SlideShare a Scribd company logo
Empowering medical device organizations
across the product value chain
We combine our deep domain expertise with customer
understanding to provide an agile and scalable operating
model. 15 of Top 20 medical device organizations rely on us
to deliver effective and efficient regulatory, clinical, medical
and commercial outcomes every day.
© 2022 Indegene. All rights reserved. 2
© 2022 Indegene. All rights reserved. 3
We partner with you across the medical device value stream
• Data driven , Curated Solutions
• Flexible Services – Standalone or Integrated
• Seamless integration with customer and vendor teams
• Commercial structure adapted to product lifecycle
• Agile execution
• 250 years of Industry, Technology and functional
expertise.
TECHNOLOGY
ACCELERATORS
Commercial Data
Warehouse
Adverse Events
Management
Regulatory
Submissions Planning
Commercial Content
Intelligence
Learning
Retention
MLR Review
Automation
Digital Asset
Management
Campaign
Management
Clinical Trials
Design
Omnichannel Commercial
Intelligence
Regulatory
Intelligence
Authoring and
Publishing Platform
Design Support Design Transfer
Product Lifecycle
Management
Regulatory Planning
QMS & Quality
Engineering (Inc. RM)
Clinical Evaluation & Post
Market Surveillance
GTM Planning
Product Launch
Execution
Optimization &
Expansion
Assess Product-
Market Fit
End To End DATA & ANALYTICS for Smarter Decisions
1. DEFINE VALUE PROPOSITION 2. REGULATORY APPROVAL 3. COMMERCIAL LAUNCH 4. SUSTAIN & EXPAND
© 2022 Indegene. All rights reserved. 4
Product Development Services
1. DEFINE VALUE PROPOSITION 2. REGULATORY APPROVAL 3. COMMERCIAL LAUNCH 4. SUSTAIN & EXPAND
Product Lifecycle Management
Design Transfer
Design Support
Faster time
to market
Shorter
design cycle
Reduced effort on
non-core activities
Enhanced customer
Experience
Process
Consulting
AI tools and
automation platforms
Program
management experts
© 2022 Indegene. All rights reserved. 4
150+
Products designed
Reduction in patient enrollment costs
50%
1.5K+
Projects delivered across start up, Midcap,
and Fortune 500 ecosystems
Impact Design Across
• Augmented and Virtual Reality
• Wearables & data visualization
• Phygital Experiences
Design history files
documented
360+
Reduction in patient drop offs
75%
Improvement in time to market
50%
© 2022 Indegene. All rights reserved. 5
Product Marketing Services
1. DEFINE VALUE PROPOSITION 2. REGULATORY APPROVAL 3. COMMERCIAL LAUNCH 4. SUSTAIN & EXPAND
Optimization & Expansion
Product Launch Execution
GTM Planning
Assess Product-Market Fit
Personalized and Scalable
customer engagement
Customer behavior based Digital
Omnichannel Marketing
Incremental revenue through
optimized operations
Accelerated Go to
Market Plan
Primary Market Research Secondary Market Research AI based tools and intelligence Medical devices industry expertise
© 2022 Indegene. All rights reserved. 5
24 MN
Campaign impressions
per customer per quarter
20+
Successful campaigns
in 12 months
750+
MQL generated per
customer
25%
Marketing campaign
cost optimization
20%
Faster time
to launch
© 2022 Indegene. All rights reserved. 6
Quality Engineering
• DHF documentation/
remediation
EU MDR support
• Gap assessment
• Technical documentation
compilation
Regulatory support
• IVDD/IVDR
• 510k submission
• RoW registration
Clinical Evaluation
• CEP/CER/SSCP
• PMCF
Risk Management
• Risk evaluation files
Post Market Surveillance
• PMS Plan
• PSUR
• Complaint Handling
QMS implementation
Copy/Review
• Claims
• Evidence
• References
Quality, Regulatory and Clinical Services
© 2022 Indegene. All rights reserved. 7
Data and Analytics
Market
Intelligence
Market
Excellence
Salesforce
Excellence
Provider
Experience
Patient
Experience
AI-driven commercial insights Scalable analytical solutions Managed services model for
operations
On-demand services providing end-
to-end data and analytics services
for healthcare
Unstructured data Real World Data
AI based tools and
intelligence
Client Market Strategy
Therapy Areas
Reduction in Speed-to-
Standardized RWD KPIs
8+
>60%
75K+
Customer profiles unified
12+
Common data Models
20%
Increase in NBA adoption by
field force
35
Analytics ready data sets
3+
Automated and Standardized
Solutions for Predictive Analytics
25+
Advanced Analytics Projects
using RWD
© 2022 Indegene. All rights reserved. 8
Flexible Service models
Milestone based projects
Cross-functional services designed
to help customers meet their desired
outcomes
Services that augment current
customer functional teams in the
long-term or short-term
Functional support
Single projects
Individual sub-services that answer key
business questions or accomplish a
business process
Design Support Design Transfer
Product Lifecycle
Management
Regulatory Planning
QMS & Quality
Engineering (Inc. RM)
Clinical Evaluation & Post
Market Surveillance
GTM Planning
Product Launch
Execution
Optimization &
Expansion
Assess Product-
Market Fit
1. DEFINE VALUE PROPOSITION 2. REGULATORY APPROVAL 3. COMMERCIAL LAUNCH 4. SUSTAIN & EXPAND
We helped a leading
oncology brand unlock
360º customer
insights
© 2022 Indegene. All rights reserved. 9
75k+
Customer profiles
unified
12%
in Engagement
Index
20%
in NBA adoption
by field force
á
© 2022 Indegene. All rights reserved. 10
We fast-tracked the
remediation of 1,000+
DHFs for a leading
injectable manufacturer
90%
First draft
acceptance
100%
Quality, compliance,
and timelines
20%
Increased
productivity
á
© 2022 Indegene. All rights reserved. 11
We enhanced
customer experience
for a top 10 medical device
manufacturer
30%
reduction in expedites
40%
Faster time to market
á
á
Thank you!

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Medical Devices

  • 1. Empowering medical device organizations across the product value chain
  • 2. We combine our deep domain expertise with customer understanding to provide an agile and scalable operating model. 15 of Top 20 medical device organizations rely on us to deliver effective and efficient regulatory, clinical, medical and commercial outcomes every day. © 2022 Indegene. All rights reserved. 2
  • 3. © 2022 Indegene. All rights reserved. 3 We partner with you across the medical device value stream • Data driven , Curated Solutions • Flexible Services – Standalone or Integrated • Seamless integration with customer and vendor teams • Commercial structure adapted to product lifecycle • Agile execution • 250 years of Industry, Technology and functional expertise. TECHNOLOGY ACCELERATORS Commercial Data Warehouse Adverse Events Management Regulatory Submissions Planning Commercial Content Intelligence Learning Retention MLR Review Automation Digital Asset Management Campaign Management Clinical Trials Design Omnichannel Commercial Intelligence Regulatory Intelligence Authoring and Publishing Platform Design Support Design Transfer Product Lifecycle Management Regulatory Planning QMS & Quality Engineering (Inc. RM) Clinical Evaluation & Post Market Surveillance GTM Planning Product Launch Execution Optimization & Expansion Assess Product- Market Fit End To End DATA & ANALYTICS for Smarter Decisions 1. DEFINE VALUE PROPOSITION 2. REGULATORY APPROVAL 3. COMMERCIAL LAUNCH 4. SUSTAIN & EXPAND
  • 4. © 2022 Indegene. All rights reserved. 4 Product Development Services 1. DEFINE VALUE PROPOSITION 2. REGULATORY APPROVAL 3. COMMERCIAL LAUNCH 4. SUSTAIN & EXPAND Product Lifecycle Management Design Transfer Design Support Faster time to market Shorter design cycle Reduced effort on non-core activities Enhanced customer Experience Process Consulting AI tools and automation platforms Program management experts © 2022 Indegene. All rights reserved. 4 150+ Products designed Reduction in patient enrollment costs 50% 1.5K+ Projects delivered across start up, Midcap, and Fortune 500 ecosystems Impact Design Across • Augmented and Virtual Reality • Wearables & data visualization • Phygital Experiences Design history files documented 360+ Reduction in patient drop offs 75% Improvement in time to market 50%
  • 5. © 2022 Indegene. All rights reserved. 5 Product Marketing Services 1. DEFINE VALUE PROPOSITION 2. REGULATORY APPROVAL 3. COMMERCIAL LAUNCH 4. SUSTAIN & EXPAND Optimization & Expansion Product Launch Execution GTM Planning Assess Product-Market Fit Personalized and Scalable customer engagement Customer behavior based Digital Omnichannel Marketing Incremental revenue through optimized operations Accelerated Go to Market Plan Primary Market Research Secondary Market Research AI based tools and intelligence Medical devices industry expertise © 2022 Indegene. All rights reserved. 5 24 MN Campaign impressions per customer per quarter 20+ Successful campaigns in 12 months 750+ MQL generated per customer 25% Marketing campaign cost optimization 20% Faster time to launch
  • 6. © 2022 Indegene. All rights reserved. 6 Quality Engineering • DHF documentation/ remediation EU MDR support • Gap assessment • Technical documentation compilation Regulatory support • IVDD/IVDR • 510k submission • RoW registration Clinical Evaluation • CEP/CER/SSCP • PMCF Risk Management • Risk evaluation files Post Market Surveillance • PMS Plan • PSUR • Complaint Handling QMS implementation Copy/Review • Claims • Evidence • References Quality, Regulatory and Clinical Services
  • 7. © 2022 Indegene. All rights reserved. 7 Data and Analytics Market Intelligence Market Excellence Salesforce Excellence Provider Experience Patient Experience AI-driven commercial insights Scalable analytical solutions Managed services model for operations On-demand services providing end- to-end data and analytics services for healthcare Unstructured data Real World Data AI based tools and intelligence Client Market Strategy Therapy Areas Reduction in Speed-to- Standardized RWD KPIs 8+ >60% 75K+ Customer profiles unified 12+ Common data Models 20% Increase in NBA adoption by field force 35 Analytics ready data sets 3+ Automated and Standardized Solutions for Predictive Analytics 25+ Advanced Analytics Projects using RWD
  • 8. © 2022 Indegene. All rights reserved. 8 Flexible Service models Milestone based projects Cross-functional services designed to help customers meet their desired outcomes Services that augment current customer functional teams in the long-term or short-term Functional support Single projects Individual sub-services that answer key business questions or accomplish a business process Design Support Design Transfer Product Lifecycle Management Regulatory Planning QMS & Quality Engineering (Inc. RM) Clinical Evaluation & Post Market Surveillance GTM Planning Product Launch Execution Optimization & Expansion Assess Product- Market Fit 1. DEFINE VALUE PROPOSITION 2. REGULATORY APPROVAL 3. COMMERCIAL LAUNCH 4. SUSTAIN & EXPAND
  • 9. We helped a leading oncology brand unlock 360º customer insights © 2022 Indegene. All rights reserved. 9 75k+ Customer profiles unified 12% in Engagement Index 20% in NBA adoption by field force á
  • 10. © 2022 Indegene. All rights reserved. 10 We fast-tracked the remediation of 1,000+ DHFs for a leading injectable manufacturer 90% First draft acceptance 100% Quality, compliance, and timelines 20% Increased productivity á
  • 11. © 2022 Indegene. All rights reserved. 11 We enhanced customer experience for a top 10 medical device manufacturer 30% reduction in expedites 40% Faster time to market á á