1. Service Package for Life Science
Start-Ups
Regulatory, Reimbursement, Quality and
Clinical Research
In Europe and the USA
Amir Inbar, UK Office: Israel Office:
CEO 27 Old Gloucester St., 6 Ha-Teena St.,
Mediclever Ltd. London WC1N 3AX Modiin 71799
amir@mediclever.com uk@mediclever.com il@mediclever.com
www.mediclever.com +44.208.099.7435 +972.50.837.1711
1/16

2. Reimbursement
In a nut shell…
1. Reimbursement 4. Evidence Planning 9. Implementation
Landscape Report
Main Decision • Value story • Establish user base,
• Relevant, Makers • Economic model Obtain stakeholders’
codes, • Reimbursement support
coverage & Healthcare issues for clinical • Utilize existing
payment Providers study protocol reimbursement
• Reimbursement • Stakeholders’ mechanisms or:
strategy feedback
Payers • Apply for new
reimbursement
mechanisms
More Info / Pricing More Info / Pricing
2. Regulatory EU 8. Prep. / App.
and Clinical Research
Landscape Report
Regulatory, Quality
Class I (NS/M) • Technical file
• Regulatory
status Class I (S/M) 3. Quality
Management
• Device Class IIa System
classification
• Intended use & Class IIb • Design
5. Clinical 6.Perform 7.Quality
indications for Control • Design dossier
Class III Study Clinical Manag.
use procedures
Protocol Study System
• Regulatory • Other QS
route US • Review • Clinical • FDA
aspects Eval. QSR /
and/or
Class III essential Report ISO
write • PMA
for US and protocol 13485
Class II EU pre- • 510(k)
study
Class I compliance
2/16

3. Reimbursement
In a nut shell…
Mediclever provides Reimbursement consulting
services in Europe and the USA.
and Clinical Research
Regulatory, Quality
Our partners coordinate and manage the
provision of Regulatory, Quality, and Clinical
Research services in Europe and the USA, in
collaboration with Mediclever.
3/16

4. Reimbursement Landscape Report
• In order to define the existing reimbursement scenario for a new
Reimbursement
1. Reimbursement
Landscape Report
product (drug or device), we start with the Reimbursement
• Relevant, Landscape Report.
codes,
coverage &
payment In the Reimbursement Landscape Report we:
• Reimbursement
strategy • Analyze the relevant market/s, providing numbers of
currently conducted procedures, type of Payers
(insurance companies) that finance them and overall
More Info / Pricing spending.
• Find out whether there are any existing codes,
coverage policies and payment mechanisms that
could be utilized or compared to, by the new medical
product.
4/16

5. Decision Makers and Initial Strategy
This enables us to:
Reimbursement
1. Reimbursement
Landscape Report
Main Decision
• Relevant, Makers
• Define the most relevant Decision Makers for the
codes, reimbursement of your new product.
coverage & Healthcare
Providers
payment • Formulate an initial reimbursement strategy for your
• Reimbursement
strategy new product in the selected markets (Europe, US).
Payers
More Info / Pricing
5/16

6. Regulatory Landscape Report
• In parallel, or immediately after the Reimbursement
Reimbursement
1. Reimbursement
Landscape Report
Main Decision Landscape Report is submitted, our partners
Makers
• Relevant, provide the Regulatory Landscape Report to
codes,
coverage & Healthcare determine the product’s classification, intended use,
payment Providers
indications for use and the anticipated regulatory
• Reimbursement
strategy route.
Payers • Sometimes regulatory status and classification are
different between EU and US, and this needs to be
More Info / Pricing
taken into account when formulating regulatory,
reimbursement and marketing strategies.
2. Regulatory EU
and Clinical Research
Landscape Report
Regulatory, Quality
Class I (NS/M)
• Regulatory
status Class I (S/M)
• Device Class IIa
classification
• Intended use & Class IIb
indications for
Class III
use
• Regulatory
route US
Class III
Class II
Class I
6/16

7. Preparations for Clinical Study
At the next stage, when the company prepares for its
Reimbursement
1. Reimbursement
Landscape Report
Main Decision clinical study (if needed, see chart below), it typically:
• Relevant, Makers
codes, • Implements the relevant parts of its Quality
coverage & Healthcare
payment Providers
Management System (e.g., Design Controls and
• Reimbursement other QS aspects essential for US and EU pre-study
strategy compliance).
Payers
• Writes its clinical study protocol.
More Info / Pricing
2. Regulatory EU
and Clinical Research
Landscape Report
Regulatory, Quality
Class I (NS/M)
• Regulatory
status Class I (S/M) 3. Quality
Management
• Device Class IIa System
classification
• Intended use & Class IIb • Design 5. Clinical
indications for Control
Class III Study
use procedures Protocol
• Regulatory • Other QS
route US • Review
aspects
and/or
Class III essential
write
for US and protocol
Class II EU pre-
study
Class I compliance
7/16

8. Evidence Planning
At this stage, long before the clinical
Reimbursement
1. Reimbursement 4. Evidence Planning
Landscape Report
Main Decision • Value story study actually begins, we will plan the
• Relevant, Makers • Economic model required ‘evidence’ for the
codes, • Reimbursement reimbursement of your new product:
coverage & Healthcare issues for clinical
payment Providers study protocol • Value Story: Lay out the clinical AND
• Reimbursement • Stakeholders’ economic benefits of using your new
strategy feedback
product, from the identified Decision
Payers Makers’ perspective.
More Info / Pricing More Info / Pricing
• Economic Model: Quantify the
economic benefit, allow for sensitivity
analysis and later on, use it as a
2. Regulatory EU
sales tool.
and Clinical Research
Landscape Report
• Reimbursement Related Parameters:
Regulatory, Quality
Class I (NS/M)
• Regulatory Integrate in the study protocol.
status Class I (S/M) 3. Quality
Management • Stakeholders’ Feedback: Don’t
• Device Class IIa System
classification gamble. Verify with our network
• Intended use & Class IIb • Design 5. Clinical partners, representing relevant
indications for Control
use
Class III
procedures
Study Decision Makers, that they will indeed
Protocol
• Regulatory • Other QS
finance the use of your new product if
route US • Review
aspects
and/or
the claims in the Value Story are
Class III essential proven according to the presented
write
for US and protocol
Class II EU pre- clinical study protocol.
study
Class I compliance
8/16

9. Evidence Planning
Seed Funding Round A
Raise funding:
Reimbursement
1. Reimbursement 4. Evidence Planning
Landscape Report
Main Decision • Value story • At this stage, in order to finance
• Relevant, Makers • Economic model their clinical trial, many
codes, • Reimbursement
coverage & Healthcare issues for clinical
companies raise their growth
payment Providers study protocol funding round (also referred as
• Reimbursement • Stakeholders’ Series A round).
strategy feedback
Payers
More Info / Pricing More Info / Pricing
2. Regulatory EU
and Clinical Research
Landscape Report
Regulatory, Quality
Class I (NS/M)
• Regulatory
status Class I (S/M) 3. Quality
Management
• Device Class IIa System
classification
• Intended use & Class IIb • Design 5. Clinical
indications for Control
Class III Study
use procedures Protocol
• Regulatory • Other QS
route US • Review
aspects and/or
Class III essential
write
for US and protocol
Class II EU pre-
study
Class I compliance
9/16

10. Clinical Study
Seed Funding Round A
Now, the clinical trial may be
Reimbursement
1. Reimbursement 4. Evidence Planning
Landscape Report
• Value story
conducted and the resulting
Main Decision
• Relevant, Makers • Economic model ‘evidence’, substantiating the
codes, • Reimbursement claims in the Value Story, should
coverage & Healthcare issues for clinical
Providers
be published.
payment study protocol
• Reimbursement • Stakeholders’ The Clinical Evaluation Report
strategy feedback
(CER) should now be prepared,
Payers based on official European
guidance. CER may also be useful
More Info / Pricing More Info / Pricing for US submissions.
2. Regulatory EU
and Clinical Research
Landscape Report
Regulatory, Quality
Class I (NS/M)
• Regulatory
status Class I (S/M) 3. Quality
Management
• Device Class IIa System
classification
• Intended use & Class IIb • Design 5. Clinical 6.Perform
indications for Control
Class III Study Clinical
use procedures Protocol Study
• Regulatory • Other QS
route US • Review • Clinical
aspects Eval.
and/or
Class III essential Report
write
for US and protocol
Class II EU pre-
study
Class I compliance
10/16

11. Completion of Quality Management System
Seed Funding Round A
Completion of QMS
Reimbursement
1. Reimbursement 4. Evidence Planning
Landscape Report
Main Decision • Value story At this stage, if the company has
• Relevant, Makers • Economic model
not already done so, the quality
codes, • Reimbursement
coverage & Healthcare issues for clinical management system can be
payment Providers study protocol completed to ensure it complies
• Reimbursement • Stakeholders’ with US and/or European
strategy feedback
requirements.
Payers
More Info / Pricing More Info / Pricing
2. Regulatory EU
and Clinical Research
Landscape Report
Regulatory, Quality
Class I (NS/M)
• Regulatory
status Class I (S/M) 3. Quality
Management
• Device Class IIa System
classification
• Intended use & Class IIb • Design 5. Clinical 6.Perform 7.Quality
indications for Control
Class III Study Clinical Manag.
use procedures Protocol Study System
• Regulatory • Other QS
route US • Review • Clinical • FDA
aspects Eval. QSR /
and/or
Class III essential Report ISO
write
for US and protocol 13485
Class II EU pre-
study
Class I compliance
11/16

12. Regulatory Application
Seed Funding Round A
At this point the company may
Reimbursement
1. Reimbursement 4. Evidence Planning
Landscape Report
Main Decision • Value story submit the Technical File or the
• Relevant, Makers • Economic model Design Dossier (in Europe) or
codes, • Reimbursement apply for FDA Clearance /
coverage & Healthcare issues for clinical
payment Providers
Approval (in the US).
study protocol
• Reimbursement • Stakeholders’ If granted, it could start selling its
strategy feedback
products.
Payers
To obtain reimbursement, see the
next slide…
More Info / Pricing More Info / Pricing
2. Regulatory EU 8. Prep. / App.
and Clinical Research
Landscape Report
Regulatory, Quality
Class I (NS/M) • Technical file
• Regulatory
status Class I (S/M) 3. Quality
Management
• Device Class IIa System
classification
• Intended use & Class IIb • Design 5. Clinical 6.Perform 7.Quality
indications for Control • Design dossier
Class III Study Clinical Manag.
use procedures Protocol Study System
• Regulatory • Other QS
route US • Review • Clinical • FDA
aspects Eval. QSR /
and/or
Class III essential Report ISO • PMA
write
for US and protocol 13485
Class II EU pre- • 510(k)
study
Class I compliance
12/16

13. Reimbursement Application
Seed Funding Round A
Reimbursement
1. Reimbursement 4. Evidence Planning 9. Implementation
Landscape Report
Main Decision • Value story • Establish user base,
• Relevant, Makers • Economic model Obtain stakeholders’
codes, • Reimbursement support
coverage & Healthcare issues for clinical • Utilize existing
payment Providers study protocol reimbursement
• Reimbursement • Stakeholders’ mechanisms or:
strategy feedback
Payers • Apply for new
reimbursement
mechanisms
More Info / Pricing More Info / Pricing
In case existing reimbursement mechanisms 8. Prep. / App.
and Clinical Research
(Codes, Coverage, Payment) were allocated in
Regulatory, Quality
• Technical file
the Reimbursement Landscape Report, we will
• Compile the Value Story, Economic Model and
the published ‘evidence’ into a dossier that
would be used to convince Healthcare
5. Clinical 6.Perform 7.Quality
Providers to purchase your new product. Study Clinical Manag. • Design dossier
Protocol Study System
Otherwise:
• Review • Clinical • FDA
• After verifying a sufficient user-base and and/or Eval. QSR /
support from the medical community, we will write Report ISO • PMA
protocol 13485
apply for new codes, coverage policies and • 510(k)
favorable payment rates.
13/16

14. 14/16

15. Costs
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16. Some of Our Clients
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