Battle Card: Keyron’s FDA-Backed Human Trials Trigger
Keyron just hired a former FDA director ahead of first-in-human device trials. Use these sales triggers to fuel your pipeline, pitch IDE automation and clinical ops suite, and hit quota fast.
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🚀 Battle Card: Keyron
Quick trigger: Former FDA Director and Boston Scientific Leaders Join Keyron Ahead of Human Trials of First Device with Metabolic Surgery-Like Results Without Incisions (Aug 6, 2025)
👤 Decision Maker in the News
- David Feigal, Head of Regulatory Affairs · 🔗 LinkedIn
💡 Why It Matters
- ForePass is set to redefine obesity and diabetes treatment by delivering surgery-like metabolic results without incisions → Source
🎯 Core Pain Point
- Navigating first-in-human IDE submissions under FDA’s stringent device pathways
- Demonstrating clinical superiority vs. $28B/year GLP-1s and traditional surgery
💰 What to Pitch
- Primary: Regulatory Submission Automation → Accelerate IDE approval
- Expansion: Clinical Trial Management Suite → Streamline global trial ops
🗺️ Quick Context
- HQ: London, UK & Boston, MA
- Employees: ≈ 60
- Rev: ≈ $1 M (pre-revenue)
- Website: keyron.com
🤼 Competitive Intel
Which other vendors you’ll probably face to win Keyron’s business.
- Veeva Systems — Regulatory & Quality
- Unique edge: Unified Vault platform for submissions & quality
- Evaluated by Head of Regulatory Affairs for end-to-end compliance
- Greenlight Guru — Medical Device QMS
- Unique edge: Medtech-specific workflows and audit-ready docs
- Evaluated by QA & RA leads for streamlined ISO/FDA alignment
- MasterControl — Regulatory Document Management
- Unique edge: Configurable eTMF and regulatory change control
- Evaluated by Clinical Ops for IDE and global filing support
✅ Do-Now Checklist
Connect with David Feigal on LinkedIn (link above)
Craft email + DM leveraging this Keyron sales trigger and send first touch
Schedule follow-ups in CRM (Day 3 & Day 10)
Next Step
Leverage every Keyron sales trigger to fuel pipeline growth—no fluff, all action.
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🧠 Copy My Prompt for Personalized Cold Outreach
────────────────────────────
✏️ YOUR COMPANY
────────────────────────────
OUR_COMPANY = ❑❑
OFFER_BRIEF = ❑Regulatory Submission Automation❑
PROOF_METRIC = ❑≈ TBD❑
CTA_STYLE = ❑quick_call❑
TONE = ❑friendly❑
────────────────────────────
📌 TARGET COMPANY
────────────────────────────
NAME = David
COMPANY = Keyron
DEPT = Regulatory Affairs
SIZE = ≈ TBD
BOTTLENECK = navigating first-in-human IDE submissions
EVENT = leadership hires
DETAIL = former FDA Director joins as Head of Regulatory Affairs
PAIN = ensuring efficient IDE submission under FDA device pathway
SRC = http://cts.businesswire.com/ct/CT?id=ftfLlWd9aZbF2NXfwppam3Bd664=&newsLang=en&newsId=20250806803674&div=41152219
SIM_CO = ≈ TBD
WIN_METRIC = ≈ TBD
NEXT_SIZE = ≈ TBD
EMP_EST = ≈ 60
REV_EST = ≈ $1M
────────────────────────
TASK FOR CHATGPT
────────────────────────
Role: “NewsletterForLeads SDR-Assist”.
Validate any ≈ guesses via SRC.
EMAIL (keep breaks):
Subject: ≈ TBD-person Regulatory Affairs
David—noticed your Regulatory Affairs team is ≈ TBD.
That’s when navigating first-in-human IDE submissions slows growth.
We helped ≈ TBD fix this with Regulatory Submission Automation.
Result: ≈ TBD.
Quick call?
PS—next bottleneck hits ≈ TBD.
DM ≤45 words, TONE:
Saw your post about former FDA Director joins as Head of Regulatory Affairs — ensuring efficient IDE submission under FDA device pathway.
Regulatory Submission Automation. ≈ TBD.
Quick chat?