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Service Package for Life Science Start-Ups. Regulatory, Reimbursement, Quality and Clinical Research. In Europe and the USA. Amir Inbar, CEO Mediclever Ltd. [email protected] www.mediclever.com. UK Office : 27 Old Gloucester St., London WC1N 3AX [email protected] +44.208.099.7435.

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Service Package for Life Science Start-Ups

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Service Package for Life Science Start-Ups

Regulatory, Reimbursement, Quality and Clinical Research

In Europe and the USA

Amir Inbar,

CEO

Mediclever Ltd.

[email protected]

www.mediclever.com

UK Office:

27 Old Gloucester St.,

London WC1N 3AX

[email protected]

+44.208.099.7435

Israel Office:

6 Ha-Teena St.,

Modiin 71799

[email protected]

+972.50.837.1711


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9.Implementation

8.Prep. / App.

  • Establish user base, Obtain stakeholders’ support

Main Decision Makers

  • Technical file

Healthcare Providers

  • Utilize existing reimbursement mechanisms or:

7.Quality Manag. System

5.Clinical Study Protocol

6.Perform Clinical Study

  • Design dossier

Payers

  • Apply for new reimbursement mechanisms

More Info / Pricing

More Info / Pricing

  • PMA

  • 510(k)

EU

4.Evidence Planning

Class I (NS/M)

  • Value story

  • Economic model

  • Reimbursement issues for clinical study protocol

  • Stakeholders’ feedback

1.Reimbursement Landscape Report

Class I (S/M)

3.Quality Management System

Class IIa

  • Relevant, codes, coverage & payment

  • Reimbursement strategy

Class IIb

  • Design Control procedures

  • Other QS aspects essential for US and EU pre-study compliance

Class III

  • Review and/or write protocol

US

Class III

Class II

Class I

In a nut shell…

Reimbursement

2.Regulatory Landscape Report

  • Regulatory status

  • Device classification

  • Intended use & indications for use

  • Regulatory route

Regulatory, Quality and Clinical Research

  • Clinical Eval. Report

  • FDA QSR / ISO 13485


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In a nut shell…

Mediclever provides Reimbursement consulting services in Europe and the USA.

Reimbursement

Our partners coordinate and manage the provision of Regulatory, Quality,and ClinicalResearch services in Europe and the USA, in collaboration with Mediclever.

Regulatory, Quality and Clinical Research


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  • In the Reimbursement Landscape Report we:

  • Analyze the relevant market/s, providing numbers of currently conducted procedures, type of Payers (insurance companies) that finance them and overall spending.

More Info / Pricing

  • 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.

1.Reimbursement Landscape Report

  • Relevant, codes, coverage & payment

  • Reimbursement strategy

Reimbursement Landscape Report

  • In order to define the existing reimbursement scenario for a new product (drug or device), we start with the Reimbursement Landscape Report.

Reimbursement


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Main Decision Makers

Healthcare Providers

Payers

More Info / Pricing

1.Reimbursement Landscape Report

  • Relevant, codes, coverage & payment

  • Reimbursement strategy

Decision Makers and Initial Strategy

  • This enables us to:

  • Define the most relevant Decision Makers for the reimbursement of your new product.

  • Formulate an initial reimbursement strategy for your new product in the selected markets (Europe, US).

Reimbursement


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2.Regulatory Landscape Report

  • Regulatory status

  • Device classification

  • Intended use & indications for use

  • Regulatory route

Main Decision Makers

Healthcare Providers

Payers

More Info / Pricing

EU

Class I (NS/M)

1.Reimbursement Landscape Report

Class I (S/M)

Class IIa

  • Relevant, codes, coverage & payment

  • Reimbursement strategy

Class IIb

Class III

US

Class III

Class II

Class I

Regulatory Landscape Report

  • In parallel, or immediately after the Reimbursement Landscape Report is submitted, our partners provide the Regulatory Landscape Report to determine the product’s classification, intended use, indications for use and the anticipated regulatory route.

Reimbursement

  • Sometimes regulatory status and classification are different between EU and US, and this needs to be taken into account when formulating regulatory, reimbursement and marketing strategies.

Regulatory, Quality and Clinical Research


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2.Regulatory Landscape Report

  • Regulatory status

  • Device classification

  • Intended use & indications for use

  • Regulatory route

Healthcare Providers

5.Clinical Study Protocol

Payers

More Info / Pricing

EU

Class I (NS/M)

1.Reimbursement Landscape Report

Class I (S/M)

3.Quality Management System

Class IIa

  • Relevant, codes, coverage & payment

  • Reimbursement strategy

Class IIb

  • Design Control procedures

  • Other QS aspects essential for US and EU pre-study compliance

Class III

  • Review and/or write protocol

US

Class III

Class II

Class I

Preparations for Clinical Study

At the next stage, when the company prepares for its clinical study (if needed, see chart below), it typically:

Main Decision Makers

  • Implements the relevant parts of its Quality Management System (e.g., Design Controls and other QS aspects essential for US and EU pre-study compliance).

  • Writes its clinical study protocol.

Reimbursement

Regulatory, Quality and Clinical Research


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2.Regulatory Landscape Report

  • Regulatory status

  • Device classification

  • Intended use & indications for use

  • Regulatory route

3.Quality Management System

Healthcare Providers

5.Clinical Study Protocol

  • Design Control procedures

  • Other QS aspects essential for US and EU pre-study compliance

Payers

More Info / Pricing

More Info / Pricing

EU

4.Evidence Planning

Class I (NS/M)

  • Value story

  • Economic model

  • Reimbursement issues for clinical study protocol

  • Stakeholders’ feedback

1.Reimbursement Landscape Report

Class I (S/M)

Class IIa

  • Relevant, codes, coverage & payment

  • Reimbursement strategy

Class IIb

Class III

US

Class III

Class II

Class I

Evidence Planning

At this stage, long before the clinical study actually begins, we will plan the required ‘evidence’ for the reimbursement of your new product:

Main Decision Makers

Reimbursement

  • Value Story: Lay out the clinical AND economic benefits of using your new product, from the identified Decision Makers’ perspective.

  • Economic Model: Quantify the economic benefit, allow for sensitivity analysis and later on, use it as a sales tool.

  • Reimbursement Related Parameters: Integrate in the study protocol.

  • Stakeholders’ Feedback: Don’t gamble. Verify with our network partners, representing relevant Decision Makers, that they will indeed finance the use of your new product if the claims in the Value Story are proven according to the presented clinical study protocol.

Regulatory, Quality and Clinical Research

  • Review and/or write protocol


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2.Regulatory Landscape Report

Round A

Seed Funding

  • Regulatory status

  • Device classification

  • Intended use & indications for use

  • Regulatory route

3.Quality Management System

Healthcare Providers

5.Clinical Study Protocol

  • Design Control procedures

  • Other QS aspects essential for US and EU pre-study compliance

Payers

More Info / Pricing

More Info / Pricing

EU

4.Evidence Planning

Class I (NS/M)

  • Value story

  • Economic model

  • Reimbursement issues for clinical study protocol

  • Stakeholders’ feedback

1.Reimbursement Landscape Report

Class I (S/M)

Class IIa

  • Relevant, codes, coverage & payment

  • Reimbursement strategy

Class IIb

Class III

US

Class III

Class II

Class I

Evidence Planning

Raise funding:

  • At this stage, in order to finance their clinical trial, many companies raise their growth funding round (also referred as Series A round).

Main Decision Makers

Reimbursement

Regulatory, Quality and Clinical Research

  • Review and/or write protocol


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2.Regulatory Landscape Report

  • Regulatory status

  • Device classification

  • Intended use & indications for use

  • Regulatory route

3.Quality Management System

Healthcare Providers

5.Clinical Study Protocol

6.Perform Clinical Study

  • Design Control procedures

  • Other QS aspects essential for US and EU pre-study compliance

Payers

More Info / Pricing

More Info / Pricing

EU

4.Evidence Planning

Class I (NS/M)

  • Value story

  • Economic model

  • Reimbursement issues for clinical study protocol

  • Stakeholders’ feedback

1.Reimbursement Landscape Report

Class I (S/M)

Class IIa

  • Relevant, codes, coverage & payment

  • Reimbursement strategy

Class IIb

Class III

US

  • Clinical Eval. Report

Class III

Class II

Class I

Clinical Study

Round A

Seed Funding

Now, the clinical trial may be conducted and the resulting ‘evidence’, substantiating the claims in the Value Story, should be published.

The Clinical Evaluation Report (CER) should now be prepared, based on official European guidance. CER may also be useful for US submissions.

Main Decision Makers

Reimbursement

Regulatory, Quality and Clinical Research

  • Review and/or write protocol


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2.Regulatory Landscape Report

  • Regulatory status

  • Device classification

  • Intended use & indications for use

  • Regulatory route

3.Quality Management System

Healthcare Providers

6.Perform Clinical Study

5.Clinical Study Protocol

7.Quality Manag. System

  • Design Control procedures

  • Other QS aspects essential for US and EU pre-study compliance

Payers

More Info / Pricing

More Info / Pricing

EU

4.Evidence Planning

Class I (NS/M)

  • Value story

  • Economic model

  • Reimbursement issues for clinical study protocol

  • Stakeholders’ feedback

1.Reimbursement Landscape Report

Class I (S/M)

Class IIa

  • Relevant, codes, coverage & payment

  • Reimbursement strategy

Class IIb

Class III

US

  • FDA QSR / ISO 13485

Class III

Class II

Class I

Completion of Quality Management System

Round A

Seed Funding

Completion of QMS

At this stage, if the company has not already done so, the quality management system can be completed to ensure it complies with US and/or European requirements.

Main Decision Makers

Reimbursement

Regulatory, Quality and Clinical Research

  • Review and/or write protocol

  • Clinical Eval. Report


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2.Regulatory Landscape Report

8.Prep. / App.

  • Regulatory status

  • Device classification

  • Intended use & indications for use

  • Regulatory route

  • Technical file

3.Quality Management System

Healthcare Providers

6.Perform Clinical Study

5.Clinical Study Protocol

7.Quality Manag. System

  • Design Control procedures

  • Other QS aspects essential for US and EU pre-study compliance

  • Design dossier

Payers

More Info / Pricing

More Info / Pricing

  • PMA

  • 510(k)

EU

4.Evidence Planning

Class I (NS/M)

  • Value story

  • Economic model

  • Reimbursement issues for clinical study protocol

  • Stakeholders’ feedback

1.Reimbursement Landscape Report

Class I (S/M)

Class IIa

  • Relevant, codes, coverage & payment

  • Reimbursement strategy

Class IIb

Class III

US

Class III

Class II

Class I

Regulatory Application

Round A

Seed Funding

At this point the company may submit the Technical File or the Design Dossier (in Europe) or apply for FDA Clearance / Approval (in the US).

If granted, it could start selling its products.

To obtain reimbursement, see the next slide…

Main Decision Makers

Reimbursement

Regulatory, Quality and Clinical Research

  • Review and/or write protocol

  • Clinical Eval. Report

  • FDA QSR / ISO 13485


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9.Implementation

8.Prep. / App.

  • Establish user base, Obtain stakeholders’ support

  • Technical file

Healthcare Providers

  • Utilize existing reimbursement mechanisms or:

7.Quality Manag. System

6.Perform Clinical Study

5.Clinical Study Protocol

  • Design dossier

Payers

  • Apply for new reimbursement mechanisms

More Info / Pricing

More Info / Pricing

  • PMA

  • 510(k)

4.Evidence Planning

  • Value story

  • Economic model

  • Reimbursement issues for clinical study protocol

  • Stakeholders’ feedback

1.Reimbursement Landscape Report

  • Relevant, codes, coverage & payment

  • Reimbursement strategy

Reimbursement Application

Round A

Seed Funding

Main Decision Makers

Reimbursement

In case existing reimbursement mechanisms (Codes, Coverage, Payment) were allocated in 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 Providers to purchase your new product.

Regulatory, Quality and Clinical Research

Otherwise:

  • Review and/or write protocol

  • Clinical Eval. Report

  • FDA QSR / ISO 13485

  • After verifying a sufficient user-base and support from the medical community, we will apply for new codes, coverage policies and favorable payment rates.


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Costs?


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Costs

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