BLE Design & Engineering For Connected Medical Devices

Current Health builds the platform hospitals use to care for patients at home instead of in a bed.

A patient goes home with a wearable and a kit of connected devices, and their vital signs and readings flow to a clinician’s dashboard, with telehealth on top.

For a patient, that means recovering in their own bed with someone still watching. It also means hospital-grade monitoring riding on consumer Bluetooth, in homes no one controls, across medical and consumer devices from different makers that each behave differently.

DermapenWorld’s Dp4™ microneedling pens are used in clinics around the world, all kept current through a companion app.

The Dp DOCK™ is where a pen sits between treatments. It syncs the pen to the app, installs firmware updates, watches its battery, and will not let it be stored with a needle cartridge attached.

For a practitioner, that means a pen that is current and ready for the next treatment without anyone thinking about it. It also means a dock that has to work with every version of the pen and app in the field, in a clinic where it will never get a second look.

Envoy built the first FDA-approved hearing device that lives entirely inside the body.

The Acclaim™ Cochlear Implant is designed for severe hearing loss, with a sensor that uses the ear’s own anatomy to capture sound in place of an external microphone.

There is nothing to take off before sleeping or showering. There is also nothing easy to power, charge, or connect, and the parts other implants keep outside the head are sealed inside, out of reach without surgery.

A global fashion brand’s smartwatches reached millions of wrists across several product generations, and they were designed to look like watches first.

Under the face they tracked health and activity, moved logs and firmware updates to a phone over Bluetooth, and ran on a battery sized for a fashion case.

For the wearer, that meant a watch chosen for how it looked that still did what a smartwatch does. It also meant pairing with every phone and OS version its wearers owned, each handling Bluetooth its own way, at a scale where a one-in-a-million quirk came up every day.

Hyperice’s Core™ Meditation Trainer is a handheld device you cup in both palms, with heart sensors in the handles and a pulse you breathe along with.

It reads heart rate and heart rate variability to tell when you have settled into a focused state, and the app’s guided sessions respond to that.

For someone who wonders whether they are meditating right, that means a device that can tell them. It also means a consumer product whose first act out of the box is updating its own firmware over Bluetooth, in a living room, where a failed update is a returned product.

Inspire® is the first FDA-approved neurostimulation therapy for moderate to severe obstructive sleep apnea.

A small implant stimulates the nerve that controls the tongue in time with the patient’s breathing, and a connected system sits around it, with a Bluetooth remote the patient holds, an app, and a clinician web portal that monitors the implant wirelessly.

For someone who could never live with a mask, that means sleeping with nothing on their face and starting therapy with a click. It also means the system around a Class III implant has moved through several device generations while every implant already placed stays in a body for years, so no part of the system can change without accounting for every implant in the field.

One in four angiography patients has chronic kidney disease, and the contrast dye that makes the procedure possible is hard on the kidneys.

Osprey Medical’s FDA-cleared DyeVert™ PLUS diverts part of the dye before it reaches the patient, cutting the amount delivered by about 40 percent with no loss of image quality, and tracks each patient’s cumulative dose against their kidney function in real time.

For those patients, that means a heart procedure with less risk of kidney injury. It also means a tablet talking wirelessly to bedside devices inside a cath lab, one of the noisiest radio environments in a hospital, where nothing can drop mid-procedure.

Portal Diabetes holds FDA Breakthrough Device designation for the Portal Pump™, an implantable insulin delivery system.

The pump is designed to sit in the abdomen, dose from a continuous glucose monitor with a heat-stable concentrated insulin, and take refills in a clinic after weeks or months.

For someone with type 1 diabetes, that means no carbohydrate counting, no meal announcements, and no waking in the night. It also means a loop that closes with no one in it, which has to be trusted before it is ever implanted and then stays in for five to seven years.

Knowing how well a failing heart is pumping usually takes an echocardiogram and a trained operator, or a catheter threaded into the heart.

Sensydia’s Cardiac Performance System reads ejection fraction, cardiac output, and pulmonary artery pressure from disposable sensors on the chest, in minutes, at the bedside. Its ejection fraction measurement was first FDA-cleared in 2018, and the full platform holds Breakthrough Device Designation.

For a patient in an ICU or emergency department, that means answers without a referral or a procedure. It also means one measurement running across sensors, a gateway, a tablet, and the cloud, carrying patient data the whole way, while the platform is still being proven in clinical studies.

A smart building startup is developing an automation platform for commercial buildings, one that controls and monitors dense fleets of connected devices across facilities shared by many tenants.

For a building operator, the aim is one system running the connected devices of an entire property. It also means radio working through metal enclosures and motor interference at extreme device density, and a security model that has to hold across every tenant, device, and door it touches.

A stealth-stage medical startup is developing an implanted neuromodulation therapy that its clinicians can adjust without the patient in the room.

For the patient, that means a therapy that changes when it needs to instead of at the next appointment.

It also means every adjustment travels from a clinician’s screen to a device inside someone’s body, and that path has to be trusted at Class III stakes before anything is implanted.

Synchron ran the first FDA-approved clinical trial of a permanently implanted brain-computer interface, and all six patients met the primary safety endpoint.

The Stentrode® is placed through a blood vessel, with no open brain surgery, and sits in a vein beside the motor cortex reading the intent to move.

For someone with severe paralysis, that means texting, browsing, and opening apps by thought alone. It also means the connection out of the body is the whole product, at Class III stakes. Nothing the implant does reaches a screen unless that link holds.