Similar to other technologies that have dramatically influenced the medicine world, such as X-Ray Imaging or the Medical Thermometer, 3D printing has the potential to significantly improve upon the current medical standards. Although this technology has started being used around 20 years ago in procedures such as anatomical modeling for bony reconstructive surgery planning or joint replacement and craniomaxillofacial reconstruction, today’s hospitals are still somewhat reluctant in adopting this innovative technology. The reasons for this phenomenon can be included in three main brackets: strategic, tactical and financial issues.
In terms of strategy, the clinical trial process represents one of the impediments. Even though some clinical trials have been conducted in pre-surgical applications, these have reliability concerns in terms of the small sample size or in the lack of further long-term evaluation of the results.Thereby, more data in clinical trials is needed to aid the implementation of 3D printing. Another strategic aspect is represented by regulatory and legal problems. Current policies and guidelines are either incomplete or non-existent in medical applications of 3D printing. With this in mind, several major law firms are leading the way, establishing sub-specialties related to medical 3D printing. Another impediment is represented by the organisation and staffing. Outsource versus In-house 3D printing, the proper staff to be in charge with 3D printing and the smooth implementation of this technology within the current environment are just some questions that hospital’s administration must find answers to.
Tactics-wise there are also some aspects to be considered. Firstly, certain staff competencies must be met. These range from basic medical knowledge and imaging to 3D printing hardware and CAD/3D software understanding. Having enough personnel that have a foot in the 3D technology world and in the medical environment is most certainly difficult. In addition, quality control and inspection can also be a daunting task for health institutions. Given the fact that every device leaving the manufacturing chain is different and customized, traditional measurement methods can prove to be ineffective. Hence, the regulators must lay more emphasis on the development of a methodology system for control and evaluation of 3D printing in the medical world.
Furthermore, when considering the implementation of 3D technologies, some financial considerations must be made. To begin with, the reimbursement process must be clarified for 3D technologies. The reimbursement for procedures that includes 3D printing must be put in place in national healthcare systems and insurance companies. The chain of intermediaries (payer, surgical team, medical devices company, 3D printing company) and the lack of transparency can be the factors that also make the reimbursement process more challenging. In addition, a medical institution should consider the implementation of an In-house 3D printing facility, the cost of this investment and the return on it must be analysed. From capital costs that can range around 10.000 to 1 million dollars on the higher end of the spectrum, to fixed costs (salaries, training, certain agreements) and variable costs (materials) must be considered. Afterwards, the direct comparison with an outsource option must be made and from there the profitability analysis of implementing 3D technologies can be deduced.
For this technology to have a brighter outlook, combining the knowledge of clinical experience and manufacturing process within 3D is a solution to a more rapid adoption of this very promising technology. By bringing together people from the above-mentioned groups and by sharing of information, the stakeholders can facilitate the leveraging of this technology in the medical world.
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3D Printing in Medicine:Challenges Beyond Technology
Proceedings of the 2017Design of Medical Devices Conference DMD2017 April 10-13, 2017, Minneapolis,Minnesota, USA