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Research and Development

Our commercial approach is geared towards invention, revolution, and improvement in health care; owning to which we continuously strive to introduce sustainable medical solutions into the market that improves the quality of life worldwide. We understand the medical  challenges and attempt to think outside the box solution. We achieve this goal by joining the forces of our research experts and industrial pioneers.

At Kamal, we in-house a dedicated research and development subdivision, whose only motto is to innovate new medical devices and improve the existing ones. Experimentation and advancement are often predominant in our R & D division. Our team follows a systematic R&D cycle that begins with thought processing and theorizing, followed by exploration, and then into design and development. It involves proficiency in design competencies, the latest technical resources, thorough testing facilities, and an in-depth understanding of the patient and the market. To strengthen our research and development activities, we have collaboration with India’s most renowned research partners; IIT Delhi, CSIR India, and Maulana Azad Institute of Dental Sciences.

What do we do?

We develop or improve products through a stringent and well-controlled series of interconnected processes, whose output is a new or better medical product.

Research

 
Our R&D team works diligently with the sales and marketing team to establish unmet patient and market needs. Our team is then able to interpret market context and customer requirements into a tangible design input. Gradually the scope of work is established, which includes project feasibility & management, design, and development planning, quality, and regulatory aspects.

Conceptualization and Development of Prototypes

With technological advancement, the initial concept is generated using advanced digitized software. We then leverage this concept to establish work ideas using CAD to develop functional prototypes. Complex mitigation measures are used to lower the risk profile of the devices. Our design and development processes are streamlined to scrutinize each stage.

Design Verification and Validation

Several rigorous tests are conducted during this stage, which exposes the product to worse case scenarios and ultimately enables to product to perform exceptionally well in real-life conditions. Special attention is given to device ergonomics – often known as human factors engineering

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Our Current Research and Development Project

01. Everolimus Eluting Coronary Stent System

The stent design which is fabricated from Cobalt Chromium L605 is the main component of the Everolimus eluting coronary stent system. The CAD model of the various stent designs was prepared & an in-house evaluation has been done by checking various characteristics of the stent-like crossing profile, foreshortening, recoil, dimensional measurement, coating integrity, etc. by stereoscopic microscope. After successful in-house evaluation, the Finite element analysis (FEA) was performed at an external laboratory. After successful completion of FEA, the physical samples have been prepared and a series of in-vitro engineering studies were carried out at external laboratory-like Stent simulated use, particulate matter analysis, coating integrity, coating fatigue, retention force, trackability & pushability analysis, retention force, long time coating durability, coating thickness measurement, recoil, foreshortening, a tensile test of the delivery catheter, etc. as per ISO 25539-2. This FEA analysis & In-vitro engineering bench test is part of the design review.

02. Stent descaling process

Improvement in Existing Process:
A descaling is one of the manufacturing steps/processes which is used to remove the metal oxides, which are formed during the stent laser cutting process. Already in-use process took more time (more than 6 hours) to remove the oxides. To reduce this time of the descaling process, so that overall the manufacturing time could be reduced, a new formulation for the descaling process was introduced and optimized by several trials. It was tested for its applicability. With the help of this new formulation, the descaling process was carried completed with a time span of just one hour (+/- 10 minutes) and the oxides were removed. This new formulation is implemented in routine production and it is giving desired outputs. The descaling process is validated with this new formulation.

03. Stent Electropolishing process

Improvement in Existing Process:
The Stent is subjected to an Electro-polishing process to get the required final dimensions of the stent as well as surface smoothness at the edges (for biocompatibility), at the inner surface, and at the outer surface. The existing Electropolishing process was carried out with a single stent. i.e., the Electropolishing process was conducted for a single stent at a time. However, this is quite time-consuming. Hence improvement was needed in this process to reduce the time consumption. Thus R & D was conducted to improvise the EP process in a manner that multiple stents could be polished at a time. This improvisation was successful and currently, three stents are being electro-polished at a time. This was increased the production capacity several folds while maintaining the quality of process outcome.

04. Everolimus-Eluting dilatation balloon Catheter (PTCA)

With the development & trend usage of drug-eluting stents, the scenario of PCI has changed dramatically with more & more adoption. However, there is an issue of ISR (In-stent restenosis) in the treated vessel. To overcome this, there is a need for the usage of the drug-eluting balloon in the concerned vessel. Also, in a few indications like bifurcation lesions, small vessels etc., the usage of the drug-eluting balloon is recommended. Since Everolimus & Sirolimus API are highly lipophilic, the encapsulation of them is very much important & to prove this concept, we would have to perform a series of testing (including pre-clinical & clinical trials) which are covered under this project.

05. PTCA Catheter

The drug-eluting stent (DES) is manufactured by us. The stent delivery catheter is a main raw material to manufacture DES and currently, we are importing this from Mauritius. Apart from this, there is a need for pre dilatation & post dilatation (after stenting) in the concerned coronary vessel. We are also looking forward to adding these types of PTCA catheters to our product portfolio. Moreover, if this is manufactured in our premises then we can have a full quality control with us & we do not need to depend on the vendor side. The cost of raw-material (i.e., PTCA Catheter) could be reduced. Given the above, there is a need to develop PTCA catheter indigenously.

06. Drug-Eluting Bioresorbable Scaffold

The current generation of the drug-eluting stent is made from cobalt-chromium & platinum/chromium alloy which remains permanent in the coronary artery. We are looking forward to the development of a Bioresorbable scaffold that will be completely degradable over the period once artery remodeling is completed & it is completely healed.

07. PTA Dilatation Catheter

Currently, this device is getting imported for the treatment of the Indian population. We are looking forward to setting up mfg. facility for PTA range of products (pre & post dilatation), there is a huge export opportunity for these types of products

08. Everolimus-Eluting dilatation balloon Catheter (PTA)

Currently, this device is being imported for the treatment of the Indian population. We are looking forward to setting up a mfg. facility for Drug-eluting PTA range of products (pre & post dilatation), there is a huge export opportunity for these types of products. There is an issue of ISR (In-stent restenosis) in the treated peripheral vessel. To overcome this, there is a need for the usage of drug-eluting balloons in the concerned vessel. Also, a few indications like bifurcation lesions, small vessels, usage of the drug-eluting balloon is recommended. Since Everolimus & Sirolimus API are highly lipophilic, the encapsulation of them is very much important & to prove this concept, we would have to perform a series of testing (including pre-clinical & clinical trials) which are covered under this project.

09. TAVI (Transcatheter Aortic valve implantation)

Currently, this device is being imported in India and the cost is very high. Access to this therapy to the Indian population is a challenge. We are looking forward to developing this device to have easy access to our Indian population & product quality shall be as per global regulatory requirements. Our target is to supply this device at an affordable cost so that patients can have the advantage of clinical benefits of this device and can have improved life

10. Self-expanding Nitinol Stent

Currently, India is highly dependent on imported devices & access to the Indian population is quite tough. We are looking forward to developing this device for easy access to the Indian population with international quality levels as per applicable regulatory guidelines. Export is a big opportunity for this device. Hence the route of development will be defined & executed accordingly

11. Interventional guide wires (PTCA & PTA)

Currently, India is highly dependent on imported devices. We are looking forward to developing this device in-technical collaboration with overseas design partners for easy access to the Indian population with international quality level as per applicable regulatory guidelines. Export is a big opportunity for this device. Hence the route of development will be defined & executed accordingly.

12. Zygomatic Implants

Zygoma implants are different from conventional dental implants in that they anchor into the zygomatic bone rather than the maxilla. They may be used when maxillary bone quality or quantity is inadequate for the placement of regular dental implants or rehabilitation of Oral cancer patients. Bone grafting procedures in the jaws have the disadvantage of prolonged treatment time, restriction of denture wear, the morbidity of the donor surgical site, and graft rejection.
The Zygoma implant is available in length ranging from 30-60mm compared to the conventional two-piece implant which is 6-16mm. The head of the Zygoma implant is engineered to allow insertion of prosthesis attachment at a 45-degree angle to the long axis of the implant. Currently, there is no indigenous company making Zygomatic implants. There is a special CNC machine and tooling required. The current Indian market is serviced by International companies only.

13. PEEK Implants

Titanium Modified Peek as an alternative Implant System. The objective for this project is to develop an indigenous implant system with the modulus of elasticity compatible with both cortical and cancellous bone which can be achieved with PEEK Compensating for the aging effect & decrease in Osseointegration potential Special tools and machine requirements for machining PEEK and reinforcement of Titanium on the surface. Currently, no Indigenous company is working on this concept

14. Bone Grafts and Membranes

Bone grafts & Membranes are artificial bone substitutes used in bone and soft tissue defects. Currently, we have only 2 manufacturers of synthetic bone substitutes in India however the market is dominated by international companies. This would require working with Calcium Phosphate/ Hydroxyapatite / Bioactive glass / synthetically derived collagen fiber / periodontal fiber.

15. Titanium, Zirconia & PEEK Prosthetic Range

Manufacture different types of prosthetic components for different types of implant connections in different materials Titanium, Zirconia & PEEK which will cater to various clinical scenarios.

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