FlatVaultCertainty Engineered
Product Development & Strategy Partner

Complex devices. Clear direction. Fast execution.

FlatVault is an engineering and product development partner specializing in technically demanding medical devices. From early feasibility through manufacturing and regulatory readiness, we help teams reduce risk, solve difficult problems, and bring products to market faster.

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Certainty Engineered

Four commitments behind every engagement.

Precision

Applying deep technical expertise to complex medical devices.

Protection

Mitigating risk at every stage of development.

Acceleration

Streamlining the path from concept to commercialization.

Execution

Delivering practical engineering with real-world results.

15+510(k)s supported
$1M+Client funding secured post-engagement
3–5 wksAverage concept to prototype
100%Projects delivered on time
How We Work

A five-stage path, every time.

Every engagement moves through the same five stages, whether we're starting from a sketch or picking up where your team left off.

01

Discover

Define the clinical need, constraints, and success criteria.

02

Design

Concept development and early regulatory strategy in parallel.

03

Develop

Engineering, prototyping, and iterative testing.

04

Verify

Verification, validation, and design controls documentation.

05

Deliver

Manufacturing transfer and commercialization support.

Ready to engineer certainty for your device?

Tell us where you are today — we'll tell you what it takes to get to clearance.

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Services

Capabilities built for regulated devices.

Every engagement draws on the same four disciplines — engineering, regulatory strategy, manufacturing, and commercialization — sequenced to match where your product is today.

01 — Product Development

We take early-stage ideas and ambiguous requirements and turn them into tested, manufacturable hardware — without losing sight of the regulatory road ahead.

  • Concept generation & feasibility studies
  • Mechanical & design engineering
  • Rapid prototyping & bench testing
  • Design verification & validation planning
02 — Regulatory Strategy

Regulatory strategy shapes engineering decisions from day one — not after the design is frozen. We build the submission story alongside the product.

  • Predicate & pathway analysis (510(k), De Novo, PMA)
  • Design history file & design controls setup
  • Quality system alignment (ISO 13485, 21 CFR 820)
  • Submission preparation & agency interaction support
03 — Manufacturing Solutions

We bridge the gap between a working prototype and a repeatable production line, working alongside contract manufacturers or in-house teams.

  • Design-for-manufacture & design-for-assembly review
  • Supplier selection & process qualification support
  • Tooling, fixturing & pilot-line setup
  • Process validation (IQ/OQ/PQ)
04 — Commercialization Support

Launch readiness touches everything from supply chain resilience to sales-facing technical materials. We help make sure clearance isn't the finish line — it's the starting line.

  • Supply chain & cost-down strategy
  • Post-market surveillance planning
  • Technical & clinical collateral support
  • Investor & partner technical diligence

Not sure which stage you're in?

Most clients start with a short technical review before we scope anything. Let's talk.

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Prototyping

In-house prototyping capabilities.

From first article to complex, multi-part assemblies, our in-house shop lets us iterate quickly without waiting on outside vendors.

Multi-Axis Milling

Precision machining of complex geometries in a single setup.

Swiss Machining

Tight-tolerance turning for small, high-precision components.

SLA 3D Printing

High-resolution resin printing for fine detail and smooth finishes.

FDM 3D Printing

Fast, durable functional prototypes across a range of materials.

Post-Processing

Heat treat, blasting, and cleaning to finish parts to spec.

Complex Assemblies

Multi-component builds brought together under one roof.

Have a part that needs to come to life?

Send us your design and we'll tell you the fastest path to a working prototype.

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Contact

Let's start the conversation.

Tell us about your device and where you are today. We typically reply within one business day.

Something went wrong sending your message — please email us directly instead.
Thanks for reaching out — we'll be in touch within one business day.

Phone

(317) 313-1791

Office

Noblesville, IN