Founder-Led Regulatory, Clinical, and Quality Strategy for High-Stakes Medical Device Decisions

Executive-level support for medical device companies navigating FDA, EU MDR, and global approval decisions where timelines, valuation, and market access are on the line.

A confidential discussion to assess whether SHOTUNE is the right fit for your situation.

Our Mission

SHOTUNE exists to help medical device companies make better regulatory, clinical, and quality decisions earlier—before those decisions become delay, remediation, or lost enterprise value.

We work where approval durability, commercialization timing, audit readiness, and diligence confidence materially matter.

Our Team

A team of experienced professionals committed to excellence. Focused on delivering reliable solutions and measurable outcomes.

Chris Collins

Chris Collins has 20+ years of experience in vascular medical devices, specializing in R&D, regulatory affairs, FDA submissions, and global compliance across multiple international markets and complex product development lifecycles.

Scott Doig

Scott is a medical technology leader with 28+ years of experience in device development and regulatory approvals. He now works as a consultant supporting product development, regulatory, and quality.

Douglas McCorquodale

Douglas is a Quality and Manufacturing leader with 30+ years of experience in compliance and process improvement, and is a Six Sigma expert driving operational excellence across global regulated industries.

What Executive Teams Value About SHOTUNE

Founder-led delivery, not delegated consulting
Integrated clinical, regulatory, and quality judgment under one accountable leader
Experience across Class I–III and high-risk device portfolios
Commercially grounded strategy built for regulator scrutiny, not just documentation output

How We Help

Shola Sulaimon, DVM, MSc, PhD.

Founder & Principal Consultant

Dr. Shola Sulaimon is a global clinical, regulatory, and quality strategy leader with over 18 years of MedTech experience and a record of 70+ successful CE Mark approvals across Class I–III devices.

A former senior leader at Medtronic, she has worked across regulatory strategy, clinical evidence, post-market lifecycle management, remediation, and portfolio execution—supporting organizations operating under FDA, EU MDR, and global regulatory scrutiny.

Through SHOTUNE, Dr. Sulaimon provides founder-led, executive-accountable advisory support for organizations where regulatory, clinical, and quality decisions materially affect commercial outcomes.

Education & Credentials

Doctor of Veterinary Medicine (DVM)

MSc, Clinical Sciences

PhD, Clinical Sciences

Project Management Professional (PMP)

Need Senior Judgment Before Risk Becomes Exposure?

Bring your situation. We will assess whether SHOTUNE is the right fit and where risk most likely sits.