Designing a Pharma Hub for Combination Products

A combination product in the pharmaceutical industry is a therapeutic or diagnostic product that combines two or more regulated components, such as drugs, medical devices, and biological products. Designing a pharmaceutical hub for combination (or companion products) requires careful consideration of various operational and technical components. By understanding the following considerations, pharmaceutical companies can create efficient and effective HUBs that support the development and commercialization of innovative new products:

• User-Centered Design: The design should prioritize ease of use, safety, and effectiveness and be intuitive and easy for a diverse user base, including HCPs, staff, patients, and caregivers. This includes understanding the end user’s needs and ensuring the interface is intuitive and accessible.
• Integration of Components: The HUB should seamlessly integrate the different components of a combination product. This includes ensuring that any software or digital interfaces work harmoniously with Centers of Excellence (COEs) or qualified sites of care. Establishing expectations and aligning with each site is essential to ensuring the proper interactions and information are provided when needed.
• Data Security and Privacy: Protecting sensitive user data is paramount in healthcare-related products. Multiple third-party interdependencies can occur throughout the patient journey, and it is necessary to create an environment where everyone knows who has access rights to sensitive user data.
• Interoperability: Ensuring the HUB can work with other platforms and devices is essential for a smooth user experience. This often involves integrating with manufacturers’ quality assurance systems and manufacturing timelines to match the patient’s scheduled therapy.
• Scalability: When redesigning a program’s current HUB platform, it is pivotal to design a system that can scale to accommodate future updates and growth without requiring a complete redesign.
• Cost and Resource Constraints: Balancing the need for high-quality design and functionality with budget and resource limitations can be difficult to buy in from senior leadership who may be accustomed to traditional HUB configurations.
• Testing and Validation: Rigorous testing and validation processes are essential to ensure the HUB functions correctly under all expected conditions.
• Post-Market Surveillance: After the product has launched, continuous monitoring and feedback collection are necessary to identify any issues that arise in real-world situations and when to make necessary adjustments.

Communication is also critical. Adjusting the patient touch points and offering multiple communication channels that meet the patients’ preferences is also helpful when designing a HUB, i.e., phone calls, emails, text messages, chat, or a patient portal. This will ensure optimal patient engagement and adherence. Effective follow-up and providing relevant resources can help keep patients engaged with their treatment plans, ensuring they understand what their course of therapy will entail, including duration of therapy, time and travel commitments, and the physical and emotional impact on the individual and their families. Lastly, regularly asking for feedback via patient and provider surveys is vital during the hypercare stage to ensure you are constantly improving.