A65 Consulting, LLC is a boutique medical device engineering consulting firm headquartered in the Denver Metropolitan Area, specializing in full-service engineering, project management, and leadership services for innovative medical devices. Founded in January 2018 by Steve Donnigan, PE, CPM, MSME, the company provides comprehensive product development services from concept to launch, serving medical device manufacturers, biotech startups, and established healthcare companies.
History
Founding and Background
A65 Consulting was founded in January 2018 by Steve Donnigan, a Professional Engineer (PE) and Certified Project Manager (CPM) with a Master of Science in Mechanical and Biomedical Engineering from Colorado State University. Prior to establishing A65 Consulting, Donnigan accumulated extensive experience in the medical device industry, including roles at Hewlett Packard, CONMED Corporation, Baxter Healthcare, and CPS Innovations (acquired by Siemens Healthcare).
Donnigan began his career as a Development Engineer at Hewlett Packard from 1993 to 1999, where he designed automated scanner alignment systems and developed motion control software. He earned both his Bachelor of Science in Mechanical Engineering and Master of Science in Mechanical/Biomedical Engineering from Colorado State University, completing his graduate thesis in 2000 on “Design of an Automated Sample Delivery System”.
From 1999 to 2002, Donnigan operated his first consulting venture, Acumen Design Engineering, LLC, in Fort Collins, Colorado, providing product development solutions in biomedical, computer, and consumer markets. This early entrepreneurial experience laid the foundation for the later establishment of A65 Consulting.
Company Evolution
Since its founding in 2018, A65 Consulting has grown to serve more than 20 clients across the medical device industry. The company’s engineering leadership and services have contributed to significant client outcomes, including over $300 million of projected new product revenue, multiple FDA 510(k) submissions, numerous new patent applications, reduced complaint rates, and 90% on-time completion of mission-critical projects.
The firm operates as a small boutique consultancy, allowing for personalized service and seamless integration with client teams. Client testimonials consistently emphasize the company’s ability to integrate into existing engineering teams without extensive management overhead, providing what one R&D Engineering Director described as “a flexible expansion of my group”.
Services and Expertise
A65 Consulting offers comprehensive medical device engineering services spanning the entire product lifecycle:
Mechanical Engineering: The firm provides end-to-end mechanical engineering solutions, including precision mechanism design, high-volume disposable device design, hardware and electromechanical system design, complex robotic and automated system design, electronic enclosure design, FEA and classical engineering analysis, tolerance analysis with GD&T, thermal design, and SolidWorks CAD modeling and drawing creation. The company specializes in designing patented high-force, close-tolerance surgical systems for high-volume manufacturing.
System Engineering: A65 Consulting develops system architectures that meet product requirements and project objectives, implementing risk mitigations derived from hazard analysis and FMEA (Failure Mode and Effects Analysis). Services include requirements traceability, verification and validation protocols and reports, human factors engineering, voice of customer (VOC) surveys and interviews, and system troubleshooting with root cause investigation.
Manufacturing Engineering: The firm implements design for manufacturing/assembly (DFM/DFA) principles to optimize production processes and reduce costs. Manufacturing services include cost of goods sold (COGS) estimation, fixture and tooling development, investigating and solving production problems, manufacturing instruction creation, production line layout and balancing, supplier selection and management, and efficiency improvements.
Project Management and Leadership: A65 Consulting provides leadership services to guide engineering teams through the challenging product development process. The company can integrate with existing leadership teams or step into interim roles to fill gaps until permanent replacements are found. This leadership approach has been particularly valuable for clients facing tight deadlines, missing critical knowledge, or team distractions.
Industry Impact and Recognition
Medical Device Engineering Market Context
A65 Consulting operates within the rapidly growing medical device engineering market, which was valued at $8.2 billion in 2023 and reached $9.0 billion in 2024. The global medical device engineering market is projected to grow at a robust 10.1% compound annual growth rate (CAGR), reaching $14.7 billion by 2029. This growth is driven by increasing complexities in medical devices, including artificial intelligence, machine learning, IoT connectivity, and miniaturization, all of which require specialized engineering services.
The medical device engineering industry increasingly demands multidisciplinary approaches to design, development, and manufacturing, requiring deep knowledge in biomedical engineering, software development, electronics, and material science. Boutique firms like A65 Consulting are positioned to serve this market by providing specialized expertise without the overhead of larger consulting organizations.
Client Success Stories
Client testimonials highlight the company’s value proposition. Paul, CEO of a medical device entrepreneurship venture, stated: “A65 has been invaluable when needing to start or scale up a design project. I used Steve and his team over the past five years, across multiple medical device companies and a variety of different design challenges. They always deliver. When you need an experienced team fast, this is the place to turn. What I like the most is how A65 can seamlessly integrate into your team”.
An R&D Engineering Director at a virus analytics company described how A65 Consulting completed a critical fluidics model in parallel with minimal management demand, allowing the team to resolve defects that might otherwise have persisted. Another R&D Engineering Director at a medical device company praised the firm’s comprehensive capabilities: “They are one of the most complete consulting groups you will have the pleasure to work with. From engineering to project and functional management, they can do it all and do it well”.
Gabrielle, a Product Manager at an orthopedic company, emphasized the collaborative approach: “Steve is so easy to work with and was able to work with product management to ensure we were not only making a good product but meeting the users needs from all aspects. Communication and teamwork were what made Steve feel like a part of the team from day one”.
FDA Regulatory Expertise
The firm’s expertise extends to FDA regulatory compliance, a critical component of medical device development. A65 Consulting has contributed to more than eight FDA 510(k) submissions and supports clients through the complex FDA design control requirements specified in 21 CFR 820.30 and ISO 13485 standards. The company’s approach to medical device prototyping includes clear communication, technical planning, and careful management of documentation to align with industry standards, including Medical Device Regulation (MDR) compliance.
Business Model and Approach
Client Engagement Process
A65 Consulting follows a structured five-step engagement process:
Step 1: Request a Proposal — Prospective clients email or call to request a proposal for their medical device project.
Step 2: Proposal and Contract — The firm develops a customized proposal outlining scope, timeline, and pricing.
Step 3: Kickoff Meeting — The engagement begins with a comprehensive kickoff meeting to align on design requirements and project objectives.
Step 4: Design, Testing, and Iteration — Expert engineers work on the project with regular client meetings, prototype testing, necessary adjustments, and design iterations.
Step 5: Documentation and Project Completion — The project concludes with comprehensive documentation meeting regulatory requirements.
Competitive Positioning
A65 Consulting positions itself as a premium medical device consulting company that delivers high-performing designs and meets product development objectives without “burning through budgets and delivering average work”. This positioning distinguishes the firm from larger consulting companies and aligns with industry trends favoring boutique firms offering targeted expertise.
The consulting services industry continues to experience strong growth, with management, scientific, and technical consulting services recording $37.8 billion in operating revenue in 2023, representing an 11.5% increase from 2022. Within this landscape, boutique firms specializing in medical device engineering can command premium rates due to their specialized knowledge and ability to integrate seamlessly with client teams.
Leadership
Steve Donnigan, PE, CPM, MSME serves as Founder and Principal Consultant of A65 Consulting. Donnigan holds Professional Engineer (PE) licensure in Colorado and Certified Project Manager (CPM) certification. His educational background includes a Bachelor of Science in Mechanical Engineering and a Master of Science in Mechanical/Biomedical Engineering, both from Colorado State University.
Donnigan’s professional experience spans over 25 years in medical device engineering and product development. Key career milestones include Development Engineer at Hewlett Packard (1993-1999), Owner and Principal Consultant at Acumen Design Engineering, LLC (1999-2002), Senior Mechanical Engineer at CPS Innovations (2002-2005), Senior Mechanical Engineer at CONMED Corporation (2005-2008), Project Manager and Principal Engineer at Baxter Healthcare (2008-2015), and R&D Engineering Manager at CONMED Corporation (2015-2018).
Throughout his career, Donnigan has developed expertise in precision mechanisms, high-volume disposable device design, hardware and electromechanical systems, complex robotic and automated systems, and regulatory compliance for FDA submissions.
Location and Operations
A65 Consulting is headquartered in the Greater Denver Area, with the principal located in Highlands Ranch, Colorado. The Denver Metropolitan Area provides strategic access to a growing medical device industry cluster in Colorado, which includes established medical device manufacturers, biotech startups, and research institutions.
The firm operates as a small boutique consultancy, allowing for flexibility in team composition and the ability to scale resources according to project needs. This operating model enables A65 Consulting to provide specialized expertise without the overhead costs associated with larger engineering firms.
Industry Trends and Future Outlook
The medical device engineering industry is experiencing rapid transformation driven by technological innovation and regulatory evolution. Key industry trends impacting A65 Consulting’s market include technological advancement in AI-driven and interconnected devices, increasing regulatory complexity with MDR and FDA requirements, growing outsourcing and partnerships with boutique consulting firms, and sustained market growth projected to reach $16.12 billion by 2031.
Contact Information
Company Name: A65 Consulting, LLC
Founder and Principal Consultant: Steve Donnigan, PE, CPM, MSME
Phone: (303) 880-3350
Location: Greater Denver Area (Highlands Ranch, Colorado)
Website: https://a65consulting.com
LinkedIn: https://www.linkedin.com/company/a65-consulting-llc/
Contact Page: https://a65-consulting.squarespace.com/contact
