Too often research papers that claim to be designing a better clinical treatment, in tissue engineering/ regenerative medicine, use the scientific method to prove that the new design gives a statistically significant difference in an important bioprocess; without discussing how this improvement helps meet the desired clinical performance requirements. An important clinical performance bioprocess, in tissue engineering/ regenerative medicine, is the rate of the healing/regeneration bioprocess.

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... designing treatments, in this case, the critical relationship is between design parameters and the healing/regeneration rate. Typically, before the relationship between design parameters and clinical performance can be tested, the design needs to be proven with preclinical tests in an animal model; preceded by in vitro evaluation. Part of the design process is to develop models that predict clinical performance based on preclinical performance. The whole process is iterative, since it is unlikely that achieving the selected preclinical bioprocess performance goals will initially lead to meeting the clinical performance goals. The more quantitatively the relationships are modelled in the bioprocess cascade the easier it is to make tweaks in the performance goals for a bioprocess to help meet the clinical performance goals. The goal of this paper is to help justify the importance of quantifying the relationship between design parameters and bioprocess rates (with clinical performance bioprocess rates the most important) in general and by the use of three examples: wound healing, drug delivery, and fracture fixation. For wound healing, it is important to measure the bioprocesses that make up the actual healing rate (an important clinical outcome) as well as the relationships between design changes and clinical outcome. For drug delivery, the critical part usually left out is the bioprocess of breakdown of the drug being delivered. For fracture fixation, a degradable regenerative bone plate was used as an example. In this case, in vivo bioprocesses of material degradation and tissue healing/regeneration should be characterized both separately and how they influence each other.