Medical Device Design & Engineering Since 1999
DeviceLab's Customers
Best-in-Class Medical Device Design
DeviceLab’s Award-Winning Medical Device Team is the Best Choice for Driving Your Innovation From Concept to CommercializationOver 20 Years of Medical Device Design Experience
For more than 20 years, DeviceLab has been earning a well-deserved reputation for its best-in-class medical device design mastery. Our deep experience in designing award-winning medical devices is not just a reflection of our tremendously talented medical device designers in the United States, that have completed more than 300 projects of varying complexity. It also highlights our comprehensive understanding of what it truly takes to satisfy customer expectations, risk management, regulatory concerns, safety hazard requirements, standardization, and much more.
We Give Peace of Mind to Our Clients Through Unmatched Experience & Excellence
- Device Lab Process Page. See how our projects typically proceed.
- Device Lab Regulatory Compliance Page. See how we maintain regulatory compliance.
Unparalleled Qualifications
- ISO 13485 Certified (Medical Device Design and Development).
- 400+ engagements.
- Gold medal award from MDEA (Medical Design Excellence Awards).
- 20 years of operations.
Unmatched Experience in Device Design & Development
- We are expert innovators.
- Regulatory compliance is in our DNA.
- We are adept at facilitating lab testing and FDA approval.
- We perform quick design studies all the way to soup-to-nuts projects.
Always Learning – Staying on the Cutting Edge of Medical Device Design
- Our designers create outstanding designs by following the latest design trends.
- Our engineers stay current with the latest medical technologies and design tools.
- Our proprietary process moves quickly through each phase of development.
- We adapt easily to changes in the regulatory landscape.
What Our Customers Say
CEO Recommendations
-
“Dac is a great industrial innovator. I’ve used DeviceLab for the past 5 years on several projects. Dac has been an instrumental partner and an extension to our development team. Thanks Dac”Winn Hong ; Co-founder, President/CEO at Varocto, Inc.
“At TinyKicks we have a strong and ongoing relationship with DeviceLab and Dac’s organization. DeviceLab is extremely competent, start-up friendly, and responsive. Our partnership is developing even stronger as our Company and products evolve. Our core team of Dac, Donald and Khoi give us a major competitive advantage.”France Dixon Helfer ; President & CEO of TinyKicks LLC
-
“Our development teams have found them easy to work with, providing substantial technical and creative value, on a time and cost effective basis.”
Robert Case ; President | Robert Case & Associates, Inc.
“Creative solutions overcame complex design issues such as a patient weight management system, handicap accessibility and arm translational/rotational movement.”Drew Knopfel ; Vice President of Engineering | PharmaSmart International
-
“Dac and his team have the creativity, technical depth and dedication necessary to bring new products to market quickly and effectively.”
Paul Smith ; President | Adapt360 / Inspect2GO
“The entire team at DeviceLab quickly understood our objective, and were proactive in making suggestions “Michael Favish ; CEO | Guardion Health Sciences
-
“DeviceLab is an industry leader in the design of innovative and complex projects. We’ve worked together often and I could not find a more exceptional company to work with.”
Richard W. Henson ; CEO | ResVeRx, Inc.
“I have personally worked with DeviceLab for over 15 years at multiple companies. They have a vast list of experience specifically in medical device design and production.”Jay Dinsmore ; President & CEO | Protowest, Dinsmore & Associates, Inc.
-
“DeviceLab is a go to company for mechanical design projects from concept through manufacturing. I would highly recommend DeviceLab for any mechanical design work.”
Jeff Blanton ; President | Waypoint Leadership, Inc
“DeviceLab was exceptionally resourceful, always ready to have creative solutions for any problem that we encountered.”Brigitte Phan ; Patent Agent | Allergan
-
Getting Your Project Started
Collaboration with DeviceLab, a leading medical device consultant, begins with an in-depth discussion. You share your vision for designing medical devices, and we assess the resources and expertise required for your project. Following this, we prepare a detailed Project Proposal, which outlines the medical device design services to be performed, provides estimated timelines and costs, and lists the deliverables we will provide. If our proposal aligns with your expectations, we proceed by executing a Development Contract, and DeviceLab commences the work on your medical device design. We prefer to initiate projects with a comprehensive kick-off meeting, ensuring all stakeholders are present to provide their valuable inputs, setting a solid foundation for your medical device development journey.
Start Getting Your Medical Device Developed Today
DeviceLab's experienced team streamlines the journey of your new medical device from initial concept and design through to manufacturing and market launch. The first step couldn't be simpler: Reach out to DeviceLab today to arrange a complimentary and confidential consultation on medical device development. Whether you're looking for service, advice from a seasoned company, insights from a knowledgeable firm, or assistance with medical device product or software, DeviceLab is your go-to partner in transforming medical device concepts into market-ready realities.
Request Consult
DeviceLab's Medical Device Product Specialties
DeviceLab is a full-service provider in the medical device industry, offering unparalleled expertise in designing medical devices across various applications. Our medical device design services are comprehensive, covering everything from initial concept to final product realization. As a seasoned medical device consultant, we specialize in a wide array of medical device product specialties, ensuring that your innovative ideas are transformed into practical, effective, and safe medical solutions.
-
Digital Health, Wireless & Wearables
Read More
Digital Health, Wireless & Wearables
Connecting patients to care givers using wearable devices, sensors, smart phones/tablets, apps, and cloud technologies is rapidly changing modern healthcare.
-
Lasers & LED Technologies
Read More
Lasers & LED Technologies
Leveraging compact lasers and LED sources to enable safe and novel diagnostics and therapeutic devices. Medical devices that use precisely focused light sources to treat or remove tissues.
-
Diagnostic Instruments
Read More
Diagnostic Instruments
Complex electro-mechanical IVD diagnostic systems for laboratory, Point-of-Care, and hospital. Including system controls, measurements, fluidics, optics, Software, and data management.
-
Patient Monitors / Imaging Systems
Read More
Patient Monitors / Imaging Systems
Reliable, patient-friendly monitoring of vital signs: Body Temperature, Pulse Rate, Respiration Rate, and Blood Pressure. Class I, II and III diagnostics and therapeutics systems for hospital, home, and office use.
Proven Process for Developing Medical Devices
The DeviceLab medical device design process is regularly and rigorously reviewed to ensure it streamlines the process without sacrificing any critical phases or steps. Our proven four-phase medical device process ensures swift but sensible movement from medical device concept & design to commercialization.
Six Critical Paths in Medical Device Development
Because DeviceLab operates in the highly regulated medical device space, we employ a formal design process. It’s not enough that your product passes compliance testing, you need proof that the design was produced by a controlled process and that all unacceptable risks have been mitigated. Our development processes comply with ISO 13485, ISO 14971, and 21 CFR 820 to assure that you have that proof.
The Intellectual Property Support Track describes activities intended to support obtaining patents to protect your product and associated technologies. While we’re not lawyers, we can prepare disclosures and provide technical review for patent applications.
The Product Design Track describes the tasks from research to design validation. This includes all the technology development, design and engineering work, testing, and documentation of the design.
The Risk Management / Design Controls Track describes tasks necessary to assure your device is safe and complete the Design History and Risk Management Files needed for regulatory approval.
The Manufacturing Track describes tasks required to ensure that your device is properly and efficiently manufactured with reasonable cost and high reliability.
The Human Factors / Usability Track describes the tasks needed to ensure that the design of your device addresses user needs, precludes use errors, and garners loyalty among end users. Importantly, it also includes the formal studies often expected in filings today.
The Compliance and Regulatory Support Track describes tasks directly associated with planning and executing a regulatory strategy for your product that assures timely approval, wherever you intend to market it.
More on Our ProcessMedical Device Design for the Newest Breeds of Products & Categories
The gap between the future of medical device design and the present is rapidly closing, and nothing illustrates this more than the staggering increase of new medical devices that integrate with mobile, wireless, and IoT technologies.
-
Prostate Imaging System
DeviceLab designed and integrated this innovative ultra-sonic prostate imaging cart within schedule in just 4 months.
Learn More -
Bioelectric Research ODIN 1
Non-neurological conductive pathways, including connective tissues, charged biochemicals and ions that move through lymphatic channels.
Learn More -
Immunoassay Diagnostic Bench Top System
DeviceLab integrated three technologies (optics, system control and software) into one platform to create this complex immunoassay instrument.
Learn More -
Breast Biopsy
DeviceLab developed this product at record pace in just 4 months. The resulting magnetic sample separation system performs heating.
Learn More -
LenSx Laser Eye Surgery System Case Study
This was LenSx’s first product in the marketplace. The goal was to establish top tier product identity in the Ophthalmic industry.
Learn More -
Phillips Zoom UV Lamp Case Study
DeviceLab designed and developed this complete dental system ahead of schedule in 6 months and received a vendor award from its client.
Learn More -
Babylance Safety Heelstick Case Study
Our goal was to design a device that would provide an easy and effective heelstick solution for obtaining a blood sample from the heels of newborns.
Learn More -
Dialysis System
In developing this innovative new dialysis cart, a key challenge to make this complex system very easy to use.
Learn More -
Ophthalmic Laser Cart for Fortune 500 Company
DeviceLab was selected to design this laser-enabled, keratoplasty system due to our expertise in large-scale system integration.
Learn More -
Cataract Surgery Footswitch
Ergonomics were key to project success. DeviceLab met each of the project’s unique challenges, including the ability to seal 8 mechanically activated switches under 3 feet of water.
Learn More
DeviceLab is More Than a Medical Device Design Company
DeviceLab launched its groundbreaking Wireless Medical Device Center in 2014, and our inclusion in Microchip Technology Inc.’s Design Partner Program and Microchip’s 32-bit MPU specialist group means your electronic medical device design project can leverage the relationship for world-class development.
We’re your champion and ally throughout a carefully designed process that recognizes your medical device project’s unique goals and objectives. As such, a medical device design project can involve any combination of the following:
- Medical Device Business Plan Analysis
- Commercialization and Ramp Up
- Concepts and Group Brainstorming
- Contract Manufacturing
- Ergonomics and Human Factors Analysis
- Feasibility Studies
- Incubation and Funding
- Legal (e.g., Intellectual property, patents, and trademarks)
- Market Research
- Marketing and Distribution
- Pilot Production and Beta Site Evaluation
- Medical Device Prototype Development
- Regulatory Compliance (e.g., navigating the Food and Drug Administration (FDA) approval process, clinical trials, acquiring CE and UL marks)
- Use, Environmental and Fatigue Testing
