Paper 16.111

D. B. Stefan and D. A. Gilbert, "Practical Advice: Navigating the Landscape for Using 3D Body Scanners in a Medical Environment. Do's, Don'ts and Maybes.", in Proc. of 7th Int. Conf. on 3D Body Scanning Technologies, Lugano, Switzerland, 2016, pp. 111-129, doi:10.15221/16.111.


Practical Advice: Navigating the Landscape for Using 3D Body
Scanners in a Medical Environment. Do's, Don'ts and "Maybes."


David B. STEFAN 1, David A. GILBERT 2

1 Novaptus Systems Inc., Chesapeake VA, USA;
2 The Hague Plastic and Cosmetic Surgery Center, Norfolk VA, USA


Background: The medical branch of sciences can be a close-knit, difficult fraternity to enter. This in part is due to sensitivities about historical incidents that border on what would colloquially be called "quackery," or "charlatanism." In the name of both protecting the profession as well as the patient, the equivalent of trade associations were created. These associations established standards for the medical profession. Later, governmental organizations developed as regulatory authorities. The private associations and public government agencies combine in such a way as to as to form what some have called an insular community.
This "establishment" is a double-edged sword. On one hand, it has served its purpose by elevating the bar for quality of practitioners and consistency of care. On the other hand, the myriad of rules and regulations make it difficult for new ideas and new applications to enter from the outside. Worse, these rules have a tendency to change and can be subject to different interpretations. This paper gives a primer, based on practical experience on how to field a 3D scanner system into a medical facility, both for commercial services and also for research purposes.
Methods: There have been many opinions as to what constitutes a medical device. "Treat, Diagnose or Cure," is a general rule of thumb. If a device directly claims to do any of these, it probably falls under a "medical device" label and must be approved by the appropriate authorities for use on human subjects. Measurement and Photography are different in the sense that one can certainly bring a smart phone with a camera or a tape measure from a hardware store into a medical environment and use their respective functions. A 3D body scanner used in the clothing industry combines both photography and measurement capabilities, and herein lies the gray area between commercial functionality and possible research. The 3D scanner is capability of multidimensional measurements that reveal new insights into the shape of the subject in the scanner. These measurements were previously unavailable. By combining these newly available measurements and forming new ratios and an evaluation scale it is possible to quantify certain physical conditions, such as obesity. In a sense, a 3D body scanner can then fall into the "Diagnose" category.
Discussion: Placing a 3D body scanner in a medical surrounding without awareness of the regulatory environment is not a good plan. Because this is a gray area, certain approvals and procedures are recommended. The most straightforward path is to have a qualified sponsor within the medical community, preferably an actual M.D. perform the role of the Principal Investigator (PI). The PI generates a research construct, including the desired end goal. This construct contains the framework of how the data is to be collected, handled. analyzed and eventually presented. This forms the part of proposal to be presented to an Independent Review Board (IRB). The IRB is an unbiased committee of medical professionals, generally sponsored by a university that conducts medical research. Their role is to ensure integrity of the research, security of the data, evaluate the risks to human subjects and that the researchers are qualified and certified to perform the research tasks. An extremely important part of the IRB submission is the consent form that the human subjects must sign. Without such consent, certain data on the subject might not be able to be used and could be discarded.
Conclusion: This paper outlines the procedures for the IRB protocol process, perhaps the most expedient way to get a 3D scanner fielded for use within a medical environment. It can be a lengthy approval process and the submission can also be quite detailed, particularly for the Human Subjects section. However, once the IRB is approved and the protocol followed, the anthropometric measurements provided by the 3D body scanner can be utilized to their full extent and, more importantly, can also be combined with the subject's other medical information, such as blood work or prescription medicine. The paper also explores two other alternatives. One alternative is to submit a 3D body scanner to receive unconditional medical device approval. This has many drawbacks, chief of which is that existing scanning technology quickly becomes obsolete. Less expensive and perhaps more accurate and portable 3D scanners are rapidly appearing. Certification of one type of scanning technology could be an expensive mistake. Yet another alternative is to petition the authorities for a "Non-Invasive Device Exemption." This approach generally requires legal counsel and associated expenses. Pros and Cons of the various approaches will be examined.


Full paper: 16.111.pdf
Proceedings: 3DBST 2016, 30 Nov.-1 Dec. 2016, Lugano, Switzerland
Pages: 111-129
DOI: 10.15221/16.111

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