911 Emergency Injectables Pack

Product Overview

The 911 Injectables Pack is a slim-line, climate-controlled medical vault containing single-use, pre-measured emergency medications (injectable and auto-injector formats), engineered for:

• Immediate emergency access

• Zero dose calculation

• Strict misuse prevention

• Pharmaceutical-grade thermal stability

• Digital chain-of-custody logging

Designed as a platform, not a kit.

Core Design Principles

• One emergency → one dose

• No vial sharing

• No reconstitution under stress

• No uncontrolled access

• No temperature ambiguity

Typical Injectable Contents (Example Adult Pack)

All medications are single-use micro-doses, prefilled or cartridge-based.

• Epinephrine

  • 0.3 mg IM (anaphylaxis)

  • 1.0 mg IV/IO (cardiac arrest)

• Naloxone – 4 mg (opioid overdose)

• Midazolam – 5 mg (active seizure)

• Ketorolac – 15–30 mg (acute pain)

• Fentanyl – 50 mcg (severe pain, controlled)

• Glucagon – 1 mg (severe hypoglycemia)

Pediatric, geriatric, and protocol-specific SKUs supported.

Ultra-Miniaturized Packaging

• Micro-cartridge or slim prefilled syringe

• Typical liquid volume: 0.5–2.0 mL

• Overall medication vault thickness target: <40 mm

• Case footprint: tablet-sized or smaller

Security Architecture (Non-Negotiable)

Multi-Layer Tamper Resistance

1. Physical

• Tamper-evident syringe caps

• One-way needle shields

• Break-seal indicators

2. Electronic

• Per-dose electronic lock

• Case-level lock + dose-level lock

• Unauthorized access detection

3. Digital

• Event-based unlock (e.g., verified 911 call, EMS code, physician authorization)

• Time-limited access window

• GPS + timestamp logging

4. Chemical / Mechanical (Optional Advanced Tier)

• Needle blockage if tampered

• Internal plunger disablement

• Chemical matrix that irreversibly neutralizes dose if compromised

Climate Control & Pharmaceutical Integrity

Operating Reality

Unattended vehicles routinely experience:

• Summer: +60–75 °C (140–167 °F)

• Winter: −20 to −30 °C (−4 to −22 °F)

Injectables Pack Solution

Active Micro-Climate Vault

• Vacuum-insulated core

• Phase-change thermal buffer (PCM)

• Bidirectional thermoelectric control (heat + cool)

• Internal battery + vehicle power

Guaranteed Drug Integrity Window

• Controlled Range: 10–35 °C

• Alert Range: <5 °C or >35 °C

• Hard Lockout: ≤0 °C or ≥40 °C

• Automatic dose disablement if frozen or overheated since last validation

Thermal Chain-of-Custody

• Continuous temperature logging

• Freeze-event detection

• Shelf-life derating if exposed

• Cloud or device-local audit trail

User Experience (Emergency Optimized)

• Green = Ready

• Yellow = Attention Soon

• Red = Locked / Unsafe

• No menus, no scrolling, no decisions under stress

• Audible + visual cues only when critical

Platform Architecture

• Slim injectable vault

• Optional vehicle dock

• Optional home / wall dock

• Enterprise fleet management

• 911 / EMS data integration (future)

Manufacturing & Cost Estimates (High-Level)

Per-Unit Hardware (Estimated, Scaled)

ComponentCost (USD)

Insulated micro-vault$20–35

Thermoelectric + control electronics$25–45

Battery (LiFePO₄)$10–20

Sensors (temp, tamper, ID)$5–10

Enclosure + seals$15–25

Estimated BOM (device)$75–135

Medication Fill Cost (Typical)

• $5–30 per dose (drug-dependent)

• Controlled substances require added compliance cost

Target Wholesale (Device + Initial Load)

• $250–600, depending on SKU and regulatory tier

Regulatory & FDA Considerations

Classification

• Combination Product (Drug + Device)

• Likely 21 CFR Part 4 pathway

FDA Pathways (Depending on Claims)

• 510(k) for device components (if predicate exists)

• PMA unlikely unless novel drug delivery mechanism

• NDA supplement if reformulated drugs

• Human Factors Engineering (HFE) required

• Shelf-life & stability studies mandatory

Key Regulatory Hurdles

• Freeze-thaw stability validation

• Electronic lock failure modes

• Emergency-use risk analysis

• Controlled substance handling (DEA)

• Labeling clarity for layperson use

• Cybersecurity (if networked)

Why Pharma Is Positioned to Win

• Existing NDAs

• Stability labs already in place

• Controlled substance infrastructure

• Regulatory credibility

Competitive Advantage

Traditional Kits911 Injectables Pack

No temp controlActive climate assurance

Multi-dose vialsSingle-use only

No misuse preventionMulti-layer lockout

Unknown degradationLogged thermal history

EMS-only viableCivilian + enterprise

Strategic Opportunity for Pharma

This platform enables pharma companies to:

• Extend emergency drug reach beyond ambulances

• Create new OTC-adjacent emergency categories

• Build subscription-based drug refresh models

• Establish first-to-market safety leadership

• Own emergency reliability, not just molecules

Summary

The 911 Injectables Pack transforms emergency medications from fragile consumables into secure, reliable, digitally governed lifesaving systems.

It is not just a product.
It is a new standard for emergency drug deployment.