History of Medical Device Regulation

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Below is a brief history of Medical Device Regulation in the United States over the past 80 or so years. Key moments have been highlighted that reflect the changing landscape of Medical Devices.

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HQSI (Healthcare Quality Strategies, Inc)

HQSI (Healthcare Quality Strategies, Inc.) provides independent medical review for private and government insurers, hospitals, third-party administrators and employers. As a URAC-certified review organization, and NAIRO member, HQSI conducts reviews in all key medical specialties always adhering to the highest ethical and professional standards.

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WANT LESS “LIABILITY” AND MORE “RELIABILITY” FROM YOUR CLINICAL MOBILITY SOLUTION?

Article | March 2, 2020

I recently discussed the different ways that consumer-grade smartphones can compromise patients’ health, safety and overall care. However, some clinicians and healthcare administrators have indicated in recent months that they need help selecting the right enterprise-grade mobility solutions for their unique operating models and workflows. There are many different hardware and software options, and a single rugged device can come in multiple configurations. So, how do you know if you’re picking the right communication tools for your clinicians? The key is to first set performance expectations for the total mobility solution rather than the device alone.

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PHARMA TECH

4 Tech Trends That Will Shape Pharma in the Coming Years

Article | March 2, 2020

Technological innovations disrupt many industries, but the speeds of their adoption in the pharma industry have become more rampant than ever. A report from global market advisory firm ABI Research predicts that by 2030, the pharma industry will have spent over $4.5 billion on digital transformation. This is due to many things, from the need to optimize production lines to patent protection. A decade from the forecasted market peak there have already been many applications of these rising tech trends. So let’s have a look at some of them: Digital monitoring system Pharma businesses need to comply with certain regulatory requirements before their drugs can be sold on the consumer market. For example, they need to be stored at a certain temperature. The state of the drugs manufactured and used during clinical trials also needs to be monitored. Fortunately, digital monitoring systems created by companies like Aptar Pharma, Primex, and Monnit, have made it easier to provide the reports regulatory boards such as the Food and Drug Administration and Central require. Aptar Pharma, for instance, offers sensors that can monitor and record the patients’ adherence level during ophthalmic clinical trials. Meanwhile, Monnit’s freezer monitoring solution provides data logs that can be filed as proof of compliance. It doesn’t matter what kind of pharma data you need — there will be a digital monitoring system that can help you collect it. Extended reality Extended reality (XR) is used to describe all real-like virtual environments that are generated by computer programs. The two most common types of XR are augmented reality (AR), where digital graphics are overlaid onto the real world, and virtual reality (VR) where the user is “transported” to a digital world through headsets. To create realistic projections, VR and AR technologies are built with complex and densely packed electrical PCB designs. From wiring the schematic to comparing physical validation rules, all of this is carefully done to ensure that the technology has all the 3D features it needs. Pharma has many uses for this kind of technology. For example, one of Augray’s solutions is to allow researchers to better visualize human models using XR. XR can also be used in lab and manufacturing training. Before letting people train onsite, XR solution providers like SoftCover VR and Labrodex Studios can create simulations that let them familiarize themselves with the equipment virtually. This is very important in the pharma industry, as one error can easily contaminate the drugs. Artificial intelligence Whether it’s for drug discovery research or clinical trials, artificial intelligence (AI) can help accelerate the process. AI is a technology that “learns.” AI programs, after they’re made, are immediately trained to detect patterns and features in the data to help collect insights. British startup Pangaea Data helps global pharma companies identify patient cohorts and trials using AI algorithms. AI can also be trained to perform mundane tasks more efficiently, like arrange clinical data for researchers or gather studies. An AI program called Atomwise does this by analyzing thousands of existing medicines and picking out the ones that can be repurposed to treat diseases it wasn’t initially made for. This was even the AI that identified two drugs that could mitigate Ebola’s effects in 2015, saving multiple lives. In the future, AI can be taught more things that will allow them to aid medical research. Additive manufacturing Additive manufacturing, commonly known as 3D printing, is an industrial production process that lets businesses create 3D products using successive layers of a specific material. Since 3D printers will literally print any object with the right blueprints, additive manufacturing has been a big help in the mass production of drugs. However, researchers are now finding more uses for additive manufacturing — one of which is in the field of precision medicine. Precision medicine takes into account the patient’s lifestyle, history record, and even genetics. Eventually, they're given medicine that’s specially tailored for their body. Since blueprints can easily be edited, combining drugs can be done faster and with more accuracy. Of course, additive manufacturing’s application in this field is still at its testing phases, but researchers are hopeful about the results. New discoveries are made in the pharma industry thanks to technology, and more will continue to do so as long as breakthroughs are made. Businesses should always be updated on these emerging trends, lest they want to be left behind by the competition.

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Do Clinical Trial Delays Mean Trouble for Pharmaceutical Stocks?

Article | March 2, 2020

Pharmaceutical stocks have been somewhat of a safe haven for investors as the coronavirus outbreak spread from China to the rest of the world. But as the pandemic deepened, now resulting in more than 782,000 cases worldwide, even these "safer" companies are beginning to feel the effects. The U.S. is now the coronavirus epicenter, with the most cases -- more than 161,000 as of today. Initial concerns for drugmakers had to do with the supply of active pharmaceutical ingredients, which often come from China. The worry was that pharmaceutical companies wouldn't be able to produce enough of their drugs for patients.

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Clinical Supply Availability & Speed to Study Start-Up

Article | March 2, 2020

If you’re part of a clinical study team racing a new product to commercialization, you likely live by these two simple rules: time is money, and the first one to market wins. But just because it’s simple doesn’t mean it’s easy. That ticking clock is background noise to the responsibilities of regulations, study protocols, supply chains, and patient recruitment — all the details that must be worked out before a study can even begin. The pressure is always there. The longer it takes for a study to start, the longer it takes to complete.

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Spotlight

HQSI (Healthcare Quality Strategies, Inc)

HQSI (Healthcare Quality Strategies, Inc.) provides independent medical review for private and government insurers, hospitals, third-party administrators and employers. As a URAC-certified review organization, and NAIRO member, HQSI conducts reviews in all key medical specialties always adhering to the highest ethical and professional standards.

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