Regenerative engineered therapies rely on live cells and/or biologically active scaffolds, creating inherent challenges associated with variability and consistency in source and final products. Each patient, donor, and product application is unique, making the development of new products and therapies that are safe and effective complex. To further understand the factors that contribute to successful regenerative engineering products, the Forum on Regenerative Medicine hosted a workshop exploring factors and sources of variability in the development and clinical application of regenerative engineering products, characteristics of high-quality products, and how different clinical needs, models, and contexts can inform product development.