The global delivery of healthcare is more focused on medical outcomes, delivering results for patients and tying industry profits to these factors. This fundamental change to the industry's structure is happening slowly and at different rates worldwide, with the case for change being strong and compelling as population growth, higher incomes and an uptick in lifestyle-related health conditions increase the demand for access to healthcare. Technological advances also continue to support targeted disease and associated-therapy identification, including large-molecule therapies such as biologics.
"The biopharmaceutical industry has seen a significant increase in the production of large-molecule drugs like biologics. In ten years, this market will be as large as the self-administered insulin market is today," says Bill Welch, chief technology officer at Phillips-Medisize.
The transition to outcome-based care needs a strong device strategy, in order to create a delivery system that is suited to specific patients and drug formulations. Uncovering the risks and opportunities in delivery innovation is essential, as are creating a development path and device roadmap that covers everything from clinical trials to market approval and post-approval enhancements. A comprehensive device strategy balances the biopharmaceutical company's need for innovation and cost-effective drug delivery systems with the total disease management requirements that are associated with outcome-based healthcare. From a development standpoint, the presence of a strategy drives the direction of concept feasibility through to production, addressing the fact that 'me-too' devices do not create differentiation or add value.
Large-molecule biologics present several challenges for the biopharmaceutical industry, especially for patient deliveries that often take the form of self-administered injections. The viscous solution often requires special care to ensure proper dosing, and a more challenging dose administration leads to lower dosing adherence rates and reduced patient outcomes. In an effort to improve dosing adherence and therapeutic outcomes, biopharmaceutical companies are focusing on drug delivery devices, including connected systems that facilitate information sharing between patients and caregivers. For injection systems, this information may take the form of injection speed, dose volume, and the date and time of delivery. Connected drug delivery systems allow patients and caregivers to have a 360° view of the patient and the disease to manage adherence and improve outcomes by understanding the effects of the regimen.
Development programmes that gain market acceptance frequently implement a device strategy that drives the creation of connected systems and devices that are manufacturable. For example, integrating design for manufacturability (DFM) and design for assembly (DFA) activities ensures that the device concept will achieve the quality, cost and risk targets outlined in the device strategy. This, therefore, produces a cohesive development plan and manufacturing strategy throughout the process.
Phillips-Medisize recently acquired Medicom, which expanded its European footprint, device strategy and connected health capabilities. "We partner with large and small clients to help them uncover innovative approaches and develop a solid device strategy for the molecule that is focused on the patient and improved management of the disease," states Medicom CEO Morten Nielsen.
Partnerships facilitate smooth transitions by reducing time, cost, regulatory burdens and market risks; however, a disjointed approach marginalises development, introduces lurking risks, isolates strategic design decisions and negatively impacts downstream activities. Furthermore, if DFM and DFA are introduced at the end of the design phase, manufacturing strategy no longer aligns with the device strategy, which introduces late-stage changes that threaten stakeholder requirements and programme feasibility. Biopharmaceutical partnerships must understand the value of device strategy and commit to connecting early strategic efforts with intended solutions. While design development and user considerations are important, they remain part of the value proposition that is delivered once a device strategy has been implemented, giving rise to beneficial-biopharmaceutical partnerships that are based on innovation.