Home / Design & development process
Concept through clinical build under an ISO 13485 quality system. Each phase carries defined deliverables and a stated exit condition at its milestone.
Entry at any phase. Most programs join at Phase 3 or 4.
Architecture
Design inputs, feasibility, regulatory assessment, conceptual configurations.
PHASE 2Design iteration
Two to three design and prototype loops with test plan and evaluation.
PHASE 3Design for manufacturing
Vendors, tooling, assembly process, risk management, pre-validation.
PHASE 4Verification & validation
DMR, work instructions, V&V build and testing, biocompatibility, packaging.
PHASE 5Clinical ramp-up
Clinical build, site qualification, study protocol and approval to start.
Why gated
Each gate specifies a named outcome and the condition that must be satisfied to pass it, followed by a decision to fund the next phase, repeat an iteration, or stop.
Program status resolves to a defined position — preliminary design freeze passed, V&V build in progress — which is reportable to a board or investor without qualification.
Where a phase does not meet its exit criteria, that is identified at the gate rather than accumulating as unreported schedule risk.
Documents and hardware, listed before the phase starts.
A stated condition, met or not met, rather than a calendar date.
Fund the next phase, repeat an iteration, or stop.
The same engineer through the phase, contactable directly.
The program
Deliverables, key tasks and exit gate for each phase. Duration is scoped per program, driven by device complexity and required iteration count.
Before anything gets built, we establish what the device has to do, what is technically uncertain, and which conceptual configurations are worth prototyping. The output is a chosen architecture, not a pile of options.
Milestone 1
Design architecture selected
One architecture chosen and justified, ready for prototyping.
Two to three loops of design, build and test on components and partial assemblies. This is where the critical technical questions from phase 1 get answered with hardware instead of opinion.
Milestone 2
Design concept selected
A functional bench-top prototype and a concept worth carrying into manufacturing design.
The phase where a working prototype becomes a device that can actually be built repeatably, by trained technicians, from parts a real supply chain can deliver. Skipping it is the most expensive shortcut in device development.
Milestone 3
Preliminary design freeze
Design, process and supply chain stable enough to build against. Changes after this point cost real money, which is the point of the gate.
Proving the device does what the design inputs said it would, and that it can be built that way every time. The documentation produced here is what a regulator, an auditor and an acquirer all eventually read.
Milestone 4
Full design freeze
Verified, validated, documented, and ready to build for clinical studies.
Building the devices that go into patients. Clinical quantities assembled under the quality system, with the site and protocol work running alongside so the build is not waiting on paperwork or the reverse.
Milestone 5
Clinical study begins
Devices in the field, records behind them, and a manufacturing process that can be scaled rather than rebuilt.
Running through all five
Regulatory pathway is treated as a design input from Phase 1 rather than a documentation exercise at the end of the program.
PHASE 1
PHASE 2
PHASE 3
PHASE 4–5
Where you join
Programs are commonly engaged mid-path. Identify the current development stage and the applicable phases and gates will be scoped accordingly.
Physician-originated concept or an unmet therapy requirement. Design inputs defined and architecture selected.
The most common entry point. Device performs in the lab but the process does not transfer to repeatable production.
V&V or clinical quantities assembled under a quality system, or bench space and technicians for internal execution.
Senior engineering resources
Programs have access to senior engineering with decades of hands-on medical device experience — development, cleanroom manufacturing, process engineering, validation and quality systems. That experience includes the design and launch of more than 17 medical devices, and the implementation and certification of both ISO 13485 quality systems and ISO Class 7 cleanroom facilities.
| Area | Capability |
|---|---|
| Device development | Concept, feasibility and prototyping. Product and component design, design for manufacturability, design specifications, reviews and freeze. DV/V, DOE and risk analysis. Accelerated aging and shelf-life. Sterilization and biocompatibility studies. Design History File support. |
| Catheter & interventional | Neurovascular, cardiovascular and coronary, peripheral, pulmonary and radial access. Microcatheters, access catheters, sheaths and delivery systems. Braided catheter construction and hydrophilic coating application, concept through commercial manufacture. |
| Cleanroom & manufacturing | ISO Class 7 cleanroom planning, buildout, certification and operational readiness. Production line setup, GMP practice and operator training. Process development and optimization. Equipment selection, installation and qualification. Production layout, workflow and Lean manufacturing. Tooling and fixture design. |
| Validation & transfer | IQ/OQ/PQ and process validation. R&D-to-manufacturing transfer, pilot production, scale-up and commercial implementation. Cycle-time, yield and cost improvement. |
| Quality & regulatory | ISO 13485 quality system implementation. Design controls and DHF documentation. Process and equipment qualification, V&V documentation, controlled manufacturing procedures. FDA and international regulatory technical support. Manufacturing licensing and facility readiness. Quality investigations and issue resolution. |
| Technical leadership | Engineering and R&D program management, OEM program management, manufacturing operations leadership. Scheduling and resource planning, supplier and subcontractor management, capital equipment and facility planning, production scale-up and team development. |
| Tools & methods | SolidWorks, AutoCAD, Pro/ENGINEER, 3D modeling and production drawings. FMEA, DOE, IQ/OQ/PQ, process validation, Lean manufacturing, Microsoft Project. |
Available to OEM programs as engineering leadership, hands-on execution, or both — from early development through validated commercial production.
Scope a program
Provide the current design state and target milestone. Response identifies applicable phases, deliverables and exit criteria for each gate.
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Program inquiries submitted here receive a response by the next business day.