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ScopeGuard Health LLC · Branchburg, NJ · Confidential
ScopeGuard Health
Company Overview · April 2026

The compliance gap hiding in every GI endoscopy center — and the software that closes it.

Every independent GI endoscopy center in the country is legally required to document a nine-step reprocessing workflow for every scope, every cycle, every day. Most do it on paper. Paper fails silently — and when it fails, the consequences are severe.

65%
of GI facilities cited for reprocessing non-compliance
6,400
patients notified in a single reprocessing failure
$0
what paper costs — until the day it doesn't
The problem

What Tuesday morning looks like at a typical GI center

M. Torres is a skilled, conscientious sterile processing tech. The system around her is broken — not because of negligence, but because paper-based documentation fails silently.

7:18am
M. Torres, CSPDT
CF-001 pre-clean begins
Point-of-use wipe, channel flush. Paper log form pulled from binder. Time written by hand.
7:52am
Documentation gap
CF-001 log incomplete — AER data unattached
Steps 1–4 filled in. Steps 5–9 blank. AER printout still in tray.
⚠ Undocumented cycle
9:18am
Maintenance gap
CF-003 hits cycle limit — no alert generated
Scope reaches 1,400 cycles. Olympus IFU §8.3 requires maintenance review. No system tracks this.
⚠ Maintenance overdue
3:30pm
Survey readiness gap
Administrator unaware of 3 documentation gaps
Incomplete CF-001 log. CF-003 maintenance overdue. CF-004 incident not cross-referenced to patient case.
⚠ 3 potential citations
What administrators say

The problem is not awareness. It's the absence of an affordable solution.

"A surveyor walked in unannounced. She asked for the last 90 days of reprocessing logs for every scope. It took us four hours to pull together something I wasn't even confident was complete."
ASC ADMINISTRATOR — NJ INDEPENDENT GI CENTER
"The thing that scares me isn't the actual reprocessing. It's the documentation gap between what we do and what we can prove we did."
ADMINISTRATOR — AAAHC-ACCREDITED CENTER
"I found out a scope had failed its cycle limit when the Olympus rep mentioned it during a service call. We'd used it on 40 patients after it should have been flagged."
GI CENTER DIRECTOR — PA
When it goes wrong

Three documented incidents. All traced to missed steps and inadequate documentation.

2004–2008 · VA Medical Center, Murfreesboro TN
Wrong connector installed. Reprocessed once daily — not between patients. Undetected for 5 years.
Congressional hearing convened
6,387
patients notified · 10 confirmed hepatitis cases
July 2024 · Legacy Mount Hood Medical Center, Portland OR
Infection control practices not followed during endoscopy procedures. 2 years undetected.
Provider suspended
2,200
patients notified · HIV and hepatitis exposure
October 2024 · Vanderbilt University Medical Center, Nashville TN
Inappropriate scope administration in GI Endoscopy Lab. Nashville — ASCA conference city.
Top-10 academic medical center · Still happening in 2024
Top 10
Four months ago. This is not a historical problem.
Why now

Three structural forces are making this problem bigger, not smaller.

Each of these would independently justify a compliance software market. Together they create a compounding urgency that makes 2026 the right moment to enter.

📈
Colorectal cancer rates are rising — and screening now starts at 45
In 2021 the USPSTF lowered the recommended screening age from 50 to 45, adding an estimated 19 million newly eligible patients to the colonoscopy pipeline. At the same time, colorectal cancer incidence in adults under 50 has been rising for two decades — a trend that is accelerating demand for diagnostic endoscopy across all age groups. More procedures means more reprocessing cycles, more documentation requirements, and more liability exposure from documentation gaps.
19M
newly eligible patients added since 2021
21%
projected ASC procedure volume growth 2024–2034
10.3%
CAGR in reprocessing software market through 2033
⚖️
Federal and state compliance requirements are tightening — simultaneously
After a period of relaxed enforcement during and after COVID, regulatory scrutiny of ASC infection control is returning with force across three separate channels at once.
AAMI ST91:2021 — Updated storage and documentation standards
Section 6.4 revised: max hang-time for dried endoscopes reduced from 72 to 60 hours. Documentation requirements tightened. Most independent centers are unaware their current protocols are non-compliant.
CMS — Expanding ASC quality reporting and survey scope
CMS added 32 new procedures to the ASC covered list in 2024 and 21 more in 2025, expanding the scope of what must be documented. The prior authorization demonstration program launched December 2025 across 10 states including NJ, PA, and MD — all Phase 1 ScopeGuard markets.
New Jersey — Healthcare Finance Enhancement Act (June 2025)
Significantly expanded the universe of NJ ASCs subject to annual assessments. Beginning 2026, single-room surgical practices previously exempt are now included. The regulatory burden on independent NJ centers is increasing, not decreasing.
💻
Independent GI centers are finally ready for software — and there's nothing built for them
GI ASC EHR adoption now exceeds 80%. These centers are cloud-comfortable and already pay for vertical SaaS across scheduling, billing, and clinical documentation. The paper reprocessing log is not a preference — it's a default in the absence of an affordable, purpose-built alternative. Enterprise solutions (Censis ScopeTrac: $80–120K implementation) have always been out of reach. ScopeGuard enters at $400–1,200/month with no hardware and a 5-day implementation. The market is ready. The product category does not yet exist.
The solution

ScopeGuard Health — purpose-built compliance software for independent GI endoscopy centers.

A browser-based platform that replaces paper reprocessing logs with a guided digital workflow. No hardware. No IT department. Live in 5 days.

✓
Guided 9-step reprocessing checklist
Each step timestamped and confirmed in real time by the sterile processing tech. AER machine log imported automatically.
📋
One-click audit export
90-day survey-ready report formatted for AAAHC, Joint Commission, or CMS — generated in seconds, not hours.
🔔
Real-time alerts
Scope maintenance thresholds, missed documentation steps, and scope-to-patient linkage tracked automatically. Administrator is never blindsided.
📡
Regulatory update feed
AAMI ST91, FDA safety communications, and accreditor requirement changes surface automatically. The platform stays current so the administrator doesn't have to.
Competitive landscape

Paper is the incumbent at 100% market share. Nothing purpose-built exists for the independent GI ASC.

ScopeGuard Health ✓
Built for independent GI ASCs · Browser-based · No hardware · Live in 5 days · AAAHC + TJC + CMS export · $400–1,200/mo
Censis ScopeTrac
Hospital-focused · $80–120K implementation · Hardware required · Designed for 400-bed hospital sterile processing departments
Generic CMMS
Not GI-specific · No AAMI ST91 workflow · No AER integration · No accreditor export formats
Paper logs
100% market share today · Free until the surveyor walks in · The incumbent we are replacing
The market

Not 3,500 ASCs. 847 real, reachable targets.

We start with the full universe and filter to our ideal customer: independent, GI-focused, accredited, 3+ scopes, in our Phase 1–2 geographies.

6,500
Total Medicare-certified ASCs (US)
3,500
GI endoscopy-focused
2,100
Independent (non-PE-consolidated)
847
Phase 1–2 priority targets · AAAHC/TJC · 3+ scopes · NJ / PA / MD / TX
$29M ARR
at full 847-center penetration · TAM growing 10.3% CAGR through 2033 · 19M newly eligible patients as screening age drops to 45 (USPSTF 2021)
Business model

Simple annual SaaS. Priced by scope count. No hardware, no implementation fee.

Starter
1–4 scopes
$4,800/yr
Core — most common
5–10 scopes · AER import · accreditor export
$8,400/yr
Pro
11–20 scopes · multi-site dashboard
$14,400/yr
88–92%
Gross margin at scale
<8 mo
CAC payback period
115%
Target net revenue retention
~$200K
Capital to breakeven
Competitive landscape

The honest 2x2. Independent GI ASCs have a compliance software need that no existing product addresses.

x-axis: built for independent ASCs vs. hospital/enterprise. y-axis: GI reprocessing specific vs. generic sterile processing.

← Hospital / enterprise Independent ASC →
Censis ScopeTrac
Hospital-focused · $80–120K implementation · Hardware required · Designed for 400-bed sterile processing departments
Olympus ENDO-AID
Vendor-locked · Only works with Olympus scopes · Not accreditor-neutral
ScopeGuard Health ✓
Built for independent GI ASCs · Browser-based · No hardware · Live in 5 days · AAAHC + TJC + CMS export · $400–1,200/mo
Generic CMMS
Not GI-specific · No AAMI ST91 workflow · No AER integration · No accreditor export formats
Hospital EHR modules
Wrong cost structure · Requires IT department · Built for inpatient scale
Paper logs
100% market share today · Free until the surveyor walks in · The incumbent we are replacing
↑ GI reprocessing specific  ·  ↓ Generic sterile processing
Known risks — and how we address them

We've identified five risks. Each has a specific mitigation built into the plan.

These are the questions a skeptical administrator — or a serious investor — will ask. We'd rather surface them first.

🩺
Risk 1 — Clinical credibility
No one will trust their accreditation record to a platform without clinical validation behind it.
High
An ASC administrator's primary concern isn't whether the software works — it's whether she can defend it to a surveyor. A product without a credentialed clinical voice behind it will not close a sale, regardless of features or price.
Our approach
Hire a fractional CSPDT or CFER-credentialed clinical compliance consultant at founding stage — before we build anything. Every workflow step is validated by a practitioner who has actually done it.
Build a 2–3 seat clinical advisory board of active ASC administrators. These are reference-able names — people who answer the phone when a prospect calls.
Lead every sales conversation with the clinical advisor's credentials, not the product features. Free 90-day pilot offer removes financial risk from early adopters.
🔐
Risk 2 — HIPAA and data privacy
A platform storing patient-linked reprocessing records is a HIPAA Business Associate. Any gap here ends the company.
High
GI administrators have been burned by software vendors who didn't understand HIPAA. A BAA gap, a data breach, or an unclear data use policy creates legal exposure for the facility — and a career-ending event for the administrator who signed the contract.
Our approach
AWS HIPAA-eligible infrastructure (RDS, S3, CloudFront) from day one. No PHI stored in non-eligible services. Encryption at rest and in transit.
Standard Business Associate Agreement drafted and reviewed by healthcare SaaS counsel before any pilot customer signs. BAA is a requirement to demo, not a contract afterthought.
SOC 2 Type I roadmap: target Q2 2027. Type II by Q4 2027 — sequenced to align with first enterprise-tier prospect conversations.
⚙️
Risk 3 — Adoption at the point of use
The administrator buys it. The sterile processing tech ignores it and keeps using the clipboard.
Medium-High
The daily user is a busy clinical tech under time pressure. If the platform adds friction rather than removing it, it gets worked around. Adoption failure at the tech level means the administrator gets no compliance value — and churns.
Our approach
Clinical compliance consultant validates UX against real workflow before build — not after. The step sequence and timing in the platform must match how reprocessing actually happens, not how the IFU says it should happen.
AER machine log auto-import eliminates the most time-consuming documentation step. The platform should save time, not cost time.
Mobile-first design (iOS app or mobile browser) — not a desktop tool — because reprocessing happens at the sink, not at a desk.
Alert framing: "safety net" not "surveillance." Alerts flag genuine exceptions, not every micro-action. This distinction is critical for tech buy-in.
📉
Risk 4 — Private equity consolidation
Our target customer — the independent GI ASC — is being acquired by PE-backed groups who will bring their own enterprise software.
Manageable
PE consolidation is accelerating — about 1 in 10 gastroenterologists now practices within a PE-backed group, and the number of 3–9 physician independent practices has declined 41% over the past decade. Florida's major metros are already 30%+ PE-consolidated.
Our approach
Phase 1 geography (NJ/PA/MD) chosen specifically because PE consolidation is lower than Florida and major Texas metros. Maryland has the highest ASC density per capita nationally and remains predominantly independent.
ScopeGuard's switching cost is legal liability — an administrator who has passed one survey using our records has strong incentive to stay, even if acquired. We become part of the compliance record.
Long-term: PE-backed groups with 30+ locations need standardized compliance infrastructure too. The enterprise tier is a Year 3 opportunity, not a Year 1 problem.
🔧
Risk 5 — Hardware vendor lock-in
Olympus, Pentax, and Fujifilm could bundle proprietary reprocessing software with scope purchases, locking out independent platforms.
Medium
The three major endoscope manufacturers each have existing software platforms — Olympus ENDO-AID, Pentax's scope management tools, and Fujifilm's data systems. If any of them bundled reprocessing compliance software into scope service contracts or purchase agreements, they could create a de facto lock-in that crowds out independent software providers at the point of sale. A center that buys Olympus scopes and gets compliant documentation software "for free" has little incentive to evaluate ScopeGuard.
Our approach
Vendor-locked solutions are a structural weakness, not a strength. Olympus ENDO-AID only works with Olympus scopes — a center with a mixed fleet (Olympus colonoscopes, Pentax upper endoscopes, Fujifilm sigmoidoscopes) cannot use a single-vendor solution for its full compliance record. ScopeGuard is vendor-neutral by design.
Accreditor export formats (AAAHC, TJC, CMS) are our deepest competitive moat. A manufacturer's scope management tool is built to log machine cycles — not to generate the specific audit documentation formats that surveyors require. That's a compliance product, not a device product.
Independent GI administrators are already skeptical of manufacturer software — they've seen vendor lock-in create operational problems when scopes are serviced or replaced. The "vendor-neutral, works with any scope brand" positioning is a genuine selling point, not a defensive claim.
ScopeGuard Health LLC
971 US Highway 202N #8052 · Branchburg, NJ 08876
April 2026 · Confidential