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果冻影院 support towards commercial adoption and uptake of medical devices into the NHS.
GOING TO MARKET:
Having completed the primary clinical and performance evaluation, release of a new Medical device onto the market then requires manufacturers to:
- Undertake further, post market surveillance of safety in the wider population.
- Establish Vendor chains for after-sales training and service provision, problem reporting, tracking distribution and implementing recall procedures if required.
In practice, the resources required for such an undertaking are often beyond 果冻影院 and the Device would be expected to be commercially adopted:
- SELL OUT:聽Device sold in entirety for one-off deal to a company/manufacturer
- LICENSED OUT:聽果冻影院 retains the device but grants license to company for marketing
- SPIN-OUT:聽果冻影院B investment establishes a separate commercial entity to market the device
CE-MARKING:
鈥淗aving a patent on a device is effectively useless without a CE Mark鈥�
CE-marking is a declaration of conformity with the EU鈥檚 Medical Devices Directive (MDD) and is:
- NOT a requirement for clinical trial/evaluation (NB. such evidence may be required for CE-marking)
- A requirement to place a device on the market in the EU聽
Devices are grouped by increasing risk, with increasing assessment requirements:
| Risk Class | Risk Description | Examples |
|---|---|---|
| Class I basic (non-measuring, non sterile) | Low | Reusable surgical instruments (e.g. forceps, scissors, scalpel to be sterilised locally); ECG electrodes; Beds; Wheelchairs |
| Class I measuring | Low | Stethoscope; Thermometer; Non-invasive blood pressure; Volumetric urine bag |
| Class I sterile | Low | Sterile dressing (non-medicated); Examination gloves (e.g. item is supplied sterile then discarded) |
| Class IIa | Medium-Low | ECG machine (recording only); diagnostic ultrasonic equipment; Hypodermic needles (NB. invasive, but exception as used only transiently); Suction equipment; Fridge (blood) |
| Class IIb | Medium-High | ECG machine (continuous - with alarms [e.g. ICU]); Infusion pumps; Invasive blood pressure, Ventilators; orthopaedic implants; Contraceptives; Haemodialysis machine; X-ray machines |
| Class III | High | Drug eluting cardiac stents; Heart valves; Ultrasound equipment for use in interventional cardiac procedures |
| Active Implantable Medical Device (AIMD) | High | Implantable pacemaker; Implantable defibrillator |
Class I devices can be self-certified (i.e. manufacturer ensures compliance with all the relevant essential requirements of the Medical Device Directive (MDD) and provides written statement to this effect), the device can be CE marked and then placed on the market.聽Although not required to ISO13485 standard, an appropriate Quality Management System is required to
develop and maintain a Class I device. CE mark holding demands continual effort (e.g. post-launch surveillance) and 果冻影院 usually defaults to an option with an external company holding the CE mark.
NHS ADOPTION:
Continuously undertake internal and external stakeholder review of the Device:
- The Device Development Group should meet regularly (at least every 6 months)
- Ensure the identification and measurement of tangible data that will support adoption (e.g. outcomes meaningful to ward managers, hospital laboratory managers)
Be mindful of the key 鈥榝acets鈥� developed for successfully adopted devices:
- FISCAL OPPORTUNITY: Clearly defined and attractive market potential
- SYSTEM OPERATIONS:聽Awareness and solutions to operational challenges of delivering the healthcare
- COMMUNICATION:聽Effective publicity of the device聽throughout its lifetime
- HUMAN FACTORS:聽Minimized use-related hazards, risks and inconvenience wherever practically possible
- PROOF:聽Provision of 鈥榳ork as done鈥� evidence (i.e. in both clinical and laboratory scenarios)
- IPR:聽Secure intellectual property rights (IPR) as early as possible, then drive for market adoption as soon as possible聽(do not delay by developing next device generation)
果冻影院 Support:
鲍颁尝鈥檚 builds on an increasingly vibrant translational culture across the wider university community by providing integrated support for translational research and industrial partnerships.聽
果冻影院 has implemented and is growing strategic platform partnerships to facilitate the accelerated development, commercialisation and adoption of its medical devices into the NHS.
