medical device a to z

1. 0
Medical Device -Engineering and Domain View

2. 1
Medical Device development stakeholder

3. 2
Medical Devices
Market size Approx $ 300 B
Cardiovascular
devices
Ophthalmology
devices and
equipment
Orthopedic devices
and equipment
Dermatology,
cosmetics, and
wound
Surgical devices
and equipment
care
Vascular devices
Urology devices
and equipment
Imaging
equipment
Analytical equipment
Drug delivery
systems
Diabetes equipment
Patient
monitoring
equipment
Diagnostic
equipment and
systems equipment
Respiratory devices
and equipment
Sterilization products
Dental devices and
equipment
Women's health
devices and
equipment
Industry Sectors in the Medical Device Industry
Regulations Body
US - FDA (Food & Drug Administration) & CDRH (Center for Devices and Radiological Health)
Europe - BSI, TUV/RH,TUV/SUD, KEMA, etc in Europe
Japan - Ministry of Health, Labor and Welfare( MHLW), Pharmaceutical and Food Safety Bureau, Office of Medical Device Control
India – Indian FDA

4. 3
Initiation
Opportunity and
Risk Analysis
Formulation/Concep
t and Feasibility
Phase
Design and
Development/Verifi
cation & validation
Phase
Final
validation/Product
Launch Preparation
Phase
Product Launch and
Post-Launch
Assessment
(overall R&D spending of $30 bn in 2007)
Initial evaluation of
possible development
of commercial product
Definition of design
input based on
customer needs and
technical requirements
Development of
product design and of
manufacturing process;
verification &
Validation
Final validation of
manufacturing process;
preparation of product
introduction
Market introduction of
product; continuous
improvement
Phase I Phase II Phase III Phase IV Phase V
Medical Device Product Development Lifecycle
Project
Definition
Acceptance/Concept
Charter
Initial
Design
Acceptance/Development
Agreement
Gat
e 1
Final
Design
Acceptance/Ramp
up
Readiness
Product
launch
Acceptance/launch
Readiness
Gat
e 4
Gat
e 3
Gat
e 2
Financial Review
Market Analysis
Competitive Assessment
Early Risk Assessment
Legal/IP Analysis & Filings
Regulatory & clinical Path
Project Plan & Timeline
Customer input/VOC
Investigational Clinical
Evaluation
Early Concept Selection
Prototype (Performance)
Analysis
Initiate & Maintain DHF
Initial dFMEA
IP landscape, review of
filings
Initial Regulatory Strategy
Initial Re-imbursement
Strategy
Initiate DFM (Tooling,
Fixturing)
Customer/Manufacturing
Prototype Evaluation
Product Design
Development
Design V&V
Maintain DHF/DMR &
Project Timeline
Design Risk Analysis
(dFMEA)
Patent Review
Regulatory Strategy update
Regulatory Submission
Reimbursement strategy
update
Supplier Collaboration
Initial Process FMEA
Detail Producibility Analysis
Product Branding
DHF/DMR Completion
Market Launch Plan
dFMEA Update & Review
Design O/p = Design I/P
Final patent Review with
R&D
Obtain Regulatory Approval
Finalize Reimbursement
Strategy
Mfg/Ops Scale up
Full Process Qualification
Clinical Validation
Sales Training
Physician Training & sales
efforts
Product improvements
Post Market Surveillance
Update Reimbursement as
needed
Process Improvement as
needed
Update Design Control
Docs
Quality Audits
Post-Launch Clinical
Validation
Reps Attend Surgical Cases
Reimbursement Path
Begin Process
IQ/OQ/PQ/PPQ
Clinical Validation Plan
$ 4 bn $ 12 bn $ 8 bn $ 4 bn
$ 2 bn

5. 4
Initiation
Opportunity and
Risk Analysis
Formulation/Concep
t and Feasibility
Phase
Design and
Development/Verifi
cation & validation
Phase
Final
validation/Product
Launch Preparation
Phase
Product Launch and
Post-Launch
Assessment
(overall R&D spending of $30 bn in 2007)
Initial evaluation of
possible development
of commercial product
Definition of design
input based on
customer needs and
technical requirements
Development of
product design and of
manufacturing process;
verification &
Validation
Final validation of
manufacturing process;
preparation of product
introduction
Market introduction of
product; continuous
improvement
Phase I Phase II Phase III Phase IV Phase V
Medical Device Product Development Lifecycle
Project
Definition
Acceptance/Concept
Charter
Initial
Design
Acceptance/Development
Agreement
Gat
e 1
Final
Design
Acceptance/Ramp
up
Readiness
Product
launch
Acceptance/launch
Readiness
Gat
e 4
Gat
e 3
Gat
e 2
Financial Review
Market Analysis
Competitive Assessment
Early Risk Assessment
Legal/IP Analysis & Filings
Regulatory & clinical Path
Project Plan & Timeline
Customer input/VOC
Investigational Clinical
Evaluation
Early Concept Selection
Prototype (Performance)
Analysis
Initiate & Maintain DHF
Initial dFMEA
IP landscape, review of
filings
Initial Regulatory Strategy
Initial Re-imbursement
Strategy
Initiate DFM (Tooling,
Fixturing)
Customer/Manufacturing
Prototype Evaluation
Product Design
Development
Design V&V
Maintain DHF/DMR &
Project Timeline
Design Risk Analysis
(dFMEA)
Patent Review
Regulatory Strategy update
Regulatory Submission
Reimbursement strategy
update
Supplier Collaboration
Initial Process FMEA
Detail Producibility Analysis
Product Branding
DHF/DMR Completion
Market Launch Plan
dFMEA Update & Review
Design O/p = Design I/P
Final patent Review with
R&D
Obtain Regulatory Approval
Finalize Reimbursement
Strategy
Mfg/Ops Scale up
Full Process Qualification
Clinical Validation
Sales Training
Physician Training & sales
efforts
Product improvements
Post Market Surveillance
Update Reimbursement as
needed
Process Improvement as
needed
Update Design Control
Docs
Quality Audits
Post-Launch Clinical
Validation
Reps Attend Surgical Cases
Reimbursement Path
Begin Process IQ/OQ/PQ/PPQ
Clinical Validation Plan
$ 4 bn $ 12 bn $ 8 bn $ 4 bn
$ 2 bn
Propensity to outsource/offshore
Patni Presence
Activities Initiated in 2010

6. 7
Eco System

7. 8
Eco System
Benefits
New Business Concepts
New Product
New Strategies to Grow portfolio
New Process

8. 9
Eco system – Activities
Interactive Activities Sessions :
Professional events, Forum
Road Show, Trade Shows
Conference, Meetings

9. 10
Few Emerging Areas

10. 11
“ Human factors is a marriage of psychology and engineering : the application of
a scientific body of knowledge about human strengths and weaknesses to the design of technology”
Human Factors
Human Factors Ergonomics
Work in Neutral Postures
Reduce Excessive Force
Everything in Easy Reach
Work at Proper Heights
Reduce Excessive Motions
Minimize Fatigue and Static Load
Minimize Pressure Points
Provide Clearance
Move, Exercise and stretch
Maintain an comfortable
Environment

11. 12
Human Factors of Medical Devices

12. 13
Laparoscopic Grasper
Project Involves the following aspects:
• Reusable and Smooth operation
• Parallel jaws gripping technique over V Shaped gripping.
• Sleek design with 4 DOFs
• Faster time to market
Client Benefits/ Key Value Adds
B
H
L
l
Operation
Closed Position
Open Position
120
15 degrees
5 mm
16 mm
550

13. 14
Assistive Devices
Assistive devices.flv

14. 15
Concept Assistive Devices
Handle Assembly along with
contact pressure sensor
Electronic module
including wireless
sensor Nodes+
Accelerometer+3 axis
gyros
User interface
(Bluetooth, USB etc)
Rubber Foot including
Contact pressure sensor
Walking stick Concept
Automatic pill dispatcher
Motorized Wheel Chair

15. 16
Telemedicine and Platforms

16. 17
17
Patient End--
Telemedicine Center
Doctor’s End--
Telemedicine Center
Telecom Network
Evaluated and
recommended
Service Provider
Developed
complete technical
solution around
H.264+H.323
Developed
Application
Interface for doctor
and patient end
Evaluated and
selected video
conferencing
hardware Camera,
TV, Network
Adaptor
Solution Development: Telemedicine Application

17. 18
Cardiac Implants

18. 19
Deep Brain Stimulation
DBS .flv

19. 20
Deep Brain Stimulation

20. 21
DBS Surgery

21. 22
DBS Programmer DBS Device
Deep Brain Stimulation Devices

22. 23
Future Direction

23. 24
Stents .flv
Stents Design, Orthopedic Implants Design
Surgery .flv

24. Company Confidential 25
Thank You