An approach to regulating medical devices from the US FDA's now out
Effective regulation’s a vital part of setting and maintaining high standards. In an article in Frontiers in Medicine, Tina Morrison and her colleagues describe an approach by the US Food and Drug Administration (FDA). Its Center for Devices and Radiological Health (CDRH) regulates medical devices, and emphases regulatory science with computational modelling for medical devices.
Computational modelling is an increasingly powerful evaluation and regulatory tool for medical devices. Dealing with merging technologies resulting in novel products is one of the FDAs challenges. Using computational modelling can transform medical device design and evaluation. It can simulate treatment outcomes and clinical trials for imaging systems.
The simplest and most common use of computational modelling for medical devices is simulating their performance under a variety of conditions that mimic aspects of clinical or use environments.
The primary use is for regulatory submissions is identifying appropriate bench testing configurations, such as worst-case or clinically challenging conditions, for cardiovascular, orthopaedic, and surgical implants. Its second common use is to provide evidence that supports safety assessments of patients with and without implanted devices when they’re exposed to radiofrequency (RF) fields of MR systems.
Continuous development is underway too. A CDRH team is developing and validating a framework for streamlining the market entry of imaging systems relying solely on simulation instead of clinical trials.
Using the approach to the increasing range of mHealth and wearables could close the knowledge gap. Directing users, especially clinical professionals to devices that do what the claim to do will be a huge step forward for Africa’s mHealth initiatives.
- 552 views
- January 18, 2019
- Tom Jones
Rural India uses eHealth with containers
Shipping containers re-appear in many guises, from roadside cafés to holiday homes. It should come as no surprise that they should have become part of the future of India’s eHealth network.
A report in The Nation Online says in 2013, Dr. Anurag Agrawal, of the New Delhi-based Institute of Genomics and Integrative Biology (IGIB), saw the possibilities of including shipping containers’ versatility in his work towards a link between genes and lung disease. His plan was to use the movable containers to house and collate health records in rural areas so specialists could analyse the data to identify links between height, weight and predisposition for developing specific lung diseases. The analysis leads on to developing and delivering treatments.
A container appeared in a village in Uttar Pradesh. Villagers soon had video access to a doctor and could see a paramedic in person. They could also leave blood samples and submit cardiograms.
This initial success was hindered by IGIB’s link to government. It is one of India’s 39 state-funded Council for Scientific and Industrial Research laboratories, and is limited its scope to expand.
Then IGIB partnered with the Indian hospital chain Narayana Health (NH) and Hewlett-Packard (HP) to install over 40 eHealth container centres across India. The service includes EMRs, bio-metric patient identification and integrated diagnostic devices. It’s a business model that could be appropriate for Africa’s drive towards UHC.
India has one doctor for every 11,000 people, well below WHO’s recommended rate of one per 1,000lth. The eHealth container with HP cloud technology offered a dynamic solution. Clinical and administrative data is monitored and medical advice provided remotely.
Dr Agrawal believes more benefits are available. Telemedicine has improved access to second opinions and international consultation in urban areas. It’s benefits in rural India may be more limited.
- 537 views
- October 18, 2018
- Matt Jones
Will the new Apple watch be a big hit?
Apple is renowned for technological advancement and innovation. During their annual product launch this year, Apple announced the new series 4 watch. It’s not your average wearable. This watch boasts mHealth features such as electrocardiogram (ECG) monitoring and fall detection, and allows you to share this data with your healthcare practitioner.
These features are impressive. Apple is snapping up opportunities to break into the rapidly expanding mHealth market, from fitness tracking to a health app and now wearable ECG. But there’s a nagging concern too. What impact will this wearable ECG have on the healthcare system? Could Apple’s new innovation spur an increase in unnecessary healthcare utilisation?
These are concerns that I seem to share with other healthcare practitioners who worry that consumers may incorrectly attempt to diagnose complex cardiac conditions themselves. There are also concerns about the sensitivity and specificity of the device, which if not great, could spark a mass of panic-stricken consumers due to false positives.
While this new innovation is an important movement towards better patient management, it is vital that the counsel of healthcare practitioners is not diminished. Consumers must be advised to use it cautiously to augment their healthcare management rather than replace professional management.
Similarly, the medical community needs to work more closely with companies like Apple who drive much needed innovation.
- 613 views
- September 20, 2018
- Ameera Hamid
Dr Conuslta’s eHealth and technology business model’s transforming Brazil’s healthcare
Extending healthcare access is one of eHealth’s objectives. Using it to improve healthcare efficiency can help, but modestly. Dr Conuslta, a Brazilian start up in 2011, shows that an imaginative and innovative business model that uses eHealth and medical technology to relocate blocks of healthcare and slashes its costs for low-income families may have more impact. It’s a model that can fit Africa’s UHC goals.
An article in Forbes describes the initiative. Dr. Consulta charged patients a flat $30 fee for a consultation with a physician of their choosing from 50 specialties. Some patients pay nothing, depending on their health condition and ability to pay. Prices for on-site exams, such as MRIs, blood tests and mammograms range from $3 to $30.
Typical premiums for Brazil’s health insurance plans for access to one GP can be about $120 a month Off-site exam fees for lab work or specialist visits can be about $200 each, more than six times Dr Consulta’s higher rates. Only about 25% of Brazil’s population can afford this.
These low prices are achieved by a business model that invests in diagnostic technology and services in clinics and using AI to develop its own EMRs. It also engages some healthcare professionals as co-workers who use Dr Consulta’s clinics as a resource, not as employees. These combine to achieve high patient volumes, long-term relationships with patients and low-price out-of-pocket payments that sustain financial viability. The large, stored clinical data volume helps to achieve precise medical outcomes, which in turn, reinforces this long-term relationships with patients
Dr Consulta’s eHealth includes AI to analyse scientific and medical statistics to identify the probability of people contracting chronic health conditions. It can then treat them promptly to minimise or eliminate the risks. It engages patients with updated information and recommendations about their illnesses or conditions.
These bespoke communications are constructed from information in the core health management data warehouse using the Oracle marketing tool Responsys. For each patient, using age, health history and treatment plan, the Responsys automatically recommends:The new health services provide links for patients to schedule services. After each visit, Dr Consulta sends follow-up surveys to solicit feedback on patients’ experiences with their doctors and their results. Cloud applications support its marketing, finance and supply chains complete the eHealth profile. While it’s extensive and modern, its benefits depend on the transformative impact of its business model. Large, established hospitals with eHealth legacies are often less agile in reaching under-served, low-income patients. Dr Consulta’s a healthcare model that Africa’s health system could consider as part of their UHC pursuits.
- 552 views
- September 06, 2018
- Matt Jones
Villgro Kenya financing Uganda’s MamaOPe and clinicPesa
East Africa’s startup ecosystem is growing. clinicPesa and MamaOpe, two innovative Ugandan enterprises, are set to take up capital from Villgro Kenya, an investment firm with its HG in India. The goals are to raise clinicPesa’s and MamaOpe’s profiles, underpin the initial growth, and enhance the availability and accessibility of eHealth services in economically vulnerable areas.
clinicPesa’s support’s USD$40,000. MamaOpe’s USD$25,000
An article in Wee Tracker says Villgro focuses on finance, mentoring and networking support for social enterprise startups. Its business model focuses on projects in agriculture, education, energy and health. Its partners are usually early-stage for-profit solutions for disadvantaged individuals and communities. The outfit’s recent extension into Kenya expands the reach of these broader.
clinicPesa’s a digital micro-savings and loans platform. It provides users with convenient and affordable access to quality healthcare services by accessing their savings and loans for a range of registered health services providers. Many families slip further in to poverty after accidents or meeting unexpected medical emergencies. clinicPesa reduces out-of-pocket spending on medical bills, medicines or treatments so users to avoid excessive debt or property sales to cope.
MamaOpe group’s a biomedical initiative. It aims to minimise pneumonia misdiagnoses and associated delayed treatments. These are primary reasons many deaths from the disease. The MamaOpe team’s developed a biomedical smart jacket to help healthcare workers who are not doctors in low resource areas to gauge pneumonia’s primary symptoms and diagnose it accurately.
Villgro’s been keen to add East African startups to its portfolio. Kenya’s Villgro Innovations Foundation offers a structured programme that includes finance, mentoring and connections to wider healthcare networks. These contribute to steps towards East Africa’s Universal Health Coverage (UHC). Will Villgro be offering these opportunities across all Africa soon?
Watch this YouTube clip about clinicPesa.
- 656 views
- July 24, 2018
- Matt Jones
Stethee reinvents the stethoscope with AI
The worlds first Al enabled stethoscope system has been launched by M3DICINE Inc.
The design itself is revolutionary and operates as easily as the traditional stethoscope. However, it allows users to listen to the lung and heart sounds with a more sophisticated amplification and filtering technology. Heart and respiratory sounds captured are sent via Bluetooth to the Stethee Android or iOS App which enables a wider range of diagnostic capabilities.
The Stethee system comes in three core products:FDA cleared Stethee Pro for medical and healthcare professionalsStethee Vet for veterinarians and animal professionalsStethee Edu developed specifically as an education and research tool
The technology platform behind the Stethee AI engine , named “Aida” can analyze the heart and lung sounds to build a unique personal biometric signature. In addition to this, Aida automatically tags geo-location and environment data to each sample in real time. This offers a completely new dimension of data analytics for public health planning by allowing one to understand what effects environmental factors such as pollution, temperature or humidity have on our heart and lungs.
Aida also analyzes this encrypted and anonymised data in order to learn and report back quantitative clinically actionable data to vets, doctors and other healthcare professionals. Not only does it identify and analyze heart sounds and respiratory activity but also patterns that may indicate a disease condition. The data is represented in real time in the Stethee App, therefore making it easy to understand vital signs.
The potential for the Stethee to be used in remote rural areas is quite vast because its relatively easy to use and results can be shared and analyzed promptly by a medical specialist anywhere in the world. This is invaluable to the improvement of patient care, more especially to remote rural areas where access to screening services or a cardiologist is very difficult.
- 775 views
- July 20, 2018
- Nontobeko Shabangu
QuantumMDx offers low cost DNA tests at points of care
As technology help DNA test costs and prices tumble, the range of opportunities expands. While conventional supply and demand economics hints that higher prices attract suppliers, lower prices reduces them, disruptive technology’s changing the DNA testing model.
QuantumMDx, a UK firm based in Newcastle UK,, offers DNA tests at point of care. They can cost as little as £5, about US$6.65, each. It takes a few minutes to extract DNA into a biosensor that can multiplex in thousands. Its Q-POC™ assays provide data for whole genome sequencing and creating gold pathogen surveillance networks. Global Good Intellectual Ventures aims to bring technology to solve global problems. QuantumMDx works with them.
Plans are in place to expand from the four main services currently supported. They’re:Tuberculosis has an in vitro diagnostic device for future multi-drug resistance Tuberculosis treatment regimensWarfarin has a pharmacogenomic assay to determine optimum dosage of the anti-coagulantSexually Transmitted Infections (STI) uses a panel test for quick and easy screening to help containment, including a test for Human Papilloma Virus (HPV) enabling health workers to use molecular diagnostics to screen and treat in a single visitMalaria has uses a drug susceptibility panel to support malaria eradication initiatives.
Africa’s an important market for QuantumMDx. It has the highest regional malaria burden and the lack of healthcare infrastructure in many communities hinders health workers’ ability to diagnose and treat the infection. Empiric diagnosis is a common technique.
Rapid Diagnostic Tests (RDTs) are simple to use and don’t need laboratory infrastructure. They’ve been crucial in dealing with malaria, but have an inherent lack of sensitivity to detect low-level asymptomatic infections, so cannot alone move a country from high burdens to eradication. QuanumMDx sees its role as essential. How will Africa’s health systems move to mobile diagnostics at points of care.
- 531 views
- June 28, 2018
- Tom Jones
Drones are good for your health
Stuck in in deep marshland in Norfolk, a very rural, flat part of England, or anywhere else, isn’t a good health initiative. Being rescued by a drone is. A report on the BBC website says a 75 year old man was separated from his friends while walking near Titchwell, a particularly wet and soggy part of the county. He was missing for 21 hours, and stuck in a marsh.
Police used a drone to find him, and it did. He was admitted to hospital and treated for hypothermia. It’s another example of good drone use.
Without the drone, the outcome could’ve been different. It’s another graphic illustration of the case for drones. Africa’s eHealth strategies for emergency services should have plenty of them.
- 431 views
- June 26, 2018
- Ameera Hamid
Cancer detecting pen to be piloted in Texas
We often hear from surgeons that distinguishing cancerous tissues during surgery may be difficult. This is a challenge that has been tackled by a group of researchers from the university of Texas who have developed a revolutionary pen. The MasSpec Pen is coupled to a mass spectrometer and can identify cancerous tissue during surgery in real time.
The MasSpec Pen is able to diagnose cancer within twenty seconds during surgery. The pen is placed over a tissue and uses touch to make a diagnosis. A foot pedal triggers the device to release water droplets which extract molecules from the tissue. The water is drawn into the mass spectrometer. It then analyses the molecular compositions to determine if the tissue is cancerous or not. This also eliminates time waiting for results to return from the pathologist.
While the diagnosis may be quick, the accuracy is still spot on. During a trial, 300 patient samples were analysed and the MasSpec Pen was able to detect four types of cancer; breast, thyroid, ovarian and lung cancer with over 96 % accuracy. This could allow surgeons to remove all cancerous tissue and prevent further complications later on. Similarly, it will eliminate the risks of unnecessary removal of normal tissue.
Over the next several months, three of the devices will be installed in Texas hospitals. The cost of this revolutionary pen is still being debated, but this could well be a useful tool for rural and remote hospitals in Africa to quickly and easily detect cancers.
- 606 views
- May 28, 2018
- Nontobeko Shabangu
Low-cost video laryngoscope developed in South Africa
“Innovation is change that unlocks new value” - Jamie Notter. This is what Cape Town Anaesthesiologist, Dr Caroline Corbett, is doing with her video laryngoscope invention. SmartBlade, is a cost effective, novel and real-world solution to the management of a difficult airway.
It uses forward-thinking smartphone technology to link with video laryngoscopy, thus allowing clinicians to easily intubate difficult airways. The clinician can suction a soiled airway or perform apnoeic oxygenation, both without interrupting attempts to intubate.
The customised mobile application also facilitates video conferencing, image capture, recording and secure data storage. SmartBlade aims to become a standard of care in advanced airway management.
This novel device won the WFSA-Fresenius Kabi Anaesthesia Innovation Award in 2017. The South African Society of Anaesthesiologists (SASA) is proud of this accolade and looks forward to seeing it being used in South African hospitals in the future.
- 968 views
- April 23, 2018
- Ameera Hamid
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