Operations
How the model is delivered and sustained
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.
9
Channels and Customer Relationships
Operations Block — How You Reach and Support Stakeholders
Channels and Customer Relationships
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.
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.
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.
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.
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.
| 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.
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.
| 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 |
10
Key Partners
Operations Block — External Organizations Essential to Delivery
Key Partners
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
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.
| 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 |
11
Key Activities
Operations Block — What You Do In-House
Key Activities
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.
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?
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.
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.
| 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 |
| 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 |
12
Key Resources
Operations Block — Critical Assets That Make the Model Work
Key Resources
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.
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.
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.
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.
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.
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.
| 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 |
| 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 |