Patient by Design - A Life-cycle Concept for Medical Products
For those of us working in the medical products industry, the concept of quality by design is ubiquitous in everything we do. Quality by design (QbD) is a concept by which quality is designed into a medical device, drug or biologic, rather than being tested for in the final product. QbD experts would likely roll their eyes at my simplified description of a concept that defines all processes and procedures used to develop medical products. But, the simple idea of designing quality into the medical products we create is profound and fundamentally important for protecting public health.
It is from this perspective that I introduce Patient x Design (i.e. Patient by Design). Patient x Design is a concept by which we include patient input throughout the medical product life-cycle. Like Qbd, Patient x Design compels medical device sponsors to seek patient input at all points during medical product design, development, clinical testing, regulatory submission, post-market surveillance and beyond. There is momentum gathering around the value of patient input to medical product sponsors, regulatory agencies, and clinicians. Now is the time to create an ecosystem built around the idea that patient input is critical to medical product development and implement strategies that ensure the patient is consulted at every point along the way.
Beginning in July, I will be generating an email newsletter called Patient x Design that will focus exclusively on patient-centered policy and practices in the medical products industry. The newsletter is aimed at gathering and interpreting information related to the rapidly growing field of patient-focused policy. There are so many activities being done by a variety of organizations around the world. Patient x Design newsletter will curate these activities and distill the information in a way that is useful for industry, patient organizations, and regulatory bodies. The goal is to disseminate this concept of Patient x Design to increase awareness and uptake of policies and practices that ensure the patient is designed into all medical products, not taken for granted at the end.
If you are interested in subscribing to Patient x Design, you can sign up here. The first 100 people to input their mailing address will also get a glossy printed version of my Patient-Focused Policy Infographic. Look for the first Patient x Design newsletter July 1, 2019 and for additional content on my web site www.esc-strategic.com in the coming months.