Ahead of the PDA Europe conference in November 2011, Team's Andy Fry wrote a short article for the PDA magazine 'PDA Letter' on device usability.

1. Letter
P e o p l e • S c i e n c e • R e g u l a t i o n
Volume XLVII • Issue #9 www.pda.org/pdaletter October 2011
Personalized Medicines: The
Next Big Thing in Healthcare
18
6 Vote for 2012 Officers 12 More Development Means 34 EMA/U.S. FDA to
and Directors Less Filings with ICH Q 11 Continue Collaborations

2. of Pre-Filled
rse
Device Usability: Getting It Right from the Start
Sy
ve
ring
Uni
es
T he
Andy Fry, Team Consulting
Recently there to integrate human factors engineering burden of delivering a dose. This process
In
ice has been a from the outset and throughout prod- should also be satisfactory from the regula-
s
&
je c
ti o n D e v huge increase in uct development. At each stage of the tory point of view as you can demonstrate
interest within the process—concept generation, prototyp- that patient usability has been central to
pharmaceutical and drug ing and final embodiment—the device the development and that it has been cor-
delivery community around “human fac- must be placed in the hands of users, rectly and thoroughly assessed.
tors” (HF), or usability. Interest is not be- then they must be watched and their ac- As well as the focus on observation at the
ing driven by new regulations; instead, it tions analyzed. beginning, middle and end of develop-
is a change in the behavior of regulators. ment, the best advice is to follow the us-
It is worth highlighting at this point that
Regulators increasingly are concerned usability research is not only about sta- ability engineering process with passion
about inadequate device safety and are tistical data, the U.S. FDA places a great and creativity, which involves under-
placing greater emphasis on seeing proof deal of importance on observational standing the FDA guidance, ISO/IEC
that misuse of devices will not impact analysis that has been unpicked, chal- 62366 and ASNI/AAMI HE75:2009
patient safety. As a result, devices are documentation from cover to cover. Yes,
lenged and discussed qualitatively; after
being rejected at the point of approval they are regulatory necessity, but they
all, the causes of misuse might be down
and either require in-depth user analy- also offer exceptionally useful best prac-
to a range of factors such as the user’s
sis studies to prove their safety or, in the tice guides for integrating human factors
psychology, the design of the device or
worst case, expensive redesigns to actu- principles throughout development and
the instructions.
ally address issues. greatly increasing your chances of get-
Observing patients or caregivers using ting your therapy and device through
As far as the regulators are concerned, prototypes or the final product can pro- the regulators and into the market.
“usability” is primarily focused on user vide some invaluable insight especially
safety: The patient must be able to use About the Author
when successfully combined with ana-
the device correctly and without risk, lytical and empirical HF techniques. By Andy Fry is a member of the PDA and is the
and the company must be able to prove founder of Team Consulting Ltd, a UK-based
doing this at all stages you can adapt the
that this is the case. medical device developer. Andy will be
design and functionality of the device as speaking at the forthcoming PDA Universe
To reduce the risk of a product being re- it evolves and in the end help achieve the of Pre-filled Syringes and Injection Devices
jected by the regulator (at least on the objective of safe and appealing devices that Conference (see p. 46) on the topic of trends
basis of safety), companies should strive minimise the core physical and cognitive in parenteral drug delivery.
Personalized Medicines continued from page 22
medicine has the potential to improve folio as opposed to a major blockbuster treat disease and cure patients through the
health outcomes and bend the cost curve drug, according to an article in Bloomberg promise of highly efficacious medicines as
by making the health system more effi- Businessweek. (7)The author says, “There’s well as regenerative options. Targeted with
cient. According to a Personalized Medi- no certainty … as the markets for specific the greater goal of more effective disease
cine Coalition press release, Castellani’s drugs shrink, that drug companies will be treatment tailored to specific patient needs,
speech “emphasized the biopharmaceu- able to make up for the size of their lost this effort appears to allow better ways of
tical sector’s commitment to personal- blockbusters by developing enough new improving quality of life for patients.
ized medicine amid the complexities of products to treat the same population References
applying insights from recent discoveries their drugs previously treated.” However,
1. Miesowicz, Fred, “ApplicationNote:
in genetics and molecular biology to re- the same article states: “The hope is that
Dendritic Cell-Based Immunothera-
search and development.” increased safety and quality assurance—
peutics: An Automated Solution to
Future of Success or of Failure for Industry? and the possibility of moving drugs up Manufacturing Personalized Medi-
As more personalized medicines reach into earlier phases of treatment—could cines,” Genetic Engineering & Bio-
commercial scale, pharma companies bolster sales and help make up for nar- technology News, November 2007,
will need to find innovative ways to raise rower markets for each drug.” (7) www.genengnews.com/gen-articles/
funds, since they will be relying on a small- A paradigm shift is beginning in the world applicationnote-dendritic-cell-based-
er market of drugs in their product port- of medicines based on this better way to immunotherapeutics/2274/
continued at bottom of page 52
30 Letter • October 2011