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Welcome to SCTIMST

Check out the programmes and their status:
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Welcome to SCTIMST

Check out the programmes and their status:

Objectives & Deliverables


Objectives:

1. To develop coronary stent system prototypes.
2. Vendor identification - titanium nitride coating, balloon catheters, stent cutting and          polishing, delivery system accessories

Deliverables:

1. Coronary stent system prototypes.
2. To carry out proof of concept in vitro and in vivo studies to verify the design.

Salient Features


Progress till date


Technology Readiness Level (TRL)

TRL-4

Key Players (Collaboration)


Challenges


Objectives & Deliverables

Standard approach to stimulating human nerve cells uses electrical current.Optical nerve stimulation overcomes many of the problems like pain associated with electrical stimulation: it requires no physical contact with the nerve cells. Light source can be tuned to precisely hit a small desired area.The project will focus on the feasibility of optical neural stimulation.

Objectives:

To check the wavelength, power and power density required for nerve stimulation in tissue specimens. Whether this power density induce any tissue damage. The depth of penetration of the laser diodes for intact stimulation through skin. Reproducability of the results.

Deliverables:

  • Prototype devices
  • Device Design Dossier
  • Material Evaluation Matrix
  • Device Evaluation Matrix

Salient Features

  • Replacement for electrical stimulatio
  • Reduced pain perception

Progress till date

  • PoC studies in progress

Technology Readiness Level (TRL)

TRL-2

Key Players (Collaboration)

  • Dr. R S Jayasree, Scientist F  (Principal Investigator)
  • Dr. Sruthi S Nair(Principal Clinical Investigator)
  • Category: Neuroprosthetic Device

Challenges

  • Clinical acceptance

Objectives & Deliverables

The extra cellular matrix, from tissues of animal origin after removal of unwanted cells, has a rich load of natural bio-molecules that promote tissue regeneration.  This makes the extracellular matrix an excellent choice for enhanced wound healing.

Objectives:


  • Process development
  • Biological characterisation
  • Preclinical evaution

Deliverables:

  • Proces knowhow
  • Device Design Dossier
  • Material Evaluation Matrix
  • Device Evaluation Matrix

Salient Features

Combines three natural biological matrix components such as:
i.   Fibrin- composite matrix which is hemostatic
ii.  HA which hydrates the wound
iii. Amnion to use as an implantable biodegradable matrix to promote wound healing through guided tissue regeneration in vivo

Progress till date

  • Process development complete

Technology Readiness Level (TRL)

TRL-4

Key Players (Collaboration)

  • Dr. Lissy K Krishnan,Scientist G (Senior Grade) (Phase Principal Investigator)
  • Dr. Prasanth Varkey (Principal Clinical Investigator)
    Category: Biologic / Combination Device

Challenges

  • Knowhow transfer
  • Rwmateria sourcing
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Objectives & Deliverables

MRSA is a bacterium that is tougher to treat because it is resistant to some commonly used antibiotics.A microbial strain which produces an antibacterial agent which is active against MRSA has been isolated. Project aims at detailed characterization of this antimicrobial molecule.

Objectives:

Detailed identification of the organism using different methods.
Identify and standardize conditions of expression of the antibiotic molecule of interest.
  • Complete identification upto species level of the Bacillus sp.
  • Dynamics and timelines of production of the antibacterial molecule by the organism.
  • Standardisation of production conditions of the antimicrobial molecule.

Deliverables:

  • Process knowhow
  • Device Design Dossier
  • Material Evaluation Matrix
  • Device Evaluation Matrix

Salient Features

  • Different applications include usage as drug, antimicrobial coatings etc.,

Progress till date

  • Batctera identified and characterised

Technology Readiness Level (TRL)

TRL-1

Key Players (Collaboration)

  • Dr. A Maya Nandkumar,Scientist G  (Principal Investigator)
  • Category: Biologic / Combination Device

Challenges

  • Fermentation and purification of the antimicrobial molecule 
  • To standardise conditions of fermentation 
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Objectives & Deliverables

 An Implantable Cardioverter Defibrillator (ICD) is a battery-powered device implanted under the skin of the chest, which is able to perform cardioversion, defibrillation and  pacing of the heart.Cardioversion is a procedure by which an abnormally fast heart rate (tachycardia) or other cardiac rhythm disorders are treated using electrical signals. Defibrillation is a treatment for life-threatening cardiac fibrillation (unsynchronized contraction of heart muscles) using electrical shocks.

Objectives:

  • Develop a set of ICD prototypes.
  • Carry out the proof of concept experiments to finalise the design, processing steps and packaging and sterilization aspects.

Deliverables:

  • Device prototypes
  • Device Design Dossier
  • Material Evaluation Matrix
  • Device Evaluation Matrix

Salient Features

  • Improved detection algorithms
  • Enhanced service life

Progress till date

  • Specifiction development

Technology Readiness Level (TRL)

TRL-2

Key Players (Collaboration)

  • Mr. Muraleedharan C V, Scientist G (Senior Grade) (Principal Investigator)
  • Prof. N Namboodiri (Principal Clinical Investigator)
  • Category:Cardiovascular Device

Challenges

  • Battery with enhanced service life
  • Wireless communication
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Objectives & Deliverables

Parylene (poly paraxylylene) is a material used for coating medical devices and device delivery systems for imparting coatings with very low friction coefficient, good conformity and excellent dielectric properties. 
The projects aims to develop the parylene coating on different substrates which can be further extended in the fabrication of medical devices such as Left Ventricular Assist Device (LVAD), Deep Brain Stimulator (DBS) etc and for the delivery system  for  Aortic Stent graft, Atrial Septal Defect Occluder, Flow Diverter Stent etc.

Objectives:

  • Develop parylene coating process on metallic and polymer substartes
  • Safety and efficacy characterisation

Deliverables:

  • Process knowhow
  • Material Evaluation Matrix

Salient Features

  • Lubricious coating
  • Reduces metal ion elution

Progress till date

  • Process development in progress

Technology Readiness Level (TRL)

TRL-1

Key Players (Collaboration)

  • Dr. Ramesh P,Scientist G  (Principal Investigator)
  • Category: Cardiovascular Device

Challenges

  • Process development
  • Facility setting up

Objectives & Deliverables

 Embolization involves the selective occlusion of blood vessels by purposely introducing emboli and is used to treat a wide variety of conditions affecting different organs of the human body like aneurysm, tumor isolation etc. The objective of the project is to develop an indigenous technology for radiopaque polymeric microspheres intended for embolization therapy. 

Objectives:

To develop an indigenous alternative to tantalum loaded embolization agents. This would be done by synthesizing iodinated radiopaque polymers. 
  • Synthesis and characterise appropriate iodine containing compounds that would provide radiopacity.
  • Graft iodo-compounds onto polymers.
  • Characterization of the radiopaque polymers

Deliverables:

  • Process knowhow
  • Device Design Dossier
  • Material Evaluation Matrix
  • Device Evaluation Matrix

Salient Features

  • Expected to reduce catheter entrapment, catheter blockage and less artefacts in computed tomography.
  • Helps to locate the position without the use of contrast agent.

Progress till date

  • Microsphere development

Technology Readiness Level (TRL)

TRL-2

Key Players (Collaboration)

  • Dr. Roy Joseph,Scientist G  (Principal Investigator)
  • Dr. Jayadevan E R (Principal Clinical Investigator)
    Category: Neuroprosthetic Device

Challenges

  • Microsphere development
  • Optimizing the flow characteristics
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Objectives & Deliverables

 The basic appeal of oral hypoglycaemic agents is that most people would prefer a pill or an oral liquid to an injection. However, insulin is a hormone, which is digested in the stomach and gut.The project attempts to develop a strategy for oral delivery of insulin by suitably encapsulating to protect it during its traverse through the stomach.

Objectives:

  • Nanoparticle synthesis and characterisation
  • Formulation development
  • Assessment of insulin release profiles
  • Efficacy studies in animals

Deliverables:

  • Process knowhow
  • Device Design Dossier
  • Material Evaluation Matrix
  • Device Evaluation Matrix

Salient Features

  • Oral insulin delivery
  • Liquid polymer complex for protection in the GI tract

Progress till date

  • Formulation completed
  • Efficacy studies in progress

Technology Readiness Level (TRL)

TRL-3

Key Players (Collaboration)

  • Dr. Rekha M R, Scientist F  (Principal Investigator)
  • Category: Biologic / Combination Device

Challenges

  • Enacsulation of insulin
  • Optimization of release profiles
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Objectives & Deliverables

An implantable micro infusion pump which can deliver drug to the region of interest such as peritoneal cavity, spinal cord etc.   Battery operated device will have a drug reservoir and a miniature drive mechanism for delivering the drug through a catheter . Refilling of drug can be achieved by injecting through a specific port. The device will be powered by a battery which can be recharged by transcutaneous energy transfer system (TETS) thereby avoiding percutaneous wires and associated infections.

Objectives:

  • Design and develop an implantable microinfusion pump with wireless connectivity for programming

Deliverables:

  • Device prototypes
  • Device Design Dossier
  • Material Evaluation Matrix
  • Device Evaluation Matrix

Salient Features

  • Wireless battery charging
  • Porvision of drug replenshing through injection
  • Can be used for paliative care also

Progress till date

  • Specification development completed
  • Design in progress

Technology Readiness Level (TRL)

TRL-2

Key Players (Collaboration)

  • Mr. Sarath S Nair, Engineer D  (Principal Investigator)
  • Category: Neuroprosthetic Device

Challenges

  • Trancutaneous power tranfer
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Objectives & Deliverables

Hydrocephalus is the condition in which the cerebrospinal fluid (CSF) is accumulated within the brain. Hydrocephalus is treated by a surgical operation in which a shunt which connects the brain   region to  the peritoneal cavity. Current generation devices incorporate a predefined opening pressure valves. The proposed device will have a capability to program its opening pressure after implanttion.

Objectives:

Design and develop  programmable flat type hydrocephalus shunt system in which the pressure the opening pressure  could be externally programmed to met the clinical requirements

Deliverables:

  • Working prototypes
  • Device Design Dossier
  • Material Evaluation Matrix
  • Device Evaluation Matrix

Salient Features

  • Programmable pressure valve
  • MRI Compatibility.

Progress till date

  • 3D Modelling and Test set up in progress.
  • Specification development.

Technology Readiness Level (TRL)

TRL-2

Key Players (Collaboration)

  • Mr. Anoop Gopinathan, Engineer C  (Principal Investigator)
  • Dr. Easwer H V, (Principal Clinical Investigator)
  • Category:Neuroprosthetic Device

Challenges

  • External programming of the device
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Objectives & Deliverables

Aims to develop a 3 Dimensional dermal-epidermal functional skin construct. A polymer ink based fabrication using 3D bio printing techniques used for encapsulating skin cells likekeratinocytes, fibroblasts and melanocytes for skin regeneration.

Objectives:

  • Identification and optimization of bioink formulation.
  • Characterisation of the formulaion.
  • Isolation and chacterization of skin cells (keratinocytes and fibroblast, melanocytes).
  • Printing of 3D construct as a testing platform for drugs/cosmetics.
  • Analysis of cell viability and fuctionality on 3D construct.
  • Histological analysis of the construct.

Deliverables:

  • A process for the 3D printing of skin constructs
  • Device Design Dossier
  • Material Evaluation Matrix
  • Device Evaluation Matrix

Salient Features

  • Potential to replace animal tsting of cosmetics and wound care products
  • Three dimensional confguration

Progress till date

  • Bioink formulations developed
  • Characterisation in progress

Technology Readiness Level (TRL)

TRL-1

Key Players (Collaboration)

  • Dr. Anugya Bhatt, Scientist E  (Principal Investigator)
  • Category: In Vitro Diagnosis Device

Challenges

  • Bioink formulation
  • Regulatory acceptance
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Objectives & Deliverables

Extracorporeal Cardiopulmonary Bypass is a technique where the patient heart has to be stopped or bypassed during open heart surgery.The functions of the heart and lungs will be replaced by blood pump and oxygenator respectively. Roller pumps are cost effective for bypass, but causes blood damage.Centrifugal blood pump reduces blood damage substantially. Blood flow meter is used for measuring the flow output from the pump

Objectives:

  • Improving the available design of blood pump with design for manufacturing as the core objective.
  • Evaluating the prototypes in accordance with international standards using animal blood and controlled ex-vivo evaluation.

Deliverables:

  • Device Design Dossier
  • Material Evaluation Matrix
  • Device Evaluation Matrix

Salient Features

  • Detachable drive unit adjusts the speed of the pump as required during the surgery, thus the pump can be kept very near to the patient, reducing the priming volume of the tubings.
  • The functions of the heart and lungs will be replaced by blood pump and oxygenator respectively.
  • Roller pumps are cost effective for bypass, but causes blood damage. Centrifugal blood pump reduces blood damage substantially. Blood flowmeter is used for measuring the flow output from the pump.

Progress till date

  • Design and prototyping of components and subsystems finalised.
  • Mould flow analysis for finalizing the tooling in progress.
  • Vendor development in progress.

Technology Readiness Level (TRL)

TRL-3

Key Players (Collaboration)

  • Mr. Vinodkumar V,  Engineer F (Principal Investigator)
  • Dr. Vivek V Pillai, (Principal Clinical Investigator)
  • Category: Cardiovascular Device
  • M/s. SIDD Lifesciences Pvt. Ltd, Tamil Nadu (Industrial Collaborator)

Challenges

  • Animal experiments for verifying the design
  • High precision component manufacture
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Objectives & Deliverables

A mechanical pump used to support heart function in patients who have weakened hearts. The device takes blood from the left ventricle of the heart and helps pump it to the body and vital organs, just as a healthy heart would.This can be used in patients waiting for heart replacement or patients having problems during surgery where heart will recover if it is allowed to relax for few days.

Objectives:

  • Design of a paracorporeal pump for supporting the left ventricle to a duration of 15 days with a flow rate up to 5 lpm at a head of 120mm Hg.
  • The pump will consist of a pump head with suitable inlet outlet ports, having its own integrated drive, controller, power supply systems and necessary interconnections.

Deliverables:

  • Device Design Dossier
  • Material Evaluation Matrix
  • Device Evaluation Matrix

Salient Features

  • A mechanical pump used to support heart function in patients who have weakened hearts.
  • The device takes blood from the left ventricle of the heart and pumps it to the body and vital organs, just as a healthy heart would.
  • This can be used in patients waiting for heart replacement or patients having problems during surgery where heart will recover if it is allowed to relax for few days.

Progress till date

  • Design and prototyping of components and subsystems completed
  • Subsystems getting verified against design targets
  • Vendor development in progress.
  • One provisional patent application filed for the novel magnetic bearing
  • In vitro verification experiments progressing.

Technology Readiness Level (TRL)

TRL-3

Key Players (Collaboration)

  • Mr. Nagesh D S, Scientist G(Senior Grade) (Principal Investigator)
  • Dr. K Jayakumar, (Principal Clinical Investigator)
  • Category: Cardiovascular Device
  • TTK Healthcare Ltd., Trivandrum (Industrial Collaborator)

Challenges

  • Controlling the device temperature within physiological limits.
  • Product encapsulation.
  • Infection control in Paracorporeal entry points.
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Objectives & Deliverables

Used as an alternative to conventional surgical repair of aortic aneurysms (localized blood filled balloon like bulge in the wall of large arteries).The device is tubular fabric structure with metal reinforcement which can be delivered to the site using catheters .The patient recovers fast and it requires only a shorter period of hospital stay. 

Objectives:

  • Design and prototype fabrication
  • In vitro efficacy studies
  • Preliminary in vitro safety studies
  • Proof of Concept studies on large animals

Deliverables:

  • Aortic stent graft prototypes
  • Device Design Dossier
  • Material Evaluation Matrix
  • Device Evaluation Matrix

Salient Features

  • Used as an alternative to conventional surgical repair of aortic aneurysms (localized blood filled balloon like bulge in the wall of large arteries) using vascular grafts.
  • The device is tubular fabric structure with metal reinforcement which can be delivered to the site using catheters.
  • The patient recovers fast and it requires only a shorter period of hospital stay.

Progress till date

  • Design and prototyping of device completed
  • Four patent applications filed for delivery system mechanisms and stent crown designs
  • Five design registration applications filed for five different novel stent crown designs made
  • Material indigenization program initiated

Technology Readiness Level (TRL)

TRL-3

Key Players (Collaboration)

  • Mr. Sujesh Sreedharan, Engineer F  (Principal Investigator)
  • Category: Cardiovascular Device
  • M/s. National Aeronautical Laboratories, Bangalore (Institutional Collaborator)
  • M/s. South India Textile Research Association, Coimbatore (Institutional Collaborator)

Challenges

  • Special grade fine fabric sourcing
  • Device delivery system development
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Objectives & Deliverables

Parkinson’s disease (PD) patients suffer from a variety of movement related disorders such as tremors, stiffness of limbs, slowness of movements and poor balance.  Low energy electrical stimulation of certain regions of brain using electrodes implanted in the brain controls these symptoms.Deep Brain Stimulator employs a pulse generator and a set of platinum electrodes to achieve the required effects.

Objectives:

  • Develop deep brain stimulator system prototypes.
  • Carry out the Proof of Concept experiments to finalise the design, processing steps, packaging and sterilisation aspects.

Deliverables:

  • Working prototypes
  • Device Design Dossier
  • Material Evaluation Matrix
  • Device Evaluation Matrix

Salient Features

  • Small form factor
  • Scalable

Progress till date

  • Specifications finalised
  • Prototyping completed
  • Development of clinician / patient programmers in progress

Technology Readiness Level (TRL)

TRL-3

Key Players (Collaboration)

  • Mr. Muraleedharan C V, Scientist G  (Principal Investigator)
  • Dr. Asha Kishore, (Principal Clinical Investigator)
  • Category: Neuroprosthetic Device
  • M/s. Bhabha Atomic Research Centre, Mumbai (Institutional Collaborator)
  • M/s. Shree Pacetronics (Industrial Collaborator)

Challenges

  • Encapsulation of electronics.
  • Controlling the device temperature within physiological limits.
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Objectives & Deliverables

Presence of White Blood Cells (WBC) in transfused blood could result in transmission of viral infection, immune suppression and transfusion related lung injury. Leuko-reduction is the removal of white blood cells (or leukocytes) from the transfused blood. The device employs special membranes which attracts and traps WBC as blood passes through it.

 

 

Objectives:

  • Develop leukodepletion filters
  • Safety and efficacy studies

Deliverables:

  • Working prototypes
  • Device Design Dossier
  • Material Evaluation Matrix
  • Device Evaluation Matrix

Salient Features


Progress till date

  • Specification development
  • Device design in progress.

Technology Readiness Level (TRL)

TRL-2

Key Players (Collaboration)

  • Dr. P Ramesh, Scientist G  (Principal Investigator)
  • Dr. Debasish Gupta, (Principal Clinical Investigator)
  • Category: Cardiovascular Device
  • M/s. South India Textile Research Association,Coimbatore (Institutional Collaborator)

Challenges

  • Achieving WBC removal targets
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Objectives & Deliverables

 The Annuloplasty ring is a rigid or flexible ring implanted around the mitral valve for reconstructive treatment of valvular insufficiency. The implanted device enhances leaflet coaptation while preserving the native annular shape and motion.

 

Objectives:

  • Development of rigid annuloplasty ring
  • Development of flexible annuloplasty ring
  • Safety and efficacy evaluation


Deliverables:

  • Working prototypes
  • Device Design Dossier
  • Material Evaluation Matrix
  • Device Evaluation Matrix

Salient Features

  • Minimal metal ion leaching
  • Two models - rigid and flexible configurations

Progress till date

  • Device design completed.
  • Prototyping completed
  • Efficacy tests in progress

Technology Readiness Level (TRL)

TRL-3

Key Players (Collaboration)

  • Mr. Ranjith G, Engineer E  (Principal Investigator)
  • Dr. Vivek V Pillai, (Principal Clinical Investigator)
  • Category: Cardiovascular Device

  • M/s. South India Textile Research Association, Coimbatore (Institutional Collaborator)
  • TTK Healthcare Ltd., Trivandrum (Industrial Collaborator)

Challenges

  • Precision wire bending
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Objectives & Deliverables

Artificial heart valves are devices used for replacing diseased / damaged natural valves of the heart. Bio prosthetic heart valves are artificial valves made from materials of biological origin and are preferred in elderly patients. 



Objectives:

  • Development of bioprosthetic heart valve using chemically treated animal pericardium.
  • Establishing the concept through limited invitro and invivo trials

Deliverables:

  • Working prototypes
  • Device Design Dossier
  • Material Evaluation Matrix
  • Device Evaluation Matrix

Salient Features

  • Minimal calcification
  • Improved service life 

Progress till date

  • Stent Design completed.
  • Leaflet design progressing.
  • Animal tissue sourcing established

Technology Readiness Level (TRL)

TRL-3

Key Players (Collaboration)

  • Dr. Umashankar P R, Scientist G (Principal Investigator)
  • Dr. Vivek V Pillai, (Principal Clinical Investigator)
  • Category: Cardiovascular Device
  • M/s. South India Textile Research Association, Coimbatore (Institutional Collaborator)

Challenges

  • Tissue sourcing.
  • Laser cutting of animal pericardium.
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Objectives & Deliverables

Instability of lower spine vertebrae due to spondylosis (spinal degeneration) and spondylitis (inflammatory arthritis) often lead to crippling pain.Pain relief is achieved surgically by fusing the unstable portion of the spine or immobilizing the vertebral motion segment. The device helps in joining vertebral bodies through natural healing.

 

Objectives:

To design and develop:
  • Inter - vertebral spacer - cages using titanium metal and coat them with bioactive material on the surface.
  • Inter - vertebral spacer - grafts using bioactive composite which can achieve osseointegration.

Deliverables:

  • Working prototypes
  • Device Design Dossier
  • Material Evaluation Matrix
  • Device Evaluation Matrix

Salient Features

  • Bioactive material for tissue integration

Progress till date

  • Product specifications finalised.
  • Prototyping in progress.

Technology Readiness Level (TRL)

TRL-4

Key Players (Collaboration)

  • Dr. Manoj Komath, Scientist G  (Principal Investigator)
  • Dr. Prakash Nair, (Principal Clinical Investigator)
  •  Category: Hard Tissue Device

Challenges

  • Development of device delivery system.
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Objectives & Deliverables

Bone and joint infections (Osteomyelitis) remain one of the most dreaded complications of orthopaedic surgery. Project aims at the development of a bioactive material platform, which has tuned porosity and osteoconductivity which can be used for in situ drug loading and delivery.

Objectives:

  • Development of a resorbable bioceramic matrices
  • Development of systems for in situ drug loading
  • Safety and efficacy testing 

Deliverables:

  • Bioceramic beads
  • Drug loading system
  • Device Design Dossier
  • Material Evaluation Matrix
  • Device Evaluation Matrix

Salient Features

  • In situ drug loading
  • Resorbable matrix
  • Graded porosity for the matrix

Progress till date

  • Product design completed.
  • Prototyping completed.
  • In vitro evaluation in progress.

Technology Readiness Level (TRL)

TRL-3

Key Players (Collaboration)

  • Dr. Harikrishna Varma, Head BMT Wing  (Principal Investigator)
  • Dr. Easwer H V, (Principal Clinical Investigator)
  • Category: Hard Tissue Device
     

Challenges

  • Optimizing the drug delivery kinetics.
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Objectives & Deliverables

Epileptic seizures are the result of excessive and abnormal nerve cell activity in the certain regions of brain.Intracranial electrodes are used for locating the epileptogenic regions of brain. They help to locate the regions that need to be removed by surgery for controlling epilepsy.

Objectives:

  • Development intracranial platinum and stainless steel electrodes.
  • Safety and efficacy evaluation

Deliverables:

  • Working prototypes
  • Device Design Dossier
  • Material Evaluation Matrix
  • Device Evaluation Matrix

Salient Features

  • Cost effective spot welded devices
  • Two variants - Platinum and SS 316 LVM versions

Progress till date

  • Prototyping completed.
  • Process standardization.

Technology Readiness Level (TRL)

TRL-4

Key Players (Collaboration)

 
  • Mr. Jithin Krishnan, Engineer C (Principal Investigator)
  • Dr. Ramshekar Menon, (Principal Clinical Investigator)
  • Category: Neuroprosthetic Device

Challenges

  • Yield during manufacturing.
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Objectives & Deliverables

Products extracted from human blood and meant for various therapeutic applications. These include albumin, Factor VIII and Intravenous Immunoglobulin (IVIG).The products will be validated to meet the requirements of European / Indian Pharmacopoeia. 

Objectives:

  • To standardize isolation of factor VIII and albumin from “small pool” of human fresh frozen plasma for therapeutic applications.
  • To standardize protocols and prepare 6 consecutive batches for testing and validation 

Deliverables:

  • Process knowhow
  • Device Design Dossier
  • Material Evaluation Matrix
  • Device Evaluation Matrix

Salient Features

  • Products extracted from human blood plasma, which otherwise gets discarded
  • The products will be validated to meet the requirements of European / Indian Pharmacopoeia.

Progress till date

  • Finalization of product specifications.
  • Process standardisation in progress.

Technology Readiness Level (TRL)

TRL-4

Key Players (Collaboration)

 
  • Dr. Lissy K Krishnan, Scientist G(Senior Grade) (Principal Investigator)
  • Category: Biologic / Combination Device

Challenges

  • Optimizing the drug delivery kinetics.
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Objectives & Deliverables

The incidence of cartilage injury or damage is quite common and may be traumatic or degenerative. The aim of the project is to develop injectable hydrogel for repairing damaged cartilages.The gel can also be used as a vehicle to transport cartilage producing cells to the site.

Objectives:

  • Development of injectable hydrogel 
  • Development of applicator
  • Safety and efficacy evaluation

Deliverables:

  • Process for hydrogel manufacture
  • Prototype (applicator)
  • Device Design Dossier
  • Material Evaluation Matrix
  • Device Evaluation Matrix

Salient Features

  • Injectable hydrogel based repair of  damaged cartilages.
  • Can also be used as a vehicle to transport cartilage producing cells to the site.

Progress till date

  • Finalization of product specifications.
  • Process development
  • Preclinical efficacy studies completed.
  • Preclinical safety studies in progress

Technology Readiness Level (TRL)

TRL-3

Key Players (Collaboration)

  • Dr. Prabha D Nair, Scientist G (Senior Grade) (Principal Investigator)
  • Dr. Vrisha Madhuri, (Principal Clinical Investigator)
  • Category: Hard Tissue Device
  • M/s. Phraction Scientific Pvt. Ltd, Kochi (Industrial Collaborator - Technology Transferred)

Challenges

  • Regulatory clearance.
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Objectives & Deliverables

The evaluation of potential liver toxicity represents a crucial step in the development of new drugs.Laboratory animals are used for carrying out these tests. The 3D liver constructs can be used for preliminary screening of drugs for their liver toxicity and help reduce the use of laboratory animals for drug toxicity assays. 

Objectives:

  • Establish a dedicated 3D Bio - printing facility 
  • Develop a bioink formulation for printing hepatocytes.
  • Isolation and culture of hepatocytes .
  • Printing 3D tissue constructs with primary hepatocytes.

Deliverables:

  • Setting up of 3D bio-printing facility.
  • Process know how for bioink
  • Tissue constructs for toxicity screening.

Salient Features

  • 3D liver constructs can be used for preliminary screening of drugs for their liver toxicity
  • Will help reduce animal experiments

Progress till date

  • 3D Bioprinting facility established
  • Process know how for bioink developed
  • Tissue constructs for toxicity screening - prototypes fabricated

Technology Readiness Level (TRL)

TRL-1

Key Players (Collaboration)

  • Dr. Anilkumar P R, Scientist E (Principal Investigator)
  • Category: Biologics / Combination product
  • Wake Forest University (USA) (Institutional Collaborator)

Challenges

  • Regulatory clearance.
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Objectives & Deliverables

Patients with cardiovascular implants need to monitor the blood coagulation parameters on a regular basis.  The project poposes the development of a device which will be a point of care, battery operated, hand held unit for easier measurement of blood coagulation parameters, carried out with single drop of finger prick blood. 

Objectives:

  • Design of the device & fluidics on the test strips.
  • Optimization of the assay method.
  • Integration of the method into th hardware.
  • Verification of assay platform with approprate clinical controls.

Deliverables:

  • Prorotype device
  • Device Design Dossier
  • Material Evaluation Matrix
  • Device Evaluation Matrix

Salient Features

  • A point of care, battery operated, hand held unit 
  • Measurement carried out with single drop of finger prick blood
  • Uniwque image processinmg based measurement techniqe. 

Progress till date

  • Prototypes fabricated
  • Verification with clinical controls completed

Technology Readiness Level (TRL)

TRL-4

Key Players (Collaboration)

  • Dr. Anugya Bhatt, Scientist E (Principal Investigator)
  • Dr. Harikrishnan S, (Principal Clinical Investigator)
  • Category: In Vitro Diagnosis Device
  • M/s Agappe Diagnostics Ltd, Kochi (industrial Collaborator)

Challenges

  • Cost effective test strip development.
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Objectives & Deliverables

The polymeric wound dressing for in situ loading of antibiotics. Gives the clinician the freedom to choose the drug of choice. 

Objectives:

  • Develop natural polymer based wound dressing with capability for in situ loading of antibiotics
  • Safety and efficacy studies

Deliverables:

  • Material formulation
  • Device Design Dossier
  • Material Evaluation Matrix
  • Device Evaluation Matrix

Salient Features

  • Wound dressing with capability for in situ loading of antibiotics
  • .Enhances the flexibility in the use of antibiotics and other drugs based on the clinical needs

Progress till date

  • Finalization of product specifications.
  • Process development completed
  • Safety and efficacy being evaluated

Technology Readiness Level (TRL)

TRL-3

Key Players (Collaboration)

 
  • Dr. Rekha M R, Scientist F (Principal Investigator)
  • Category: Biologic / Combination Device

Challenges

  • Process standardization.
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Objectives & Deliverables

Develop a decellularised matrix from animal tissues. The extracellular matrix from gall bladder will be developed for wound healing applications. 

Objectives:

  • Develop a process for decellularisation of the tissue.
  • Safety and efficacy evaluation of the matrix.
  • Establish regular supply of animal tissue.

Deliverables:

  • Process for ECM preparation
  • Device Design Dossier
  • Material Evaluation Matrix
  • Device Evaluation Matrix

Salient Features

  • Extra cellular matrix with a rich load of natural biomolecules that promote tissue regeneration.
  • The extracellular matrix from gall bladder for wound healing applications.

Progress till date

  • Finalization of product specifications.
  • Process development.
  • Technology transfer.
  • Clinical evaluation planned.

Technology Readiness Level (TRL)

TRL-4

Key Players (Collaboration)

  • Dr. T V Anil Kumar, Scientist G (Principal Investigator)
  • Category: Biologic / Combination Device
  • M/s. Alicorn Medical Pvt. Ltd. (Industrial Partner - Technology Transferred)

Challenges

  • Non – availability of control material.
  • Sourcing of raw materials.
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Objectives & Deliverables

The project aims at development of a non – toxic medical dressing having a high fluid holding capacity. It will be fast wicking and lint free, even when cut or trimmed. The medical dressing will have application in highly exudating chronic wounds. 

Objectives:

  • Development of material matrix of a polymer in combination with a polysaccharide
  • Demonstrate safety and efficacy.

Deliverables:

  • Material formulation
  • Device Design Dossier
  • Material Evaluation Matrix
  • Device Evaluation Matrix

Salient Features

  • Dressing having a high fluid holding capacity.
  • Fast wicking and lint free.
  • Application in certain highly exudating chronic wounds.
  • Nonsticky nature enabling painless removal
  • Configurable shapes to match the clinical needs

Progress till date

  • Finalisation of product specifications.
  • Process development.
  • Preclinical evaluation in progress.
  • One patent application.

Technology Readiness Level (TRL)

TRL-3

Key Players (Collaboration)

  • Dr. Lynda Thomas, Scientist D (Principal Investigator)
  • Category: Biologic / Combination Device
  • M/s. Phraction Scientific Pvt. Ltd, Kochi (Industrial Collaborator)

Challenges

 
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Objectives & Deliverables

Develop a point of care detection device for TB with improved speed of detection.
Loop mediated isothermal amplification (LAMP) is a nucleic acid amplification technique which could be carried out using single temperature reaction set up.The project attempts to develop a point of care device for detection of tuberculosis using the technique. 

Objectives:

  • Possibility to use a community based initiative to detect TB with low cost and high efficiency.
  • Process development & standardization.
  • Preliminary clinical verification

Deliverables:

  • Functioning prototype
  • Device Design Dossier
  • Material Evaluation Matrix
  • Device Evaluation Matrix

Salient Features

  • Loop mediated isothermal amplification (LAMP) based point of care device for detection of tuberculosis
  • Faster detection process improves the throughput

Progress till date

  • Finalisation of product specifications 
  • Networking with other organizations 
  • Prototype developed
  • Preliniminary clinical validation completed.

Technology Readiness Level (TRL)

TRL-3

Key Players (Collaboration)

  • Dr. Anoop Kumar T, Scientist G (Principal Investigator)
  • Dr. Padmakumar, KIMS (Principal Clinical Investigator)
  • Category: In Vitro Diagnosis Device
  • M/s. Agappe Diagnostics Ltd, Kochi (Industrial Partner)

Challenges

  • The need to carry out large no. of tests as a screening tool to establish avoidance of false positives.
  • Clinical validation
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Objectives & Deliverables

Growth factors are substances secreted by the body whose function is to stimulate the growth of the cells involved in wound healing and inflammation.The project will be focusing on two recombinant growth factors, for its potential application in wound healing.

 

Objectives:

  • Development of cost effective human recombinant growth factors in prokaryotes.
  • Development and validation of the process.
  • Safety and efficacy studies

Deliverables:

  • Device Design Dossier
  • Material Evaluation Matrix
  • Device Evaluation Matrix

Salient Features

  • Growth factors will enhance the wound healing characteristics
  • Cost effective device

Progress till date

  • Device design.
  • Process development.
  • Limited clinical validation.

Technology Readiness Level (TRL)

TRL-3

Key Players (Collaboration)

 
  • Dr. Anoop Kumar T, Scientist G (Principal Investigator)
  • Dr. Padmakumar, KIMS (Principal Clinical Investigator)
  • Category: Biologic / Combination Device

Challenges

  • Large scale preparation of recombinant proteins
  • Shelf life and its validation
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Objectives & Deliverables

Skin tissue engineering approaches using an electro spun biodegradable polymer scaffold with appropriate degradation profile and physico – chemical properties will be developed as a scaffold.Upon its implantation, undesirable contraction of the wound could be prevented.

Objectives:

  • Evaluation of the effectiveness of the scaffold when grafted in diabetic porcine wounds.
  • Evaluation of the scaffold when grafted in third degree burn wound in rabbit model.
  • Improve the visible light transmittance for easy examination of th wound site.

Deliverables:

  • Device Design Dossier
  • Material Evaluation Matrix
  • Device Evaluation Matrix

Salient Features

  • Skin tissue engineering approaches using an electro spun biodegradable polymer scaffold with appropriate degradation profile and physico – chemical properties will be developed as a scaffold.
  • Upon its implantation, undesirable contraction of the wound could be prevented.

Progress till date

  • Finalization of product specifications.
  • Process development.

Technology Readiness Level (TRL)

TRL-3

Key Players (Collaboration)

  • Dr. Lissy K Krishnan, Scientist G(Senior Grade) (Principal Investigator)
  • Dr. Prasanth Varkey, (Principal Clinical Investigator)
  • Category: Biologic / Combination Device

Challenges

  • Optimisation of the  material formulation to minimise the contraction and impart transparency to the material. 
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Objectives & Deliverables

An Atrial Septal Defect (ASD) is an opening or a hole in the wall that separates the two upper chambers of the heart, the atria. Conventional management technique is open heart surgery to close the hole. 

 

Objectives:

  • Design and prototype fabrication.
  • In vitro efficacy studies.
  • Preliminary in vitro safety studies.
  • Proof of Concept studies on large animals.

Deliverables:

  • Ten prototypes in three size variations.
  • Device Design Dossier.
  • Material Evaluation Matrix.
  • Device Evaluation Matrix.

Salient Features

  • NiTiNOL mesh based device.
  • Catheter based delivery.
  • Minimally invasive procedure.
  • Being a non – surgical procedure, the patient recovers fast and it requires a very short period of hospital stay.

Progress till date

  • Specifications finalized.
  • Prototyping in progress.
  • Process development in progress.

Technology Readiness Level (TRL)

TRL-3

Key Players (Collaboration)

  • Mr. Sujesh Sreedharan, Engineer F (Principal Investigator)
  • Dr. S Bijulal (Principal Clinical Investigator)
  • Category: Cardiovascular Device
  • M/s. National Aeronautical Laboratories, Bangalore (Institutional Collaborator)
  • M/s. South India Textile Research Association, Coimbatore (Institutional collaborator)

Challenges

  • NiTiNOL heat treatment.
  • Device crimping.
  • Delivery system development.
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Objectives & Deliverables

Abnormal communication between small arteries and veins within the brain are described as arterio – venous malformation resuling in seizures, intracranial bleeding, paralysis, visual loss etc. Such defects are sealed with special sealants which set on contact with blood. A non-metallic sealant is planned in the project. This will help improve MRI compatibility.

Objectives:

  • To develop an indigenous alternative to tantalum loaded embolization agents.
  • Iodinated radiopaque polymers will be employed. 

Deliverables:

  • Process knowhow
  • Device Design Dossier.
  • Material Evaluation Matrix.
  • Device Evaluation Matrix.

Salient Features

  • A non-metallic sealant is planned. 
  • Improved MRI compatibility.
  • Reduced catheter entrapment, catheter blockage.
  • Less artefacts in computed tomography.

Progress till date

  • Process development.
  • Preliminary evaluations.

Technology Readiness Level (TRL)

TRL-2

Key Players (Collaboration)

  • Dr. Roy Joseph,Scientist G (Principal Investigator)
  • Dr. Jayadevan E R (Principal Clinical Investigator)
  • Category: Neuroprosthetic Device

Challenges

  • Control of viscosity parameters of the end product.
  • Imparting adequate radiopacity. 
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Objectives & Deliverables

Intracranial aneurysm is a condition in which weakness in the wall of a cerebral artery causes a localized dilation or ballooning of the blood vessel. Flow diversion is an endovascular technique whereby the device is placed in the parent blood vessel to divert blood flow away from the aneurysm.

Objectives:

Design, prototype and establishment of concept of a NiTiNOL based flow diverter stent along with associated catheter based delivery system.  
  • Design and prototype fabrication.
  • In vitro efficacy studies.
  • Preliminary in vitro safety studies.
  • Proof of Concept studies on large animals.

Deliverables:

  • Flow diverter stent design in four sizes.
  • Ten prototypes in each size.
  • Device Design Dossier.
  • Material Evaluation Matrix.
  • Device Evaluation Matrix.

Salient Features

  • Nickel Titanium alloy (NiTiNOL)  based braided architecture.
  • Catheter based delivery to the site.
  • Minimally invasive deployment.

Progress till date

  • Specification development.
  • Prototyping.

Technology Readiness Level (TRL)

TRL-3

Key Players (Collaboration)

  • Mr. Sujesh Sreedharan, Engineer F (Principal Investigator)
  • Dr. Santhosh K (Principal Clinical Investigator)
  • Category: Neuroprosthetic Device
  • National Aeronautical Laboratory (NAL), Bangalore (Institutional Partner)

Challenges

  • Braiding architecure design.
  • Thermal treatment of the device.
  • Delivery system development.
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