BLE Design & Engineering For Connected Medical Devices

BACtrack was the first company the FDA allowed to market breathalyzers for consumer use, and in 2013 it released the world’s first smartphone breathalyzer.

BACtrack Mobile pairs with a phone over Bluetooth, turning a breath sample into a blood alcohol estimate on the screen in the person’s hand.

That means anyone can know their number before making a decision that depends on it. It also means an accuracy people stake real decisions on has to survive a wireless link to whatever phone they happen to carry.

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.

Ear Technology Corporation designs Tweak hearing products with audiologist Dr. Daniel R. Schumaier, drawing on 50 years of clinical practice.

TweakConnect pairs a Tweak sound amplifier with a smartphone app where the wearer picks an amplification profile, fine-tunes it, and switches programs as their surroundings change.

That means the wearer decides what sounds right, in the room where it matters. It also means a Bluetooth connection that has to work with whatever phone the wearer happens to own, from flagships to budget Android handsets that each handle Bluetooth their own way.

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.

In cardiac arrest, survival depends on a defibrillator working the instant a care team reaches for it.

A global acute care company is building wireless connectivity into its next generation of defibrillators, with the security architecture to protect it.

For a care team, that means the data a defibrillator gathers can move with a patient, without a cable. It also means a wireless path into a device that delivers a shock, where security can never slow it down.

A global building automation company 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.

Whether a narrowed coronary artery gets a stent often comes down to a pressure reading taken across the blockage mid-procedure.

A global cardiovascular device company makes one of the systems that delivers it, in cath labs worldwide, and is bringing its wireless link and security to a new generation.

For the cardiologist, that means a stent decision based on how blood actually flows. It also means replacing the wireless link and its security on a system already in cath labs, while the measurement stays the same.

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.

Kiddo began at GoodParents as a wristband for children ages 4 to 10, built to give parents real-time insight into their child’s health and wellbeing.

The band reads temperature, perspiration, heart rate, and motion, and the parent app turns those readings into scores for health, activity, sleep, and emotional wellbeing.

That means a parent sees how their child is sleeping and coping, along with how active they are. It also means sensors on a small child’s wrist, worn through play and sleep, have to read steadily enough to become a score a parent can trust.

Orthofix’s CervicalStim™ is the only bone growth therapy device approved by the FDA as a noninvasive, adjunctive treatment to improve cervical fusion outcomes in high-risk patients.

Its latest generation works with the STIM onTrack™ app, which reminds patients of each treatment and, in a first-to-market feature, gives physicians real-time data on whether they follow their prescription.

That means a patient healing from neck surgery gets help staying on schedule, and their physician sees adherence without waiting for a visit. It also means usage data from a Class III device worn at home has to reach the physician reliably, because it stands as the record of treatment.

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.

Pocket Radar makes radar guns used everywhere from MLB coaching staffs to youth teams.

The Smart Coach Radar™ sends every reading over Bluetooth to the Pocket Radar app, which records video with the speed embedded in it, calls the number out loud, and tracks results over time.

That means an athlete sees which pitch or swing produced which number and builds a record of progress. It also means every reading has to reach the app, even when a coach is running ten radars across a few shared iPads at the same practice.

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 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.

In CT and MRI, the contrast injector sits beside the patient while the technologist runs the scan from a control room next door.

Control from that room is common, but it usually means running cable through the wall. A global radiology company asked whether wireless could replace it.

For an imaging department, that means installing an injector without new cable through the shielding. It also means a command that starts contrast flowing has to work in every facility, and the program had to show where it could.