Stakeholders - Public GAITS Site

2

Users

Stakeholder Block — People Who Use the Solution

Read This First

Users are the people who directly or indirectly use your solution. In healthcare, they are often not the same people as the economic buyers. Separating these groups is one of the core changes the H-BMC makes to the traditional BMC. Understanding your users precisely — who they are, what they are trying to accomplish, and what would make them adopt or resist your solution — is the foundation of a credible Value Promise.

Types of Users

Direct Users

The people who physically interact with your solution: the surgeon who operates a device, the nurse who administers a treatment, the patient who wears a monitor. Direct users experience the Value Promise most immediately and are often the most vocal advocates or critics of a new solution.

Indirect Users

People who depend on the outputs of your solution without directly operating it: the GP who acts on diagnostic results generated by someone else, the administrator who uses workflow data produced by a clinical tool, the intensivist who receives a patient transferred based on an ED diagnosis. Ignoring indirect users leads to adoption barriers that are invisible until they derail implementation. A solution that works perfectly for the direct user but disrupts the workflow of indirect users will face resistance that no amount of clinical evidence will overcome.

In healthcare there is almost always a hierarchy among users. Understanding who has veto power over adoption — and who can champion it — is as important as understanding who actually operates the product.

Defining Users Precisely: The Persona

Vague user definitions are one of the most common weaknesses in early-stage H-BMC canvases. "Clinicians" is not a user definition. "Surgeons" is not a user definition. A user definition must be specific enough that you could identify real individuals, observe their workflow, and test your hypotheses with them directly.

A useful tool for achieving this precision is the persona — a concrete, composite description of a specific user type built from direct observation and stakeholder conversations. A persona is not a demographic profile. It is a behavioral description grounded in how a specific type of user actually works.

Give your persona a name. A named persona becomes a shared reference point that the team returns to across sessions, across blocks, and across iterations of the canvas. Names remind the team that users are people with multiple complex dimensions — not abstract segments. "What would Sarah think of this pricing structure?" is a more productive team conversation than "what would a charge nurse think?"

A well-formed persona addresses five elements:

Name and Role

Who are they and what is their clinical or operational role? Include whether they are a direct or indirect user, and whether they are a lead user, champion, or typical adopter.

Demographics

Age, gender, location, education, and professional background. These provide context that shapes how the person thinks, what they value, and how they communicate.

Professional Role

Job title, responsibilities, and scope of practice. Be specific about what they are accountable for, who they report to, and what decisions they can make independently.

Challenges

Key challenges and pain points they face in their role — not specific to your solution, but general to their professional context. What keeps them up at night? What do they find most difficult or frustrating about their work?

Motivators

What drives them toward or away from change — professionally, personally, and institutionally. What do they aspire to? What do they fear? What would make them act, and what would make them resist?

The test of a well-formed persona is whether a team member who has never met that user type could use it to design a meaningful stakeholder conversation. If the definition is too broad to support that, it is not yet useful.

Users and the Beachhead

Your beachhead market is defined in part by who your initial users are. The most valuable early users — sometimes called lead users — share several characteristics: they have an urgent, clearly felt unmet need; they are accessible for direct engagement; they have the authority or influence to champion adoption within their institution; and what you learn from them transfers directly to the broader Target Market.

Lead users are often already working around the limitations of current solutions. Finding and engaging them early is one of the most effective ways to accelerate both product development and commercial validation.

Worked Example — Point-of-Care Sepsis Diagnostic Device

Direct users: Emergency department nurses responsible for initial patient assessment and triage in academic medical center EDs performing more than 10 sepsis assessments per day.

Indirect users: Emergency physicians who act on the triage assessment, intensivists who receive patients transferred to the ICU based on ED diagnosis, and infection control nurses who track sepsis rates across the institution.

User persona — Sarah:

Name and Role	Sarah — charge nurse and lead user
Demographics	Female, mid-40s, urban academic medical center, BSN with 12 years ED experience, ongoing professional development in sepsis care protocols
Professional Role	Charge nurse, responsible for triage oversight, junior staff supervision, and protocol compliance in a high-volume ED; accountable to the ED Nurse Manager
Challenges	Inconsistent sepsis identification across nursing staff skill levels; high cognitive load during peak census; manual, time-consuming triage documentation; pressure to reduce time-to-treatment without additional staffing
Motivators	Driven by patient safety and desire to standardize the informal protocols she has developed over years of practice; concerned about being seen as resistant to useful change; motivated by recognition from clinical leadership for quality improvement initiatives

3

Economic Buyers

Stakeholder Block — Who Pays and Decides

Read This First

Economic buyers are the individuals or groups with the authority to approve and pay for your solution. In healthcare, they are almost always different from users and are typically focused on financial, operational, and risk considerations rather than day-to-day clinical usability. Failing to identify your economic buyer — and understand what they need to approve a purchase — is one of the most common reasons healthcare innovations stall after strong clinical reception.

One of the most dangerous assumptions an early-stage team can make is "the hospital will buy our solution." Institutions do not buy things. People do. Some people buy for their own use — those are your users. Most people in institutions buy on behalf of the organization — those are your economic buyers. Finding the right person, understanding their authority, and building a case that speaks to their specific accountabilities is the work of this block.

Who the Economic Buyer Is

The economic buyer is the person with overall authority in the buying decision. They can say "no" when everyone else says "yes," and "yes" when everyone else says "no." They are not necessarily the most senior person in the institution, and they are not necessarily the most enthusiastic about your solution. They are the person whose approval is required for the purchase to proceed.

Signs You Have Found the Economic Buyer

They have veto power regardless of other stakeholders' positions, including your clinical champion. Their focus is advancing the strategic objectives of the organization, not just departmental interests. They are likely to have profit and loss responsibility. They can approve budget allocation without seeking further sign-off.

A Practical Warning

You will never hear someone referred to as "the economic buyer." Finding them requires deliberate investigation. People in institutions also have a habit of either under-qualifying or over-qualifying who the real economic buyer is — a clinical champion may believe they control the decision when they do not, and a procurement officer may present themselves as the decision-maker when the real authority sits elsewhere.

How to Find the Economic Buyer

In simple institutional structures, the economic buyer may be a department head or a practice manager. In large health systems — with headquarters, regional offices, hospital-level management, and department structures — identifying the economic buyer is significantly more complex and requires deliberate navigation.

Ask Multiple Stakeholders

Your clinical champion is a natural starting point, but they may not have full visibility into the institutional decision process — particularly if they have not personally initiated a purchasing decision before. Ask nurses, administrators, procurement staff, and department managers the same questions from different angles. Each will give you a different piece of the picture.

Ask About the Last Time, Not the Next Time

Rather than asking "who would approve this purchase?", ask "tell me about the last time a new device or service was introduced in your department — how did that happen, who was involved, and who made the final decision?" Questions about specific past events produce far more accurate and actionable information than hypothetical questions about future decisions. People describe what actually happened, not what they think should happen.

Follow the Approval Chain

Once you have a name, ask: "If that person wanted to proceed, whose approval would they need?" Follow the chain upward until you reach the person who can commit budget without further sign-off. In large institutions this often involves a Value Analysis Committee, a department head, a finance approver, and sometimes a regional or corporate authority.

Distinguish Local from Corporate Authority

In multi-site health systems, purchasing authority for above-threshold expenditures often sits at a regional or corporate level, not at the individual hospital. A clinical champion at the hospital level may be enthusiastic and influential but lack the authority to approve the purchase. Knowing where the real decision authority sits determines who you need to be talking to.

Test Your Assumptions

Once you believe you have identified the economic buyer, verify it with multiple sources. Ask your champion: "If this person approved the purchase, would it proceed?" If the answer is "not necessarily," you have not yet found the right person.

What Economic Buyers Need

Economic buyers evaluate your solution based on its impact on the organization — not on its clinical elegance or technical sophistication. They need evidence that is specific to their institutional priorities and expressed in terms they are accountable for.

The most common economic buyer types in healthcare institutions and what they typically need are covered in the Value Quantification block (Block 6). The key principle here is that you need a separate conversation and a separate value case for the economic buyer — distinct from the clinical case you make to users and influencers.

A strong economic buyer conversation addresses three questions: what does this cost, what does it deliver in terms the buyer is accountable for, and why is this better than the alternatives or the status quo?

Worked Example — Point-of-Care Sepsis Diagnostic Device

Economic buyer — Marcus, a VAC Chair:

Name and Role	Marcus — VP of Medical Affairs and VAC Chair
Context	400-bed academic medical center, responsible for evaluating and approving all new clinical technology above $5,000
Decision Authority	Can approve purchases up to $50,000 independently; above that requires CFO co-signature
Primary Accountabilities	Reducing avoidable patient harm, managing clinical technology costs, and maintaining regulatory compliance
Evidence Required	Published safety data, peer-reviewed clinical outcomes, formal health economics analysis showing cost per quality-adjusted outcome, comparison to current standard of care
Key Concerns	Implementation burden on nursing staff, training requirements, integration with existing EHR workflow, and total cost of ownership beyond the device price
Decision Pathway	Clinical champion submits VAC application, department head endorses, Marcus reviews with finance director, CFO signs off if above threshold

4

Expert Influencers

Stakeholder Block — Individuals Who Shape Adoption

Read This First

Expert Influencers are individuals who shape whether your solution is adopted, even though they are not the user and do not make the purchasing decision. In healthcare, their influence can be decisive in either direction — they can accelerate adoption dramatically or block it entirely. Identifying them early, understanding their motivations, and engaging them deliberately is one of the highest-leverage activities an early-stage team can undertake.

A critical principle: do not only seek out people who are enthusiastic about your solution. The most valuable influencers to engage are often those who are skeptical or opposed. Their arguments will reach your economic buyers whether you know about them or not. Understanding those arguments early gives you the opportunity to address them before they derail a sale.

Types of Expert Influencers

Clinical Champions

Clinicians who believe in your solution and will actively advocate for its adoption within their institution and specialty. They have no financial relationship with your company. Their motivation is the clinical benefit they believe your solution provides. A clinical champion with credibility in your target institution is one of the most valuable assets an early-stage medtech company can have. Finding even one in your beachhead market significantly improves your probability of early adoption.

Clinical champions are frequently lead users — they are often already working around the limitations of current solutions and are motivated to engage with alternatives. They are also commonly involved in clinical trials and early feasibility studies, which gives them firsthand experience with new solutions and a stake in seeing them succeed.

Most importantly, clinical champions are typically the ones who initiate consideration by the VAC and advocate for the solution through the institutional approval process. Without a clinical champion willing to sponsor the internal case, even a technically superior solution will struggle to navigate institutional purchasing.

Anti-Buyers

Individuals who actively oppose adoption of your solution. They may prefer an existing technique, believe your solution is clinically inferior, have a professional or financial interest in the status quo, or simply be skeptical of new technology. Anti-buyers are not obstacles to be avoided — they are essential intelligence. Seek them out deliberately. Understand their specific arguments. Prepare credible, evidence-based responses. Their objections will be raised in VAC meetings, department discussions, and peer conversations whether you are in the room or not. A team that has engaged its anti-buyers and prepared responses is far better positioned than one that has only talked to enthusiasts.

Key Opinion Leaders (KOLs)

KOLs are a concept well understood in the medical and scientific community. They are highly respected experts whose published work, clinical experience, and peer relationships give their endorsements significant weight across a specialty. Unlike clinical champions who operate within a single institution, KOLs influence practice norms across institutions, health systems, and geographies. Their involvement in clinical validation studies, advisory boards, or speaker programs lends credibility that marketing cannot replicate and can accelerate adoption across an entire specialty. Identifying the right KOLs — those with genuine clinical credibility in your specific indication, not just general prominence — requires careful stakeholder mapping.

Patients and Families

Patients and families are increasingly influential in healthcare decision-making, particularly in consumer-facing applications and disease areas with strong patient advocacy communities. For most professional-facing medical innovations, patient influence is indirect — patients may ask their clinicians about a solution they have heard about, or patient advocacy groups may lobby for access. For direct-to-consumer applications or solutions in high-engagement disease areas such as oncology, diabetes, or rare diseases, patient and family influence can be the primary adoption driver and should be treated with the same rigor as any other influencer type.

How to Work with Expert Influencers

Identifying influencers is necessary but not sufficient. The value of this block comes from understanding what each type of influencer needs and engaging them in a way that advances adoption.

For clinical champions, the most important thing you can do is make it easy for them to advocate. Give them the clinical evidence they need to make the case to peers and economic buyers. Understand what institutional process they would need to navigate to introduce your solution, and support them through it. Protect their independence — a clinical champion who appears financially motivated loses credibility.

For anti-buyers, the goal is not to convert them but to understand them. Their objections often contain legitimate clinical or operational concerns that, if addressed, would strengthen your solution. At minimum, knowing their arguments in advance allows you to prepare responses for economic buyer conversations where those arguments will surface.

For KOLs, engagement typically requires a more formal relationship — advisory board participation, co-authorship of clinical publications, or involvement in study design. The investment is significant but the return in credibility and market access can be substantial.

For patients and families, engagement should be proportional to their actual influence in your specific market. In high-engagement disease areas, patient advocacy organizations can be formal partners in clinical development and market access strategy.

Worked Example — Point-of-Care Sepsis Diagnostic Device

Name, Role and Type	Key Motivation	How to Engage
Dr. Elena — ED Medical Director Clinical Champion	Tracking sepsis mortality data in her department; under pressure from hospital leadership to improve outcomes; sees the device as a quality improvement tool	Involve in early clinical evaluation. Provide data analysis support. Help her build the VAC submission.
Dr. Richard — Senior ED Physician Anti-Buyer	Believes experienced clinicians can identify sepsis without a device; concerned about over-reliance on technology among junior staff	Seek out early. Listen to his specific concerns. Design the clinical evaluation to directly address whether the device adds value beyond experienced clinical judgment.
Prof. Martinez — Infectious Disease Researcher KOL	Internationally recognized sepsis researcher; has published extensively on time-to-treatment; strong views on early intervention protocols	Invite to advisory board. Propose co-authorship on a clinical validation study. Align the device's evidence package with his published framework.

5

Authorities

Stakeholder Block — Institutional Influencers

Read This First

Authorities are institutions that influence adoption through formal power, even though they do not buy or use your solution directly. Their decisions define what is allowed, reimbursed, or recommended. Unlike Expert Influencers who act through relationships and reputation, Authorities act through rules, regulations, and formal processes that apply to everyone in the market equally.

Understanding which authorities are relevant to your solution, in which geographies, and at what stage of your development is not optional — it is a prerequisite for a viable business model. An authority you have not mapped is a risk you have not managed.

Types of Authorities

Payors

Organizations that determine whether your solution will be reimbursed, under what billing code, and at what rate. In the United States, the Centers for Medicare and Medicaid Services (CMS) Coverage, Coding, and Payment framework effectively sets the standard that private insurers follow. Without a reimbursement pathway, economic buyers cannot find a budget for your solution regardless of its clinical value — the solution must either be funded from discretionary institutional budget or absorbed as a cost, both of which significantly raise the bar for adoption. In Europe, reimbursement is determined at the member state level, requiring a separate strategy for each country you plan to enter. Payor engagement should begin early — establishing a reimbursement pathway can take years and is frequently the longest lead-time item in a commercial launch plan.

Regulators

Government bodies that determine what medical products can be legally sold, what claims can be made, and under what conditions. In the United States, the FDA regulates medical devices and software as a medical device. In Europe, CE marking through a Notified Body is required. Your regulatory pathway determines what you can claim, how long it takes to get to market, how much it costs, and what post-market surveillance obligations you carry. Regulatory strategy is not a late-stage activity — decisions made early in product development about intended use, indications, and clinical claims have binding implications for the regulatory pathway you will need to navigate. A regulatory consultant or advisor should be engaged early, not after the product is built.

Medical Specialty Boards and Colleges

Professional organizations that set clinical practice guidelines, training standards, and certification requirements within a specialty. A clinical practice guideline that endorses your approach can transform adoption — institutions follow guidelines to manage liability and maintain accreditation. A guideline that ignores or discourages your solution creates a significant adoption barrier that clinical champions alone cannot overcome. Engaging relevant specialty boards early — through clinical advisory relationships, participation in guideline development, and funding of relevant research — is a long-term investment that pays disproportionate returns in market access.

Patient Advocacy Organizations

Organizations that represent patient communities and can influence research priorities, reimbursement decisions, clinical practice guidelines, and public policy. Their power varies enormously by disease area — in some conditions such as rare diseases, HIV, and certain cancers, patient advocacy organizations have been directly responsible for accelerating regulatory approval and expanding reimbursement coverage. In others, their influence is more diffuse. Your task is to assess whether advocacy organizations in your target area have the power and motivation to affect your path to market, and to engage them accordingly. Patient advocacy organizations are also valuable sources of patient insight and can facilitate access to patient communities for research and clinical validation.

Navigating Multiple Authorities

In most healthcare markets, multiple authorities are relevant simultaneously and their requirements interact. A reimbursement strategy depends on what the regulator has cleared you to claim. A clinical practice guideline endorsement depends on the evidence base, which is shaped by what the regulator required you to study. A payor coverage decision depends on the clinical evidence, which must meet the standards set by the relevant specialty board.

This interdependence means that authority mapping is not a one-time exercise. It is an ongoing strategic activity that must be updated as your regulatory status, evidence base, and market footprint evolve. The most common mistake is addressing authorities sequentially — waiting for regulatory clearance before engaging payors, or waiting for reimbursement before engaging specialty boards. The timelines involved in each process are long enough that sequential engagement adds years to your commercial launch. Map all relevant authorities early and engage them in parallel where possible.

Worked Example — Point-of-Care Sepsis Diagnostic Device

Authority	Relevance	Key Requirement	Strategic Action
CMS	Determines reimbursement for sepsis-related diagnostics under existing DRG and CPT code frameworks	Established billing pathway under existing sepsis diagnostic codes or new code if no existing pathway applies	Engage reimbursement counsel early to map existing codes. Assess whether device fits current coding or requires new code application.
FDA	Clearance required as an in vitro diagnostic device	510(k) clearance based on substantial equivalence to a predicate device, or De Novo if no predicate exists	Identify predicate device. Define intended use and indications carefully to optimize regulatory pathway. Engage FDA in pre-submission meeting.
Society of Critical Care Medicine (SCCM)	Sets Surviving Sepsis Campaign guidelines followed by most ICUs and EDs globally	Clinical evidence demonstrating improvement in time-to-treatment and patient outcomes consistent with Surviving Sepsis Campaign priorities	Design clinical validation study to generate evidence aligned with SCCM guideline criteria. Engage SCCM-affiliated KOLs in study design.
Sepsis Alliance	Patient advocacy organization with significant public profile and relationships with hospital quality improvement teams	Demonstrated improvement in patient outcomes and commitment to equitable access	Present clinical evidence at Sepsis Alliance annual conference. Explore co-advocacy for faster diagnostic protocols in ED settings.