Device Prototyping

Device Prototyping

Poba Medical is a medical device company specializing in rapid-turn balloon and device prototyping services. Our expertise ranges from from guidewire design, self-expanding and balloon expandable stent design, covered implant and cuff design, structural heart delivery system optimization, RX and OTW catheter design, drug delivery devices, neurovascular applications, endovascular repair, ENT device optimization, woman’s health, veterinary device design, spinal disease, robotic surgery accessory tools, ablation devices, and many other emerging balloon and device concepts. Poba Medical brings a unique understanding of the medical device requirements including regulatory affairs, intellectual property, clinical trial design, design control, material selection, supplier quality systems, lead time impact, project management, and capital conservation. Through our partnership with Byond Medical our device design and manufacturing expertise spans over a combined 70 years.

R&D

We manufacture medical balloons in different varieties of Nylon, Pebax, Urethane, PET, Poba 51™, along with different blends of all of the above with 30+ years of experience.

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Clinician Entrepreneurs

Helping clinician entrepreneurs bring medical device technologies to market with custom balloon design, device prototyping and speed to market.

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Self Expanding & Balloon Expandable Stent Design

Structural Heart Delivery System Optimization

Guidewire Design

Covered Implant & Cuff Design

RX & OTW Catheter Design

Drug Delivery Devices

Neurovascular Applications

Endovascular Repair

ENT Device Optimization

Women's Health

Vetinary Device Design

Spinal Disease

Robotic Surgery Accessory Tools

Ablation Devices

R&D Projects:

Poba Medical operates in an ISO 14644 Class 8 (100,000) cleanroom environment. Many early stage development projects utilize the rapid prototyping skills of our seasoned medical device partnerships. Whether rapidly whiteboarding device concepts or turning whiteboard sessions into first prototypes or FIM devices, Poba Medical provides unparalleled creativity and development support.

Clinician Entrepreneurs:

Poba Medical targets clinician entrepreneurs looking for early stage development support or business direction with their “nagging” unmet clinical needs. Many of our inventors have strong relationships through Scientific Advisory Board appointments with the largest medical device companies in the world. Here's where Poba Medical can help. We provide direction and device prototyping support and ideas to our clinician entrepreneurs as they search for better solutions to daily patient care period.

Our deep expertise spans the landscape of specialties including; interventional cardiology, spinal surgery, cardiac surgery, ENT, gastroenterology, oncology, radiology, interventional neuroradiology, women’s health, transcatheter therapeutics, and emerging robotic surgery applications.

Sizes, Ranges and Burst Capabilities

Poba Medical operates in an ISO13485 approved ISO-8 cleanroomwith ten (10) dedicated balloon forming production lines capable of balloon production of 25,000 balloons per month/per customer. Additional catheter sub-assembly capability includes:

Diameter

1mm to 45mm

Length

5mm to 320mm

Burst

blow balloons
with RBP (rated burst pressure) of up to 48 atm - 700 PSI

Compliance

Balloons from non-compliant to semi-compliant; Materials from polyurethane to multi-layer nylons

Sizes, Ranges and Burst Capabilities

Poba Medical operates in an ISO 14644 Class 8 (100,000) cleanroom with ten (10) dedicated balloon forming production lines capable of producing 25,000 balloons per month/per customer. Additional catheter sub-assembly capability includes:

Diameter

1mm to 45mm  

Length

5mm to 320mm

Burst

Blow balloons
with RBP (rated burst pressure) of up to 48 atm - 700 PSI

Compliance

Balloons from non-compliant to semi-compliant; Materials from polyurethane to multi-layer nylons

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Balloon Shape
Nylon
Balloons
Balloon Shape
Pellethane
Balloons
Balloon Shape
Pebax
Balloons
Balloon Shape
PET
Balloons
Balloon Shape
Polyurethane
Balloons
Balloon Shape
Poba 51™
Balloons
Balloon Shape
Catheters
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