Cortex Landing Page

Move Your Medical Device to Market Faster

Get the right medical device expertise exactly when you need it to build a product designed for commercial success, without the overhead of building a full in-house team.

Trusted by innovators

medtronic
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CloudDX BW 1
Laborie1 1 2
raytheon
epineuron
neurogeneces
nia
imgi 1 Data Driven Surgical Recovery white logo 1
Cohesys logohorizontalcolour 2
TheraB Logo Main 2
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Build Medical Device Designed for Commercial Success

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Greater Market Adoption

Design products that meet the needs of clinicians, patients, buyers, and key stakeholders.

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Reduced Technical & Regulatory Risk

Bring the right medical device expertise to identify assumptions and address challenges early.



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Faster Time to Market

Build for users and make informed decisions early to reduce costly rework.

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Lower Development Costs

Avoid unnecessary rework and invest in specialized expertise only when it’s needed.

The Biggest Barriers to Commercial Success

After working with medical device companies across a wide range of technologies, we’ve found that the same challenges repeatedly stand in the way of successful commercialization.

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Limited voice-of-customer research

Leading to costly decisions based on gut instinct or limited data.

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Treating design as an afterthought

Teams focus on making the technology work first, and later think about how it will be used in the real world

Product cube with a medical cross and warning symbol.

Limited hardware development expertise

Your team has strong software or scientific expertise but lacks the hardware development experience needed for a successful medical device

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Long-term hiring for a short-term need

Hiring an in-house team is slow and long-term when many roles are only needed temporarily.

Person beside a speech bubble containing a question mark.

Limited voice-of-customer research

Leading to costly decisions based on gut instinct or limited data.

Pencil beside a clock.

Treating design as an afterthought

Teams focus on making the technology work first, and later think about how it will be used in the real world

Product cube with a medical cross and warning symbol.

Limited hardware development expertise

Your team has strong software or scientific expertise but lacks the hardware development experience needed for a successful medical device

Briefcase beside an hourglass

Long-term hiring for a short-term need

Hiring an in-house team is slow and long-term when many roles are only needed temporarily.

How Cortex Solves These Challenges

We challenge assumptions early

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two designers looking at their concept board

Before committing to architecture or features, we ask the right questions identify assumptions, and validate decisions with evidence instead of guesswork. This eliminates ambiguity and de-risk as early as possible to plot the right path with every fork in the road.

We design around real users

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Primary stakeholders in design controls for BoneTape: surgeon, nurse, and cleaning technician.

Human centered design starts from day one – we seek to understand your users, all stakeholders to understanding what your product needs to be.

We bring the right medical device expertise

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At Cortex, medical devices are all we do. Our team has worked across a wide range of device categories, giving us the experience to anticipate challenges, adapt to different products, and navigate the technical, regulatory, and usability demands unique to medical device development.

We become the team you need for as long as you need it

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Culture Team

When working with Cortex, you are scaling your team with the right specialists at the right stages of development, for the tiem it needs. Avoid the time and overhead of building a permanent in-house team.

We’re designers at heart

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Phase2

Everyone at Cortex is a “designer.” We handpicked our experts not only for their technical expertise, but for their curiosity, willingness to solve problems, and ability to explore alternative solutions. They understand how every decision impacts technical, user, business, and regulatory constraints—helping us find the best solution for every client.


See How We Helped Turn a Thesis into an Acquisition in 37 Months

Timeline of TheraB SnugLit’s 37-month development, from early de-risking and benchtop testing through prototyping, usability testing, FDA 510(k) approval, and acquisition.

See How We Helped Turn a Thesis into an Acquisition in 37 Months

Timeline of TheraB SnugLit’s 37-month development, from early de-risking and benchtop testing through prototyping, usability testing, FDA 510(k) approval, and acquisition.

Other Devices Brought to Market

FluidAI system

FluidAI

Post-operative wound drainage monitoring system

nerve stimulation system

Epineuron

Wearable nerve-regeneration stimulation system

Huron Technologies digital pathology scanning devices with integrated displays, showing multiple medical imaging systems with blue interface accents arranged on a wooden surface.

Huron

Design of digital pathology scanning systems

wearable bioelectronic system next to a phone app

Neursantys

Wearable neuromodulation device

A surgeon is using a device on a simulated mannequin head.

Cohesys

Medical ultrasonic welding tool

Our Development Process


Every step is backed by a team that’s personally invested in your success—from your first conversation through final delivery. Our size and flat structure keep leadership involved and empower our teams to move quickly.

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Basecamp

Validate and de-risk the opportunity

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Discovery & definition

Define user needs and requirements

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Concept Exploration

Explore and refine solution concepts

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Prototype Design

Build, test, and iterate prototypes

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Product design

Engineer for manufacturing and verification.

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Manufacturing

Scale production with quality

The Right Partnership Matters

At Cortex, we know that choosing the right development partner is about more than technical expertise—it’s about trust and finding a team that shares your goals. We’d love to learn about your product and explore whether we’re the right partner for you.

Let’s Start the Conversation.

Get to Market Right

the First Time