Traditional orthopaedic devices do not communicate with physicians or patients post-operatively. After implantation, follow-up of traditional orthopaedic devices is generally limited to episodic monitoring. However, the orthopaedic community may be shifting towards incorporation of smart technology. Smart technology in orthopaedics is a term that encompasses a wide range of potential applications. Smart orthopaedic implants offer the possibility of gathering data and exchanging it with an external reader. They incorporate technology that enables automated sensing, measuring, processing, and reporting of patient or device parameters at or near the implant. While including advanced technology in orthopaedic devices has the potential to benefit patients, physicians, and the scientific community, it may also increase the patient risks associated with the implants. Understanding the benefitrisk profile of new smart orthopaedic devices is critical to ensuring their safety and effectiveness. The 2018 FDA public workshop on orthopaedic sensing, measuring, and advanced reporting technology (SMART) devices was held on April 30, 2018, at the FDA White Oak Campus in Silver Spring, MD with the goal of fostering a collaborative dialogue amongst the orthopaedic community. Workshop attendees discussed four key areas related to smart orthopaedic devices: engineering and technology considerations, clinical and patient perspectives, cybersecurity, and regulatory considerations. The workshop presentations and associated discussions highlighted the need for the orthopaedic community to collectively craft a responsible path for incorporating smart technology in musculoskeletal disease care.

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We report on a new technique for microfabrication of multi-layer thick microstructures consisting of a combination of glassy carbon (GC) layers alone, or layers with both GC and negative resist. In this technique, we dope a negative tone pre-cursor polymer of GC structures with a dye that will serve as an ultraviolet (UV) light blocking layer. This allows the doped negative resist layer to act-when needed-as a sacrificial layer which subsequently will enable the patterning of multiple layers of negative resists that can be pyrolyzed and turned in to GC microstructures. In this study, we demonstrate that this method offers a high yield and reliable extension of the classical carbon micro electromechanical systems process to microstructures consisting of multi-layer of GC and a combination of GC and negative resist layers. This batch process, therefore, forms a basis for a high yield and reproducible microfabrication technology for a variety of multiple layers of GC microstructures. In this study we demonstrate: (i) the optimum mixing ratio by-weight of dye and negative resist to be 1:50 (in this case, SU-8);(ii) optimized level of UV exposure needed for the dye-doped SU-8 layer to act as a sacrificial layer (1500 mJ cm −2 ); and (iii) microfabrication of a variety of thick (>250 µm) multi-layer GC and GC/SU-8 microstructures. The devices fabricated through these techniques include an accelerometer, a micromirror, a string resonator, and a microfluidic chip.

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