Engineering
We bring together the engineering concentrations complex medical devices require. Our mechanical, electrical, systems, software, and process engineers work as one team to deliver designs that are functional, manufacturable, and ready for regulatory scrutiny.
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Overview
Engineering is where a device design becomes fully specified, testable, and manufacturable. We help biomedical innovators integrate every component and subsystem, optimize the design for manufacturability, and develop the packaging, labeling, and sterilization approach the device needs. Once formal development begins, our work is completed under engineering-level design controls. The result is a frozen design and bill of materials ready for verification and validation.
What engineering covers
Engineering turns a validated concept into a device that performs reliably and can be produced at scale. Our work brings each engineering concentration together under one program.
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Mechanical Engineering
Physical components and mechanisms designed for structural integrity, functionality, and manufacturability.
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Electrical Engineering
Electronic systems, circuit design, power management, and integration of sensors and actuators.
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Systems Engineering
Requirements analysis, system integration, and system verification and validation across all subsystems.
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Software Engineering
Embedded software, user interfaces, and secure, efficient data management.
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Process Engineering
Designs optimized for manufacturing processes that are scalable, reliable, and efficient.
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Materials Engineering
Off-the-shelf or custom materials and processing techniques matched to each application.
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Packaging & Labeling Design
Primary, secondary, and tertiary packaging, labeling, and instructions for use for pre-clinical, clinical, and commercial stages.
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Sterilization Development
Development, sourcing, and validation of sterilization cycles with external partners.
Where engineering shows up
Engineering should lead formal design and development, where the device is fully specified under design controls. It supports feasibility work before that phase and carries the design through validation and transfer.
PHASE 0
Concept Generation
Supports early technical feasibility assessment.
PHASE 1
Concept Development
Supports feasibility engineering and alpha prototype design.
PHASE 2
Design & Development
Leads design, DFM, and specification of every subsystem.
PHASE 3
Verification & Validation
Supports engineering builds and packaging, labeling, and sterilization validation.
PHASE 4
Design Transfer
Supports process verification and validation and the handoff to manufacturing.
The ROI on better engineering
Engineering decisions determine your device’s performance, cost of goods, and regulatory path. An integrated engineering team avoids the rework that comes from subsystems designed in isolation.
Superior Quality
Integrated subsystems that perform reliably as one device.
Lower Development Costs
Designs optimized for manufacturability and lower cost of goods.
Faster Time to Market
Traceable, testable designs that move efficiently through verification and validation.
Protectable IP
Engineered innovations worth protecting.
Explore our disciplines
Every program draws on a different combination of our core disciplines that together provide the rigorous development your device demands.
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Prototyping
Build and test prototypes from early feasibility through verification and validation.
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Quality & Regulatory
Maintain design controls, risk management, and regulatory compliance throughout development.
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Testing
Confirm performance with biocompatibility, feasibility, verification, and validation testing.
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Material Sourcing
Source and manage equipment, tooling, components, and third-party services.
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Ideation
Explore the clinical need, select the strongest concepts, and protect the IP created along the way.
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Design
Create safe, effective devices that integrate user needs, ergonomics, and aesthetics.
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Engineering
Mechanical, electrical, systems, software, and process engineering for complex devices.