Phillips-Medisize and Medicom Innovation Partner argue that strategic development of a drug delivery device boosts pharmaceutical industry R&D productivity, shortening development lead times while providing enhanced value for all stakeholders.
Pharmaceutical companies face higher price pressure on better - but more highly priced - products as healthcare costs strain national economies increasingly. Phillips-Medisize's chief technology officer Bill Welch and Kevin Deane, executive vice-president at Medicom Innovation Partner, observe that strategically developed drug delivery devices will drive improve patient outcomes, creating more value for the healthcare system, which in turn will improve pharmaceutical industry R&D productivity. For late-stage developments, the average yield on R&D expenditure has dropped from 10.1% in 2010 to 3.7% in 2016, as drug development costs rise.
Drugs are delivered to patients increasingly by complex devices, as opposed to traditional oral administration. As the number of internet-connected devices rises, the healthcare industry, and specifically drug delivery, will inevitably be caught up in this societal change, too, according to Welch and Deane.
Addressing productivity, Welch and Deane say pharmaceutical R&D productivity should be enhanced by focusing less on efficiency and more on effectiveness, with patients benefiting from the greater value offered by more innovative drugs and better information.
Modern drug delivery devices achieve maximum value within each individual therapy strategy, ensuring more effective treatment, potentially also reducing documentation. Medicom is proud of its approach to identify how specific delivery devices can support patients and obtain improved care results.
Welch and Deane suggest drug delivery device producers should approach the market with differentiated, rather than lower-value 'me too' solutions that simply replicate others' achievements. Only then can plans be drawn up for launch and further development of identified high-value therapies.
Strategy development should be completed within two or three months and should use existing approaches as building blocks, supported by stakeholder interviews, user research and client workshops. Rapid-prototyped delivery devices can be a useful workshop tool, as well as a means of to identifying further opportunities.
Phillips-Medisize starts each development path with a strategy stage, with market differentiation, execution and constraints-to-execution phases. The company says its approach achieves shorter lead times than conventional ones, which omit the strategy stage, plunging straight into development. The lack of a strong device strategy means the drug risks becoming a 'me too' solution; in this instance investing up front in a sound strategy generates a solid return.All development team members are involved with the entire project, saving time that would otherwise be consumed in transferring knowledge from one team member to another. Time is also saved by handling device development parallel with development of technology platforms that provide the required technology.
Welch and Deane say early planning of specific drug delivery devices for individual types of therapy "will often hold the key to unlocking greater value", creating better understanding and benefiting patients and the support they obtain from the various stakeholders - with potential spin-offs into more differentiated products. Integration of drug and device development and manufacturing is the key holistic approach and the driver towards obtaining significant improvements in R&D productivity, they conclude.
Medicom gives an injection delivery device designed for treatment of multiple sclerosis as an example of a product developed with the company's drug delivery strategy approach that maximises added values. It is a solution that improves 'event-driven' patient interaction and information sharing with healthcare professionals (HPCs) on specific MS therapy needs, to an extent that "off-the-shelf devices are simply not able to deliver".