Bioana-MedFire Start-up Package

Transforming Lives Through Innovation -Together

United States Partner

START-UP PACKAGE

Fast-track your

product development with professional expertise We guide you to more efficient approaches in developing safe, effective, high-quality devices that will positively impact people’s lives.

FIND OUT WHY researchers, entrepreneurs and startup in the medical device field rely on us.

“The Bioana Team was truly professional.

They accelerated our entry into the market faster than we expected, which moved our revenue prejections ahead of schedule.”

– Staci Mehl, VP, MedFire Innovations

POPULAR SERVICES Overcome obstacles and achieve product goals with strategic support.

Conceptualization

FDA Strategies

Patent Opportunities

Businness Simulation

Transform ideas into visual

Assess IP availability to protect your ideas

A customized game plan to facilitate faster approvals

Model and test long-term profitability

Conceptualization

Create your product with a user-oriented industrial design process Step 1: Ideation Leverage our Design Thinking methodology to help you turn ideas into something tangible.

Step 2: Sketches Receive physical and digital versions of three (3) proposed concepts.

Step 3: 3D Models/Renderings Develop conceptual, tangible versions of your product to share with others.

Patent Opportunities

Strategies to assess and secure IP protection

INTELLECTUAL PROPERTY Use our Intellectual Property Analysis to identify product novelties

and take steps to protect them.

PATENTABILITY ANALYSIS Verify the viability of a patent for your product, service or idea in your country or market.

FDA Approval Strategies Utilize best practices to increase likelihood of FDA approval Understand the step-by-step process required to obtain FDA approval for your product.

Device Classification Determine the appropriate device classification based on uses, risks, and more.

Regulatory Pathways Create a game plan to pursue FDA approval.

Business Simulator Prove your profitability

Create business models that entice and assure investors of your successful future.

FINANCIAL MODELS Layering your market analysis with our medical device cost analyses to develop compelling investment portfolios.

EARLY STAGE VALUATION Develop confident analysis of your early stage valuation propositions.

Guiding businesses at any stage to become the success stories they deserve Putting design, regulatory and business expertise at your service to pave a more efficient route to bring your innovations to market.

BIOANA SUCCESS STORIES

SELF-PAP FOR CERVICAL CANCER SAMPLING The Challenge Text stating the challenge for this device or technology. Please write 3 sentences or less.

Our Solution We designed a lower-cost, easy-to-use and effective device for women to collect the samples necessary to identify this threatening cancer.

MULTI-FUNCTIONAL DENTAL INSTRUMENT The Challenge Text stating the challenge for this device or technology. Please write 3 sentences or less.

Our Solution Innovative design to combine the four most important tools for dental restoration into a simple, aesthetically pleasing instrument with an ergonomic grip for advanced precision. skin recovery.

BIOANA SUCCESS STORIES

ZIPE®

Ziptek received FDA clearance in March 2017.

We are currently helping Ziptek with Quality Assurance.

The Challenge Text stating the challenge for this device or technology. Please write 3 sentences or less.

Our Solution Quality Assurance strategies to help this FDA-approved product continue to produce high performance in tissue repair implant surgery.

AEROSKIN The Challenge Text stating the challenge for this device or technology. Please write 3 sentences or less.

Our Solution We performed design iterations based on the results of the computational fluid dynamics, for delivering two biomaterials at the same time and providing a thin atomized cellular layer for an incredibly faster skin recovery.

BIOANA SUCCESS STORIES

TRANSPEDICULAR SCREW The Challenge Text stating the challenge for this device or technology. Please write 3 sentences or less.

Our Solution For minimizing stress concentration in the surface of the screw, we proposed a redesign of the conventional geometry of the screw aiming to redistribute stress homogeneously within its body.

We can help!

Because creating the groundbreaking medical product was the hardest part.

Our Start-up Package will provide you a path to success.

Contact us today to get started! www.bioana.com.mx

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United States partner MedFire Innovations, Inc. 2425 Camino Del Rio S, suite #125 San Diego, CA 92108 USA (888) 560-1140 medfireinfo@medfire.com www.medfireinnovations.com

CONTACT US