Regulatory, Clinical & Quality Leadership for Medical Device Companies

Where Approval Failure Is Not an Option

When regulatory risk begins to threaten timelines, valuation, or market access, SHOTUNE provides founder-led regulatory, clinical, and quality leadership for medical device companies navigating FDA, EU MDR, and global approval pathways.

We are typically engaged before first submissions, pivotal clinical milestones, EU MDR transitions, or post-market escalation—when early decisions determine downstream success.

A confidential 30-minute discussion to assess regulatory, clinical, or quality risk and determine whether SHOTUNE is the right fit.

Proven Leadership Under FDA, EU MDR & Global Regulatory Scrutiny

Founder-led regulatory, clinical, and quality strategy for medical device companies operating in high-stakes approval environments.

18+ years of global medical device regulatory, clinical, and quality leadership

70+ successful CE Mark approvals (remediation submissions, recertifications) across Class I–III medical devices

Deep cardiovascular and implantable device expertise

Former enterprise MedTech leadership, operating under real regulator scrutiny

When Executive Teams Typically Engage SHOTUNE

SHOTUNE is typically engaged when:

A submission has stalled or is approaching a high-stakes milestone

FDA or Notified Body feedback is exposing deeper evidence, strategy, or quality gaps

Clinical, regulatory, and quality decisions are no longer aligned

Leadership needs senior judgment before risk affects timelines, valuation, or diligence readiness

Core Services

Regulatory Strategy & Global Pathway

Regulator-aligned strategies across FDA, EU MDR, and global pathways that anticipate review expectations, reduce approval risk, and support durable market access.

Clinical Evidence & Lifecycle Strategy

Clinical evidence designed for regulator acceptance and durability supporting claims, benefit-risk, and post-market expectations without unnecessary rework.

Quality Management Systems & Compliance

Scalable quality systems and risk frameworks built to withstand audits, inspections, and diligence as products and portfolios grow.

Who We Are

A Founder-Led Medical Technology Clinical, Regulatory, & Quality Strategy Firm

SHOTUNE is a founder-led consultancy providing executive-level regulatory, clinical, and quality leadership to medical device companies operating in high-stakes approval environments.

Founded by Shola Sulaimon, a former Medtronic leader with 18+ years of experience and 70+ successful CE Mark approvals across Class I–III devices, SHOTUNE helps companies reduce approval risk, avoid costly rework, and build strategies that withstand FDA, EU MDR, audit, and diligence scrutiny.

Every engagement is personally led, selectively scoped, and designed for organizations where regulatory outcomes materially affect commercial outcomes.

Who We Work With

Partnering With Medical Device Companies Where Regulatory Outcomes Impact Valuation

SHOTUNE works with medical device companies where regulatory, clinical, and quality decisions directly influence commercial outcomes.

Startups advancing toward first major regulatory milestones

Growth-stage companies entering FDA, EU MDR, or global markets

Acquisition- or IPO-ready organizations preparing for diligence scrutiny

Established manufacturers managing complex portfolios, lifecycle compliance, and post-market obligations

What We Help You Achieve

Reducing Regulatory Risk. Accelerating Durable Approvals. Protecting Enterprise Value.

Regulatory outcomes are enterprise-level risks, not operational details. Delays, non-acceptances, remediation, and post-market weaknesses can materially affect timelines, valuation, and investor confidence.

SHOTUNE helps executive teams anticipate regulator expectations, reduce approval risk, and make defensible regulatory, clinical, and quality decisions before risk becomes exposure.

Why SHOTUNE

Why Executive Teams Choose SHOTUNE

SHOTUNE is engaged when clinical, regulatory, and quality decisions demand senior judgment, speed, and clear accountability—and when the cost of getting it wrong is no longer acceptable.

Executive teams typically turn to SHOTUNE when:

Internal teams lack the senior regulatory judgment needed for complex decisions

Large consulting firms move too slowly or dilute accountability

Former regulators or technical advisors do not own execution

leadership needs one accountable expert who can integrate clinical, regulatory, and quality strategy

Compared to Large Consulting Firms

Compared to Independent Consultants

SHOTUNE delivers the precision of a boutique with the judgment, accountability, and authority of enterprise leadership.

SHOTUNE Is Not Designed For

Early ideation without a defined regulatory or commercial objective

Low-cost, document-only regulatory support without senior strategic ownership

Templated consulting models or rotating junior teams

SHOTUNE is built for organizations that need senior judgment, direct accountability, and regulator-aligned decision-making when the cost of getting it wrong is material.

Founder Value Proposition

Founder-Led. Executive-Accountable. Outcome-Driven

Founder Executive Note

“I work directly with executive teams to bring clarity on risk, control over regulatory strategy, and regulator-aligned execution—so leaders can move forward with confidence when failure is not an option. My role is to ensure my clients make the right regulatory decisions early so approvals, audits, and diligence are outcomes of foresight, not recovery.”

— Shola Sulaimon, DVM, MSc, PhD

Founder & Principal Consultant

How We Work

SHOTUNE applies a disciplined, lifecycle-based engagement model that aligns regulatory, clinical, and quality decisions early reducing downstream risk, minimizing rework, and maintaining momentum toward approval and commercialization.

Every engagement is founder-led and execution-owned, ensuring clear accountability, faster decision-making, and strategies built to anticipate regulator and Notified Body expectations from the outset.

A four-step approach to commercial success

Discovery

Assess regulatory, clinical, and quality risk.

Align objectives, constraints, and decision priorities early.

Strategy

Define regulator-aligned approval pathways.

Integrate regulatory, clinical, and quality decisions.

Execution

Lead delivery with senior accountability

Maintain momentum and coherent regulator engagement.

Lifecycle

Sustain approvals through post-market and growth.

Support audits, inspections, and lifecycle changes.

FAQs

We have a stalled FDA or CE Mark submission. Can SHOTUNE step in midstream?

Yes. SHOTUNE is often engaged when submissions stall because of evidence gaps, weak regulator-facing logic, or misalignment across clinical, regulatory, and quality functions. We assess the root cause, clarify options, and help leadership determine the fastest defensible path to restore momentum.

Our Notified Body is pushing back on our CER, PMCF, or technical documentation. How do you handle this?

Notified Body pushback is rarely about documents alone. It usually signals concern about evidence defensibility, benefit-risk logic, or strategic coherence. SHOTUNE helps teams realign the regulatory, clinical, and risk narrative, close critical gaps, and reduce iterative review cycles.

Do you engage directly with regulators and Notified Bodies?

Yes. SHOTUNE supports structured FDA and Notified Body interactions, including pre-submission strategy, question responses, inspection readiness, and escalation planning.

When the Cost of Getting It Wrong Is Material, Early Judgment Matters.

Bring your situation. You will leave with clearer options and a better sense of whether SHOTUNE is the right fit.

Shola Sulaimon, DVM, MSc, PhD.

Founder & Principal Consultant

Dr. Shola Sulaimon is a global clinical, regulatory, and quality strategy leader helping medical device companies translate regulatory complexity into commercially credible action.

With over 18 years of MedTech leadership and a record of 70+ successful CE Mark approvals across Class I–III devices, she has guided organizations through FDA, EU MDR, and global pathways spanning initial approvals, remediation, recertification, and post-market lifecycle demands.

As Founder of SHOTUNE Medical Consulting Group and a former senior leader at Medtronic, Dr. Sulaimon delivers founder-led, executive-accountable support across regulatory strategy, clinical evidence, quality systems, and portfolio execution—helping organizations reduce risk, strengthen decisions, and build durable approvals.