Connected Therapeutic Devices

FDA Clearance Gets You to Market. The Connected System Earns It.

Full-stack development for connected implantables and body-worn therapeutic devices. Built so therapy adherence, clinician workflow, and outcomes data hold up in the field.

Talk With Our Team

One Team Across the Full Stack

No vendor fragmentation, no integration gaps at the seams.

Implant to Wearable

Class III implantables anchor our work.

Built for Class II and III Programs

Regulatory pathway and architecture designed together from day one.

FDA Cybersecurity Built Into Architecture

So Section 524B never slows the submission.

The Connected Medical System

A Therapeutic Device Is One Component of a Five-Layer Connected System.

We treat regulatory and architecture as one design problem, and three commitments make that integration durable rather than declarative.

A connected therapeutic device acts on the patient. That bidirectional, safety-critical interaction separates this category from monitoring, diagnostics, and consumer health.

The device delivers the therapy. The product your company ships is the system around it, five interconnected layers that each carry their own performance, security, and documentation requirements.

DEVICE Embedded firmware and wireless radio executing therapy in real time.
WIRELESS LINK BLE or near-field RF carrying commands and patient data, subject to wireless certification.
COMPANION APP OR GATEWAY The patient-facing interface and the communication bridge between device and cloud.
CLOUD PLATFORM Data infrastructure, remote therapy management, and post-market support.
CLINICIAN INTERFACE Therapy programming, patient monitoring, and clinical management.

Integration failure anywhere in that chain has patient safety implications. We build across all five layers, and the system-level decisions get made by the same team building each component.

WHAT WE SOLVE FOR

The Failure Modes We Prevent Start Early.

They live at the seams between layers, vendors, and parallel tracks that never sync. These are the six we see most.

EXPAND ALL

The Integrated System Gap

The layer a team has never shipped is the one it can't assess. On a five-layer system, most teams are deep in one and lighter in the rest.

Why It Happens

Depth in one layer doesn't transfer. A firmware team that has never built a regulatory-compliant mobile and cloud stack doesn't know where its assumptions break, and no one on the program owns the view across all five.

What it costs

Cross-layer risks never make the test plan. The integrated system ships with failure modes the team never thought to test for.

Architecture Decisions Made in Isolation

Chipset, connectivity protocol, and mechanical envelope get committed months before the clinical and regulatory requirements they need to support are fully known.

Why It Happens

Engineering and clinical development run on separate schedules, with nothing forcing them to sync. Engineering commits when procurement and tooling deadlines require it. Clinical and regulatory scope is still being shaped by classification and research that haven't concluded.

What it costs

Requirements the architecture didn't anticipate force a second architecture decision, made under deadline, undoing months of engineering built on the first.

Security Treated as a Documentation Exercise

Security work often starts when the submission process demands it, long after the architecture is locked in place.

Why It Happens

524B reads as a filing obligation, so the work lands with whoever owns the submission instead of whoever owns the architecture. But whether the device is secure was decided in that architecture, in the update path, the interfaces between subsystems, and how components authenticate each other.

What it costs

Gaps surface at submission, and the fixes cut against years of settled architecture. What should have been a design input becomes structural rework at the point in the program least able to absorb it.

Partner Fragmentation at the Seams

Nobody tests the seams between vendors until the pieces have to work as one device. Each one tests against their own contract.

Why It Happens

A contract defines a deliverable. It says nothing about the assumptions the next team is building on. Firmware's timing assumptions and mobile's connection-state assumptions can both be correct and still not match.

What it costs

The failures that surface have no owner. Every vendor delivered exactly what their contract specified, so the fix means renegotiating scope on a schedule that's already moving.

Connected System V&V Starting From Zero

The therapy mechanism gets validated on its own. The connected system delivering it has never been tested as a whole.

Why It Happens

Every process on the program was built to validate the therapy. None of them cover the system under dropped connections, low battery, or concurrent users. There is no traceability or test infrastructure to extend, so system V&V gets scoped for the first time after the therapy work is done.

What it costs

A firmware fault or a connectivity drop that corrupts therapy delivery has nothing in place to catch it. Standing up system V&V becomes an unplanned program of its own, inside a timeline that never accounted for it.

The Design History is Built After the Fact

By the time the Design History File comes due, the reasoning behind the design lives only in the heads of people no longer on the program.

Why It Happens

Partners treat design controls as paperwork to close out after the build instead of a controlled process the build runs under. While decisions are being made, capturing the reasoning behind them is nobody's job.

What it costs

The product carries missed user needs, uncaught risks, and design choices no one can reliably verify. Closing the file means reassembling the record from memory and scattered artifacts.

Every one of these traces to the same root. Decisions made in isolation, early, before the system is whole. That is where we work.

Tell Us About Your Challenge

REGULATORY & COMPLIANCE

We Build Inside the Regulatory Environment.
It Shapes How We Work.

We treat regulatory and architecture as one design problem, and three commitments make that integration durable rather than declarative.

SECURITY & DESIGN CONTROLS

Regulatory strategy baked into architecture from day one.

Security designed at the system level. 524B documentation generated as part of development. Design controls reflect an actual controlled process because the process was controlled from the start.

DECISION INPUTS

The right perspectives pulled into decisions early.

Some engineering decisions carry human factors, clinical, or regulatory weight, and we know which ones before they’re made. We pull those inputs in at the decision point, from your team, your advisors, or partners we recommend, so the work holds up at validation and review.

Backends How We Work Traceable Architecture Dark

TRACEABILITY

Verification evidence built alongside the system.

Requirements trace to tests, automated and manual, across every layer as the system comes together. When your team runs system-level V&V, they start with working test infrastructure and coverage at the seams rather than building it from scratch.

The result is a device engineered for clinical use and regulatory submission simultaneously, which prevents the late-stage rework that comes from treating regulatory as documentation applied after engineering is done.

Clinical Domains

We've Built Therapeutic Systems Across the Clinical Landscape

That landscape spans implantable and body-worn devices, and the clinic and home workflows around them. Every domain below is grounded in delivered programs.

Neurology

Implantable Neurostimulators

Peripheral nerve stimulation, brain-computer interfaces, and related neuromodulation platforms.

Audiology

Implantable & Worn Hearing Devices

Cochlear implants, fully implanted hearing systems, and externally worn hearing aids.

Cardiology

Cardiac Monitors & Defibrillators

Implantable cardiac monitors and external defibrillators.

Endocrinology

Drug Delivery Devices

Insulin delivery systems and connected medication platforms for chronic conditions.

Pulmonology

Connected Respiratory Therapy Devices

Sleep apnea therapy, chest wall oscillation, and airway clearance platforms.

Orthopedics

Connected Bone & Spinal Therapy Devices

Bone growth stimulation systems and spinal therapy platforms.

Urology

Implantable Bladder & Pelvic Therapy Devices

Neurostimulation systems for underactive bladder, incontinence, and related pelvic therapy applications.

Select work

Therapeutic Device Programs We've Delivered

Here are a few of the products we’ve supported with Bluetooth Low Energy architecture, troubleshooting, and full-system integration.

Patient using the Inspire Sleep Apnea Therapy System, with implantable device, handheld remote, and mobile app display for tracking therapy and sleep duration.

Inspire Medical

FDA-Approved Implantable Therapy for Obstructive Sleep Apnea

Multi-generational BLE connectivity for a Class III implantable neurostimulator, implemented alongside first-of-its-kind near-field inductive telemetry across the handheld remote and programmer cable. Built to IEC 62304 with an end-to-end security posture, supporting the system from early design through global commercial launch.

IEC 62304

PMA Approved

FDA Class III

Implant

Neuromodulation

Sleep Apnea

Connectivity Architecture

BLE

Systems Integration

Cybersecurity

Inductive Telemetry

Synchron

Implantable Brain-Computer Interface for Patients with Paralysis

BLE connectivity architecture and custom cybersecurity spanning the implantable device and external devices for a first-of-its-kind Class III brain-computer interface. Engaged from an early-generation device to define a connectivity and security foundation scalable through IDE submission, pivotal study, and commercialization.

Implantable Medical Device

Neuromodulation

Paralysis

Brain-Computer Interface

FDA Class III

IEC 62304 Class C

IDE

Systems Integration

Connectivity Architecture

BLE

Cybersecurity

Implantable & External Devices

Osprey Medical

Connected Cath Lab Equipment for Angiography Procedures

BLE connectivity linking a control tablet to multiple DyeVert units in a high-RF, high-interference cath lab environment. Diagnosed RF performance issues and redesigned the antenna for reliable wireless operation, then built remote device management into the next-generation system.

Connected Clinical Device

Contrast Management

Cardiology

Cath Lab

FDA Class II

510(k) Cleared

IEC 62304

Systems Integration

Connectivity Architecture

Wi-Fi

BLE

RF/Antenna Design

MDM

Remote Device Management

PNQ Health

FDA-Cleared iOS App for a Tinnitus Therapy Device

BLE connectivity architecture linking a native iOS application to a non-invasive in-ear therapy device, with a compliant data security model for a Class II SaMD. Delivered from product definition through 510(k) clearance on an accelerated timeline without compromising regulatory rigor.

Clinical Software (SaMD)

Audiology

Tinnitus

BLE

FDA Class II

510(k) Cleared

IEC 62304 Class B

Connectivity Architecture

BLE

Native iOS

Cybersecurity

Explore All Our Work