Your Stakeholders Have Changed. Has Your Evidence Strategy?

I give a lecture at Johns Hopkins on the U.S. healthcare economic landscape.

Every summer, I start the same way: I ask the students whether the U.S. healthcare system is easy or hard to navigate.

They always laugh. Because the answer is obvious.

But here’s what I tell them next: it’s not just hard. It’s also changing and it’s changing fast.

The stakeholders you’re designing evidence for today are not operating under the same constraints, incentives, or decision frameworks they were even 18 months ago. If your evidence strategy hasn’t kept up, you’re building toward a target that’s already moved.

What Changed?

Here’s the reality: the financial and operational reality of U.S. healthcare has fundamentally shifted.

In 2024, hospitals were being crushed by labor inflation. Staffing shortages dominated executive discussions. Expense categories were running 15 to 20% above historical levels. The question health systems were asking was: “Can we staff the hospital?”

By late 2025 and into 2026, the question changed.

Now it’s: “How do we move more patients through the same infrastructure?”

Labor pressures have moderated. But overall costs haven’t. Hospitals are doing more with fewer people. FTEs per adjusted occupied bed continue to fall, while adjusted discharges, patient days, and operating room utilization are increasing. Operating room minutes, for example, increased ~6% year-over-year in early 2026.

Translation: Health systems solved part of the staffing crisis. But they didn’t solve the cost or capacity crisis.

The bottleneck is no longer staffing. It’s operational efficiency.

It’s Not Just Hospitals

Payers are under pressure too.

In 2025:

• UnitedHealth Group reported that medical costs exceeded expectations by approximately $6.5 billion, driven by higher utilization across physician visits, outpatient services, and specialty care.

• Humana posted a net loss of $862 million in one quarter, attributed to increased medical costs and a decline of approximately 550,000 Medicare Advantage members.

• Elevance Health reported medical costs growing faster than expected in both commercial and government populations, with the medical benefit ratio climbing to approximately 88.9%.

Even when payers are growing revenue, margins are being pressured by higher utilization, specialty pharmacy, ER use, behavioral health, and higher-acuity members.

Translation: “Better outcomes” is not enough anymore. The value story has to show measurable impact on cost, utilization, workflow, or capacity.

So What Does This Mean for Medtech Evidence Strategy?

It means the stakeholders deciding whether to adopt, reimburse, or recommend your technology are asking different questions than they were a year ago.

And if your evidence strategy was designed to answer last year’s questions, it’s already outdated.

Let me walk through what I mean.

The Stakeholder Shift: What They Used to Care About vs. What They Care About Now

Health Systems / Providers

Then (2023 to 2024):

• Can we recruit and retain staff?
• Can we manage workflow with skeleton crews?
• Will this technology add to clinician burden?

Now (2025 to 2026):

• Can we increase throughput without adding headcount?
• Will this technology save clinician time or automate workflow?
• Can this help us move more patients through the OR, ED, or inpatient units?
• Does this reduce procedure time, prevent complications, or avoid readmissions?

What this means for evidence:

Your study needs to measure time savings, workflow impact, capacity gains, or operational efficiency, not just clinical outcomes.

If your protocol doesn’t capture those metrics, you’re not speaking the language health systems are using to make adoption decisions right now.

Payers (Commercial and Medicare Advantage)

Then (2023 to 2024):

• Does this technology improve outcomes?
• Is there clinical evidence supporting use?

Now (2025 to 2026):

• Does this technology reduce downstream utilization (ER visits, readmissions, specialist referrals)?
• Does it prevent high-cost complications or avoid unnecessary procedures?
• Will this help us manage higher-acuity populations more cost-effectively?
• Can we demonstrate ROI within 12 to 18 months?

What this means for evidence:

Payers want to see real-world utilization data, cost-offset modeling, and population-level impact. They want to know that your technology won’t just improve care, it will help them manage the financial and operational pressure they’re under.

If your evidence plan focuses on clinical efficacy but doesn’t address utilization, cost avoidance, or population health management, you’re missing the key decision drivers.

Medicare Advantage Plans (Specific Pressure Point)

Medicare Star Ratings are one of the most important financial drivers for companies offering Medicare Advantage plans. A lower Star Rating means less revenue from CMS, lower margins, and reduced ability to compete for members.

Star Ratings are based on dozens of measures, including:

• Preventive care (vaccinations, screenings)
• Medication adherence
• Chronic disease management
• Customer service and member satisfaction
• Health outcomes

What this means for evidence:

If your technology can demonstrably impact any of the metrics that feed into Star Ratings (eg. medication adherence, chronic disease management, preventive screenings, care coordination) that becomes a direct financial value driver for MA plans.

Your evidence strategy should be designed to capture and communicate that impact.

Purchasers (Employers, IDNs, ACOs)

Then:

• Does this align with our benefits strategy?
• Will employees or members use it?

Now:

• Does this help us manage the affordability crisis?
• Will this reduce our total cost of care?
• Can we demonstrate value to our board, our CFO, or our membership?

Employer-sponsored health insurance premiums surpassed $26,000 annually for family coverage in 2025. Many employers are shifting costs through higher deductibles, narrower networks, and stricter prior authorization requirements.

What this means for evidence:

Purchasers need evidence that your technology addresses affordability, reduces total cost of care, or improves population health outcomes in ways that justify the investment.

The Strategic Question: Is Your Evidence Strategy Built for 2023 or 2026?

If you’re in the middle of designing a post-market, pragmatic, or real-world study right now, ask yourself:

• Does this study measure operational efficiency, workflow impact, or time savings?
• Does it capture utilization data that payers and health systems can use to model ROI?
• Does it address the capacity, cost, and throughput pressures health systems are facing right now?
• Does it generate evidence that could influence Medicare Star Ratings or value-based care contracts?
• Is the comparator strategy aligned with how care is actually being delivered in 2026, not 2023?

If the answer to any of these is “no” or “I’m not sure,” your evidence strategy may be out of sync with the stakeholder reality you’re about to enter.

What a Stakeholder-Aligned Evidence Strategy Looks Like

An evidence strategy that’s aligned with today’s stakeholder priorities doesn’t just check regulatory and clinical boxes. It’s designed around the decisions your evidence needs to change.

That means:

1. Understanding What Each Stakeholder is Being Measured On

Health systems are being measured on throughput, length of stay, readmission rates, and cost per discharge.

Payers are being measured on medical loss ratios, Star Ratings, member retention, and cost trend.

Purchasers are being measured on total cost of care, affordability, and member satisfaction.

Your evidence strategy should be designed to help them succeed on their metrics.

2. Choosing Endpoints That Speak to Stakeholder Constraints

If a health system’s constraint is operational capacity, your endpoints should include:

• Procedure time
• Workflow efficiency
• Staff time saved
• Throughput improvement

If a payer’s constraint is rising utilization, your endpoints should include:

• ER visit avoidance
• Readmission reduction
• Preventable complication rates
• Medication adherence (if relevant to Star Ratings)

Clinical outcomes still matter. But they’re not enough on their own anymore.

3. Building Real-World Evidence That Reflects Real-World Constraints

Pragmatic and real-world studies are not a shortcut around rigor. Done well, they make rigor relevant.

The best real-world studies are designed to answer:

• How does this technology perform in the settings where it will actually be used?
• What is the operational, clinical, and economic impact in routine care?
• Can this be implemented without collapsing under its own complexity?

The Reality: Your Stakeholders Changed Faster Than Your Evidence Plan

The U.S. healthcare system is not static. Stakeholder priorities shift in response to financial pressure, regulatory change, operational constraints, and market dynamics.

In the last 18 to 24 months, those shifts have been significant:

• Hospitals moved from a staffing crisis to a capacity and efficiency crisis.
• Payers moved from managing post-COVID utilization swings to managing affordability and margin compression.
• Purchasers moved from benefits design to cost containment.

If your evidence strategy was designed before these shifts happened, it may not be aligned with the decisions your stakeholders are making right now.

What to Do if Your Evidence Strategy Is Out of Sync

If you’re reading this and realizing your current study or evidence plan may not be aligned with today’s stakeholder reality, here’s what you can do:

1. Pressure-Test Your Protocol Against Current Stakeholder Priorities

Ask:

• Does this study generate evidence that speaks to the operational, financial, and capacity pressures stakeholders are facing in 2026?
• Are the endpoints aligned with how stakeholders are being measured and incentivized?
• Will this study help a payer justify coverage, a health system justify adoption, or a purchaser justify investment?

2. Consider Whether You Can Augment Your Existing Evidence

Sometimes the core study is solid, but it’s missing one or two key data points that would make it stakeholder-relevant.

Can you add:

• Workflow or time-savings data?
• Utilization tracking (ER visits, readmissions, follow-up care)?
• Patient-reported outcomes that align with value-based care metrics?
• Real-world implementation feasibility measures?

The Bottom Line

Great products don’t sell themselves in U.S. healthcare. Evidence sells them. But only if the evidence is aligned with the decisions stakeholders actually need to make.

Your stakeholders have changed. The pressures they’re under have changed. The metrics they’re measured on have changed. The questions they’re asking have changed.

If your evidence strategy hasn’t changed with them, you’re solving yesterday’s problem with tomorrow’s data.

TTi’s Perspective

At TTi, we help medtech companies build evidence strategies that are aligned with the stakeholder landscape they’re actually entering not the one they left behind.

That means:

• Understanding the macro and micro forces shaping stakeholder priorities
• Designing studies that generate evidence stakeholders can actually use to make decisions
• Sequencing evidence generation so the right data arrives at the right decision point
• Translating clinical, operational, and economic evidence into stakeholder-specific value communication

Because the best evidence in the world doesn’t matter if it doesn’t change the decision.

Before you launch your next study, ask: What might we be missing?

Not because your team has done anything wrong. But because the stakeholder landscape is moving and your evidence strategy needs to move with it.

Remember:

Evidence is only valuable if it changes the next decision.

– Dr. April