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It's time for the pharmaceutical industry to consider electronic innovations as part of their life cycle management strategies.
Introducing a novel delivery system is a common strategy in pharmaceutical life cycle management. Manufacturers of injectables, for example, often supply drugs in low-cost mechanical devices such as prefilled syringes and autoinjectors that precisely control the amount of drug dispensed.
Today, pharmaceutical companies also have an opportunity to package their products with low-cost, disposable electronic devices. Doing so would not change formulation development. It could, however, extend the market life of pharmaceutical products and offer consumers more functionality and value. Adopting these technologies is now feasible because device capabilities are improving through miniaturization, and ultra-low cost electronic circuits. Microcontrollers, and tiny batteries that last the lifetime of the product are commercially available. Components keep getting smaller, and their power consumption is low. They also have more capabilities built into them, including reliable embedded memory that can perform user functions such as compliance monitoring.
The diagnostics industry already has incorporated microelectronics into disposable devices to make life easier for customers. For example, the disposable "Clearblue Digital" pregnancy test (Unipath, Bedford, UK) uses inexpensive electronics, optics, and display functions. Another example is the Innovo insulin delivery device (Novo Nordisk, Princeton, NJ), which contains a built-in memory that records the number of units of the patient's most recent insulin dose, how much time has elapsed since it was taken, and tracks dosage history. A digital display shows a six-second countdown feature that indicates when the entire dose has been delivered and when the needle may be withdrawn.
The clinical trial process also can benefit from the features and functions offered by incorporating electronics and associated information technology software. For example, one key issue in clinical trials is patient compliance. Obtaining good data depends on achieving a high degree of patient compliance with treatment protocols. Electronic devices can keep track of every instance in which a pill is removed out of a vial, thereby creating a record that is more reliable than self-reported data. Data could then be transmitted back to the manufacturer via the Internet and stored in data warehouses for analysis.
Electronics and memory chips facilitate data collection during long-term studies and can provide information about safety, embedded patient instructions for use, overdose protection, integrated diagnostics, and therapeutics. Advanced mechanical–electronic delivery systems can eliminate erroneous information from data sets, thus making trials more reliable and less expensive to conduct. Automatic data collection also is less invasive for patients.
Combining electronics, software, and extended service programs into an enhanced device can link customers with the pharma company long after a drug has come off patent. Although the total manufacturing cost of upgraded electronic devices for drug delivery may be higher than those of earlier passive mechanical devices, electronically enhanced devices can command a premium price and provide distinct advantages in functionality and usability. The pharma industry is well known for its research into innovative pharmacology, but I believe it is time for the industry to look beyond its boundaries and incorporate the electronics innovations common in other industries as a practical way to extend product lines with an eye to the future.
Andrew Diston is the senior vice-president and US managing director of Cambridge Consultants (Boston, MA), an international product development and design firm, firstname.lastname@example.org.