March 20198Smarter processes ensure smarter tech for optimized outcomes.Additive manufacturing (or 3D printing) is not new to science and has been evolving for many decades and now includes 4D printing. Traditional forged or molded implants are clearing the path for a wave of novel 3D printing processes and manufacturing that has even resulted in a shift in the regulatory paradigm to accommodate innovative methods, less understood by regulators. My past colleagues at the FDA are becoming well versed not only in the technology but also trying to stay ahead of the curve to address potential implications towards patient safety even prior to industry submissions. Implants are being designed that are more anatomically individualized, whether they are patient-specific guides, implants or truly `custom' prostheses. Pushing the envelope of the `custom' definition for large scale manufacturing of devices is going to be a barrier to entry that the FDA will have to concede in the relatively near future. The ability to scan and image human structures is becoming so finely detailed with drastically shortened turnaround that traditional manufacturing methods already feel archaic in comparison. Although truly custom is already commercialized in parts of Asia and Australia, patients globally will soon have their individual preferences met beyond compare.Computational modeling is already incorporated in all facets of device development including regulatory review but will become standard, even replacing traditional test methodologies. Augmented Reality (AR) and Virtual Reality (VR) enhanced surgical planning, remote surgery, device design, device testing and device templating are happening, and after having helped develop and design some simple processes and platforms, I cannot wait for many of these possibilities to become reality. AR and VR allow a surgeon to think better and perform better in all aspects of biomechanical constructs. Many implants already offer numerous modeling capabilities and templating solutions and pretty soon AR and VR will take that beyond gaming as machine learning probes deeper.Robotics will advance the care of the patient and streamline various parts of complex procedures that are definable through hierarchical instructional sets. Eventually, however, the tactile sensitivity to complete an operation from `skin to skin' as we say, will displace highly skilled surgeons to that of an instructional guide andclinical decision-maker rather than pure operator. An exceptional robot for orthopedic surgery is yet to be developed even though there are some on the market today. With skilled robotics to facilitate surgery, will eventually come intelligent robotic assistive manipulators that will augment and supplant surgical assistants. Various limb positioners exist today that are non-robotic but they still reduce assistant need and fatigue. Robots may in fact improve the physician-patient relationship since the MD can focus more on patient-centric care withexpanded time for face to face interactions and smoother operations and transitions. Even while robots may not displace the entire surgical team that soon in our future, one aspect that will be transformed very quickly will be the Sterile Processing Department (SPD) which is often poorly managed in most hospital systems. SPD is the backbone of surgical care delivery and yet one of the weakest links in the spectrum of care ­ a cardiac surgeon cannot replace a heart valve if the valve is out of stock when the chest is already cracked open. Robots and Robotic Process Automation (RPA) will crush that THE AGE OF ORTHOPEDIC INTELLIGENCEFaisal M Mirza, MD, FRSCSC (OrthoSynthesis Inc.)ByIn My Opinion
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