First and foremost, Vitamin D is a prohormone, in other words, “it is converted into a hormone by our body” (Fookes, 2018). It is deemed a fat soluble vitamin, as it can be readily absorbed with fat and is often stored in the liver and fatty tissues, and can take on several different forms. The primary two forms of Vitamin D are Vitamin D2, otherwise known as ergocalciferol, and Vitamin D3, or cholecalciferol (Raman, 2017). The vitamin has, for the most part, been universally accepted as being absolutely essential to human health, playing a fundamental role in several of our bodies key functions, including but not limited to: calcium absorption, modulating cell growth, and our immune system function (Fookes, 2018). 

As mentioned, the primary source of Vitamin D is the sun. Our bodies, specifically our skin, make Vitamin D when exposed to UV by converting the cholesterol in our skin to Vitamin D3 (Raman, 2017). However, obtaining the nutrient from a natural source such as the sun means that there are numerous factors that can disrupt or reduce the amount of Vitamin D our bodies are getting. For example, where you live, the season, the weather, and even the time of day can all substantially alter the amount of Vitamin D our body creates (Vitamin D). As a result of these factors, people that live further away from the equator, are elderly in age, or suffer from an illness or disability that prevents regular sun exposure, are all more likely to be at risk of a Vitamin D deficiency (Fookes, 2018). For this reason, it is especially important to note that there are two other sources from which Vitamin D can be obtained: food and supplements. Vitamin D can also be obtained through a small variety of foods, including mushrooms, butter, cheese, egg yolk, and fatty fishes such as salmon, as well as from various forms of natural supplements (Fookes, 2018).

While the current Health Canada recommendation stands at 400 IU (10 µg) per day of Vitamin D, the scientific community has largely agreed that this is often insufficient (Raman, 2017). In fact, it was reported that approximately 42% of people in the United States are currently suffering from low Vitamin D levels (Bjarnadottir, 2017). That being said, there is no definitive cut-off point for deficiency, which has led to some controversy surrounding what exactly is considered a sufficient verses an insufficient level of Vitamin D within the scientific and medical communities. The Institute of Medicine (IOM) declares any Vitamin D level above 20 ng/ml sufficient, while the Endocrine Society states that the threshold to be considered sufficient in Vitamin D is slightly higher, at 30 ng/ml (Fookes, 2018). It is also important to note that the exact level of Vitamin D needed for each individual may vary depending on a multitude of factors including: their age, race, geographic location, time of year, sun exposure, and typical clothing attire. Against this background, research has shown that a “daily vitamin D intake of 1000–4000 IU, or 25–100 micrograms, should be enough to ensure optimal blood levels in most people” (Bjarnadottir, 2017). A 2009 study published in Osteoporosis International  found that Vitamin D levels of approximately “75 to 110 nmol/l provide optimal benefits for all investigated endpoints without increasing health risks”, which is a level approximately 9 out of 10 people do not achieve. These levels can be best obtained with oral doses of Vitamin D in the range of 1,800 to 4,000 IU per day (Bischoff-Ferrari, 2009). Bearing this in mind, an upper or maximum limit of 4000 IU (100 µg) per day of Vitamin D is commonly agreed upon, meaning individuals should not exceed this limit without first discussing it with a healthcare practitioner (Fookes, 2018).

Nonetheless, regardless of these debates the scientific community is united in their awareness that Vitamin D has a multitude of health benefits, many of which are still being discovered. One study in particular used randomized control trials to prove that “Vitamin D supplementation was related to a statistically significant 12% reduction in mortality” (Keum & Giovannucci, 2014). While another study published in the Cochrane Central Register of Controlled Trials found that their evidence suggested Vitamin D supplements at “moderate to high doses” may reduce the risk of Cardiovascular Disease (Wang, 2010). Additionally, and perhaps most intriguing of all, was a study published in the Cochrane Database Systemic Reviews, which consisted of 56 randomised trials with 95,286 participants providing “usable data on mortality”. After administering Vitamin D to the group of participants, ranging from 18 to 107 years of age, for 4.4 years, the researchers concluded that “Vitamin D decreased mortality in all 56 trials analysed together” (Bjelakovic et al., 2014).  Lastly, Vitamin D has more recently been speculated to reduce the health impacts of COVID-19 (Lovnicki, 2020). While it is important to note that in the case of many of these studies, isolating out a specific root cause for the specific biological effect or change in human health from the various other uncontrollable factors of daily life is rather difficult, as is differentiating between correlation and causation, and therefore, many of the researchers of these studies agree that more extensive research is needed to further validate these results and understand the full capabilities of Vitamin D.

In summary, ensuring sufficient quantities of Vitamin D on a daily basis is unequivocally essential to good health. While the scientific community may be still experimenting and deliberating new and abstract health benefits of the vitamin, it is indisputably vital to good bone healthy, our calcium and phosphorus levels, our immune system, and protecting our bodies against various cardiovascular and respiratory diseases. Undoubtedly, one of the most significant steps anyone can take is to have their vitamin D level determined by a simple blood test. From there, they can assess if any further action, such as Vitamin D supplementation is needed, and if so, by how much. This simple step may be one of the largest and most important public health strategies available to us.  Any questions or concerns regarding your personal Vitamin D levels or the best way to increase your intake of Vitamin D should be directed to a healthcare professional.

For more information, please contact Focal Point Research Inc.  We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA.

References:

Bischoff-Ferrari, H.A., Shao, A., Dawson-Hughes, B. et al. Benefit–risk assessment of vitamin D supplementation. Osteoporos Int 21, 1121–1132 (2010). https://doi.org/10.1007/s00198-009-1119-3

Bjarnadottir, A. (2017). How Much Vitamin D Should You Take For Optimal Health? Retrieved from: https://www.healthline.com/nutrition/how-much-vitamin-d-to-take

Bjelakovic, G., Gluud, L. L., Nikolova, D., Whitfield, K., Wetterslev, J., Simonetti, R. G., Bjelakovic, M., & Gluud, C. (2014). Vitamin D supplementation for prevention of mortality in adults. The Cochrane database of systematic reviews, (1), CD007470. https://doi.org/10.1002/14651858.CD007470.pub3

Fookes, C. (2018, October 23).  Vitamin D. Retrieved from: https://www.drugs.com/vitamin-d.html

Keum, N., & Giovannucci, E. (2014). Vitamin D supplements and cancer incidence and mortality: a meta-analysis. British journal of cancer, 111(5), 976–980. https://doi.org/10.1038/bjc.2014.294

Lovnicki, C. (2020, November 3). COVID-19 and Vitamin D: Correlation or Coincidence? Retrieved from: https://focalpointresearch.net/canadian-regulatory/covid-19-and-vitamin-d-correlation-or-coincidence/

O’Connor, A. (2020, June 10). Exploring the Links Between Coronavirus and Vitamin D. Retrieved from https://www.nytimes.com/2020/06/10/well/live/coronavirus-vitamin-d-immunity.html

Raman, R. (2017, October 8). What Vitamin D Dosage Is Best? Retrieved from: https://www.healthline.com/nutrition/vitamin-d-dosage

Vitamin D. Government of Canada. Retrieved from: https://www.canada.ca/en/health-canada/services/nutrients/vitamin-d.html

Wang, L., Manson, J. E., Song, Y., & Sesso, H. D. (2010). Systematic review: Vitamin D and calcium supplementation in prevention of cardiovascular events. Annals of internal medicine, 152(5), 315–323. https://doi.org/10.7326/0003-4819-152-5-201003020-00010

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In a usual process, a vaccine takes about an average of 10 years to be created. However, since this vaccine is needed quickly, this process has been fast-tracked. This process includes; Preclinical testing, where scientists give the vaccine to see if animals produce an immune response; Phase I when scientists conduct safety trials in which a small number of people are given the vaccine to ensure an immune response will occur; Phase II, which involves expanded trials with the testing of many people from various age groups;  and Phase III, where the vaccine is distributed to thousands of people and the results are compared to those who receive a placebo. It should be noted that during phase II, a certain amount of the test population must experience an immune reaction for the vaccine to be considered effective. For example, a COVID-19 vaccine in the United States must demonstrate an immune response in 50% of the population to be deemed effective.  Once a vaccine has gone through this process, it can then be approved for use.  

Despite the extensive testing process, there are already many vaccines in the beginning stages of this process. There are currently 142 vaccines in pre-clinical evaluation, twenty-four in phase I, fifteen in phase II, and four in phase III. These vaccines have various mechanisms of action, which are controlled by the type of virus included in the vaccine. The virus in the vaccine could be the full inactivated virus, a live attenuated virus, or parts of the virus such as protein, DNA, or a non-replicating viral vector. A list of the types of vaccines and their stages can be found here.  

Recently, the most promising vaccine appears to be one from the University of Oxford that is licensed to AstraZeneca. The vaccine has demonstrated efficacy in early stage testing. Although there seems to be a front runner, it is very possible that multiple vaccines with different mechanisms will be successful and distributed. This will help meet demand and help us return to our usual lives faster.  

For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA. 

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The decline in the biomedical technology industry was seen in the last weeks of March due to an overall decline in sales, procedures, and testing. As well, many hospitals restricted their surgeries to only necessary surgeries to preserve resources and staff. This resulted in great losses for hospitals and suppliers. However, the losses for hospitals continued through the cost of increasing PPE, reconfiguring spaces, new medical equipment, and the need for increased labor. Although some hospitals have started to allow elective surgeries to begin, such as hospitals in China, the surgery rate has not returned to its normal amount. It has been theorized that this is from consumer hesitation and concern of safety. Therefore, although the decline is lessening, it may still be a while until the biomedical technology industry and hospitals return to normal. 

With that being said, certain biomedical technology companies have actually experienced a dramatic increase in sales in certain departments. Companies that were already producing products that could aid in the coronavirus pandemic, such as assistive breathing and intensive care devices, have experienced an increase in profit caused by the high demand.  For example, Hillrom, a producer of non-invasive ventilators, patient monitoring devices, and smart beds, experienced an extreme increase in sales. In fact, the company increased ventilator production by fivefold and are hiring temporary and permanent employees. 

Other biomedical technology companies have experienced a market gain through the creation of precautionary medical equipment, such as Hologic. Hologic developed a SARS CoV-2 diagnostic test that is compatible with many hospital’s systems. The test produces results within three hours. Since the release of the test, the company has experienced their highest groth rate in eight years and has increased their production of the tests by 12-fold. 

People have recognized this ability to succeed in the biomedical technology industry during this time, but some people have been dishonest when trying to find success. As such, the US FDA has seen an increase in fraudulent products. An explanation of the US FDA’s guidance for innovators and researchers can be found  here. Therefore, although the biomedical technology field can help greatly during this difficult time, it is important to remember the regulatory steps required in the process. 

For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA.

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Patent protection is often considered the Holy Grail of innovation. If you have a shiny new invention, it will benefit from long-term protection. A patent can allow you to build your business and hopefully sell it and make you very rich. But like most things, there are shades of grey.

Say you are able to get a patent. How strong is it? Can a smart person work around it? And even if your patent is rock solid, that does not stop copycats. A patent only allows you to sue them for infringement. That’s a huge misunderstanding for many new innovators. What if you launch and five copycats appear on the market? You need deep pockets and a talented legal team to deal with this. I have seen innovators abandon their patents because they didn’t have the funds or stamina for the litigation.

Going back to the entrepreneur with an old molecule. Many of the regulatory hurdles had been overcome by previous innovators. The few remaining ones seemed surmountable. I have seen projects like this become hugely successful with rapid scale up and sales execution. If copycats arrive, the entrepreneurs continued to innovate with product improvements, line extensions, and new sales and distribution channels.

Sure, a rock-solid patent is great to have but it’s not the only option to make you a successful innovator.

Our YouTube Channel showcases our Lectures on Innovation Series featuring our “Patents” video, which continues this article in more depth. Watch it here.

For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA .

Rob Fichtner, October, 2019

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Once knowledge of coronavirus becomes available, innovators will need to be ready to invent various creations in the health industry to aid in gaining control of novel coronavirus. Those in the medical device community can help by creating diagnostic technologies. The technologies would be most effective if they could be used quickly- similar to a swab test. The technology would be even more beneficial if the common person were able to use it, resulting in mass diagnosis. Although innovative medical devices would be useful, those diagnosed would still need treatment. Thus far in the treatment of novel coronavirus, care givers have only been able to treat the symptoms of the virus and not the virus itself. Despite researchers’ and pharmaceutical developers’ best efforts, there has yet to be a vaccine for novel coronavirus.

This ultimately leads to the question, how long? How long until medical device technologies and a treatment for coronavirus are available to the public? A troublesome question, with an even more troublesome answer. Even if research on the novel coronavirus became extensive enough to create medical devices or vaccines, these creations would still

have to undergo routine analysis and testing. Those of us in the medical device, pharmaceutical, and regulatory fields know that the process can be long and frustrating at times. The WHO has attempted to accelerate the process through releasing guidelines on subjects including rapid data sharing, research during infectious disease outbreaks, and emergency use of unproven treatments. As well, evaluators in the regulatory field have protocols in place to aid in accelerating the analysis, testing, and trial period of vaccines and technologies for disease outbreaks. Despite this, it is doubtful a vaccine will be available for several months. For now, all we can do is hope researchers and innovators are working together to share knowledge about the virus and can create solutions to this growing global health problem.

Please click on the links to see more information regarding the novel coronavirus from CBC News, the WHO, the CDC, and the Harvard Business Review. To see all the guidelines provided by the WHO for managing infectious disease outbreaks ethically click here.

For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA

Emily Campbell

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This new in-lab testing method not only eliminates the need for animal testing by providing the opportunity to analyze bioactive ingredient uptake in hair and skin but has many other benefits as well. These new hair and skin models provide insight into a formulation reaction to skin or hair, exploration into diffusion rates, and interactions between materials. The models also offer the inspection of ingredient-ingredient reactions both during storage and application. Finally, the models allow the study of ingredient reaction and toxicity at a molecular level. Because the new hair and skin models can be used for such extensive testing, there is little to no need for animal testing at all.

On top of the great amplitude of testing opportunities, the new models allow shortening time in the cosmetic design process. These models were created with the idea of quick in-lab testing by being compact. As well, the extensive testing options available with these models, permits the focused observations of single or multiple ingredients in the lab. By being compact and opportunistic in its testing methods, these models permit the rapid elimination of potential options, which abolishes the need for large scale testing and repetitive trial and error. This in turn reduces the overall design process in the cosmetic industry.

In the end, the new hair and skin testing models offer an important alternative to animal testing and can reduce time in the design process for many cosmetic products. With incredible benefits that models like these provide, it is exciting to see the bright and cruelty-free future of cosmetics. What a great start to 2020 for everyone involved in the cosmetic testing community.

To see another article about this topic, please click here.

For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA

Emily Campbell

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When it comes to complaints, these are things I look at:

1. The seriousness of the complaints. In my world of regulated products, these usually pertain to adverse reactions, issues of health and safety etc.

2. The percent of complaints to units sold.

3. Trends. Are complaints going up, down, sideways?

In the case of my recent sleepless entrepreneur, none of the complaints was particularly serious. In terms of the absolute number, a dozen seemed like a catastrophe. But it turns out that there were over half a million units sold; the complaint rate was about 0.002%, miniscule. In terms of trends, it was a predictable steady growth of complaints as the business expanded. Time for a good night’s sleep!

The other advice I give to entrepreneurs is if you are not getting complaints or at least some type of feedback, I would be concerned. Unless you are an absolute genius, your product will launch with further optimization needed. All within reason of course. So I say, embrace your complaints. Master dealing with them. And use them as learning for your next generation innovation.

Our YouTube Channel showcases our Lectures on Innovation Series featuring our “Complaints” video, which continues this article in more depth. Watch it here.

For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA .

Rob Fichtner, October, 2019

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So, how does it work? The laser ultrasound machine consists of two lasers; one that emits a light wave and one which receives a soundwave. The conversion from light to sound waves occurs on the skin. The light wave causes the blood vessels in the skin to expand. The body then cools the blood vessels causing them to shrink. This rapidly repeats as continuous light wave approach. The repetition of this process results in vibrations along the skin. These vibrations make up a soundwave. The conversion from light to soundwave was critical for this cutting-edge medical device as soundwaves travel deeper into the body allowing for a more in-depth image of the desired area.

After the conversion, the soundwave travels into the body and is reflected at varying frequencies as skin, muscle, and bone tissue absorb different amounts of the produced soundwave. The reflected soundwave is then absorbed by the second laser. Finally, the information received by the second laser is translated into an image. This medical device is profound by converting the light wave to a soundwave in order to remain independent from the body.

Although ultrasound is already considered a non-invasive procedure, the ability to conduct one without any contact at all is beneficial to patients who cannot be touched. Such patients could be infants, burn victims, and patients trapped in an accident. The researchers at MIT hope to improve the depth and accuracy of this new medical device. The researchers also hope to decrease the size of the technology with the aspiration of making the laser ultrasound a household medical device for preventative and proactive medical care. With technology like this already being discovered this early in 2020, it is clear that the future is bright, inventive, and upon us now!

To see an explanation of the laser ultrasound directly from MIT, please click here. For another article on this topic, please click here.

For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA

Emily Campbell

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The factors for success and failure are complex. Some pertain to sales and marketing which are not in my wheelhouse. What has interested me my entire career are the scientific, engineering and related technical aspects of innovation and new product development that contribute to success or failure.

I set out to produce this very brief series of videos after witnessing yet again, a number of innovations going seriously off the rails. Like in any profession, after almost 40 years, you can almost smell trouble as you walk in the room. My goal with these lectures was not to be comprehensive, not by any means. I simply wanted to site some basic examples of mistakes that have been sadly made by all manner of companies, big and small.

I have worked for large multinationals, with innovators in their basements, and everything in between. What I know is that mistakes made by innovators have nothing to do with company size. It has been breathtaking to watch some very large and smart companies make some of the most foolish and avoidable mistakes. The only difference is the amount of money that goes up in smoke.

I’ll end with a few disclaimers. For innovators developing information technology products and services, parts of my commentary will not be as relevant. My life has been in regulated products, drugs, cosmetics, medical devices, natural health products and foods and beverages.

Secondly, I don’t believe there is any quick fix or magical solution for successful innovation. The intent of these lectures is to highlight some landmines that have destroyed the dreams and fortunes of some very promising innovators.

Finally, I don’t want to discourage entrepreneurs or innovators. The world needs you. But most importantly, the world needs you to succeed. If these lectures were to help even a single innovator avoid catastrophe, I would consider this to have been a success. Thank you for watching.

For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA

Rob Fichtner, August, 2019

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Health Canada has stated that the Medical Devices Directorate will take a life cycle approach to regulating medical devices. In particular, it will “bring together specific post-market functions now led by the Marketed Health Products Directorate, with the pre-market functions of the Therapeutic Products Directorate.” The intent of this approach is to create an organization that uses modernised processes to be able to respond to rapid innovation cycles, increases scientific and policy capacity across the medical device life cycle, and better aligns Canada with our international counterparts. Health Canada has also stated that the Directorate will “allow for a much greater emphasis to be placed on expanding Quality Management Systems to include both internal and external components, and the implementation of ISO 9001, as well as enable better postmarket surveillance capacity for devices”.

The Canadian federal government has implemented several other policy initiatives, including the Regulatory Review of Drugs and Devices (R2D2), the Medical Devices Action Plan (MDAP), and the Treasury Board’s Regulatory Review (RR), that all aim to increase focus on medical devices and, more specifically, the management of medical devices across their life cycles. Combined, these initiatives, along with the Medical Devices Directorate will create a system that is dedicated to the regulation of medical devices and to “improving the safety, oversight and quality” of the medical device landscape, according to a Regulatory Focus article on the issue.

More information from Health Canada on the Medical Devices Directorate can be found here.

For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA.

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