Operations

How the model is delivered and sustained

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The Operations tier is where strategy meets execution. It covers the four blocks that determine how your solution reaches customers, what external relationships make delivery possible, what you must do better than anyone else, and what assets you need to protect your competitive position. While the Stakeholder and Economic Model tiers answer "what" and "why," the Operations tier answers "how." For early-stage teams, this tier is often underspecified — the urgency of product development and fundraising can crowd out the operational thinking that determines whether a good product becomes a sustainable business.

Channel considerations and operational requirements differ meaningfully between HealthTech and Digital Medicine solutions. Select your solution type to see content relevant to your context.

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9

Channels and Customer Relationships

Operations Block — How You Reach and Support Stakeholders
Read This First

Channels and Customer Relationships define how you reach users, economic buyers, and influencers, and how you establish and maintain relationships with them over time. In healthcare, this is not primarily a marketing challenge — it is a trust-building challenge. Institutions adopt new solutions slowly and cautiously. The relationships you build before a sale determine whether a sale is ever possible.

A useful way to think about customer relationships is through three stages: Get, Keep, and Grow. Each stage requires different activities and different kinds of investment.

The Three Stages of Customer Relationships
1
Get Identify and engage the right stakeholders before a purchase decision is possible
2
Keep Sustain engagement and embed your solution in clinical practice after adoption
3
Grow Expand adoption within existing institutions and leverage early successes to enter new ones
1

Get

Getting customers in healthcare means identifying and engaging the right stakeholders before a purchase decision is possible. At the early stage, this is almost entirely relationship-driven. The most effective channels for building initial relationships in medtech include clinical partnerships with hospitals and research institutions, medical conferences and professional networks, scientific content and educational outreach, and advisory boards and accelerator programs.

Clinical partnerships are the most credible entry point. Early pilots, clinical studies, and usability evaluations conducted in partnership with target institutions generate both evidence and relationships simultaneously. The relationship here is collaborative — working closely with clinicians as partners in developing and validating the solution, not just as eventual customers.

2

Keep

Keeping customers in healthcare requires sustained engagement that goes well beyond the initial sale. Training, onboarding, and ongoing clinical support are not post-sale overhead — they are determinants of whether the solution becomes embedded in clinical practice or quietly abandoned.

The most important principle at this stage is maintaining direct contact with clinical users. If you rely entirely on intermediaries to maintain customer relationships, you will lose the intelligence you need to understand how your solution is actually being used. Direct relationships with users are a strategic asset, not just a customer service function.

Evidence generation continues after the sale. Supporting early adopting institutions in generating and publishing clinical data is one of the most valuable things you can do to sustain and expand the relationship.

3

Grow

Growing customer relationships means expanding adoption within existing institutions and leveraging early successes to enter new ones. Reference sites are your most powerful growth tool — a respected institution that has adopted your solution and is willing to discuss their experience with peers is worth more than any marketing activity.

Penetration and retention require ongoing investment. Late adopters within an institution need their own introduction, training, and support. Treating the sale as complete when the contract is signed is one of the most common reasons medtech companies underperform their market size estimates.

Channel Strategy by Market Stage

Channel strategy is not static. The approach that is right for your beachhead is rarely the right approach for your Target Market, and the approach for your Target Market will likely need to evolve further as you expand beyond it.

Beachhead Market — Direct, relationship-driven, and founder-led. The primary purpose of your channel is learning, not revenue generation. Every early customer interaction is a discovery conversation as much as a sales conversation.

Target Market — Structured direct sales supplemented selectively with distribution. The decision should be driven by economics and relationship requirements, not the desire to scale quickly. Where your solution requires significant clinical support and relationship maintenance, direct sales is usually preferable even when more expensive.

Expansion beyond the Target Market — Channel model evolution. Moving into new geographies, adjacent clinical segments, or new institution types typically requires a deliberate reassessment of the channel model. The model that won your Target Market may not be right for the next market.

HealthTech: Direct Sales vs Distribution

For medical devices and diagnostics, the channel decision between direct sales and distribution is one of the most consequential you will make.

Direct Sales
Your own sales force calls on institutions, builds relationships with economic buyers and clinical champions, manages the sales process, and supports customers after the sale. Direct sales preserve full control over how your solution is positioned and what you learn from the market. The cost is high and scales slowly. For early-stage companies targeting a focused beachhead, direct sales is almost always the right approach — the proximity to early adopters is how you learn fast enough to iterate.
Distributors
Third-party organizations that sell your solution alongside other products to their existing customer base. Distributors provide immediate access to established customer relationships and geographic reach. The tradeoff is significant: the distributor stands between you and your customer. You lose direct visibility into how your solution is being used, what objections are being raised, and what is driving or blocking adoption. Build explicit mechanisms for maintaining direct customer contact if you use a distributor.
Group Purchasing Organizations (GPOs)
Consortia that aggregate purchasing power across multiple healthcare institutions to negotiate preferred pricing and supply agreements. GPO contracts can provide access to large numbers of institutions simultaneously and signal institutional validation. However, GPO contracts do not sell your product — they make it available. A GPO contract without a parallel direct engagement strategy rarely drives meaningful adoption on its own.

Other HealthTech Channel Considerations

Clinical training as a channel activity. Complex devices require significant clinical training before a user can operate them safely. Training programs are not just post-sale support — they are a channel strategy. For complex devices, the question is not just how you reach the customer but how you make them competent and confident enough to adopt.

Field clinical engineering. Many medical device companies deploy field clinical engineers — technically trained staff who support clinical users during procedures and maintain the relationship between sales cycles. This is a high-cost investment that pays disproportionate returns in complex, high-stakes clinical environments.

Distributor management in regulated markets. In international markets, local distributors often handle regulatory submissions, reimbursement negotiations, and customer relationships simultaneously. Selecting distributors with the right regulatory expertise and institutional access is a strategic decision, not a procurement one.

Worked Example — Point-of-Care Sepsis Diagnostic Device
Stage Channel Relationship Type
Get Clinical partnership with 3 academic medical center EDs for initial usability evaluation and pilot study Collaborative — co-design of evaluation protocol with ED medical directors and charge nurses
Get Presentation at Society of Critical Care Medicine annual conference Credibility-building — presenting early clinical data to SCCM-affiliated KOLs and ED physicians
Keep Direct clinical support during first 90 days of use at each adopting institution Hands-on — dedicated clinical specialist present at first 20 uses to support workflow integration
Keep Quarterly outcome data review with ED medical director at each site Evidence partnership — supporting institutions in tracking and publishing sepsis outcome improvements
Grow Reference site program — supporting first three adopting institutions in presenting outcomes at regional ED conferences Peer advocacy — turning early adopters into active advocates within their professional networks
Grow Expansion outreach to other ED departments within adopting health systems Internal expansion — leveraging system-level relationships to enter adjacent sites without a full sales cycle

Digital Medicine: Direct Sales vs Distribution

Digital medicine companies rarely use traditional device distributors. The equivalent channel structures differ in important ways.

Direct Sales
Direct sales remain the right approach for early-stage digital medicine companies targeting a beachhead. The sales process typically involves clinical, IT, and administrative stakeholders simultaneously — requiring a team capable of navigating multiple decision pathways in parallel. Founders or senior staff should lead early sales directly to ensure the intelligence gathered from early customers informs product development and go-to-market strategy.
Channel Partners
Digital medicine channel partners are typically technology companies — EHR vendors, health system IT partners, or digital health platforms — rather than traditional device distributors. A channel partnership with Epic, Oracle Health, or a similar EHR platform can provide visibility through the EHR app marketplace, reduce the IT approval burden, and signal institutional credibility. These partnerships require technical integration investment but can significantly accelerate access to large institution networks.
Platform Marketplaces
EHR-integrated app marketplaces, professional clinical app stores, and digital health platform ecosystems can function as distribution channels for validated digital solutions. Unlike GPOs for devices, platform marketplace listings can drive direct clinician discovery and reduce procurement friction in systems that have pre-approved the platform. Reimbursement and formal institutional adoption still require a parallel engagement strategy.

Other Digital Medicine Channel Considerations

IT and security approval as a channel barrier. Before a digital solution can be deployed, it must pass IT security review, data privacy assessment, and often EHR integration evaluation — managed by CISOs and IT departments who evaluate on entirely different criteria than clinical stakeholders. Mapping the IT approval process is as important as mapping the clinical and purchasing decision pathway.

EHR integration as a channel strategy. Integration with the institution's electronic health record system is often a prerequisite for adoption. An EHR integration partnership — particularly with Epic or Oracle Health — can function as a channel in its own right, providing visibility through the EHR marketplace and reducing the IT approval burden significantly.

Direct-to-clinician and direct-to-patient channels. Some digital solutions can reach users without institutional purchasing — through professional app stores or direct-to-patient consumer channels. These channels bypass the institutional sales cycle entirely but typically do not generate reimbursable revenue until an institutional or payor coverage pathway is established.

Subscription economics and channel incentives. Recurring revenue models create different channel dynamics than capital purchases. Channel partners accustomed to device sales may not be well-suited to selling subscription solutions — their incentive structures are built around one-time transactions. Digital medicine companies often need direct sales capabilities even where device companies of comparable size would use distribution.

Pilot-to-enterprise conversion. Digital solutions are frequently introduced through departmental pilots requiring separate enterprise-wide adoption decisions. Planning for the pilot-to-enterprise conversion pathway from the start — including which stakeholders need to be engaged, what evidence is required, and who makes the enterprise decision — is a channel strategy requirement, not an afterthought.

Worked Example — AI-Powered Clinical Decision Support for Sepsis
Stage Channel Relationship Type
Get 90-day pilot program at 3 Epic-enabled academic medical center EDs, structured with explicit conversion terms Collaborative — co-design of alert threshold parameters with ED informatics leads and clinical champions
Get Epic App Orchard listing following initial validation — driving inbound discovery from Epic-deployed institutions Platform-mediated — institutional IT teams initiate contact through Epic marketplace inquiry process
Keep Monthly algorithm performance review with clinical informatics lead at each deployed institution Evidence partnership — monitoring alert accuracy, false positive rates, and clinical response rates together
Keep Quarterly CISO security review update — providing updated SOC 2 reports and penetration test results Compliance relationship — maintaining IT stakeholder confidence in data security posture
Grow Enterprise expansion within adopting health systems — converting single-ED pilots to system-wide deployments Enterprise relationship — engaging system-level CIO and CMO for multi-site contract negotiation
Grow Clinical publication support — co-authoring outcomes data with clinical champions at reference sites Peer advocacy — reference site publications driving inbound interest from peer institutions
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Key Partners

Operations Block — External Organizations Essential to Delivery
Read This First

Key Partners are external organizations that are essential to delivering your value proposition and building a sustainable competitive position. They are not simply vendors or outsourced service providers — they are strategic relationships that bring capabilities, assets, or access that you cannot easily replicate internally within a reasonable timeframe or budget.

Key Partners vs. Outsourced Vendors

The distinction between a Key Partner and an outsourced vendor is important and frequently confused. An outsourced vendor provides a commodity service that any competent provider could fill — general legal counsel, bookkeeping, office IT support. A Key Partner provides something that materially strengthens your competitive position or enables a capability you could not build alone.

The test is simple: if you lost this relationship tomorrow, how long would it take to recover, and what would it cost? If the answer is weeks and minimal cost, it is a vendor. If the answer is months or years and significant strategic cost, it is a Key Partner.

Selling Your Value Proposition to Partners

Your Key Partners need to believe in your solution. A contract manufacturer that understands the clinical problem you are solving will invest more, move faster, and absorb more uncertainty than one that sees you as just another client. This means selling your value proposition to your Key Partners, not just negotiating terms. Share your clinical evidence. Explain the unmet need. Make them part of the mission.

Key Partner Types in Medtech

Clinical Research Partners
Hospitals, academic medical centers, and research institutions that provide patient access, clinical expertise, IRB infrastructure, and institutional credibility. Clinical research partnerships generate the clinical evidence that drives regulatory submissions, reimbursement applications, and commercial adoption. They also provide co-authorship opportunities and reference site credibility that cannot be purchased. The relationship is collaborative — the institution's researchers and clinicians are co-investigators, not just service providers.
Contract Manufacturers (CMOs)
Organizations that manufacture your device or its components under contract. A strong CMO brings regulatory-compliant manufacturing facilities, process engineering expertise, quality management systems, and scalable production capacity. Selecting the right CMO is a strategic decision — their quality systems will be scrutinized in your regulatory submissions, their capacity determines your ability to scale, and their IP policies affect your ownership of jointly developed process innovations.
Contract Research Organizations (CROs)
Organizations that manage clinical trials and regulatory studies. CROs bring clinical trial design expertise, site management capabilities, regulatory submission experience, and established relationships with clinical sites. Choosing a CRO with specific experience in your device category and target regulatory pathway is essential — generic CRO expertise does not transfer well across device categories.
Technology and IP Partners
Universities, research institutions, or companies that contribute foundational intellectual property, algorithms, materials, or platform technologies. Managing these relationships carefully — including licensing terms, IP ownership of jointly developed improvements, and publication rights — is critical to protecting your competitive position.
Market Access and Reimbursement Partners
Specialized consultancies with deep payor relationships, reimbursement expertise, and health economics capabilities. Establishing a reimbursement pathway can take years and is frequently the longest lead-time item in a commercial launch plan. The right partner brings knowledge of existing coding frameworks, relationships with CMS and private payor medical directors, and experience building health economics evidence packages.

Depending on the specific business model, key component suppliers, academic collaborators, or other organizations whose loss would materially impair your ability to deliver your value proposition may also qualify as Key Partners.

Worked Example — Point-of-Care Sepsis Diagnostic Device
Partner Type Strategic Value What Would Be Lost
Massachusetts General Hospital ED Clinical Research Partner IRB approval, 400 sepsis cases per year, co-investigator credibility, reference site for VAC submissions 12-18 months of regulatory and commercial momentum; loss of primary reference site
BioMed Contract Manufacturing CMO ISO 13485-certified facility, established 510(k) submission track record for IVD devices, cartridge manufacturing expertise 18-24 months to qualify alternative manufacturer; regulatory resubmission risk
Precision Clinical Research CRO Sepsis-specific clinical trial experience, established relationships with 15 target ED sites, FDA pre-submission meeting experience Loss of site network and regulatory expertise built over 2 years of relationship
University of Barcelona Bioengineering Technology Partner Foundational biosensor IP licensed to the venture; ongoing algorithm development collaboration Loss of core IP position; potential competitive exposure if relationship terminates
HealthEcon Advisors Market Access Partner CMS coding analysis, established private payor relationships, health economics model for sepsis diagnostic category 12+ months delay in reimbursement pathway development
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Key Activities

Operations Block — What You Do In-House
Read This First

Key Activities are the things your company must do itself to deliver its value proposition and sustain its competitive position. They are not a list of everything your company does — they are the activities that are central to your competitive advantage and that you would be strategically exposed if you outsourced or neglected.

The discipline of this block is identifying which activities are truly core and which are important but not strategically differentiating. Activities that are important but not core should be candidates for outsourcing or partnership. The right framework for making this distinction is the three-test standard for core competencies developed by C.K. Prahalad and Gary Hamel.

Three Tests for Core Competencies
1
Relevance Gives customers something that strongly influences their decision to choose your solution
2
Difficulty of Imitation Is hard for competitors to replicate — creating durable competitive advantage
3
Breadth of Application Opens up a meaningful range of market opportunities beyond your current beachhead
1

Relevance

An activity passes the Relevance test if it gives your customer something that strongly influences their decision to choose your solution. If removing or weakening this activity would not affect whether customers choose you over alternatives, it is not a core competency.

In medtech, activities that typically pass the Relevance test include clinical evidence generation, regulatory execution, and core technology development. The Relevance test forces an honest conversation: what do we do that our customers actually value, and what do we do because we have always done it?

2

Difficulty of Imitation

An activity passes the Difficulty of Imitation test if it is hard for competitors to replicate. An activity that a well-funded competitor could match within six months provides little defensibility. An activity that requires years of accumulated clinical relationships, proprietary data, or specialized expertise creates a durable competitive moat.

The Difficulty of Imitation test is often where early-stage teams are most honest with themselves. A technology that can be replicated by a larger competitor with more resources is not a sustainable competitive advantage — the sustainable advantage comes from what you build around the technology.

3

Breadth of Application

An activity passes the Breadth of Application test if it opens up a meaningful range of market opportunities beyond your current beachhead. A core competency relevant only to a single narrow application provides limited strategic value. A core competency applicable across multiple indications, geographies, or customer segments is a platform for growth.

The Breadth of Application test is not a reason to avoid focus — early-stage companies must focus. But it should inform how you frame and protect your core activities and how you think about the long-term strategic value of what you are building.

Key Activities in a Pre-Revenue Company

For early-stage teams, Key Activities should be tightly focused on proving the concept, meeting regulatory requirements, and building the foundation for commercialization. Activities that are typically core include product development and iteration, regulatory strategy and submission execution, clinical evidence generation, and customer and business development. Activities typically outsourced at this stage include component manufacturing, clinical trial management, and commodity professional services.

Worked Example — Point-of-Care Sepsis Diagnostic Device
Activity Relevance Difficulty of Imitation Breadth of Application Core?
Biosensor algorithm development High — drives diagnostic accuracy High — proprietary dataset, 3 years development Medium — applicable to other infectious disease diagnostics Yes
Clinical evidence generation High — influences VAC and payor decisions Medium — requires clinical relationships and time High — evidence platform applicable across indications Yes
Regulatory strategy and submission High — determines what can be claimed and sold Medium — requires category-specific expertise Medium — transferable to adjacent device categories Yes
Cartridge manufacturing Low — commodity process once designed Low — replicable by any ISO-certified CMO Low — specific to current device format No — outsource
General financial management Low — does not influence customer decisions Low — commodity service Low No — outsource
Worked Example — AI-Powered Clinical Decision Support for Sepsis
Activity Relevance Difficulty of Imitation Breadth of Application Core?
ML model development and retraining High — drives alert accuracy that determines clinical adoption High — proprietary training dataset grows with each deployment High — model architecture applicable to other clinical risk prediction tasks Yes
EHR integration engineering High — prerequisite for institutional deployment Medium — Epic FHIR integration is replicable but requires deep expertise High — integration capability applicable across all Epic-deployed institutions Yes
Clinical validation study design High — required for regulatory clearance and payor coverage Medium — methodology replicable but takes time to execute Medium — study design expertise transferable to adjacent indications Yes
Security compliance (SOC 2, HIPAA) Medium — prerequisite for institutional IT approval Low — compliance frameworks are standardized Low — specific to regulated data environments No — outsource audit, maintain controls internally
Cloud infrastructure management Low — commodity capability Low — any competent DevOps team can manage Low No — outsource
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Key Resources

Operations Block — Critical Assets That Make the Model Work
Read This First

Key Resources are the assets your company must have to deliver its value promise and sustain a defensible competitive position. The test is whether the asset is essential to delivering your value proposition and whether losing it would materially impair your competitive position. Key Resources fall into five categories.

Five Categories of Key Resources
1
HumanTeam, advisors, clinical relationships, and domain expertise
2
PhysicalPrototypes, lab equipment, testing facilities, and data infrastructure
3
IntellectualPatents, trade secrets, proprietary data, contracts, and brand
4
RegulatoryClearances, approvals, approved indications, clinical data packages, and IRB approvals
5
FinancialCash, grants, loans, equity, and credit lines that fund operations and development
1

Human Resources

In knowledge-intensive healthcare businesses, human capital is often the most important and most difficult to replace resource. Critical human resources typically include a core technical team with device-specific expertise, clinical advisors with credibility in the target specialty, regulatory experts who understand the specific submission pathway, reimbursement specialists, and sales professionals with established institutional relationships.

Advisors and board members who have navigated similar regulatory, clinical, and commercial challenges bring pattern recognition that is genuinely scarce. Identifying advisors who are not financially vested in your specific technology — who will give you honest assessment rather than encouragement — is one of the highest-leverage investments an early-stage team can make.

2

Physical Resources

Physical resources for early-stage medtech companies are focused on enabling research, prototyping, testing, and regulatory preparation. Most physical resources at the early stage should be leased, borrowed through incubator relationships, or accessed through partners rather than owned outright. Capital efficiency matters — building owned physical infrastructure before it is strategically necessary consumes resources better deployed on clinical evidence and regulatory execution.

3

Intellectual Resources

Over 90% of the value of companies listed on major stock exchanges is attributable to intangible assets. In medtech, the intellectual resources that matter most include patents and patent applications that protect the business model and market position (not just the technology), trade secrets and know-how protected by NDAs, curated datasets, customer and clinical site databases, contracts with hospitals and key partners, and brand equity.

A critical point on patents: the goal of a patent portfolio is to protect the business, not the technology. A patent that prevents competitors from entering your market is valuable. A patent that protects a technical approach that competitors can design around is less so.

4

Regulatory Resources

Regulatory assets are among the most defensible resources a medtech company can hold. They take years and significant capital to build, cannot be purchased directly, and confer rights and credibility that competitors must replicate independently. Key regulatory resources include FDA clearances and approvals, CE marks and notified body certifications, approved indications, clinical data packages that support future label expansion, and active IRB approvals at target clinical institutions.

Regulatory assets compound over time — each clearance, each approved indication, and each active clinical relationship makes the next one easier to obtain.

5

Financial Resources

For early-stage medtech companies, managing financial resources is not a finance function — it is a survival function. Key financial resources include cash and short-term liquidity, grants and non-dilutive funding, convertible notes and seed investment, equity investment at later stages, lines of credit, and bootstrapped revenues from consulting or services.

The single most important financial resource metric is runway — how many months of operating costs are covered by current resources. Always know your runway. Running out of cash before reaching a fundable milestone is one of the most common and most avoidable causes of medtech company failure.

Worked Example — Point-of-Care Sepsis Diagnostic Device
Resource Type Why It Is Strategic Risk if Lost
Dr. Chen — Chief Scientific Officer Human 15 years biosensor development experience; inventor on core patents; primary relationship with clinical research partners Loss of core technical leadership and IP continuity; 12+ months to replace
Biosensor development lab (incubator) Physical Access to specialized electrochemical testing equipment not available commercially; enables rapid iteration Loss of 6-month development advantage; significant capital required to replicate
Patent portfolio (3 granted, 2 pending) Intellectual Protects core biosensor architecture and cartridge design; blocks competitor replication of key technical approach Competitive exposure in primary market; freedom-to-operate risk
FDA 510(k) clearance (IVD, sepsis biomarkers) Regulatory Legally permits sale and marketing in US market; defines cleared indications; basis for reimbursement application Cannot sell in US market without replacement; 18-24 months to re-obtain
Active IRB approval — MGH ED Regulatory Enables ongoing clinical data generation at primary reference site Loss of primary evidence generation site; 6-12 months to replace
$2.4M seed funding (18 months runway) Financial Funds regulatory submission, clinical validation study, and first commercial hires Premature capital raise at unfavorable terms; potential loss of key hires
Worked Example — AI-Powered Clinical Decision Support for Sepsis
Resource Type Why It Is Strategic Risk if Lost
Dr. Patel — Chief AI Officer Human 10 years clinical ML experience; architect of core sepsis prediction model; primary relationship with Epic integration team Loss of model architecture expertise and Epic partnership; 12+ months to replace
Proprietary sepsis training dataset (180,000 encounters) Intellectual Largest labeled sepsis dataset assembled from real ED encounters; trains and validates the prediction model; grows with each deployment Competitive exposure — no equivalent dataset exists; loss would require 3+ years to rebuild
Epic App Orchard listing Intellectual Provides inbound discovery channel and reduces IT approval burden in Epic-deployed institutions; signals platform validation Loss of primary inbound channel; reduced IT credibility in 70%+ of target institutions
FDA De Novo clearance (SaMD, sepsis risk prediction) Regulatory Permits marketing claims about clinical decision support; required for payor coverage application; establishes predicate for future submissions Cannot make cleared claims; payor coverage application delayed; 18-24 months to re-obtain
Active IRB approval — 3 reference EDs Regulatory Enables ongoing prospective data collection for algorithm retraining and outcomes publication Loss of evidence generation pipeline; algorithm improvement stalls
$3.1M seed funding (20 months runway) Financial Funds regulatory submission, 3 pilot deployments, Epic integration engineering, and first enterprise sales hire Premature Series A at unfavorable terms before pilot conversion data available