All medical institutions and facilities including hospitals and pharmacies have been trying to facilitate medical treatments of patients, especially during the COVID-19 crisis.
As such, Noble, an Aptar Pharma company and provider of drug delivery training device programs for pharmaceutical companies and original equipment manufacturers, launched “Human Factors Plus” (HF+), a service aimed at supporting its customers in bringing new products to market.
The human factors engineering is an essential factor of product development for drug delivery and medical devices, according to the Food & Drug Administration (FDA), which recommends making it a strong part of the design control process to maximize the likelihood that a new device will be safe and effective for its intended users.
Device deficiencies can result in delays for patients receiving effective treatment, as well as lost time and revenue for the sponsoring company. When delays occur in the competitive medical healthcare environment, it leads to lost market share difficult to recover from.
“Human factors engineering provides empirical and analytical evidence that a device and its labelling can be used safely and effectively by the intended patient,” according to Kevin Cluff, senior research human factors engineer at Noble. “This process involves testing the numerous touch points where patients interface with a drug product, including packaging, IFUs, prescribing information, quick reference guides and device indicators and controls,” he added.
The benefits of human factors vary from producing easier-to-use devices and better patient understanding of device use to more effective and efficient training that improves patient compliance and medical outcomes, the company highlighted in a statement.
“Human factors engineering also helps reduce the risk of user errors, product complaints and recalls,” the Aptar Pharma company expressed.
The new service efforts broadens the existing range of value-added benefits from Aptar Pharma services, whilst complementing Noble’s expertise in conceptualization, design and development, mechanical/electrical/software engineering, project management, quality management, manufacturing, commercialization and logistics services as well.
“Noble is proud to be the voice of the patient and to support the patient across every stage of their journey,” explained Tim McLeroy, executive director of marketing and patient services. “We understand how to leverage the application of human factors engineering and we know how to build a better patient experience.”
Wearable tech market to more than double in growth by 2026
Over the years, fitness technology has grown from the bulky fridge-like mainframes to the sleek finesse of fitbits, containing more processing power than the computers that put a human on the moon.
For context, innovative tech has gone from having a dedicated room to a dedicated pocket, allowing us to work, study and monitor our health.
Which is exactly why wearable tech is regarded as an emerging trend that integrates electronics to the daily activities and fits into the changing lifestyles and can be worn on any part of the body. As such, experts predict that the next market with this same growth potential will be wearable technologies market.
A report from Mordor Intelligence projects that the Wearable Technology Market was valued at USD 27.91 billion in 2020 and is expected to reach USD 74.03 billion by 2026 and work at a CAGR of 17.65 percent over the forecast period (2021 – 2026).
The report published that the ability to connect to the Internet and the establishment of data exchange between a network and a device is the driving factor that led to increases wearable tech. The study considered several wearable technologies, including Smartwatches, Head Mounted Displays, Smart Clothing, Ear Worn, Fitness Trackers, Sleep Aides and wellness devices among others.
The report tracks both the volume and value of these products at a global level and region level in specific. The wearable tech market has evolved owing to the emergence of sensors among other technology.
Incorporating these sensors into a dedicated wearable device driven by the impact of smartphones being used daily, on the GPS, or the IMU (consist of accelerometer, gyroscope, and magnetometer), the report explained, mentioning that they have helped the fitness tracking wearable to monitor body activities using these sensors.
“The smartwatch category is also experiencing a rise, owing to the additional features, like the brand that suits the everyday lifestyle. Smartwatches are seeing a surge in new users, including the older population, because wearable makers, such as Apple and Fitbit, are adding health-monitoring features that appeal to older people and keep them updated about their health status in real-time,” the Mordor Intelligence report continued.
A perfect example of this is Apple’s features such as a fall detection app and an EKG monitor to the Apple Watch Series 4, while Fitbit added a feature to detect sleep apnea. According to the report, Apple’s 2019 fiscal year noted that it got nearly as much revenue from sales of its collection of wearable products and accessories as it derived from selling its old Mac computers which appears well on its way to becoming its second most significant line of products after the iPhone and its third-largest business category overall after its smartphone and services segment.
The company’s booming wearables and accessories segment helped to make up for the declining iPhone sales. In the period, sales of wearable and accessories products grew 54 percent in the last quarter of 2019 compared to the prior year to USD 6.5 billion, the report further explained.
Chronic heart and kidney failure to be treated by implantable device
While all sectors in our lives are being updated with the recent technological trends and ways to facilitate people’s lives, new technologies are being created to help people with their health amongst other issues.
As such, Paragate Medical, an NGT3 VC portfolio company, has developed a remote, implantable device solution for heart and kidney failure patients.
Most remote solutions use telematics to offer some type of remote monitoring, however founders Dr. Yair Feld, Nitai Hanani, and the team at Paragate have developed a solution that monitors and provides 24/7 home-based care to patients coping with chronic heart and kidney failure.
Mechanical bypass of the kidneys
Relatively recent research has shown that heart failure is a significant risk factor for kidney disease. As in, when the heart is no longer pumping efficiently, it becomes congested with blood, causing pressure to build up in the main vein connected to the kidneys and leading to congestion of blood in the kidneys, too.
Diuretics are currently the gold standard treatment but of the 26 million heart failure patients annually around the world, over one third are diuretic resistant, according to CORDIS, EU research results.
“Current solutions for fluid overload in diuretic resistant patients such as IV diuresis, ultrafiltration therapy and peritoneal dialysis all carry complications and are acute treatments which do not prevent recurrence,” the research said.
Paragate’s IPUD (Implantable Peritoneal Ultrafiltration Device) is a minimally invasive and fully implantable device that serves as a mechanical bypass of the kidneys. It actively, continuously, and non-aggressively removes excess fluid from the body to keep patients balanced at home.
How does it work?
IPUD improves the clinical condition of fluid overloaded patients by continuously removing extracellular fluids with a unique implantable peritoneal ultrafiltration device, operating non-aggressively and independently from the kidneys’ function.
The device is minimally invasive and the flat absorption device interfaces with the intraperitoneal membrane and applies a hydrostatic pressure gradient. It then continuously and slowly absorbs systemic isotonic extracellular fluid and drains it to the urinary system preventing recurred accumulation.
The device has a projected service life of 3 years and recharging the device has been made simple for the patients via wireless charging, needed on a weekly basis.
The company conducted successful preclinical studies and is planning to begin the clinical trials this year.
New British technology identifies 800,000 high-risk patients from COVID-19
A new technology introduced by the UK has helped clinicians identify 800,000 adults who may be at higher risk from COVID-19 contagion and placed them under high priority to receive the vaccine as part of the country’s vaccination program.
This technology – which was developed by subgroup of NERVTAG, led by the University of Oxford and funded by the National Institute for Health Research (NIHR) – analyses a combination of risk factors based on medical records, to assess whether somebody may be more vulnerable than was previously understood, helping clinicians provide vaccination more quickly to them and ensuring patients can benefit from additional advice and support.
According to a statement published by the British government, the analysis is made possible via new technology and emerging evidence regarding the impact of the disease on different groups and who could be most vulnerable – which means further steps can be taken to protect those most at risk.
“The model’s data-driven approach to medical risk assessment will help the NHS identify further individuals who may be at high-risk patients from COVID-19 due to a combination of personal and health factors,” Deputy Chief Medical Officer for England Dr Jenny Harries said.
Harries added that this action ensures those most vulnerable to COVID-19 can benefit from both the protection that vaccines provide, and from enhanced advice, including shielding and support, if they choose it.
Up to 1.7 million patients have been identified. Those within this group who are over 70 will have already been invited for vaccination and 820,000 adults between 19 and 69 years will now be prioritized for a vaccination, the government said in its statement.
The patients identified through the risk assessment will be sent a letter from NHS England in the coming days explaining that their risk factors may help identify them as high clinical risk and that they are included within the support and advice for the clinically extremely vulnerable.
“They will be invited to receive a COVID-19 vaccine as soon as possible if they have not already had the jab, and will be given advice on precautionary measures, including shielding where this is current advice. Their GPs are also being notified,” the British government’s statement explained.
The research – commissioned by England’s Chief Medical Officer Chris Whitty and funded by the National Institute of Health Research – found there are several health and personal factors, such as age, ethnicity, and body mass index (BMI), as well as certain medical conditions and treatments, which, when combined, categorizes persons as high-risk patients from COVID-19.
“The independent validation from the Office of National Statistics (ONS) is considered the ‘gold standard’ in quality assurance. The ONS has shown that the model performs in the ‘excellent’ range, and accurately identifies patients at highest risk from COVID-19,” Sarah Wilkinson, Chief Executive of NHS Digital, which has been using the model, said.
According to the government’s statement, the University of Oxford had turned their research into a risk-prediction model called QCovid, which has been independently validated by the ONS and is thought to be the only COVID-19 risk prediction model in the world to meet the highest standards of evidence and assurance.
“The QCovid model, which has been developed using anonymized data from more than 8 million adults, provides nuanced assessment of risk by taking into account a number of different factors that are cumulatively used to estimate risk, including ethnicity,” Lead researcher Professor Julia Hippisley-Cox, a general practitioner and Professor of Clinical Epidemiology and General Practice at University of Oxford’s Nuffield Department of Primary Care Health Sciences, said.
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