Translational Research: The Cornerstone for Medical Technology Advancement

Abstract

Significant improvements in quality of life and mortality have occurred over the last century due to the giant advancements in medical innovation. Medical innovation continues to move forward, and it is expanding to areas never explored before. In particular, the advancement in big data analytics is now enabling the rapid progress in the understanding of gene influence in human diseases. The progress in medical innovation achieved until today is significant; however, the potential that future technologies have to modify patterns of disease thought to be incurable is mind-boggling. In the present issue of Toxicologic Pathology, a wide variety of devices and validation platforms are presented as a clear evidence of the multidisciplinary approach that is necessary for the progress of this field. As a clinician, scientist, and medical device innovator, I am confident that this special issue dedicated to the “Pathology of Medical Devices” will be of great value to the scientific and medical device innovation community.

If at first the idea is not absurd, then there will be no hope for it.

Albert Einstein Significant improvements in quality of life and mortality have occurred over the last century due to the giant advancements in medical innovation. The history of medical innovation is enormous, and it is full of lessons of success and failure. A new revolution in medical innovation started with the introduction of biologic agents able to either prevent or treat infectious diseases. Nineteenth-century giants such as Louis Pasteur revolutionized patient care. A second wave of innovation occurred after the introduction of X-rays. Imaging enabled for the first time the evaluation and understanding of disease states as never seen before. An inflection point in medical device innovation occurred with the introduction of medical device technologies. At this point in history, the use of technologies already used in other industrial fields improved the diagnosis and treatment of complex disease conditions. Clinicians of the premodern era were just as curious and inventive as today’s and with rustic techniques and tools, they sometimes influenced the natural history of disease, albeit not always for the better. The same scientific curiosity and brewing creativity can be observed in medicine today, still motivated by improving patient health and quality of life.

The successful introduction of medical technologies into the clinical arena follows a complex and not always predictable process, and it requires a coordinated effort involving a multidisciplinary team working in good harmony and collaboratively (i.e., scientist, regulatory experts, engineers, pathologists, imaging specialists, clinicians). In today’s world, bringing a new drug to market may cost in excess of US$1.8 billion while the cost of bringing a low to moderate risk 510(k) product to market can be close to US$100 million (Morgan et al. 2011; Makower, Meer, and Dened 2010). The journey to clinical market is rarely linear, encounters many challenges, and may take anywhere from five to ten years from inception to approval. It is therefore imperative that appropriate testing and efficient clinically oriented decision-making process lead the way to avoid mistakes and waste in resources. Failures occurring early during the experimental process may halt the further development of disruptive technologies. On the other hand, failures occurring late during the developing process (sometimes at a clinical stage) lead to a massive waste of resources. Failure is an inherent risk in innovation, and a calculated failure risk analysis should always be part of the medical innovation process. Unfortunately, due to the large development costs and inherent risks, medical innovation is greatly impacted by financial drivers. In today’s environment, technology developers, and investors at large, preferentially support therapeutic areas with greater market size and regulatory predictability and a faster return on investment. In consequence, business, and not technology-related decisions, commonly stifles innovation and impacts the further development of medical innovation.

The clinical adoption of medical technologies depends on its regulatory approval, ease of use, and availability of solid biological and clinical data. Then, the development of a solid preclinical and clinical data and strategy is key and is contingent upon the understanding of the human disease process and the use of relevant and established translational models. Computer simulation is becoming an important component in the experimental process of medical technologies. However, in vivo evaluation by the use of animal models continues to play a key role and remains widely used as the best predictors of clinical safety and efficacy. Many factors come to play when selecting an appropriate animal model including anatomical, economical, and ethical considerations. For medical implants, similarities to human anatomy is key. Also, the potential to reproduce potential mechanisms of failure and healing response seen in humans is particularly important. Results from animal studies enable researchers to optimize biomaterial selection and implant design, and refine and test procedural performance. In addition, preclinical studies may contribute to the development of appropriate procedural flow and optimize implantation technique. As medical innovators, we owe a great deal of debt to our “biosimilars” (i.e., fellow mammals) and must always provide them with the best available care. Good science is rooted in good ethics.

Medical innovation is moved forward by technological advances in biomaterial and manufacturing research and development. However, clinical introduction and adoption can only be achieved through a thoughtful step-by-step verification approach. Proof of principle is achieved by the demonstration of a therapeutic effect via in vivo imaging or tissue-level pathology. For technology developers, demonstrating positive tissue-level effects confirms the validation of their technological approach. In vivo imaging and high-quality histopathology have become of paramount importance in the experimental process of medical technologies. It is of utmost importance that the evaluation of these outcomes is rooted in solid scientific basis, standardized analytical techniques, and be reported in a way that reflects the relevance to human disease conditions. The medical innovation landscape is rapidly expanding, and efforts to standardize analytical methods and clarify pathology end points are critically needed. This special edition is a great example of achieving such milestone.

Medical innovation continues to move forward, and it is expanding to areas never explored before. In particular, the advancement in big data analytics is now enabling the rapid progress in the understanding of gene influence in human diseases. The progress in medical innovation achieved until today is significant; however, the potential that future technologies have to modify patterns of disease thought to be incurable is mind-boggling. In the present issue of Toxicologic Pathology, a wide variety of devices and evaluation platforms are presented as a clear evidence of the multidisciplinary approach that is necessary for the progress of this field. As a clinician, scientist, and medical device innovator, we are confident that this special issue dedicated to the “Pathology of Medical Devices” will be of great value to the scientific and medical device innovation community.