FRSCSC (OrthoSynthesis Inc.)

Faisal M Mirza

Smarter 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 allfacets 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 problem with reliable repeatable logical algorithms of workflow, eliminating inconsistent patterns and rudimentary cataloguing and inventory tracking.

Mesenchymal stem cells (MSC) and platelet rich plasma (PRP) therapeutics are currently in vogue and will evolve several leaps further by the middle of the next decade. So much is changing in our understanding of MSC and PRP along with various other regenerative technologies from individual growth factors, to peptides to gene therapies, to safer absorbable metals that I suspect that only two more generations of joint arthritis will necessitate current total joint replacement technologies. We as orthopedic surgeons are shifting our thoughts towards prevention as more valuable than replacement. As such, replacement will likely be taken to an inspiring new level through ‘smart’ tech within current and developing implants hurtling us all towards advanced tech futuristic robotic prostheses for severe injuries from trauma, such as limb replacement modules. Our ability to offer unique solutions to injured war veterans has already begun with the advent of various osseo-integrated implants, but will continue beyond rudimentary hydroxyapatite coated titaniumstems.

Combination devices and implants are just scratching the surface of innovation. Researchers are already developing implants coated with various drugs, antibiotics, antibodies, and biologic coatings to enhance the function of the device to help integration, adhesion, fixation, in order to reduce failures and revisions, as well as improve the early return to function by promoting healing. This is happening globally and everyone will benefit. Why should anyone want an inertmetal implant, when you can have an absorbable biologically active alloy coated with a biotech drug to enhance adhesion, improve early fixation, promote bone strength, reduce failure, prevent infection, promote longevity and stimulate adherent muscle and nerve to improve overall rehabilitation and return to sport? We are not quite there yet, but many investigators are beyond imagining this and pushing through this wall. The idea of inert material properties for implantation will be thrown out the window as an absurd product of elementary thinking. We are biologically active human machines, so why would we want a product in our bodies that does not immediately adhere, grow, mold, build, and adapt to us rather than sitting idle waiting to get infected, loose, or break? Bio-engineering will be completely re-formulated and re-invented—beyond Mechano-Biological- Physiological-Regenerative-Restorative Technology.

Evidence based outcomes may not be a technological advancement per se but the harnessing of our ever-increasing higher quality data enhances our data integrity and validity through better scrutiny and reproducibility, by its sheer volume of Level I Evidence along with community-wide data integration to reach across the globe, will be a technological masterpiece. This will allow us to clean up our dirty data over the past several decades into comprehensive, categorical, measurable, searchable, patient-specific terabytes, thus increasing precision and accuracy that continues to improve, not just in general but to honed precision to patient demographics and co-morbidities and geographic variance. In this manner, we can understand outcomes to drive innovation by not only asking better questions but revamp our current thinking into logical algorithms of computational stories. Cleaner data will promote harnessing the power of computational intelligence in a manner that we could never have done before. Better data makes smarter analytics, computational models, improved design, custom prints and smarter workflows that evolve faster and become more durable.

Artificial Intelligence (AI) is already becoming a vital construct in healthcare but deserves a brief mention even though the topic itself is too broad. AI will not only improve device development and innovation in orthopedics, suffice to say that organized clinical algorithms of care with accepted guidelines permeating upon open platforms of structured and unstructured datasets, along with reliable outcome measures within a comprehensive deep learning curve penetrating all levels of care from simple lacerations to complex spinal deformities; will offer orthopedic surgeons, real-time augmented AI interfaces to help achieve excellent patient care. If you combine the best of intuitive, deep-learning AI with the best of robotics and computational analytics, then this author will finally be able to retire.