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Portfolio Awards Capabilities Approach

Every device should start with how you want it to finish.

Ola Tech designs medical devices differently: we start with the customer, then engineer the product, quality systems, reimbursement, and regulatory strategy to get your product safely into patients' lives. That patient stays the reference point at every stage of the journey.

CORE TENANTS
Technical product design Customer exploration Quality systems (ISO 13485) Regulatory & FDA strategy Reimbursement strategy Business development Commercial plan
FIG. 3 — CLOSED LOOP IMPLANTABLE MODULATOR 20.0 MM 24.0 MM TITANIUM ENCLOSURE HEADER / CONNECTOR LEAD BODY ELECTRODES SCALE 2:1 — REV A PILOT PRODUCTION — CLINICAL RELEASE
Ola Technology Portfolio
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Patients Carrying Our Technology
Portfolio

Programs engineered for optimal clinical impact.

Neurostimulation Platform
Hybrid-Powered Stimulation system, from concept, to ASIC architecture through FDA submission.
Cardiac Rhythm Management
Implantable sensor design with IEC 60601 verification and 510(k) clearance.
Percutaneous Drug Delivery Stimulator
Programmable acute infusion pump and stimulation dosing.
Sensor Implant
Ultra-low-power stimulation ASIC and enclosure.
Awards

Trusted By 100+ Medical Device Companies Around the Globe.

Capabilities

Rounding out your technical development team to get to market.

Implantable Circuit Design
Low-power analog and mixed-signal design for hermetically sealed, battery- or wirelessly-powered systems, built to survive decades inside the person who needs it.
Stimulators
Charge-balanced stimulation architectures, closed-loop, from single-channel peripheral devices to high-density neural interfaces.
Quality Systems
ISO 13485 and 21 CFR 820 quality management systems built to hold up under audit, not just at launch.
Regulatory
FDA submission strategy across Breakthrough, 510(k), De Novo, and PMA pathways, informed by direct clearance experience.
Business Development
Reimbursement, Customer Interviews, Positioning, Partnerships, and Capital Strategy that carry a device from bench to the patients who are waiting for it.
Approach

We begin with the Finish Line in mind.

Most companies start with an invention or concept and hope it becomes an approved, impactful, marketable product. We start at the other end: the patient living with the device, the clinician who trusts it, the payer who signs off on it. Every circuit, every quality record, and every regulatory strategy gets engineered backward with that in mind.

That means the same patient stays in view at every stage of the journey, from the first architecture review to the last post-market report, so nothing has to be redesigned, re-explained, or resubmitted later.

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START HERE
Patient Outcome
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Regulatory Pathway
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Reimbursement
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Product Design
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Concept & Prototype
Where most teams mistakenly start
We define the outcome first, then engineer backward through regulatory, reimbursement, quality, and product design to ensure product-market fit.
TEAM
Product
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Reimbursement
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Quality & Regulatory
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Business Development
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