Case Studies Flashcards
A healthtech startup has developed an AI-powered genomic diagnostic tool for endometriosis. How would you develop their market entry strategy for France?
Framework: Profit Improvement Framework
1.Analyze current pricing vs. competitor offerings and perceived value
2. Evaluate target segments to identify highest-value customers
3. Review production costs and identify optimization opportunities
4. Calculate breakeven volume and develop strategies to increase utilization
5. Consider reagent rental vs. capital purchase models
6. Explore menu expansion to increase per-device revenue
7. Recommend value-based pricing tied to clinical outcomes
A leading companion diagnostics company wants to expand beyond oncology testing. What growth strategies would you recommend?
Framework: Growth Strategy Framework
- Map adjacent therapeutic areas with emerging targeted therapies
- Evaluate existing technical capabilities vs. new market requirements
- Analyze pharma pipeline to identify potential partnerships
Prioritize opportunities by market size, competition, and technical fit - Recommend staged approach:
a) Leverage existing technology for near-term growth
b) Develop new capabilities for high-potential therapeutic areas
c) Consider strategic acquisitions to accelerate entry - Design pharma partnership strategy focusing on co-development opportunities
A healthcare AI startup has developed an imaging analysis algorithm for dermatology diagnostics but needs to reduce operational costs. What approach would you take?
Framework: Cost Reduction Framework
- Analyze cost structure to identify largest expense categories
- Optimize cloud computing usage and implement auto-scaling
- Evaluate offshore development for non-core functions
- Implement tiered customer support model
- Review data storage and processing architecture
- Consider open-source components for non-proprietary features
- Develop customer self-service tools to reduce support costs
- Recommend automation of manual review processes
A European diagnostic company is considering entering the at-home testing market. Should they pursue this opportunity?
Framework: Market Entry Framework
- Size the market by test category and growth trajectory
- Analyze consumer adoption trends and barriers
- Map competitive landscape and unique positioning opportunity
4.Assess regulatory requirements and timeline by country - Evaluate technical feasibility of adapting lab tests for home use
- Calculate unit economics and breakeven volume
- Recommend targeted entry strategy focusing on:
a) Tests with clear consumer value proposition
b) Markets with favorable regulatory environment
c) Distribution channels with lowest acquisition costs
A biotech firm has discovered a novel biomarker for early pancreatic cancer detection. How should they approach commercialization?
Framework: New Product Launch Framework
- Define target patient population and clinical use case
- Develop clinical validation strategy focused on sensitivity/specificity
- Map stakeholder needs (physicians, payers, patients)
- Create evidence generation plan for regulatory approval
- Design reimbursement strategy with health economic analysis
- Evaluate build vs. partner options for lab infrastructure
- Recommend phased launch:
a) Initial focus on high-risk populations through specialty centers
b) Expansion to broader screening based on initial data
c) Long-term potential for preventive screening
A diagnostic company is launching an innovative liver disease test across multiple international markets. How should they develop their pricing strategy?
Framework: Pricing Strategy Framework
- Analyze country-specific factors:
a) Reimbursement systems
b) Competitive landscape
c) Physician practice patterns
d) Economic parameters - Calculate cost-plus baseline and value-based ceiling
- Develop differential pricing strategy aligned with:
a) Local willingness to pay
b) Value perception by market
c) Reference pricing constraints - Recommend contracting approach by country
- Design price protection strategies for cross-border reference
6.Create evidence plan to support value-based pricing
A diagnostic company is considering investing in technology for continuous monitoring of interstitial fluid. Should they proceed with this investment?
Framework: Investment Decision Framework
- Assess technology readiness and development timeline
- Calculate total investment required vs. available capital
- Analyze market opportunity and competitive landscape
- Evaluate strategic fit with existing product portfolio
- Model revenue potential and time to breakeven
- Identify key risks and mitigation strategies
- Recommend go/no-go decision with stage-gated investment approach:
a) Initial focus on technical feasibility
b) Proceed to clinical validation with positive technical results
c) Commercial scale-up based on clinical and market validation
A traditional IVD manufacturer is considering acquiring a digital health startup with AI-based diagnostic interpretation software. Is this acquisition advisable?
Framework: M&A Decision Framework
- Evaluate strategic rationale and fit:
a) Technology synergies with current portfolio
b) Market expansion opportunity
c) Capability acquisition vs. build - Conduct target company assessment:
a) Technology differentiation and IP
b) Team expertise and cultural fit
c) Revenue model and growth trajectory
Perform financial analysis:
a) Valuation vs. comparable transactions
b) Synergy potential
c) ROI projection - Identify integration challenges and mitigation strategies
Recommend acquisition with specific integration plan or partnership alternative
A premium diagnostic player faces a new entrant offering a low-cost POCT analyzer targeting emerging markets. How should they respond?
Framework: Competitive Response Framework
- Assess competitive threat:
a) Performance comparison
b) Target customer overlap
c) Potential market share impact - Evaluate strategic options:
a) Maintain premium positioning
b) Develop value-line offering
c) Acquire or partner with competitor - Calculate financial impact of each option
- Recommend differentiated strategy:
a) Emphasize total cost of ownership advantage
b) Enhance service and support offerings
c) Consider market-specific value-line product
d) Develop tiered pricing for volume-sensitive segments
A diagnostic company struggles with lengthy regulatory approval timelines across different markets. How can they optimize this process?
Framework: Process Optimization Framework
1.Map current regulatory submission process
2. Identify bottlenecks through time analysis
3. Benchmark against industry best practices
4. Recommend process improvements:
a) Implement parallel workstreams
b) Establish pre-submission meetings
c) Develop standardized submission templates
d) Create regulatory intelligence database
e) Consider modular submissions where possible
5. Suggest organizational changes:
a) Cross-functional regulatory strategy team
b) Dedicated market specialists
c) Early integration of regulatory considerations
A healthtech startup has developed an AI-powered genomic diagnostic tool for endometriosis. How would you develop their market entry strategy for France?
Framework: Market Entry + Stakeholder Analysis
- Analyze current diagnostic pathway (7-year avg delay presents opportunity)
- Map key stakeholders: gynecologists (adoption), patients (awareness), payers (reimbursement)
- Evaluate regulatory pathway: CE mark requirements, IVDR classification
- Define evidence generation plan: clinical validation vs. standard diagnosis
- Develop reimbursement strategy: RIHN pathway or private pay model
- Recommend phased approach: partner with reference centers first, then expand
A biotech company has developed a neoantigen-based cancer vaccine for solid tumors showing efficacy in Phase II. How would you approach European commercialization?
Framework: Market Access Framework
- Assess genetic screening infrastructure by country (France has 28 molecular genetics platforms)
- Evaluate manufacturing/logistics capability for personalized production
- Identify optimal patient population for launch (cancer type with highest unmet need)
- Develop evidence package for HTA bodies, emphasizing:
a) Incremental benefit over standard of care
b) Cost-offset potential vs. expensive late-line treatments - Consider early access programs in key markets
- Partner with diagnostic companies for companion testing
A digital health company has developed an AI-driven diabetes management system combining CGM with automated insulin delivery. Which European markets should they prioritize?
Framework: Market Prioritization Framework
- Analyze three dimensions by country:
a) Disease burden (prevalence, costs)
b) Digital health adoption and infrastructure
c) Reimbursement paths for digital therapeutics - Evaluate competitive landscape: existing solutions vs. new technology
- Define value proposition for key stakeholders:
a) Patients: improved outcomes, quality of life
b) Providers: clinical workflow integration, time savings
c) Payers: reduced complications, hospitalizations - Recommend initial markets with favorable reimbursement (Germany DiGA, France ETAPES)
- Develop evidence generation strategy for broader adoption
A pharmaceutical company has compounds targeting aging mechanisms (senescence, inflammation). What clinical development strategy would you recommend?
Framework: Clinical Development Strategy
- Target specific age-related conditions rather than “aging”:
a) Sarcopenia, frailty syndrome, or cognitive decline - Design trials addressing geriatric-specific challenges:
a) Include elderly patients with comorbidities
b) Select appropriate endpoints (functional vs. surrogate)
c) Account for polypharmacy - Develop aging biomarker panel for patient stratification
- Consider adaptive trial designs to optimize dose/schedule
- Plan for real-world evidence collection post-approval
- Partner with academic aging research centers for credibility
A healthcare system needs help assessing cybersecurity vulnerabilities and developing a comprehensive security strategy following several breaches. How would you approach this?
Framework: Risk Assessment + Mitigation Strategy
- Conduct tiered risk assessment:
a) Technical infrastructure vulnerabilities
b) Third-party vendor security evaluation
c) Staff security practices and training gaps - Prioritize interventions based on:
a) Criticality of systems/data
b) Likelihood of breach
c) Implementation complexity - Develop defense-in-depth strategy:
a) Technical controls (encryption, access management)
b) Administrative controls (policies, training)
c) Physical controls (device security) - Create incident response plan and conduct simulations
- Establish governance structure for ongoing security management
A pharmaceutical company needs a real-world evidence strategy for their newly launched rare disease therapy. What approach would you recommend?
Framework: Data Strategy Framework
- Define key objectives:
a) Support reimbursement negotiations
b) Identify new indications
c) Monitor long-term safety - Design multi-modal data collection:
a) Patient registry with PROs
b) Claims data analysis
c) Digital biomarker collection - Establish data governance and privacy framework
- Plan staged evidence generation:
a) Short-term: safety and utilization patterns
b) Medium-term: effectiveness vs. clinical trial
c) Long-term: quality of life impact, economic outcomes - Partner with patient advocacy groups for engagement
- Leverage AI/ML for pattern recognition in complex datasets
A medtech startup has developed a novel ex vivo lung perfusion system. How would you drive adoption in transplant centers?
Framework: Technology Adoption Framework
- Segment transplant centers by volume and capability
- Quantify value proposition:
a) Increased organ utilization rate
b) Improved post-transplant outcomes
c) Economic impact (reduced waitlist mortality) - Identify early adopters at high-volume centers
- Develop specialist training program
- Create reimbursement strategy:
a) Additional procedure code vs. bundled payment
b) Value-based contracting options - Generate evidence comparing outcomes with/without technology
- Establish organ procurement organization partnerships
A hospital network wants to reduce its environmental footprint by optimizing waste management. What strategy would you recommend?
Framework: Operational Efficiency Framework
- Conduct baseline waste audit (volume, type, source, cost)
- Prioritize interventions by impact:
a) Operating room waste reduction (highest volume)
b) Infectious waste reclassification (highest cost)
c) Single-use device reduction or reprocessing - Implement behavioral interventions:
a) Clear signage and sorting stations
b) Department-specific training
c) Gamification and competition - Establish procurement guidelines for supplier packaging
- Calculate ROI: treatment cost savings vs. implementation costs
- Set measurable targets with quarterly reporting
A biotech company has developed an AI platform for drug discovery. How would you validate their approach with a pharmaceutical partner?
Framework: Partnership Strategy Framework
- Design proof-of-concept study:
a) Select therapeutic area with established targets
b) Benchmark against traditional discovery methods
c) Define clear success metrics (time, cost, novelty) - Structure tiered partnership model:
a) Initial validation phase with milestone payments
b) Expansion rights for successful programs
c) Option-to-license terms for hits/leads - Address data access and algorithm training needs
- Establish IP framework for AI-generated innovations
- Create joint governance structure
- Develop timeline with clear go/no-go decision points
An oncology center wants to implement a comprehensive precision medicine program for prostate cancer. What implementation roadmap would you recommend?
Framework: Implementation Roadmap
- Assess current state:
a) Genetic testing capabilities and turnaround time
b) Molecular tumor board expertise
c) Electronic health record integration - Develop stratified testing approach:
a) Targeted panel for initial cases
b) Comprehensive genomic profiling for complex cases - Create clinical decision support tools
- Establish partnerships with targeted therapy manufacturers
- Implement patient identification algorithm
- Train multidisciplinary team on genomic interpretation
- Track outcomes to demonstrate clinical and economic value
- Develop pathway for expanded testing based on initial results
A biotech company has developed a novel enzyme replacement therapy for an ultra-rare lysosomal storage disorder. How would you evaluate the commercial opportunity and develop a market entry strategy?
Framework: Market Opportunity Assessment + Rare Disease Launch Strategy
- Conduct disease landscape assessment:
a) Epidemiology and patient population sizing
b) Current standard of care and unmet needs
c) Key opinion leader mapping - Develop value proposition by stakeholder:
a) Patients/caregivers: clinical benefit vs. burden
b) Physicians: practice integration considerations
c) Payers: health economic value demonstration - Create evidence generation roadmap:
a) Clinical trials and endpoints
b) Real-world evidence needs
c) Patient-reported outcomes - Plan market access strategy:
a) Pricing corridor based on value and analogues
b) Early access and named patient programs
c) Innovative payment models for high-cost therapy - Recommend go-to-market model for ultra-rare population
A large hospital system wants to implement a digital transformation strategy to improve patient experience, clinical outcomes, and operational efficiency. How would you approach designing and implementing this strategy?
Framework: Digital Transformation Framework + Change Management
- Assess current digital maturity:
a) Technology infrastructure and systems
b) Data accessibility and integration
c) Digital capabilities among staff - Identify priority transformation areas:
a) Patient engagement and access
b) Clinical workflow optimization
c) Analytics and decision support
d) Operational efficiency - Develop technology roadmap:
a) Core platform selection/optimization
b) Build vs. buy decisions for applications
c) Integration architecture - Create implementation strategy:
a) Phased approach with quick wins
b) Change management and training
c) KPI definition and tracking methodology - Design governance model with clinical leadership involvement
A medical device company with a portfolio of diagnostic imaging equipment is facing increased competition and pricing pressure. How would you help them realign their portfolio strategy for sustainable growth?
Framework: Portfolio Strategy Framework + Resource Allocation
- Analyze current portfolio performance:
a) Growth-share matrix positioning
b) Profitability by product line
c) Competitive position by segment - Evaluate market trends:
a) Technology evolution (AI integration, miniaturization)
b) Care setting shifts (inpatient to outpatient)
c) Value-based purchasing trends - Identify portfolio gaps and opportunities:
a) Adjacency expansion potential
b) Integration/ecosystem opportunities
c) Service and software components - Develop portfolio evolution strategy:
a) Investment prioritization framework
b) Sunset/divest recommendations
c) Innovation focus areas
Create implementation roadmap with resource allocation
A pharmaceutical manufacturer wants to develop a comprehensive sustainability strategy to reduce its environmental footprint while creating business value. What approach would you recommend?
Framework: Sustainability Strategy + Cost-Benefit Analysis
- Conduct environmental impact assessment:
a) Carbon footprint across value chain
b) Water usage and waste production
c) Material sourcing and packaging
2.Benchmark against industry leaders and standards:
a) Competitor initiatives
b) Science-based targets
c) Regulatory requirements and trends - Identify priority initiative areas:
a) Manufacturing process optimization
b) Supply chain transformation
c) Product packaging redesign
d) Green chemistry implementation - Develop business case for each initiative:
a) Environmental impact reduction
b) Cost savings/avoidance
c) Brand value and market positioning benefits - Create implementation roadmap with clear targets and metrics
A U.S.-based medtech company has developed an innovative remote monitoring platform for cardiac patients and wants to expand into European markets. How would you develop their cross-border market access strategy?
Framework: Market Entry + Cross-Border Strategy
- Conduct market prioritization analysis:
a) Market size and growth by country
b) Reimbursement landscape
c) Competitive intensity
d) Regulatory requirements - Develop country entry sequence based on:
a) Ease of market access
b) Strategic importance
c) Resource requirements - Design evidence generation strategy:
a) Core clinical evidence package
b) Country-specific requirements
c) Health economic models tailored by market - Create go-to-market approach by country:
a) Distribution model (direct vs. partnership)
b) Pricing strategy accounting for cross-reference
c) Localization requirements - Develop resource allocation plan across markets
A regional health system wants to redesign their diabetes care pathway to improve outcomes, reduce costs, and enhance patient experience. How would you approach this patient pathway optimization?
Framework: Patient Journey Mapping + Service Design
- Map current state pathway:
a) Patient journey steps from diagnosis to ongoing management
b) Care transition points and handoffs
c) Pain points and inefficiencies - Analyze performance metrics:
a) Clinical outcomes (HbA1c control, complications)
b) Utilization patterns (ER visits, hospitalizations)
c) Patient experience measures - Identify improvement opportunities:
a) Care coordination enhancement
b) Digital tool integration
c) Self-management support
d) Community resource integration - Design future state pathway:
a) Redesigned workflows and responsibilities
b) Technology enablement
c) Patient engagement approach - Develop implementation plan:
a) Phased rollout strategy
b) Staff training and change management
c) Measurement framework
A mid-sized pharmaceutical company is evaluating an opportunity to in-license a Phase II oncology asset targeting a novel pathway. How would you approach evaluating this opportunity and developing a recommendation?
Framework: License Evaluation Framework + NPV Analysis
- Assess therapeutic potential:
a) Mechanism of action differentiation
b) Clinical data strength
c) Development risks and timeline - Evaluate market opportunity:
a) Target population sizing
b) Competitive landscape and standard of care evolution
c) Pricing potential based on value proposition - Analyze financial considerations:
a) Deal structure and terms
b) Development and commercialization costs
c) Revenue projections and NPV/ROI - Assess strategic fit:
a) Portfolio complementarity
b) Capability requirements vs. existing resources
c) Long-term strategic alignment - Recommend go/no-go decision with key terms
A large pharmaceutical company wants to develop a comprehensive health data strategy to enhance R&D productivity, improve commercial effectiveness, and create new business models. What approach would you recommend?
Framework: Data Strategy Framework + Capability Building
- Assess current data assets and capabilities:
a) Internal data sources and accessibility
b) External data partnerships
c) Analytics infrastructure and talent - Identify priority use cases across value chain:
a) R&D (trial optimization, target identification)
b) Commercial (customer segmentation, engagement optimization)
c) New business models (digital therapeutics, risk-sharing agreements) - Develop data acquisition and governance strategy:
a) Build/buy/partner decisions
b) Data quality standards
c) Ethical and privacy framework - Design organizational model:
a) Centralized vs. federated analytics
b) Capability building approach
c) Partnership ecosystem - Create implementation roadmap with quick wins and long-term vision
A specialty care provider group wants to transition from fee-for-service to value-based care models. How would you help them develop and implement this transformation?
Framework: Value-Based Care Transformation + Change Management
- Assess readiness for value-based care:
a) Current care delivery model
b) Data and analytics capabilities
c) Financial reserves and risk tolerance
d) Provider alignment and compensation - Evaluate potential value-based model options:
a) Pay-for-performance
b) Bundled payments
c) Shared savings
d) Full capitation - Develop care model transformation strategy:
a) Population health management approach
b) Care coordination enhancements
c) Quality measurement framework
d) Patient engagement model - Design financial model and risk management approach:
a) Revenue projection under new models
b) Cost structure optimization
c) Risk mitigation strategies - Create implementation roadmap with payer negotiation strategy
A regional government wants to develop a healthcare innovation ecosystem to attract investment, create jobs, and improve health outcomes. How would you approach designing this innovation strategy?
Framework: Innovation Ecosystem + Economic Development Strategy
- Assess regional assets and capabilities:
a) Academic and research institutions
b) Healthcare delivery systems
c) Existing industry presence
d) Workforce and talent pipeline - Identify strategic focus areas based on:
a) Regional strengths and differentiation
b) Global market trends and needs
c) Local health priorities - Design ecosystem components:
a) Innovation infrastructure (incubators, accelerators)
b) Funding mechanisms (grants, venture capital)
c) Regulatory support and sandbox environments
d) Talent development programs - Develop stakeholder engagement strategy:
a) Public-private partnership models
b) Industry-academia collaboration frameworks
c) Patient and community involvement - Create implementation plan with economic impact metrics
