Medical device development

We transform your ideas into prototypes and prototypes into ready-to-sell products -- fast.

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We get it. Getting a medical device to market can be stressful.

It can feel like a race against time
There is no room for mistakes
Regulations are confusing
And not enough R&D or Engineering personnel to make it happen
This usually ends up in setbacks, unnecesary costs and market entry delays of years.
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Our services

No matter at what stage of
development you're in, we're here to help.

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Our services

We work with Startups and Enterprises.

Top Solutions for

Startups

Concept development – Industrial Design

MVP Prototypes for market testing

Design for Manufacturing and Assembly

Small Batch Prototype Production for Testing

FDA 510k Clearance and registrations

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Top Solutions for

Enterprises

Expand your in-house R&D and Engineering team

Product portfolio upgrades/improvements

Design Optimizations

Substantial Equivalence Benchtop Testing for 510k

Product Quality Testing

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Our value proposition

What makes Bioana Unique?

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Problem Identification

We are good in identifying the real problem to solve.

User Centered Approach

We design the correct product for market success.

Design for Manufacturability

We design products that can be built for a seamless transition to production.

Industrial Design

If the product is both necessary and useful, then we don’t hesitate to make it beautiful.

Biomedical Experts

We have specialized experts in the field.

FDA Quality System and Design Controls

Quality is embedded into our system, as a disciplined approach to innovation, that empowers the best results in a faster way.

Four simple steps to get your product to market.

01

Contact us

Fill out our contact form or schedule a call with us. We can also send a mutual Non-Disclosure Agreement.

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02

Discovery Call

Together we'll discuss your project and the next steps to take.

03

Proposal

We'll prepare a proposal based on your needs.

04

Kickoff

The moment we've been waiting for. It's time to get your product to market.

Bioana

The engineering behind great medical products

We are a passionate, creative, visionary and skilled team that care about improving people’s health by solving problems with simple design and clever engineering.

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We help our clients transform their ideas and market opportunities into safe, cost-effective and innovative medical products through a fast-systematic design process. Our projects can be classified under 4 main categories:

Cardiovascular
Orthopedics
Sample Collection Devices
General Hospital Devices

We can provide complete turnkey development services for your product or we can focus on a subsystem. Either way, we become an extension of your team to ensure an optimal outcome.

Our Work

Learn more about our work.

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Bioana

Get your product to market today.

We will provide you with a fast-track development of a safe, effective and ready to sell product delivered on-time and on-budget for you to become the first to reach the market, a real innovator. We want to help you achieve the satisfaction of seeing your product saving patients lives or improving their health and quality of life.

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Got any questions?

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