Apr 19, 2020 During the Coronavirus outbreak the, Additive Manufacturing sector (AM), best known as the 3D printing technology, has proven its definite value as a critical supplier for the healthcare sector. While the usual supply chains have failed to deliver the emergency medical equipment, 3D printing companies and hobbyists have created a global movement to supply local hospitals and emergency workers with ventilator parts, connecter tubes, and different kinds of personal protection equipment (PPE). Spentys, a Belgian start-up that offers an all-in-one 3D scanning, modeling, and printing platform to create high-quality immobilization devices, is one of the many companies that took the initiative to tackle limited medical supplies caused by the COVID-19 outbreak. In a matter of days, the company turned ‘crazy’ ideas that could help out healthcare providers into practical solutions. This story from Spentys is a case of agility, and about the potential of 3D technology in general.
As a company that has developed expertise in the mass-production of 3D printed medical devices, I believe we have a responsibility towards our medical ecosystem to reallocate our resources to fight back against COVID 19. I firmly believe that innovation and technology have a key role to play in this combat.
Figure 1 Healthcare workers using PPE produced by Spentys. Photo Credit: Spentys
Similar to other technologies that have dramatically influenced healthcare, such as X-Ray Imaging or the Medical Thermometer, 3D printing has the potential to improve the current healthcare standards significantly [1]. Although this technology is already being used in the healthcare sector for over 20 years in procedures such as anatomical modeling for bony reconstructive surgical planning in the field of orthopedics and CMF, it is only recently that hospitals are looking to implement 3D technologies in more different procedures [2]. Today, most hospitals are still somewhat reluctant to adopt 3D technology innovation [3]. The reasons for the reluctancy can be categorized as follows: strategic, tactical, and financial reasons. The recent and ongoing COVID-19 outbreak can have long-lasting effects on all three of these dimensions:
Strategic
The clinical trial process represents one of the main obstacles for disruptive change. 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 long-term evaluation of the results [4]. Thereby, more data in clinical trials is needed to aid the implementation of 3D printing. Regulatory and legal problems represent another strategic aspect [5]. Current policies and guidelines are either incomplete or non-existent in medical applications of 3D printing.
The current COVID-19 outbreak and the fast solutions that AM bring (e.g. Decathlon scuba diving goggles that can be modified with 3D printed parts to be used as face shields or ventilation masks) have made the clinical testing of 3D technology a top priority.
Tactical
Tactics-wise, there are also some significant aspects requiring consideration. Firstly, specific staff competencies must be met, ranging from medical knowledge to 3D printing hardware and CAD/3D software understanding. Having enough personnel that is familiar with the 3D printing technology implemented in a medical environment is most certainly painful. Besides, quality control and inspection can also be a daunting task for health institutions. Given the fact that most equipment made by a 3D printer is different and customized, the traditional measurement will be mostly ineffective. Hence, the regulators must emphasize the development of a holistic methodology system for the control and evaluation of 3D printing in healthcare.
Figure 2 Breathing apparatus consumables printed at Spentys using Digital Laser Printing technology (DLP). Photo Credit: Spentys
The current situations, where healthcare workers need to respond quickly to the rapidly increasing influx of patients, implies that suppliers that are flexible and efficient become tactical partners of the emergency responders. 3D printing technology, and its deep customizability, is crucial to meet the increasing demand for specific, sometimes rare equipment. Healthcare providers are actively looking for creative yet clinically approved ways to save lives and are willing to implement new technologies that can deliver on this request.
Financial Considerations
When considering the implementation of 3D printing technologies, some financial considerations must be met. First, the reimbursement process must be clarified for 3D technologies. The reimbursement for procedures that include 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. Besides, a medical institution should consider the implementation of an in-house 3D printing facility. All costs, from capital cost to fixed costs (salaries, training, certain agreements) and variable costs (materials), must be considered and compared with an outsourcing option.
Figure 3 Spenty’s production center. Photo Credit: Spentys
Governments and local hospitals are dealing with unethical suppliers that are capitalizing on the situation by pushing up the price. In almost all communities, we hear reports of equipment that does not match the technical specifications of the material ordered, and hence cannot be used. In the worst of cases, the material will never be delivered. Local 3D printing facilities are, in many cases, becoming the trustworthy partners emergency responders need to react to the crisis.
What’s next?
The current pandemic has leveled the playing fields for all suppliers. After the crisis, it will be essential to reflect and to reconsider future orientations. The healthcare sector will need to decide on which technology it wants to invest in and what vision of the future it will subscribe to. The main goal of the healthcare system remains the reduction of time and costs, having the right equipment ready for the right patient at the right time. The coronavirus and the particular pathologies that it brings have resulted in a growing demand for specific hardware (ventilations machines) in quantities that the traditional supply chains of hospitals cannot meet. Together with medical experts, Spentys, and other 3D printing medical companies can accommodate the specific needs of customized healthcare and provide multiple solutions. 3D printing technology is an integral part of the solution to bridge the gap in customizability, cost structure and delivery time [6].
Furthermore, 3D printing technology brings personalization to the masses in healthcare. By promoting and utilizing the additive manufacturing technique of 3D printing, many collaborations will flourish as the demand for personalized healthcare is increasing. Spentys wants to assist healthcare providers, especially in orthopedics, to treat patients faster, cheaper, and most importantly, better. Although the current achievements of 3D printing technology – and the vital role it plays in assisting healthcare providers saving lives during the pandemic – are awe-inspiring, we are barely scratching the surface of the potential of the disruption AM is bringing to healthcare.
References:
[1] https://interestingengineering.com/10-medical-inventions-of-all-time-that-changed-the-world
[2] Rybicki FJ. 3D Printing in Medicine: an introductory message from the Editor-in-Chief. 3D Printing in Medicine, 1–1.
[3] 3D Printing in Medicine: Challenges Beyond Technology
[4] A Roadmap from Idea to Implementation – 3D Printing for Pre-Surgical Applications
[5] Traditional legal principles. Reed Smith. 2015.
[6] 3d printers and 3dprinting: technologies, processes and techniques. Sculpteo.
[7]Itagaki MW. Using 3Dprinted models for planning and guidance during endovascular intervention: atechnical advance. Diagnostic and Interventional Radiology, 21, 338–341.
[8] Proceedings of the 2017 Design of Medical Devices Conference DMD2017 April 10-13, 2017, Minneapolis, Minnesota, USA
About the Author:
Co-founder & CEO of Spentys
“I’m the CEO & co-founder of Spentys, European-based startup specialized in the mass-customization of orthopedic immobilisation devices through the use of 3D technologies. We have set up the company late 2017 with my co-founder Florian De Boeck. We are active throughout Europe and outside, with production facilities across 5 countries. We firmly believe that the future of health lays in mass personalization of care, which will have an added-value for every citizen in our societies.We want to be an active actor of this societal change.”
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