Breaking down barriers in medical device design...
03 February 2020
Designing new products for the medical device sector is extremely challenging & complex. The healthcare industry is quite rightly heavily regulated, with new products often used in life or death situations. Here, Russell Overend, Managing Director at multi-disciplinary product design & development consultancy, Wideblue explores the challenges of designing new MedTech products to help professionals & patients in the medical sector.
This article was originally featured in the February 2020 issue of EPDT magazine [read the digital issue]. Sign up to receive your own copy each month.
All manufacturers must comply with the EU Medical Device Directive in order to legally design and manufacture any medical device for use within the EU. A CE mark on the equipment certifies that the provisions of the Directive have been complied with. For companies wanting to sell into the USA, there are separate FDA laws to be complied with.
Changes currently underway are resulting in a large backlog in regulatory approvals. The Medical Device Directive is being replaced by new Medical Device Regulations. This will require new or additional certification for existing products. Some notified bodies (organisations designated to assess and certify conformity of products before they are placed on the market) have announced their intention to exit the CE marking review process.
Post-Brexit, UK companies selling medical devices in Europe fear their current notified body certification may no longer be valid. Many companies are therefore now registering with EU notified bodies. All of these factors are driving up delays, worry and expense for regulatory compliance of medical devices. Companies seeking to bring new medical devices to market are well-advised to seek specialist help long in advance of any application.
Wideblue has worked with clients across a wide range of MedTech devices for more than a decade and has observed some common trends in the development of new medical devices that mirror technological advances across the board. In general, medical devices are becoming smaller and battery powered, meaning that ever more energy-efficient electronics have to be packed into smaller spaces, driving greater miniaturisation of electronic components.
Many new devices also have wireless capabilities built-in, with data being transmitted to a nearby device, server or remote site. Data security, encryption and patient confidentiality are therefore key considerations, as patient data may be transmitted across multiple nodes. In terms of wireless network choice, there are trade-offs between speed, reliability and longevity; for instance, 5G may be fastest, but 2G, Bluetooth or Wi-Fi might be more reliable – and more likely to be available in some scenarios.
Battery size also continue to reduce, but there are often trade-offs between size, cost and capacity. However, with battery technology advancing rapidly, in future, this may not be such an issue. If the device is to be worn by the patient (for instance, health monitoring equipment), it must be small, comfortable and unobtrusive.
Clients also increasingly demand that multiple functions run off single devices. Many low cost sensor and memory components can enhance medical device functionality or help with a new product’s postmarketing surveillance (PMS) requirements. Wideblue often add an ‘engineering function’ to new devices to log useful (non-confidential) data. Structured properly, this data can help demonstrate compliance with PMS responsibilities, such as logging usage frequency, battery voltage, ambient temperature/humidity, device performance and attempted misuse. This is considered a best practice approach to monitor how new devices are performing and being used. If a device is reliant on internet connectivity to operate, designers must consider denial-of-service, either though lack of signal or DDoS attacks, and this must be factored into the product’s ISO14971 risk assessment.
Award-winning product design & development consultancy, Wideblue was established in 2006 after a management buyout of the Polaroid Corporation’s European R&D division (working on its flagship instant camera range) – and became part of technology product design, development & manufacturing firm, Pivot International in April 2018. With deep expertise in imaging, optoelectronics and bio-medical engineering, and in-house skillsets spanning physics, optics, electronics and software, through to mechanical engineering, prototyping, medical devices, manufacturing and supply chain management, WideBlue has a track record of helping clients take innovative and novel product ideas from drawing board to prototyping, and on to full scale manufacture and commercialisation.
Case study: N-Tidal personal capnometer
Wideblue has successfully developed a groundbreaking novel medtech device for its client, Cambridge Respiratory Innovations Limited (CRiL). The device, N-Tidal, is a small battery-powered personal capnometer, used to measure the amount of CO2 in exhaled breath. Changes in CO2 concentration as a patient breathes in and out can be used to assess the health of a patient’s lungs. Currently, in normal hospital use, capnometers are large bedside machines connected to a patient’s face mask, or a sensor located in life support equipment. N-Tidal is transformational and can be used as a personal, portable respiratory monitor.
In developing this new product innovation, Wideblue sought to miniaturise and simplify advanced technology to such a point that a handheld, battery-powered device could be developed for use by patients at home, as well as by GPs or respiratory specialists. Wideblue used an infrared LED, tuned to the peak CO2 absorption wavelength, developing some patented infrared optics to measure CO2 levels as the patient breathes through the device. Miniaturisation enabled the sensor to be located directly in front of the mouth – giving far better resolution of the CO2 concentration in each individual breath profile.
The device is used by the patient simply breathing in and out through a breath tube in a normal relaxed manner. A replaceable breath tube, with integrated infrared window, prevents cross-contamination and means that the device can be used by multiple patients. Within seconds, a traffic light system (red, amber, green) on the device can tell the user the health status of their lungs, and will, if necessary, indicate whether a follow up message or call for further treatment is required. Electronics within the device capture data from the sensor, analyse the breath record and wirelessly transmit the data to a secure server.
Despite the high tech nature of the personal capnometer, the biggest challenges were miniaturisation, ergonomics and usability. There are other respiratory devices in use, such as peak flow meters and spirometers, but they are difficult for patients to use, requiring them to blow hard into a tube. As the first device of its kind, the personal capnometer had to be intuitive and simple to use. The device will be used by patients with respiratory-related diseases, such as asthma, COPD and CHF. Early clinical results show that data from the device can be used to predict attacks or exacerbations in advance, by measuring changes in CO2 profiles. Doctors can then decide if a change in medication is required to prevent an attack.
The device is currently undergoing clinical/user trials – and has already produced superb clinical results. Subject to successful completion of these trials – and regulatory approvals – we expect units to go into commercial production during 2020.
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