“We plan to tap the niche 3D printed customized medical implant market in India”

Melbourne-based and Australian-owned medical device company, Anatomics has been manufacturing and marketing surgical products to surgeons since 1996. Anatomics pioneered CT scan-derived surgical implant technology. In an exclusive face to face interaction with Mr Srinivas Bhylahalli, Vice President, Anatomics, the BioVoice News tried to know about the company’s innovative 3D printed implant products, its current Asia-Pacific operations, and Indian market plans. Read the excerpts:

Please tell our readers about the Anatomics, its product offerings globally?

Anatomics is an Australian medical devices company founded more than 20 years ago. It has been a pioneer in making quality devices since its early days. We are a company of experienced and dedicated team members who strive for better surgical outcomes by initiating internal product developments and searching the world for the latest innovations in technology to make surgical procedures more effective for our partners and more comfortable for their patients.

The 3D printing in medical applications was the company’s first entry product and as the company was founded by a neuro-surgeon, the initial applications of the product lines were mostly in neuro surgery. So, we specialize in the patient specific solutions that means every implant, surgical tool we design and manufacture are custom made for individual patient in each case. Therefore, instead of mass manufacturing the products where the patients may have to be tailored to suit the implants, here they are customized as per the needs of the patients.

Anatomics manufactures patient specific cranial, facial, chest wall and other skeletal and soft tissue implants and surgical tools for reconstructive surgeons in Australia and around the world. To complement these products, Anatomics has developed a range of software to assist surgeons and medical staff in both ordering and designing their surgical products. We have also partnered with innovative companies to provide surgeons with state of the art technology for both neuromonitoring and electrosurgery.

Who are your targeted clients? How do you look at the individual cases and how are these products different?

The company’s clientele includes neurosurgeons, plastic and reconstructive surgeons, oral and maxillofacial surgeons, orthopaedic surgeons, ENT surgeons and thoracic surgeons.

For each case, we create tailored implants. For example, if there is a tumor in sternum, you have to cut the ribs to remove it. In order to create the replacement structure back in place, we create a product with titanium alloy and a mix of poly-carbonate and other materials to suit the requirement. Another example is of a maxillofacial surgery or what is called the plastic surgery in which instead of using silicon, we use polymeric material.This ensures that the patients don’t have to go back again to the doctor after six months.

How do you operate in Asia and particularly in India?

We have been selling only the cranial implant products in India so far. Custom cranial implants have been sold in Indian market for the last 3-4 years since we started with a distributor based in New Delhi. The business in India has been small for us. We haven’t entered into the market with other products yet as the primary market of focus has been united states, Europe, New Zealand, Australia and couple of other countries in Asia including Singapore, Malaysia and Hong Kong.

But now having established the Asian headquarters at Singapore, we plan to build our operations in India and other countries in Asia. Within next 2 years, we will build up the capability in Singapore and also devise a business model for India. We want to now start introducing our other products such as spinal implants, orthopedic products. Again, we will like to go into the very niche areas such as tumors, bone tumors, extremely complex re-revision surgeries of the hip etc. Those are the niche areas where the value proposition and product differentiation is very high. Instead of using the standard implant, we will custom make the implant so that you don’t have to do the re-revision surgery. So, in this way, our products are quite unique and innovative.

So, does that mean you will also market stents in India? What are your India plans?

We won’t be doing stents but we will introduce implants such as hip, shoulder, and other parts which are not very well served as of now. What we plan to do in the next nine months is to establish the key clinical partnerships with surgeons across states. These surgeons must be innovators who value the importance of the 3D printed implants and results it could bring to patients. We will also look at creating new business models in India as the products that are highly priced in western nations might not work here. We will try to work on a well suitable product line that maintains the quality yet is affordable in India.

As of now we haven’t come up with a India specific business strategy but we are working on it. We see the enormous potential in India due to the unmet needs of huge number of people here. Opportunities are there but there are challenges such as regulatory and market access. The way system works, how clinicians work, surgeons and supply chain are all factors. Pricing being one of the issue as the products offered by us are expensive. We are looking for building partnerships including distributors and manufacturing companies. Partnerships with the hospitals, clinicians and surgeons are also on cards.

How aware is the market in India about the 3D implants and what are you doing to create the awareness among your target audience?

The awareness levels are very low when it comes to the use of 3D printing in medical practices in India. Our strategy is to build relationships with relevant stakeholders by attending the conferences of importance, one on one meetings with clinical innovators enthusiastic about new developments in 3D printing. They will be our champions of knowledge as they will use it and gain the first hand experience followed by spreading the word around. It is going to take time as the global innovations will spread slowly. The doctors from India will come to know about these through social media and other mediums as well. They will travel to various other countries and gain knowledge first hand. I guess things will pick up in next couple of years.

What is the current use of 3D printing in medical implants within India?

In India, the usage is limited as of now. There are only few startups who have been working on the 3D printed products. Very new and yet to build upon their capability to manufacture implants that are safe. It is a learning curve for them but it is a matter of time, that they will create unique products. But at this moment, we have an edge due to the long experience we have in this space. We have our own softwares to design and test various aspects related to the implants. These are extremely complex processes and those will take time.

What I have seen happening in India are the patient centric anatomy models that are used for pre-surgery planning. The doctors would be interested in the real time models where they could actually understand the issues in patients. I have seen such anatomy models being used but it is a drop in the ocean. So, that is the low hanging fruit where we could witness more companies venturing into the area. But the surgery and implants would require more capabilities and intellectual property. That is where we see the scope.

There have been few major changes in the medical device rules in last for one year. How do you look at it for 3D printed devices?

I am aware only about the latest medical device policy. Not sure whether there are any specific rules for 3D printing and when the India regulatory system is going to catch up on that. But that doesn’t mean there would be any hurdles for 3D printed implants in India. The regulation would be based on the quality and not the way it is manufactured. There would be pros and cons for that but that is how I see it happening as of now.

What about the price control measures on the medical implants?

For us, the price control measures are good and significant for ethical business. The big companies in most of the cases enjoy good relations with the surgeons and many dynamics happen due to it. If the price control regulations are not there, they won’t allow a tiny company like us to recommend product even if at the one tenth of the cost. It opens opportunities for us.

Given there are huge number of patients due to population size in India, we are targeting the niche areas. Personalized medicine in medical devices is happening around the world. It is happening in developed nations and getting better in India. Global trends in the area will also impact India apart from other healthcare issues. The 3D printing will become an enabler in addressing some of the gaps in efficiency issues.