What lean-agile partners does

Lean-Agile Partners is a Boston-based boutique consulting firm founded in 2009 by Nancy Van Schooenderwoert (President and Managing Partner) and Brian Shoemaker (Principal at ShoeBar Associates), operating as a privately held, founder-owned partnership with no external funding. The firm specializes in applying Agile and Lean methods to safety-critical regulated industries where traditional Agile adoption is constrained by formal standards and certification requirements, with primary emphasis on medical-device software (FDA, 21 CFR, 510(k) documentation review, EU MDR, IEC 62304), aerospace and defense (DO-178C), and industrial-control systems. Service lines include an introductory training course for regulated medical software, executive and team coaching, customized consulting engagements (FDA submission document review, QMS alignment), and authored content in the form of a 2018 primer book and a 2021 case studies book. Methodological differentiators include Storycrafting, Mob Programming adapted for embedded systems, and an Agile Hardware practice.

The firm's commercial model is professional services revenue from training, coaching, and customized consulting engagements priced on a quote basis, supplemented by modest book sales through Amazon and conference honoraria. Customer logos disclosed include GE HealthCare, Bluefruit Software, and Atomic Object, alongside an unnamed medical-device, aerospace, industrial-control, financial-services, and consumer-products customer base. Go-to-market is driven by thought leadership at embedded-software and Agile conferences (including QA&Test Embedded, the SDMD Conference, and Agile community events), authored publications, podcast appearances (Pharma IQ), and webinars. Geographic reach extends beyond the US headquarters into the UK, Germany, Japan, India, China, Norway, Sweden, Switzerland, and Spain through on-site engagements and international keynote appearances.

Name

lean-agile partners

Legal name

Lean-Agile Partners, Inc.

Website

https://leanagilepartners.com

Company type

Private

Founded year

2009

Operating status

Operating

Short description

Lean-Agile Partners is a Boston-based boutique consulting firm providing Agile and Lean training, coaching, and customized regulatory consulting to medical-device, aerospace, industrial-control, financial-services, and consumer-products companies in safety-critical regulated environments across the US, Europe, and Asia.

Ownership category

akta.pro rank

Product category

Management Consulting — Agile/Lean for Regulated Industries

NAICS

Management Consulting Services (54161), Other Scientific and Technical Consulting Services (54169)

SIC

Services-Management Consulting Services (8742)

akta.pro primary industry

Scaled Agile & Enterprise Product Delivery (SAFe/LeSS/Nexus) (EDABAHAJ)

akta.pro secondary industry

Digital Workplace & Collaboration Consulting (BPAHAEAH)

Keywords

• Agile consulting services
• Medical device training
• Safety-critical systems
• Regulated industry coaching
• Embedded systems training

Headquarters

HQ city

Greater Boston

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Marketing or Sales, Operations, Technology or R&D

Revenue model

1. Training and Workshops: On-site training courses for clients, with flagship course 'Agile Introduction for Regulated Medical Software' presented at client sites and selected conferences such as SDMD. Book included with course enrollment.
2. Coaching Services: Coaching for all roles from hardware development to QA to Regulatory Affairs to enable implementation of Agile practices. Coaching bridges gap between training and actual adoption.
3. Customized Consulting Assistance: Specific services including document review for FDA and other regulatory bodies, review of 510K submissions, and diagnostic help for stalled Agile adoption initiatives.
4. Book Sales: Sale of 'Agile Methods for Safety-Critical Systems: A Primer Using Medical Device Examples' and 'Agile Methods for Safety-Critical Systems: Case Studies of Medical Product Companies' through Amazon and included with training courses.
5. Conference Presentations and Keynotes: Revenue from speaking engagements at industry conferences worldwide, including keynote presentations at QA&Test Embedded, SDMD, and various Agile conferences.

Pricing tiers

Go-to-market motion2 records

Distribution channels4 records

Marketing channels6 records

Core offering

Lean-Agile Partners provides Agile training, coaching, and customized consulting services to organizations developing safety-critical and regulated software products. The firm specializes in adapting Agile and Lean methods for industries such as medical devices, aerospace, industrial controls, and financial services, and offers a published book series on Agile methods for safety-critical systems.

Product overview

Lean-Agile Partners is a specialist consulting and training company offering Agile adoption services for safety-critical and regulated industries. Their portfolio consists of training courses (including the 'Agile Introduction for Regulated Medical Software' course with included book), coaching services spanning all organizational roles, customized consulting assistance for FDA documentation and 510K submissions, and published books including the primer and case studies volumes on Agile methods for medical devices. They sponsor the Software Design for Medical Devices (SDMD) conference and offer comprehensive workshop programs covering all aspects of Agile implementation from project initiation through task tracking.

Differentiator

Problem solved

Functional benefit

Products and services

• Agile Training Courses (including "Agile Introduction for Regulated Medical Software")
• Agile Coaching and Embedded Coaching Engagements
• Customized Consulting and Advisory Assistance
• "Agile Methods for Safety-Critical Systems" Book Series
• Conference Workshops and Speaking Sessions

Quantifiable outcome

• 3x productivity improvement in embedded software development
• +2 more outcomes

Named customers4 records

Segments5 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Six partnerships are on record, tiered minor, core and major.

• Lean Data SolutionsminorStrategic or Co-development Partner · 1 January 2010Lean Data Solutions co-hosted 'Leading Lean Software Development Workshop' with Mary and Tom Poppendieck in Glasgow, Scotland in May 2010 alongside Lean-Agile Partners.
• ShoeBar Associates (Brian Shoemaker)coreStrategic or Co-development Partner · 1 January 2009Brian Shoemaker, Principal Consultant at ShoeBar Associates, collaborates with Lean-Agile Partners on consulting, training courses, and book publications. Brian specializes in FDA validation, software quality assurance, and 21 CFR Part 11 compliance for healthcare products companies. Together they developed training programs and co-authored books on Agile for safety-critical systems.
• Agile AlliancecoreGTM or Marketing PartnerActive supporter of Agile Alliance. Founder Nancy Van Schooenderwoert served as track co-chair for Agile Alliance's main conference (Agile 20xx) from 2011-2013 and for first 3 years of deliver:Agile conference.
• Agile New EnglandcoreGTM or Marketing PartnerActive supporter and founding organization of Agile New England. Nancy Van Schooenderwoert is founder and past president of Greater Boston's premier Agile user group. She chaired ANE's 'Agile for Executives' program and initiated ANE's annual Mob Programming conference beginning in 2016.
• Software Design for Medical Devices (SDMD) ConferencemajorGTM or Marketing PartnerLean-Agile Partners sponsors and presents at SDMD conference (Software Design for Medical Devices). Offers discount registration for conference attendees. Nancy Van Schooenderwoert and Brian Shoemaker present workshops and keynote presentations at annual SDMD events.
• Collaborators NetworkminorImplementation/ SI/ Consulting PartnerLean-Agile Partners maintains a network of expert collaborators with specialties including engineering practices (test driven design, continuous integration, backlog management), operations practices (regulatory compliance, risk management), and business practices (managing autonomous teams, HR, Legal, Budgeting functions).

Scale indicators5 records

Recent moves5 records

Expansion highlights4 records

Direct peers

• Scaled Agile (SAFe): Provider of the SAFe framework and associated training/certification for enterprise Agile adoption. Comparable as a competing Agile training and certification provider, though operating at much larger scale and broader scope than Lean-Agile Partners' safety-critical niche.
• Industrial Logic: Agile consulting, coaching, and training firm with deep technical engineering roots. Comparable because it sells similar enterprise Agile coaching and training services, overlapping in target buyer (regulated/complex product organizations).
• Mountain Goat Software: Agile training and consulting firm known for Scrum and product ownership courses. Comparable as a competing Agile training provider for enterprise teams, with overlapping delivery model (courses + coaching).
• Scrum.org: Professional Scrum training and certification organization. Comparable because it delivers Agile/Scrum training, certification, and enterprise coaching as a paid service to software and product teams.
• Atomic Object: Custom software consultancy with embedded and Agile expertise, named as a collaborator and webinar guest of Lean-Agile Partners. Comparable as an Agile-focused embedded/medical software consulting firm serving regulated industries.
• Bluefruit Software: UK-based embedded software consultancy featured in Lean-Agile Partners' Mob Programming case study. Comparable as an embedded software development firm applying Agile practices in regulated contexts.
• ShoeBar Associates: FDA validation and software quality consulting firm co-founded by Brian Shoemaker, a Lean-Agile Partners co-author and long-time collaborator. Comparable as a regulated-industry Agile/FDA consulting peer and co-delivery partner.

Emerging players

• LeSS Works (Bas Vodde & Craig Larman): Provider of LeSS (Large-Scale Scrum) training and certification. Comparable as a niche scaled-Agile training provider competing for the same enterprise training dollars, though with a different framework focus.

Broad incumbents

• Accenture Agile Services: Global consulting firm offering large-scale Agile transformation services across regulated and non-regulated industries. Comparable as a broad incumbent serving the same enterprise buyer for Agile adoption, but at materially greater scale and scope.

Others

• ICAgile: Consortium providing Agile certifications and learning paths across multiple frameworks. Comparable as an enabling/ecosystem participant in the Agile training market rather than a direct consulting competitor.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/lean-agile-partners-inc

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about lean-agile partners