Introduction to 3D Printing in India
3D printing, a relatively new wave of manufacturing technology has made huge impact on healthcare industry globally by providing customization to a growing number of healthcare applications and bringing down the cost. Also known as additive manufacturing, this technology has been around the world since 1984 and but it was not until a couple of years back that the healthcare industry in India really began to take notice. Today, 3D printing is being used in various fields such as dentistry, neuro surgery, maxillofacial surgery, and orthopedic surgery, predominantly to make pre-surgery models or guides to achieve higher success rate in surgeries and reduce the overall cost of surgery.
Recently, doctors in Mumbai have used an orthopedic implant designed and manufactured in India for a spinal reconstruction surgery. Prosthetics is another area where 3D printing technology is making noise. This technology makes it possible to manufacture prosthetic limbs (sockets) at much lower price and also more quickly. Researchers in India such as Pandorum Technologies are also looking at possibility of printing out living tissues for medical research and therapeutics and develop artificial liver.
Current Status of the Market
Though the technology has started garnering interest of healthcare professionals, it is still a long way to get into mainstream usage. Traditional manufacturing technologies are still the order of the day. The healthcare professionals attribute high cost and need to justify the benefits over traditional technology in order to increase adoption rate.
Convincing the physicians about the benefits is the biggest challenge. A pre-surgery model costs anywhere from ₹5,000- ₹20,000; however, physicians do not find a need for it. “It is not a big deal to plan a surgery (for a regular case)”, says a senior radiologist who also owns a diagnostic center that offers 3D printing services, that is, they do not see any differential benefit for the additional cost. Currently, 3D printing is being considered for usage in only complex surgery cases. They do not find the necessity for usage of pre-surgery guides for all surgery cases. Excerpts from a few reputed senior surgeons are as follows,
“Not everyone though is convinced about the merits of the medical breakthrough. We normally do not use custom-made implants for 2 vertebral level problems. Regular off the shelf implants and bone grafts are good enough. Custom made implants is required in special situations”, an orthopedic surgeon at the All India Institute of Medical Sciences (AIIMS).
“Customized implant is not a replacement option for everyone. Each defect or disorder is unique, and when conventional methods do not offer the required results, then the only answer is 3D designed customized implants. This easily restores function, form and esthetics, and it is cost effective too”, a senior maxillofacial surgeon from Center for Technology Assisted Reconstructive Surgery, who does extensive work in 3D printing.
Existing Business Models
As the technology is relatively new, the software is expensive; there are a handful of companies who provide these services across India. The pre-surgery guides and models get printed in India. Some companies have their own proprietary software, for example Osteo3D, while many use software from international companies such as Materialise or open source software.
For 3D printing body parts, companies provide 3D printing software modeling (.stl files) services and the actual devices (such as implants) get printed outside India. This is because to import a medical grade printer, it can cost a few crores of rupees. Custom duty, international shipping charges, and VAT adds another 60-70% to the cost of the printer. A local vendor offering 3D printing services was noted saying, “Printer costs a few crores. (Raw) Materials (like Titanium) are also expensive. Moreover, there are other charges like maintenance and post-processing costs.” Moreover, 3D printers are mostly single material printers, that is, a printer using one type of material is not compatible to be used with another type of raw material. In a country such as India where scalability is still a question, vendors do not want to invest on a printer only for usage in medical purposes.
Indigenously made printers or low-cost versions of printers from China, South Korea and other Asian countries are not certified to be used for medical grade applications such as body parts. Moreover, there is a general inclination and confidence among medical fraternity for CE or FDA certified printing processes and printers. “We are talking about producing customized implants. Even FDA does not have a regulatory protocol for 3D printed devices; however, the printer and process used for printing are regulated. We do not have this in India. The (indigenous) printers we use here are ISO certified”, says a local 3D printing (healthcare) vendor who has his own indigenous proprietary software.
Challenges in India
Cost is the biggest challenge in the Indian market. Patients pay out of pocket and there is no reimbursement/insurance coverage. The question is how to convince the patients to pay additional few lakhs when they do not see a perceived benefit. A renowned physician says, “Some practitioners who wish to utilize 3D printing are bound by the consent of the patient as the expenses have to be borne by the patient. The patient may or may not understand the importance of 3D printing for his/her case and may refuse the proposal as it is an additional cost.”
Researchers and doctors are trying different ways to make the technology affordable to better penetrate the Indian market. For instance, the 3D printed models are being designed locally (.stl files) and send it to European countries for printing. This reportedly reduces the cost by less than half according to a surgeon, “For a customized cranial implant, an international company can charge you up to ₹4 lakh; however, we are doing it for about a lakh. We design it here, and print it in FDA approved units in UK or Germany. Though margins are down, we are looking at market penetration rather than profit (angle) right now.”
Next Steps and Conclusion
Though applications such as dentistry have already started reaping benefits of this technology, it is going to take time for 3D printing being used for treatment, such as printing body parts, to take-off. Companies interested in investing in this market need to approach it with caution as it is not a market for all (that is, mass production). The application where it is currently finding maximum use in India is surgeries related to trauma, (benign) tumors, and secondary defects (of hard tissues). Indian companies such as Imaginarium which is into 3D printing for multiple industries namely jewellery, automotive, apart from healthcare and medical devices have found success in this market as they have multi-purpose printers for multiple applications.
3D printing does seem to have the potential to be one of the biggest game changer in the coming decades. As rightly quoted by a medical practitioner, “Surgeons have to start trying the technology to understand the benefit”. Medical technologies often are expensive when they enter the market, with their prices getting reduced over time.
The widespread use of this technology will only lead to better treatment modalities and approaches, better materials, and eventually better lives for both the patient as well as the surgeon.
With more number of surgeons and hospitals using the technology, many applications are being invented and innovated. India is not far behind in the usage of this technology. With the ever increasing volume of patients, it is just a matter of time that India emerges as a premier destination not just for medical treatment but also for technology based world class medical treatment.
