Top 50 medical device product design and development companies (2026)

Updated July 2026.

Bringing a new medical device to market is hard. You're carrying the cost of design and development and the regulatory burden for every market you want to sell in. On top of that, you're responsible for building something safe enough to put in front of patients.

Most teams don't do all of that alone. They bring in a product design and development partner to fill the gaps in engineering, human factors, regulatory, and manufacturing. This is our running list of the firms worth knowing, refreshed for 2026. We've pulled out five picks at the top, added a short guide on how to choose, and profiled the rest so you can shortlist a partner that fits your device, your class, and your stage.

A quick note on the five picks: we weighed how deeply a firm understands medical device work, its track record and reputation, and its reach, then cross-checked against the firms that medtech professionals consistently recommend to each other. These are a starting point, not a verdict on any one firm. The right partner depends on your technology, your risk class, and where you are in the build.

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What's inside

• Our 5 picks for 2026
• How to choose a design and development partner
• Design firm or contract manufacturer: what's the difference?
• The full list of firms
• Recommended by the medtech community
• Frequently asked questions

Our 5 picks for 2026

Here's the quick version, then the details.

CLEIO

Website: cleio.com

Headquarters: Montreal, Quebec, with a US office in Indianapolis, Indiana

CLEIO earns the top spot here for one reason: few firms understand medical device development as deeply. It's spent two decades doing almost nothing else, with 2,500-plus device projects since 2005 and a team of 80-plus experts who bring strategy, design, engineering, and quality assurance together under one ISO 13485 system. That focus shows up in the therapeutic areas it knows cold, including oncology, respiratory, cardiovascular, and digital health, and in how fast it can read a program and anticipate what regulators and users will need. It works with startups and established manufacturers alike, and it's built to carry a device from early strategy into production without losing the thread. If you want a partner whose instincts are tuned to medtech specifically, CLEIO is a strong first call.

Velentium

Website: velentium.com

Headquarters: Katy, Texas, with an office in Lafayette, Colorado

Velentium is an engineering firm built around active therapeutic and diagnostic devices, the kind that stimulate, sense, or deliver therapy and carry real risk if they fail. It works with clients of every size, from seed-stage startups to Fortune 500 companies, and takes a program from design through manufacturing. Its standout strength is device cybersecurity: it's one of the few development partners that treats security as a core engineering discipline rather than a late checkbox, which matters more every year as FDA expectations tighten. If your device is active, connected, or security-sensitive, Velentium belongs on your shortlist.

Flex

Website: flex.com

Headquarters: San Jose, California, with 100-plus sites worldwide

Flex is another giant that pairs product design with manufacturing at a scale few can match. For medtech, its strength is connected and digital health: it has built a platform and a track record for launching and scaling devices that have to meet privacy, security, and regulatory requirements at once. Teams building wearables, remote monitoring, or app-connected devices tend to shortlist Flex early. Its footprint spans roughly 30 countries, so it can put engineering and production close to most markets.

Veranex

Website: veranex.com

Headquarters: Raleigh, North Carolina

Veranex has spent the last few years building something the industry keeps asking for: design, engineering, preclinical, clinical, regulatory, quality, and market access under one roof, with 25-plus years of medtech experience behind it. It calls the model an innovation CRO, and the point is fewer handoffs between vendors as your device moves from sketch to submission. If your program spans both design and clinical evidence, Veranex is set up to carry both. It's a strong fit for teams that want one accountable partner across the whole path to market.

StarFish Medical

Website: starfishmedical.com

Headquarters: Victoria, British Columbia, with offices in Toronto and Irvine, California

StarFish is Canada's largest full-service device design, development, and commercialization firm, with around 230 people across three sites and a long record with startups and global companies alike. In November 2024 it acquired Omnica Corporation, the respected Southern California design and engineering firm, which now runs as its Irvine office and adds four decades of design and prototyping depth. StarFish covers mechanical, electrical, software, human factors, and regulatory work, and it's active in the community through its podcast and events. It's a good match if you want a North American partner who can take you from concept to production.

These five weigh depth of medtech understanding, track record, and reach, plus how often peers name them. They aren't a ranking of who does the most business with any one vendor, and they aren't the only strong option here. Read the full list below, then match a firm to your device type, risk class, and stage.

How to choose a design and development partner

A few things separate a partner who'll save you time from one who'll cost you a re-design:

• ISO 13485 certification. A partner working inside a certified quality system produces design records you can defend in an audit. Ask to see the certificate and the scope it covers.
• Design controls and a real DDF (design and development file). Your device needs design inputs, outputs, verification, validation, and a design history file. Make sure the firm builds these as it goes, not afterward.
• Human factors and usability. Use error is a leading source of device problems and a hard part of your submission. Look for in-house human factors.
• Regulatory and submission support. Ask whether they've taken devices in your class through 510(k), De Novo, or PMA, and whether they'll help assemble the submission.
• Design transfer and manufacturing. Ask how they hand off to manufacturing, or whether they manufacture themselves.
• Therapeutic-area fit. A firm that's manufactured devices like yours will move faster.
• Communication. You'll live with this team for months. Clear updates and honest pushback are worth more than any polished pitch.

For the mechanics behind these, see our guides on design controls, ISO 13485, and design verification and validation.

Design firm or contract manufacturer: what's the difference?

The terms blur, because a lot of firms now do both. A design and development firm focuses on turning a concept into a working, compliant device: research, industrial design, engineering, human factors, and the design records behind them. A contract manufacturer, sometimes a CDMO, focuses on making the device at volume. The firms that cover both, and several on this list do, can carry you from an early sketch through design transfer and into production without a handoff to a new company. If you only need one side today, be clear up front, and ask how the other side works when you need it.

The full list of firms

Fearsome

Website: fearsome.co.uk

Location: Glasgow, United Kingdom

Fearsome works with medical and industrial product companies to move discoveries into market-ready products, with a focus on neurosurgery, wearables, diagnostics, and safety. It offers full service from an idea through production setup, certification, and launch. Founded in 2002, it runs studio, workshop, and testing facilities in Scotland and works across the UK, Europe, and the US, with quality systems audited to ISO 13485.

HTD Health

Website: htdhealth.com

Location: New York City, and Europe

HTD Health plans, designs, and develops software as a medical device, with a focus on digital health. Its teams support the full SaMD life cycle: strategy, risk management, human factors, compliant agile development, verification, software validation, design control, DDF, and QMS advisory, plus FDA guidance. It maintains an ISO 13485 quality system and complies with EU MDR and US FDA requirements, and it's delivered 160-plus healthcare projects for 100-plus customers.

Cortex Design

Website: cortex-design.com

Location: Toronto, Ontario, Canada

Cortex Design uses human-centered design and engineering inside a regulatory framework to improve quality of life through the products it develops. It's an award-winning firm certified to ISO 13485 and ISO 9001, established in 1999. Its Design for Commercialization approach is built to be flexible, so it can meet a client where they want to engage, and it's another firm medtech peers tend to recommend.

Vantage MedTech

Website: vantagemedtech.com

Location: Lenexa, Kansas

Vantage MedTech offers design and manufacturing from concept through production, working with both startups and large device companies. Its services include feasibility, development and prototyping, planning for new product introduction, clinical and commercial manufacturing, and after-market support. Its Advantage Platforms help compress development timelines, and its manufacturing scales from first-in-human builds to full launch volumes.

Priority Designs

Website: prioritydesigns.com

Location: Columbus, Ohio

Priority Designs brings 25-plus years of product development to devices, covering the full process from human factors and usability through design, development, verification, and validation. Its team includes biomedical engineers, human factors researchers, designers, soft-goods experts, and prototyping specialists. It's a firm medtech people name often when recommending development partners.

Jabil (including Nypro Healthcare and Radius)

Website: jabil.com

Location: St. Petersburg, Florida, with sites worldwide

Jabil is one of the largest design and manufacturing organizations in the world, and its healthcare group runs device programs from concept through full-scale production. Inside it, Nypro Healthcare handles high-volume device and drug-delivery manufacturing, and Radius Innovation and Development covers early engineering, industrial design, and regulatory support. With more than 30 ISO 13485-certified sites, Jabil fits teams that need to design a device and then make it at global scale.

Delve

Website: delve.com

Location: Madison, Wisconsin, with offices in San Francisco, Philadelphia, and Boston

Delve is a design and engineering firm with more than 50 years of history and 1,200-plus device projects, including the Dexcom G6 continuous glucose monitor and the EXOGEN bone-healing device. Its strength is human-centered design borrowed from consumer products, which shows up in devices people find easy to use. It's ISO 13485-certified and runs a disciplined design-transfer process into manufacturing.

HS Design (HSD)

Website: hs-design.com

Location: Morristown, New Jersey

HS Design is an award-winning firm focused on medical and scientific device design. Its work covers opportunity definition, brand and development strategy, user research, human factors, industrial design, and user interface design, backed by in-house mechanical, electrical, and embedded software engineering. Over a 40-plus year history it's served both Fortune 100 companies and early-stage startups. HSD is ISO 13485-certified, so its design work fits inside a compliant quality system.

Glassboard

Website: glassboard.com

Location: Indianapolis, Indiana

Glassboard is a full-service design and engineering firm for medical devices, working from concept through commercialization across research, design, human factors, and the mechanical, electrical, and software disciplines. Its team is known for transparency and clear communication through a project, and for design-transfer work that sets a device up for stable, profitable manufacturing. It's a name that comes up often when medtech people recommend development partners.

Global Center for Medical Innovation (GCMI)

Website: gcmiatl.com

Location: Atlanta, Georgia

GCMI is the Southeast's first comprehensive medical device innovation center, a 501(c)(3) non-profit that's worked with more than 50 startups, clinician innovators, and university teams since 2012. Its designers and engineers help take ideas from concept to market while holding down cost and time, backed by a network across IP, regulatory, quality, and investment. It's a strong fit for early-stage teams and academic spinouts.

Plexus

Website: plexus.com

Location: Neenah, Wisconsin

Founded in 1979, Plexus is a global company of around 20,000 people offering product design, manufacturing, supply chain, and after-market support. Its electronics depth shows up in devices for diagnostic imaging, drug delivery, surgical tools, and monitoring. Plexus works across the full life cycle, from design and engineering through production.

Design and Industry (D+I)

Website: design-industry.com.au

Location: Sydney and Melbourne, Australia

D+I is a certified industrial design and product development consultancy with a 30-year record and more than 170 design awards. Its team of 50-plus engineers has worked with companies like Siemens Healthcare, Universal Biosensors, and Stryker. Notable releases include one of the smallest commercial ultrasound systems and a waterproof behind-the-ear cochlear implant. D+I supports devices from strategy through production.

Cambridge Design Partnership

Website: cambridge-design.com

Location: Cambridge, United Kingdom, with a US presence

Cambridge Design Partnership is a full-service product realization firm covering research, product design, packaging, technology development, and mechanical and electronics engineering. It has decades of experience in drug delivery, diagnostics, and surgical equipment, and its ISO 9001 certification spans research through manufacturing development. The firm is set up to plug into your own quality system as an external partner.

Kapstone Medical

Website: kapstonemedical.com

Location: Charlotte, North Carolina

Kapstone offers full product realization, from early concept to launch, for everyone from established manufacturers to first-time inventors. Its services run from concept and project management through engineering, with 3D-printed prototyping and support for regulatory planning, 510(k) and CE mark work, and quality-system setup. It also helps on the commercial side, including distribution, IP strategy, and licensing.

Celestica

Website: celestica.com

Location: Toronto, Canada, with sites worldwide

Celestica brings manufacturing and supply chain solutions built for device makers, with strengths in complex electro-mechanical systems and high-volume single-use devices. It's also delivered surgical instrumentation, in vitro diagnostics, imaging, and patient monitoring. From a start in 1994, it now runs more than 35 sites. Celestica covers design through manufacturing and select after-market services.

Orchid Orthopedic Solutions

Website: orchid-ortho.com

Location: Mason, Michigan

Orchid is a leading provider of outsourced design and manufacturing for orthopedic devices: implants, instruments, and technologies for joint reconstruction, spine, sports medicine, trauma, and dental. Its capabilities include casting, injection molding, forging, coatings, machining, and complex instrument assembly. If your device is orthopedic, Orchid is built around exactly that.

Team Consulting

Website: team-consulting.com

Location: Cambridge, United Kingdom

Team Consulting designs and develops medical devices for companies including Sensile Medical and Meridian Medical Technologies, with deep strength in drug delivery. Its award-winning team handles user research, concepting, CAD, prototyping, and a full set of electronics, software, and systems engineering services. Recent work includes a system to keep transplant livers alive and a connected sleep-apnea mask. Team is a good fit for complex drug-delivery and connected-device programs.

Planet Innovation

Website: planetinnovation.com

Location: Box Hill, Australia

Planet Innovation designs and manufactures regulated biomedical products and connected devices, with a quality system certified to ISO 9001 and ISO 13485 and real experience in the FDA-regulated US market. Its capabilities span industrial design, systems and software engineering, optics, and manufacturing. Award-winning work includes an IVF imaging incubator and an automated culture-plate reader.

Donatelle

Website: donatellemedical.com

Location: New Brighton, Minnesota

Donatelle brings a 50-year history in device design, development, and contract manufacturing. Its services include product development, prototyping, injection and liquid silicone molding, precision machining, packaging, and process validation. Its engineers have worked on pacemakers, implantable monitors, ventricular assist devices, diagnostic instruments, and drug-delivery products.

Bressler Group

Website: bresslergroup.com

Location: Philadelphia, Pennsylvania

Bressler Group has been designing devices for 45-plus years, with more than 100 design awards and 230-plus patents. Its multidisciplinary approach covers strategy, digital and physical design, user research, and engineering analysis. Work spans therapeutic and life-support equipment, patient monitoring, diagnostic gear, infusion pumps, and injection devices. Bressler doesn't manufacture in-house, but it offers production management and consulting.

Biomerics

Website: biomerics.com

Location: Salt Lake City, Utah

Biomerics is a design, engineering, and manufacturing partner with a lot made in-house: medical polymers, coatings, advanced catheters, extrusion, and device assembly. Its engineers run a stage-gate design process that keeps design, manufacturing, and regulatory requirements aligned. Its testing labs, process development, and validation services help partners reach market faster with safer products. It's especially strong for catheter and interventional devices.

Integrated Computer Solutions (ICS)

Website: ics.com

Location: Waltham, Massachusetts

ICS builds connected, wearable, and IoT medical devices with a focus on software and user experience. It has depth in the technologies behind embedded and mobile devices, including Qt, QML, OpenGL, Android, QNX, and C++. Its work includes custom hardware and real-time operating systems for infusion pumps, respiratory devices, and imaging. ICS is a good fit when software and interface quality make or break the device.

Freudenberg Medical

Website: freudenbergmedical.de

Location: Kaiserslautern, Germany, with US and global sites

Freudenberg Medical is a global design and manufacturing firm with sites in California, Massachusetts, Minnesota, Indiana, Costa Rica, Ireland, China, and Germany, each certified to ISO 13485. Its services fall into device design and development, manufacturing, lean project management, and quality and regulatory support, with FDA-registered facilities and cleanrooms. It produces upward of 80 million custom molded components a year for IVD makers.

Synectic

Website: synectic.net

Location: Boston, Massachusetts, and the eastern US

Synectic develops devices for inventors and startups, covering user needs, specifications, IP review, regulatory work, clinician studies, and clinical trials. It also offers machining and prototyping, and it can scale into full production through its parent company, Mack Molding. That means a project can run in-house from idea to launch.

Novo Engineering

Website: novoengineering.com

Location: San Diego, California

Novo Engineering runs a five-phase development process inside a quality system, taking Class I, II, and III devices from concept through manufacturing transfer. Its services include risk and hazard analysis, verification and software validation, design control and DDF documentation, and full regulatory compliance. It has particular depth in autoinjectors, pen injectors, insulin pumps, wearable drug delivery, and IoT devices.

Sunrise Labs

Website: sunriselabs.com

Location: Bedford, New Hampshire

Sunrise Labs fields a team of 65-plus engineers offering full development and engineering services, with in-house processes that meet ISO 13485. It works with companies of every size and aims for cost-effective design with a focus on time to profit. It's also active in publishing white papers on device development.

Nectar

Website: nectarpd.com

Location: Long Beach, California

Nectar is a product design and development firm that helps device companies create and commercialize new products. It covers marketing and design strategy grounded in research, a human-factors-led approach to design, and integrated mechanical, electrical, and software engineering. Its client work includes NuVasive, BeneChill, and KOS Pharmaceuticals.

Tiller Design

Website: tillerdesign.com

Location: Rozelle, Australia

Tiller Design covers design, development, and commercialization: pre-development guidance, feasibility and proof-of-concept work, prototyping, IP generation, and human factors and interface design. For device makers it adds firmware and electronics development, product certification, and document control, plus outsourced manufacturing at high and low volumes. Its work has helped partner products reach large market valuations.

Research Collective

Website: research-collective.com

Location: Tempe, Arizona

Research Collective is a specialist in human factors and user experience research for devices. Teams rely on it to set usability testing criteria, run human factors studies, find use-related issues, and design solutions, with client work for Bard, Boston Scientific, Medtronic, Mayo Clinic, and GE Healthcare. It also keeps a participant database and can recruit general and special populations for research.

Karten Design

Website: kartendesign.com

Location: Marina del Rey, California

Karten Design is a product design and commercialization consultancy that's partnered with device companies for 30-plus years. Its approach brings design strategy, research, industrial design, and mechanical engineering together, plus packaging and on-brand materials for each product. Its client list includes Biotronik, Boston Scientific, Abbott, Axonics, Baxter, and Medtronic.

Insight Product Development

Website: insightpd.com

Location: Chicago, Illinois

Insight Product Development serves clients like Hill-Rom, Boston Scientific, and ConMed with design strategy, R&D, design for manufacturing, connected devices and software, human factors, and engineering. It runs startup services and an accelerator program from its Chicago lab and office space. It's helped startups such as ivWatch and Somna Therapeutics reach market.

RND Group

Website: rndgroup.com

Location: Indianapolis, Indiana

RND Group builds FDA-compliant software for device makers and works as an extension of your product team, managing software development from concept to release. Its expertise covers FDA Part 820 and Part 11, ISO 13485, IEC 62304, software lifecycle management, and verification, across mobile, desktop, and embedded targets. Recent clients include Convergent Dental and Rheonix.

HaA Design

Website: haapd.com

Location: Wakefield, Massachusetts, with offices in Seoul and Taipei

Founded in 1999, HaA is a full-service design and development firm focused on devices, with more than 100 patents and a long list of design awards. Its work spans research and strategy, brand and logo, industrial and interface design, engineering, prototyping, testing, quality documentation, and manufacturing. Its clients have included P&G, Johnson & Johnson, and Boston Scientific.

Naglreiter Device Development

Website: nmddo.com

Location: Miramar, Florida

Naglreiter is a full-service device design firm offering outsourced engineering and management for clients from Fortune 500 companies to small teams. Engagements range from short-term offsite support to full on-site product incubation. It has particular depth in neurovascular, peripheral, and cardiovascular products, surgical tools, and heart valve repair and replacement.

Boston Engineering

Website: boston-engineering.com

Location: Boston, Massachusetts

Boston Engineering offers full design and development across the product life cycle, including DDF documentation, verification and validation, and QMS implementation. Its work includes an electrostatic wound-healing bandage, blood-filtration equipment, and a drug-infusion pump built to reduce medication errors. It also designed an endoscope that earned five patents and a CE mark.

Kablooe

Website: kablooe.com

Location: Minneapolis, Minnesota

Kablooe is a full-service product research, design, and development firm. It helps clients add development capacity and expertise through its Design Driven Development Process. It specializes in medical devices and can take on products beyond medtech as well.

EG-Gilero

Website: eg-gilero.com

Location: Morrisville, North Carolina

EG-Gilero is a medical device company with design, tooling, testing, and manufacturing across North Carolina, New York, China, and the Dominican Republic. It offers outsourced design and development plus contract manufacturing, from human factors research and concept work through device classification, 510(k) support, packaging, and testing. Its work includes releases with Pfizer, Bayer, and Cardinal Health.

Johari Digital Healthcare

Website: joharidigital.com

Location: Rajasthan, India

Johari Digital is a global medtech manufacturer with 40-plus years of experience and a facility compliant with MDSAP, ISO 13485, and FDA 21 CFR 820. Its services run from design and development through electronics and mechanical engineering, prototyping, system integration, packaging, and supply chain, plus regulatory support. It serves both large medtech companies and startups from a 65,000-square-foot facility in India with an R&D center in Europe.

Banner Medical Innovations

Website: banner-medical.com

Location: Carol Stream, Illinois

Banner Medical is an ISO-certified supplier of components and services focused on reducing supply-chain complexity and risk through commercialization. Its services include on-hand medical-grade materials such as stainless steel, titanium, and cobalt chrome, plus raw-material processing, packaging and labeling, traceability, and 510(k) approval-process consultation. It specializes in orthopedic devices, spine implants, surgical instruments, and dental implants.

Design Solutions

Website: design-solutions.com

Location: Chanhassen, Minnesota

Design Solutions provides medical product development engineering for therapeutic, diagnostic, analytical, and biotech companies. It works from concept generation through manufacturing, applying proven design methodologies with a flexible business model and a focus on quality assurance throughout.

QURE Medical

Website: qure-med.com

Location: Twinsburg, Ohio

QURE Medical provides engineering and product design support to device companies, using 3D modeling and finite element analysis to iterate designs and drive down cost. Alongside development and regulatory support, it supplies components: silicone tubing, fluid management, drug-delivery parts, surgical tools, and other custom molded solutions. Companies value it for its combined design and manufacturing capability.

Product Creation Studio

Website: productcreationstudio.com

Location: Seattle, Washington

Product Creation Studio is a full-service design and development firm focused on devices, organized around development strategy, product design, experience design, engineering, innovation management, and manufacturing support. It combines electrical and mechanical engineering, industrial design, firmware, quality assurance, and usability. Its client work includes Gilead, Intel, Johnson & Johnson, and Precor.

Creation Technologies

Website: creationtech.com

Location: Burnaby, Canada

Creation Technologies is a full-service design, development, and OEM firm with design and manufacturing under one roof and a focus on devices. Its services include turnkey and partial development, prototyping, accelerated design transfer, lean manufacturing, traceability, and logistics for complex systems. It holds quality and regulatory certifications from ISO and other bodies.

Lumenous Device Tech

Website: lumenous.com

Location: Santa Clara, California

Lumenous offers engineering and manufacturing for device makers, with a record that includes the first industrialized stent-cutting system and early laser-micromachining of nitinol. It also coordinates third-party services like lab testing, finite element analysis, and fatigue testing. Its manufacturing covers laser cutting, shape-setting, electrochemistry, metrology, and quality assurance.

Battelle

Website: battelle.org

Location: Columbus, Ohio

Battelle helps device companies move from idea through evaluation and commercialization, with strengths in device security, drug delivery, usability, human-centered design, and neurotechnology. Its cross-industry teams bring science and engineering expertise across a wide range of disciplines. Whether you need development and design, rapid prototyping and testing, or FDA-submission support, Battelle can take a concept toward market. Its brand carries weight well beyond medtech.

Triple Ring Technologies

Website: tripleringtech.com

Location: Silicon Valley (Newark, California), with offices in Boston, Toronto, and Copenhagen

Triple Ring is a co-development firm for medtech and life sciences, founded in 2005, that works alongside clients across R&D, product development, manufacturing, and regulatory approval. It's known for smart, sensor-driven, and imaging devices, and for risk-sharing engagement models that include fixed-bid work and co-investment. Its client work includes HeartBeam's 3D-vector ECG device and MediBeacon's wearable monitor, which earned FDA Breakthrough Device Designation. It came recommended in a medtech practitioner thread, and its co-development model fits teams that want a partner with skin in the game.

DK Engineering

Website: dkengineering.com

Location: San Diego, California

DK Engineering is a full-service product engineering firm serving devices along with other markets. Its clients include Alcon, Bausch and Lomb, BD, Cardinal Health, Haemonetics, and NuVasive. Its engineering, regulatory expertise, and product portfolio make it a steady partner for device programs.

Benchmark

Website: bench.com

Location: Tempe, Arizona

Benchmark provides manufacturing solutions with production sites in ten countries and capabilities across markets, including device development. Over a 40-year history it's contributed products in fluid management, imaging, surgical robots, and connected devices. It specializes in electronic systems and has worked with clients like Medtronic. Benchmark covers design through manufacturing.

Nordson Medical

Website: nordsonmedical.com

Location: Boyle, Ireland, with US and global sites

Nordson Medical is a solutions provider for device companies, with operations in Ireland, Israel, Mexico, and the US. It offers ready-made components and technologies plus an outsourced design and development service that runs a six-step process from concept feasibility through design transfer. Its practices align with FDA design-control guidance, so devices meet user needs and stay safe and effective.

Marturion

Website: marturion.co.uk

Location: Northern Ireland, United Kingdom

Marturion is an independent team of 30-plus people that includes engineers, quality managers, workshop staff, and a marketing group. It designs electronic circuits and embedded software, and it adds workshop services for prototyping and testing plus a small MDD-compliant facility for low-volume production.

DeviceLab

Website: devicelab.com

Location: Tustin, California

DeviceLab is an ISO 13485-certified device design and development firm that's been in business for 20-plus years, with 400-plus projects behind it. It specializes in wearable devices, LED and laser products, IVD diagnostics, patient monitors, and imaging, for use at home, at the point of care, or in the hospital. It's won an MDEA Gold Award and works with clients from early-stage teams to Fortune 100 companies.

Precision Systems (PSI)

Website: psi-software.com

Location: Horsham, Pennsylvania

Precision Systems has long experience in FDA software development for devices, with a focus on efficiency and flexibility as requirements change. It helps clients hold their market position with ongoing technical support, whether building a new custom system or reengineering an outdated one.

Recommended by the medtech community

When we asked medtech founders, engineers, and operators on LinkedIn which design and development firms they'd vouch for, a set of names came back again and again. Several already appear above: Glassboard, Cortex Design, Priority Designs, and Triple Ring. A few more worth a look, straight from the people who've worked with them:

• Factor 7 Medical
• Kaleidoscope Innovation
• Inertia (product development)
• Beacon Launch Partners
• Innovate Medtech
• G8WAY Services
• Legacy Design and Development

These are peer suggestions rather than profiles we've written up, so treat them as leads for your shortlist and do your own diligence.

Frequently asked questions

What does a medical device product design and development company do?

It helps you turn a device concept into a working, compliant product. That usually means user and market research, industrial design, mechanical, electrical, and software engineering, human factors, prototyping, and the design records regulators expect. Many firms also handle regulatory submissions and the handoff to manufacturing.

How do I choose the right partner?

Start with ISO 13485 certification and proof they build proper design controls and a design and development file (DDF). Then check human factors capability, regulatory and submission experience in your device class, how they handle design transfer or manufacturing, and whether they've shipped devices like yours. Communication matters as much as capability.

What's the difference between a design firm and a contract manufacturer?

A design and development firm turns a concept into a compliant device. A contract manufacturer, or CDMO, makes the device at volume. Many firms on this list do both, which lets you avoid a handoff between companies as you move from design into production.

Do I need an ISO 13485-certified design firm?

It's strongly recommended. A partner working inside a certified quality system produces design documentation that holds up in an audit and transfers cleanly into your own records. Ask to see the certificate and the scope it covers.

How much does medical device product development cost?

It varies widely by device class, complexity, and how much of the work you outsource. A simple Class I device costs far less than a connected Class III system with clinical evidence needs. Most firms will scope a project in phases, so you can budget stage by stage rather than all at once.

Where are the top medical device design firms located?

They're spread across the US, Canada, the UK, Europe, Australia, and Asia. This list includes firms on several continents, so you can find a partner in or near your market. Proximity helps with communication and on-site work, though many firms run programs remotely.

How long does it take to develop a medical device?

For most devices, plan on one to three years from concept to submission, depending on class and complexity. Software as a medical device can move faster, while a novel implantable with clinical trials takes longer. A good partner gives you a realistic timeline early, not an optimistic one.

Free Download: Want a PDF copy of this list? Click here to download your free version of the Top 50 Medical Device Product Design and Development Companies.

The bottom line

The right partner can be the difference between a device that reaches patients and one that stalls in development. Use this list to build a shortlist, weigh each firm against your device class, stage, and therapeutic area, and talk to a few before you commit. Whoever you choose, the goal is the same: a safe, effective device that clears regulatory review and improves the lives of the people who use it.

Building the device is one half of the job. Managing design controls, risk, and your quality system is the other. See how Greenlight Guru helps device teams connect design, risk, and traceability as they build.