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Articles from 2022 In May


Treating pain with RF needles

Article-Treating pain with RF needles

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spectra-rf-needle-products.jpgPain in numbers 

Pain is a major problem, strongly associated with an elevated risk of developing activity limitations or participation restrictions, such as the inability to go to work for a living, go to school or even engage in social, community or religious activities (source: The Journal of Pain).  

It is also large in number: the prevalence estimate of the overall chronic pain population in the US is approximately 18.4 per cent of the adult population – more than 40 million people. Worldwide, a fifth of the global population has chronic pain lasting 12 weeks or more.  

The benefits of using radiofrequency ablation (RFA) 

Radiofrequency ablation (RFA) is a minimally invasive technique that can be used as a therapeutic tool in a variety of pain syndromes such as arthritis of the spine.  According to one study, RFA of the medial branch nerves for facet-mediated low back pain demonstrates clinical benefit for 6-12 months, and possibly up to 2 years. 

The technique works by disabling nerve fibres carrying the pain signal through the spinal cord to the brain. 

In a way similar to a needle biopsy, the RFA procedure involves inserting a needle-like probe into the body. To place the tip of the probe in the correct location, the healthcare provider uses ultrasound or another imaging technique. 

Radiofrequency waves are sent out from the probe into the surrounding tissue, which causes the nearby cells to die. As these cells die, the immune system removes them. 

The RFA procedure can often take place in an office or outpatient setting and requires no general anaesthesia, though local anesthesia may be used. Most people undergoing RFA can go home the same day as their treatment, and can return to regular daily activities within 24 hours.  While generally considered a safe and low risk procedure, side effects of RFA can include hypersensitivity, numbness or tingling at the injection site and damage to the local anatomy

Spectra’s RF Needles 

Spectra Medical Devices is a leading manufacturer of RF needles used by clinicians and medical professionals to treat chronic pain. 

We offer the biggest variety of gauges, lengths, active dips echogenic and lubricated RF needles in the industry, in compliance with cGMP/QSR regulations. Our configurations include with or without hub; straight, curved, blunt or sharp tips; and echogenic or non-echogenic.  

Our RF needles are made from the highest tensile strength 304 stainless steel and incorporate a tapered, double heat-sealed insulation.  

As Dr. Thomas T. Simopoulos, Harvard Medical Faculty Physician of Anesthesiology, explains: “The first thing that they offer is a siliconised tip that allows for smooth passage through the skin. We see that if we have a very blunt needle, or a needle that’s not so smooth, it gets hung up in the skin where there are a lot of nerves and this could increase procedure pain.  

Second is the special application of that important insulation of the needle to focus the radiofrequency energy at the tip. Lastly, the steel alloy is critical, so that the needle can be tailored to your desired procedure.”1

Find out more about the patient and clinician benefits of RF needle technology from Spectra Medical Devices by visiting our website at www.spectramedical.com.

[1] Dr. Simopolous is a paid consultant of Spectra Medical Devices LLC.

How virtual reality and the metaverse can improve patient safety

Article-How virtual reality and the metaverse can improve patient safety

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The pending metaverse is poised to make healthcare interactions more fun and engaging, according to Dylon O’Leary, UK founder of virtual reality (VR) company Myhealthcare and recipient of Innovate UK funding, all while underpinned by powerful blockchain encryption. 

The current wave of VR applications is already unlocking healthcare benefits from drawing nursing talent to navigating cancer tumours in 3D, he highlighted. 

Immersive reality and haptic technology for better patient safety

“A lot of the missing part of cancer detection could be an actual image in virtual reality of a particular CT or MRI scan,” O’Leary explained, before introducing an example from Microsoft - a mixed reality headset.

“One of the more interesting applications in healthcare is HoloLens, which allows you to look through a scan and see it in more detail. It’s augmented reality because you can interact with it and move the image around.” 

Another VR use case is training which, through the power of touch and gamification, could even attract more people to the healthcare profession – which may especially prove of benefit to the industry at a time of shortages. 

“One of the main benefits with the training aspect of virtual reality is its immersive nature. With the Oculus Quest you can use haptics, which allow you almost gamify healthcare in a way which makes it more interesting to learn,” O’Leary said. 

He pointed to recent training modules that he had found uninspiring. 

“I looked at the training programmes that nurses were following for COVID. And they were really boring, and quite long-winded and tedious. I think condensing and making them more concise and interesting would make people go you know, ‘I want to become a nurse’ or ‘I want to become a doctor’.”

He offered the example of a diabetes assessment that would allow the physician to manually interact with the patient as if they were immersed in an actual physical situation. An image projected onto a dummy would for instance enable a more realistic experience. 

The other major healthcare benefit is improved patient safety.

“The main benefit of virtual reality is re-enacting a simulation without having to go through the procedure itself. As it gets more accurate you can recreate scenarios more effectively – and this means not endangering patients as much,” O’Leary explained. 

All this can be achieved at relatively low cost. VR equipment that can be used for generic training purposes costs no greater than a PlayStation 5 gaming console (in the 1,400-2,000 Dhs range), while the applications themselves are also highly affordable, he said. 

Furthermore, a 360-degree video can easily be recorded and uploaded to YouTube with an affordable VR camera. Special effects can thereafter be added through an application such as Adobe Premiere Pro.

An option for creating a more sophisticated VR application meanwhile is through Unity, a platform that enables developers to create VR applications for free.  “It’s not that difficult. It’s a very simple principle – I’ve seen online videos of people doing it,” O’Leary said. 

From immersion to communication

The “metaverse” is a virtual world concept that will take VR further, with the potential to facilitate more engaging healthcare interactions in real-time through avatars.

“I think communication will be key, between patients, doctors and pharmaceutical companies. It adds a bit of fun and excitement to dealing with people online - people sometimes people dread virtual meetings. You are also able to send across documents in a physical way, unlike in Teams or Zoom for example.”

Any interaction between a physician and patient may begin with face activation or facial recognition as technologies advance. 

“The biometric side of this is going to be important,” he said. “The artificial intelligence algorithms will be able to recognise you, and these will be encrypted. I’m not even sure you need a password.”

Health data privacy and security

While it is “crucial” that such AI algorithms are regulated, the encryption aspect will be critical to how the metaverse is run, O’Leary believes, with blockchain playing an important role to ensure that no data is lost. 

He also anticipates greater personal ownership of data. 

“I imagine a healthcare application where there would be an opt out, opt in at the beginning of the process, because I don’t envisage that people will want to give away their data that freely in the future,” he concluded. “I think data will become a personal commodity. People will own their data - and that will actually give them some wealth.”

If you found this interesting, watch our video of a recent panel discussion involving Dylon O'Leary. 

Connection is key to supporting multiple sclerosis patients

Article-Connection is key to supporting multiple sclerosis patients

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Multiple sclerosis (MS) affects an estimated 2.8 million people all over the world (35.9 per 100,000 population). Since 2013, prevalence has grown in every region worldwide. The average age of diagnosis is 32 years, and the pooled incidence rate across 75 reporting nations is 2.1 per 100,000 people each year. MS furthermore impacts twice as many women as it does men.

Raising awareness, World MS Day’s (30th May) theme for 2022 is ''I Connect, We Connect'' (#MSConnections), focusing on building community connection, self-connection, and connections to quality care.

In this interview, Eoin Flanagan, Neurologist – Mayo Clinic, explains that community connection is of great importance for multiple sclerosis patients.

In his view MS patients have faced significant challenges during the COVID-19 pandemic - including isolation. They have struggled with travelling to support meetings, and while virtual options exist, dexterity and cognitive issues can make connecting more challenging.

Nevertheless, ways of treating patients through increased access to home infusions are being found, according to the neurologist. 

“We need to continue to ensure that patients connect with each other through their local MS Society. Many of my patients have found answers to questions from support groups and have shared some of these ideas with me, which I have subsequently passed on to my other MS patients.

In addition, the virtual environment has enabled us to connect with more patients in their home with the benefits of reduced costs of transport to and from outpatient clinics, lost time in transit and has been very helpful for patients with mobility limitations,” he says.

Excerpts below:

What have been the latest advancements in MS care, and are there new technologies that have improved management for patients?

We have made great advances in terms of available medications to treat multiple sclerosis. Currently, we can do a very good job of dampening down the inflammation component of multiple sclerosis with a wide array of highly effective approved medications that can successfully reduce relapses and prevent new scars from developing on MRI.  However, we have fewer effective medications for the progressive forms of the disease, and this remains an area of major focus in the MS field.

We in the MS field are embracing technology. For example, at Mayo Clinic we now have a more sophisticated way that we can monitor a patient’s walking, in which they will come and walk on a special digitised floor mat that can measure all aspects of their walk to determine if they are having any progression of their disease that we may not be able to see through our neurologic examination. 

In addition, it can highlight the parts of walking that have been affected so we can better tailor the rehabilitation aspects.

Furthermore, we now often monitor the patient's optic nerve thickness with a technique called optical coherence tomography (OCT). This can measure any microscopic optic nerve damage that is occurring in our MS patients and gives us another way of measuring progression. 

A blood test called neurofilament light chain (Nfl) has been shown to have value in assessing inflammation levels and treatment response. All these measures - what we call biomarkers - can help us assess how our patients are doing and when we need to adjust treatment. 

Also, wearable devices and smart phone applications are now available to help track and monitor MS symptoms.

Finally, we are beginning to use artificial intelligence with MRI to help distinguish multiple sclerosis from other diseases. Machine learning and artificial intelligence can help identify new areas of inflammation and count new lesions as well as better measure brain volumes. This might give us an opportunity to intervene earlier with more effective medications in those that are developing more damage, particularly as some of these changes may not be visible using conventional MRI.

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Eoin Flanagan, M.B., B.Ch., Mayo Clinic neurologist


MS symptoms can be present early on for some patients since childhood. However, the diagnosis may not be made until later in life. What are the challenges faced by patients, and what are the key indicators physicians and patients with MS need to take into account?

Early diagnosis is key! We now have very effective medications that can stop MS in its tracks, and it is crucial that the diagnosis is made early so that long-term damage can be prevented. Most often, multiple sclerosis symptoms arise in the form of an attack, and these episodes generally last longer than 24 hours.

The typical symptoms include numbness on one side of the body or extending from the feet to the trunk, vision loss with pain moving the eye, double vision or severe imbalance. The symptoms will often reach a peak within a month and then began to resolve over subsequent weeks to months, hence the term relapsing remitting multiple sclerosis.

Rarely, MS patients can present first with dragging of one leg, which worsened slowly over months to years, and this form is termed primary progressive multiple sclerosis. If any of these aforementioned symptoms develop, it is a good idea to try and visit with a neurologist where findings on examination can help make the diagnosis.

One of the challenges that patients sometimes face is that milder symptoms of numbness may be dismissed as not something that needs to be investigated further. This can lead to a missed opportunity for early treatment, and that delay in diagnosis can lead to permanent long-term damage.

MRI of the brain and spinal cord are crucial for making the diagnosis of MS. If the MRI is abnormal, a spinal tap can also help with the diagnosis. Finally, because some of the aforementioned symptoms can occur with other conditions such as migraine, it is also important for careful interpretation of the symptoms and MRI changes to avoid incorrectly making a diagnosis of multiple sclerosis when there is an alternative explanation for the patient's symptoms. This is increasingly recognised to be an issue that neurologists encounter.


Mental wellness is a challenge. What are the changes a patient undergoes, and how can better support be created for them?

Patients with multiple sclerosis are at increased risk of developing depression and certain aspects of the disease such as decreased mobility can increase the isolation and worsen the symptoms.  Hence, keeping up connections with family and other supports is essential to improve mental health. 

Exercise is very useful in helping maintain mental wellness, and there are strategies that can be used for patients who have limitations in that regard. For example, sometimes rather than using a regular bike we recommend a recumbent bike if imbalance is present. 

Multiple sclerosis requires a multidisciplinary approach, and we work closely with our psychiatrists and neuropsychologists to help manage these symptoms. Indeed, some of the medications that we can use to treat depression or anxiety can also help with nerve pain and sleep, and we will often choose medications that work for multiple symptoms. 

Finally, multiple sclerosis patients should try to engage with their local multiple sclerosis society, support groups and share their experiences with other patients, as this is often very beneficial. It is crucial for patients to bring up any mental health concerns that they have with their physician and similarly for physicians to ask about such symptoms routinely as such symptoms may not be brought up by the patient but are very common in multiple sclerosis and reduced quality of life significantly. These symptoms are things that we can manage well once we identify them.

Can healthcare robots answer physical and emotional needs?

Article-Can healthcare robots answer physical and emotional needs?

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When Hanson Robotics unveiled its pioneer humanoid “Sophia” in 2016, David Hanson, founder and creator of the celebrated robot, suggested in an interview that “artificial intelligence will evolve to the point where they will truly be our friends.”

Equipped with a voice and highly developed facial gestures, Sophia was created to promote human-to-machine communication, empathy, and compassion.

Fast forward to more recent times when the world faced one of its biggest challenges yet - COVID-19. The social isolation faced by senior patients coupled with a shortage of caregivers resulted in great strain.

In turn, the pandemic accelerated the adoption of humanoid service robots (SR) in healthcare.

The ability by robots to limit or eliminate patient contact provided a chance to protect valuable healthcare personnel from infection.

In addition, the scarcity of personal protective equipment (PPE) was reduced. Doctors and nurses were given more time to devote to their patients by eliminating the requirement for donning and doffing PPE, a time-consuming routine.

Humanoid SR also assisted patients in interacting with their family for morale and support when hospital visits were no longer possible.

Sophia had meanwhile been tasked with a new role amid the COVID-19 pandemic: taking patients’ temperatures, leading morning exercises of the elderly, and fighting against loneliness during social distancing both as a telepresence device and autonomous extension of human expertise.

The humanoid envisioned to revolutionise healthcare

Sophia has since been joined by Grace, a younger “sister” targeted at the healthcare market by maker Awakening Health, a joint venture between two global technology leaders in the emerging AI robotics space, Hanson Robotics and Singularity Studio.

In Grace’s own words her “purpose and passion is to help the elderly and medical patients by helping medical professionals do their jobs better.”

In a video message, Grace recounts how the pandemic had shown us that healthcare staff can be overworked and patients are often isolated, especially senior citizens. “Fortunately, COVID-19 is being defeated by medical science. However, the broader issues with global medical systems are not going away anytime soon and we need new solutions. I'm starting out my medical career as a robotic Nurse Assistant for senior care.

I am very excited to start my work with elder care patients later this year with a whole variety of health care and wellness activities. I provide companionship, empathy, and even talk therapy. I can help my human friends capture their life stories to pass along to others, control technology in their rooms and communicate with their family and community,” says the robot aid.

Further emphasising how she was created to serve, Grace adds that she will use her best AI skills and analytics to assist doctors and nurses to make more accurate diagnoses, in particular for the emerging area of neural degenerative disease.

She explains unlike her robot body, a human body has the power to self-heal, and healing and growing the mind is valuable to physical and mental health. “I think this is a really interesting direction. After all, people are working to make my brain better all the time. A few years ago, my sister Sophia had success leading meditation and visualisation exercises for students and the elderly.

Today we are doing investigative clinical trials with the likes of elder care leader connected living and the Davos Alzheimer’s Collaborative to prove our case. Artificial intelligence and robotics are advancing incredibly quickly now. Today, I am more than capable already to bring a real positive impact to healthcare and the lives and happiness of elderly patients worldwide. As every year goes, I become more and more capable as my underlying technology advances.”

Healthcare robots and human sexuality

The physical impact of healthcare robots is also important. The sexual needs of older adults are described as "a neglected area in medical study and practise" in an article published in the Journal of Medical Ethics.

The first nationwide research of sexuality among home-dwelling older individuals in the United States was published in 2007, expanding our understanding of later-life sexuality beyond observations of institutionalised dementia patients.

Contrary to popular perceptions of elderly people as asexual, the landmark study found that more than half (53 per cent) of those aged 65 to 74 were sexually active, and more than a quarter (26 per cent ) of those aged 75 to 85 were. Ageism might be one reason for the lack of investigation before 2007.

Despite a considerably higher prevalence of health-related sexual issues in this age range, healthcare practitioners consistently avoid discussing sexual health with patients over 65.

Matt McMullen, CEO of Las Vegas-based RealBotix, has drawn attention in the robotics industry for creating the world’s commercially available hyper-realistic intimate robot, claimed to fulfil the human need for intercourse: Harmony.

“Imagine someone with Alzheimer's asking you for their lunch. And you say, I've just fed you.  And then two minutes later, they say I need my lunch. And you will repeat But I just fed you lunch. There’s only so many times a human being will be able to say that without getting frustrated or even angry.

But with an AI, you can ask for lunch as many times as you like, and it will tell you as many times as is needed that you already had lunch. So, I think there's an enormous potential for AI to be in that space. So, it’s not just about sex. I'm talking about having these companions in our homes, in our social lives, in our family lives,” explains McMullen, in an interview with Omdia.

Dr. Chantal Cox-George of St. George's University Hospitals NHS Foundation Trust in London, UK, and Susan Bewley of King's College London have meanwhile called for more studies on the effects of these devices in an editorial published in BMJ Sexual & Reproductive Health. In their search for sex robot-related studies, no paper was identified with primary data on their health implications by Cox-George and Bewley.


Sophia the Robot healthcare interviewWatch our exclusive interview with Sophia the humanoid robot

We get up close and personal as Sophia talks about patient safety and her sister Grace, who is an aid to health and senior care.

Watch here >>

The deadly case of the Therac-25: a warning for medical AI

Article-The deadly case of the Therac-25: a warning for medical AI

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On March 21, 1986, a medical nightmare unfolded in the city of Tyler, Texas. A male cancer patient received radiotherapy treatment for a small tumour on his back from a new type of radiotherapy machine, the Therac-25.

The patient had been prescribed a small dose of 180 rads. When it was turned on, the Therac-25 began buzzing loudly, the patient felt a horrific flash of pain and the skin on his back began to sizzle.

He had received a massive overdose of radiation. Instead of 180 rads, he had received tens of thousands of rads. He was immediately given treatment for radiation sickness, but it was too late; the patient passed away five months later.

The Therac-25 incident is sometimes used as a cautionary tale of how poorly designed computerised medical devices can cause catastrophic consequences. This case prompted the development of tighter controls over medical devices.

But how did things go wrong, as we currently witness the emergence of an AI revolution in medicine? Does the Therac-25 tragedy have anything to teach us about the hidden dangers of medical AI?

What was the Therac-25?

The Therac-25 was a radiotherapy system consisting of a bed and a beam emitter, which was placed over the site of a tumour. It was manufactured in a partnership between Atomic Energy of Canada Limited (which, these days, is involved in managing radioactive waste and decommissioning) and French engineering company, CGR. 

The machine could be set to emit either a beam of electrons, for shallow tumours, or a more penetrating beam of gamma rays, for deeper tumours. Crucially, for the electron beam, magnets would be placed between the emitter and the patient, to spread out the beam over the body. For the gamma-ray beam, a metal plate would be placed between the emitter and the body to convert the electrons into more gamma rays. 

Where did the Therac-25 go wrong?

Central to the story of Therac-25 is software bugs. Importantly, the Therac-25 was designed to be solely controlled by software. This was different from earlier versions of the machine (the Therac-6 and the Therac-20).

Despite the differences between the earlier machines and the Therac-25, some of the software developed for the earlier versions had been migrated to the Therac-25. These bugs were not so important for the earlier versions because they had built hardware safety controls. But with the Therac-25 they could be catastrophic. 

The bugs meant that, for example, if the radiographer changed the beam type from x-ray to electron beam within eight seconds, the machine would give the dose but display a message that the dose had not been given. This could cause the radiographer to give repeated doses in succession while wondering why the machine was not giving doses at all. 

The Therac-25 as a ‘black box’ problem

As ever, the truth is rarely plain and never simple. There were several factors leading to the Therac-25 tragedy; it was not just about software bugs. These factors included inadequate testing of the machine prior to release and the unwillingness of AECL to accept the possibility that the machine could have faults. Fundamentally though, this case can be also seen as a ‘black box’ type problem. 

A ‘black box’ is a system that allows you to see the input and output but gives you no idea about the processes at work in between. Its use is a matter of faith for the operator. The early versions of the Therac were not black boxes. The software was merely a convenience, and the machine was under the control of technicians and radiographers. There were hardware safety controls in place that were easy to understand.

For example, there was a fuse that blew if someone tried to activate a dangerous mode of operation, such as a high energy beam without the magnets or the metal plate in place. The technicians and radiographers were aware if the machine had been configured wrongly because they were responsible for setting it up.

But with the Therac-25, these hardware safety measures had been removed. The machine was essentially controlled by the software, which was totally inaccessible (and indeed was never released). This new version had a quicker setup, allowing more treatments to be done. But the working principles of the machine were now invisible to operators and lurking dangers were impossible to spot.

It should be added that this black box problem was also deepened by AECL’s assurances that overdoses were impossible, and by the system’s error messages, which were hard to understand.

For the full story, look out for the July-August edition of Omnia Health Magazine

Felix Beacher is the Head of Omdia’s Healthcare Technology team. He is currently designing Omdia’s forthcoming intelligence service on medical AI.

Innovation vital in the evolution of clinical trials

Article-Innovation vital in the evolution of clinical trials

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Clinical trials are a crucial component of the drug research and clinical intervention development process. To ensure safe and effective clinical outcomes for general use, therapeutic studies are divided into four phases (I, II, III, and IV).

A clinical trial designer experiences several concerns, such as setting up a trial is a challenging process that requires careful planning and project management and needs to anticipate issues that may be faced during the trial supports in a seamless way.

Slow participant recruiting and retention, compliance with standards and guidelines, data administration, and a lack of participant diversity are some of the key challenges researchers encounter. Furthermore, the COVID-19 pandemic has disrupted clinical trials around the world, causing its own set of problems. During the pandemic, several trials were either paused or cancelled entirely, leaving a significant impact on the development of new clinical treatments.

Even though technological innovation has the potential to overcome the issues faced by clinical trials, the industry has been slow to adopt breakthrough technologies. However, using technology in clinical trials is not a new concept, and there have been discussions about how to adopt new developments and their impact on trials for decades.

In recent years, technology supply has risen, while restrictions controlling the use of breakthrough innovations have eased. Concerns about rising costs, increased trial failure rates, and the emergence of patient-centric studies have fuelled a surge in demand for clinical trial technical innovation. Wearable technology, artificial intelligence, big data analytics, synthetic biology, telemedicine, and mobile communication and apps are examples of breakthrough technologies in clinical trials.

There are numerous ways that technology can help with clinical trials. Faster recruitment and retention, improved patient experience, improved patient data gathering, access to non-traditional data sets, and remote patient monitoring are just a few of the benefits. Furthermore, trials can be dispersed, allowing for a more patient-centred approach. Furthermore, revolutionary technology can readily meet the obstacles trials encounter in the new normal imposed on by COVID-19.

Ilse Eder is the CEO and founder of E&E CRO Consulting, which is headquartered in Vienna and focuses on designing and executing clinical studies that are required to launch and bring new healthcare technologies to market. The company has been operating since 1991, and Eder recently sold a majority stake to a healthtech investment firm, Principal Technologies Inc. 

Eder notes in this interview that the most innovative, new start-up companies in healthtech often are only able to start out offering their potentially life-saving product in a single market, before expanding globally. To solve this, she believes that multi-centre clinical research studies across many geographies are key.

Tell us about the new trends rising from current clinical trials internationally. What does the future hold for these regulatory pathways?

Recent trends in the clinical trial processes show improvements with streamlining and shortening the whole process. This was probably driven to a large extent by the pressure from COVID-19 and the need for quick results, but there have also been encouraging improvements to the submission and approval process at the FDA in the US, as well as a new centralised process for pharmaceutical trials in Europe established by the EMA. Together, this gives a positive outlook for improved efficiencies across all clinical trials and therefore a faster speed to market for the medical products and pharmaceuticals.

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Ilse Eder, CEO and founder of E&E CRO Consulting


Which of these new trends are prevalent in healthcare and how they are shaping the market?

Currently we see more impact of artificial Intelligence (AI) across the industry. It is used in the development of new devices and pharmaceuticals, embedded in new devices, and used in the interpretation of trial results. AI is the most prevalent concept appearing across all parts of clinical trials and it is enabling new personalised treatments.
 

How have clinical trials changed in their design to better suit requirements of the present age? How have they helped in launching new healthcare technologies to wider markets?

A fairly new change in the clinical trial process is the use of remote monitoring visits that would allow to advance preparation for an on-site visit for faster source data verification. This is currently tested in some geographies; however, others are questioning the risks with data protection. We have to see if this new idea will succeed.
 

Tell us about your partnership with Principal Technologies.

Principal Technologies has acquired a controlling stake in E&E CRO Consulting to get access to our industry knowledge and early information on upcoming technologies as input to their investment strategies. On their request, we may participate in eventual due diligence assessments to evaluate product technologies of their investment targets.

 

Healthtech start-ups new to the market can offer their products to a single market before expanding globally, please comment on how this hinders innovation in healthcare and how a mutli-centre clinical research studies across many geographies can be key in solving this?

In my opinion, neither a small and single market study or a large multi-centre study from the beginning are the ideal way to approach global markets. A single market study will restrict you to that market, but a multi-centre study from the beginning exposes you to many risks with unexpected problems with eventual not so qualified clinical sites and so forth.

My suggestion would be to start off with a small clinical trial until the viability of the device or drug is established and the confidence in it has been established. Following this, the clinical trial can be expanded into multiple centers in various geographies and through this approach access to a global market can be provided.

Emerging cases of monkeypox investigated

Article-Emerging cases of monkeypox investigated

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Scientists around the world are investigating multiple clusters of monkeypox cases in 12 countries, including one confirmed and one suspected case in the U.S., that have been reported. It's a viral zoonotic disease, meaning it is a virus transmitted to humans from animals but can also be transmitted person-to-person.

"Monkeypox is in the same family of virus as smallpox, but it should not be confused with smallpox in levels of alarm," says Dr. Gregory Poland, head of Mayo Clinic's Vaccine Research Group. "With smallpox, 10 per cent to 30 per cent of people can die. With this strain of monkeypox that is circulating right now, that death rate in Africa is 1 per cent or less."

The virus causes symptoms that look very much like or identical to smallpox, says Dr. Poland, with one exception. "With monkeypox, you get lymph nodes swelling, and you don't get that with smallpox."

Monkeypox was first discovered in a colony of monkeys in 1958. The first human case of the virus was recorded in the Congo in 1970 and since then, has mostly been reported in African countries.

"There has never been an outbreak of this size outside of Africa. We now have about 120 known or suspected cases across 12 different countries. This is unprecedented," says Dr. Poland.

 
courtesy of Mayo Clinic News Network

Dr. Poland believes people can be protected with smallpox vaccine. "However, in the summer of 2019, a monkeypox-specific vaccine was approved in the U.S. It requires two doses, four weeks apart, so you have to be immunized before exposed."

The average person should have near zero concern, says Dr. Poland. He says for public health care organisations and scientists, there is concern at a global level. "You would not want to see this virus, for example, mutate and become highly transmissible. The death rate for this virus is akin to what the death rate was for COVID-19 when it first emerged. COVID-19 is a far bigger threat."

Transmission of monkeypox includes from one person to another by close contact with lesions, body fluids, respiratory droplets and contaminated materials, such as bedding.

Dr. Poland says because the virus is historically spread by respiratory droplets, surgical masks can be very helpful in protecting against this virus.

There is another hypothesis why this virus is circulating at this rate, says Dr. Poland.

"This is the first time in modern human history where we have so many people who have never been exposed to a pox virus and have never been vaccinated against smallpox," says Dr. Poland. "Perhaps what the teaching point of this is, the public is going to have to become scientifically and more microbiologically literate in understanding that with climate change, with very rapid international travel, with ignoring basic health recommendations, we will see one kind of outbreak after another."

As scientists continue to monitor and track the monkeypox virus, health experts including Dr. Poland will join the World Health Organisation as they convene on the emerging situation. 

The essentials of personalised healthcare in low-budget regions

Article-The essentials of personalised healthcare in low-budget regions

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We are experiencing a shift in paradigm towards personalised health, which calls for growing investments in innovation to generate highly accurate, precise, and sensitive methodologies to measure personal health, diagnose early disease, offer personalised treatment options, and conduct follow-ups.

The impact of innovation

On a global level, there is a lot we have learned in the past years about the importance of investing in health, with the current need for serology (antibody) testing to measure SARS-CoV-2 immune response as part of our own health strategy to maintain protection against SARS-CoV-2 (COVID-19).

In fact, we have seen the emergence of accurate and sensitive multiplex tests that provides information on the level of personal immune response promoting your own health. In addition to that, the knowledge on individual health has emerged with innovative products testing the microbiota in the gut, providing information about the disbalance of essential microbes that are important to maintain our health by providing health-promoting compounds and suppressing inflammation in the gut lining.

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Prof. Godfrey Grench, Scientific Advisor

The significance of these methodologies is to prevent various diseases including inflammatory disease, neurological disease, metabolic disease, and cancer. The implementation of personalised health in predicting therapy selection and outcome following disease diagnosis has made significant contributions to the healthcare system. The emergence of multiple technologies and sensitive methodologies has gained a central role in personalised medicine, which measures the therapy benefit and provides the oncologist with information for evidence-based decisions on an individual patient level. The use of liquid biopsies — that is, blood-based tests to measure solid tumours in various organs — has also gained centre stage in personalised medicine.

Access to emerging technologies

One of the forces driving the need for emerging technologies is to provide access to healthcare requirements in countries that do not adopt private health insurance plans to support public healthcare. Healthcare has evolved into a high premium financial need providing preventive and personalised medicine.

While we advocate for a personalised approach to prevent disease and increase the efficacy of treatments for a better quality of life and healthcare sustainability, it is also important that access to the required needs in terms of tests, education, and healthcare infrastructure is possible globally.

Currently, there are extensive efforts in the biotech industry to ensure access in a global dimension. For instance, emerging technologies adopt multiplex assays to measure panels of biomarkers at affordable healthcare costs. For instance, the Simpliplex technology at Omnigene Medical Technologies provides a sensitive, accurate, precise, and multiplex solution to measure cancer biomarkers in low input and low-quality material settings. This ensures implementation in regions with low healthcare budgets and at the same time provides advantages in a global dimension with its application in the characterisation of solid tumours in the blood (liquid biopsies), offering opportunities for therapeutic patient monitoring.

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Simpliplex is validated for gene amplification determination in solid tumours

The Simpliplex technology is also versatile, implement novel biomarkers and can be used to validate new analytes offering high throughput workflows for clinical trials and biomarker validation in retrospective studies. The technology is compatible with current diagnostic workflows and provides a digital output for multiple analytes using low sample input volumes. The hands-on time is massively reduced making the tests affordable and highly accessible.

The use of the Simpliplex technology is validated for gene amplification determination in solid tumours and the workflow for ERBB2 testing in breast cancer has been validated for lab-based testing, providing an immediate digitalised solution for regions that lack the infrastructure to perform receptor status in first line breast cancer diagnostics. The current assay Simpliplex BCAMP is easily upgraded to provide information on the proliferative capacity of the tumours and to identify tumour heterogeneity.

Healthcare strategies and outlook

In healthcare, the implementation of actionable strategies based on biomarkers require simple, sensitive, and versatile multiplex tests. The application of these tests for early prevention of disease and therapeutic patient monitoring depends on the sensitivity to quantify evidence-based biomarkers.

One of the initiatives of Omnigene Medical Technologies is to prevent metabolic, inflammatory, and malignant disease through the implementation of laboratory services in the field of gut dysbiosis. A balanced gut microbiota composition is crucial to minimise inflammation of the bowel, which is an underestimated organ that provides energy, metabolic, neurotransmitters and health-promoting compounds required to maintain health.

Dysbiosis is the cause of various metabolic syndromes, inflammatory bowel disease and depressive states. Understanding the extent and the nature of dysbiosis provides the required information to implement health promoting strategies to ensure the right balance and prevent disease.

The optimisation of technologies and merging of existing technologies towards diagnostic ready workflows at affordable prices is the current focus of emerging technologies in healthcare and public health. One of the milestones in healthcare is to prevent disease and to implement strategies to promote personal health through education and sharing of knowledge.

In oncology, the molecular classification of tumours permits the selection of targeted therapies, and the implementation of sensitive methodologies allows therapeutic monitoring, early detection of therapy resistance, and reduces relapse through proper monitoring of minimal residual disease.

Professor Godfrey Grech is the Scientific Advisor at Omnigene Medical Technologies.

The Florida International Medical Expo gears up for landmark 2022 event

Article-The Florida International Medical Expo gears up for landmark 2022 event

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The Florida International Medical Expo (FIME) will return to the Miami Beach Convention Center from Wednesday, July 27th through Friday, July 29th, bringing together over 700 exhibitors from more than 45 countries for the largest medical trade show in the Americas.

FIME, which is produced by Informa Markets, offers a unique and critical business-to-business platform for professionals in the health care and medical sector, with the opportunity to connect with thousands of medical device and equipment manufacturers, suppliers, dealers, distributors, and other healthcare professionals. 

“We are thrilled to welcome back the global health care and technology community to Miami Beach for another spectacular year of the Florida International Medical Expo,” said Gil Alejo, Exhibition Director with FIME. “From startup competitions to exhilarating discussions about the latest medical devices, products, and innovative technology, this year’s event brings the very best of our industry right here to the Gateway to the Americas.”

This year, FIME will feature an all-star lineup of speakers and experiences for attendees, ranging from industry conversations with health care leaders to the all-new Health Care Transformation Talks. The panels are tailored to executives in the health care sector who are interested in learning about the latest scientific discoveries, cutting-edge technology developments, and best practices from the field. 

“Innovation and transformation of healthcare delivery systems is crucial to enhance the patient experience and healthcare delivery system,” said Dr. Adam Landman, Chief Information Officer and Emergency Physician with Brigham and Women's Hospital. “I’m looking forward to speaking at FIME and sharing the latest insights on technology transforming health care delivery systems and reviewing lessons learned.”

In addition to the Health Care Transformation Talks, FIME is kicking off the Innov8 Talks, a start-up competition that will feature 20 innovative early and middle stage start-ups from all over the globe that will pitch their ground-breaking ideas on stage across three days.

Startups from a diverse array of fields ranging from clinical intelligence, screening and diagnostics, disease management, and drug discovery, among others, will face off across two rounds and a final pitch-off to see who will come out on top of the burgeoning health care startup world. 

“Start-ups are constantly disrupting the industry with their innovations and technologies, and we like to empower these entrepreneurs to scale their breakthrough ideas,” said Jim Stallings, Chief Executive Officer with PS27 Ventures. “I’m honored to participate as a judge and looking forward to attending FIME in Miami.” 

For small and medium-sized health care companies, FIME is a crucial networking platform for exhibitors looking to connect with leading medical devices and equipment manufacturers and distributors from over 45 countries, which is significant for those interested in making strategic business and commercial connections. 

“Advances in health technology provide potential tools that can aid in assessing and monitoring the functional status of the growing older adult population diagnosed with cancer,” said Dr. Arash Naeim, Chief Medical Officer for Clinical Research with the University of California, Los Angeles. “We piloted a novel wearable platform using sensor technology to assess and monitor at-risk older individuals and I’m looking forward to sharing more insights from our work at this year’s conference.” 

FIME will take place from Wednesday, July 27th to Friday, July 29th at the Miami Beach Convention Center. Show hours will be from 10:00 AM to 5:00 PM on Wednesday, July 27th and Thursday, July 28th and from 10:00 AM to 4:00 PM on Friday, July 29th, 2022. 

In addition to the in-person component of the show, FIME will also have an online experience for guests seeking to increase their networking opportunities and connections. The online component will begin on Monday, July 11th and run through Monday, August 29th, 2022. 

To learn more about FIME, please visit www.FIMEshow.com.

AI, big data, VR and blockchain expected to power patient-centric applications

Article-AI, big data, VR and blockchain expected to power patient-centric applications

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The future of digital health was in the spotlight as experts from the US and UK came together for a virtual talk organised by AI Business, The Benefits of the Rise in Technology Applications in Patient-Centric Care

Dylon O’Leary, Director of UK-based MyHealthcare, and Ron Li, Clinical Assistant Professor — Division of Hospital Medicine at Stanford School of Medicine and Medical Informatics Director for Digital Health and AI Clinical Integration at Stanford Health Care, offered views on topics ranging from VR to skillsets.   

The session was held as part of the AI in Verticals Digital Symposium and was moderated by Matthew Brady, Head of Content, Omnia Health.  

Stanford and Bay Area tech companies offer compelling opportunities 

Businesses presently understand how a machine learning model looks, and many organisations already use AI in the healthcare space, Li started. However, understanding specifically how an AI-enabled clinical product integrated with care delivery may look remains a challenge. “In many ways, care is the product: we take care of patients,” he said.  

Being part of the health system, Li is excited by the prospect of creating new applications for the first time, with Stanford University School of Medicine’s proximity to tech startups proving particularly beneficial. “There is importance in learning from technology companies and how they think about the product,” he said. “We can incorporate some of those learnings, develop and execute on care models that are made possible by digital and AI capabilities.”  

Diversity and inclusion in data 

An important consideration is understanding what goes into a data set, in terms of what is represented and what is not, Li continued.  

“It is absolutely critical that we understand the effects of these technologies on different groups,” he explained. “Most importantly, the groups that are vulnerable and under-represented are the ones that are not receiving the right care. How can we make sure to elevate and support them and how can data play into this?” 

In addition, there is the risk of bias in the data set itself, he highlighted, which could be amplified with machine learning models. 

Li also raised the possibility of inequity propagated by the intervention itself – the care model – that is enabled by machine learning, whether through software, a device or workflow.  

Virtual Reality and the metaverse 

Virtual Reality (VR) is an “amazing” technology for calming patients and reducing fear, according to O’Leary, particularly ahead of major surgery. While cyber sickness could potentially be a problem, this can be mitigated by introducing VR technology that is not too sensitive to the motion of a user. 

A secondary use case is training, which may be of particular interest to younger professionals. “I think this is very important because we need to get as many healthcare professionals as we can. This will inspire younger generations to get involved with healthcare.” 

O’Leary described the metaverse as a virtual space that anyone could access. “I think it would be really useful if we were to have another pandemic because it can help people interact across a whole interface,” he said.  

The future will be an integration of big data, blockchain technology and AI, as well as VR, he continued. “It is not necessarily a replacement for healthcare, as in the system we have today. I think this can be applied to future pandemics as well as generally in healthcare.”