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Medical Device Development

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

Ola Tech develops medical devices in reverse. We define the clinical outcome, regulatory pathway, and reimbursement case first, then engineer the product and quality system to meet them. The patient remains the reference point at every stage, so nothing gets redesigned, re-explained, or resubmitted later.

See how we work
Technical product design
Customer exploration
Quality systems (ISO 13485)
Regulatory & FDA strategy
Reimbursement strategy
Business development
Commercial plan
Early concept sketches beside the working handheld prototype they became
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Regulatory Market Approvals
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Issued Patents
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Commercial Revenue Enabled
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Patients Living with Ola Technology

Products with the patient in mind.

Tined implantable lead under microscope inspection
Neurostimulation Platform
Hybrid-powered stimulation system carried from concept and ASIC architecture through FDA submission.
Clinical infusion and stimulation console in use at the point of care
HyperSonic Therapy
Non-invasive neuromodulator with IEC 60601 V&V to early clinicals.
Wearable ankle-worn neurostimulation devices
Percutaneous Drug Delivery Stimulator
Programmable acute infusion and stimulation dosing in a single percutaneous platform.
Millimeter-scale hermetic sensor implant beside a penny for scale
Sensor Implant
Ultra-low-power sensing ASIC in a hermetic, implant-grade enclosure.

Trusted by more than 50 medical device companies worldwide.

G2 award badges: Leader, Best Support Mid-Market, Momentum Leader, High Performer Europe, High Performer Mid-Market, and Best Relationship

The depth your development team needs to reach the market.

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
Implantable Circuit Design
Low-power analog and mixed-signal design for hermetically sealed, battery- or wirelessly-powered systems, built to provide maximum therapy for the patients in need.
Market Access
Reimbursement strategy, health economics and outcomes evidence, coding and coverage pathways, and payer relations, so the question of who pays for the device is answered before it is built.
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
Customer discovery, positioning, partnerships, and capital strategy that carry a device from the bench to the patients waiting for it.

We begin with the finish line in mind.

Most companies start with an invention and hope it becomes an approved, reimbursed, marketable product. We start at the other end: the patient living with the device, the clinician who trusts it, and the payer who signs off on it. Every circuit, quality record, and regulatory decision is engineered backward from that endpoint.

The costliest failures in this industry are rarely technical. They come from discovering the regulatory pathway, the reimbursement case, or the real customer too late. Thirty years of programs have taught us to settle those questions before the first prototype, not after.

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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, so the device that reaches the bench is the one the market has already accepted.

Specialists across the commercial pathway.

Product and business development lead
Product & Business Development
Reimbursement lead
Reimbursement
Quality and regulatory lead
Quality & Regulatory
Clinical lead
Clinical

Wherever your program stands, start the conversation.

An early conversation costs nothing. A late course correction costs dearly.

Get in touch
We typically reply within one business day.