The Top 15 Medical Device Development Companies

A Class II medical device typically takes two to three years to move from initial concept to FDA clearance, and that’s before a single unit reaches the factory floor. Engineering constraints and regulatory review alone can trigger several rounds of redesign before a prototype is even ready for volume production.

Picking the right medical device development company early can cut months, sometimes years, off that timeline, while the wrong fit can leave a promising device stuck in the prototype stage indefinitely.

We’ll cover 15 established medical device development companies, ranging from boutique design studios to large-scale manufacturers, to help your device team find the right match for its specific project.

Top Medical Device Development Companies at a Glance

1. StudioRed

StudioRed

Best for

Industrial design and manufacturing solutions

Headquarters

Menlo Park, CA

Founded

1983

Notable clients

7-Eleven, Microsoft, GE Healthcare, Meta

From a benchtop analyzer small enough for a classroom to a surgical system engineered to match a premium medical brand, StudioRed has spent more than four decades turning ideas like these into finished, FDA-cleared products.

A single team stays on each project from the first sketch through the tooling that puts it into production. Keeping one team in-house protects the original design intent, since nothing gets lost in the handoffs that happen when different firms handle each stage of development. It also means requirements like FDA and ISO 13485 get built into decisions early rather than discovered during a review months later.

The studio has picked up more than 200 international design awards over four decades, including honors from IDEA and Good Design. You can treat decades of award recognition as proof StudioRed has already worked through problems many younger firms are still learning to handle.

Check out StudioRed’s biotech and medical device portfolio to see that track record in action.

2. Battelle

Battelle

Best for

Complex R&D and regulated medical products

Headquarters

Columbus, OH

Founded

1929

Notable clients

NIH, DARPA, Spark Biomedical

As a nonprofit applied science and technology institute, Battelle channels most of its medical design and development work through government and academic research programs. Its projects tend to focus on neurotechnology and drug delivery systems rather than fast turnaround commercial design. Its portfolio includes early-stage research that many product studios wouldn’t take on, alongside longer clinical development timelines.

Device testing runs through its uLAB, a human-centered design space built to mimic clinical conditions with real users. Most of Battelle’s client relationships stay confidential, with case studies published anonymously, which makes its track record harder to verify than firms that name specific projects.

3. StarFish Medical

Starfish Medical

Best for

Full-service development for startups and mid-size companies

Headquarters

Victoria, BC

Founded

1999

Notable clients

LumiThera, ENDRA Life Sciences, Canary Medical

StarFish Medical‘s client roster skews toward startups and mid-sized medtech companies more than large multinational device makers. Its device experience covers cardiovascular and diagnostic products, along with more specialized categories like ophthalmology and microfluidics.

StarFish also keeps most engineering in-house, covering electronics and mechanical design as well as the software and human factors work a device needs to move through validation. StarFish’s in-house range lets it carry a device from early concept through manufacturing transfer, using its own specialists at each stage instead of bringing in outside firms along the way.

4. Rev1 Engineering

Rev1 Engineering

Best for

First-of-kind, minimally invasive device development

Headquarters

Temecula, CA

Founded

2007

Notable clients

Ablative Solutions, Topera (acquired by Abbott), Ablation Frontiers (acquired by Medtronic)

Rev1 Engineering specializes in innovative medical devices that you can’t build by adapting an existing product, such as structural heart tools that require engineering a solution from scratch. The firm operates as a subsidiary of ASAHI INTECC, a Japanese healthcare product development company, which gives it financial resources and room to experiment that a typical independent design shop wouldn’t have.

Rev1 runs its own cleanroom manufacturing space near its Temecula headquarters, built for early-stage and low-volume production rather than full-scale runs. That setup suits earlier-stage projects better than mass production.

5. Veranex

Veranex

Best for

Integrated design-through-clinical development

Headquarters

Raleigh, NC

Founded

2021

Notable clients

Not publicly disclosed

Veranex is younger than its device design roots suggest. Summit Partners formed the company in 2021 by rolling up several established design and clinical research firms, including Ximedica, a device developer with decades of history, into one medtech services group. That means much of Veranex’s technical expertise predates its own founding date.

The firm handles more of a device’s path to market internally than most design firms manage alone, reaching past initial engineering into steps like reimbursement strategy and market research. Firms on this list that focus mainly on industrial design or engineering usually hand those later stages to separate consulting groups, work Veranex keeps under its own roof instead.

6. Stryker

Stryker

Best for

Large-scale orthopedic and surgical equipment manufacturing

Headquarters

Kalamazoo, MI

Founded

1941

Notable clients

N/A

Homer Stryker was a practicing orthopedic surgeon before he became a device maker, and many of his company’s early products stemmed directly from problems he encountered while treating patients. His oscillating cast saw, one of the company’s best-known early inventions, allowed surgeons to remove casts without cutting into the skin beneath, a common hazard with the blades used at the time.

Today, Stryker designs and manufactures its own branded product lines rather than taking on outside development projects the way most other companies on this list do. Hospitals and surgical staff buy Stryker equipment directly, so its device work stays within its own portfolio rather than running through a client roster.

7. Paragon Medical

Paragon Medical

Best for

Surgical instruments and implantable devices

Headquarters

Pierceton, IN

Founded

1991

Notable clients

Not publicly disclosed

Paragon Medical operates as part of AMETEK, a diversified industrial technology and design company. Its work centers on manufacturing implants and surgical instruments for orthopedic device brands, including hip and knee replacements and spine and trauma hardware.

Paragon’s unique bioskills labs allow surgeons to practice techniques and test new instruments on cadaver or synthetic tissue before a device reaches the operating room. Running that testing in-house helps Paragon catch design issues earlier in development, ahead of a product’s actual release.

8. DeviceLab

DeviceLab

Best for

Connected and wireless medical devices

Headquarters

Tustin, CA

Founded

1998

Notable clients

Alcon (LensX), Philips (Zoom), MediPurpose (babyLance)

DeviceLab has completed more than 100 projects over its history, most of them tabletop instruments and handheld tools like diagnostic analyzers and laser-based surgical systems. The firm’s strongest specialty is combining mechanical and optical engineering into a single compact device, often incorporating custom electronics rather than relying on off-the-shelf components.

DeviceLab holds ISO 13485 certification for its design and development work. Its project list includes dental equipment and ophthalmic surgical tools, spanning multiple clinical specialties. Most of its clients are based in Southern California, though the firm has also taken on device projects from companies across the country.

9. Tecan

Tecan

Best for

Complex medical instrument contract manufacturing

Headquarters

Morgan Hill, CA

Founded

1990

Notable clients

Illumina, Abbott, Boston Scientific

Tecan builds instruments that combine fluid handling with optics or precision motion control inside one compact housing, the kind of benchtop or point-of-care device where those systems need to work together directly. Integration at this level is hard to split across separate specialists, so most companies in this category keep design and manufacturing with a single contractor.

Its manufacturing footprint spans facilities in Northern California and Penang, Malaysia, each large enough to support higher-volume production once a device moves past its early manufacturing stage.

10. Medtronic

Medtronic

Best for

Large-scale implantable and chronic disease management devices

Headquarters

Minneapolis, MN

Founded

1949

Notable clients

N/A

Medtronic started in 1949 as a medical equipment repair business run out of a Minneapolis garage. Fixing other companies’ equipment exposed gaps in what was available at the time, which eventually pushed the founders into building devices of their own.

Medtronic’s legal headquarters moved to Dublin after a 2015 merger with Covidien, though its operational base has stayed in Minneapolis. Like the other large device makers on this list, Medtronic designs and sells its own product lines directly to health systems rather than taking on outside development projects.

11. Phillips-Medisize

Phillips-Medisize

Best for

Drug delivery and high-volume CDMO manufacturing

Headquarters

Hudson, WI

Founded

1964

Notable clients

Bayer, GlucoModicum

Phillips-Medisize focuses heavily on drug-delivery devices that pair hardware with a drug or biologic, like autoinjectors and insulin pens. In 2025, it added Vectura’s inhalation technology, including dry powder and metered-dose inhalers, expanding its reach further into that side of drug delivery.

The company runs roughly 30 development and manufacturing sites spread across three continents, a scale most firms on this list don’t operate at. Drug delivery and diagnostic work account for the vast majority of its revenue, ahead of general medical device manufacturing.

12. Jabil Healthcare

Jabil Healthcare

Best for

Large-scale medical device manufacturing

Headquarters

St. Petersburg, FL

Founded

1966

Notable clients

Elvie, Candela, MIS

Jabil Healthcare operates as a dedicated business unit inside Jabil Inc., a global electronics manufacturer that spent decades building consumer and industrial hardware before expanding into medical devices. The healthcare unit launched in 2020, years after Jabil’s broader manufacturing business had already become a success.

Jabil’s scale carries over directly into its medical device work, giving Jabil Healthcare manufacturing capacity closer to a large electronics contractor than a specialized medtech shop. Its healthcare segment covers categories like minimally invasive devices and robot-assisted surgery equipment, built using the same production infrastructure as its non-medical electronics business.

13. Cadence Inc.

Cadence Inc.

Best for

Development-to-manufacturing transition

Headquarters

Staunton, VA

Founded

1985

Notable clients

Not publicly disclosed

Cadence Inc. runs manufacturing sites in Virginia, Pennsylvania, Rhode Island, and Wisconsin rather than concentrating production in a single location. Its work centers on some of the same orthopedic categories as Paragon Medical, including spine and joint replacement hardware.

Cadence recently expanded cleanroom capacity at its Virginia facility, adding capacity for higher-volume production as client programs move from prototype to full manufacturing. Projects such as drug-delivery components and diagnostic sub-assemblies run through the expanded space alongside the company’s orthopedic device lines.

14. Pathway Medtech

Pathway Medtech

Best for

Contract manufacturing with regulatory support

Headquarters

Austin, TX

Founded

2013

Notable clients

Not publicly disclosed

Pathway Medtech was founded in 2013 by two mechanical engineers, making it a newer, smaller operation compared to others on this list. The company built its practice around folding regulatory support directly into contract manufacturing, so FDA clearance work runs alongside production.

The firm has worked with more than 40 companies and helped bring more than two dozen products to market since opening. A client list of that size suggests a business built around close, hands-on work across a limited number of active projects at a time, rather than the volume that larger firms on this list can handle.

15. GE HealthCare

GE Healthcare

Best for

Diagnostic imaging and large-scale medical technology manufacturing

Headquarters

Chicago, IL

Founded

1892

Notable clients

Not publicly disclosed

GE HealthCare traces its roots to 1892, when General Electric’s early X-ray work laid the groundwork for what would become its medical technology division. The unit only became an independent public company in 2023, when General Electric spun it off from the rest of the business.

Imaging equipment and patient monitoring systems make up the bulk of GE HealthCare’s current product lines, which, like Stryker and Medtronic products, are sold directly to hospitals. Its Edison platform layers AI and data tools on top of that hardware, aimed at applications such as faster image analysis and hospital workflow management.

How To Choose the Right Medical Device Product Development Company

The right choice depends on more than reputation alone. Where you land often depends on your device’s development stage, your regulatory path, and how you plan to handle manufacturing once a design is ready.

The factors below cover what to consider before signing with any development partner.

1. Define Your Device Type and Development Stage

A surgical instrument, a connected wearable, and an implantable device call for different design skills and testing protocols. Matching your device type and current development stage to a firm’s actual experience narrows the list fast, before you invest time in demos or calls.

StudioRed, for example, keeps one team on a device from concept through manufacturing support, so you’re not stuck re-explaining design decisions to a new vendor every time the project moves into another stage.

2. Verify Regulatory Experience

Look for a firm with a track record of FDA 510(k) submissions, PMA support, or CE marking, depending on where you plan to sell the device.

ISO 13485 certification is common enough among credible firms by now that most already carry it, so it works best as an early screening step.

3. Evaluate the Firm’s Portfolio

Ask for case studies in your specific device category instead of a general portfolio page. A firm that has already solved problems similar to yours will move faster and make fewer mistakes than one starting from scratch in that category.

Some firms can only share limited details due to client confidentiality, but you can ask directly about relevant experience even when the case study itself is thin.

4. Ask About Manufacturing Transfer

Some firms hand off once they deliver a working prototype, leaving scale-up to your team or a separate contract manufacturer. Others stay involved through production ramp-up, supporting tooling and supply chain setup as volume increases.

Firms like StudioRed fall into the second group, working through manufacturing support rather than stopping at a finished prototype. Ask directly which model a firm defaults to, since assuming the wrong one can add months to your timeline.

Let StudioRed Take Your Medical Device From Concept to Clinic

Choosing among medical device development companies comes down to matching a firm’s strengths to where your device sits today. A firm’s fit becomes clearer once you ask how its past work lines up with your specific device category. StudioRed can speak to that experience from the first sketch through manufacturing support.

StudioRed has spent more than 40 years turning early concepts into devices that make it through FDA review and into clinical use, work you can see across our biotech and medical product portfolio. If you’re weighing a development partner for your next device, contact us today, and our team will walk through what your specific project would need at each stage.

FAQ

What’s the Difference Between a Medical Device Design Firm and a CDMO?

A medical device design firm focuses on engineering and product development, then often hands the finished design to a separate manufacturer. A contract development and manufacturing organization (CDMO) handles both development and production under one roof.

Many of the firms on this list sit somewhere in between, offering design work along with in-house prototyping or low-volume manufacturing support, without functioning as a full-scale CDMO. It helps to ask directly which parts of the process a firm owns, and at what volume, before signing on.

How Long Does Medical Device Development Take?

Medical device development timelines vary widely by device class and complexity. A simple Class I device might move from concept to market in under a year, while a Class III implantable device on the PMA pathway can take three to five years once you factor in clinical trials and FDA review.

Regulatory strategy and manufacturing readiness tend to add more time than the engineering work itself.

What Regulatory Certifications Should a Development Partner Have?

ISO 13485 certification is the baseline standard for quality management in medical device development, and most credible firms carry it. Beyond that, look for direct experience with FDA 510(k) submissions, PMA support, or CE marking under EU MDR, depending on where the device will be sold.

A firm that can point to specific past submissions is a stronger signal than certification alone.

When Should a Startup Bring in a Development Partner?

Most startups benefit from bringing in a development partner as soon as they have a validated concept and a rough sense of the regulatory requirements. Early involvement helps avoid design choices that create problems later during FDA review or manufacturing scale-up.

Waiting too long to bring in outside expertise is one of the more common ways early-stage teams add unplanned time and cost to a project.