A new industry book published by Springer makes the case that understanding patients as whole people, not just end users, is foundational to biopharmaceutical product development. Bold Insight Managing Partner Gavin Lew contributed to the volume, Patient-Focused Development of Biopharmaceutical Products, part of the AAPS Advances in the Pharmaceutical Sciences Series. The book draws on expertise from across the pharmaceutical, medical device, and human factors fields to address how patient needs should drive every stage of development.

Lew co-authored Chapter 2: The user’s ecosystem alongside Paul Blowers of AbbVie. The chapter draws on Bold Insight’s extensive experience conducting ethnographic and human factors research across therapeutic and drug delivery systems. It explores the complex, real-world environments in which patients manage their diseases, from interactions with health-care providers and pharmacists to the role of caregivers, digital tools, and global contexts. Using detailed patient vignettes, the chapter illustrates how understanding a patient’s full ecosystem is essential to designing therapies that support safe, effective, and sustainable use.

“A therapy doesn’t get used in a lab. It gets used at 7am before work, or by someone managing three other conditions, or by a caregiver who’s exhausted,” said Lew. “The patient experience is an ecosystem at play. If you don’t understand this world, then how can you design for it? This book makes a compelling case that patient centricity isn’t a box to check; it’s the foundation of everything. And the ecosystem can be designed.”

The book is structured as a unified story, tracing the full arc of biopharmaceutical product development from early discovery research and user needs through regulatory expectations, commercial strategy, and a century-long case study on diabetes care. It is published as an open-access resource, making it freely available to researchers, clinicians, and industry professionals worldwide. A hardcover edition is also available for purchase. Access the full book here.

About the AAPS book series
The AAPS Advances in the Pharmaceutical Sciences Series, published in partnership with the American Association of Pharmaceutical Scientists, is designed to deliver volumes authored by opinion leaders and authorities from around the globe, addressing innovations in drug research and development, and best practice for scientists and industry professionals in the pharma and biotech industries. 

About Bold Insight
Bold Insight is a UX and human factors research agency based in Chicago and London. Executing projects that span the product development life cycle, we conduct user research that informs early product design through global human factors validation. We work with digital, next-generation technology, from medical devices to mobile apps, IFUs to customer journeys. Learn more about our work in healthcare.