What drives the development budget?
- Imaging architecture: channels, acquisition timing, processing, memory, interfaces, power and thermal requirements.
- Probe work: compatibility of an existing probe versus new acoustic, electrical and manufacturing development.
- Software and modes: acquisition sequences, processing, controls, APIs, data access, verification and maintenance.
- Industrial and mechanical design: enclosure, ergonomics, thermal paths, assembly and serviceability.
- Verification and validation: acoustic output, electrical safety, EMC, software, mechanical and other applicable tests; any required clinical work.
- Regulatory and quality work: classification, submission pathway, risk management, documentation and legal-manufacturer responsibilities.
- Production and supply: tooling, calibration, production tests, sourcing, build quantities and technology-transfer requirements.
Reusable components may reduce some development work, but only when their interfaces, performance, evidence and licenses match the new product. Reuse does not automatically remove system verification or regulatory obligations.
Estimate by milestones, not a generic duration
| Phase | Work to estimate | Exit evidence |
|---|---|---|
| Requirements | Intended use, markets, probe, modes, outputs and constraints | Approved scope, responsibilities and acceptance criteria |
| Architecture and design | Probe, acquisition, processing, electronics and enclosure | Reviewed interfaces, designs and verification plan |
| Prototype | Build and integrate the imaging chain and packaging | Measured prototype performance and unresolved risks |
| Verification and validation | Applicable tests and any necessary clinical work | Traceable reports against defined requirements |
| Submission | Preparation, filing, review and responses to questions | Applicable regulatory decision—not merely receipt of a filing |
| Production and transfer | Assembly, calibration, test procedures, supply and transfer | Agreed production-readiness and handover evidence |
Some work can overlap, but dependency, lab availability, procurement, redesign and regulator questions affect calendar time. Maintain an explicit critical path and contingency rather than adding isolated phase estimates.
What does the FDA's 90-day goal mean?
The FDA describes a 510(k) decision goal of 90 FDA Days. Its review clock excludes days on hold for an Additional Information request. The decision can be substantially equivalent or not substantially equivalent. This is not a promise of clearance in 90 calendar days, nor the duration of device development, preparation or production.
Source: FDA: 510(k) Submission Process. The appropriate US pathway must be established for the device; do not assume every product qualifies for 510(k). For the EU, plan the applicable conformity-assessment requirements under the medical-device regulatory framework. This guide is general information, not a device-specific regulatory assessment.
How to control cost and schedule risk
- Make the brief testable. Specify the first product's required functions and acceptance conditions.
- Validate reuse assumptions. Review compatibility, available evidence, licensing and remaining work before calling a platform proven for the new product.
- Plan interfaces early. Connect probe, electronics, data transfer, processing and enclosure budgets.
- Build documentation alongside the design. Define who owns each record and test report.
- Stage investment. Use milestone evidence to decide whether to proceed, redesign or stop.
What to send for a scoped estimate
Provide intended use and markets, probe requirements, imaging modes, depth and field of view, host, RF/IQ or image outputs, enclosure constraints, quantities, existing design assets, desired milestones and budget. Request separate assumptions for engineering work, external tests, regulatory preparation, manufacturing and ongoing support.
See the complete device-development scope and the partner-selection checklist.
Explore the OEM development guides
Frequently asked questions
Questions and answers
How much does OEM ultrasound development cost?
There is no single project price. Probe work, acquisition and processing architecture, modes, enclosure, verification, regulatory work, quantities and transfer scope determine the budget. Request an estimate that identifies deliverables, assumptions, exclusions and external costs.
How long does ultrasound development take?
The schedule depends on requirements, reusable designs and evidence, integration, procurement, testing, regulatory review and production preparation. Estimate milestones and dependencies for the actual scope rather than applying a universal duration.
Does the FDA 90-day goal mean clearance in 90 calendar days?
No. The FDA describes a 510(k) decision goal of 90 FDA Days, excluding days on hold for an Additional Information request. Preparation, development and production are outside that clock, and a decision does not necessarily mean clearance.
Can ALEVA's scope include regulatory documentation?
Agreed engineering records, requirements traceability and verification evidence can be included to support a finished-device submission. The submission strategy, legal manufacturer and remaining regulatory responsibilities must be defined for the project.
Does reusing an engine eliminate verification?
No. Reuse may reduce some work when compatibility, evidence and licensing fit the new product. The integrated device still requires the applicable verification, validation and regulatory assessment.
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