POTENTIALS FOR PROMOTION OF BIOMEDICAL ... FOR PROMOTION OF BIOMEDICAL TECHNOLOGY DR W SELVAMURTHY Distinguished Scientist & Chief Controller R&D Defence Research & Development Organization

POTENTIALS FOR PROMOTION

OF BIOMEDICAL TECHNOLOGY

DR W SELVAMURTHYDistinguished Scientist & Chief Controller R&D

Defence Research & Development Organization

New Delhi

© RFHHA. All rights reserved

TARGET

FOCUS

ECONOMIC DEVELOPMENT

Creation of

newer

Technologies

Commerciali

zation of

Intellectual

Property

Attraction of

Hi-Tech

Enterprises

RESEARCH & DESIGN


NEED FOR PROMOTION OF BMT

•Huge Market in India

Estimated Annual biomedical devices requirement=Rs 15,000

crore

80% is imported

20% is indigenous

•Nucleus of expertise available

•Life cycle support

•Product upgrades


DOCTORS

SCIENTIST &

ENGINEERS

INDUSTRY

CONSORTIUM


• Royalty Model (Outright sale off of mature

technologies )

• Total Risk-Revenue Partnership Sharing

Model ( Partnership from the stage of

Conceptualization)

• Partial Risk-Revenue Sharing Partnership

Model ( Partnership from certain level of

Maturity)

Models for Public Private Partnership


CONCERN

•Huge competition through import

•Indian Industry yet to mature to combat

Market forces

•Capacity Building in industry for R&D and

Manufacturing

•H R for R&D in BMT inadequate

•Products Upgrades for market need


STRATEGIES

•Assessment of Market for Medical Equipments & Devices

•Prioritization

•Technology Capability Mapping

•SBMT can facilitate

•Enacting IMDRA

•Interim measure - Drug controller

•Patronage from Govt institutions

•Industries involvement from the inception of project


SOCIETY FOR BIOMEDICAL TECHNOLOGY, BANGALORE

• INTERMINISTERIAL INITIATIVE OF GOVT OF INDIA

• COLLABORATING PARTNERS

– DRDO

– DST

– DEPT OF RURAL DEVELOPMENT

– MINISTRY OF WELFARE

– MINISTRY OF HEALTH

• OFFICIALLY LAUNCHED IN JUNE 1993

• REGISTRAR OF CO-OP SOCIETIES, KARNATAKA

• REGISTERED OFFICE – DEBEL, BANGALORE

• CEO – DIRECTOR, DEBEL & A PROG. MANAGER


SOCIETY FOR BIOMEDICAL TECHNOLOGY, BANGALORE

OBJECTIVE:

TO UTILIZE DEFENCE TECHNOLOGY SPIN-OFFS FOR

INDIGENOUS DEVELOPMENT OF MEDICAL PRODUCTS

WHICH ARE BEYOND THE REACH OF COMMON MAN

SELF RELIANCE IN MEDICAL TECHNOLOGY © RFHHA. All rights reserved

Floor Reaction Orthosis

Nodal Agency :

Collaborators :

Medical Partners :

CPDC, SBMT

Min of Social Justice

NIMS, Hyderabad

Features

• Camps organised in AP,

Bangalore, Trivandrum and

issued to polio children

• 4 different sizes developed and

frozen

Status

• Carbon-carbon composites

• Light weight – 300-400 gms

TOT: ALIMCO, Kanpur


Kalam-Raju Stent

Nodal Agency :

Medical Partners :

DMRL

CARE Hospital

Features

3000 Stents sold

Cost : Rs. 7,500-10,000/-

• Material : 316L Austenitic SS

• Mechanical : 0.2 % Proof stress [444 Mpa], Tensile strength [758 Mpa],

% Elongation [50], Hardness [220 HV]

• Surface Finish : Electro polishing

• Others : Radio Opacity, Metallic Surface Area [15-18%], Expansion Pressure

[4-5 atm]

Status

TOT: ACAL, Hyderabad© RFHHA. All rights reserved

Opthalmic Laser

Laser Type : Nd:YAG [1064 NM]

Pulse Energy : 1 - 10 mJ

Pulse Duration : 7 nano sec

Nodal Agency :

Medical Partners :

LASTEC

• LVPE Hospital

• RP Eye Hospital

Features

• ToT completed

• Limited production by BEL, Pune

• Expected cost Rs. 5 to 6 lakhs

• 3 equipments sold

Status

• Spot size : 10 - 15 micron

• Aiming Laser : He - Ne visible

TOT: BEL, Pune© RFHHA. All rights reserved

Slit Lamp Microscope

Slit width & length : 0-14 mm (1,2,3,5,9, 10 & 14)

Filters : Green, Cobalt Blue

Illumination lamp : Halogen Lamp, 12 V, 30 W

Microscope : Binocular sereoscopic

Nodal Agency :

Others :

Medical Partners :

Date of Initiation :

PDC :

DEBEL

OFD, Dehradun

• LVPE Hospital

• Minto Eye Hospital

June 1996

June 2000

Status

Clinical Trials completed

FeaturesOFD, Delhradun to produce


Human Implantation – Surgical Scheme

Insertion into the sclera

Suturing that scleraPlacement of the artificial eye lens

alongwith motility / support peg© RFHHA. All rights reserved

The Patient’s MRI Scan

Taken after 6 months

Taken after 6 months Taken after 4 months

Taken after 4 months


Side face Looking down Looking forward

The Transformation…

T H E F I R S T P A T I E N T

TOT: CGCRI, Kolkata© RFHHA. All rights reserved

Plastic Aspheric Magnifiers – Low Vision Aids

• Light weight

• Low cost

• High field of view

• No peripheral Aberrations

• Available in Four powers

• +16, +20 D, +24 D, +28 D.

• Designed all four types of aspheric

lenses and developed in PMMA

• Cost per Magnifier using Injection

Moulding Technique Rs 250 to 300.

Features

Difficulty in recogniosing close (distant) objects

Difficulty in reading with normal spectacles

Dificulty in getting education or training courses

Difficulties of People with Low Vision

IRDE, Dehradun

Min of Social Justice & Empowerment

National Award winner

Nodal Agencies


INDIGENOUS TITANIUM DENTAL IMPLANT

TOT: Indident Medical Devices, New Delhi© RFHHA. All rights reserved

Titanium Dental Implant

Cylindrical 4 mm dia. screw implants placed in bone and bar/ superstructure (Dental/ Crown) made

Nodal Agency :

Collaborators :


PDC :

INMAS, NFTDC

SPL

Nov. 1997

Jun. 2003

Features

• Clinical trials carried out

• 65 implants placed in patients

• 4 services and 2 civil institutions

carrying out trials

• Marketability by June 2002

Status


Nodal Agency :

Medical Partners :


PDC :

INMAS, NFTDC

Defence & Civil Institutions

Dec 1998

Dec 2000

Features

• 300 cases carried out in clinical trials

• Product marketed by NFTDC

• 100 kits sold so far

Status

Titanium Bone Plate

• 1.5 & 1 mm CP titanium bone plates

• 2 mm dia screws

• Surgical drills and screw driver


Ti Plate Mesh Fixed To Lower Jaw To

Rehabilitate Hemimandibulectomy

(Post Cancer Surgery)

Ti Plate Mesh Used To

Reduce Fracture Mandible


Cavitron-Scaler

• Light and compact product

• User friendly directional switches

• Elegant hand piece parking with unique swiveling facility

• Ergonimically designed hand piece

• Omni directional access to the hand piece for ease of use

• Bulky power transformer zclose to the mains

• Friction padded shoes for enhanced stability

Features

• Wide frequency range 20 kHz to 35 kHz

• Automatic tuning of drive frequency

• 50% initial power setting

• Power level LED indication

• Power current tripper fuse

• Isolated electrical and water circuits

• Detachable electrical and water connections

• Hand-piece with enhanced thermal limitations

• Fully autoclavable hand piece

• Operation muted when tip unloaded

• Fully indigenous materials /components

• Universal electronics for any transducer type

State of the art Features

NPOL, CochinNodal Agencies:


Critical Care Ventilator

THE FIRST INDIGENOUS

VENTILATOR

COST EFFECTIVE

• DEVELOPED IN COLLABORATION WITH

PRICOL INDUSTRIES, COIMBATORE

• TECHNOLOGY TRANSFERRED TO PRICOL

• CLINICAL TRIALS SUCESSFUL

• LIKELY TO BE IN MARKET SOON


Gigli Saw

Nodal Agency :

Medical Partners :


PDC :

DMRL

• NIMS

• NIMHANS

• AIIMS

June 1998

June 2000

• For Neurosurgery

• For Orthopaedics

• Biocompatible material

• Special design

• Precision methodology

Features

• Multicentric Clinical Trials

completed

• ToT completed

• Marketed by Andhra

Biomedicals, Hyderabad

Status


Stress Test System

Nodal Agency :

Medical Partners :

DEBEL

NIMS, KEM, Medicity

Features

• ToT completed

• Limited Production: MH, Secunderabad

NIMS, Hyderabad

• Manufacturer : Andhra Cardiology Associate

Cost : Rs. 3.5 lakhs

Status

• Host : PC with printer

• Data Acquisition : Card 1 - Amplifier

• System : Card 2 – Signal

Conditioner, Digitiser

• Software : Monitoring

Analysis

Documentation

Review

• Supervisor : Protocol

• Programme : (Bruce/ Astrand)

TOT: Andhra Cardiologist Associates Pvt. Ltd, Secunderabad© RFHHA. All rights reserved

Cytoscan

• MICROSCOPE : Biological Research Microscope

• CAMERA : CCD with 512 X 584 pixel S Pal System

• FRAME GRABBER : 512 X 512 pixel, 256 grey level, 25 frames/sec

• COMPUTER : PC with 4 MB RAM, 200 MB HDD

• SOFTWARE : Interactive Image Analysis Software

Nodal Agency :

Medical Partners :

DEBEL

NIMS, KMIO,

AF Path Lab.

Features

ToT : Done

Total Installed : 5 Nos

Cost : Rs. 3.5 Lakhs

Status

TOT: Jupiter Orga Ltd, Secunderabad© RFHHA. All rights reserved

External Cardiac Pacemaker

Nodal Agency :

Medical Partners :

RCI, Hyderabad

Medicity, NIMS,

Manipal Hospital,

KEM Hospital

Status

Cost : Rs. 22,000/-

Features

Voltage Output : Continuously variable 0.1 to 12 volts

Pulse Rate : Continuously variable 30 to 180 ppm

Power Source : 9 volt miniature snap connector

Dimensions : 165 mm(L) x 65 mm(W) x 30 mm(H)


RECEIVER-STIMULATOR UNIT

Electrode

Array

Hermetic seal

header

Micro chip

Titanium

Casing

COCHLEAR IMPLANT

PROJECT UNDER PROGRESS


VIRTUAL REALITY LAPAROSCOPIC SURGERY SIMULATOR


Hooke Joint

Roll Wheel

GripperActuation

Gripper

Roller for articulation


IMPROVED SURGICAL TOOL FOR MINIMALLY INVASIVE SURGERY


Biocompatible tube of ID 5 mm and OD 7

mm. Window to be created using CO2

laser cutting.

PMMA rod of 5 mm dia cut as shown for

inserting pressure sensor chip. Vertical cut

facilitates wires.

Fabricated sensor chip inserted and

bonded along with pressure sensor

diaphragm.

The sensor device inserted into capsule

and sealed with biocompatible adhesive

paste.

MICRO SENSOR FOR INTRACRANIAL PRESSURE MEASUREMENT

PROJECT UNDER PROGRESS© RFHHA. All rights reserved

DBS is a surgically implanted, battery-operated

neurostimulator—similar to a heart pacemaker

to deliver electrical stimulation to targeted areas

in the brain that control movement, blocking the

abnormal nerve signals that cause tremor and

PD symptoms.

DEEP BRAIN STIMULATOR

PROJECT UNDER PROGRESS© RFHHA. All rights reserved

DEVELOPMENT OF PERCUTANEOUS HEART VALVE

TECHNOLOGY


THE PERCUTANEOUS BALLON VALVULOPLASTY IS BEING

DEVELOLPED FOR SUCCESSFUL TREATMENT STENOTIC

DISEASES THAT WILL AVOID SURGICAL VALVE

REPLACEMENT


GLYCOSYLATED HEMOGLOBIN


HAPO Bag

• Prevention & treatment of HAPO

• Neoprene coated rubber bag

• Air tight zip; controlled leakage

• Pressure of 130 mm Hg (lowering of 3000 m)

• CO2 absorbent cannister

• Mechanical and electronic models

Nodal Agency :

Medical Partners :


PDC :

DEBEL, Bangalore

153 GH

Jun 1997

Jun 1999

• ToT completed

• 500 pieces given to

soldiers at high altitude

Status

Features

TOT: Raksha Polycats, Pune

Bengal Water Proof, Calcutta© RFHHA. All rights reserved

NITRIC OXIDE – OXYGEN THERAPY FOR HAPO

Supplied to Army© RFHHA. All rights reserved

Nitric Oxide – Oxygen for HAPO


Inhalation Therapy for Alveolar Deposition (ITAD)

A new concept for treating PHT/ AMS/ HAPE

•Based on Aerosol re-

entry and drying

•Useful for mild-

moderately breathless

patients

•Anukool II developed

for severely

breathless/

unconscious patients

•Based on Spacer

Principle

Anukool Nabulizer

Ventilation Scan

Perfusion Scan

Pre-therapy Scan

Post-therapy Scan

Conventional

Anukool


Mobile Operation Theatre Complex


New Treatment Modality:

Pentoxyphylline, Aspirin &Vitamin C

•Rewarming – Tea Decoction Medium

(37o – 41o C )

•Aloe Vera Cream

COLD INJURIES

LTLTLTRT RT RT

0-DAY 2-DAY 14-DAY

BASELINE MEDICATION RECOVERY© RFHHA. All rights reserved

HEALTH CARE

LeptospirosisPlague Dengue

TyphoidMalaria

Water TestingInfection Imaging

Cancer therapy


Clinical Trials using 2-Deoxy-D-gluose (2-DG)

• Indigenous 2DG clinically evaluated in more than 60 patients

Better Tolerance with minimal Toxicity

-

Clinical Trials of 2DG

•Successful Phase III clinical trials 60 Cases evaluated

Improvement in median

survival and Quality of

Life observed

Animal studies

Clinical studies

ToT done (DRDE, INMAS, Dr. Reddy’s Lab)


1HR

Anterior view

Tubercular

lesion

4 HR

Anterior view

TM

SINGLE VIAL COLD KIT OF CIPROFLOXACIN FOR BACTERIAL

INFECTION IMAGING

TOT: BRIT, Mumbai© RFHHA. All rights reserved

Protection against simulids

Repellents DEET & DEPA

Yellow Garments - Least attracted

Malaria Control

Personal protection

- Herbal Repellents, Vaporizer

Herbal medicine against P. falciparum

Mobile Clinic & Vaccine

Herbal medicine

- Skin Diseases

- Poisoning

Cloth impregnated with repellent against Leech

Synthetic & Herbal

Timur Oil & Bottle Brush Oil

Supplied to Army© RFHHA. All rights reserved

Patients treated : 177 Complete

recovery : 50 patients (30-450 days) Above 50%

recovery : 127 patients (Progressing)

Clinical trial on Anti-leucoderma

ToT done to AIMIL Pharamceuticals, Delhi © RFHHA. All rights reserved

Dressing for Wound Healing

1. Chorio Amnion Membranes

From Placenta (Human)

Cleaned

Washed

Dried

Radiation Sterilized


Dressing for Wound Healing

2. Silver Based Bandages

Nylon Fabric + AgNo3

• All are radiation sterilized with Gamma Radiation

• Used by Dermatologists at SN Medical College, Jodhpur and Col Pradeep

Bhargave, Senior Advisor Surgery, Command Hospital (NC), c/o 56 APO

i)

i)

Argenton - N

Ag in Metal form

Ag in Ionic formNylon Fabric + AgNo3

Argenton - N



Light Weight Foldable Stretcher• 6.6 kg weight, all weather use

• Non-corrosive durable fabric, structural material

• Can withstand 120 kg weight on difficult terrain. Non-reactive to Human Body

• TOT Completed

•User trial by Army in progress at 1 Corps and 4 Corps HQ TOT: ALIMCO, Kanpur


•Huge potential

•Creation of New Department of Biomedical

technology (DBMT)

•Institutionalization of International

collaboration

•Joint ventures

•Active collaboration among stakeholders

Conclusions


Documents

POTENTIALS FOR PROMOTION OF BIOMEDICAL ... FOR PROMOTION OF BIOMEDICAL TECHNOLOGY DR W SELVAMURTHY Distinguished Scientist & Chief Controller R&D Defence Research & Development Organization