By Melissa Fassbender, Associate Editor, MDT
More than 235 million people world- wide suffer from asthma, according to the World Health Organization.
So when Italian pharmaceutical company,
Chiesi Farmaceutici, developed a new medicine in the form of a powder, they turned to
product development firm Cambridge Consultants ( www.cambridgeconsultants.com) for a
revolutionary inhaler design. The result of the
collaboration is the NEXThaler, an innovative
dry powder inhaler with an intuitive design.
“Our brief from Chiesi Farmaceutici was
The NEXThaler: A New
Type of Inhaler
The Project: A pharmaceutical company that developed a new powder asthma medication
needed a delivery device.
The Solution: A product development firm handled all aspects of the development of an inhaler device
with an intuitive design.
to design an intuitive and simple to use
inhaler. We started with a blank sheet of paper, and worked our way through a number
of different concepts,” explains Matthew
Allen, drug delivery program director for
Through brainstorming, they came up
with different ideas on how to achieve their
objective; however, the primary focus was to
keep the device simple and easy to use.
Designing for Simplicity
“There were many stages of development,”
explains Allen. The first stages of the design
process included conversations and sketches
on whiteboards. Next, the team began mold-
ing foam prototypes for handling. “We used
engineering foam that was hand formed
with a scalpel, so we could have a physical
model to demonstrate size and shape of
Using such prototyping tools allowed the
designers to iterate models more quickly,
and to get physical designs into the hands of
users for feedback. “As the concepts became
more refined, we held early stage user studies
using ‘looks like’ prototypes manufactured by
stereolithography,” he adds. These proof of
principle models were used to further test the
functionality of the device.
The NEXThaler was then modeled in 3D
using both ProENGINEER and Solid Works
CAD packages. Ansys Fluent computational
fluid dynamics modeling software was used
to design the aerosolization engine and air
paths, and some finite element analysis mod-
ules packaged with 3D CAD, were carried
out in the early days to assist in designing the
flexible features of the device. Finally, Cam-
bridge Consultants used a bespoke software
tool for statistical tolerance analysis. “These
manufacturing techniques offer efficiency and
fast turnaround which is useful during the
development phase of a device,” says Allen.
The device comprises functional groups
of components coupled together. The dosing
mechanisms meter the drug from a reservoir
and the counting mechanisms include the
breath-actuated mechanism that activates
the dosing group under a certain air flow,
allowing the dose to be taken, and the dose
counter to decrement only after an effective
release of the therapeutic dose.
In the final stages of the design process,
the team built two cavity injection mold tools
and used the parts to verify the design. “In
order to scale up the design to commercial
level, further tools were built, including soft
tools, to both explore the design space, investigate potential design improvements for scale
up, and to build devices for development of
the assembly process,” Allen adds.
Designing for simplicity—using the
NEXThaler is easy. “All you have to do is
open it, inhale through it, and then close it;
there is nothing else the patient has to do.”
There is no active aerosolisation engine;
instead, the aerosolization is produced by the
patient breathing—a primary design challenge
according to Allen.
There is a reservoir inside the device that
houses the medicine and every time a patient
opens the cover and breathes through it,
the right dose of the powder formulation is
dispensed. To sense the user’s breath, the
device is equipped with a small vane that
moves when the patient breathes, triggering
the dispensing mechanisms.
When Italian pharmaceutical company, Chiesi Farmaceu-
tici, developed a new medicine in the form of a powder,
they turned to product development firm Cambridge
Consultants for a revolutionary inhaler design.