Wellness Tech Due Diligence: Why Many 3D-Scanned Insoles Are Placebo — A VC’s Checklist

Hook: Your dollars shouldn’t fund placebo tech disguised as personalization

Investors in consumer wellness know the pitch: a sleek app, a phone-based 3D scan, and a promise of custom biomechanics that will relieve pain and unlock performance. But in 2026 the bar is higher — and many startups that sell 3D-scanned insoles are selling perception more than physiology. This guide gives VCs a technical and commercial checklist to separate genuine product-market fit from placebo-driven wellness tech, with concrete tests, KPIs, and due-diligence scripts you can use at diligence meetings.

Why focus on 3D-scanned insoles now (late 2025–2026)

Recent reporting and product launches (including high-profile consumer rollouts in late 2025 and early 2026) have shown the thin line between true biomechanical innovation and clever marketing. Press attention has exposed examples—companies like Groov received critical scrutiny in January 2026 for making bold customization claims without objective validation. That pattern is part of a broader 2026 trend: investors, regulators and consumers now expect clinical evidence, traceable manufacturing, and measurable outcomes. The era of “scan + hype” is ending; the era of evidence-led wellness tech is here.

Macro signals changing the diligence landscape

• Regulatory scrutiny: Authorities and marketplaces are flagging unsubstantiated health claims. In the EU, AI governance and medical device oversight tightened in 2024–2025; in 2026 marketplaces delist products that lack validation.
• Investor discipline: LPs demand real-world evidence and clear unit economics before Series A+.
• Consumer skepticism: Review aggregation and return statistics increasingly expose placebo-first products.
• Manufacturing advances: 3D printing and digital production matured in 2024–25, but variability and QC remain real risks at scale.

How placebo shows up in wellness tech

Placebo products often share common behavioral and commercial patterns. Recognizing these patterns fast can save time and capital.

• Heavy reliance on testimonials: Photos, influencer posts, and unblinded user quotes instead of blinded trials or lab measures.
• Opaque personalization: “Custom” equals a fancy 3D scan but no measurable adjustment to pressure distribution or gait.
• Low scientific rigour: Small internal studies with no control arm, short follow-up, and outcomes that are primarily subjective.
• High return rates: Users try the product, report no objective benefit, and return after the trial — often with weak warranties that become operational headaches.

VC’s Due-Diligence Checklist: Technical & Clinical

Use this checklist verbatim in diligence decks, term-sheets, or LOIs. Ask for documentation and demonstrations, not marketing slides.

1) Scan fidelity and repeatability

• Request raw scan data from multiple subjects. Are the point clouds or meshes available, or only processed marketing renderings?
• Test repeatability: ask the team to rescan the same foot three times across two different devices/operators. Expected threshold: inter-scan variance < 1–2 mm on key anatomical landmarks (heel, metatarsal heads).
• Confirm alignment and registration methods. Are scans corrected for posture and weight-bearing? Static scans alone are weaker than load-bearing pressure-coupled scans.

2) Biomechanical rationale and objective endpoints

• Demand a clear causal chain: scan → design change → measurable biomechanical effect → clinical outcome. If the link has gaps, the product is likely placebic.
• Insist on objective biomechanical endpoints: plantar pressure redistribution, peak pressure reduction (kPa), center-of-pressure trajectories, step length and cadence changes, and gait symmetry metrics.
• Avoid sole reliance on patient-reported outcomes (PROs); use them in conjunction with objective measures.

3) Manufacturing and material science

• Ask for material certificates (COA) and mechanical testing: compression set, Shore hardness, fatigue cycles. For durable insoles, fatigue life > 6 months of daily use under expected loads is a reasonable baseline.
• Audit production variability. For 3D printing: document layer resolution, post-processing, and quality control thresholds.
• Obtain a sample set from multiple production batches and run a blind fit and objective pressure test.

4) Clinical validation — what counts in 2026

• Prefer randomized controlled trials (RCTs) or at least a prospectively registered cohort study. Key features: blinded assessors, predefined endpoints, adequate sample size, and objective measures.
• For pilot evidence, demand an independent lab report comparing the product to neutral insoles or established orthotics using pressure mats or motion capture.
• Check publication quality: peer-reviewed journals, transparent methods, statistical power calculations, and access to anonymized datasets where possible.

5) Algorithm governance (if using ML personalization)

• Review model inputs, outputs, and training data provenance. Does the training dataset represent the target population (age, BMI, gait patterns)?
• Ask for model performance metrics across subgroups and a plan for model updates. In 2026, investors expect explicit data governance and model “shadow mode” rollout logs.
• Request documentation that demonstrates bias testing and safety monitoring, especially if the product makes health claims.

VC’s Due-Diligence Checklist: Commercial

Clinical promise is necessary but not sufficient. Below are commercial signals that separate a repeatable business from an expensive MVP.

6) Demand validation and early traction

• Evaluate funnel metrics: visitor → scan completion → purchase conversion. Healthy hygiene benchmarks in wellness DTC: scan completion > 40%, post-scan purchase conversion > 5–10% depending on price point.
• Measure cohort retention: 30‑, 90‑, 180‑day active usage or repurchase. Suggested checkpoint: 90‑day retention > 35–45% for subscription or upgrade-driven models; for single-purchase orthotics retention is less meaningful but warranty claims and repeat purchases of alignment products matter.
• Review return rates and reasons. Anything above 10–15% for footwear/fit products is a red flag unless mitigated by strong exchange logistics.

7) Unit economics and channel strategy

• Unit economics: COGS for custom insoles (materials + processing + shipping) should be clearly modeled. Look for a gross margin >50% at scale or a credible plan to reach it via automation or higher price tiers.
• Customer acquisition: CAC payback < 12 months is a practical target for consumer wellness. LTV/CAC > 3 is preferred.
• Channel diversification: DTC is fine for discovery, but durable scale often requires clinical channels (clinics, insurers, sports teams) or retail partnerships.

8) Refunds, guarantees, and operations

• Operational excellence is a moat here: fast exchanges, clear instructions for scanning, and a no-hassle return process cut friction and refund rates.
• Ask for case-handling SLA metrics: time to replace/adjust, percent resolved on first exchange.
• Check warranty abuse patterns. High fraud in online returns often accompanies placebo products.

9) Regulatory and legal posture

• Determine whether the product has been marketed as a consumer wellness good or a medical device. Ask counsel about likely classification in key markets (US, EU, UK).
• Request any correspondence with regulators and marketplace takedown history. Transparency here is a positive signal.
• Confirm IP claims: design files, process patents, or trade secrets are less valuable than strong partnerships and clinical evidence, but they matter for defensibility.

Practical tests you can run in a single diligence meeting

Run these live. They’re cheap, fast, and reveal whether the product is science-first or marketing-first.

1. Ask the founder to show raw scans and the transformation pipeline: raw mesh → processed model → toolpath/manufacturing file. Time how long each step takes.
2. Request a blind fit test: take three anonymized pairs of insoles (different batches), put them on the same pressure mat, and ask the team to explain variation. Look for objective metrics, not marketing language.
3. Perform a claims audit: for each benefit listed on the website, ask for the direct evidence link. There should be an evidence map connecting claims to studies or internal test reports.

Red flags vs. green flags (quick checklist)

• Red flags: heavy influencer marketing with no trials; “custom” that is only cosmetic; single-arm self-reported studies; high refund/return rates; nonexistent QC reports.
• Green flags: independent lab benchmarking; RCTs or pre-registered cohort studies; clinic pilots with objective outcomes; transparent manufacturing QA and clear post-sale support.

Case snapshot: Groov and why it matters (January 2026)

Public reporting in early 2026 highlighted Groov’s slick in-store scanning experience and consumer-facing claims. That coverage is instructive because it exposed common pitfalls: emphasis on experience over evidence, and the lack of objective biomechanical proof presented to consumers. For investors, Groov-style launches show that impressive retail tech and a strong brand story can create early sales — but not sustainable clinical or unit-economic defensibility. Use that as a cautionary tale: marketing-fueled adoption can mask systemic churn and refund costs that surface later.

Advanced strategies for value creation (how to move winners to category leaders)

If the startup clears the checklist, here are value-creation moves VCs can push for to scale credibly in 2026.

• Invest in an independent RCT: a pragmatic RCT across 2–3 clinical sites with objective pressure-mat endpoints and 6‑month follow-up will unlock payers and clinical distribution.
• Build clinic partnerships: integrate scanning into podiatry and physical therapy clinics to capture medically relevant use cases and reduce CAC.
• Productize data services: offer gait analytics dashboards to clinics or coaches as a SaaS add-on, creating recurring revenue beyond hardware.
• Localize manufacturing: invest in regional digital factories to reduce lead times and variability and to support B2B scale for teams and clinics.
• Implement robust ML governance: shadow-mode personalization before full rollout, and publish model performance by subgroup to reduce bias and regulatory risk.

Sample diligence questions to ask the founder (ready to use)

1. Can you show the last 20 raw scan files and the processed CAD files that produced the shipped insoles?
2. What objective biomechanical measures do you use to decide a design change? Share before/after pressure-mat data for at least 30 users.
3. What are your batch defect and return rates for the last 12 months? Provide supporting returns data and reasons.
4. Where does your model’s training data come from? Show subgroup performance metrics and bias tests.
5. Which regulatory filings or opinions have you obtained, and have you ever been contacted by a regulator about claims?

KPIs and thresholds — a practical cheat sheet

• Scan repeatability: inter-scan variance < 1–2 mm on key landmarks.
• Objective pressure reduction: average peak pressure reduction > 10–15% vs neutral in pilot testing.
• Return rate: < 10–15% at scale.
• CAC payback: < 12 months; LTV/CAC > 3 for sustainable DTC.
• 90‑day retention: > 35% for subscription features; for single units, metric of interest is warranty/adjustment requests < 20%.

Final thoughts: placebos cost more than money

Funding a placebo product costs not only capital, but reputation and founder time. In 2026, the wellness market rewards companies that combine credible biomechanics, objective validation, and repeatable operations. Use this checklist to demand evidence, verify claims, and structure milestones that align incentives. When a founder can map scan → biomechanics → outcome with transparent data and robust manufacturing, you’re looking at a defensible business. When all you get is a beautiful scan and a powerful story — proceed with skepticism.

“In an age of rapid digital fabrication and AI personalization, investors must ask for the data behind the magic trick.”

Actionable takeaways

• Bring this checklist to your next diligence call: demand raw scans, objective pressure-mat data, QC reports, and clear unit economics.
• Run the three live tests in-meeting (raw data request, blind pressure test, claims audit).
• Require an evidence milestone in term sheets: an independent pilot or RCT with predefined objective endpoints within 12–18 months.

Call to action

If you lead diligences for consumer health or want a reusable one-page checklist, download the compact PDF version of this due-diligence checklist and subscribe to our investor newsletter for monthly signals, early warning indicators, and curated trial results across wellness tech. Or contact us to run a rapid technical audit before you write a check — we specialize in separating durable product-market fit from high-gloss placebo tech.

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