“We guide companies to market efficiently by applying the right level of effort at the right time with systems engineering and technical leadership. Our expertise helps teams avoid rework while ensuring they don’t over-engineer solutions or miss critical requirements.”
–Chad Gibson, Managing Partner
CMD MedTech provides comprehensive systems engineering consulting and technical leadership for medical devices, helping companies navigate complex development challenges and achieve predictable project outcomes. Our systems engineering consultants bring the breadth of experience and technical depth needed to guide your project from concept to market efficiently while avoiding costly late-stage problems.
Why Choose CMD MedTech for Systems Engineering Consulting
- Our team members helped pioneer systems engineering for medical devices, establishing processes now used throughout the healthcare industry
- We bring extensive experience across diverse medical device types, from body-worn sensors to surgical robots and diagnostic equipment
- Our technical depth combined with leadership skills allows us to coordinate cross-functional teams effectively
- We understand regulatory requirements and how technical decisions impact FDA pathways
- We have a proven track record implementing systems engineering processes at major medical device companies
- We specialize in right-sizing development efforts based on device risk and complexity
What Is Systems Engineering and Technical Leadership?
Systems engineering for medical devices goes beyond traditional project management or individual engineering disciplines. Our systems engineers provide technical leadership by guiding teams through all the hurdles of medical device development with the breadth of experience to know what’s ahead from both technical and regulatory perspectives.
This includes defining system architecture, managing technical risk, coordinating cross-functional teams, and ensuring that software, hardware, mechanical, regulatory, and quality efforts integrate seamlessly. Good systems engineers understand how seemingly simple changes in one area can impact multiple other systems, requiring coordinated responses across all engineering disciplines.
Unlike a project manager who focuses on schedule and budget, or individual engineers who focus on their specific discipline, systems engineers manage the technical big picture to prevent expensive integration problems and late-stage design changes.
5-Step Process for Systems Engineering Success
How We Work With You
Benefits of Our Medical Device Technical Leadership
Reduce development risk and exponentially increasing costs by identifying and addressing technical issues early when they’re manageable and affordable
Accelerate time-to-market through efficient coordination and elimination of rework
Optimize resource utilization with right-sized efforts focused on what matters for your device
Improve team coordination by managing technical dependencies and integration challenges
Navigate complex stakeholder dynamics with the confidence and communication skills needed to lead diverse teams including surgeons, regulatory experts, and engineering specialists
Ensure regulatory alignment with development approaches that meet FDA expectations from the beginning
Gain predictable project outcomes through systematic risk management and technical planning
Receive strategic technical leadership, not just documentation–we actively guide technical decisions and coordinate teams rather than simply generating required documents
Pricing for Our Technical Leadership Services
Our systems engineering consulting services are customized based on your project complexity, team size, and engagement model. We offer flexible arrangements from full program leadership to targeted support for specific technical challenges. Contact us to discuss your project needs and receive a tailored proposal.
FREQUENTLY ASKED QUESTIONS
The earlier the better. The greatest value comes from engagement during project planning and requirements phases, but we can help at any stage. Early engagement prevents costly late-stage design changes and creates a strong technical foundation.
Project managers focus on schedule and budget, while systems engineers define technical scope, manage technical risk, and ensure teams are building the right thing the right way. We combine both perspectives through proven program management and systems engineering partnerships that optimize technical and business outcomes. Our technical leadership for medical devices integrates perspectives across software development, hardware engineering, regulatory requirements, and business constraints simultaneously.
Yes, especially for complex projects. Individual engineers focus on their disciplines, while systems engineers coordinate across all disciplines and manage the technical big picture. Even experienced teams benefit from someone managing system-level integration and dependencies.
Projects of any size involving multiple engineering disciplines, regulatory requirements, or significant technical complexity can benefit from systems engineering and technical leadership. This includes most medical devices beyond simple mechanical instruments.
Absolutely. Our systems engineers complement project managers by providing the technical expertise needed to build realistic schedules, understand dependencies, and manage technical scope effectively.
We can assess your project and help you understand where systems engineering would provide value. Many companies discover they need this expertise after problems arise, but early consultation can prevent those issues.