A Doctor standing and pointing at healthcare icons

Pioneering The Future of Effective Wound Care Solutions

The multi-award-winning company, Kent Imaging Inc., is a leading Medtech firm based in Calgary, Alberta, Canada. The company’s technologies – namely SnapshotNIR – are enabling clinicians to drive better outcomes in wound care, limb preservation, and surgery, with its diagnostic-driven imaging technology that assesses tissue oxygenation. Consequently, Kent Imaging has, once again, earned itself the esteemed title of Best Medical Imaging Technology Development Company, 2022 – Canada.

Effective wound management stems from consistent, in-depth wound healing monitoring and persistent therapy. Tissue oxygenation is a key indicator in a wound’s capacity to heal and tracking how this healing is progressing, as the delivery and uptake of oxygen in the tissue plays a fundamental role in cellular function and tissue epithelialization. Traditional equipment used in the observation of tissue perfusion and oxygenation is often large, immobile, and expensive. It is, in essence, incredibly limiting. As a result, patients are oftentimes wrapped up in lengthy appointments, invasive protocols, and a lack of accessibility. Additionally, many of these devices on the market only measure perfusion in the large vessels. SnapshotNIR measures tissue oxygenation in the critical microvascular network.

A Canadian company, Kent Imaging Inc., is on a crusade to optimise the technology utilised in this area. As such, Kent has established itself as an innovator, specialising in the production and marketing of advanced imaging equipment for wound care, limb preservation and surgical applications. Over the years, the company has filed multiple patents for ground-breaking technologies, with the goal of aiding both national and international healthcare systems.

Its flagship product, SnapshotNIR, serves as the latest generation of near-infrared tissue oxygenation imaging. The portable and lightweight technology is a far cry from the clunkiness of its predecessors and as easy to operate as a point-and-shoot camera, therefore able to be seamlessly integrated into clinical and surgical workflows. Furthermore, it is a wholly non-invasive piece of technology – SnapshotNIR uses no dyes or injectables, no consumables, and needs no direct patient contact to capture images wherever the patient is situated.

Supported by over two decades of research, SnapshotNIR uses near-infrared (NIR), reflectance-based technology. With this technology, SnapshotNIR measures relative amounts of oxygenated and deoxygenated hemoglobin in the microcirculatory network where oxygen exchange is happening. With a simple click of a button, clinicians are provided with a clear, easy to read, tissue oxygen saturation map that can provide valuable insight to help make informed, patient-centric medical decisions.

The SnapshotNIR device has a variety of applications, and can be used in cases of wound care, limb preservation, and reconstructive surgery. To provide some examples, the device can be leveraged in hyperbaric oxygen therapy (HBOT) to qualify patients for this advanced treatment modality, and then to assess the effectiveness of this treatment over the prescribed number of sessions. This is extremely valuable from both a time and economic standpoint as it can assist in patient compliance and enable the documentation of continued therapeutic success or the end of treatment. SnapshotNIR can be used to provide insight into the adequate preparation of a wound bed for the application of advanced therapies and then continue with the documentation of the efficacy of the therapy. In the interoperative environment, Snapshot can indicate the level of oxygenation in a surgical flap to provide insight into the likelihood of flap survival. This can impact decisions made while still in the OR. Within limb preservation, for instance, time is of the essence and the identification of poor tissue oxygenation in the peri-wound and surrounding tissues can serve to expedite vascular referral and intervention. In the United States alone, statistics show that every 30 minutes, $1 million is spent on diabetic foot complications, and 80% of non-traumatic amputations are a result of peripheral arterial disease (PAD) – over 50% will die within the first five-years of amputation. Kent Imaging’s solution means that access to non-invasive vascular assessments is increased, not only saving limbs, but potentially lives.

Additionally, the product enables clinicians to provide a greater standard of care to patients. Healing chronic wounds can often be a slow and frustrating process as wounds can be deceiving. In many instances, the status of the wound healing progress cannot be fully evaluated with visual inspection alone. With SnapshotNIR, practitioners gain insight that allows them to offer patients timely, informed, and, in some cases, life-saving solutions. This technology provides real-time insight through non-invasive, accurate and actionable data, which can result in better patient compliance and more positive outcomes.

The impact that SnapshotNIR has had has been significant– patients and clinicians alike have nothing but high praise for the product, and these testimonies are displayed across Kent’s website. Dr. Duane Cumberbatch has used the technology in a plethora of cases, and for one of his patients, an elderly woman suffering from chronic vascular wounds on each of her ankles, it forged almost unprecedented results. After suffering from these wounds for over six years, thanks to SnapshotNIR and Dr. Cumberbatch’s treatment, within six months of her first visit, her ankles were almost completely healed.

It is clear that Kent Imaging’s SnapshotNIR offers multiple benefits to both its users and their patients. Dr. Duane Cumberbatch’s experience with the product is mirrored within additional expert testimonies, including that of the Save a Leg, Save a Life Foundation. The organisation specialises in building awareness around the issues, care requirements and potential complications that can arise from diabetes or PAD-related chronic wounds.

The Foundation is now utilising SnapshotNIR in its community outreach screening events. “To be able to use a screening device like Snapshot that can give us information in a short amount of time is invaluable. As we grow our program and do more events around the country and elsewhere, wherever we have technology at our screenings, I think everyone benefits,” summarises Dr. Desmond Bell, a key player, and the creator of the foundation. The SnapshotNIR device is an exciting advancement in wound care technology. There is an increasing amount of evidence that displays the technology’s positive impact on client outcomes and the work clinicians can fulfil. In turn, Kent Imaging is changing the future for wound care, limb preservation, and reconstruction patients.

For business enquiries, contact Sandra Jenks at Kent Imaging Inc, via the website – https://www.kentimaging.com

Pierre Lemire
Scientist working on medical research in a lab

Community-Based Sites: Casting a Wider Net to Close the Data Diversity Gap in Clinical Trials

The publish or perish culture surrounding clinical trials is influenced by politics, economics, and sociocultural factors, all either nourishing the research landscape or creating the equivalent of a hurricane. But while these overarching obstacles loom large in pharmaceutical company boardrooms, frontline investigators are grappling with other, more immediate, pitfalls impacting the volume and diversity of data coming out of clinical trials.

Low enrollment, lack of diversity, and limited research sites currently rank as the top impediments to robust data. However, one innovative company is enabling trial sponsors to pre-emptively stave off Food and Drug Administration (FDA) rejections and limited efficacy by providing a foundational element for what could be the antidote: utilizing community-based research sites.

By connecting sponsors with smaller community trial sites, Inato is paving the way for greater enrollment diversity and amping up the data flowing out of clinical trials.

 

The Data Diversity Challenge

To provide some perspective, clinical trials take an average of eight years between initial testing to product approval, with only one in six gaining full FDA approval. A retrospective review of all FDA submissions between 2000 and 2012 showed that nearly 16% of rejected studies could have salvaged their research had they enrolled a larger, diversified population sample.

Given that nearly 95% of the population is excluded from study participation solely because they live too far away from academic testing centers, the consistent lack of diversity is not surprising. A whopping 70% of all clinical trials worldwide occur at just 5% of research sites, which primarily draw patients from populations within 40 miles of trial sites. In terms of inclusivity, racial diversity is a significant issue. For example, FDA’s Center for Drug Evaluation and Research’s (CDER’s) Drug Trials Snapshots Summary Report found that just 6% of trial enrollees were Asian. Further, 75% of the patients enrolled in industry-sponsored clinical trials in academic medical centers and community hospitals are white.

The diversity problem goes beyond race, however. Consider that only 8% of cancer patients enroll in cancer trials, and less than 2% of cardiovascular disease trials reported any female sex-specific cardiovascular risk factors. Racial, gender, demographic, and geographic limitations drive up costs, dampen external validity, prolong timelines, and limit the generalizability of findings to the population at large.

 

Enabling a Patient-centric Approach

Decentralized trials, which depend less on traditional research facilities and specialist intermediaries for data collection and instead leverage virtual tools (e.g., telemedicine, sensory-based technologies, wearable medical devices, home visits, patient-driven virtual health care interfaces, home delivery of study drugs and materials), are often held up as the solution to the diversity problem. However, direct involvement and care of a physician is still crucial – particularly with complex trials. Engaging community-based sites overcomes this limitation, allowing patients to seek treatment close to home while receiving necessary support.

By enabling the participation of community-based research sites, companies like Inato are helping to improve representative data collection on a global scale and, in some cases, salvage existing trials that are struggling with enrollment. As a part of a patient-centric approach to clinical trials, community research sites bring access to patients worldwide, including those populations who have historically lacked access to clinical research.

Inato advances inclusion through its Marketplace platform, which reinvents the partnership model between sponsors and sites by reliably matching sites and clinical trials worldwide, opening access to a broader range of sites, and expanding the patient pool. Since June 2020, the company has built a network of over 1,500 community research centers in 40 countries to enroll patients in more than 70 disease areas.

Showcasing the success of this model is a global healthcare company that, due to the pandemic, faced delays in its trial timelines, fewer patients participating in trials, and the rising need to enroll patients quickly as more trials were taking off. Within their portfolio, an increasingly challenging disease area was multiple sclerosis (MS), for which several trials were running simultaneously. These included trials for Relapsing MS (RMS) – a historically arduous recruitment and enrollment area. The sponsor decided to post the trials to Inato’s Marketplace platform, allowing sites the opportunity to self-identify which trials worked best with their patient population and availability. The working relationship between Inato and the sites also enabled the trial sponsor to have a comprehensive view of each sites’ capabilities, ultimately selecting several to successfully participate in multiple MS trials.

For populations that are typically harder to recruit for, like RMS, Inato works closely with community sites to identify those with access to qualifying patients. In this case, the extensive process of pre-identifying patients that met trial criteria allowed one community-based center from Inato’s network to achieve the US First Patient In (FPI) in the RMS Phase II trial. In all, over 70 patients were identified for the RMS trials alone, with one site screening two patients within the first week of activation for a Phase III study.

 

The Power of Community

For the global trial sponsor, Inato’s approach to bridging the gap between sites and sponsors translated into the successful launch of eight studies across several disease areas and nine countries. Using Inato’s Verified Commitment, the sponsor’s team could ensure the trials will meet enrollment goals before they begin screening and receive verified patient commitments from nearly 250 patients across these eight trials.

That organization has since expanded its relationship with Inato to include asthma and chronic obstructive pulmonary disease (COPD). It is a strong business case for the power of expanding clinical trial opportunities to often-underutilized community sites, which sets the stage for employing an inclusive research model.

The reality is that traditional clinical trials face more obstacles than ever due to rapidly evolving political, economic, and socio-cultural shifts that are exacerbating existing data and enrollment diversity challenges. By enabling access to the personalized care of community-based doctors, Inato optimizes the advantages of patient-centric trials. Its online marketplace platforms connect large sponsors with diverse community sites and provide those smaller sites with valuable enrollment support, leading to broader population representation and the benefits that come with it.

Increasing diversity, inclusivity, and reach in clinical trials through companies like Inato is emerging as the antidote to publish or perish.

Closeup of a someone fingerlocking their hands, and a mental health first aider comforting them

Embrace Mental Health First Aiders for Better Work Wellbeing

In recent years, mental health has moved up the agenda. From being a topic that was invariably brushed under the carpet and deemed ‘personal’, it has gained increasing attention in all walks of life. Within the health service, across the media, highlighted by celebrities, talked about in schools and gradually discussed more openly in society – how poor mental health negatively impacts people is now securing traction. Not least, within the workplace.

Covid-19 has accelerated this. As people worried about their physical health because of the virus, finding themselves having to accommodate dramatically changed working and personal lives, as well as dealing with job insecurity, bereavement, remote learning and working, isolation and much more – many people’s mental health was under greater pressure in the past couple of years than ever before.

This inevitably impacts workplace wellbeing as cases of anxiety and depression increase and firms need to respond. This is where mental health first aid really comes to the fore and training staff is crucial.

The latest CIPD Health and Wellbeing at Work report found that only 38% of HR professionals think managers are confident enough to have sensitive discussions on employee wellbeing and signpost to the right experts. Whether managers or not, when staff are trained as mental health first aiders, they are taught to spot the signs of mental health issues, offer initial help and guide a person towards support. It’s intuitive training – you learn that it’s not about giving advice, you never pass judgement or offer opinion. But you do nudge them in the right direction so they can access the right support.

The Healthcare Communications Association (HCA) organised the training that our employees went on. As a healthcare communications agency, operating in the service sector, we know how important our people are. That means that to get the best out of them, we must support them in reaching their goals and helping them develop – or, indeed, making it equally fine for them to remain in the roles they are in, if that suits them better.

We know that dialogue is as much about listening as it is about speaking – and that sits at the core of this training. Listening is essential to achieving productivity and building relationships at all levels.

Active consideration is central to our approach to ensuring mental wellbeing in our team. This involves careful and considered thought in everything that we do. It means not just listening but acting on what you’re hearing and seeing. It’s the small signs that can be the most telling.

Workplace wellbeing doesn’t mean that everyone must always agree and that it can only be achieved by working in perfect harmony. Healthy conflict is acceptable and to be encouraged – no two people are the same, everyone has different working styles. Indeed, as businesses and organisations look to diversify, the way people work, interact and communicate may vary more.

Nurturing an empathetic stance – seeing the world through other people’s eyes – is one of the central requirements and becomes more important as companies become more inclusive and grow their businesses. There is a balance to setting achievable, healthy challenges – that can keep people stimulated and learning – without piling on undue, or unnecessary, stress. You don’t want a workforce in a constant state of tension and always feeling ‘hyper’.

Give people space to learn; no one is perfect and mistakes will happen, but they are also the best opportunities to learn and it is for colleagues and managers to have resolve and fix any mistakes so that the individual can learn and grow from the experience in a supported manner.

There are steps to take to ensure mental wellbeing. Encouraging open dialogue and operating open-door policies are a start. Invest in HR support – and this may mean bringing in external resource if the business is too small to support a dedicated HR department of its own. Don’t just send one or two people on mental health first aid training – work towards sending all your employees.

Go back to the basics such as encouraging staff to take their lunchbreaks – just as important when home working as when in the office – and to use all their annual leave. Beyond that there are additional measures such as days off for volunteering and having an extra day for your birthday that be considered. At our company, we give everyone the opportunity to have four charity days a year.

With hybrid working entrenched, building in regular one-to-ones, away days and socials has become more important. These can instil a sense of belonging, especially as aspects of post-lockdown life can be isolating. Deep dives into the company purpose reinforce for employees why they work for the business and what it stands for; sharing that sense of why they do what they do and why it matters.  This can be particularly effective when combined with an immersive away day experience, free from outside influences and working day pressures.

In industries like ours, which are highly competitive and fast paced, the mental load on employees is high. In the service sector we expect a lot of staff and if their mental health isn’t prioritised, there’s a risk of burnout. Using the elastic band analogy – we all like to be stretched a bit, indeed we’re happiest when we’re comfortably stretched, but not so far as to snap.

It is imperative for us all to monitor each other – we have a duty to support and nurture our staff and colleagues. Mental health first aid can work as a vital steppingstone to instilling good mental health practices into wider company culture and ensure everyone knows what to be looking out for in others, as well as themselves. Everyone is different, there’s no right and wrong, and we can all adapt where we need to.

 

Written by Molly Coxon, Page & Page and Partners

Molly Coxon
Molly Coxon
Covid Vaccine

Which Technologies are Helping Us Fight the Coronavirus?

Covid Vaccine

The pandemic has had a major effect in our lives, and it still remains to be seen how much it will have changed the way we live, once it has gone away. But thankfully, we did have science and technology on our side, in this fight, which helped us keep the virus as much under control as possible, by learning about it and finding ways to prevent it from causing even more deaths. Here is a quick glance at a few technologies that saved us from an even greater sanitary crisis.

 

Detecting the Virus

When the pandemic started, in China, the biggest issue that health organizations in the country were faced with, was to find a test that would enable them to identify those that were infected by it rapidly, so that they could isolate them. One of the very first rapid tests that appeared as a solution, was through the technology of microplate readers. In less than 30 minutes, laboratories were able to confirm that a person was free of the COVID-19 or not. It definitely helped save a lot of lives then, but it is still helping us in various other discoveries, regarding the coronavirus.

Thanks to a luminescence plate reader, we can proceed to pseudo virus neutralization assays. We can study the interactions by using BRET, FRET and TR-FRET techniques. Finally, it is also the technology that enables ELISA of viral antigens or host antibodies. In other word, plate reader technology has played a large part in our battle with the coronavirus and will continue to do so, for other viruses as well, in the years to come.

 

Treating the Patients from a Safe Distance

The second problem that the healthcare system faced, was how to treat patients without risking more infections. Quickly, the system became overloaded with patients. To have so many individuals going to emergency rooms was simply not a good idea. That is where telehealth technologies came in, and helped keep patients protected, and doctors as well. Although it already existed before the pandemic, it is fair to say that this technology grew exponentially during that period, changing people’s habits, in terms of visiting their doctors. For some, this may become a semi-permanent solution as well, in the future, including the disabled.

Telehealth technologies made it possible for patients to be seen, as well as diagnosed from a doctor, through an audio-visual communication, between the two parties. Taking place in real-time, these visits could be held through mobile phones, tablets or computers. As long as both parties had a webcam on their devices, the connection could be made. It could even be used for conference purposes, if more than one specialist was needed on the call. This technology also saved a lot of people from being infected, and it will remain a great tool for any infectious diseases that may come our way, in the future.

 

Helping to Provide Medical Equipment

One of the biggest problems that the world had to deal with, during the pandemic, was the lack of equipment. It was true of masks, ventilators, and filters, amongst many other items. It was not a small issue, since it was the primary cause of the healthcare system breakdown, which in truth never fully recovered. That is in large part why governments created so many restrictions for the population. But one technology came in to help create more equipment: 3-D printing. 

This kind of technology can recreate almost any item, as long as the blueprint is available. It also does so at a much lesser cost. So, at the height of the crisis, back in 2020, many people started offering their 3-D printing machine, in order to help build all the equipment necessary to help hospitals that were lacking them. It became particularly useful for parts of ventilators that were badly needed at the time. It has positioned itself as a great solution for anything that is needed in regards to short-term supply. 3-D printing is only at its beginning and should change the world in many different ways over the next decade.

 

Helping identifying the Virus

Gene editing technologies is going to help us win so many other fights, in the future. This time, it made it possible for scientists to isolate the virus and find out the full sequences of its genetic material. It enabled researchers to understand its origins better and was an important element in the fact that we were able to create a vaccine so rapidly. 

As soon as the sequences were known, more than twenty pharmaceutical companies starting on the development of these vaccines. The first clinical trial was done in Seattle, USA, and this was all made possible in great part by gene editing technologies, more specifically on the knowledge that it brought on CRISPR-Cas9 (Clustered Regularly Interspaced Short Palindromic Repeats – CRISPR-associated protein 9).

Runners waiting at the start line

Tech Doping: a Serious Threat to Competitive Sport or a Step in the Right Direction?

A number of high-profile sports and stars have become infamous for doping over the years. We’re all familiar with doping in terms of using performance-enhancing drugs, but what about a lesser-known type – tech doping?

Here we’ll discuss whether tech doping is the latest threat to competitive sport or whether it’s good news for athletes.

 

What is tech doping?

Tech doping is defined as gaining an unfair competitive advantage through using sports equipment. It refers to any equipment with features that provide the athlete with an unfair advantage.

A high-profile incident of tech doping comes in the form of shoes. Carbon fibre plate technology, patented by Nike, is an innovation that has come about in the past ten years and has been proven to enhance running performance. It keeps toes straight and allows the shoe’s foam to condense and inflate more quickly, both features which result in less energy loss for the runner.

All six marathon medallists from the Rio 2016 Summer Olympics were wearing shoes with the technology, leading to concerns that athletes sponsored by Nike had an unfair advantage. What’s more, all running world records have been broken since the introduction of this innovation. As a result, World Athletics banned shoes with a sole thickness of over 40mm, prompting Nike to release a version that complied with these regulations.

Tech doping isn’t a clear-cut issue and there are a lot of discussions around what classifies as tech doping.

 

Is tech doping a growing threat?

Tech doping was first recognised as a potential threat by the World Anti-Doping Agency (WADA) in 2006, and there have been a number of high-profile cases since then. The Beijing 2008 Summer Olympics was the scene of a tech doping issue, but this time in swimming. Most of the swimmers who competed wore the Speedo LZR suit, which increased speed by around 4%. Some swimmers even reneged on their sponsors to wear the swimsuit. As a result, 23 out of 25 world records were broken.

Paralympic athletes have also been embroiled in tech doping scandals due to modified prosthetic limbs. Of course, amputee Paralympians require their prosthetic limbs to be able to compete, so the items themselves aren’t an issue – but modifying them may be.

The question of prosthetics potentially contributing to tech doping has crossed the barrier between the Paralympic and Olympic games, with Blake Leeper disallowed from running against able-bodied athletes in 2021. World Athletics (WA) argued to the Court of Arbitration for Sport that Leeper’s blades counted as a “mechanical aid” advantage against runners without them, under Rule 6.3.4 of the WA’s Technical Rules.

 

The future of tech doping

Following its consultation on sports doping in 2006, WADA recognised its potential as a threat, but doesn’t govern tech doping – instead leaving it to independent sporting bodies. It does recommend the banning of certain items or equipment that enhance athletes’ performance.

Often, equipment bans come in after they’ve already been used in a professional sporting competition, such as the cases of Nike’s carbon fibre plates and the Speedo LZR suits, making it difficult to prevent it impacting the sport in the first place. Traditional drug doping is easier to prevent because athletes are subject to drugs tests.

Performance-enhancing equipment is intrinsically linked to the resources available to athletes and teams. Affluent countries including the USA, Great Britain, Germany, and France dominate the all-time Olympic medal tables. These economies have access to better technologies and equipment, which can translate to success on the world stage.

There’s also a question of where we draw the line. Science and technology have enhanced sport in so many ways over the years, and new innovations are enhancing athletes’ performances without being flagged as tech doping. Wearable tech is allowed during some elite sports competitions – The FA allows wearables that are not dangerous – but it could be argued this gives athletes an advantage over those who don’t have them.

Tech doping will no doubt be a topic of conversation at the Paris 2024 Summer Olympics and Paralympics, as summer Olympic games have been the setting for many past tech doping controversies. Nike has released the Alphafly shoe that still contains carbon fibre plating but complies with current regulations, so it’ll be interesting to see how tech doping is going to be dealt with going forward.

 

Unlike traditional doping, tech doping in sports is muddy territory. It’s clear that some equipment can enhance the performance of athletes, but isn’t that the purpose of scientific and technological innovations in sport? And where do we draw the line between simply improving athletes and enhancing their performance beyond reasonable measures? Sports scientists and sports science degrees are dedicated to the study and improvement of athletic performance, and this can involve technology. If tech doping is to be eliminated from sport, governing bodies must determine what counts as cheating, and what is simply innovation and improvement.

Closeup of phone screen with health app open

Health Apps: Offering Wellbeing Solutions or Exacerbating Our Health Problems?

In the era of smartphones, we can now manage and even improve our health on our handheld devices. Whether you’re struggling with your mental health, want to boost your physical health with your exercise regime or, you’re seeking to achieve a better night’s sleep – there’s a wide choice of apps to turn to for support.

Apps range from guided meditation to comprehensive running plans, and they can even track your sleep and mood. But are they doing more harm than good?

With some insight from Jonjo Hancock-Fell at private health cover firm, Westfield Health, will explore how certain types of health apps could potentially have a negative impact on your health and wellbeing

 

Could sleep apps be making our sleep worse?

Some of the most innovative uses of health technology are apps that track our sleep. Whether you use your mobile phone or a smartwatch, you can track how long you slept for, the time you spent in deep and REM sleep, and even set an alarm to wake you up in your lightest phase of sleep (which is proven to be the easiest time to wake up).

Many of these apps are designed to help us sleep better by waking us at the right moments and providing insights into how we’re currently sleeping. But, conversely, they could be making our insomnia worse – or even triggering insomnia in the first place.

Sleep disorder specialist Dr Guy Leschziner has said that these apps are making us anxious and obsessed with sleep, which negatively impacts our ability to, well, sleep. If these apps tell us we’ve had a bad night’s sleep, it acts as a placebo and makes us behave as though we have slept poorly – even if that’s not the case. They also don’t offer much in the way of actionable support, instead just offering data on how well we’ve slept the previous night.

 

Fitness apps put too much pressure on people

Similar to sleep trackers, wearable tech has given us insights into our fitness performance. We can track our running progress through our improved time and speed, and even see our energy expenditure throughout the day, with prompts to get moving if we’ve been stationary for too long.

These apps and devices are designed to be motivational but can make us feel worse about ourselves. The Digital Health Generation survey found that young people felt “anxiety and terror” when using these apps. It also noted that they can lead to unhealthy, obsessive behaviours such as overexercising and dangerous calorie restrictions.

While these apps can help us track progress, it’s important to not overuse them. They can help us understand if we’re not active enough during the day, but they can lead us to feel guilty and, as a result, engage in obsessive exercise.

 

Do mental health apps prevent you seeking real support?

Mental health apps, like Calm and Headspace, are almost as commonplace on our devices as Facebook and Twitter. Research has shown that the 15 most popular mental health apps were downloaded over a million times between February and May 2020 as lockdown took its toll on our mental wellbeing.

These apps have come under fire for their lack of scientific evidence, with academics criticising studies that argue they are effective. Some used a small sample size, while others focused on people who weren’t receiving mental health treatment, meaning they couldn’t conclude that these apps help people manage existing mental health conditions.

Another issue pointed out by psychologist Chris Noone is that these apps can prevent people from seeking professional support for their mental health conditions. While some users may see improvements when using these apps, they aren’t a replacement for tailored support delivered by qualified experts.

 

Are all health apps bad?

While it’s clear that some health apps can worsen the problems they’re designed to help with, they can have a place in our lives. These apps should never be used as standalone solutions to medical problems though.

Apps like sleep monitors and fitness trackers can help us to identify a problem, but alone, they are not the solution. If you’re finding yourself tired throughout the day, for example, a sleep tracker can help you identify that you wake frequently through the night. Equally, a mental health app can help you track your mood, identify triggers, and provide in-the-moment meditation exercises, but formal therapy, with the help of private health cover, and medication may be required.

The apps are best used in conjunction with professional medical care. After using them to identify patterns, you could show your GP the information that identifies stress as a cause of sleep deprivation, and they can then provide you with the right treatments. Monitor your use of these apps and be aware they could trigger or exacerbate obsessive and anxious behaviours and prevent you from speaking to your GP.

 

As technology has grown more advanced, we now have access to health support at our fingertips. And while health apps can be useful to help us identify patterns or give us the opportunity for a mindfulness break, they aren’t the solution to our health problems. Instead, they should be used sparingly to support professional medical diagnosis and treatment.

Med tech being used to check a patient's vitals

Why Wearable Technology Can Assist the Healthcare Sector Expect the Unexpected

Thanks to advances in smart phone technology coinciding with gym closures caused by lockdowns during the COVID-19 pandemic, smart watches and alternative wearable health devices transitioned from something of a “novelty toy” to an important aspect of everyday life.

Depending on the device, model, and manufacturer, these devices have the capability to measure blood pressure, blood oxygen levels, ECG, and even heart rhythm irregularities.

Dr Gero Baidara, Clinical Director of GPDQ, speaking about the role of these devices during the pandemic noted: “This year, in particular the ability to read one’s oxygen saturation, heart rate, and temperature has been invaluable in monitoring whether or not the wearer is suffering from symptoms of COVID-19.”

While we may not be at a stage where we can transfer all trust about our medical safety to digital technologies, there is no denying these devices are carving out a future for themselves within the healthcare sector, and with good reason too. With that in mind, we want to explore whether wearable technology can successfully alleviate stress in the healthcare sector and ultimately assist it to prepare for the unexpected.

 

Health has gone digital

According to medical-advicenetwork.com there were 350,000 digital health apps on the market in 2021– that number was up 90,000 on the previous year. It should come as no surprise that people want to know about their health, particularly when it’s easy to find out, and doesn’t involve visiting the doctor.

But, what about the NHS? Are they calling upon the help of these services in the same way as the general public?

Some hospitals have already been utilising the capabilities of wearable devices for quite some time, issuing them to patients with diabetes so they can actively monitor their health stats.

The Freestyle Libre device has been available on the NHS for almost three years now. Similar in size to a £2 coin, this device measures glucose levels and relays essential information to an e-reader or smartphone so users can receive real-time findings, allowing them to take action when necessary.

As for the global wearable medical devices market, well, it’s growing exponentially. As of 2019, the largest market by region was in the US & North America. However, Central Europe is anticipated to speed past their Transatlantic counterparts over the course of the next decade, fuelling a market growth rate of almost 20%.

A global market analysis report conducted by Grand View Research details how: “the rising popularity of connected devices and the Internet of Things (IoT) and the rapid growth of the technologically literate population globally are anticipated to fuel the demand for wearable technology over the forecast timeframe.”

Global wearable medical devices market graph
Source: P&S Intelligence

How the pandemic highlighted a need for change

The first thing worth noting is the sheer volume of individuals now using digital healthcare technology to assist them with their regular healthcare needs. By the end of 2021 there were, for instance, more than 22 million active users of the NHS App.

In July 2021, the NHS reported that more than 50,000 people had registered organ donor preferences on the app during June while more than 600,000 prescriptions and 50,000 GP appointments were requested. While patients were actively prompted to use the digital platform, it could be said that the British public have actually become more accepting of technology’s place in their healthcare, and so now is the time to implement more.

In one scheme in Northwest London cited in the BMJ ‘wearables’ were used during the pandemic to analyse the condition of people who were quarantining before or after travelling abroad alongside healthcare workers who weren’t able to isolate at home. The scheme “collected the vital signs of people quarantining and round-the-clock data was monitored by a trained team.”

The technology involved varied. “Medical grade wearables can be as simple as a sensor that measures a single variable, such as a photoplethysmography. Others are more complex pieces of hardware worn around the arm or as a patch on the chest, that gather a selection of vital signs, with information typically relayed to clinicians for monitoring or analysis.”

The scheme was able to reduce the strain on the healthcare sector by limiting otherwise unavoidable transmission of COVID-19 and reducing contact between health staff and potentially infectious patients, thereby also reducing the use of PPE, which reached dangerously low levels in the early months of the pandemic due to ongoing issues with supply chain and manufacturing.

In many respects, the scheme was a roaring success and emphasised just how much wearable technology has to offer an incredibly stretched healthcare provider.

Pritesh Mistry, Policy Team at The King’s Find, added: “Wearable devices can give a level of reassurance when people are being treated remotely that they’re not in danger.”

Perhaps the biggest stand-out feature of these devices is their ability to measure, record, and analyse round the clock and alert medical professionals when signs of concern or danger are reached.

 

NHS plans for wearable devices

Back in 2019 the NHS released the “Long Term Plan” which highlighted the healthcare service’s vision to implement digital devices across the board in a bid to limit hospital admissions and protect and reassure those who are being cared for remotely.

It also gave a view to the different types of NHS contracts suppliers can go on to win.

At present, the use of wearable devices remains minimal and is limited to certain areas of the country, perhaps because introducing such rapid developments during a period of such catastrophic turbulence as the pandemic would have been almost impossible. However, as we navigate the period ahead when it is clear that there will be continuing strain on the NHS, particularly hospitals, as they try to catch up with the backlog of procedures delayed by the pandemic whilst also dealing with intermittent COVID surges and exhausted staff, perhaps now is the best time to invest in options that will limit the strain on personnel and services.

A January 2019 report by the National Audit Office on NHS financial sustainability concluded that:

“The growth in waiting lists, the slippage in waiting times and the existence of substantial deficits in some parts of the system, offset by surpluses elsewhere, do not add up to a picture that we could describe as sustainable.”

The rapid introduction of wearable devices could reduce the need for routine and follow-up appointments while providing patients with reassurance that their condition is both stable and monitored, thereby enabling NHS resources to be focused on reducing waiting lists and providing urgent services.

It remains to be seen when and how the major introduction of wearable tech to the British healthcare system will occur. However, we are fairly confident its arrival will be in the not-too-distant future. With this arrival comes a rise in opportunity for a host of tech and software providers who are able to fulfil what are likely soon to be important NHS contracts.

 

Written for GHP

Food Hygiene

3 Ways the Food Hygiene in the UK is Changing

Food Hygiene

Protecting consumers from food safety hazards is a primary concern of the UK government, which is why they introduced appropriate legislation requiring establishments to establish minimum standards. 

Despite leaving the EU, the UK government assures the public that their food safety standard and consumer protection remains unchanged. They will remain committed to implementing a robust and effective regulatory regime, which means businesses in the food industry can continue to operate as usual. For most businesses, there will be no changes in how they are regulated and operate. Still, a few changes have been observed lately. 

Here are some ways food hygiene in the UK is changing.


1. The Brexit Effect 

Leaving the EU has significant disruptive potential in the UK’s food industry due to labour shortages and increased ingredient sourcing costs that could impact the food supply chain and, eventually, food hygiene. However, the Food Standards Agency has assured the public that the high food and animal welfare standards will not be affected post-Brexit. But food campaigners warned that consumers might be subjected to lower standards and unsafe food products that would promote intensive farming, damage animal welfare, and trigger diseases like superbugs due to antibiotics overuse in farming.

Under the post-Brexit regime, ministers can exercise wide-ranging powers to change the standards on food and agriculture at the stroke of a pen. These will include altering rules on the type of medication allowed on livestock or adjusting the level of pesticides to use. Under the EU, these rules were strictly regulated.

A survey centred on the trade deal with the US revealed that British consumers would not be willing to sacrifice their food standards for the mere purpose of free trade deals. 79% of the respondents stated that they would find lower-quality important from the US, such as those vegetables grown with pesticide and were banned in the EU, unacceptable. Meanwhile, about 80% of the respondents objected to hormone-fed chicken imported to the UK.


2. COVID Mean Tougher Cleaning Standards 

Now that we’re in the middle of the Covid-19 pandemic, it’s more important than ever for the food sector to continue prioritizing the safety of their customers and staff and ensure that all employees adhere to the government guidance on the prevention and control of Covid-19 infection. 

Currently, there’s not yet any evidence that food or food packaging can become a source or vehicle of transmission for the Covid-19 virus. However, to prevent the spread of Covid-19 within the workplace, food businesses must continue implementing effective health and safety procedures and the Covid-19 prevention and control measures. Companies are also urged to apply Food Safety Management Systems (FSMS), which includes proper hygiene practices and the application of HACCP or Hazard Analysis and Critical Control Point.

Physical distancing, regular hand washing, and wearing face coverings are some of the basic measures that companies must implement to prevent the spread of Covid-19 in the food production and handling industry. Company managers and staff must ensure that these measures are adhered to at all times to minimise the spread of the Covid-19 virus.

In line with the government advice, food businesses must make sure that the risk assessment of their business should address the risks of the spread of the Covid-19 virus. They must apply the government social distancing guidance at all times. Food businesses that are restarting or have made any changes to their business operations must review and update their HACCP where necessary. 

When restarting your food business operations, you must review your usual start-up procedures after temporarily shutting down, including employee’s undertaking uptodate food hygiene training. It would be best to consider whether any additional procedures will be required. Your assessment should consider the length of time your business has been out of operation. While reviewing the procedures, consider the cleaning requirements for your business and include an assessment of any pest control.


3. Natasha’s Allergy Law 

Another change in UK food hygiene has something to do with the “Natasha’s Law“, which requires businesses to label all pre-packaged foods for direct sale, including a complete list of the ingredients. The 14 major allergens must be highlighted on the list.

This Law was named after Natasha Ednan-Laperouse, a teenager who died after eating a pre-packaged baguette, which did not come with ingredients labelling at that time. All pre-packaged food products are now required to be labelled, including pre-wrapped sandwiches. Fast foods that have already been packed before the customer places the order and supermarket items like meat and cheeses from the deli counter must also be labelled.

Natasha’s Law applies to foods packaged in the same place where they were sold before being ordered. Foods that are pre-packaged somewhere else will now require food ingredients labelling and emphasize the 14 allergens. The Law offers more consistency in the labelling of pre-packed products while giving more protection for people with food intolerances and allergies whenever they purchase “grab and go” foods. 

Except in situations that require immediate action, local authorities responsible for enforcing the Law are advised to take an appropriate risk-based approach for any breaches. Furthermore, the FSA advises that authorities handle minor errors with extra guidance and support according to these changes, especially during the early months of implementation.

The Food Standards Agency has long been assisting businesses in preparing for the changes for well over a year, providing them with tools to help them fully understand which products will be covered by this new law. Furthermore, the FSA encourages customers to make their allergies known to food businesses and their staff when ordering food. This has been highlighted in the #speakupforallergies campaign earlier in the year, encouraging young people to be vocal about their allergies when ordering food.

The chief executive of Food Standards Agency has welcomed the change, stating that Natasha’s Law could help to drive down the number of hospital admissions resulting from food allergies, which have seen a significant increase in the east two decades, and to further prevent tragic deaths such as the case of Natasha Ednan-Laperouse.

Veterinary

3 Ways the Veterinary in the UK is Changing

Veterinary

The Pet Food Manufacturer’s Association has revealed that the population of pets in the UK has significantly increased since the start of the pandemic, especially among young people looking for a companion pet during the lockdown. And this is good news for the UK’s veterinary industry. 

But over the past few years, the industry has undergone mixed conditions. Revenue was expected to increase at a rapid rate. However, it has shown high volatility in the past year since the Covid-19 pandemic has forced many vet clinics to shut down temporarily. Thankfully, the industry has rebounded strongly, all thanks to the significant increase in the pet population in the UK and some other factors. 

Below are some ways the veterinary in the UK is changing.


1. Acceleration of Telemedicine 

Telemedicine refers to the act of practising medicine from a distance. Whenever a vet diagnoses a pet’s condition, recommends a specific treatment, or provide a prescription without ever seeing the pet in person, that practice is considered “telemedicine”. In the same way that most health services for humans have gone digital due to the Covid-19 pandemic, telemedicine has also accelerated in the vet industry. Instead of taking their pets to a vet clinic, pet owners have turned to emailing, texting, and video calling veterinarians.

Research shows a 20% increase in the number of vets offering digital or remote consultation due to the Covid-19 pandemic, and almost half of these vets have been offering online services. The surge in interest in the demand for online vet services has significantly changed how the vet industry works. This trend is expected to continue in the coming years, even when the Covid-19 pandemic is over.

One company in the UK that offers online vet services has revealed a 900% increase in the demand for their services since the lockdown started. Last November 2020, the Federation of Veterinarians of Europe published a paper assessing the use of telemedicine in veterinary care. The paper highlighted how digital health tools could increase access to vet services even in remote locations and across geographies, offering convenience to pet owners and providing them better access to veterinary services.

However, the paper also recognized that the widespread uptake post-pandemic could come with challenges unless regulatory bodies implement clear guidance regarding remote consultation, remote prescription, remote diagnoses, and the use of data.


2. More Vets Going Locum 

Currently, one in four vets in the UK works as independents, either as an independent service provider or a locum vet. A locum is a person who temporarily fills in a permanent staff position. Therefore, being a veterinary locum means temporarily working as a vet, which is a short-term option to gain experience around vet practices while having the freedom to work at any time convenient for you. It’s also an excellent opportunity to travel, as some locum work requires taking up jobs in different places worldwide.

Locuming is a process where the vet locum works in short-term practices for vet clinics requiring extra staff to manage the increased workload or cover staff shortage due to sickness, holidays, etc. Working as a vet locum can be enjoyable and exciting in your veterinary career. It offers excellent flexibility and balance to your life.

Perhaps you wanted to learn and experience other clinical practices, or you may be frustrated in your current position and seek change. Others would take up locuming to earn extra bucks since they are saving up for something, while some would just want to take things a bit easier for a while. So instead of working full time, they only want to take up locum work in the meantime. Whatever the reasons are, working as a locum vet does come with many advantages. You can work on your own terms, take up work at any time convenient to you, and increase your earnings at the same time.

Take note that you are not limited to locum vet jobs within the UK, when working independently. You can take up jobs anywhere you want, from Europe to Australia and New Zealand, which is also an excellent opportunity to travel. If you do not fancy travelling far, there will surely be plenty of locum opportunities within a few miles from where you live. Given all the benefits that come with working as a locum vet, it’s not surprising why so many vets have taken up locuming jobs.


3. More Females Enter the Sector 

It’s been found that around three-quarters of new vets are female. Experts predict that this trend has been this way for a long time now. There are many reasons behind these, although all of these are merely speculative. Some say that this could partly be due to the popularity of veterinary TV programmes, which attracts a broader demographic. It could also be due to the improvement in sedatives as restraints for larger animals, making it easier and more manageable for females. The increasing pet population in the UK could be a factor, too.

Another reason behind the rise of female vets is that corporate practices have now been found to have much more transparent and standardised salaries. While this is a good thing in itself, corporatisation brings a perceived ceiling to wages that have been seen as one of the reasons why there’s an increasing number of females entering the vet industry. Most men would prefer to receive higher salaries and would therefore gravitate towards STEM careers that tend to pay more. As a result, high corporatisation rates may have, in part, encouraged men to stay away from a veterinary career, but not the case for women.

Finally, the veterinary industry seems to include another data point to the theory that if an industry starts to become more female-oriented, the salary level could drop. This can also work the other way around, where computing has become something that’s performed mainly by men instead of being a menial job carried out by women. As a result, the salary level in this field could start to shoot up.

Nutraceuticals

The Historic Andes Food Storage Techniques Fuelling Modern Day Nutraceuticals

Nutraceuticals

A food storage technique over 700 years old is at the heart of the way we continue to process world’s favourite foods, build safe medicines and prepare for emergencies. As the technology faces a resurgence due to global warming and changing diets, why don’t we know more about freeze drying? Diana Morris from European Freeze Dry explores its history and bright future.

Food processing techniques are generally thought of as new modern methods to ensure food lasts longer, producing higher yields and providing additional nutrients. For most food processors, including European Freeze Dry, these techniques take place using modern equipment with highly detailed monitoring and testing facilities.

However, for freeze drying, its roots go back hundreds of years, before the age of high-tech systems or climate-controlled logistics. The technique traces back to the Incan Empire in the foothills of the Andes, where the potatoes which grew in the harsh climate were too bitter to eat fresh and didn’t store well for the long journey back to settlements.

By learning to expose the potatoes to the freezing overnight temperatures and drying them out during sunlight hours, the result was a dehydrated, more palatable potato which the Incans could transport and store ready for consumption for years. The final product, called chuño, can still be found in traditional meals around Peru and Bolivia to this day.

Today, coffee is the most well-known freeze dried product but the list of consumables which benefit from the technique to seal in flavours and increase their longevity is almost endless.

Modern technology has allowed for much greater precision in applied temperatures, greatly increasing the variety of products which can benefit from the technique and extending the benefits to pharmaceutical and nutraceutical products.

 

Technology retains structure, taste and nutritional value

In our freeze drying facilities in Preston, UK and Kirke Hyllinge, Denmark, we process hundreds of tonnes of freeze dried ingredients every year, from meat and fruit products, through to seasonings, ready meals and healthcare products.

Freeze dried products start with a frozen item, which is then loaded into a pressured chamber with a vacuum applied. Under the vacuumed conditions, neither ice or water can exist and when a gentle controlled heat is applied the water leaves each item in a vapour trail which is then captured on an ice condenser at the rear of the chamber.

The process takes approximately 24 hours, carried out in a set of ‘chambers’ which can be controlled at various temperatures and time schedules depending on specific product requirements. Using modern monitoring methods, we can track the variety of heat and time needed which varies from a structure heavy item such as chicken and beef to soft fruits such as strawberries.

The result is a freeze dried product with all the water content removed, whilst retaining the look, structure, taste and nutritional value of the original. The items can then simply be rehydrated with water, sauces or any wet ingredient. In addition, the final product can also be milled or compacted into powders and tablets.

With virtually zero water content in the final processed product, freeze dried ingredients benefit from greater longevity at ambient temperatures. For some products, that can mean a shelf life of up to 25 years and potentially longer, without the need to add any artificial preservatives or additives.

 

Freeze drying moves beyond food to pharma

Indeed, boundaries are continuing to be pushed when it comes to freeze drying and how the technology can be applied to pharma and nutraceutical products.

First used as a method to maintain the viability and life of vital drugs such as penicillin during the Second World War, freeze drying can also offer great benefits in stabilising pharmaceutical and nutraceutical products.

Advantages of freeze drying also include the much-reduced potential for micro-organisms existing in such low amounts of water, ensuring that nutraceuticals can stay safe to consume over an extended time period.

We are constantly breaking new ground with our customers and bringing new ideas and products to market to support special dietary requirements and how the natural qualities of certain foods can provide health benefits, from adding a nutritional supplement to a diet, through to targeting more specific benefits such as aiding weight loss or cancer prevention.

 

Reliable food chains for an uncertain world

As our lives and diets change, the popularity of freeze dried products continues to grow with some investment analysts estimating a Compound Annual Growth Rate for the industry of up to eight per cent by 2026.

While freeze dried meals offer a nutritious meal which can be instantly rehydrated, the possibilities of the technology also allow for long-life products which can distributed and ready to eat in hostile environments, such as those threatened ever more so by climate change, disasters or famine.

As citizens prepare for a less certain food chain due to floods, fire and emergencies, more people are turning to a reliable food backup should the shelves run empty or in more drastic situations people find themselves isolated from food options.

Similarly, as we place an additional focus on the public health of our global society, a greater rise in natural medicines will rely on the rise of preventative and treatment healthcare products that have long life viability.

The Incas were undoubtedly ahead of their time, but not even they could have predicted the impact their potatoes would have on our modern world.

Pharmaceutical Products

Outsourcing the Pharmaceutical Product Lifecycle

Pharmaceutical Products

By Timm Pauli, senior director and head of global regulatory informatics and operations at PharmaLex. Dr. Marie-Charlotte von Brevern, associate director of global program management at PharmaLex.

How to improve efficiency and drive innovation with limited resources

Ongoing lifecycle maintenance of medium or large portfolios puts a tremendous resource strain on pharmaceutical companies. These activities are crucial to keeping your products on the market but can stretch teams thin, making it harder for companies to focus on new product development, line extensions and further global roll-out activities.

At the same time, both product maintenance and product development are becoming more complex. Ever-changing regulations across global markets, specific CMC requirements for special product categories, a move toward innovative clinical approaches (such as decentralized clinical trials, adopting Bayesian models for trial designs, and applying digital tools for electronic patient reported outcomes), and increased digitization of many regulatory processes all require specific expertise that might be unavailable in-house.

Outsourcing can provide needed relief for management in numerous ways. In-house teams can regain time to focus on value-added tasks. Leadership can save on the budget by avoiding costly staffing and technical infrastructure upgrades. External expertise and perspectives can support teams in innovative ways, offering new, more efficient approaches and methods to support product lifecycle activities.

 

Taking a strategic approach

However, if such outsourcing projects are carried out piecemeal, most of your management and oversight activities will still fall to internal resources. Instead, outsourcing programs that adopt a strategic approach are more likely to give internal teams the support and flexibility they need to focus on new projects. Truly transformational outsourcing should combine operational activities for any product portfolio with state-of-the-art program management and coordination, KPI and reporting measures, as well as ad-hoc support for any additional one-off projects, and would also involve the outsourcing partner taking full responsibility, or ownership, of the program.

Typical reasons mid- to large-sized pharma companies choose to outsource:

  • Enable internal resources to focus on value-added, strategic activities
  • Reduce complexity for in-house teams
  • Foster scalable and flexible resource models
  • Quickly connect with a large pool of external expertise in flexible and cost-effective ways
  • Gain access to the latest technology solutions without having to make changes to existing on-site infrastructure, saving the company time and money
  • More seamlessly manage new technical requirements (based on new or changed technical requirements from health authorities)
  • Tap into operational excellence across different therapeutic and functional domains as well as process expertise and technology innovation

A primary consideration for companies is how to achieve cost-effective and flexible portfolio maintenance, while not jeopardizing quality and compliance. There are different ways in which a comprehensive portfolio maintenance outsourcing program can benefit pharmaceutical companies.

The first is that outsourcing allows companies to leverage strategic, expert-driven support to streamline maintenance operations across all regulated functions, both at a central and local affiliate level, all backed up with quality measures, KPIs and reporting tools.

Another reason companies seek outsourcing support is if they need more information about regulatory requirements in certain markets, but lack the in-house expertise on the topic or process. Alternatively, sometimes companies have a workload peak and need short-term support to supplement their internal resources.

Other increasingly important considerations today are that technology solutions are becoming ubiquitous throughout the business and must be regularly updated and improved to keep pace with new developments, requirements and specifications. This has become an even greater priority with the move to advanced technologies, such as automation and natural language processing as companies embrace the digital transformation. What makes the process more complex is that most pharmaceutical systems require appropriate quality management testing and validation, further increasing the administrative burden. Outsourcing the pre-configuration, testing and validation to experts helps companies to stay on top of the digital transformation.

 

Considered partnerships

Regardless of where you seek to leverage support, when choosing to outsource it’s important to select a partner that will take responsibility for your process or portfolio. After all, your marketed product portfolio is your most valuable intellectual property and the basis of your success. At its best, an outsourcing partnership can provide you with a new level of support and insight. This opens the door for a wide range of opportunities, including:

  • Switching your focus to innovation. By removing the burden of handling the regulatory maintenance of your company’s mature product portfolio, your internal team of experts can turn their attention to new products and processes.
  • Access to an expert pool of external resources, including specific knowledge around product types, technologies and processes that may not be available in-house. These might include:
    • Therapeutic areas
    • Technology capabilities, including expertise in implementing, validating and maintaining regulatory solutions such as regulatory information management systems; deep knowledge of new data standards such as Identification of Medicinal Products; as well as experience with leveraging innovative technologies to support operational excellence, such as robot process automation (RPA), natural language processing (NLP)  and machine learning.)
    • Market access and real-world evidence
    • Local or regional regulatory intelligence
    • Strategic advice during development, initial filing, and lifecycle maintenance
  • Having access to local regulatory support for global maintenance of a mature product portfolio to meet ongoing compliance requirements.
  • Expanding local presence by partnering with external staff based in markets where you do not have on-site operations.
  • Addressing resource gaps when your in-house team is working at maximum capacity.
  • Adopting a cost-effective solution rather than investing in additional full-time specialist staff.
  • Reducing technical and administrative burden and alleviating the pressure to keep up with the digital transformation pace by shifting system ownership to outside vendors.

 

Stay current, stay compliant

The pharmaceutical industry is faced with mounting pressures amid ever-changing requirements around pharmaceutical product development and lifecycle maintenance. As a result, companies must stay current to ensure compliance. This can best be achieved by looking to external partners for support, ensuring workload flexibility for your internal teams and the opportunity to focus on value-adding activities without compromising compliance. It’s important that your outsourcing partner is willing and able to take ownership of the programs or projects they manage. Furthermore, with innovation now intrinsically entwined with technology advancements, any outsourcing partner should have demonstrated expertise with supporting the digital transformation, for example, by helping to streamline processes through automation and by leveraging capabilities such as NLP and RPA to support innovation.

Gaining access to specialist expertise, flexible global work forces and innovative state-of-the-art technology solutions provides long-term value for pharma companies across multiple areas of the business.  Strategic, well-considered outsourcing ensures you focus on and build upon innovation; it gives you access to the type of dedicated and specific expertise that you are unlikely to have internally; it allows you to expand into new and emerging markets while ensuring you understand and meet local requirements; it allows you to leverage support during peaks; and it ensures you keep pace with the latest digital developments. Importantly, as the article explores, all these opportunities can be gained through outsourcing based on partnership, collaboration, trust and demonstrated expertise.

Scientist testing food for dangerous chemicals

HACCP Plan 25 Years Later: Where We’re At

Twenty-five years ago, the FSIS (Food Safety and Inspection Service) issued its landmark final rule. Known as PR/HACCP, the “Pathogen Reduction/Hazard Analysis and Critical Control Point” was created to lower the risk and numbers of pathogenic microorganisms forming on meat and poultry products. The rule also reduces the incidence of foodborne illnesses that result from consumption of these animal products. Finally, the rule offered a new framework that modernized the current system of inspection for meat and poultry products. The goal was to reduce the potential of contamination through proactive means rather than reactively. According to FSIS Administrator Paul Kiecker, “Food safety is an ever-evolving process. HACCP marked a dramatic change in food safety and how FSIS approached its mission of keeping food safe and the role of inspecting processing establishments.”

 

Results From the Final Rule

The HACCP plan includes sanitation requirements that were motivated in part by the FSIS addressing the issue of harmful bacteria found on raw meat and poultry products. These bacteria, including Salmonella and E. coli O157:H7, continue to be major food hazards that are associated only with meat and poultry. A study released in 2012 revealed that the HACCP final rule had achieved its goal. Statistics collected as part of the study research showed that Salmonella contamination on broiler chicken carcasses dropped 56 percent between 1995, before the HACCP final rule was announced, to 2000. In the same timeframe, the number of foodborne illness cases resulting from Salmonella on broilers had dropped by 190,000.

 

The Outbreaks of 1993

1993 was a turning point for the federal government in how it addressed pathogens and outbreaks. An E. coli O157:H7 outbreak traced to a fast-food restaurant in the Pacific Northwest selling ground beef resulted in the deaths of four children. The outbreak also caused close to 200 others to develop serious ongoing health issues. The majority of those affected by this outbreak were less than 10 years old. The FSIS was already working on regulations that would require a systematic approach to food safety. These measures were to be used in food production and included preventative measures that would reduce the risks of illness to consumers. 

 

What The Changes Included

FSIS officials and the public requested different methods to ensure and improve food safety. The events of 1993 meant that the previously standard ways had to change.  What resulted was a science-based inspection system that caused a noticeable shift in the USDA’s regulatory philosophy. Instead of inspecting finished products for biological, chemical, and physical hazards, the HACCP rule required establishments to use preventative measures to avoid these hazards in the first place. Part of this process included the development and implementation of written sanitation standard operating procedures. Added to this were FSIS pathogen reduction performance standards for Salmonella, and record-keeping procedures. And finally, the PR/HACCP final rule altered and defined the roles of both the establishments and the federal government in the food safety inspection process. Establishments were given the flexibility to make decisions on food safety specific to their particular establishment. The previous system, which was command-and-control based, required approval of production-associated decisions from a government inspector. With HACCP in place, the industry is completely responsible for the decisions made related to food production and the execution of the decisions. The FSIS’s role under HACCP is to conduct inspections to verify compliance with food safety standards, and enforcement to address non-compliance.

 

What They Had To Say

“I had the privilege to see first-hand the most significant change at that time for both FSIS and the industry,” says Paul Wolseley an Executive Associate for Regulatory Operations in the FSIS Office of Field Operations. “By moving away from a command-and-control methodology of conducting inspection to a science-based approach for controlling food safety hazards in meat and poultry products, we greatly enhanced our ability to protect public health.” He added, “The shift to HACCP paved the way for innovations that continue today.” William Shaw, the FSIS Executive Associate for Laboratory Services weighs in on the changes made to microbial testing programs, saying, “The HACCP program was a paradigm shift for the Agency.” He goes on to state, “The need for verification led to the largest scale microbial testing program by the Agency. It’s evolved into the FSIS annual sampling plan we issue today.” 

 

The Process Has Since Extended To Egg Product Inspection

Since 1996, the HACCP regulations have been updated to address more establishments and other food products. In 2020, the regulations covering egg product inspections were amended so that egg processing plants must now develop and implement HACCP procedures. This will align them with other FSIS-regulated products. According to Agency Administrator Kiecker, “The evolution of our policies and inspection programs means FSIS can be more proactive instead of reactive when it comes to stopping an outbreak.” It is because of this ever-changing landscape that the FSIS keeps promoting and maintaining the highest standards found in the food production process. In doing so, the Agency has kept its mission of protecting the public through food safety as its top priority.

 

Final Thoughts

Food safety is a serious matter. It continues to be now that we are twenty-five years past the implementation of the HACCP final rule. The safe production and handling of food consumed by the public is the key behind the HACCP regulations. Foodborne illnesses can cause death, and outbreaks as recent as 1993 provided evidence that supported a change in the regulations. With new guidelines that are more science-based, the number of incidents related to bacteria and foodborne illnesses has dropped significantly. Plus, with better food safety standards in place, consumer confidence has increased and restaurants and food production facilities have seen some very good years in business. With these guidelines in place, and a proper inspection and enforcement program, the HACCP standards continue to lead the way in maintaining food safety for the US public.