Cell biology is more important than biomechanics or engineering design. This principle is the basis of intelligent design, which in this case refers to the idea that scientists must take the time and effort to understand the interlacing of man-made materials and natural human cell biology at the point of design.
For centuries man has approached the human body form from an engineering perspective, believing that a “parts replacement” mentality would serve our biomechanical needs with little significance—never considering the biocellular consequences of foreign material in vivo. It is only since the Industrial Revolution that modern surgery has attempted to rebuild the biophysical structure of man with advanced materials. Early in this attempt the lack of understanding of bioactivity and the interlacing of the biomechanical requirements of organ systems overlooked the critical interplay between tissue and material interfaces with the so-called biomaterials of construction and cellular biology.
We have since discovered that our understanding of human tissues science, once thought to play only a passive by-stander role in implant success, is now the driving force of bioengineering technology. What was once thought to be acute medical implant progress has, over time, demonstrated chronic problems. One only has to peruse FDA medical device recall rolls over the last decade and recognize that many failures are material failures. Some of this is not completely the fault of clever design, but rather the fault of not considering the chronic consequence of introducing a foreign (manmade) material into that 6 million-year-old milieu of cellular biology processes where the adaptive immune response does not shut down.
|Learn more about the Future of Biomaterials during the Medtech Polymers Day at MD&M East, June 20 in Philadelphia|
Consequently, the goal of today’s medical implant technology should be the adoption of intelligent design, an upfront understanding of the material consequences on bioactivity early in the design phase of a device. This understanding must be made through the scope of cell biology, mechanobiology, biophysics, biochemistry and biotechnology with the objective of achieving true biocompatibility and the essence of true regenerative medicine. How do we promote the need to alert bioengineers and implant device designers to develop a more critical appreciation of cell and tissue biology?
Companies can no longer underestimate the importance of having experts in cell biology on staff. A biotechnology should play an equal role in design in-put, ensuring that there is an integration of the consequences of the adaptive immune system to the homeostatic marriage of synthetic material and human cellular biology.
Peter D. Gabriele is vice president, Emerging Technology for Secant Medical. Prior to Secant Medical, Gabriele was technical director at ARmark Authentication Technologies, LLC, where he cofounded the corporate division and medical fiber platform technology. Before that, Gabriele was technical director and R&D fellow at Adhesives Research, Inc. Gabriele has a Bachelor’s in biology-chemistry and a Master of Science degree in biochemistry from University of Hartford. He also holds Master of Science degrees from the University of Pennsylvania (PENN Engineering and The Wharton School of Business) and Johns Hopkins University (biotechnology). Gabriele holds over 40 U.S. and foreign patents issued and pending. He has published more than 30 scientific and trade papers. He has received several awards including the Roon Foundation Award for scientific contribution to coatings technology for his work in biocide photo-oxidation and the Dahlquest Award in adhesive science for advanced surface analysis.