Importance of indigenous R&D and manufacture of medical devices

Prof K Siddique-e Rabbani

DEPT OF BIOMEDICAL PHYSICS & TECHNOLOGY

University of Dhaka, Bangladesh

President, Bi-BEAT Ltd.President, Relevant Science & Technology Society, BangladeshPresident, Bangladesh Medical Physics Association

Email: rabbani@univdhaka.eduwww.bmpt.du.ac.bdwww.bibeat.com

2nd WHO Global Forum on Medical Devices, 22-24 Nov, 2013, Geneva

X-Ray & ECG invented more than 100 years back. How many of the global population get the benefits today?

80% of global Population living in Low Resource Countries(LRC) ARE DEPRIVEDof modern technology, Particularly of medical devices.

80%

What do we want ?: Modern medical devices should benefit the whole of the Global population

Existing commercial model has failed

What is the Existing Model ?

R&D and Innovation � Patent � Production in a few HRC* �

Very strict & Expensive testing requirements �High profit �

global distribution at very high price

• HRC: High Resource Country

GLOBAL DISPERSION OF MEDICAL DEVICES

WILL NOT HAPPEN

THROUGH THIS MODEL

Failure of existing model

WHY ? (Viewed from an LRC)

A. UNAFFORDABLE ���� Reasons?

1. Large economic disparity

2. Small volume production (Unlike Television, PC)

3. Continuous R&D (improvement & competition)

4. Very high R&D manpower cost in HRC

5. High Patent costs

6. High cost for Quality test certificates (due to very strict conditions and again, high manpower cost)

7. High profit margin

Failure of existing model

WHY ? (Viewed from an LRC)

B. NOT SUSTAINABLE, INTERRUPTED SERVICE ����Reasons?

1. Even if equipment procured, maintenance and repair extremely difficult.

2. Equipment thrown away on malfunction, even new or after a few months / years of use.

3. Lack of technical expertise is there, but not the main reason

i. Lack of spares, difficulty/ high expense in importing

ii. Technical details not supplied, commercial secrecy

iii. Recent use of computer and microcontroller � more secrecy, local repair impossible, even with expertise.

iv. Technology gap is widening, difficult to bridge the gap.

Solution

EMPOWER PEOPLE IN LRC

Develop R&D and manufacture capability in each LRC

� People with necessary Engineering knowledge available

� Needs only a twist in education and training for design

and manufacture

What will happen with this solution?

1. Local maintenance and repair ensured

2. Equipment can be used for lifetime, decades

3. Availability of technical expertise

4. Availability of spares

5. Uplifting of local technical capability

6. Contribute to bridging of technological gap

Bangladesh Experiencein

developing capability for

Indigenous R&D and manufacture

Computerised EMG/EP equipmentExpertise gained through a UK link

First computerised equipment made in Bangladesh (1986-88)

First nerve conduction service in Bangladesh (1988)

Main equipment:

24 years, still running

(PC interface hardware & software changed)

Iontophoresis equipment(Anti Sweat)

Treatment of excessive sweating of palms and soles (since 1990’s)

Over 18 years: Hundreds of units being used by patients at home

Muscle & Nerve StimulatorMuscle & Nerve StimulatorFor physiotherapy (since 1990’s)

Many units sold over last 18 yearsUsers include: Hospitals, Clinics,

Physiotherapists, patients

Better probe design

Dynamic Pedographfoot pressure distribution

Helps prevent leg amputation for diabetics

First set up in a

neighbouring country 3

years back. Still continuing

under routine use.

Listed in WHO

Compendium of Innovative

Technology - 2011

Recently installed at a diabetic hospital in

Bangladesh

Also developed a method

for making customised

shoe insoles based on

the Pedograph output

Dynamic Pedograph

14

TELEMEDICINE

In LRCs most people live in rural areas

Qualified doctors not available in rural areas

Technicians available

Telemedicine via

Internet and Mobile

phones allow service of

qualified doctors from

towns and cities.

Has big potential in LRCs.

Expert Centre

(in towns)

Rural Centre

Rural Centre

Rural Centre

Rural Centre

Rural Centre

Rural Centre

15

Improvised Digital StethoscopeReal time sound transmission

A microphone insert is fixed at a cut end of the rubber tube of a commercial stethoscope

TelemedicineWe developed both hardware equipment and software

Digital ECG, designed from scratchReal time signal transmission

� Real time data transmission

� Small data package (Raw data transfer)

Improvised Digital Microscope

Much cheaper than imported ones.

Telemedicine

Digital X-Ray View Box

Bangladesh has 800 Rural health complexes with Microscopes, X-ray machines and technicians -but no qualified Pathologists or Radiologists

A simple Prosthetic hand that can write & solderA simple Prosthetic hand that can write & solderImprovised using a hand of a ‘Mannequin’Cost: about £20, with service, about US $50

The girl can write, type, and solder electronic circuits, making her self-dependent.

Lifelike hand gave her self-esteem back

At US $3 to $5, heats 5L to

10L water to more than

600C in 1½ to 2 hours in

clear sun. Destroys

diarrhoeal germs even at

450C to 500C because of

added UV contribution.

2 to 3 harvests per day in

tropical countries

Prevention – Public Health

Our innovation: Solar Pateurisation, Domestic Scale,

Very Low cost, easily available raw materials, simple technology

Survival kit (for disasters, emergencies)

Life Roll

4 inflatable chambers –One for water, 3 for air (blown by mouth)

1½ to 2 hours in clear sushinewill destroy diarrhoeal germs

Support equipment:

Voltage Protector – protects equipment including medical devices even if 440V appears on 220V line!! Successful commercialisation of a entirely new product, since 1989.

(It really happens!

A simple fault, arising out of casual behaviour, widespread in LRCs cause this)

Built-in Stabilisation, surge suppression

� The innovator can rectify errors quickly after marketing.

� The innovator can think of new products that are cost effective, technically feasible

� Thus can keep up in business competition too

� Such industries can grow quickly

� They know value of R&D and patience

� Can absorb and utilise inventions of future innovators (as in the West now)

Therefore programmes should target science & Engineering graduates, available in LRCs

New Lesson from experience:

Technology innovators should themselves become entrepreneurs

We are not patenting our products!!

Looking towards an Open Healthcare Technology

People to get the power and capability themselves

We plan to teach technology,

manufacture and entrepreneurship to

Third World scientists and engineers,

ask them to produce the equipment in

their own country and sell

website: www.bmpt.du.ac.bd

Thank You