Medical Device Design, Prototyping & Manufacturing Services

All the way from first prototype to serial manufacturing

Kii.am. Your idea's realization partner.

Think of us as the design department you wish you had next door. We give you that "in-house" feeling – quick to respond and always clear about progress. You get the convenience of your own team, plus the deep skills of a dedicated specialist.

Built with care and cleverness.

Our job is to do the best job. We don’t rush just to beat the clock. With seasoned engineers for mechanical, electronic, and optical challenges, we focus on smart, solid solutions.

Our services are always part of an integrated process and are not offered on a stand-alone basis.

The initial steps

Ideation

Consult with us about your initial product designs so that we can help you with tailored solutions.

Alpha prototype

Bring your own or let us make one. We'll run all the tests - and take you to Beta - to ensure it meets your expectations.

Advanced design

Design feasibility

Bring us your initial designs for refinement, or let us help you design from scratch.
Checklist: product requirements, specifications, design-for-manufacturing, ergonomics, user comfort.

Presentable prototype

It may go through numerous checks and recalibrations to ensure we’re on the right path. The end result is a high-end prototype for you to rely on and show with confidence.

Regulation

Regulatory compliance

For each of your target markets, we undertake all the processes to ensure that your product meets the established requirements of regulatory bodies, industry standards and internal quality control procedures. That includes dealing with FDA 510 (k), Pre-Market Notification and producing test reports. Check out how we take your product through regulation.

Manufacturing

Capabilities

We order, aggregate and assemble everything in-house - PCBs, LEDs, plastic and metal parts, and other components. It's an intensive process, with the eye constantly on quality and productivity.

Serial production

For volumes reaching tens of thousands of units annually, we provide full, tailored manufacturing services. It meets most expectations. Production is in Israel.

QA and QC

Comprehensive testing and inspection are undertaken to prevent defects and ensure you have consistency, compliance and dependable quality.

Packaging and Shipping

We handle all assembly and packaging arrangements. We tailor shipping to meet your needs — always looking out for what works best.

Customer support

Continuous care

Once your product has entered the manufacturing phase, we provide ongoing support to guarantee your satisfaction. We're also alert to user feedback that may indicate engineering and design improvements.

Kii.am is the ultimate 'engineering and production department next door' - always ready to respond with initiative and intuition. Make your product the best it can be.

Kii.am is the ultimate 'engineering and production department next door' - always ready to respond with initiative and intuition. Make your product the best it can be.

Frequently Asked Questions

What services does Kii.am offer?

Kii.am provides end-to-end medical device development services: concept design, rapid prototyping, custom electronics and PCB design, LED and optical engineering, industrial design, firmware development, regulatory preparation support, and serial manufacturing. We handle the full development cycle under one roof.

What types of devices does Kii.am develop?

We specialize in complex handheld and desktop medical devices, particularly those involving LEDs, optics, custom electronics, battery management, DC motors, pumps, bluetooth, touchscreens, and precision mechanical assemblies. Our primary markets are dental, dermatology, and veterinary devices.

How is Kii.am different from other contract manufacturers?

We are an integrated engineering and manufacturing partner. The same team that designs your device also manufactures it. There are no handoffs between departments, no lost context, and no translation errors between prototype and production. This integrated approach results in faster development, fewer design revisions, and products that match engineering intent.

What is the typical development timeline?

Timelines vary by device complexity, but a typical project from concept to first production units takes 12 to 24 months. This includes concept design, prototyping iterations, design validation, regulatory preparation, tooling, and production setup. We provide a detailed timeline estimate after our initial scoping call.

Does Kii.am handle regulatory submissions?

We provide regulatory-aware engineering: maintaining design controls, design history files, risk management documentation, and testing protocols throughout development. We coordinate with your regulatory consultant or RA team to ensure all engineering documentation is organized for FDA 510(k), CE marking, or other submissions.

What production volumes can Kii.am handle?

Our manufacturing facility handles production volumes from hundreds to tens of thousands of units per year. We manage the full transition from prototype to serial production, including injection mold tooling, assembly line setup, and quality assurance processes.