My Rx Pad A go-to-market guide for digital health startups, founders, and solution providers from Digital.Health by Daniel Kraft, MD. Topics: the digital health adoption gap; evidence strategy including matching evidence tiers to claim tiers, engagement and retention data, real-world evidence and HEOR; regulatory positioning including general wellness claims, FDA enforcement discretion, Software as a Medical Device, 510(k), De Novo, and Predetermined Change Control Plans; buyer landscapes across health systems, clinicians and medical practices, pharma and life sciences, employers and payers, and direct-to-consumer, including sales cycle length and deal-killers; reimbursement-aware product design around RPM, RTM, and chronic care management CPT code families; distribution channels; buyer diligence readiness including HIPAA, Business Associate Agreements, SOC 2 Type II, and FHIR integration; and escaping pilot purgatory with predefined success criteria and pre-negotiated conversion terms.
Getting your digital health solution adopted.
Healthcare doesn’t buy like other industries — and most digital health companies discover that after burning eighteen months. This guide covers what actually moves adoption: evidence matched to claims, a deliberate regulatory lane, buyer-by-buyer realities, reimbursement-aware design, and pilots that convert instead of stalling.
Innovation isn’t the bottleneck. Adoption is.
The core insightDigital health solutions rarely fail on technology. They fail in the gap between a working product and an adopted one — where evidence, regulation, workflow, security review, and reimbursement decide outcomes long before product quality does.
Healthcare buying has properties most playbooks from consumer tech and SaaS don’t prepare you for: the user, the buyer, and the payer are usually three different parties; a single skeptical stakeholder (clinical, IT, security, legal, compliance) can veto a deal any of the others love; and the cost of a bad adoption decision — measured in patient safety and clinician time — makes buyers rationally conservative.
The companies that break through don’t treat these as sales obstacles to talk past. They treat evidence, regulatory posture, security documentation, workflow fit, and a billing story as product surface area — built deliberately, in the right order, for the channel they’ve chosen. That’s the frame for everything below.
Evidence strategy: match the tier to the claim.
Evidence is not a compliance checkbox — it’s the asset that compounds while paid marketing depreciates. But over-building evidence for claims you don’t make wastes runway, and under-building it for claims you do make kills deals in diligence. The discipline is matching tiers.
Feasibility & engagement data earns you pilots: usage, retention, satisfaction, and a credible clinical rationale. Be honest about attrition — sophisticated buyers read retention curves before outcomes tables, and discovering hidden churn in diligence costs you the deal and the reference.
Peer-reviewed outcomes evidence earns you clinical adoption: published results against a meaningful comparator (usual care or active control — not waitlist), in a population resembling the buyer’s. One strong publication outperforms ten white papers, because clinicians and health system evaluators discount anything that didn’t survive review.
Health-economic evidence earns you payer, employer, and pharma contracts: cost-of-care impact, HEOR modeling, and increasingly real-world evidence from your own deployments. Instrument your product to generate this from day one — retrofitting data collection after launch is painful and slow.
Choose your regulatory lane deliberately.
Your claims determine your pathway — and your pathway determines your cost, timeline, and what buyers will believe and pay for. From the maker’s side, the trade looks like this.
| Lane | What it costs you | What it buys you | Watch out for |
|---|---|---|---|
| General wellness | Nothing regulatory; fastest to market. | Speed and iteration freedom. | Claim ceiling: no disease claims, weaker clinical positioning, limited reimbursement paths. |
| Enforcement discretion | Careful claims and design discipline. | Device-adjacent functionality without premarket review. | The line moves with guidance updates; document your rationale. |
| 510(k) clearance | Months and meaningful cost; a predicate strategy. | “FDA-cleared” positioning, medical claims, enterprise credibility. | Your predicate choice constrains your claims. |
| De Novo | Longer, costlier, evidence-heavier. | First-of-kind positioning — and you become the predicate others cite. | You’re also drawing the map for competitors behind you. |
| AI/ML products | Validation plus a post-market monitoring story. | A PCCP lets you pre-authorize model updates instead of re-filing. | Buyers now ask about drift monitoring and update governance — have answers. |
Know your buyers — they don’t buy alike.
“Selling to healthcare” is five different motions with different cycles, decision-makers, and deal-killers. Most companies can run one well at a time.
| Buyer | What they’re really buying | Typical cycle | What kills the deal |
|---|---|---|---|
| Health systems | Outcomes plus operational ROI, delivered without integration pain or security risk. | 12–24 months | No executive sponsor; security/IT stall; unclear internal owner post-launch. |
| Clinicians & practices | Workflow relief and better patient outcomes — with a billing story where relevant. | Weeks–months | Added clicks; making the clinician your data-entry workforce; no evidence one-pager. |
| Pharma & life sciences | Patient support, trial enablement, engagement, and data — wrapped in compliance. | 6–18 months | Legal/compliance friction; ambiguous data rights; inability to scale across brands. |
| Employers & payers | Engagement that moves cost trend and member satisfaction, provable actuarially. | 6–12 months, benefits-cycle timed | Weak engagement economics; no HEOR story; missing the enrollment window. |
| Consumers (DTC) | Immediate, felt value — and trust with their health data. | Days | Acquisition costs outrunning lifetime value; churn; trust-eroding data practices. |
Design for how the money already flows.
If your buyer is a provider organization, the single most powerful reframe available to you is turning your product from a cost center into a revenue line. Established CPT code families — remote patient monitoring (the 99453/99454/99457/99458 family), remote therapeutic monitoring (98975–98981), and chronic care management — already pay providers for activities your product may enable. A solution designed so its use maps cleanly onto those code families, with the documentation and time-tracking to support billing, sells a fundamentally different story than one asking for budget.
If your channel is employers, payers, or pharma, fee-for-service codes matter less than engagement economics, outcomes, and increasingly value-based arrangements where you share risk on results. And if you’re direct-to-consumer, your “reimbursement strategy” is really a willingness-to-pay and retention question — though employer and plan benefit programs can become a second channel once engagement is proven.
Whichever route: decide early. Reimbursement-aware design touches data capture, documentation, workflow, and even clinical protocol — retrofitting it after launch is one of the most expensive mistakes in the sector. And verify current codes, thresholds, and payer policies as you build; they shift with every fee schedule cycle.
Eight questions every serious buyer will ask you.
Diligence readiness is one of the cheapest ways to compress a sales cycle. Have crisp, documented answers to these before the first enterprise conversation.
Run pilots that convert.
Pilot purgatory — endless evaluations that never become contracts — is the sector’s most common slow death. The antidote is negotiating the ending before the beginning.
An enthusiastic innovation team is a start, not a sponsor. Before committing resources, identify the executive with budget authority who owns the outcome — and confirm they’ll be in the room at evaluation.
Specific, measurable, agreed in writing before launch: clinical or operational metrics, engagement thresholds, staff-time impact. Criteria defined after the fact are always defined against you.
Agree on commercial terms that activate if criteria are met — pricing, scope, timeline. A pilot without a pre-negotiated path to contract is unpaid market research.
A defined evaluation window with data collection built in from day one. Open-ended pilots drift; instrumented ones generate the real-world evidence that sells the next ten deals.
If criteria are met, execute the pre-agreed terms. If the buyer stalls anyway, take the documented results, the reference conversations, and the lessons — and spend your runway on the next qualified buyer instead of a second free pilot.
A commercialization glossary.
Eighteen terms from the rooms where adoption decisions get made.
- Pilot purgatory
- Successive pilots that never convert to contracts — typically for lack of written success criteria and a pre-negotiated conversion path.
- Clinical champion
- The internal clinician advocate who sponsors a solution through a buying organization; deals without one rarely survive procurement.
- Software as a Medical Device (SaMD)
- Software intended for a medical purpose, regulated as a device in its own right.
- 510(k)
- FDA premarket pathway demonstrating substantial equivalence to a predicate device already on the market.
- De Novo
- FDA pathway creating a new classification for novel low-to-moderate-risk devices without a predicate.
- Predetermined Change Control Plan (PCCP)
- FDA mechanism allowing pre-specified post-market updates to AI/ML devices without re-filing for each change.
- Business Associate Agreement (BAA)
- The HIPAA-required contract between a covered entity and a vendor handling protected health information on its behalf.
- SOC 2
- Independent audit report on security, availability, and privacy controls; Type II covers controls over time and is the enterprise expectation.
- FHIR
- Fast Healthcare Interoperability Resources — the dominant EHR data-exchange standard, and the default answer to integration questions.
- Real-world evidence (RWE)
- Clinical evidence from real-world data such as EHRs, claims, and device data — increasingly expected alongside trial results.
- HEOR
- Health economics and outcomes research — the analysis quantifying clinical and economic value, central to payer and pharma deals.
- Remote patient monitoring (RPM)
- Clinician-ordered physiologic monitoring with established CPT code families — a common reimbursement anchor for provider-channel products.
- Remote therapeutic monitoring (RTM)
- Monitoring of non-physiologic therapeutic data such as adherence and therapy response, with its own code family.
- Prescription digital therapeutic (PDT)
- FDA-authorized therapeutic software requiring a clinician’s order, distributed via hub or pharmacy pathways.
- Digital formulary
- A curated list of vetted digital tools a practice or system recommends — increasingly the gate providers use to reach clinicians at scale.
- P&T committee
- Pharmacy & Therapeutics committee — the governance model health systems increasingly extend to evaluating digital tools.
- Value-based care (VBC)
- Payment models tying reimbursement to outcomes and cost rather than volume — a growing channel for solutions that reduce total cost of care.
- Land and expand
- Entering an organization with a narrow, low-friction deployment and growing the footprint after demonstrating value.
Founders frequently ask.
How long does a health system sale really take?
Does my product need FDA clearance?
What evidence do I need at each stage?
What is pilot purgatory and how do I avoid it?
What security paperwork do buyers expect?
How do I get clinicians to recommend my product?
Should I build around reimbursement codes?
How do buyers actually discover new solutions?
Be discoverable where buyers already search.
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