Design and Development of Medical Devices

Sameer D Saral, Director – Operations Trivitron Healthcare Pvt Ltd, Chennai

INTRODUCTION

Trivitron: Healthcare Segments Served

DIAGNOSTICS

Ultrasound

X-ray

Mammography

Laboratory

INTERVENTION & CARE

Operating Theatre

Critical Care

Nephrology

Ophthalmology

Trivitron Journey

Established Trivitron to bring world class medical technology and IVD

to India.

Tied-up with world leaders in medical technology market.

1997-2002

Established strong sales and service network pan-India.

Ventured into production and introduced Trivitron

branded products Cellenium, Labmate and Nanolab.

Ranked among Top 10 Medical Technology companies

of India known for its after sales service support.

2002-2007

Manufacturing JV with Hitachi-Aloka Japan, Biosystems Spain, Johnson Medical Sweden.

Established South Asia’s first medical technology park.

Forayed into emerging markets across the world.

Made major acquisitions in Kiran / Labsystems / IPI / Star Trivitron / Vision.

2007-2012

No 1 Medical Technology company of Indian Origin with 8 Functional Factories and

over 4 R&D centers in Asia/ Europe.

Expanding R&D/ Innovation efforts with collaboration with globally renowned medical

universities.

Global Footprint of Own/ Distribution network in over 165 countries.

Kiran/ Labsystems used as Global Brand in Imaging and IVD space.

Service Delivery partnership with Apollo Group of Hospitals in Dialysis and Dental

Space. Exploring options in Imaging space.

Lab Medicine/ Ophthalmology presence through Metropolis/

Maxivision.

2012 - Present

Trivitron Value Pyramid

“Inventions”. Introduce unique

Concepts, products, global

presence.

Have own Design centre.

Design through innovations

for value adds.

2018 - Game Changer

MANUFACTURING

• Eight CE / US FDA approved facilities

INNOVATION

• Active R&D partnerships across the world

GLOBAL REACH

• Sales & Distribution System

• Key Acquisitions

Trivitron: Growth Drivers

Trivitron Medical Technology Park

South Asia’s First Medical Technology Park

Size : 25 acres

Location : SIPCOT Sriperumbudur, Chennai

Capacity : 15 independent factories

Standard : 100% adherence to ISO, CE, US FDA, JGMP in phases

Trivitron Medical Technology Park

Present Operations

• Ultrasound & Colour Doppler

• Biochemistry Reagents

• POC Kits

• ELISA Kits

• PCR Kits

Upcoming Facilities

• X-Ray

• Other:

– Trivitron Skills Development Center

Manufacturing Facilities

Chennai, India - Plant I

Area : 32,500 sq.ft

Staff : 35

Partner : Hitachi-Aloka, Japan

Output : 1000 units per year

Certified : ISO 13485 – 2012,

CE, JGMP

Area : 24,363 sq.ft

Staff : 25

Partner : Biosystems, Spain

Output : 150,000 l of reagents

per year

Certified : ISO 13485

Manufacturing Facilities

Chennai, India - Plant II

Area : 6,000 sq.ft

Staff : 10

Partner : NA, Own

Output : 25,000 units

Certified : CE

REAGENTS

Area : 4,300 sq.ft

Staff : 15

Partner : Johnson

Output : 300 units

Certified : CE

MODULAR OT

Area : 3,500 sq.ft

Staff : 15

Partner : NA, Own

Output : 600 units

Certified : CE

CRITICAL CARE

Manufacturing Facilities

Area : 60,000 sq.ft

Staff : 50

Output : 158,000 units

Certified : ISO 9001, ISO

13485, CE

MUMBAI, INDIA

Area : 6,000 sq.ft

Staff : 40

Output : 25,000 units

Certified : ISO 13485,

CE

PUNE, INDIA

Area : 39,730 sq.ft

Staff : 30

Output : 1,500,000

units

Certified : ISO 13485,

CE

HELSINKI, FINLAND

VISION MEDICAD

Diagnostics - Imaging

– Ultrasound systems

– Color Doppler systems

– Radiation Protection Apparel

– Imaging Accessories

– X-Ray, C-Arm, CR, DR

Intervention & Care

–Modular OT

–Ventilators

–Defibrillators

–ECG machines

–Patient Monitors

–Infusion devices

Diagnostics - Lab

–Biochemistry reagents

–Hematology reagents

–Neonatal screening kits

–Cardiac Bio-Markers

–POC kits

Manufactured Portfolio

R&D Initiatives In-Vitro Diagnostics

Partnership

• Next Generation Point of Care Platform using innovative technology

Turku University -Finland

• Advanced Testing on LC - MS/MS platform

Agilent Technologies - USA

• Antibiogram Kits

Anna University -Chennai

•Scientific Advisory

•World's First Point of Care Celiac testing kitUniversity of

Tempere - Finland

• Collaboration discussions - for IVD/ Medical Imaging focused R&D efforts

University of Tartu, Estonia

• Collaboration discussions - for IVD/ Medical Imaging focused R&D efforts

CMC Vellore

R&D Initiatives - Intervention & Care

• Wireless ECG and vital signs devices

IIT Madras-Chennai

• Heart valves, membranes, oxygenators

SCT Institute-Trivandrum

• Retinal Screening devices for public access

L.V. Prasad -Hyderabad

Medical Devices

• Any instrument, apparatus, appliance, material or other article, including the software

• Intended to be used for human beings for the purpose of

– Diagnosis, prevention, monitoring, treatment or alleviation of disease, or compensation for an injury or handicap,

– Control of conception

Medical Devices - Range• Over 900 product groups

• Covering 50 clinical specialisation

• Broadly classified as

• Diagnostic devices• MEDICAL INSTRUMENTATION• Testing kits and reagents

• Therapeutic devices• Implantables• Disposables & Re-usables

Indian Scenario

• Huge growing market supplied essentially by

imports

• High healthcare delivery costs

• Growth of indigenous technology essential for strengthening the Indian industry

• Public supported R&D is hugely required

• Development of materials and devices is the

biggest challenge

Initial Steps

Identify

Strategic Focus

Problem Identification

Need Statement Development

Screen Needs

Disease State Fundamentals

Treatment Options

Needs Filtering

Analyse

Stakeholder Analysis

Market Analysis

Conceptualise

CONCEPT GENERATION

• Ideation and Brainstorming

• Concept Screening

CONCEPT SELECTION

• Intellectual Property Background study

• Regulatory Basics

• Business Models

• Prototyping

• Final Concept Selection

Planning Execution

DEVELOPMENT STRATEGY & PLANNING

Intellectual Property Strategy

R&D Strategy

Clinical Strategy

Regulatory Strategy

Quality & Process Management

Marketing and Commercial Strategy

INTEGRATION

Operation Plan and Financial model

Business Plan development

Funding Sources

Licensing and Alternate pathways

How we started

Experts Team

• Setup a Scientific Advisory Board comprising of a Team of Experts from the Healthcare Services Industry

List Needs

• Listed out the needs of the Clinicians based on the diseases that need attention

Finalise

• Looked at cost, ease of use, Technology life cycle, long term implications, cost of design, cost of manufacturing, etc. before shortlisting the products

Where we are today

• Limited interest in manufacturing due to the inverted customs duty structure

• Lack of talent in India for design, development and manufacturing

• No support for R & D - funds availability a major constraint

• Academia – Industry association missing • Device safety, Device efficacy and end use need

better guidelines and strict enforcement. • Current norms for Clinical trials are more relevant

to the Pharma Industry and these need better classification based on application.

Challenges

• Classification of converging devices (Lab on a Chip), DES (Device with Drug), Multiplexing diagnostics devices can be a difficult task with fast evolving technologies

• Bio Materials classification – Plastics, Metals, etc.

• Raw Material and Packing material Vendor qualification criteria

Challenges

• Manufacturing environment criteria

• Handling and treatment of Biologicals

• Safety norms for these – usage as well as disposing of these

• Labeling norms and process

• Validation of software for Medical applications

• Maintaining Patient data Confidentiality

• Connectivity protocols (WiFi/BT) and data safety

Conclusion

• Medical Devices manufacturing still at a nascent stage

• Many aspects need to be addressed before this becomes an Industry of preference

• Regulatory would lay an important role at various levels – choice of raw material, disposal of waste – for manufacturer as well as end user, clinical trials protocols and implementation/monitoring, ethical issues, QC norms, certification bodies, etc. Clear guidelines to be defined and implemented

• Sunrise industry and can be the future to substitute imports – MAKE IN INDIA

Thank You