Innovating tailored biomedical implant solutions

The Pune based Orthocrafts Innovations has been developing an indigenous product portfolio of medical implants using bioabsorbable polymers and their composites

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Pune: It all began nine years back when the Pune based National Chemical Laboratory (NCL) Chief Scientist, Dr Ashish Lele was first introduced to screws made of polymer called polylactic acid (PLA) to be used for repair of torn anterior cruciate ligament. That instantly attracted his attention due to unique properties of the polymer being absorbable inside the body and retaining mechanical properties upto certain time period. He in turn introduced this product to Dr V Premnath, also a Chief Scientist at NCL. The product was promising and was sufficiently challenging to stir the enthusiasm amongst both. Having teamed up before to develop biocompatible maxillofacial volume filling implants, both decided to take up the challenge and initiated efforts towards development of the product.

In year 2010, Piyush Joshi, a polymer engineer from the University of Pune joined the team. His expertise helped team to identify the benchmark properties of the product to be developed and economics of the product. Team soon recognised that what was going to be important is to make bioabsorbable polymers with varied properties. All the efforts of the team were directed towards synthesis of appropriate molecular weight PLA material.

Team participated in Lab2Mkt program of Venture Center which helps scientist entrepreneurs to take their business ideas into the market. Team raised a small funding to setup initial experiments to synthesize the bioabsorbable polymers and carry out further market research. With sustained market research team understood that this single product soon leads to envisage the whole product portfolio using bioabsorbable polymers and their composites.

bioabsorbable interference screw editedProduct Status: Orthocrafts has developed the minimum viable product for bioabsorbable interference screw and currently gearing for pre-clinical and clinical trials. The company is also in process of dev eloping solutions for shoulder, knee, ankle and elbow surgeries which involves attaching soft tissues to bone.

By year 2012, the team identified other products using similar polymers. At that time, there were no Indian manufacturers of biomedical grade PLA and this was a real setback for Indian medical device manufacturer and surgeons to rely on foreign players. Team saw this as an opportunity and decided to use their expertise to develop the bioabsorbable materials and products using same for India. This was the moment when the idea was taking firm roots to be considered as platform to create new venture. Over next two years team was building its knowhow in chemistry of medical grade PLA and was waiting for appropriate funding opportunity.

The opportunity striked when BIRAC announced a grant funding scheme titled as “Biotechnology Ignition Grant.” Team realized that this will be an excellent opportunity to bring their efforts to fruition. Team participated in the funding scheme. On receipt of approval from BIRAC team established a start-up, Orthocrafts Innovations on 5th June 2014.

It was never an easy route…..

Path was never simple at the beginning. Lack of ready infrastructure, non-existent dialogue between product users and product developers, access to crucial raw materials were the most common hurdles. One of the great challenges faced by Orthocrafts was to identify and execute suitable technology transfer model from NCL.

In its initial days Orthocrafts faced issues with putting required resources at one place such as skilled man power, equipment and funds etc. However, the company faced major challenge in terms of taking business idea from ideation stage to prototype stage through existing ecosystem. There were hurdles in terms of setting up right mechanisms to transfer technology to start-up, possibility of scientist participating in start-up, scarcity of scale-up funding for ideation stage to first prototype. Today Orthocrafts has overcome all these hurdles and accelerated their efforts to take innovation to market.

Ashish LelePiyush JoshiDr-V-Premnath1

(L-R) Dr Ashish Lele, Director and Scientist, National Chemical Laboratory, Mr Piyush Joshi, COO and Executive Director and Dr V Premnath, Advisor and Head, NCL Innovations.

The founders thank NCL’s innovation team for their prodigious efforts and continued support. Orthocrafts today enjoys necessary technology rights for material and product development, they say, adding that it is unique in terms of a company structure, where scientists from CSIR are allowed to take equity and be a promoter of the company. Orthocrafts is amongst the first few start-ups where CSIR’s “Scientist Entrepreneurship Scheme” has come to fruitation. So far it has been successful in setting up new trend amongst scientists, who now are thinking of shifting from traditional technology development and transfer model.

Transformation of an idea into enterprise

The genesis of Orthocrafts lies in Lab2Mkt program of Venture Center and Proof of Concept initiative at Venture Center. The idea bagged its initial funding of mere Rs 7 lakhs from Proof of Concept initiative. However, this kick-start funding proved to be a lifeline. On successful development of SOP for polymer materials Orthocrafts decided to develop downstream product (ACL screw) for which they received grant funding support from BIRAC.

Orthocrafts envisages catering to global biomaterial users with focus on orthopaedic applications. It will aggressively grab opportunities to work with surgeons and hospitals to cater to their needs. Considering India’s growing potential in medical tourism. The firm will focus on multispecialty hospital chains in tier 1 cities. However, the company says it will establish connections with surgeons in tier 2 and tier 3 cities to increase its impact.

One of the biggest challenges for Orthocrafts will be to navigate through almost nonexistent regulatory system in India. “We also envisage that acceptance of product amongst the medical fraternity will take some time but we wish to deliver a world class innovation at disposal of Indian surgeons,” reveals Piyush adding that “While we face strong competition from current foreign players in Indian market, we are confident that we will be able to penetrate through market.”

Giving a sneak peek into the vision that drives the company, Piyush says, “Orthocrafts Innovations believes that materials development for biomedical applications is its niche and will transform medical device industry slashing time to develop product and cost.” Talking about future, he says, “We plan to capture the value in development of biomedical grade polymers suitable for implants and downstream products using same. We plan to work closely with Indian medical device users to develop newer products. Ability to tailor the materials making them suitable for product development is Company’s’ biggest strength.”

Way forward

The market for medical implants that use biodegradable materials is more than 150 million USD. Global soft tissue repair market is pegged at 10 billion USD. The company is looking at initially tapping into Indian market and aspires to generate a million-dollar revenue stream in few years of operations.

Orthocrafts intends to develop its portfolio of products by expanding into new biocompatible bioabsorbable materials such as PDLA (poly D lactide) and PCL (polycaprolactone). It also aims to develop next level of downstream products such as suture anchors and tacks for hernia repair. “The startup will focus on building a strong IP portfolio for these materials and products as we go ahead, says Piyush who adds that the company has developed the minimum viable product for bioabsorbable interference screw and currently gearing for pre-clinical and clinical trials, “We are also in process of dev eloping solutions for shoulder, knee, ankle and elbow surgeries which involves attaching soft tissues to bone.”

Starting from raw material to final product, Orthocrafts has developed its own proprietary process of making polymers and further processing them into various shapes. It envisages another couple of years to launch its products into market.