Biomaterials and Medical Devices

The Biomaterials & Medical Devices Division is a multidisciplinary research group whose mission is to develop materials, devices, implants and approaches for biomedical applications. Our research activities are targeted to provide state-of-the-art healthcare to all segments of Indian population primarily at ‘affordable cost’. Our technologies are aligned to national missions such as Swasthya Bharat, Make in India and Innovate in India. The division is among few forerunners in the country involved in developing materials and devices for biomedical applications.

We strongly believe in collaborative research and through effective alliance programs, that include close association of scientists, technologists, surgeons and industries, we actively work on research project that translate into effective healthcare products. With this ideology our research group has developed ceramic femoral head articulating against standard polyethylene of hip joint prosthesis. This product has been clinically tested followed by commercialization. Currently, we are working on new ceramic matrix composite for ceramic-on-ceramic articulating system for Total Hip Arthroplasty. To improve osseointegration of metallic implants we have developed bioactive hydroxyapatite (HAp) coating using plasma spraying and these coatings have been tested clinically. Other commercial biomedical products developed by the division include bioglass coatings, bioactive ceramic scaffolds with controlled porosity characteristics, calcium phosphate granules (single and biphasic) for dental and orthopaedic applications and hydroxyapatite based integrated orbital implant. Other important materials for biomedical applications that are currently under development include ceramic composites, hard coatings, bioglass and nanopowder for drug delivery. In addition to healthcare section, our division is developing ceramic components such as high-temperature, non-shrinkable ceramic potting material, freestanding diamond windows and diamond rods for supports in helix traveling-wave tube (TWT), as a part of India’s contribution towards International Thermonuclear Experimental Reactor (ITER) program.

The division has developed 11 technologies, commercialized 9 technologies and received two best technology awards from Government of India. We currently hold 23 patents including 2 USA and Japan patents. Currently, the division has research funding of ₹ 489 million (USD 7.69 million) during 2012 – 2018 and the divisional members include 7 scientists, 8 technical staff, 17 students (10 Ph.D.; 2 M.Tech; 5 Project staff).

1) Bioactive glass woundcare matrix for healing of diabetic ulcer (clinical trials are being initiated with industry support)
2) Electrospun composite dressing mat made of collagen derived from sweet water fish-skin waste and novel ion doped bioactive glass for the treatment of various wounds including normal, diabetic and burn (Animal trial completed)
3) Novel ion doped bioactive glass and egg-shell membrane (derived from egg-waste) composite as wound-dressing material for scar free wound management. (Animal trial completed)

Due to our extensive collaboration throughout the country and abroad, our research activities include:

1. Orthopaedic, dental and maxillofacial implants/materials
   1. Ceramics and ceramic composites for hip and knee prosthesis.
   2. Metallic and ceramic implants for finger joints, oncology and spine replacement.
   3. Bioresorbable materials for bone replacement.
   4. Bioactive glass and ceramic based cements/materials.
2. Tissue engineering & drug delivery
   1. Bioactive, porous materials for orbital implants and wound dressing applications.
   2. Tailored/designed scaffolds for onsite drug delivery.
   3. Nanoceramic based inorganic drug delivery systems for cancer therapy.
   4. Multifunctional nanofibrous scaffolds based system for cartilage regeneration.
   5. Bioactive glass based dressings for hemostasis/wound healing
3. Reconstructive and Trauma materials
   1. Tailored/designed scaffolds for orthopaedic, cosmetic, cranioplasty reconstruction.
   2. Patient specific and customized implants via additive manufacturing.
4. Coatings
   1. Hard, wear resistance and biocompatible metallic, ceramic and composite coatings for load-bearing implants.
   2. Bioactive, osteoconductive and osteoinductive coatings on bioinert medical materials.
   3. Porous coatings for bone tissue ingrowth.
   4. Microwave plasma chemical vapor deposition of diamond coatings.
5. Other materials and areas
   1. Ceramic and polycrystalline diamond materials for electron tubes.
   2. Ceramic joining.
   3. Microwave processing of ceramic materials.
   4. Unconventional cancer and wound treatment.

Collaboration
India

• Indian Institute of Technology, Madras.
• Indian Institute of Technology, Kanpur.
• Indian Institute of Technology, Delhi.
• Indian Institute of Science, Bangalore.
• Indian Institute of Technology, Kharagpur.
• Vellore Institute of Technology, Vellore.
• National Institute of Technology, Suratkal.
• Malaviya National Institute of Technology, Jaipur.
• West Bengal U of Animal & Fishery Sci, Kolkata.
• Sancheti Inst. for Orthop. & Rehabilitation, Pune.
• Tata Memorial Hospital, Mumbai.
• Jubilant Kalpataru Hospital, Barasat.
• Disha Eye Hospitals and Research Centre (P) Ltd., Barrackpore, West Bengal.
• Sri Sankaradeva Nethralaya, Guwahati.
• Saijyothi Eye Institute, Secunderabad.
• Sir Ganga Ram Hospital, New Delhi.
• Wockhardt Medical Centre, Kolkata.
• R.G. Kar Medical College & Hospital, Kolkata.
• Burdwan Medical College & Hospital, Burdwan.
• Calcutta Medical College & Hospital, Kolkata.
• Regional Institute of Ophthalmology, National Medical College and Hospital, Kolkata.
• N.R.S. Medical College and Hospital, Kolkata.
• Sambhu Nath Pandit Hospital, Kolkata.
• Calcutta Medical Research Institute, Kolkata.
• All India Institute of Medical Sciences, New Delhi.
• Maulana Azad Dental College & Hospital, New Delhi.
• Dr. Rafi Ahmed Dental College & Hospital, Kolkata.
• M/s General Surgical Company (India) Pvt Ltd., Chennai.
• M/s Orthotech, Gujarat.
• M/s Mu Biomagg, Gujarat.

Foreign

• Medical University of Vienna, Austria.
• Washington State University, USA.
• University of Louisville, USA.
• A.M. Prokhorov Gen. Phys. Inst., Russia.
• University of Aveiro, Portugal.
• University of Turku, Finland.
• Abo Academy University, Finland.
• Univ. of Vigo, Spain.
• Mindanao State Univ., Philippines.
• Universität Bremen, Germany.

1. Ceramic based total hip prosthesis (ceramic-on-PE).		2.Plasma spray hydroxyapatite coating on metallic biomedical implants.
3. Manufacture of bioactive ceramic scaffolds with controlled porosity characteristics.		4. Calcium phosphate granules (single and biphasic) for dental and orthopaedic applications.
5. Hydroxyapatite based integrated orbital implant.		6. High-temperature protective coatings for automobile heater plugs.
7. Glass lining coatings.		8. High-temperature protective coatings.
9. Bioactive glass coatings for orthopaedic and dental applications.		10. Plasma spray grade hydroxyapatite powder preparation.
11. Injectable, biodegradable bone cement composite with/without drugs.		12.”Multi-ion doped hydroxyapatite for dental and orthopedic applications’. Status: Pre-clinical studies completed. 13. Development of a novel ceramic based antacid compound for the treatment of hyperchlorhydria. Status: Preclinical studies completed 14.“Useful trace elements containing hydroxyapatite/ β-tricalcium phosphate from biogenic resource, Status: Pre-clinical studies completed.

Technologies under development

Technology Readiness Index: Idea, Concept Definition, Proof of Concept, Prototype, Lab Validation, Technology Development, Technology Demonstration, Technology Integrated, Market Launch.

(A) On-going Divisional Projects:

(B) Completed Projects

1) In vitro tribological and electrochemical testing facilities (Nanovea, USA; Bio-Logic Science Instruments SAS, France):

Our tribological testing system is equipped with rotating and pseudo linear reciprocating type wear testing modules. The test setup also contains accessories to carry out tests in physiological fluid with precise temperature control to represent biological environment in the body. Ball-on-disc or pin-on-disc wear testing can be performed using tribometer with 3 mm and/or 6 mm diameter ball/pins rubbing against test samples. Normal loads up to 40N can be used for tests. Our tribometer instrument has been recently upgraded with tribocorrosion test accessories, which enable isolation of contribution from mechanical wear and corrosion. Electrochemical testing setup has potentiostat, galvanostat, electrometer and frequency response analyzer (FRA) designed to perform several electrochemical research experiments. We extensively use this instrument for electrochemical performance evaluation, such potentiodynamic, electrochemical impedance analysis, of variety of materials and coatings we develop for biomedical applications. Recently, the instrument has been upgraded with tribocorrosion test accessories, which enable isolation of contribution from mechanical wear and corrosion

2. Electrospinning equipment (Super ES-1, M/s E-Spin Nanotech Pvt. Ltd., Kanpur, UP, India):

Electrospinning is a technique used for preparing polymer/ceramic/composites fibers (both nano and micro fibrous patches) using precursor polymer/ceramic solution subjected to high DC electric field. Typical potential difference is applied in the range of 5-25 kV and the distance between needle tip to collector is typically kept at 10-20 cm to obtain electrospunfibers.

3. Incubator Shaker (Spac N Service, Kolkata, india)

Specifically designed for long term and stable continuous operation ideal for pharmaceutical or biotechnology research for storage, incubation or release studies. Incubators to provide condition for optimal growth of microbiological cultures. It consists of speed and temperature controller which is required for the individual experimental protocol. The Maximum speed of the rotator is 200 rpm within a temperature range in the region of 25-60°C.

4. Ion chromatography (792 Basic IC, Metrohm AG, Herisau, Switzerland)

Ion chromatography is a chromatographic process that separates ions and polar molecules based on their affinity to the ion exchanger. Typically Metrosep Organic Acids‐250 (6.1005.200), Metrohm, Switzerland, separation column comprising polystyrene divinyl benzene copolymer with sulfonic acid groups as carrier material (column dimension: 250 × 7.8 mm). A thermostated conductivity detector, attached to the IC having a cell volume of 1.5 mL, measuring alternating current in the conductivity range 0‐1000 mS cm⁻¹ at 1 kHz for detection of the trace level ions in the analyte viz., Arsenite and arsenate, borate, organic acid etc. Further, Metrosep A Supp 5 – 250/4.0 separation column comprising Polyvinyl alcohol with quarternary ammonium groups having column dimension of 250 x 4.0 mm with a maximum pressure of 15MPa. This column is used for the detection of nitrite, bromide, nitrate, and iodide, chloride, sulphate etc in trace amount.

5. Scratch Adhesion Tester (Ducom Instruments (Bangalore, India, TR-101-IAS)

There is a growing trend towards the use of modified surfaces for improved performance and life of components. Modifications are invariably in the form of coatings on base material. They are deposited by electroplating, vapor phase deposition, diffusion, thermal spray or welding. Coatings need to be characterized for parameters like scratch resistance, critical load, adhesion and nature of damage under high stress. The Scratch Tester by Ducom facilitates these measurements over a wide range of parameters. Start load in the range of 1 to 200N with a loading rate of 0-20N/sec. Maximum stroke length is 50 mm. Scratch speed in the range of 0.1-2 mm/sec and offset is in between 0.1-2 mm.

6. Stability Chamber ( CSZ, Cincinnati Sub-Zero, OH 45241, USA)

Stability chambers are widely used in pharmaceutical laboratory, clinical trials, material testing and stability studies as per ICH guidelines. Test chamber is designed to create extremely stable temperature and humidity environments inside closed cabinet, a prerequisite condition to analyze the effects of pre-specified conditions w.r.t. temperature, humidity or both on life saving drugs and medicines, biological samples, electronic components and even industrial machine parts etc. This is suitable for stability studies including Long Term: 2-8°C, 25°C/60% RH, 25°C/40% RH, 30°C/35% RH or 30°C/65% RH, Intermediate: 30°C/65% RH and Accelerated: 40°C/75% RH, 25°C/60% RH.

Dr. Vamsi Krishna Balla
Chief Scientist and Head
Phone: +91-(033) 2322 3219
Fax: +91-33-24730957
E-mail: vamsiballa@cgcri.res.in