Medical Hardware
Medical Device Prototyping
Raonebytes helps health-tech teams turn medical and wellness hardware concepts into working prototypes: sensor electronics, firmware, connectivity, enclosures, and documentation-ready engineering outputs. The difference between a medical prototype and a generic one is that the constraints arrive first. Isolation, leakage current, EMC immunity, material contact, software safety class and traceability all shape the schematic before anything is drawn, because retrofitting them after a working bench unit usually means starting the electronics again.
The short answer
Medical device prototyping turns a health-tech concept into working sensor electronics, firmware, enclosure and documentation that a regulated programme can build on. A connected health prototype typically costs $8,000 to $20,000 and takes 8 to 14 weeks, with simpler enclosed devices starting near $5,000. These are pre-clinical proof-of-concept units, not certified medical devices: certification, clinical evaluation and submission belong to your regulatory pathway, and the prototype exists to make that path cheaper and shorter.
Common builds
Wearable monitors
Connected diagnostics
Therapy devices
Clinical proof-of-concepts
Remote monitoring hardware
What Raonebytes delivers
Sensor electronics
Low-noise analog front ends for biosignals, MCU and radio selection, power architecture and custom PCB layout, with isolation barriers and creepage distances placed according to the applied part classification rather than added afterwards.
Embedded firmware
Sampling, filtering, connectivity, secure logging, over-the-air update and hardware-in-the-loop test benches, structured so requirements, architecture and unit verification can map onto an IEC 62304 lifecycle if the device is heading that way.
Prototype enclosure
Ergonomic enclosures, skin-contact and grip geometry, charging concepts and compact mechanical integration, with material candidates chosen against the contact category the device will eventually have to justify.
Documentation trail
Requirement lists, design rationale, schematics, BOM with part traceability, test procedures and measured results, delivered so your quality system or regulatory partner can absorb them instead of reconstructing them from a working board.
What makes this hard
The constraints that decide whether a design survives contact with the real world.
The regulatory pathway is a design input
A device claiming substantial equivalence to a predicate under an FDA 510(k) inherits that predicate's technological characteristics and performance expectations, which constrains sensing method, materials and claims from day one. A genuinely novel low to moderate risk device with no predicate goes the De Novo route instead, which creates a new classification and demands its own performance evidence, so the choice changes what the prototype has to demonstrate.
Patient isolation constrains the whole electronics design
IEC 60601-1 sets leakage current limits and requires defined means of protection between the patient connection and anything mains-derived, which forces isolated supplies, isolated data barriers and creepage and clearance distances into the layout. These are board-area and topology decisions, so a bench prototype built on a non-isolated development kit rarely survives the transition to a compliant design.
Biosignals live near the noise floor
ECG, EMG and bioimpedance signals sit in the microvolt to millivolt range against electrode impedances that drift, plus motion artefact that shares a frequency band with the signal of interest. Getting usable data means front-end gain and filter design, driven shielding, electrode selection and artefact handling in firmware, and it is the part most schedules underestimate.
Traceability has to start at the first prototype
Design controls expect a documented line from a user need through requirements, design outputs, verification evidence and risk controls, and reconstructing that trail later from commit history and email is slow and unconvincing. Recording why a component, tolerance or algorithm was chosen while the decision is being made costs very little during prototyping and is expensive to recover afterwards.
Standards and protocols that shape the design
Identifying these early is what keeps them from forcing a redesign later.
- IEC 60601-1
- The general standard for basic safety and essential performance of medical electrical equipment. It classifies patient connections as Type B, BF or CF applied parts, sets patient and enclosure leakage current limits, requires one or two means of patient or operator protection depending on the hazard, and expects a defined essential performance the device must keep under single fault conditions.
- IEC 60601-1-2
- The collateral standard for electromagnetic disturbances, which sets immunity levels by intended use environment rather than a single blanket figure, so a home healthcare or emergency services device faces harsher tests than one confined to a professional healthcare facility. It also includes proximity immunity to RF wireless equipment across common radio bands, which in practice means a phone held next to the device must not degrade its essential performance.
- ISO 14971 and ISO 13485
- ISO 14971 defines the risk management process: identify hazards, estimate and evaluate risk, apply risk controls in priority order (inherently safe design first, then protective measures, then information for safety), and evaluate what residual risk remains. ISO 13485 is the quality management system standard the organisation holds, covering design controls, document and record control, supplier controls and traceability, and it is the client's certification to obtain, not something a design partner confers.
- IEC 62304
- The software lifecycle standard for medical device software, which assigns safety class A, B or C based on the severity of injury a software failure could cause and scales the required rigour accordingly. Class B and C add architectural design, integration testing and detailed verification, and every class requires software of unknown provenance (any RTOS, BLE stack or vendor SDK) to be identified, version-controlled and assessed for known anomalies.
- ISO 10993
- The biological evaluation series, applied through the risk management process and scoped by contact type (intact skin, mucosal, breached surface, blood path, implant) and contact duration (limited, prolonged, long term). For a skin-worn device that usually means cytotoxicity, sensitisation and irritation evaluation on the exact materials, adhesives and colourants used, which is why material candidates and any cleaning or disinfection regime should be settled during prototyping rather than at the pilot build.
Typical technology stack
Biosignal front ends
Integrated AFEs such as the TI ADS129x family for ECG and EMG with lead-off detection and respiration impedance, and optical AFEs like the TI AFE4404 or Analog Devices MAX86141 for PPG based heart rate and SpO2 work. Discrete front ends only where an integrated part cannot meet the noise, channel count or electrode configuration required.
Compute
Nordic nRF52 and nRF5340 parts where BLE and low sleep current dominate, and STM32L or STM32U series where analog peripherals, DSP throughput or a longer industrial supply horizon matter. Selection also considers whether the vendor stack can be treated as documented SOUP under IEC 62304.
Connectivity
Bluetooth Low Energy for body-worn devices, using the Bluetooth SIG standard GATT services (Heart Rate, Health Thermometer, Pulse Oximeter) where an existing profile fits so third-party apps interoperate without a bespoke protocol. Wi-Fi or LTE-M appear where a bedside hub or a remote monitoring device has to reach a backend without a phone in the loop.
Power and battery safety
Lithium polymer packs with a protection IC, fuel gauge and a charge path designed around the isolation requirement, sized against a measured duty cycle rather than a datasheet current figure. Cell and pack selection also has to account for IEC 62133-2 safety testing and UN 38.3 transport testing, both of which are far easier with a mainstream qualified cell than a custom one.
Materials and mechanical
Medical-grade polycarbonate and ABS grades, silicone for skin-contact surfaces and seals, and adhesives selected with the biocompatibility evaluation in mind rather than for assembly convenience. Sealing targets and disinfectant compatibility matter too, since a device wiped down with alcohol or quaternary ammonium several times a day will fail on material compatibility long before it fails electrically.
Data path
Encryption in transit and at rest, per-device identity and key handling, and audit-friendly logging designed in from the start, because health data carries obligations under HIPAA in the US and as special category data under GDPR in Europe. Where the prototype only needs signal quality evidence, we prefer de-identified or synthetic datasets so no identifiable health data enters the engineering environment at all.
Why this matters
Most health-tech hardware programmes stall in the same place: a promising bench demonstration that cannot become a compliant device without redesigning the electronics. The usual causes are a non-isolated architecture, a front end that only works on a clean desk, materials chosen before anyone asked what touches skin, and a documentation trail that has to be reverse engineered. Raonebytes designs the electronics, firmware, enclosure and test evidence as one system, with those constraints treated as inputs rather than a later compliance exercise. To be clear about scope: we build early engineering prototypes and manufacturing-ready proof-of-concept devices, and formal clinical validation, certification and regulatory submission should be handled with qualified regulatory partners. Our closest adjacent work is the telepresence robot and the AI-based kids toy, both of which combined low-power sensing, battery-powered embedded design and safety-led enclosure decisions for use around people.
Frequently asked questions
What does a medical device prototype cost?
A connected health device prototype typically runs $8,000 to $20,000, covering sensor electronics, custom PCB design, firmware, enclosure and bench validation. Simpler enclosed devices with a single sensing modality can start near $5,000. The main cost drivers are the number of biosignal channels, whether patient isolation is required, and how much verification evidence you need alongside the working unit.
How long does a medical device prototype take?
Most prototypes take 8 to 14 weeks from kickoff to a tested unit. Schematic and layout usually take 3 to 4 weeks, fabrication and assembly 2 to 3 weeks, and firmware plus signal validation the remainder. Analog front-end tuning against real signals and electrodes is the most common source of extra time, since bench signal generators flatter a design that struggles with live artefact.
Is the prototype a certified medical device?
No. What we deliver is a pre-clinical, proof-of-concept engineering prototype, designed with the relevant safety, EMC and documentation constraints in mind, but not certified, cleared or approved. Certification testing, clinical evaluation and any regulatory submission sit on your pathway and should be run with a qualified regulatory partner or test house.
Are you ISO 13485 certified or FDA registered?
We do not claim a medical device quality management system certification or a device registration, and you should treat any prototyping vendor claiming to confer one on you with caution. ISO 13485 certification applies to the organisation placing the device on the market, which is you. Our role is to design against the constraints those standards impose and to hand over design outputs, rationale and test evidence in a form your quality system or regulatory consultant can take up directly.
How do FDA and EU MDR requirements affect the design?
In the US the practical fork is between a 510(k), which demonstrates substantial equivalence to an existing predicate device, and a De Novo request for a novel low to moderate risk device with no predicate. In Europe, EU MDR (Regulation 2017/745) classifies the device under Annex VIII, requires conformity assessment through a notified body for most classes above Class I, and expects technical documentation, clinical evaluation, UDI assignment and post-market surveillance. Both routes reward deciding the intended use and claims early, because those determine class, and class determines how much evidence the design must carry.
Can you handle biocompatibility and EMC testing?
We design for them and support them, but the formal testing is done by accredited laboratories. Practically that means we shortlist materials and adhesives so the ISO 10993 evaluation is straightforward, apply EMC-aware layout, filtering and shielding so the device has a realistic chance at IEC 60601-1-2 immunity levels, and prepare the test articles and documentation the lab will ask for. Pre-compliance checks during prototyping catch the expensive failures before a formal test slot is booked.
Related capabilities
Build with Raonebytes
Send your requirements and get a fixed quote, typically within 24 hours. NDA on every project.