sees patients adhere to a drug
better, then will they be more willing to pay for it because it
boosts outcomes?
He advised attendees that they shouldn’t underestimate
their data strategy because the data is powerful, beyond
sending reminders.Connected devices will be part of daily
life but there’s a lot the industry needs to do, including being
faster to market and adopting technology from the consum-
er electronics industry. “The opportunity is there. It’s not just
an opportunity but a responsibility.”
Three types of patients
Dr. Giana Carli Lorenzini, Postdoctoral Research Fellow in
the Department of Design Sciences at Lund University, dis-
cussed the three types of patients:
• The pre-user who’s just been diagnosed and may be
prone to making “naïve mistakes” with treatment
• The experienced user, who’s already adapted to a routine
and packaging
• The user-advocate, involved in patient advocacy groups
and looking beyond their own care to the community of
patients at large
While it’s not a reason not to update a package or device, it’s
important to consider that when changes are made, the expe-
rienced user may revert and make mistakes. She is continu-
ing research, working on a post-doc, studying the routines
Pharmapack 2019 Highlights Connected Devices, Adherence Packaging, continued
and feelings of seniors. They’re sharing their medication use
through pictures from home. “Now I’m looking at cases that
were successfully developed and what they did to make an
inclusive design,” she says.
Smart packaging
Where does the smart package fit into the digital healthcare
ecosystem? Dr. Alex Cole, Chief Scientist Aurora/Strategic
Marketing Analyst at CPI, said, “The whole thing only works
if you know the patient is taking the medication. It’s the glue
that holds it together. The package or device doesn’t have to be
connected but you have to get that info into the ecosystem.”
Everything about pharmaceutical and device packaging is
so controlled, from fill levels to storage conditions. But there
isn’t any environmental monitoring or traceability with the
patient. He recounted a story in which a nurse accidentally
left a fridge thermometer on top of the fridge, and continued
to record a 21°C reading all day. Even though the drugs were
safely inside the fridge, the products had to be thrown out.
With smart packaging (and/or connected packaging) and
more integrated healthcare ecosystems, Dr. Cole said that
opportunities include lower product wastage all the way to
the patient, improved adherence, more informed patients,
reductions in dispensing errors and reductions in accessi-
bility issues. He mentioned smart blister packaging, such as
Med-ic Smart Blister from Information Mediary Corp and

Stevanato Group’s Cartridge-based wearable device was selected as the Best
Innovation in Drug Delivery Device in the Pharmapack Awards.
Schreiner Medipharm’s smart blister package, which gener-
ates data in real time when a patient pushes a tablet from a
cavity, which may include medication type, extraction time
and specific cavity.
As Braun had mentioned, Dr. Cole said that adoption rates
are still slow. “We need this massive collaborative approach
and we need all the partners to see the benefits.” CPI is work-
ing with universities and patient groups, pharmaceutical
companies and government bodies, looking atways to im-
prove offerings and adoption.
CPI, which develops printable electronics, is looking at
ways to use electronics to overcome some challenges by pro-
Pharmapack 2019 Highlights Connected Devices, Adherence Packaging, continued
Dr. Cole pointed to the need for packaging such as Schreiner Medipharm’s
smart blister package, which generates data in real time when a patient pushes
a tablet from a cavity.
ducing technologies that are flexible, capable of high volume
production and printable on very thin substrates so that they
can be embedded in compact designs.
Disposable electronics?
The elephant in the room when it comes to these high-tech-
yet-single-use packaging designs is that we cannot continue to
pump electronics into the waste stream. Dr. Cole said that they
are also investigating options to recycle these components,
and potentially use the connectivity of the designs themselves
to reach the patient and help guide them in terms of how pa-
tients should properly recycle or dispose of the packaging.
Healthcare Industry Cannot
Ignore Environmental Impact
Recycling or reusing medical devices? It’s coming. A presentation at Pharmapack
highlighted green guides and carbon footprint opportunities.
By Keren Sookne, Director of Editorial Content
 Healthcare Industry Cannot Ignore Environmental Impact

“Historically, we have been an industry that’s tended to

shy away from [sustainability]. It’s driven me to get much
more interested and involved in this,” said Gregor Anderson,
Managing Director at Pharmacentric Solutions at February’s
Pharmapack Europe.
Right now, fast moving consumer goods (FMCGs), particu-
larly foods, are under the spotlight. But the healthcare indus-
try can expect more scrutiny in the coming years.
Where is the drive coming from in healthcare? Anderson
Gregor Anderson, Managing Director at Pharmacentric Solutions at February’s says it’s a mix of internal factors such as corporate social re-
Pharmapack Europe. sponsibility reporting as well as external factors:
• Healthcare strategies that seek to reduce carbon foot-
print, like Aarhus Hospital’s initiative
• Regulatory requirements (e.g. EU packaging reporting
and taxation)
• Retailer packaging reporting requirements, such as
those from Walmart and Tesco
• Increased demand in benchmarking and performing life
cycle analyses (LCAs)
• Consumer expectations and subsequent competitor
strategies
• “Red face” test, showing that you’ve optimized your de-
sign and used the least materials possible
Consumers are certainly more educated on environmental
impacts than in years past. Anderson noted that in his time
Green guides are an important tool.
at GSK, patients made this known, with one saying that they

felt guilty throwing the product away each month.
“We have to work as an industry-wide consortium on this.
The medicine is king but if we can work together and iden-
tify materials and processes that do have CO2 benefits, we
could make a big difference,” Anderson noted. “We’ve never
accounted for actual CO2 savings. You save money when you
save CO2, either by enhanced process or materials.”
Positive impacts can come from unlikely sources. A logis-
tics company scraped barnacles off their boats, making the
vessels more efficient and using less fuel. Seemingly little
things can add up.
Anderson described a sustainability spectrum that compa-
nies fall on, ranging from reactive to mature. On the initial
reactive side, companies are doing what they can to “stay le-
gal,” progressing through stages until they are differentiating
their products and businesses, building trust and ultimately
changing the marketplace.
Opportunity: metered dose inhalers
Anderson discussed the major opportunity that healthcare
product manufacturers have to make an impact. Take the in-
haler market. It’s projected to be worth $43 billion by 2025, with
the market split between metered dose inhalers (MDI) at 60%,
dry powder inhalers (DPI) at 30% and smart mist inhalers/neb-
ulizers at 10%. Globally, volumes of single-use doses and multi-
dose devices globally are in the billions (with billions of associ-
Healthcare Industry Cannot Ignore Environmental Impact, continued
ated packaging units)… and that’s just for respiratory products.
Breaking down LCA numbers for Relvar 92/22 by device, pro-
duction, API, distribution, use and end of life, he showed how
the device and pack breakdown enable better understanding
of CO2 impact and where changes can be made. The figures in-
cluded the energy to manufacture the package and device itself.
By making processes more efficient, such as enhancements
that speed up lines, companies can reduce environmental
impact. One key consideration is that pharmaceutical com-
panies typically don’t make the devices, they design them or
buy them from suppliers, so they must work with suppliers
early on to engineer out costs.
CO2 numbers
Anderson pointed out that the CO2 numbers themselves
don’t mean much until you begin to compare them to others.
The carbon footprint of a Big Mac is approximately 4,000 g of
CO2 equivalent gases per serving, where a vaccine’s is under
1,500 and an MDI’s is under 500. He said the awareness is im-
portant and he thinks we should start the discussion around
waste with end users.
The green impact of non-adherence
It’s wasteful when patients don’t take their medication as
prescribed. The pharma industry as a whole has to do more
to make patients realize they are part of the total solution,

Carbon footprint breakdown by component.
Huhtamaki won a Pharmapack award for Push Tab®, a flexible blister that
eliminates PVC.
Healthcare Industry Cannot Ignore Environmental Impact, continued
starting with effective training, particularly with medical de-
vices. Companies can add tools—such as a reusable whistle
on an inhaler—that lets the patient know that they’ve tak-
en the dose and offers positive reinforcement. Autoinjector
trainers also help patients adhere. “From sustainable point
of view, you’re encouraging correct device use,” he said.
Propellants
Propellants are another area that governmental bodies are
targeting. In fact, the UK parliament released a document on
reducing F-gases that said the National Health System (NHS)
should set a target that by 2022 at least 50% of prescribed in-
halers are low GWP [Global Warming Potential], and that the
government should ensure that by 2020, at least 50% of MDIs
are recycled. With Brexit, it’s only one nation but the NHS in
the UK is a huge market. Anderson was concerned at the lack
of fanfare as he stumbled on this information, asking, “Is any-
one beside GSK looking at this? This is news to people… even
among producers of MDIs. They have to be made aware.”
Green guides
Anderson stressed the importance of having a green guide
at every company, which enables informed discussions be-
tween business groups along with mutual cooperation to-
ward the goal. The benefits, he said, are as much commercial
as they are environmental because saving CO2 saves money.

The guide should set clear expectations of requirements for
primary, secondary and tertiary packaging and help design-
ers rapidly asses the environmental impact of designs, with
prevention being most favorable.
He presented the 7 Rs of GSK’s waste hierarchy:
• Reduce – Reduce the mass of materials, complexity and
the life cycle footprint of packaging
• Remove – Remove unnecessary materials or those with
environmental concerns
• Reuse – Reuse the component (a hurdle in pharmaceu-
ticals)
• Recycle– Design for recyclability
• Renew – Increase the use of materials and energy from
renewable sources
• Reward – Improve the environmental impact of the sup-
ply chain, accounting for patient, customer and consum-
er needs at lower cost
• Respect – Use responsible suppliers
Inhaler recovery
GSK is putting its money where its mouth is when it comes
to recycling. The company saw that their inhalers were the
second biggest contributor to their global footprint, just af-
ter the transportation aspects involved in producing and
supplying products globally. around the world. “Complete
Healthcare Industry Cannot Ignore Environmental Impact, continued
the Cycle” is GSK’s recycling and recovery scheme for all
respiratory inhalers, in which the company provides a con-
venient way for patients to recycle their inhalers.
The company reports that by the end of 2017, over 1.2 million
inhalers had been recycled and recovered. This has saved carbon
dioxide emissions equivalent to taking 5,199 cars off UK roads.
At this point, Anderson noted, this is perhaps only 1.3% of
inhalers, “but the opportunity is there. This is what we have
to do if it can’t go into waste stream.”
Key takeaways
• Poor adherence is never “green.”
• Design and specify inhalers (and packaging) to be op-
timized. This means maximizing shelf life while mini-
mizing materials. Use an LCA to understand the carbon
footprint of each component and look at ways to refill
where possible and make electronics reusable.
• Engage your suppliers in this effort.
• Use new “greener” propellants wherever possible.
As devices become implanted with small electronics, the
need for assessment is even greater. Anderson concluded,
“With connected devices, what is going to happen when all
these end up in the waste stream? No one’s talking about it,
we’ve got to talk about it.”
The Shift from Hospitals
to Home Care Continues to
Shape Packaging
The future role of patient adherence tracking, flexible packaging options and
sustainability continue to challenge the healthcare industry.
By Keren Sookne, Director of Editorial Content
 The Shift from Hospitals to Home Care Continues to Shape Packaging

The point of care is not always at the hospital or doctor’s of-

fice. As this trend increases, whether from convenience and
comfort or cost reduction—the packaging community must
continue to evolve, according to a panel discussion I hosted
on Feb. 6 with industry experts during Pharmapack Europe.
The shift from hospital care to home health means that
healthcare manufacturers have to meet the unique needs of
patients outside of a clinical setting. As Uri Baruch,Head of
Drug Delivery at Cambridge Design Partnership, noted, the
last mile and home administration are both a major chal-
lenge and opportunity: we track and control every aspect of
the product but once it’s at the patient’s home, but we don’t
have oversight into how it is used, adhered to or stored. With
the rise of drugs that cost into the thousands per dose, it is
A panel discussion with industry experts during Pharmapack Europe highlights
imperative to ensure the technology is in place to ensure adherence packaging and sustainability.
drug safety and adherence at the home or clinical setting.
One hurdle to overcome is the “big data” question. What do Speed and flexibility as batch sizes decrease
manufacturers, clinicians and insurance companies do with Anil Kumar Busimi, Head of Global Product Management
this information? Will insurance companies change more Syringe Business at Schott Pharmaceutical Packaging, point-
when patients don’t adhere? The general public is already ed out the increasing importance of both standardization
concerned with data privacy. Will they be willing to get con- and flexibility in packaging options. There are different vials
nected to apps and platforms that track their adherence, par- at every company. Why isn’t there standardization?
ticularly if they’re worrying about increasing health costs? With the trend toward smaller batch sizes, manufacturers
Another key question in connected devices and packaging: need flexibility to shift to different sizes and packaging for-
Why are we throwing “smart” at a package? There has to be a mats quickly, which is such a different mentality from the
value-add for business, beyond improving patient adherence. legacy, blockbuster drug production that focused on speed-

ing up production and consistent product sizes. Busimi said
that ready-to-use options and industry standardization and
can help, so that projects benefit from some “modular” ma-
chinery or packaging aspects versus bespoke… everything.
Marie-Liesse Le Corfec, Global Portfolio Marketing Head,
Prefilled Systems at BD, said that we need more industry col-
laboration and partnerships, in addition to the flexibility to
run products on different packaging sizes. As pharmaceuti-
cal companies must get products to market faster to help pa-
tients, packaging, device and machinery suppliers can help
pharma companies by offering drug companies the informa-
tion packages they need in streamlined ways, including val-
idation and testing data. It’s almost as if the packaging com-
munity can aid in being a “delivery device” to help pharma
companies deliver drugs to the market.
Sustainability
Sustainability questions still lurk, though the topic is be-
coming much more popular. While the pharma and med de-
vice industries are slow to adopt any changes, much less sus-
tainability initiatives, the panelists all agreed there is much
room for improvement.
Ger Standhardt is Executive Director of HCPC Europe,
which recently developed a research database to create an
overview for members of the available research in the field
of patient-friendly and adherence packaging. He said that
The Shift from Hospitals to Home Care Continues to Shape Packaging, continued
we have to talk about ways we can recycle, or better still, re-
duce. The healthcare industry cannot continue to add plas-
tic to the environment the way it was in decades past, both
for environment and the court of public opinion. More and
more, pharmaceutical manufacturers are asking for packag-
ing with reduced environmental footprints.
Another key part of this, as David Braun, Global Head of
Medical Device Business Solutions at Merck, noted, is deter-
mining the value-add of packaging. Consumers are increas-
ingly eschewing packaging waste, at times even opting for
“packaging-free” food stores. Medical packaging must deliver
value, and that value must be communicated to the patient.
In his presentation at Pharmapack, Braun spoke of the great
opportunity that connected devices present if implemented
correctly, and that healthcare can learn from the fast-mov-
ing consumer electronics industry.
Ultimately, panelists said that patient desires and inde-
pendence were the driving forces for change, or for keep-
ing things the same. Le Corfec mentioned that an existing
device was on the table during an evaluation and the pa-
tient remarked that that was what they wanted. Just because
a device has been around for years doesn’t mean it’s not
valuable or needs to be changed. “We have to listen to the
patient,” she said.
UK Wants 50% of Metered Dose
Inhalers Recycled… By 2020
A speaker at Pharmapack Europe found a lofty goal in a UK document about reducing
F-gases. Do the device manufacturers know about it?
By Keren Sookne, Director of Editorial Content
 UK Wants 50% of Metered Dose Inhalers Recycled… By 2020

Governmental bodies are looking at ways to reduce environ-

mental impacts. This is great news, however, it’s important
that the healthcare manufacturers affected by sustainability
goals are involved, or at least informed of, the decisions.
Gregor Anderson, Managing Director at Pharmacentric Solu-
tions, brought up an important example of this at Pharmapack
2019. Propellants are an area that governmental bodies are
targeting. In fact, the UK parliament released a document on
reducing F-gases that said the National Health System (NHS)
should set a target that by 2022 at least 50% of prescribed in-
halers are low GWP [Global Warming Potential], and that the
government should ensure that by 2020, at least 50% of metered
dose inhalers (MDIs) are recycled. With Brexit, it’s only one na-
tion but the National Health System in the UK is a huge market.
A speaker at Pharmapack Europe found a lofty goal in a UK document about
reducing F-gases. Do the device manufacturers know about it?
Here’s the actual text:
“The NHS should set a target that by 2022 at least 50% of pre- exceeding this target. It should also consider medical waste,
scribed inhalers are low GWP. It should publish annual prog- such as MDIs, in its waste strategy.”
ress reports. We were disappointed to find that so few MDIs
are disposed of responsibly. We therefore recommend that the Commentary
Government should work with medical professionals, pharma- Anderson was dubious that many companies have heard of
cists, the pharmaceutical industry and patients to significantly this lofty goal, and with the slow-moving nature of pharma-
improve the recycling of MDIs; this makes both environmen- ceutical and medical device industry changes, it highlights
tal and economic sense. The Government should ensure that an important issue that government sustainability goals
by 2020, at least 50% of MDIs are recycled. The Government must be communicated and offer appropriate time frames
should publish annual data showing progress in reaching and for success.
Environmental Reporting
Gains Priority for
Pharmaceutical Industry
During Pharmapack Europe 2019, Lorax Compliance COO Michelle Carvell urged
the pharmaceutical industry to prioritize its environmental reporting obligations for
packaging or risk high financial penalties.
By Jim Butschli, Editor

During Pharmapack Europe 2019, Lorax
Compliance COO Michelle Carvell urged
the pharmaceutical industry to prioritize
its environmental reporting obligations for
packaging or risk high financial penalties
Environmental Reporting Gains Priority for Pharmaceutical Industry
The Lorax Compliance COO addressed the issue Feb. 6 at Pharmapack, saying
that businesses in this sector may not be aware of the full extent of environmen-
tal Extended Producer Responsibility (EPR) legislation and the changes that will
be implemented from the E.U.’s Circular Economy package.
“The pharmaceutical industry has many regulatory hoops to jump through,
so it’s perhaps understandable that environmental reporting has been as less
of a priority,” said Carvell. “Nevertheless, many pharmaceutical companies are
highly globalized and export and import into numerous markets. As more E.U.
countries focus on improving their packaging collection, sorting and separat-
ing capabilities, this industry, like many others, will need to prepare for these
changes and consider how they will impact their operations.”
Carvell explained the recent legislation changes in both the E.U. and international-
ly, including Germany’s VerpackG scheme, which requires businesses to register to a
dual reporting system, and carries a maximum fine of €200,000 for non-compliance.
“The industry should expect further reforms over the next two years in line with
the E.U.’s 2018 Circular Economy package,” she said. “Planning for these changes is
not something to leave until the last minute. The VerpackG scheme, for example,
caught many businesses unawares when it was implemented January 1, 2019. A
number of other EPR programs are changing and if businesses that are unable to
source the necessary data they will automatically be subject to higher default fees.”
Case Study: The Emotional Side of
Pediatric Infusion
At Pharmapack 2019, a human factors study highlighted anxiety and
other delivery issues, offering insights into the real-world challenges of
managing pediatric drug delivery.
By Keren Sookne, Director of Editorial Content
 Case Study: The Emotional Side of Pediatric Infusion

The study of human factors in healthcare is a rapidly evolv-

ing space. The focus is shifting from summative studies (to
prove what’s been developed) to formative studies earlier in
the development. These formative studies that can help de-
velopers understand user context, extend user understanding
and illuminate challenges in the user’s treatment experience.
In a case study presented at Pharmapack 2019, Chris Franz-
ese, Lead Clinical Analyst at Matchstick, and Adam Kalber-
matten, Director of Marketing at Terumo Pharmaceutical
Solutions, shared some of the observed real-world challeng-
es of managing pediatric drug delivery.
“When you’re thinking about new products to develop,
pre-formative studies help manufacturers understand users
and the context in which the products are used,” said Kalber-
Chris Franzese, Clinical Leader at Matchstick, manages a team of clinicians
matten, whose company makes infusion sets that are combined supporting client projects related to combination product and medical device
with hemophilia medication from a separate manufacturer. development and usability testing.

Hemophilia affects many children, typically males more

often than females. If the disease state is severe, the patient
may need infusions several times a week (either from a par-
ent or from themselves, depending on age). “It can be quite a
heavy disease burden,” he noted.
Terumo partnered with Matchstick to study patient and
caregiver experiences. Though they didn’t begin with a set
idea of how they would segment the study, they observed
clear trends between the adults using the products on them-
selves and pediatric patients.
Patient age makes a difference
By time the time a person with hemophilia reaches adult-
hood, infusion is typically a part of life—finding veins, re-
constituting medication. Kalbermatten explained, “They are
like pharmacy techs how fluidly they perform the infusion.
These patients consider this a part of their routine.”
The study with Matchstick involved filming the patients during
drug delivery. One patient was clear in his message that he is not
fragile, and that when he infuses, it makes him 100% normal.

But that sense of confidence and control does not neces-
sarily carry over to pediatric patients and the parents who
perform the infusions. The pediatric study was narrowed
to children under 12 years of age, and yielded some unique
challenges.
The emotional toll
Parents who must infuse reported much anxiety and dis-
tress. Kalbermatten said, “Infusion is one of the largest chal-
Adam Kalbermatten, Global Director of Marketing at Terumo, address the crowd
at PharmaPack 2019.
Case Study: The Emotional Side of Pediatric Infusion, continued
lenges, and the skill that comes along with it… there’s an
emotional component to delivery.”
One parent remarked that their sadness comes from twice
weekly infusion, including her child’s reaction to the needle
poke. Though the infusions are “only twice a week,” they ex-
plained that their child’s bad days are really bad.
Parents may experience a range of negative emotions in-
cluding a fear of infusing, concerns over finding a vein and
causing their child pain. “These emotions turn into barriers
and translate into real adherence issues,” he noted.
Home storage becomes troublesome
A family home is not central supply at a hospital. Homes
are typically not equipped to handle large volumes of medi-
cal supplies. “There is a lot of clutter from the drug itself and
any supplies associated such as vials, adaptors, tourniquets,
gloves and sterile drapes,” said Franzese. It can be tough to
organize and can even take up an entire kitchen cabinet,
which also add to the burden.
Another parent in the study had a child who required port
management, so a wide variety of supplies had to be kept
at home. There were many plastic bags from the supplies,
and she repurposed the bags into “grab and go” kits. Franz-
ese noted that one reason was for the convenience, but the
parent also felt it was entirely wasteful to see all the bags go
in the trash.

Observing the process
Preparation for infusion requires multiple items and steps,
and that means many points for contamination. After film-
ing parents infuse their children, the team discovered many
real-world issues—and differences between actions and what
they say they do—that could potentially be addressed with
packaging advancements such as:
• Juggling supplies to keep them off the surface.
• Taking a phone out mid-preparation to scan the bottle
for an app, introducing an opportunity for bacteria from
the phone to hands.
• In one parent’s case, priming the system with saline solu-
tion first, so that if something went wrong, they would
only waste saline and not the drug itself. “Even the ex-
pert hadn’t seen that before,” said Franzese.
One child expressed that he feels scared of the process, and
prefers a routine in which all family members sit in the room
during the infusion at home. In the video, the father stepped
Case Study: The Emotional Side of Pediatric Infusion, continued
in and pressed the bandage post-infusion while the mother’s
hands were full of supplies. Did the father wash his hands?
What if that third hand is unavailable while the primary care-
giver deals with removal and disposal?
The team also noted that disposal can be tricky. There are
tools available, but patients and caregivers don’t always have
the right one at home. They may have an insulin sharps con-
tainer that does the job but is not ideal.
The question Franzese posited is whether there is anything
drug and device manufacturers can do to help parents pre-
pare and infuse, and reduce possible contamination. Addi-
tionally, what can be done to reduce anxiety for the child?
Ultimately, the study offered insights into users—the dos-
ing environment, the emotional state and emotional needs
of the patient and caregiver—that can be shared with drug
manufacturers and supplier stakeholders to help inform fu-
ture device and packaging decisions.
Should My Device Be Connected?
Live from Pharmapack Europe, a device design consultant shared an approach for
deciding on connectivity and packaging upgrades, along with the real question you
should be asking yourself when making the call.
By Keren Sookne, Director of Editorial Content

Patients and consumers are rightfully worried about
what happens to their data once it’s in a company’s hands.
From major phone glitches to a smart thermometer com-
pany selling data to sterile wipe manufacturers, there’s a
lot of uncertainty that comes with the territory of using
any smart device.
At Pharmapack 2019, Alex Driver, Senior Consultant at UK-
Based design and development firm Team Consulting, said
that despite the concerns, people still use phones and other
connected devices daily because (obviously) there’s a value
that far exceeds the perceived cons.
The barriers to going connected with medical devices in-
clude negative attitudes toward sharing data, technical com-
plexity and potential wastefulness.
But for many devices, there may be enough pros to forge on
with connecting. These opportunities include:
• Improving patient competence
• Helping patient engagement
• Communicating therapy benefits
• Adherence support
• Disease self-management
• Differentiating among competition
• Building confidence in clinical trial results
• Learning about patient behavior
Driver was very clear in his message: “To connect or
not to connect” isn’t the right question. Drug and device
Should My Device Be Connected?
Be selective about what you communicate to the user. For example, an Apple
watch offers a very pared down view of activity for the day for a convenient user
experience.
manufacturers should really be asking themselves, “What
problem am I trying to solve?”
There has to be value (such as the opportunities listed
above) that meet patient, healthcare provider, payer and reg-
ulatory needs.
He discussed a potential approach for deciding to go con-
nected. There are three categories of solutions:
• Dumb: Everything is unconnected. The patient deals with
their doctor through face-to-face interactions, email or text.
• Smart: The device may prompt the user, but data re-
mains on the device, visible only to the user.
• Connected: Data is shared with the cloud either contin-
uously or by intermittent download. Data is available to
those with permission.

For Team Consulting, the company gathers a multi-disci-
plinary team and works through a matrix with opportunities
across the top and categories of devices on the Y-axis. They
populate the matrix, noting how each type of device could
meet the benefit.
To bolster patient adherence for example, a dumb device
may receive a packaging redesign so that the package steps
the user through the package. A smart device may prompt
the user through the use of an LCD screen, while a connect-
ed device could share data with the healthcare provider so
that the user is prompted with an email or phone call.
For each part of the matrix, they ask how well a solution meets
the particular stakeholder need, noting risks or technology con-
straints. They ask if the outcome could be achieved with a dumb
solution. Ultimately, the best answer may be a suite of solutions
and not one single design update or choice to connect.
Connecting an existing device
More often than not, Driver said you’ll be modifying an
existing device. If this is the case, try not to impact de-
vice functionality to avoid the need to reverify and reval-
idate. For example, if you put something in an inhaler’s
air path to sense inhalation, it might inhibit the air flow.
You could place a microphone on the outside of the de-
vice to listen for a change in tone, maintaining the air
path as it was validated.
Should My Device Be Connected? continued
How do you integrate connectivity? You may be able cre-
ate a sleeve for the device so that existing devices (and
manufacturing lines) remain as is. The benefit is that a
sleeve is reusable and cuts down on the cost of treatment,
but you are relying on the user to add it on. You have to
ask yourself what the user is getting in return for that add-
ed step. Value-added functions for the patient may include
easy communication with phone/app for convenience or
smart reordering.
You may also consider a bolt-on in the manufacturing
process, removing a piece of casing. In this case, you are
not asking the user to perform the extra step, but every
time they throw out the device, they throw out the elec-
tronics with it.
Be selective about what you communicate to the user. For example, an Apple
watch offers a very pared down view of activity for the day for a convenient user
experience.

If the connectivity is fully Integrated (i.e. you change the
moldings), the risk is that you likely have to revalidate your
product and production line.
Driver offered attendees several other tips including:
• Create a quick and dirty prototype, the earlier the better.
Companies such as Nordic Semiconductors, Texas In-
struments and Diolan make development boards which
can be used for quick prototyping.
• When testing early, get feedback from a set of stakehold-
ers (not only the users).
• Deciding what to sense is really key—more data means more
storage space, a greater power budget and greater cost.
• Be selective about what you communicate to the user. For
example, an Apple watch offers a very pared down view of
activity for the day. There’s a lot of data in the background,
but the user is seeing a simple and appealing set of three
colorful circles and trying to close the gap (see image).
• Don’t overlook voice control. This feature is quite prev-
Should My Device Be Connected? continued
alent in the consumer electronics industry for good rea-
son. As Driver noted, “There’s quite a lot of opportunity
there. You don’t have to interact with a user interface.
You ask a question more or less when you think of it, so
this may reduce cognitive load for the user.”
• Right now, voice commands are mostly about making a
request. But the industry may be moving toward systems
providing the user with prompts.
• A successful app or device will likely strike a balance of
functionality and utility (not just novelty), and will not
make the user do things they don’t want to do.
Key takeaway
The human factor cannot be overlooked. If the user is los-
ing privacy to use a connected device, they need some oth-
er benefit to motivate them to engage with the system. “And
feeling better might not be enough,” Driver said. “We have to
shift patient behavior with good design.”
New Pharmapack Awards Include
Patient-Centric and Eco Designs
Phillips-Medisize, Stevanato, Schott AG, Aptar Pharma, Stiplastics and Huhtamaki
were awarded in the Exhibitor Innovation Category while Pierre Fabre Cosmetic, UCB
Pharma and Vemedia were awarded in the Health Products Category.
By Keren Sookne, Director of Editorial Content
 New Pharmapack Awards Include Patient-Centric and Eco Designs

Each year, innovative companies submit new packaging and drug delivery
designs for Pharmapack Award consideration. The awards recognize new
products set to shape the future of the industry. As Pharmapack Brand Director
Silvia Forroova explained, the committee only considers developments that
emerged since the previous year’s conference, ensuring that the awards
highlight the latest in packaging advances.
New in 2019,the Health Product Category has 2 special recognitions:
• Patient-Centric Design Award in Partnership with HCPC Europe
• Eco-Design Award in Partnership with Adelphe

Here are the 2019 Winners:
“Excilor 2-in-1 Wart Treatment” by Medical
Brands, co-developer: Vemedia
Patient-Centric Design Award
The Excilor 2-in-1 Wart Treatment is an
innovation in the OTC wart treatment mar-
ket, combining two best-in-class technolo-
gies into a single device.
Wart sufferers today are limited to either
cryo or acid treatment options with limit-
ed efficacy and long treatment schedules.
The single device is the first product bring-
ing both cryo and acid therapies together
providing faster treatment time and fewer
applications.
New Pharmapack Awards Include Patient-Centric and Eco Designs, continued
“Steril Cosmetic” by RPC BRAMLAGE, co-devel-
oper: Pierre Fabre Cosmetic
Eco-Design Award
This pump integrates a one-way valve, at
the tip of the actuator, which is opening and
closing in function of the pressure reached
in the dosing chamber during the actuation.
The pump is 100% plastic and it is 100%
recyclable. The Airfree technology allows
to integrate PCR material in the external
layer of the bottle because it is not in con-
tact with the formula.
This pump is a world premiere regarding
dispensing of sterile cosmetic, it is the prod-
uct of six years research and development,
covered by six patents. Everything is made in
France in Oyonnax.
“Cimzia 200mg/Vial Lyophilized Powder Pack”
by UCB PHARMA, co-devoloper: RONDO
Eco-Design Award
The package combines eco-friendliness,
compliance to dose regimen and user safe-
ty. With some 12 improved or new features
added to the package, the move towards this
improved secondary packaging solution is fit-
ting with the UCB strategy that aims to render
UCB operations carbon neutral by 2030.
The package incorporates new and inno-
vative packaging features that shift the para-
digm of pharmaceutical packaging based on
actionable insights collected – most of them
focusing on package size, recyclability, sus-
tainability, and waste reduction. Some in-
sights collected were covering nurse safety
and compliance aspects, as well.
 New Pharmapack Awards Include Patient-Centric and Eco Designs, continued

Exhibitor Category

Best Innovation in Drug Delivery Device

The third-generation Connected Health Platform (CHP) from Phillips-Medisize, a Molex company,
helps pharmaceutical companies and drug delivery device developers reduce risk, cost and time to
market with leading innovation and technology accelerators. This cloud-based platform provides a
safe, scalable and trusted medical device data system (MDDS) built on technology from the world
leader in health data interoperability. It encompasses extensive information-sharing, analytics ca-

Connected Health Platform by Phillips-Medisize pabilities, robust cybersecurity and streamlined regulatory documentation.
Its advanced analytics package is designed for connected drug delivery devices, biosensors
and regulated Mobile Medical Applications (SaMD/MMA). Ultimately, connected health solu-
tions may help patients improve medication adherence and manage chronic conditions.

Best Innovation in Drug Delivery Device

The cartridge-based wearable is an easy, discreet, effortless device for adjustable regi-
mens, offering an alternative to traditional pen-injectors. Thanks to its innovative yet simple
technology, it ensures a painless, intuitive and quick administration of the drug.
It has been designed to be a discreet and comfortable device that makes the patient’s life
easier even in a dynamic context, including traveling or playing sports.

Cartridge-based wearable device by

Stevanato Group

Push Tab® by Huhtamaki Flexible Packaging Germany GmbH & Co.KG
Best Innovation in Solid Dosage Packaging
Push Tab® is an alternative opening for strip packaging. The Push
Tab® material for strip packs makes it easy to remove tablets simply
by applying pressure. Featuring top barrier properties and various seal
layers, the material from Huhtamaki offers the option of a child-safe
packaging solution. The barrier properties are not affected in any way
as a result of pushing through the film and guarantee the highest levels
of product safety.
Different versions and forms ensure adequate market differentia-
tion and are an interesting alternative to blister or cold-form appli-
cations. The application is PVC-free, cost-effective and suitable for
different climate zones. A recyclable version is under development.
New Pharmapack Awards Include Patient-Centric and Eco Designs, continued
IQ-DOSE by Stiplastics Healthcaring
Best Innovation in Solid Dosage Packaging
IQ-Dose (intuitive and quick-dose) is an efficient, easy-to-use
device made for dosing and counting mini-tablets. It is especially
useful during trial phases for pediatric medicine, but also for spe-
cific treatments such as Parkinson’s disease, oncology treatment,
psychiatrics and more. This new solid form of pellet allows the ad-
ministration of tiny doses, exactly adjusted to a patient’s needs; the
disadvantage, however, is that the small size of the pills make them
difficult to count.
The IQ-Dose is a new solution for overcoming these difficulties.
Hygienic and accurate, the device allows the selection of the exact
quantity of mini-tablets prescribed, from one to 24, in one go, without
the need for any contact with the hands.

syriQ BioPure® by Schott AG
Best Innovation in Packaging Material & Component
SCHOTT’s new syriQ BioPure® prefillable glass syringes were de-
signed specifically for the biologics market, keeping sensitive drugs
stable, easing administration and shortening time to market. Im-
proved drug stability is reached through enhanced manufacturing
processes, which lead to ultra low tungsten level and low adhesive
residuals resulting in reduced risk of potential interactions with oth-
er materials.
Additionally, a homogeneous silicone layer ensures a consistent glid-
ing performance, which is essential to ease administration for the pa-
tient. Functionality is achieved through tighter dimensional tolerances
and a verified compatibility with safety devices. The syringes are made
of FIOLAX® borosilicate glass and are available in more than 48 pre-val-
idated configurations.
New Pharmapack Awards Include Patient-Centric and Eco Designs, continued
QuickStart™ Injectables by Aptar Pharma
Best Innovation in Packaging Material & Component
Aptar Pharma QuickStart™ is an innovative way to deliver inject-
able development solutions to pharmaceutical customers, demon-
strably accelerating bench-to-market time. Designed specifically
for R&D labs, biotech companies, start-ups and universities, Quick-
Start™ provides everything needed for the small volume filling of
high-value formulations.
QuickStart™ combines best-in-class components from Aptar Phar-
ma, Schott and EMA, enabling innovators to benefit from multiple
configurations shipped from a single source, and available to order
through a convenient e-commerce portal. These components satisfy
all regulatory requirements, allowing developers to access commer-
cial scale quality at development stage costs, meaning performance
at project outset can be maintained at scale up.