The Amount of Free Surgeries Using Additive Technologies Will Grow: Doctor of Medical Science Roman Gorbatov
How do additive technologies affect the development of new treatment methods? How does the law regulate the application of 3D printing in healthcare? These issues are revealed by Roman Gorbatov, Head of Additive Technologies Laboratory of the Federal State Budgetary Educational Institution of Higher Education ‘Privolzhsky Research Medical University’ of the Ministry of Health of the Russian Federation, in an interview with 3D Print Expo.
Roman Gorbatov is a Doctor of Medical Science, first category trauma orthopedist, Associate Professor of the Department traumatology, and military surgery named after Kolokoltsev, as well as the Head of Additive Technologies Laboratory of the Federal State Budgetary Educational Institution of Higher Education ‘Privolzhsky Research Medical University’ of the Ministry of Health of the Russian Federation. He is a board member of the Association of 3D printing specialists in healthcare.
Interviewer: 3D Print Expo (3DPE)
Respondent: Roman Gorbatov (R.G.)
3DPE: How long has been Russia applying additive technologies in healthcare? In what sectors they are most popular?
R.G.: The first publications about the application of 3D printing in Russian healthcare appeared in the 1990s. However, various health professions have started extensively using additive technologies since 2016. It was then that the All-Russian research and practice conference ‘3D innovations in healthcare and pharmacology’ took place in Nizhny Novgorod and one established the Association of 3D printing specialists in healthcare.
Currently, 3D printing in Russian medicine is highly in-demand in traumatology and orthopedics, neurosurgery, maxillo-facial surgery, dentistry, cardiology, urology, and oncology. Year by year, we can see more and more investigations on the additive technology application in other health professions.
3DPE: What printing technologies are most sought after in healthcare? Why?
R.G.: Such 3D printing technologies as FDM, SLA, DLP, and SLS are quite popular in practical healthcare. FDM printing is most frequently used to produce orthoses, insoles, training and pre-surgery planning drafts, matrices for creating implants out of filler materials, guide pins for operative measures.
SLA and DLP technologies are primarily utilized in dentistry. Implants are often produced using SLS technologies. For example, components of individual titanium endoprostheses.
3DPE: What free surgeries are now performed using 3D printing? How efficient are they for patients?
R.G.: I have relevant data as of December 2018. Back then, Russia provided more than 877 patients with free surgical treatment according to eight clinical testing protocols. Four of them were dedicated to hip arthroplasty with 3D printing; two of them were aimed at knee joint endoprosthesis replacement; one of them treated patients suffering from bone tissue defects with customized precision bone replacement transplants; and the last one was related to reparative neurosurgical treatment using phantom pre-surgery three-dimensional modeling of skull defects and three-dimensional printing of an individual implant to close skull defects.
Today, we are expecting the increasing number of clinical testing protocols: it means that the amount of free surgeries using additive technologies will grow. The efficiency of 3D printing additive technologies in the patient treatment is proven by several studies.
According to one of them, precise preoperative planning based on individual models of hips substantially helps to improve the treatment results. Initially, it is referred to patients with cotyloid cavity defects. 3D technologies in such a treatment allow to reduce the surgery time, decrease the extent of blood loss, and cut the likelihood of intraoperative complications caused by the complexity of implant insertion.
3DPE: How can you assess modern prostheses based on additive technologies? What are their capabilities for patients?
R.G.: One of the relevant revision hip replacement challenges is the necessity for precision replacement of cotyloid cavity defects. Stable installation of the acetabular shell is also a difficult process.
One of the solutions is the application of three-dimensional printing technologies. A 3D printer will allow to produce custom three-flange acetabular components based on pre-surgery computer tomography in terms of patient’s bone loss parameters.
In the following cases, additive technologies help to recover the joint rotation center and reliably fix an individual component of the endoprosthesis in order to enhance the treatment efficiency, make patients feel better after the surgery, and reduce the probability of post-surgery complications.
3DPE: How can 3D printing speed up the treatment and recovery of patients? In what cases?
R.G.: One of the examples of 3D printing technologies assisting us in the patient treatment is the application of personal implants out of filler materials to replace bone tissue defects after tumor removal.
Due to cutting-edge health technologies, we can conduct an organ preservation surgery and remove the bone tissue tumor. When the tumor is large after its resection, it can frequently result in bone defects that should be replaced with implants. Additive technologies allow us to produce an individual implant right during the surgery. Following computer tomography data, one creates a matrix intraoperatively filled with the filler material. In 7-10 minutes after its freezing, the matrix is dismantled, and the implant is put into the patient.
The similar technique is used in the surgical treatment of patients with oncopathology of bones of upper/lower limbs and skull. Besides, one performs single-step bone grafting of defects using filler material implants. They are customized for each patient, designed by three-dimensional printing technology, and able to replace bone defects of any complexity, form, and size.
Therefore, the surgery is faster, patients recover within a shorter period of time, while the number of post-surgery complications is reduced. Moreover, 3D printing technologies improve patients’ life quality.
3DPE: Tell us about the legal aspects of additive technology application in healthcare.
R.G.: Additive technologies are a promising healthcare area. They require well-defined statutory regulation because of allowing to develop new treatment methods. Unfortunately, current legislation is far from advancing this issue: there are some gaps in the definition of 3D model quality, material standardization, etc.
Nowadays, it is crucial to provide security of 3D printed objects, comply with the patients’ rights when applying individual items, prevent the use of prohibited or limited materials during 3D printing, and avoid legal barriers to the evolution of 3D printing technologies in healthcare.
As of today, handling of individual healthcare products is regulated by paragraph 5 of Article 38 of the Federal Law of the Russian Federation No. 323-FZ “About bases of protection of public health in the Russian Federation”. It stipulates that medical products made to private orders of patients, which are subjected to the special prescription requirements of health workers and which are intended for the personal use of a certain patient, are not subject to the official registration. It is also confirmed by the Order of the Government of the Russian Federation No. 1416 “About approval of Rules of state registration of medical products” and by the letter of the Federal Service for Surveillance in Healthcare. Thus, individual 3D printed medical products based on anthropometric measures of certain patients are not subject to the official registration. Judging from the literal interpretation of the above-mentioned provisions of law, the official registration applies to materials used to produce customized medical products.
3DPE: What are you going to tell conference guests? What specialists is your presentation aimed at?
R.G.: I will introduce information about the market volume of 3D printed medical products both in Russia and abroad, as well as about core technologies applied in healthcare. You will be able to discover more about the growth dynamics of this area in Russia and about locations of major centers of medical 3D printing.
I will tell the audience what free surgeries based on 3D printing are performed in Russia and show the results of treatment using additive technologies. I will definitely focus on the legal support of medical 3D printing, as well as on new software, cutting-edge materials, and equipment (including Russian-made ones).
The presentation will highlight the results of 3D printing application in dentistry, pharmacology, manufacturing of customized means of patient rehabilitation, particularly hearing aids. Furthermore, I will present the outcome of bioprinting application in the development of human organs and tissues, and key growth directions of medical 3D printing in Russia and worldwide. I will share unique clinical case studies of applying additive technologies to treat patients.
The given information will be interesting to both doctors of various health professions and non-medical specialists.
Roman Gorbatov will make his presentation on October 4 at 3D Print Expo.
The full conference program is available here ►►►