Ideation

Requirements and Planning

The ideation process begins with understanding the needs of our clients, intended product users, and other stakeholders to ensure that both program constraints and product objectives are clearly understood and documented.

Learn more about how Key Tech’s Product Conceptualization service, Voice of Customer (VOC) process, and Quality and Regulatory experts ensure you have well-defined user and market inputs, a sound development plan, and the material needed to generate excitement with stakeholders and investors.

Concept Exploration

We research, brainstorm, and generate solution concepts that balance performance, usability, and stakeholder priorities—often leading to valuable new IP. Our team focuses on defining the right architecture early through system block diagrams, space-claims, and use workflows to guide key decisions and reduce long-term costs. Risk management is built into every step, addressing technical and programmatic challenges before they impact downstream development. 

Learn more about how Key Tech’s Architecture Development process provides confidence that you’re developing the right product with the right approach.  

Feasibility

We derisk and validate concepts early to ensure your technology can be demonstrated within a realistic system architecture before significant investment. Our team stress-tests and refines initial designs to build a strong foundation, setting your program on a faster, more confident path to success. 

Learn more about how Key Tech uses Test Bed Development and Human Factors Studies to collect the critical data for proving technical and product feasibility. 

Development

Once the architecture is validated, your product moves into formal, design-controlled development. This phase typically includes Alpha and Beta prototyping with functional testing to confirm the integrated design meets user and technical requirements. Our shared goal: a fully tested product ready for manufacturing ramp-up and successful launch. 

Alpha and Beta Development

Alpha and Beta development phases provide critical proof points for your leadership team and investors. In Alpha, we design, prototype, and test the integrated system to demonstrate market and technical viability. In Beta, we refine the design based on Alpha learnings and conduct further testing to ensure it meets all user and technical requirements. Rapid prototyping and low-volume manufacturing provide devices for technical characterization, gathering client feedback, and human factors studies. 

Commercialization

Your end goal is to commercialize a successful product. We will prepare a production-ready design package and manufacture initial builds at Key Tech or work closely with another manufacturing team to ensure a smooth ramp-up. 

Pilot Builds

As part of our Manufacturing Solutions, Key Tech rapidly builds in-house pilot units suitable for clinical studies, electrical safety testing, and final verification and validation. These builds use production materials and follow defined pilot assembly and checkout procedures. 

We also support alternate manufacturing paths—collaborating with client in-house teams or vetted contract manufacturers. Key Tech maintains design ownership through pilot builds and ramp-up to ensure continuity, reduce risk, and accelerate your path to market. 

Verification and Validation

Our Systems Engineering teams verify that hardware, software, firmware, and system outputs meet defined input requirements. We also coordinate with accredited labs to complete EMC, electrical safety, biocompatibility, and other compliance testing. 

In parallel, we work closely with your team to validate that the finished product meets user needs, conducting summative usability testing to confirm that safety-related risks are fully addressed. 

Regulatory Approvals

Our Quality & Regulatory team will guide your product through the necessary stage gates to obtain market approval. At this point, we will be confident that the product design and supporting DHF are in compliance with all intended sales markets, allowing you to focus energy on product sales and marketing activities. 

Manufacturing Ramp Up

Once the product is approved and the design is complete, Key Tech accelerates the transition to high-quality, high-volume production. We embed manufacturing design principles throughout development to reduce total product cost while maximizing reliability and manufacturability. Our engineers support scale-up by developing custom assembly and quality control procedures, along with software and fixtures that streamline production, increase throughput, and maintain quality at speed. 

On Market Improvements

On-market improvements can strain your supply chain and manufacturing systems. Key Tech provides on-demand, multidisciplinary support to enhance launched products within existing production constraints. We also identify and implement design updates—from new features to hardware or software enhancements—when increased functionality or reliability is needed. 

Case Studies

Our end-to-end process transforms complex technologies into intuitive products for the world’s leading medical technology brands. Learn about some of our latest work on the market today.

Capabilities

Transforming complex technologies into intuitive experiences is no easy task. Offering an industry-leading, high-quality development process for various products, according to regulatory requirements, for multiple markets requires even more tenacity and an impeccable team. At Key Tech, our multidisciplinary team hails from many professional backgrounds. This widespread expertise allows us to work confidently, in compliance, across industries.