Industrial Automation Magazine India

Health care sector has the strictest guidelines and regulations

Published on : Friday 08-11-2019

Dr Thirumurugan S V M responded to some questions from Industrial Automation about 3D printing in health care.

Health care is one of the main users of 3D printing technology. How widespread are the applications?

3D printing technology has made its presence felt in almost every discipline. The technology has its origins in the mid to late 1980s. Its use, including medical and dental applications, is in no way inferior and has been developing with rapid strides, especially over the last decade. New 3D printers are far superior to their predecessors. There are nearly 10 different 3D printing technologies in the world now and each has its pros and cons.

The applications are enormous and innovations are happening each and every day using all of the above technologies. Gartner research says, by 2025, nearly 25% of the surgeons will practice on 3D printed models prior to patient surgery. The CAGR of 3D printing technology and materials has consistently been more than 20% in the health care industry along with the uptick in number of patents filed towards health care. The most common medical applications are: anatomical models for teaching and surgical training; bio-printing of cells, tissue scaffolds towards organ-on-a-chip concepts; customised orthotics and prosthetics; drug printing; medical devices; and patient specific implants.

Augmented reality (AR), Artificial intelligence (AI) and virtual reality (VR) being developed for educational and training purposes are in lock-step with the 3D technology. Smart materials and sensors are bringing unimaginable advancements in diagnostic and monitoring aspect of health care. The combination of AR, VR, smart materials and sensors along with 3D printing will bring innovations which are beyond our imagination in the field of health care.

Are there adequate safeguards in terms of standards and hygiene vis-à-vis the materials used?

More than any industry, the health care sector has the strictest guidelines and regulations that need to be followed. Every country has its regulatory bodies like US has the FDA, Europe has MDR & EMA and CDSCO of India. The overall materials can be consolidated in to 3 forms: Solid – FDM based materials; Liquid – SLA, DLP, Polyjet, Bio-inks and Hydrogels and Powder – Powder based polymers and metals.

FDA approval is mandatory and it is used as the gold standard for most of the 3D printable materials for health care applications. The materials have different forms and it is supposed to be biocompatible in order to enter inside or maintain contact with the body for a period of time where it should not cause any sign of troubles. Most of the countries which makes these materials at least have their own certifications. 

Within medical, the dental sector has witnessed widespread adoption. How has this impacted the segment?

More than general medical applications, dental segment has been explored for applications using 3D printing technology. The development of materials has been expedited to a great extent such that it supports almost all the dental applications. Certain applications cannot match digital manufacturing methodologies with reference to the quantity of production in given time and quality of the material printed with precision. Concepts have been developed to scale where a dentist can have his/her own complete digital workflow at a very reasonable price. Having the complete digital dental workflow is akin to having every solution required in one’s hands and enabling one to deliver any work on the patients in few hours instead of waiting for few days with utmost precision and exemplary finishing. The 3D printing technology can accomplish dental tasks starting from aligners, bridges, crowns, dental models, dental implants, dentures, metal copings, removable appliances, surgical guides, wax try-ins and veneers.

How about the skills and training aspect? Is there adequate support for associated design and software?

Persons with design and software expertise in health care are rare. Engineering products can be designed on CAD and few other software where courses are widely offered and are easy to learn. But for health care, there are limited training centres and it is only just catching up over the last couple of years. In some cases, people purchase 3D printers without having the requisite knowledge about the associated software, post processing equipment and how they can be effectively leveraged. A person with general medical and dental knowledge along with software and design experience would be ideal in this modern world of technology assisted health care.

If they have only one of these competencies, then the others need to be learnt to be able to excel in health care software design. Half a decade ago, the number of software options available for health care applications was very limited. The available software was expensive and there were very few free offerings in which the final output was not accurate enough to be trusted and incorporated for actual practice. Now, there are a handful of software products available to satisfy the demand.

Healthcare professionals and design engineers are now learning to expertly use these software tools. There are individual computer models available for every application and purposes. For example, a software for MRI/CT/CBCT (DICOM) data to convert in to .stl format. Similarly we have different software for implant designing, orthodontic treatment and prosthetic designing which we can select depending on its suitability.

What about the hardware? Are the 3D printers manufactured indigenously?

The hardware or the 3D printers have been in development since the late 1980s. 3D Systems and Stratasys have been pioneers in this technology for over three decades. These technologies and others that have followed were always patented, thereby limiting wide adoption due to a monopoly. The moment their patents’ term expired, lot of new manufacturers started manufacturing the printers indigenously at a considerably low cost. 3D printers have been developed according to different industry needs. The build table where the models will be printed has been improved and it was increased to create bigger models using different materials through various techniques to improve the printing speed and quality, which are important aspect that impacts adoption.

What are the barriers faced in widespread adoption of additive manufacturing in medical field?

There is a great disparity when it comes to using 3D printing technology in different parts of the world. Developed countries like USA, Canada, Australia and certain countries in Europe have started to use a complete digital platform for their diagnostic, education and surgical planning purposes. Developing countries like India and China are gradually adapting to the technology whereas most African countries which are underdeveloped have not got much adoption of it. The health care budget and financial constraints seem to have a direct impact on the acceptance of advanced technologies. If the government and insurance providers lend support, there can be a significant increase in utilising these technologies.

The cost of 3D printing technology alone is not an issue – it is a one-time investment. But the printing material and maintenance costs are the cause for worry especially in developing countries as the competing conventional labs and treatment costs are much lesser when compared to other developed countries.

Dr Thirumurugan S V M is 3D Health Care Consultant and Orator, engaged in Clinical Research, and a Key Innovative Associate Member of 3D printing, and 3D Printing World Community Club, India.