Sadowski (Antares): First, it is important to consider the fact that the product will be used without the direct supervision of healthcare professionals.
Companies should conduct extensive background research and ethnographic studies to fully understand the patient and the likely
environment of use. The design can be established based on the findings of the investigations and the pilot device can be
tested with the patient in a variety of expected actual-use settings to confirm that the product will perform as intended.
BioPharm: The ability to offer adjustable doses, for example in diabetes, has great potential. What progress is being made in this
Kaufman (SHL Group): We see progress in the development of unique and robust mechanical designs that can accommodate the need to offer adjustable
doses. This allows for the device to remain cost effective, as some drugs do not have a market price that justifies complex
drug delivery technology. However, we do see a renewed drive to incorporate electronics into some of the more expensive devices,
which is perhaps inspired by the trend of cutting-edge designs related to smart phone and tablet innnovations.
Sadowski (Antares): Technologies that provide dose adjustability have already been developed and commercialized. Cartridge-based, multidose pens,
for example, have achieved excellent acceptance in the administration of insulin. Companies are now working on improving dose
adjustability and confirmation of correct dose by applying advanced electronics that aid ease of use and add intelligent features.
BioPharm: What are the challenges of manufacturing devices suitable for self-administration?
Kaufman (SHL Group): Main challenges include anticipating numerous device usage scenarios against which to test the device, ensuring quality consistency,
and providing robust production lines to respond to mass production needs. To address these challenges, device manufacturers
should work closely with biopharmaceutical companies to better understand end-user feedback and use it to more accurately
reflect and construct usage scenarios for device testing. In addition, device manufacturers need to continually invest in
the latest in-house capabilities and processes.
Novara (BD): In most cases, customers will want some level of customization; they rarely want off-the-shelf devices. The challenge for
manufacturers is delivering these differentiated customized devices at an affordable cost—for both the customer and the manufacturer.
Companies are utilizing modular platform technology to develop and customize devices.
The market place is also uncertain and highly dynamic. Manufacturers are business-to-business organizations selling devices
to pharma and biotech companies. If their business changes, suffers, or is impacted, so is that of the device manufacturer.
This requires methodical portfolio management and operational planning to optimize the business.
When customers choose a device partner, they make device-based decisions, but also company-based decisions. They will be looking
for factors such as a global reach and full service support, including support with global registration, and the ability to
offer a differentiated benefit.
Sadowski (Antares): The most important aspect of making devices for self-administration is ensuring that they perform as intended in the hands
of the patient. That means we need to first understand the patient. There are well-established ethnographic research methodologies
that can be used to learn about patients and the environment in which they will use medicine. However, even today, many companies
delay addressing this aspect in clinical programs. As a consequence, products have been launched in a configuration that is
clearly not well suited for self-administration. Only later, after the product fails to meet market expectations, does the
company initiate programs to address the needs of self-administration. It can be argued that keeping the configuration as
simple as possible (e.g., in a vial) reduces development risk and cost,but this must be balanced against the resulting market
risk, particularly when competitors introduce a product that better addresses self-administration challenges.
BioPharm: Needle-free devices seem to have lost some traction in the market, why might this be the case?
Kaufman (SHL Group): At this time, innovations in drug delivery devices with needles continue to move forward in addressing the growing need to
administer biologics. Autoinjectors and pen injectors have been proven to be effective, safe and reliable devices. With this
established track record, needle-based devices will continue to strengthen their position in the self-administration market.