The evolution of patient-centered healthcare has paved the way for drug-device combination (DDC) products, a transformative convergence of therapeutics and technology. By integrating large or small molecule drugs with medical devices, these innovations promise streamlined treatments, enhanced patient compliance, and improved therapeutic outcomes. The growing prevalence of chronic and life-threatening conditions such as cancer, diabetes, and heart disease, among others is propelling advancements in the DDC market, underscoring their potential to revolutionize care.
However, the journey from development to commercial success is fraught with challenges that demand strategic foresight. Addressing human factors, implementing robust design controls, and ensuring rigorous quality standards are essential for transforming promising concepts into viable products.
The Role of Human Factors in Design
Human factors engineering (HFE) lies at the heart of DDC development. By analyzing how patients and caregivers interact with the product, manufacturers can optimize usability, reduce errors, and enhance safety. Early and iterative usability testing, coupled with feedback from diverse patient populations, allows companies to refine packaging, labeling, and device functionality. This user-centric approach not only fulfils regulatory requirements but also fosters adherence and improves outcomes.
HFE and usability studies should be embedded early in the design process. By integrating exploratory and formative studies during the investigational new drug (IND) application phase, followed by progressive studies to culminate in Summative studies and Validation, companies can streamline regulatory submissions. Collaborative dialogue with agencies like the FDA ensures a smoother path to approval and commercialization.
Challenges in Design Control and Development
The successful integration of a drug and a device requires meticulous design control to address the unique challenges posed by combination products. The compatibility of the drug product and the device, as well as the potential impact on the product’s stability and performance, must be thoroughly assessed during the development phase.
Whether managed internally at the biopharmaceutical company or through a preferred partnering Contract Development and Manufacturing Organization (CDMO), it is imperative that multi-disciplinary teams collaborate across drug product development and packaging design to ensure compatibility.
Manufacturing Excellence and Supply Chain Resilience
Ensuring consistent quality requires adherence to stringent good manufacturing practices (GMP). This adherence is crucial for ensuring the reproducibility and reliability of the products, and involves implementing rigorous quality control measures at every stage of production, starting from raw material sourcing and sterile filling of the drug product into primary containers, to the final assembly, labeling, testing and packaging of the drug-device combination product. Validation of scalable manufacturing processes is crucial to maintain product reliability throughout its lifecycle from clinical trials to commercial market supply.
The complexity of DDCs also necessitates robust supply chains. Companies must establish strong relationships with suppliers and partnering CDMOs, implement risk mitigation strategies, and develop contingency plans to address potential disruptions. This is especially important given the interconnected nature of the drug and device components, each with distinct manufacturing and sourcing considerations.
Strategic Device Selection
Typically in preparation for phase IIb clinical trials, biopharmaceutical companies seek to make decisions on the therapy’s drug-device strategy. Decisions about the delivery device—whether a prefilled syringe, autoinjector, or safety-enhanced system—should align with the target product profile and patient needs. Decisions should be made if there is a unique need for device innovation for specific patient populations or if traditional, readily available platforms would be suitable. Selecting established platforms that have already received regulatory approval, may be deemed lower risk for a new program and may provide greater speed to market, providing a first to market advantage. Companies must also navigate the intellectual property landscape to ensure freedom to operate when pursuing device innovation.
It is noteworthy that biopharma companies may opt to progress several DDC forms for the same product, depending on factors such as reimbursement models, strength and user populations, in-home vs. institutional administration, geographic considerations, etc. As an example, companies may look to commercialize both in Autoinjector as well as Prefilled Syringe with Needle Safety Device. This may also be considered as a risk mitigation strategy for commercial filing as well.
Conclusion
DDCs represent the future of personalized medicine, offering safer and more effective treatments. By prioritizing human-centric design, meticulous development, and building robust supply chains, companies can overcome challenges and bring transformative therapies to patients worldwide.
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