Key Tech

Key Tech brings together interdisciplinary scientists, engineers, and designers to develop products that integrate novel technologies such as:

• Advanced sensors
• Wireless and connected systems
• Ultrasound-based technologies
• Microfluidics and fluidic cartridges
• Optics and electrochemistry
• Robotics and lab automation

The company works with industry-leading global companies as well as innovative startups to keep their development pipelines fresh and competitive.

Key Tech operates under an ISO 13485 certified quality system for medical device design and development.

Markets and Applications

Key Tech focuses on complex, regulated, and science-driven products, particularly in:

• In vitro diagnostics (IVD)
• Drug delivery and pharmaceutical systems
• Med-tech and medical devices
• Lab science and cell and gene therapy-related systems
• Industrial and select consumer products that rely on advanced sensing and automation

Location and Contact Information

Headquarters address 40 E. Cross Street Baltimore, MD 21230 United States

Phone 410-385-0200

Email TalkToUs@keytechinc.com

Website https://www.keytechinc.com

Business hours are not listed on the website; prospective clients should reach out by phone, email, or the contact forms on the site to coordinate a meeting or call.

Core Manufacturing Services

Manufacturing Process Development

• Develops scalable manufacturing processes and systems tailored to each product.
• Designs and optimizes assembly workflows, from early feasibility builds through full-scale production.

Design for Manufacturability and Assembly (DFx)

• Applies Design for Manufacturability (DFM), Design for Assembly (DFA), and broader Design for Excellence (DFX) principles.
• Considers reliability, cost, usability, and scalability during design.
• Works cross-functionally with engineering, quality, and manufacturing teams to reduce time to launch.

Pilot, Clinical, and Low-Volume Builds

• Supports pilot and clinical builds and low-volume commercial builds, including at Key Tech when appropriate.
• Establishes pre-production quality metrics and monitors yield and nonconformances.

Quality Controls and Traceability

• Implements ISO-aligned processes and records for manufacturing.
• Develops build documentation, work instructions, and production travelers.
• Defines quality controls, FAT/SAT protocols, and IQ/PQ procedures.
• Creates traceable production records and monitors nonconformances.

Tooling, Fixtures, and Test Strategy

• Designs custom fixtures, tooling, and QC test strategies for assembly and verification.
• Integrates in-line test strategies and, where appropriate, evaluates automation options.
• Provides rapid tooling solutions to support short-run production.

Supply Chain Strategy and COGS Modeling

• Defines supply chain strategies and supports sourcing and vendor selection.
• Performs cost-of-goods (COGS) modeling and tracking to support commercial viability.

Transfer to Manufacturing and Ongoing Support

• Prepares comprehensive transfer documentation packages for contract manufacturers or in-house teams.
• Supports contract manufacturer (CM) selection and onboarding.
• Assists with assembly line layout and flow optimization.
• Provides on-site and remote production support during and after transfer.

When to Engage Manufacturing Solutions

Clients typically engage Key Tech's Manufacturing Solutions team:

• During development, to embed manufacturability and quality into the design.
• Ahead of pilot or clinical builds, to establish robust processes and documentation.
• Prior to transferring to a contract manufacturer or internal production team.

These services are customized to each program, with the goal of reducing risk, shortening time to launch, and ensuring a reliable, scalable manufacturing approach.

Overview

Since 1998, Key Tech has been transforming complex technologies into intuitive products for the world's leading medical technology brands and innovative startups. The team provides end-to-end product development services for hardware, software, and consumables, taking ideas from early concept through feasibility, verification and validation, and preparation for manufacturing and commercial launch.

Core Service Areas

End-to-End Product Development

• Develops integrated hardware, software, and consumables into fully functional, verified products.
• Follows ISO 13485 controlled processes to deliver reliable, manufacturable solutions.
• Prepares designs for clinical testing, regulatory approval, and commercial launch.

Product Conceptualization

• Translates product visions into clear sketches, renderings, and early concepts informed by technical insight.
• Provides visuals and concept directions to help generate investor and stakeholder excitement.

Architecture and Feasibility

• Defines system architecture and technical approaches for new products.
• Uses data-driven feasibility work to de-risk concepts before large investments.
• Clarifies requirements, constraints, and technology choices to reduce surprises later in development.

User-Centered Design

• Applies user research, human factors engineering, and interface design to create intuitive, effective products.
• Focuses on real-world workflows, user needs, and intended use environments.
• Follows FDA guidance and IEC 62366 for usability and human factors.

Lab Automation

• Designs intelligent automation solutions to streamline scientific workflows.
• Aims to reduce manual effort, increase throughput, and improve data reliability.
• Works closely with scientific teams to integrate automation into lab processes while maintaining compliance.

Due Diligence and Technical Review

• Provides independent technical insight to support investment and strategic decisions.
• Reviews designs, technologies, and product concepts to uncover risks and validate assumptions.
• Helps clients move forward with greater clarity and confidence.

Quality and Regulatory Support

• Offers quality and regulatory (QA/RA) consulting for companies ranging from startups to global leaders.
• Supports regulatory strategy, compliance documentation, and submissions to help products reach market readiness.
• Integrates quality and regulatory considerations into the design and development process from the outset.

Typical Clients and Use Cases

Key Tech typically supports:

• Medical technology and diagnostics companies developing new instruments or platforms.
• Pharmaceutical and drug delivery teams creating delivery systems and connected therapeutics.
• Lab science and life science organizations needing automated or instrumented solutions.
• Innovators seeking an experienced engineering and design partner from concept through manufacturing transfer.

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