The Secret to a Successful Product Launch: - Emerson Consultants ...

The Secret to a 

Successful Product Launch: 

Integrating Reimbursement, Clinical, 

Regulatory, and Marketing Strategies 

Kelli Hallas 

Executive Vice President of Reimbursement 

Emerson Consultants, Inc. 

OMTEC June 2011 

Copyright Emerson Consultants, Inc. 2011 

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Disclaimer 

The information contained in this presentation is provided for educational purposes 

only. 

Brand manufacturers should contact the appropriate entities for product-specific 

guidance. The examples cited in this presentation are not reflective of any Emerson 

Consultants, Inc. projects. 

No information contained within this document may be used without the consent of 



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Objectives 

Understand why it is critical to integrate strategies early 

in the development phase 

Focus on how to integrate four completely unique 

strategies 

Discuss how successfully integrating strategies can 

impact your business 

Determine when and what to integrate into the process 

Create a “blueprint” template for your unique technology 

to have a positive impact on product launch 


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Why the Need to 

Integrate Strategies? 

Work smarter 

Consistent approach-lay groundwork for 

future projects and create efficiency 

Reduce internal costs 

Expedite approval 

Generate revenue faster 

Gain market acceptance 

Become market leader 


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Why the Need to 

Integrate Strategies? 

Clinical protocol critical to reimbursement, 

regulatory, and marketing success 

Needs of FDA, CMS, and the market are 

different but a well-designed study can 

incorporate all these stakeholder’s needs 

Most importantly, in today’s healthcare 

environment a company cannot successfully 

bring a product to market on a project-by-project 

basis 


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Questions to Ask….. 

Is it a New Technology? 

First to market 

What are the indications for use? 

Align with existing codes/coverage decisions 

What is the site of service? 

Safety 

Different reimbursement rates/methods 

Class l, ll, or lll 

What is the clinical data requirement? 

FDA 

CMS or other payers 

Societies 

Market 


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Questions to Ask 

What does the FDA Guidance Document require? 

Example: Coronary Drug-Eluting Stents— Nonclinical and Clinical Studies 

(draft guidance March 2008) 

FDA encourages study sponsors to use the pre-submission process to gain 

informal feedback on proposed clinical protocols for DES, including 

feasibility or pivotal studies. 

Study design may be superiority or non-inferiority 

End points: death, MI, Target Lesion Revascularization (TLR), Target Vessel 

Revascularization (TVR), stent thrombosis) 

How does FDA guidance document impact 

reimbursement? 

VBRs and IBDs with allograft 

One on label and one off label 

Payers will not cover and pay for off label use 

Marketing cannot promote 


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What does CMS/Payers need? 

Are there Coverage Decisions? 

CMS, local/national 

What do they say? 

How will technology be affected? 

What input have payer Medical Directors 

given relative to outcomes measure? 

Is there enough sufficient data to satisfy 

the payer’s needs? 


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Can the technology show substantial 

clinical improvement over the current 

standard of care? (New Buzz Word) 

-reduced mortality rate 

-reduced rate of device related complications 

-decreased rate of subsequent diagnostic or therapeutic 

interventions 

-decreased number of future hospitalizations/physicians visits 

-more rapid beneficial resolution of the disease process treatment 

because of use of the device 

-decreased pain, bleeding or other quantifiable symptoms 

-reduced recovery time 

-minimally invasive (percutaneous vs. open) 


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How does the “global” cost of the procedure 

compare with the cost of the gold standard? 

Economic data collection during trial 

Depending on these answers is the technology 

cost effective i.e. shows more value for the 

money spent when compared to reasonable 

alternative? 

Improve net health outcomes 


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What is the competition doing? 

ClinicalTrials.gov 

Abstracts, Posters, Presentations at Professional 

Society meetings 

Reimbursement initiatives (coding meetings, 

payer coverage meetings) 

FDA Panel meetings 


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In order to accurately answer all these 

critical questions and develop a strategy to 

meet all stakeholder needs you will need 

to create the…… 


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“A” Team 

REGULATORY AFFAIRS 

CLINICAL RESEARCH 

REIMBURSEMENT 

MARKETING 


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Regulatory Affairs 

Navigate the FDA process 

Ensure product approval/clearance 

Import/export requirements 

Biocompatibility, preclinical & engineering 

test requirements 

Determine indications for use 

Relevant standards & guidance 


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Clinical Research 

Produce clinical data to support regulatory 

submissions 

Ensure study endpoints are satisfied 

Develop studies to support “substantial 

clinical improvement” and “comparative 

effectiveness” 

Determine components of the clinical 

strategy to support intended use for FDA 

and payers 


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Reimbursement 

Secure coverage and payment 

Position treatment within professional 

society or payer guidelines 

Ensure patient accessibility to technology 

Create the economic value proposition for 

sales and marketing 

Incorporate clinical data into statements of 

positive net health outcomes 


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Marketing 

Create procedure awareness 

Drive adoption 

Develop the sales strategy 

Develop the product value proposition 

based on intended use 

Execute the publication strategy 

Determine point of distribution 


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Critical Components of the 

“Blueprint” 

Product Development Phases 

Milestones (what you want to achieve) 

Functional groups (who is involved in the specific activity 

to reach the milestone) 

Key integrated activities (what specifically is being 

done to ensure the milestone) 


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Product Development Phases 

Phase I: Conceptualization 

Product idea is conceived 

Phase II: Verification 

Can product be built? 

Phase III: Validation 

Is it reproducible, marketable, will it get 

approved? 

Phase IV: Commercialization 

Will it sell, to whom, and for how much? 


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Refer to Handouts for 

Phases I-IV 

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Copyright Emerson Consultants, Inc. 

February 12, 2009 

It Pays to Integrate 

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Phase I:Conceptualization 

Milestones 

Marketing assessment and strategy 

Individual function strategies 

Integrated business plan 

Secure buy in from senior management 


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Phase I:Conceptualization 

Key integrated activities and functional 

groups 

Identify product specs 

Determine pricing strategy 

Identify geographic areas for 

commercialization (US-OUS) 

Determine indication for use 

Develop individual strategies 

Deliver final integrated business plan 


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Claims Matrix 

Device Description: Implantable device 

Indications for Use: Weight reduction in morbidly obese patients with a BMI >35 with two co-morbidities who have failed 

six months of conservative weight reduction alternatives 

Claim Category 

Benefit Statement 

describing Claim 

Clinical Data 

Requirements 

Regulatory 

Implications 

Reimbursement 

Risk for Approval 

of Claim 

Weight Reduction Reversible 

Minimally Bridge to reduction 

In comorbidities 

invasive surgery 

100% 50% Reduction Lose excess enough reversible 

in Apnea glycemic postoperative 

to qualify (diabetic serious for Index surgery index) 

weight 

without loss index Hypopnea 

adverse (obstructive complications 

(e.g., CABG) events sleep 

apnea) 

Moderate • N=300 Type Monitoring Smaller II, diagnosed population 

severe of AE’s 

OSA • 3 within during Sicker year 2 clinical Follow-up 

population yrs trial 

• Not Study Shorter insulin design duration follow-up –– 3.5 

to dependent reverse 4 yrs procedure 

• Can Outcome: be singlel reduction arm I 

HbA1c 

• Class Precedent Preclinical Pre-clinical Shorter III regulatory IDE/PMA testing drug and 

& 

• pathway device Precedent pilot studies 

trials trials 

• Precedent for Statistical No OSA long-term therapies trials 

• for OSA significance claims alternate therapies will may 

therapies Class be needed II to 

• Regulatory support claim 

pathway 

precedents 

• Coverage Important Collect Will payer endpoints decisions reimburse to 

mandate substantiate for decisions two payers surgeries? 

co-clinicamorbidities 

and mandate economic %EWL 

• acceptable benefit Study sites for must 

coverage be within bariatric 

COE network 

Low 

High Moderate 

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Milestones: 

Finalize design 

Bench testing 

Publication strategy 

Pre-clinical studies 

Feasibility trial 

Pivotal trial protocol design 

IDE and ethics submissions 


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Key Integrated Activities 

Update individual strategies 

Monitor market changes and competition 

Establish bench test requirements and test plans 

Develop risk management plan 

Pre-clinical studies 

Develop clinical protocol 

Build relationships with key stakeholders 

Establish clinical trial reimbursement 

Select investigators 

Develop study budget 

Develop patient recruitment plan 

Develop publication strategy 


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Develop Clinical Protocol 

Protocol Summary Example 

Ablation Device for Treatment of Drug Refractory Symptomatic Paroxysmal 

Atrial Fibrillation 

Purpose 

Primary Study 

Objective 

To compare the safety and effectiveness of the Ablation Device to antiarrhythmic 

drugs (AAD) in the treatment of atrial fibrillation 

To demonstrate that the Ablation Device is more effective than medical 

management with AADs, with an acceptable safety profile, for treating 

patients with symptomatic Paroxysmal Atrial Fibrillation (PAF) who were 

refractory or intolerant to AAD therapy. 

Study Design A prospective, randomized, controlled, multi-center study, involving up to 200 

subjects. 

Patient 

Population 

Key Inclusion Criteria: 

1. Patients with symptomatic PAF who had 3 AF episodes in the 6 months 

prior to randomization 

2. Failure of at least one AAD 

3. Age 18 years or older 


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Develop Clinical Protocol 

Protocol Summary Example 

Patient 

Population 

Study Groups 

Primary 

Endpoints 

Clinical Sites 

Key Exclusion Criteria: 

1. Previous ablation for AF 

2. Amiodarone therapy at any time during the previous 6 months 

3. CABG procedure within the last 180 days 

4. History of a documented thromboembolic event within the past year 

5. Presence of implanted ICD 

6. Myocardial infarction within the previous 60 days 

7. LVEF



Conduct pivotal trial 

Develop clinical trial reimbursement strategy 

Collect, analyze, and report data 

Submit PMA/510(k) 

Execute publications 


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Implement publication strategy 

Update risk management plan 


Continue market development activities 


Execute clinical trial 

Implement clinical trial reimbursement strategy 

Execute patient recruitment 

Finalize pricing strategy 

Finalize marketing and sales plan 

Execute regulatory submission, agency interaction, and approval 

Develop payer value proposition 


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Payer Value Proposition 

Validate to payers that product has Substantial Clinical 

Improvement compared to gold standard 

Minimally invasive 

Faster recovery time 

Less medication 

Fewer revisions 

Less follow-up 

Return to normal daily activities 

Cost Benefit (has positive net health outcomes) 

Published Guidelines (accepted by societies) 

Professional Society Recommendation 

Tech Assessment (unbiased review and approval) 

It Pays to Integrate 

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Regulatory approval 

Sales and marketing implementation 

Post-market study 

Obtain coverage and codes 

Publications 


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Update risk management plan 


customers, agencies, payers 


Execute sales and marketing plan 

Field reimbursement support 

Submit coding applications 

Call on payers 

Post market study strategies and claims expansion 

Ongoing regulatory, compliance, monitoring, and reporting activities 


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Marketing and Sales Plan 

Customer Field Staff Product Marketing Plan Market Development Plan 

Direct sales reps vs. 

distributors 

FCE/clinical support 

staff 

Service and order 

entry staff 

Locations 

Numbers (# accounts 

per staff) 

Qualifications 

Product positioning 

Product promotion 

materials 

Product pricing 

Target customers/ 

accounts 

Sales plans to reach 

target customers 

Therapy positioning 

Therapy clinical results 

promotion materials 

Therapy education plans 

(use of KOLs/clinical results) 

Audits to find patients/ 

best practice studies 

Post-approval studies 

Shared Plans 

Sales training materials and plans 

Technical/clinical training materials and plans 

Public relations 

Website strategies 


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Key Functional Group Activities 

by Phase 


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Best Practices for 

Creating an Integrated Strategy 

Identify the milestones 

Identify the key functional groups 

Create realistic metrics 

Create a blueprint 

Strategy integration is not inherently 

complex if you START EARLY! 


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Final Thoughts… 

“Integration” will have a different meaning 

to every department and every company 

Do not let the concept be complex 

Choose the appropriate key functional 

groups 

Create realistic metrics 

Be flexible-others may need to 

engage along the way 


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And Most Important… 

Start early! Start early! Start early! 


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Thank You 

Kelli Hallas 

Executive Vice President 


kellih@emersonconsultants.com 

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Reimbursement, Regulatory, and Marketing Consulting 

Full Service CRO 

www.emersonconsultants.com 


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