WALSH
BioOps Advisors

From Lab to Launch — Operational Excellence for MedTech Leaders

I help medical technology and life sciences companies build world-class operations, launch products successfully, and scale with confidence. With 20+ years of executive leadership at Medtronic, Smith+Nephew, and in the startup world, I bring the expertise of a Fortune 500 operations executive with the agility and focus of a dedicated advisor.

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$175M
Biologics P&L Led
$100M
Savings Delivered
9
Named Products Launched
Global
Medtronic BCM Award
About

Senior MedTech advisory, grounded in real-world executive experience

Jen Walsh, MBA
Jen Walsh, MBA
Founder & Managing Principal

Jen Walsh is a senior MedTech consulting advisor specializing in biologics operations, regenerative medicine commercialization, and manufacturing strategy for medical device and life sciences companies navigating growth, transformation, or product launch.

Over two decades at Medtronic — including leadership of a $175M biologics operation spanning tissue-based biologics, bone grafting, and stem cell manufacturing — she personally commercialized nine named products across FDA 510(k) and PMA pathways. As a Lean Sigma Master Black Belt, she delivered $100M in cumulative savings across 13 global manufacturing sites, and created a revenue-based Business Continuity Management model that was adopted enterprise-wide at Medtronic.

Her experience spans the full arc of the industry: Fortune 500 executive leadership at Medtronic and Smith+Nephew, and founder-level startup experience as CTO of M2 Medical Innovations — fundraising, IP strategy, and regulatory pathway included. Clients get an advisor who has actually run the operations they are trying to build.

Credentials at a Glance

  • 20+ years of MedTech executive leadership
  • Medtronic & Smith+Nephew director-level roles
  • Founding CTO, M2 Medical Innovations
  • Lean Sigma Master Black Belt
  • 9 named FDA-cleared product launches
  • 13 global manufacturing sites
  • Enterprise-wide Medtronic BCM award
  • Rutgers Biomaterials advisory board
Services

Four core advisory areas, each backed by a proven track record

01

Biologics & Regenerative Medicine Operations

Global manufacturing strategy for tissue-based biologics and regenerative medicine — built on two decades leading Medtronic's $175M biologics operation.

  • Site assessment, benchmarking & performance improvement
  • Supply chain design and risk mitigation for biologics
  • Tissue banking operations, quality systems & FDA compliance
  • Scale-up from R&D to commercial manufacturing
02

FDA Commercialization & Product Launch

Nine named products personally commercialized across 510(k) and PMA pathways — from design controls through launch readiness.

  • FDA 510(k) regulatory strategy & commercialization planning
  • Launch readiness: manufacturing, quality & go-to-market
  • International market entry alongside U.S. commercialization
  • Investor-facing technical & commercialization strategy
03

Operational Excellence & Lean Transformation

$100M in cumulative savings delivered as a Lean Sigma Master Black Belt across 13 global sites — including proprietary, award-winning CI programs.

  • Enterprise Lean Six Sigma program design & deployment
  • Cost reduction roadmaps — proven 6%+ COGS reduction YoY
  • Quality system improvements & CAPA effectiveness
  • Lean culture building & Green/Black Belt certification
04

Business Continuity & Supply Chain Resilience

Creator of a revenue-based BCM model piloted in Medtronic's Restorative Therapies Group and adopted enterprise-wide — recognized with a Global Operations award.

  • Business continuity planning & supply chain risk assessment
  • Site risk stratification & mitigation planning
  • Single-source dependency analysis & dual-source strategy
  • Crisis response & operational resilience frameworks

Also available: manufacturing strategy & global operations, fractional CTO/COO services for venture-stage MedTech, and board advisory & executive coaching.

Proprietary Programs

Two award-winning programs, ready to deploy at your facility

Uniquely among MedTech consultants, Jen designed, deployed, and scaled two proprietary continuous-improvement programs inside Medtronic — both nationally recognized, both available as packaged engagements.

The Shark Tank Continuous Improvement Program

An employee-driven innovation and Lean engagement program: "Idea Entrepreneurs" pitch improvement ideas to "Idea Investors," and winning teams — staffed with a Project Manager, Black Belt mentor, and new Green Belts — implement them through DMAIC. A high-engagement CI culture with real, measurable outcomes.

Medtronic RTG Star of Excellence Award · Lightning Talk, Society of Women Engineers WE15

Onsite ASQ Green Belt Certification Program

A custom onsite certification program that develops your employees into certified change agents for quality — building internal CI capability instead of indefinite dependence on outside consultants.

ASQ Princeton Section 307 Award — "Raising the Voice of Quality," World Quality Month
Proof Points

Nine named products, commercialized under her direct leadership

CompanyProductCategory
Medtronic / OsteotechMagniFuse™Bone Grafting
Medtronic / OsteotechPlexur M®Bone Grafting
Medtronic / OsteotechKinesis™ BMACStem Cell / Bone Marrow Aspirate
Integra LifeSciencesDuraGen™ XSDural Regeneration Matrix
Integra LifeSciencesSuturable DuraGen™Dural Regeneration
Integra LifeSciencesNeuraGen® 3cmNerve Regeneration
Integra LifeSciencesNeuraWrap™ 4cmNerve Regeneration
Integra LifeSciences1.5mm NeuraGen®Nerve Regeneration
Integra LifeSciencesMasterGraft Matrix StripsBone Graft

Awards & Recognition

  • Global Operations & Business Services Award — Mitigating Global Operational Risk (2020)Medtronic
  • RTG Star of Excellence Award for Quality and InnovationMedtronic
  • "Raising the Voice of Quality" Award, World Quality MonthASQ Princeton Section 307
  • Lightning Talk, WE15 National Annual ConferenceSociety of Women Engineers

Global Manufacturing Reach

Operational excellence leadership across 13 manufacturing sites spanning the U.S., Europe, and Latin America:

Warsaw, IN · Eatontown, NJ · Deggendorf, Germany · Neuchâtel, Switzerland · Costa Rica · Humacao, Juncos & Villalba, Puerto Rico · and additional U.S. facilities
W

Let's talk about your operations

Currently accepting a limited number of consulting engagements for medical technology, biologics, and life sciences companies. If you're looking for a senior advisor with real-world executive experience — not just frameworks — I'd welcome a conversation.

Email JenConnect on LinkedIn