Team's Andy Fry writes about the role that electronically-enabled drug delivery devices could play in the future of drug delivery. This article appears in Future Science's Therapeutic Delivery - http://www.future-science.com/loi/tde (volume 3, issue 7, July 2012) and is reproduced with their consent.

1. Editorial
Electronically enabled drug-delivery devices:
are they part of the future?
“Ideally, the future will see well-designed electronically enabled delivery devices and non-electronically enabled
delivery devices both entering the market and providing greater patient choice and improved compliance.”
Keywords: adherence/compliance n drug-delivery devices n electronics n self management
Since the turn of the 20th century, electronics that if electronic functionality can be added,
and pharmaceuticals have developed in it should be. But are the potential benefits
parallel and at pace (albeit at different speeds). always accessible, or indeed justifiable given the
Electronics are now omnipresent and advances implications of increased cost and ‘disruption’
in device-based drug delivery – such as inhalers involved? Or are other less complex design
and auto-injectors – are commonplace, and strategies possibly more relevant in different
while these two sectors have developed patient contexts and, therefore, potentially more
separately, electronics as an enabling technology effective? Just because we can, it does not mean
in drug delivery has been evolving quietly since that we should.
the 1980s. Various drivers, such as regulatory EEDDs first entered the market in the late
pressure on usability, healthcare economics, the 1970s, largely made possible by the invention Andy Fry
availability of low-cost components and a patient of the microprocessor. Their potential was first
Team Consulting Ltd., Abbey Barns,
appetite for greater functionality, means that recognized by those involved in the management Duxford Road Ickleton, Cambridge
electronically enabled delivery devices (EEDDs) of diabetes, leading to the development of the CB10 1SX, UK
Tel.: +44 1799 532 739
will be more important in the coming years. first commercial EEDD, the AutoSyringe AS6C E-mail: andy.fry@
The improvement of patient adherence is (DEKA R&D Corporation, NH, USA), a team-consulting.com
of significant interest to prescribers, payers, continuous subcutaneous insulin infusion pump
regulators and, ultimately, to patients. In fact it (CSII). EEDDs used in diabetes management
is fair to say that of all the drivers pushing the have increased in sophistication over the past
electronic agenda, it may be the most significant, 30 years and now offer touchscreen handsets,
and it is not difficult to see why. Poor adherence near-field communication to a portable monitor
has become a major problem for individuals, unit and much more. Even insulin pens – well
for society and for national economies. US established, mature mechanical devices – are now
surveys have shown that even patients with being offered with electronic memory features to
chronic conditions achieve an average of help users keep track of dosage time and size, both
only 50% adherence when using prescribed as built-in features (e.g., the NovoPen Echo® from
medication [1] ; nonadherence is estimated to NovoNordisk) or aftermarket devices (e.g., the
result in approximately 125,000 deaths per Timesulin™ smart cap). Diabetes management
year [2] , and cause 10% of hospital admissions has a long history, stretching back over 60 years
and 23% of nursing home admissions [3] . In and experience gained in insulin-delivery devices
terms of healthcare costs, this equates to an has been a stimulus to device evolution in other
estimated US$100 billion per year [4] and a loss therapeutic areas. The easypod® from Merck
of productivity (a direct loss to GDP) of around Serono is a ‘full featured’ electromechanically
$50 billion per year [4] . operated and electronically controlled injection
Electronics can reduce the cognitive, device. The first of its kind, the easypod was
emotional and physical burdens that launched in 2007 and is used to deliver hGH.
can compromise patient adherence, and At the simpler end of the spectrum, electronic
consequently compliance, by supporting users dose counters for inhalers have been available for
and helping them deal with factors including a number of years as an aftermarket product and
forgetfulness, incomprehension and anxiety. more recently, as an integrated feature of some
Those of the ‘iPod generation’ may consider inhalers and nasal delivery devices.
10.4155/TDE.12.57 © 2012 Future Science Ltd Therapeutic Delivery (2012) 3(7), 1–xxx ISSN 2041-5990 1

2. Editorial | Fry
It is fair to say that just a few years ago whereas younger patients may possibly be
electronic device features were largely considered happier to use an EEDD, someone older or less
complicated and challenging by many physically capable may prefer a simpler device.
pharmaceutical companies, both from a technical Lower cost therapies, especially those in single-
and a regulatory point of view. Now, electronic use disposable format, may also be less likely
enhancements have the potential to significantly EEDD candidates.
improve compliance, although ‘traditional’ When considering whether to opt for an
nonelectronic devices, with a sound design basis EEDD, stakeholders should focus first on the
in human factors engineering, can also help key fundamentals of good compliance: robust,
eliminate some of the negatives that compromise reliable and accurate drug delivery; clear device
adherence, from accommodating the full range of interaction cues and feedback; a ‘positive’
grip styles to minimizing pain or anxiety caused operating force that meets the capability of
when the device is in use. However, adherence is diverse users; and good ergonomics, making the
not all about usability. Even the best designed, device easy and safe to manipulate. However, if
most ‘user-friendly’ device still cannot address the a purely mechanical design is the most effective
‘self-management burden’ – ensuring the patient option, that is the right answer.
or caregiver remembers to administer the therapy Currently, the issues of user adherence and
correctly in the first place. self-management are key drivers in EEDD
EEDDs can help reduce this self-management design, but trends currently emerging across the
burden by building in functions, such as electronic pharmaceutical industry will certainly influence
alarms or instruction screens, designed to prevent future device development. For example,
user forgetfulness, incomprehension or fear. counterfeiting is a major issue for pharmaceutical
Wearable, ‘fit and forget’ EEDDs – for example, companies and healthcare providers, with the
the OmniPod® from Insulet Corporation – can WHO estimating that counterfeit drugs now
ensure consistent drug delivery is maintained account for 10% of worldwide pharmaceuticals
over the longer term. ‘On-board’ features can [101] . EEDDs have the potential to provide
also deliver relevant updates for users, caregivers therapy verification and traceability if they can
and healthcare practitioners on dosage times, say, incorporate similar technologies to those used by
or dosage patterns. the finance sector to ensure the security of banking
transactions. In my opinion, EEDDs could
“Even the best designed, most ‘user-friendly’ potentially strike a serious blow at counterfeiters,
device still cannot address the ‘self-management prompting the incorporation of more anti-
burden’ – ensuring the patient or caregiver counterfeiting features in future devices.
remembers to administer the therapy correctly Another issue is how to accommodate the
needs of the sustainability agenda and the
in the first place.”
growing raft of legislation related to disposal,
EEDDs can prove their worth when used recycling and the management of hazardous
to deliver therapies required regularly but waste. For any battery-powered device, end-of-
infrequently (again, often high-value biologics life device disposal is an issue that needs to be
such as treatments for rheumatoid arthritis). In properly addressed, especially if longer term goals
such contexts, patients do not gain sufficient include more single‑use, disposable EEDDs.
skills from repeated device use to ensure the One solution is to design reusable EEDDs; one
procedure remains consistent and compliance is example from SwissMedDev Sàrl (Switzerland)
achieved. An EEDD could provide the support is a reusable autoinjector that accepts prefilled
and feedback required to ensure the user remains syringes and automates the entire injection
confident when using the device. operation. Another solution is to retain only
The US FDA, previously very cautious the most basic electronic functionality in the
regarding EEDDs, is now prepared to consider disposable device, perhaps in the form of an
supporting their use when it can be shown that radiofrequency identification tag, while the more
they can significantly improve compliance, sophisticated support, control and monitoring
giving a significant boost to future investment systems are stored elsewhere, possibly within
in this area. However, there clearly remains a an application running on a mobile device or
place for non-EEDD products. smartphone. Passive, near-field communication
‘Traditional’, non-electronic devices will be the is a well-proven technology, used in applications
positive choice for certain patient populations; ranging from cattle tags to transport payment
2 Therapeutic Delivery (2012) 3(7) future science group

3. Electronically enabled drug-delivery devices: are they part of the future? | Editorial
cards and even ‘smart’ trainers. If used within should help patients comply with their therapy
an EEDD, patients could use a smartphone and thereby manage their condition. Only those
to check device authenticity, provide dosage features and attributes that contribute towards
alerts, log dosage records and check when a dose an intuitive and reassuring device, designed for
is complete. When the delivery device itself ease-of-use and minimal risk of error, should
is thrown away, valuable data and support is be part of any design remit. As a result, the
retained within the smartphone, making device best solution may not always be an EEDD.
disposal much simpler and more sustainable, and Technology can certainly encourage compliance,
reducing the cost of goods. but not all patients and caregivers will engage
successfully with technology. Ideally, the future
“Only those features and attributes that will see well-designed EEDDs and non-EEDDs
contribute towards an intuitive and reassuring both entering the market and provide a greater
device, designed for ease-of-use and minimal patient choice and improved compliance.
risk of error, should be part of any design remit.
Financial & competing interests disclosure
As a result, the best solution may not always be
The author is employed by Team Consulting Ltd. The
an electronically enabled delivery device.”
author has no other relevant affiliations or financial
It seems likely that EEDDs will exert a involvement with any organization or entity with a finan-
growing influence on drug delivery as our cial interest in or financial conflict with the subject matter
body of experience grows, and technology or materials discussed in the manuscript apart from those
advances and patient expectations evolve. But disclosed.
the fundamental objective – and the essence No writing assistance was utilized in the production of
of regulatory guidelines – is that every device this manuscript.
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CD000011 (2002). 4 Peterson AM, Takiya L, Finley R. Meta- drugs-counterfeits-
analysis of trials of interventions to improve idUSBRE82B00120120312
2 Burrell CD, Levy RA. Therapeutic
medication adherence. Am. J. Health Syst.
consequences of noncompliance. Improving
Pharm. 60(7), 657–665, (2003).
medication compliance. Proceedings of a
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Washington, DC, USA, 7–16 (1984).
future science group www.future-science.com 3