BioRep - FloodGate Medical

Medical device contract design & manufacturing

About Us

We’re your one partner for end-to-end success. For decades, Biorep has been delivering innovative solutions with a sole focus on designing, developing, and manufacturing regulated medical devices. We have everything entrepreneurs need: the regulatory registrations and certifications, trusted in-house expert knowledge, engineering excellence, scalable manufacturing capabilities, a broad band of global suppliers, and a vertically integrated process to take your medical device from napkin sketch to launch.

Look at the Leaders of Biorep

Felipe Echeverri

Chief Executive Officer

Victoria Enjamio

VP of Operations

Frank Martelli

Chief Financial Officer

Core Services

Medical Device Prototyping & Early Development

Validate form, fit, functionality, manufacturability, and user interface features, fast. Biorep’s rapid prototyping capabilities include rapid iteration, design for manufacturability (DFM) review, tolerancing, and early risk reduction.

We work closely in design control phases so that prototypes progressively mature into manufacturable designs. This helps you de-risk later stages.

Medical Device Contract Manufacturing (Full-Scale Production)

Once your design is ready for scale, our medical device contract manufacturing capability is your bridge to robust, high-yield production. We focus on:

-Process validation
-Traceability & serialization
-Supply chain sourcing and vendor quality
-Equipment qualification, calibration, maintenance
-Change control and CAPA management

Our vertically integrated structure minimizes handoffs and simplifies oversight. We become an extension of your engineering and quality teams.

Medical Device Assembly Services

Complex subassemblies, final device integration, and test staging all demand high precision and cleanroom discipline. Our medical device assembly services include:

-Multi-component assembly (mechanical, micro-mechanical, electromechanical)
-Automated or manual assembly depending on volume and complexity
-In-process inspection, functional and environmental testing
-Packaging interface and labeling readiness

Having assembly in-house means greater control, faster cycle times, and better responsiveness to change.

Company Spotlight Video

Success stories

Knot Pusher – Extracorporeal Knot Placement Device

Challenge:
A next generation instrument that would deliver knots tied in the extracorporeal space, and delivered to an intracorporeal target site in a limited access setting. Device needed to have secure suture retention characteristics, eliminate the hand fatigue (normally caused by existing mechanized knot delivery devices), and needed to be manipulatable in fields where access and space is extremely limited.

Solution:
Designed a device in which the primary position of the suture eyelet gate is closed (as opposed to open) in order to address hand fatigue; the moving eyelet gate closes fully to complete circumferential suture entrapment (to address suture retention security); and with an extremely low profile and offset tip to address limited access/space settings.

Result:
Utilized commercially in over 15,000 clinical procedures to date.

Atrial Lift System – Addresses the difficulty of inadequate exposure during MICS procedures

Challenge:
Need for a next gen retraction instrument that would retract the atrial wall in a circumferential manner in a limited access setting. Device needed to have: different sizes to accommodate varying atrium dimensions; be easily and securely assembled/disassembled in fields where access and space is extremely limited; and facilitate delivery of CO2 into the working space.

Solution:
Designed a device with: multiple component sizes to address varying atrium dimensions; with a flexible component (VISOR) which could be rolled into a smaller dimension and “slide” into a corresponding locking-support structure (S-BLADE) easily/efficiently/securely; and has a flexible component with the ability to “unfurl” under its own biasing to provide circumferential atrial wall retraction. The stabilization component (S-POST) which attaches to the support structure utilizes a “ball and socket” style engagement mechanism for ease of assembly/disassembly, has a CO2 port, and an open inner lumen in which CO2 can be delivered to target site.

Result:
Utilized commercially in over 10,000 clinical procedures to date.

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