Developing and Implementing a

Clinical Strategy for Biodesign

Dr.Arunkumar Annamalai
Identify the stakeholder
Patient
Relative of Patient
Payers
Doctors
Policy Makers
FDA
Sales and Distribution
Inventor
Finance
Patient
Relative of Patient
Payers
Doctors
Policy Makers
FDA
Sales and Distribution
Inventor
Finance
Patient
Relative of Patient
Payers
Doctors
Policy Makers
FDA
Sales and Distribution
Inventor
Finance
Patient
Relative of Patient
Payers
Doctors
Policy Makers
FDA
Sales and Distribution
Inventor
Finance
Patient
Relative of Patient
Payers
Doctors
Policy Makers
FDA
Sales and Distribution
Inventor
Finance
Patient
Relative of Patient
Payers
Doctors
Policy Makers
FDA
Sales and Distribution
Inventor
Finance
Patient
Relative of Patient
Payers
Doctors
Policy Makers
FDA
Sales and Distribution
Inventor
Finance
Patient
Relative of Patient
Payers
Doctors
Policy Makers
FDA
Sales and Distribution
Inventor
Finance
Patient
Relative of Patient
Payers
Doctors
Policy Makers
Regulatory Approval
Sales and Distribution
Inventor
Finance
What are the various questions
from different stakeholders?
Stakeholder Question

Patient Can I safely use this?

Relative of Patient Can I trust this device to cure my mother?

Doctor Will my patient feel better? Will it enhance my

practice?

Payers How is this device superior to others?

Regulatory Bodies (FDA) Does it meet the standards?

Marketing and Sales How shall I sell this?

Policy Makers What problem is it solving?

Finance What is the cost and ROI?

Different Stakeholders=Different
Strategies
Stakeholder Question Strategy

Patient Can I safely use this?

Relative of Patient Can I trust this device to cure my Market Adoption and
mother? Stakeholder Strategy

Doctor Will my patient feel better? Will it

enhance my practice?

Payers How is this device superior to Reimbursement Strategy

others?

Regulatory Bodies Does it meet the standards? Regulatory Strategy

(FDA)

Marketing and Sales How shall I sell this? Sales and Distribution

Policy Makers What problem is it solving? Operational Strategy

Finance What is the cost and ROI? Finance Strategy

Can there be an UNIFYING strategy
that helps all other strategies?
Bench to Bedside Challenges
Patient

Relative of
Doctor
Patient

Policy
Makers
? Payers

Regulatory Sales and

Approval Distribution

Finance
Device Engineering R and D alone
cannot handle these stakeholders
 Clinical Trials!!!
We all know about it!
What is the real problem?
COST!!!!
How do we reach our objectives
optimising our resources?
How do we reach our objectives
optimising our resources?
Requires more than a clinical trial: A
CLINICAL STRATEGY
Solution: A Clinical Strategy developed by
Clinical R and D
Patient

Relative of
Doctor
Patient

Policy
Clinical
Payers
Makers
Strategy

Regulatory Marketing
Approval and Sales

Finance
 What is Clinical Strategy
“Clinical Pathway that addresses the
company’s top priorities in a realistic
manner”

Biodesign: The Process of Innovating Medical

Technologies
by Paul Yock, Stefanos A. Zenios, and Todd J. Brinton
The Big Picture
Phases Identify Invent Implement Post Market
Surveillance

Clinical Strategy Systematic Reviews/Research Syntheses

- Integrate with
other strategies
early on
- Saves lot of time Pilot Studies (Registries/Observational Studies)
and money Pivotal Studies ( RCT, Cohort, Case Control, Cross-
- Do multiple Sectional, Case Studies, Expert Opinions)
smaller studies
systematically
Post Market
Surveillance
Studies
 Identify Invent Implement Post Market
Surveillance
Systematic Reviews/Research Syntheses
Pilot Studies (Registries/Observational Studies)
Pivotal Studies ( RCT, Cohort, Case Control, Cross-Sectional, Case Studies, Expert Opinions)

Post Market
Surveillance Studies

Formulation of Design Proposals, approvals Implementation Documentation and

and logistics/budgeting reporting
1. Papers
1. Brainstorming 1. Proposal 1. Recruitment of team 2. Technical
2. Reviews 2. Hypothesis 2. Training Documents
3. Choosing a study 3. Study Design 3. Ensuring best practices
design 4. Sample Size 4. Performance measurement
4. Identify Centers/ 5. Inclusion/Exclusion 5. QC
Collaborateurs criteria 6. Monitoring and Evaluation
6. CRF 7. Data management
7. Consent Forms
8. IRB
approval/Conflict of
interest
9. Data management
plan
 Special Note on Endpoints
• What to measure as an outcome or an
output?
• These are called as Endpoints
• Endpoints can be primary or secondary
• It can be measured;
- Quantitatively
- Qualitatively
- Mixed methods approach
- Surrogate markers
Thank you