3G wireless networks are scheduled to shut down soon. With the impending shutdown, many people have wondered how it will affect them. Older cell phones, alert systems, security, and medical devices will be affected by the 3G shutdown. If these items are not replaced or upgraded, the devices will no longer work. Here are a few ways that the shutdown will affect those medical devices.

The End of 3G

Mobile carriers introduced 3G wireless about 15 years ago to accommodate iPhone-based technology. While it helped to connect mobile devices at the time, newer technology has replaced it. Wireless carriers plan to use those 3G airwaves to expand the new 5G service. However, the loss of 3G is leading to panic for those who rely on their devices. It will not be just older mobile phones affected by the shutdown. Other devices, including those medical ones, will face a 3G shutdown.

These shutdown dates will vary throughout the year. AT&T has already decommissioned its 3G on February 22. T-Mobile (and Sprint) plans to unplug from 3G on July 1. Verizon will wait until the end of the year and shut down its 3G service on December 31. While these upcoming dates will not be a problem for most people, coverage degradation could affect some areas, especially in rural areas. In those spots, there is no replacement for the longer-range 3G. These customers might be in the dark until 5G is available in those places.

 Where does that leave medical devices?

Many people, especially seniors, have been reluctant to upgrade to newer devices that can work with 4G or 5G technology. Even with the looming shutdown, many of these Americans are unaware that they need to replace their devices. That can spell trouble. Without 3G, these devices will not be able to communicate with the network or send out a signal. In other words, these medical devices will cease to operate.

Many Americans rely on medical devices to monitor their homes and health. With COVID-19, many patients have relied on telehealth devices to receive the proper medical care and monitoring. When they stop working, it can be disastrous. These devices allow seniors and others to send medical information to their doctors or healthcare providers. These devices can also alert emergency services to get to a residence when it is needed. For example, if there is an emergency with a medical alert system, the signal will not be able to reach the proper authorities. As you can imagine, this could be fatal for those who need immediate medical help.

Unfortunately, there’s been a lack of urgency to get customers to upgrade their devices. Even some manufacturers are reluctant to get the message to their customers, especially when they are not responsible for the shutdown. Plus, there is an issue about paying for the upgrades, which many companies are not electing to do on their own. These individuals who rely on the devices might struggle to find a way to upgrade, leading to more complications.

What’s in your strategy?™ Do you need a trusted company to align your clinical, regulatory, and quality organization? At Global Strategic Solutions, we will ensure that your device meets all safety standards to hit the market quickly. Learn more by scheduling a consultation. 

Alert devices and home alarms are more complicated to upgrade than a simple smartphone. In some situations, technicians will need to get into the business or residence to make the upgrades. It is not as easy as sending a new device. These medical systems and devices will have to be properly configured so that they are ready to be used on a new network.

COVID-19 Has Caused Problems

Keep in mind that the pandemic has also added to those upgrade problems. While some manufacturers have warned their users about the pending shutdown, staffing shortages do not allow follow-ups to ensure customers are ready for the change.

The worldwide chip shortage has also added another level of concern. These shortages have tripped up the entire wearable emergency alert device industry. Some estimates suggest that half a million of these devices will need to be replaced. However, manufacturers are waiting for the chips to be delivered. Once that happens, they can send out the 4G and 5G devices to their customers.

Related: Top 5 Cutting Edge Medical Device Advancements

There are plenty of concerns about the decommission of 3G. Many people rely on these systems, especially in times of an emergency, but those medical devices might be inoperational by the end of the year.

Helping Customers Upgrade Their Devices

There is also some good news. Many medical device manufacturers have worked with their customers to help with the transition. The Federal Communications Commission has also been closely monitoring the situation. Many consumer advocates have even urged the commission to push 3G’s ending date to ensure everyone remains protected and safe.

AT&T has offered to keep 3G as a roaming option, but that is not considered a solution by many. According to the Alarm Industry Communications Committee, many vulnerable devices use systems that do not allow them to operate on a roaming basis. Along with that, all of the other mobile providers will need to offer roaming options for full coverage.

Many people want an extension on the deadline. Even four to six months can help most manufacturers reach their customers and replace those valuable medical devices. Unfortunately, that has not been the case with the 3G shutdowns. Some industry experts are looking at how the industry handled the Y2K bug. Instead of ignoring the issue, many companies actively worked to find solutions. If a quick solution is not found, it could leave millions of Americans with inoperable medical devices.

Ready or Not: The 3G Shutdown Is Coming

While the shutdown has started on some networks, many in the industry want the FCC to extend the shutdown deadlines. Some Americans are still unaware of the 3G, leaving them vulnerable if they rely on these medical devices. As of now, these shutdowns are still scheduled for summer and the end of the year.

Global Strategic Solutions in the Silicon Valley area in California is a consultancy firm committed to ensuring safety in the medical field by helping inventors and businesses take the appropriate steps to get their devices approved and ready for sale. Learn more about our services.

David R Rutledge, Pharm.D., FCCP, FAHA

+1 (630) 846-0350 cell

David.Rutledge@GlobalStrategicSolutions.com

https://GlobalStrategicSolutions.com/

If you’ve ever struggled to use a website or app or wondered why your provider’s patient portal feels like a chore every time you log in and find new information, you’ve experienced user design flaws that derail technology. As medical devices become more integrated with technology, user design becomes increasingly important.

 Your device is actually like you: a cohesive, integrated set of experiences. You like to be understood and easily get along with friends, right? It wants friends too.

Take your time with your device to make that happen. After all, you don’t want to spend months and millions of dollars on R&D only to have your medical device fail when it hits the market. To nail your user design, take your time exploring these questions that will put you in the end-users’ shoes.

What Does Your Medical Device Do?

The purpose of your medical device will dictate a lot of user design choices. For example, a blood glucose monitor that needs to be simple and easy to decipher for people of all ages and technology levels will be different than a fitness tracker designed for a younger, tech-savvy generation.

Related: What’s the Difference Between Quality Control and Quality Assurance

From deciding how simplistic the controls should be to how many features you can load onto the device, every decision depends on who will be using it. We recommend that you start with profiling the target audience for your intended device and then invest heavily in market research to get the data right.

A secret to your device’s initial success will be to limit bells and whistles for the next iteration. Keep your initial product simple and easy to use.

Related: Are you interested in learning more about how the EU MDR affects medical device manufacturing? If so, learn more about this upcoming book release from David R. Rutledge. Follow this story of intrigue and redemption within an up-and-coming manufacturer, Mythical Medical™. Coming soon!

What Features Are Important?

You’ll gain helpful insights on what features are essential as you compile market research. This is a step you absolutely should not skimp on. Start by conducting a thorough competitive analysis to identify existing comparable products. Scour product reviews and complaints on those products to identify opportunities to execute a better design.

Interview as many target users as you can to understand their needs first. These market research interviews should be conducted from a place of empathy. While you will eventually use the data you collect to make design decisions, the only goal of the interviews is to understand needs.

Make sure that you get your target users right. Spend time observing target patients as they interact with similar products or otherwise manage their conditions. Conduct trials in a lab setting to test possible features and then duplicate those experiments in the field. The end product will work best if designed for a specific group of users rather than a broad subset.

Diligently document all your research findings and then translate that data into actionable design goals. This is where your features list begins to take shape.

For example, if you are designing a medical device for it to be used while sleeping, it may be necessary to operate quietly. But ‘quietly’ is an ambiguous term. You’ll want to go one step further and identify what ‘quietly’ means and set parameters for noise levels in decibels. This detail will help the design team create prototypes that match your goals exactly.

Related: The Most Common Manufacturing ISO Standards for Medical Devices

How Will Users Interact With Your Device?

It’s vitally important to the success of your device that you do not make assumptions about what users need from your device. Every user needs a simple interface, but simple can mean different things to different people. Elderly users need minimal options, large buttons, and high-contrast text for simplicity. Tech-friendly users will appreciate more features as long as they are accessible and intuitive.

Think about how users will interact with your device. If they only need to power on and power off, then focus on the placement and function of the power button. You might also consider adding a power light to provide visual confirmation that the device is on or off. If the user takes and stores readings in the device, you will need a simplistic navigational menu that allows them to move between their current reading and their history of readings. And if the user is primarily medical field personnel, you might use technical language, whereas patient-facing interfaces should use the common language.

 Focus on answering these questions:

The problem with user design is that we are full of our own biased assumptions regarding our inventions. Inventors spend a lot of time thinking about things and deciding how they should work. And it feels foreign to interview target users or hold focus groups to find out if people would rather hear a beep when they press a button or feel a vibration. Regardless, you must let go of your agenda and spend a fair amount of time getting acquainted with real users’ needs.

Related: 5 Medical Device Startups to Look Out For

Don’t Read These Two Books (Not really.)

As a young father, I learned a simple trick to use on my teenage children. I would tell them not to do something, knowing that would be the first thing they would do. I am not a young father anymore, and you are certainly not a teenager.

There are two books that I would recommend for those of you interested in learning more about this fascinating and critical topic. Applied Human Factors in Medical Device Design edited by Mary Beth Privitera (ISBN: 978-0-12-816163-0) and Humanizing Healthcare – Human Factors for Medical Device Design (ISBN: 978-3-030-64432-1) authors RJ Branaghan, JS O’Brian, EA Hildebrand, and LB Foster.

No, I don’t receive royalties from this recommendation; just the immense pleasure of pointing you to wonderful resources. I am addicted to learning, and I know you are too. I hope this “fix” is as memorable for you as it was for me.

The Takeaway On Defining Medical Device User Needs

Creating a useful medical device can improve or even save lives. When they work well, they are helpful and widely used. But the medical world has seen more than its fair share of flops. User design failures are the quickest way to tank your medical device invention and sentence it to a life of obscurity, from tedious interfaces to devices that you can’t seem to figure out. Given the time and money that goes into development, that’s not the ending anyone is hoping for. But the good news is that taking the time to understand what users need from your device can keep you from making that mistake.

Do you need help with identifying medical device user needs? Let’s talk. We value, honor, and respect this critical element of R&D.

Global Strategic Solutions in the Silicon Valley area in California is a consultancy firm committed to ensuring safety in the medical field by helping inventors and businesses take the appropriate steps to get their devices approved and ready for sale. Learn more about our services.

David R Rutledge, Pharm.D., FCCP, FAHA

+1 (630) 846-0350 cell

David.Rutledge@GlobalStrategicSolutions.com

Are you curious about how to complete your FDA 510(K) submission this year, or if you’re even required to do so? Here’s what you’ll need to know.

Before a medical device can be legally sold on the open market, it must meet specific regulatory requirements. The requirements needed for different medical devices strongly depend on their particular device class. While many devices require Premarket Approval (PMA), that isn’t the case for all devices. For devices that don’t require a PMA, a 510(k) submission needs to be filed instead. But what is a 510(k) submission? Who is required to file one? And how are 510(k) submissions supposed to be prepared?

Thankfully, our medical device experts at Global Strategic Solutions are here to explain the essential components of 510(k) submission, so your business will know what it needs to take care of going forward. Please continue reading to learn more, and also consider contacting us if you’d like additional help going through the following submission process!

Related: How Medical Device Companies Raise Money – Build something people want

What is a 510(k) Submission, and Why is It Important?

In short, a 510(k) submission is a specific type of regulatory premarket submission made to the Food and Drug Administration (FDA) regarding Class I, II, or III medical devices that don’t require premarket approval. Also commonly referred to as a Premarket Notification, a 510(k) submission provides evidence of substantial equivalence, meaning that a medical device is sufficiently similar to another device while also being safe and effective for use. Devices are classified as substantially equivalent compared to a predicate device if they possess the same intended use, with the same or different technological characteristics that do not negatively affect safety and performance.

If manufacturers can prove their device has substantial equivalence, their submission will be published in the FDA 510(k) database. The manufacturer will communicate their device has been “cleared” by the FDA, not “approved.” This is a subtle difference, but it is the correct way to reference your 510(k) device.

Related: What Is The Difference Between Clinical Evaluation and Clinical Investigation?

Who’s Required to Complete a 510(k) Submission?

Approximately 50% of all medical devices released onto the market will require a 510(k) submission to be permitted for market sale by the FDA. Most Class I devices are exempt from 510(k) Premarket Notification requirements, while most Class II medical devices require a 510(k) submission and clearance. Many Class III medical devices require a PMA rather than a complete 510(k) submission. In short, this means the developers of certain Class I, II, and II devices may need to submit a 510(k). There are different 510(k) submissions, but this article will focus on the traditional 510(k) for teaching purposes.

Are you struggling to get your medical devices approved and ready for sale on the open market this year? Our expert medical device specialists at Global Strategic Solutions can help by providing access to a wide range of medical manufacturing consulting and data analytics services.

The 510(k) submission process takes considerable time and attention to complete correctly. Sadly, there is not a “510(k) form” per se that companies can quickly fill out and send to the FDA. Instead, submission requires a range of specific documentation to be compiled and submitted together for review. To make the process as straightforward and simplistic as possible, the FDA has graciously provided a specified guide to help businesses complete the 510(k) submission process, including an overview of the submission’s required format and content.

That said, navigating through and interpreting the FDA guidelines can be tricky, especially for newer players within the medical device manufacturing industry. Our team of medical device experts has taken the time to compile a shortlist of everything your submission will need to include and in what order. 510(k) submissions should consist of:

●     Indications for device use
●     Information on device classification
●     A list and explanation of predicate devices
●     Proposed device labeling and advertising
●     Descriptions of device specifications (including photos, engineering schematics, and documents regarding unique standards or controls)
●     Performance data from clinical testing (if applicable)
●     Sterilization, biocompatibility, and expiration information for the device (if applicable)
●     Guidance documents related to the specific device type

All documents required for successful 510(k) submissions must be carefully prepared and organized for the best chance of FDA clearance. Because many of the documents necessary for the submission are inherently developed throughout the design and development process of medical device creation, it can be helpful to start authoring a 510(k) submission in parallel with project development efforts. Doing so can help streamline the submission process and lower the chances of submission rejection.

A word of caution. There is a section that addresses whether the device is novel. Be careful here. This is not a marketing piece but a regulatory document. You are not trying to differentiate your product from the competition. You want to show substantial equivalence. You are trying to explain how your product is the same, but you may need to explain a few minor novel features.

Related: How to Write an SOP for a Medical Device

Final Factors to Consider

According to recent data, approximately 69% of 510(k) applications are rejected the first time they are presented to the FDA. While this percentage fluctuates each year, the fact is that the majority of submissions are usually denied and will need to be adjusted and resubmitted at least once before gaining FDA clearance. Unfortunately, this can put a severe damper on operations for many medical device manufacturers by preventing their technology from hitting the market for sale.

Thankfully, companies have the option to partner with expert consultation companies with vast levels of experience in getting medical devices approved for sale by the FDA. Our professionals at Global Strategic Solutions are proud to offer our services to medical device manufacturers currently operating across the globe to help ensure your devices receive the approval they need and deserve. We’ve worked with companies throughout the United States, Europe, and Asia to help expedite the medical device approval process by providing companies with a quick and affordable route to government approval and market access.

If your business is struggling to receive the approval it needs for its newly developed medical devices, please consider exploring our services to learn even more about everything we can do to help. Also, please consider exploring some of our expertly written resources for access to even more essential information on medical device development, approval, and more.

What’s in Your Strategy?

Getting a medical device properly tested, analyzed, and accepted for use on the open market can be very difficult, even for major companies with long histories of medical device manufacturing success. Thankfully, our experts at Global Strategic Solutions are here to help by providing access to a wide range of essential services. 

David R Rutledge, Pharm.D., FCCP, FAHA

+1 (630) 846-0350 cell

David.Rutledge@GlobalStrategicSolutions.com

For years, I heard about Artificial Intelligence and Machine Learning (AI/ML) and how they would impact the medical device sector. I understood software, but I’m not a software engineer by training. The closest I got to programing was using CTRL+C and CTRL+V.

I did not want that to stop me from gaining more understanding and insights into this new innovative world. So, I enrolled in a weeklong workshop here in the Silicon Valley area of California. I did not enter the training session as an expert, just the opposite. It was a personal and professional growth experience for me. I felt out of place and intimidated by those cool computer programmers and scientists—my new best friends.

Then, on November 5, 2019, I wrote my first article on AI/MI on LinkedIn: “Hey Artificial Intelligence, Let’s Be Foolish Friends.” That began an adventure for me. I had to hold on tight because this field was moving fast. Here is a critical point, the bottom line, I learned years ago, which has proven true today.

Artificial Intelligence + Human Input Beats Artificial Intelligence or Human Input Alone Every Time.

Artificial intelligence is a technology that mimics human activity, decision-making, and learning.

In the medical device and healthcare industry, artificial intelligence can (i) automate tasks, synthesize data from multiple sources, and pinpoint trends, (ii) predict which patients are at an increased risk for disease, complications, or adverse outcomes based on patient-specific data, and (iii) process and analyze information from wearable sensors and identify disease or the onset of medical conditions, and (iv) support research by evaluating large amounts of data and monitoring treatment effectiveness.

The truth is artificial intelligence has the potential to significantly improve the medical field and medical devices in multiple ways. Medical devices that harness the power of artificial intelligence have the potential to revolutionize the entire health care industry and help medical professionals effectively and accurately diagnose and treat patients while improving care.

Related: Top 5 Cutting Edge Medical Device Advancements That May Be In Your Home Soon

Medical Artificial Intelligence Defined

According to Techopedia, artificial intelligence is a branch of computer science that works to improve software solutions by giving the ability to analyze the surrounding environment and then make decisions based on the analyses done. Artificial medical intelligence is any medical technology used to collect, analyze, and make decisions based on health data.

Are you interested in learning more about how the EU MDR affects medical device manufacturing? If so, learn about this in an upcoming book release from David R. Rutledge. Follow this story of intrigue and redemption within an up-and-coming manufacturer, Mythical Medical™.

How the Continued Development of Artificial Intelligence for Medical Devices Is Benefiting the Healthcare Industry

You may have noticed that large technology companies have accelerated their design and development of intelligent products, particularly smart wearables. Some use artificial intelligence to develop new artificial intelligence applications and create new and innovative patient-friendly functionalities.

Beyond the larger tech companies, artificial intelligence for medical devices is accelerating significantly. Artificial intelligence has begun to present new opportunities in the medical device industry by providing equipment and device manufacturers the ability to:

• Reach new customer segments
• Use the collected data in new ways with no limits in volume or processing speed
• Create new methods of helping patients and developing new and unique products
• Finding hidden correlations in data, with some being discovered in real-time

Artificial intelligence in the medical device industry is fascinating. New and exciting innovations are being produced and released weekly. Some of the ways that medical services are now using AI-powered medical devices include:

• Diagnosing: Healthcare providers can provide a better and more timely medical condition diagnosis.
• Prevention: It’s possible to predict pathologies and let caregivers make informed and timely decisions.
• Care: It’s possible to automate the follow-up process with patients, even if they are being seen remotely.
• Personalization: It’s possible to personalize the treatment of every patient.

Along with the benefits above, artificial intelligence-powered medical devices can also improve medical data quality so that it’s able to be used for predictive analytics purposes. It also helps to improve the operational efficiency of all types and sizes of care institutions.

How Else is Artificial Intelligence Being Used for Medical Devices Today?

As technology continues to advance, medical device manufacturers are creating artificial intelligence devices that can be used for two primary functions:

1. Internet of Things (IoT)

The Internet of Things (IoT) is a system of interrelated, wireless, and connected devices that medical professionals utilize in terms of medical devices. The purpose is to manage data, monitor patients, work more efficiently and effectively, reduce costs, and ensure patients remain informed about what is going on. Most companies are now using IoT for medical devices to help improve patient outcomes.

2. Medical Imaging

Medical devices are also being developed with artificial intelligence to help with medical imaging. These devices produce higher-quality images with increased clarity to improve diagnosis, treatments, or monitoring. The outcomes are better than just relying on your eyes alone. It also picks up patterns your eyes may not see. Another benefit of artificial intelligence-powered imaging devices is reducing radiation exposure.

FDA Guidance for Artificial Intelligence-Powered Medical Devices

While the benefits of artificial intelligence for medical devices are evident, it’s also worth noting the challenges it faces. One example would be the need for regulation to ensure technology advancements don’t surpass oversight and testing. Like with any other technology, there is the possibility that artificial intelligence is flawed. This increases the risk that artificial intelligence medical devices may misdiagnose patients or administer improper treatment. Also, since medical devices impact a person’s health and life, they deserve to be highly regulated.

Creating regulations and the process that devices must undergo for approval takes time. The U.S. Food and Drug Administration (FDA) issued the “Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan” from the Center for Devices and Radiological Health’s Digital Health Center of Excellence. As part of this Action Plan, the agency is highlighting the following intended actions and goals:

1. Develop an update to the proposed regulatory framework presented in the Artificial Intelligence/Machine Learning (AI/ML)-based Software as a Medical Device (SaMD) discussion paper, including the issuance of a Draft Guidance on the Predetermined Change Control Plan.
2. Strengthen FDA’s encouragement of the harmonized development of Good Machine Learning Practice (GMLP) through additional FDA participation in collaborative communities and consensus standards development efforts.
3. Support a patient-centered approach by continuing to host discussions on the role of transparency to users of AI/ML-based devices. Building upon the October 2020 Patient Engagement Advisory Committee (PEAC) Meeting focused on patient trust in AI/ML technologies, hold a public workshop on medical device labeling to support transparency to users of AI/ML-based devices.
4. Support regulatory science efforts on the development of methodology for the evaluation and improvement of machine learning algorithms, including for the identification and elimination of bias, and on the robustness and resilience of these algorithms to withstand changing clinical inputs and conditions.
5. Advance real-world performance pilots in coordination with stakeholders and other FDA programs to provide additional clarity on what a real-world evidence generation program could look like for AI/ML-based SaMD.

Related: Top 5 Cutting Edge Medical Device Advancements That May Be In Your Home Soon

Until then, FDA has made progress by granting 510(k) clearance for several artificial intelligence-based systems, such as (i) QuantX, an artificial intelligence diagnostic tool aiming to improve breast cancer diagnosis; (ii) the Apple watch ECG, which uses electrodes to capture heart rhythm irregularities and cleared as an over-the-counter ECG monitoring device; (iii) AIDOC, an artificial intelligence-based system that allows radiologists to identify acute intracranial hemorrhages in head CT scans specifically for the detection of large-vessel occlusions; and (iv) Zebra Medical Vision, which secured five FDA clearances for their artificial intelligence imaging products. These examples represent a model of collaboration between innovators and regulators.

It is expected that eventually, the FDA will have a standard medical device testing process in place to help speed up the time to market for these items.

In October 2021, three competent authorities agreed to philosophies that would push the area of AI/ML into greatness. The FDA, Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) have jointly identified ten guiding principles that can inform the development of Good Machine Learning Practice (GMLP). These guiding principles will help promote safe, effective, and high-quality medical devices that use artificial AI/ML.

Strong international public health partners will be crucial to empowering entrepreneurs, manufacturers, and other stakeholders to advance responsible innovations in this area.

Book an appointment today if you are ready to learn more about global medical device approvals and how Global Strategic Solutions, LLC here in the Silicon Valley area of California might help.

Conclusion

Artificial intelligence has helped present an entirely new spectrum of diagnostic and therapeutic possibilities for patients in the past ten years. Now it has begun to power an all-new generation of systems that help doctors and other healthcare professionals deliver higher levels of care. Because of this, it is believed that artificial intelligence will lead the way when it comes to introducing a new era of startling breakthroughs related to patient care.

It’s a fun, intellectually stimulating journey. Join me—no computer programming is required!

Related: What Is the Difference Between Quality Control and Quality Assurance?

David R Rutledge, Pharm.D., FCCP, FAHA

+1 (630) 846-0350 cell

David.Rutledge@GlobalStrategicSolutions.com https://GlobalStrategicSolutions.com/

Five miles from Global Strategic Solutions, LLC, here in the Silicon Valley area of California, is where Theranos was located. I rode my Cervélo carbon fiber road bike by the building many Saturdays as I was exercising. It was my time to think creatively, plan enthusiastically, and reflect thoughtfully. Little did I know that building would be the center of misfortune and heartache that would be filled with Quality Management System (QMS) leadership lessons.

Related: Knowing These Core Elements of a Quality Management System Can Get You Promoted

If any medical device company ever wants to appreciate the need for implementing leadership and quality management principles for quality control and best practices systems, one need not look any further than the fraudulent tragedy of Elizabeth Holmes. She was the founder and former chief executive officer (CEO) of Theranos, a now-defunct health technology company.

Elizabeth Holmes led the aggressively hyped in-vitro medical device diagnostic company which claimed to have revolutionized blood testing. Her proprietary method proposed to use surprisingly small volumes of blood, such as from a fingerstick or standard finger prick, and to ultimately test dozens of specific substances, analytes, or other markers. The process could be applied to not only blood but saliva or tissue. Some have said the public could have had access to up to 240 affordable tests from a single drop of blood or small sample. The Theranos Edison machine could have changed healthcare as we know it.

Flaws Can Blind Our Views and Limit Perspectives

A fatal flaw in her business strategy was never fully vetting the innovative idea with an established “Proof of Concept” study, also known as Proof of Principle. You know, a study that would prove the concept. That it would work and provide the foundation to move forward with investors and product development engineers. Instead, the company misled investors, another fatal flaw, and the government with fancy words, innovative theories, clever photoshoots, and unproven promises.

Who needs due diligence with a Proof of Concept study when a founder and CEO has such a convincing personal story, such as being afraid of needles? Almost Everyone!

Within a few years, she went from being lauded as a business icon and medical field visionary to being stigmatized and branded as a fraud and convicted felon.

Ms. Holmes’ fraudulent business practices scandalized the medical device industry and beg the question of why her deceptions went unnoticed for so long and caused the downfall of her multi-billion-dollar company. Many employees in the trenches have better answers than me, but I’ll provide some that we should either all be able to agree on or provide a platform for discussion.

Elizabeth Holmes was 19 years old when she founded Theranos in 2003 as a sophomore, dropping out of Stanford a year later to focus on the company in 2004. The proposed technology would have revolutionized the global medical industry and eventually changed how every medical practitioner handled their diagnostic operations.

Ms. Holmes was described as the potential next Steve Jobs and a self-made billionaire. Theranos had a market capitalization value of over $9 billion. Celebrity moguls and billionaires worldwide were donating hundreds of millions of dollars to Holmes at a time.

The problem? Theranos’ breakthrough instant blood diagnosis device was severely flawed and never worked outside of proprietary theory. Claims of the company’s fraud started in 2015 were suspected as the Wall Street Journal began writing articles claiming that Theranos could not scientifically prove the viability of its device.

How could this happen? While Ms. Holmes is the face of the fraud perpetrated by Theranos, she certainly was not the only one who knew the blood diagnosis device didn’t work. Employees knew. Leaders in the field knew. It appears that leaders within Theranos knew, too. From some of the news articles, apparently, several employees voiced concerns about assumptions being made.

How did Elizabeth Holmes and Theranos convince multiple millionaires and billionaires to donate to her company without any certifiable proof of concept? Some in the media asked, “Was Theranos always a massive Ponzi scheme with Holmes paying off tiers of previous investors with new investors while buying time in the hopes of perfecting her blood diagnosis device in the meanwhile?”

Theranos, a company valued at $9 billion at the time, had collapsed by 2018. Elizabeth Holmes was criminally convicted on four counts of fraud in January 2022 and could spend decades behind bars after being sentenced.

And while the fraudulent, criminal activities of Elizabeth Holmes will become salacious fodder for news and entertainment, every medical device company should study the downfall of Theranos as a cautionary tale.

How could the operational practices of a hyped medical company break down to the point that its non-functioning proprietary technology was being anticipated by the world? The F.D.A. cleared (lay language “approved”) a Theranos quick test for herpes diagnosis in 2015. Theranos never filed paperwork showing the test worked, so how did it happen?

An obvious and troubling question that hasn’t been answered is how much the Theranos fraud case has compromised the trust of patients, regulators, the medical industry, and investors. Silicon Valley will be affected, but the ripple effect will be worldwide. This might negatively affect medical device companies promising a breakthrough invention or technique that could otherwise change the world. Steve Jobs had mockingly referred to those as, the crazy ones. Apple’s 1997 Think Different campaign was launched not long after he returned to the company he founded. It began with these words:

“Here’s to the crazy ones, the misfits, the rebels, the troublemakers, the round pegs in the square holes … the ones who see things differently — they’re not fond of rules, and they have no respect for the status quo. … You can quote them, disagree with them, glorify or vilify them, but the only thing you can’t do is ignore them because they change things. … They push the human race forward, and while some may see them as the crazy ones, we see genius, because the people who are crazy enough to think that they can change the world, are the ones who do.”

If you desire to be one of the crazy ones, we still need you!

On January 3, 2022, a federal court in San Jose, California, found Holmes guilty on 4 of the 11 charges brought against her by prosecutors. She was found guilty of three charges for wire fraud — a scheme intended to obtain money under false pretenses using a method of remote communication such as e-mail — against investors. She was also found guilty on one charge for conspiracy to commit wire fraud against investors. The jury acquitted her on four charges related to defrauding patients. They could not reach a decision on three further charges related to defrauding investors. Sentencing will begin later in the fall.

I’m in the final stages of publishing a fun, captivating book looking at a medical device company, Mythical Medical™,  that takes steps to represent the good in our medical device sector. Mythical Medical™ Coming Soon. Follow this story of intrigue and redemption within an up-and-coming fictional manufacturer. There are growth and leadership moments that we can all relate to and be proud of!

Fortunately, there are several Quality Management standards and leadership principles for medical device companies to follow. Implementing these processes can help you to build something special.

What are Quality Management Principles?

Improve Your Process: Five Quality Management Leadership Principles

If there was ever any time that a medical device company needs to reevaluate or implement its quality management principles, it’s now. Here are five quality management and leadership principles that your medical device company should always follow.

Contact Global Strategic Solutions today to receive expert consultation, advice, and help to get your medical device approved and ready for market.

Related: How Medical Device Companies Raise Money – Build something people want

Quality management principles are a group affirmed set of fundamental rules, norms, beliefs, goals, and values that become the basis for quality management in services or operations.

A company’s quality management principles are a set of operational commandments that can always be referred to as affirming and reaffirming standard best practices when conducting business, achieving a goal, and improving its performance and quality guidelines.

The basis for the concept of quality management principles was created by an international team of experts in 1947. They were looking to develop an operational and business philosophical guideline for companies to identify, detect, and rectify fatal errors before reaching the marketplace.

It was called the International Standard for Operations and they have published several standards including those that address Quality Management System Standards. There can be anywhere between seven and eight quality management principles depending on the region.

Here are the basic five that your medical device company should follow.

1. Customer Focus

Always remember that a business needs customers like a beating heart needs oxygen-rich blood. Always strive to appreciate, understand, and meet the needs of your customer base.

Strive to reach and design your product to suit customer demand. Understand the requirements and needs of your consumer base.

Related: USA FDA Medical Device Safety – The good and the better

A medical device company must create a product that serves the public good. If your product is designed to meet a demand or service and works from design to final product, you will never lose your consumer base. In other words, build products that people want now and will also want in the future.

2. Leadership

A company leader must be honest and extol a unifying purpose and vision that employees can follow by example. The leader must create a progressive, productive, and safe working environment that attracts qualified workers.

It is the leader who is responsible for the hiring practices of a company. Make sure you develop hiring guidelines that enhance your quality management principles and don’t take away from them.

3. People Involvement

Your business could not exist long without a consumer base to buy your products or a qualified workforce behind the scenes to realize goals.

Your workers need to understand and appreciate their job descriptions, goals, and how their actions affect the company as a whole. Every worker at each level of the company has a role in its failure or success, so always motivate them to succeed.

4. Process-Driven Approach

There should be a customized and proprietary process approach to determine how your business is run from the formula, design, and conceptualization stage to prototype, testing, final design, and introduction to the market. The standards also address post-production or surveillance expectations.

Having an operational process will also maintain morale if you lose key staff – all you have to do is hire competent replacements who can follow your operational approaches.

5. Systemic Management Approach

As the leader, you have enough responsibilities. Defer responsibilities as appropriate while maintaining an oversight role. Trust your workers to work in a management style to streamline processes and keep work efficient.

Final Thoughts

Proof of Concept is performed, in part, to demonstrate that critical design features of one or more of the selected design concepts perform as intended. Prototypes of critical design features can be developed to discover and address design challenges. Additionally, where a design concept relies on one or more critical manufacturing processes, these too should be proven.

We can help you with strategies around Proof of Concept. Do you need either assistance to develop your concept or a different set of eyes to evaluate your strategy? Let’s talk. What’s in your strategy?™

Contact Global Strategic Solutions today to get your medical device approved and ready for market.

David R Rutledge, Pharm.D., FCCP, FAHA

David.Rutledge@GlobalStrategicSolutions.com

https://globalstrategicsolutions.com/

+1 (630) 846-0350 cell

Unsuccessful Startups Are All The Same. They Are Uniquely Unsuccessful.

The need. The solution. The market. Can you speak to these in one minute? It can be that easy initially.

You may have heard the buzz surrounding medical device technology. It’s a growing market. Artificial intelligence, gig speed internet, and many other high-tech advancements have opened doors that once seemed very futuristic. And in the race to come up with the next big thing, there is no shortage of medical device startups this year.

But you may still be wondering one thing–who exactly is footing the bill for these endeavors? Usually family, friends, extended family, and extended friends. Then what?

That’s where it gets a little complicated. Funding for medical device companies comes from various sources, and it’s all highly competitive. And that means that medical device companies not only need to have a compelling product to lure investors, but they need to be on the top of their game in every way that it counts when it comes to running the business. Investors aren’t just looking for a promising product; they want to know the company behind the product is worth their time too. Here are some of the most common funding options this year.

Challenges for Medical Device Fundraising

The biggest challenges for medical device companies often come down to beating out the competition. Many investors look at hundreds of potential ideas before choosing just one. That’s a lot of fish in the sea to compete with. And that means that to have a real chance at getting funded, medical device companies need to run a tight ship.

The startup should involve educated and experienced guidance in either leadership positions through a MedTech accelerator or another arrangement. Investors will shy away from committing if the existing management team doesn’t have a strong background in business or the medical field.

Related: Frankenstein Sparked Development of Novel Medical Devices

 The device or product also needs to be backed with thorough market viability research and a stellar pitch deck that efficiently communicates the highlights in a brief pitch. Investors aren’t looking for devices created on a hunch; they want a surefire win, so the company that was able to put together the best data is often the one that wins the funding. For startups with limited resources, this will always be an uphill battle. We can help.

Small Business Innovation Research Grants

These grants are part of a federally-funded program to inspire innovation in business and keep American companies competitive globally. The SBIR program has been around since the 1980s, and it is one of the most popular ways for medical device startups to get the money they need. To qualify for an SBIR grant, medical device companies need to meet certain criteria, like (i) Operating a legitimate, for-profit business with appropriate licensing and registration in the US. (ii) US citizens or lawful permanent residents have more than 50% ownership and control of day-to-day operations. (iii) Have less than 500 employees, including all affiliates. (iv) Be actively engaged in research and development for innovation.

Angel Investors

An angel investor can go by different names. Perhaps you’ve heard terms like a private investor, seed investor, or informal investor. These are all different ways of saying the same thing. Angel investors are individuals or a network of pooled individual resources that support startups. They’ve become increasingly popular in the medical device community due to the risk level of technology innovation that makes traditional funding less likely.

The typical angel investor has verifiable proof of income between $200,000 and $300,000 per year or a net wealth over $1 million. When they invest in medical device companies, their investments are between $30,000 and $2 million. These investors may be drawn to Medtech startups based on personal experience. If they directly suffered from a condition that your device will improve treatment options for or if they know someone who suffered, they’re often motivated by their emotional connection. They prefer to be involved in a hands-on way.

Global Strategic Solutions provides expert consultative experience to manage your medical device companies risk. Get to know us today.

Venture Capital Funds

The tried-and-true method of financing business startups works just as well in Medtech as anywhere else. Venture capital funds are pooled investments managed by investment firms using money that individual investors place with those firms. There are many rules involved with venture capital funds. Still, the bottom line is that startups who use this approach are generally on the hook to meet a specific return on investment which means it is one of the most labor-intensive funding options that can be risky for the startup.

MedTech Incubators

Incubators and accelerators are traditionally positioned as a support role for startups. But these organizations have increasingly become viable sources of funding as well. Startups benefit in big ways from working with incubators and accelerators. These organizations often provide access to education and experience that a startup might not otherwise secure independently. When fundraising becomes a natural extension of what these organizations are already providing, it helps the startup gain the necessary experience in soliciting funds from various sources. Eventually, the startup will outgrow the incubator and begin looking elsewhere using the experience they gained here.

Special Purpose Acquisition Companies (SPACs)

SPACs are also known as blank check companies because they are formed without specific products or services. Instead, they have one goal: to acquire a promising company. Or, in other words, it is a company formed to provide capital to the right idea. With the growing popularity of medical device technology, it’s easy to see why SPACs have garnered much attention in recent years. These blank check companies do invite some scrutiny simply because they are organized, but the popular opinion is that SPACs are here to stay.

Related: 3 Medical Device Startups to Look Out For

Bulletproof Your Startup

As mentioned previously, unsuccessful startups are all the same. They are uniquely unsuccessful. However, there are five myths that can jeopardize your growth and ten strategies that you can implement to bulletproof your startup. As you build your strategy, please understand that patents attract funding, increase the value of your company, and double your chance of being successful within ten years.

What’s in your strategy? We can help you work to develop a strategy specifically for your medical device. This is a fun activity that we will lead you through to bring into focus a fundable and approvable plan or initial approach.

The Bottom Line on Medical Device Fundraising

There are thousands of great ideas out there that never get funding. It takes a whole lot more than a good idea to get things rolling. In many cases, medical device startups need to operate a viable business and show reasonable proof of claims regarding the return on investment before anyone is going to cough up money to put their product on the market. Whether the funding comes from a venture capital fund, SPAC, grant, or another source, the money always goes to the company with the best chance of success.

Again, “What’s in your strategy?”

Global Strategic Solutions, LLC here in the Silicon Valley area in California can assist you with strategic planning, aligning funding sources, developing your presentation materials, and implementing processes to collect the data necessary for product approval. Do you need patent help? Our business partners can help.

Having a virtuous, respectable, good idea is not enough. Regulators, notified bodies, clinicians, and patients know that staying focused on developing a clinically-sound product based on evidence is fundamental. There are no shortcuts. Ensuring that a product can translate into a viable business is supreme. Eventually, it is that business that investors are putting money into.

The odds of success are stacked against you. Knowledgeable consultants can give you a competitive advantage. Success lies not just in your belief, but in proving market viability. The better your product story – from development to commercialization – the better your chances in securing capital.

Don’t become another uniquely unsuccessful startup. With the right team, success is within your grasp. The next product buzz is just maybe your technology!

A Fun Read: Three Reasons Not To Hire A Consultant

Global Strategic Solutions is committed to ensuring safety in the medical device field through diligent risk assessment consultation for medical device companies. Learn more today.

David R Rutledge, Pharm.D., FCCP, FAHA

President & CEO

David.Rutledge@GlobalStrategicSolutions.com, https://globalstrategicsolutions.com/

+1 (630) 846-0350 cell

How to Write an SOP for a Medical Device

There is no shortage of documentation required when developing a medical device. Standard operating procedures (SOPs) are one essential piece of documentation required to get your medical device approved and on the market. Putting together this documentation can be confusing, but when it is done well, this documentation provides clear directives. Writing an SOP that is clear and effective can make the difference between an approval process riddled with issues and a successful device.

The first step in writing an effective SOP for a medical device starts with understanding the purpose of these documents. SOP’s can serve many different purposes, and while they are a required checklist item for regulatory compliance, they are not a reiteration of regulations. Before you begin writing, you should get clear on what you are writing and for whom you are writing it.

Related: What is the Difference Between Quality Assurance and Quality Control

What is an SOP?

Standard operating procedures (SOPs) provide written instructions for completing specific tasks. Ultimately, an SOP provides the basis for quality control activities. These documents address process and safety compliance steps that help keep things uniform during testing, production, and use. These documents are a vital level of protection if problems arise with the use of the device in the future.

Related: From Product Approval: Sharing PMS Information is a Healthy Behavior

An SOP provides detailed operational information that allows anyone with any experience to replicate a procedure or a process. Companies use these documents to ensure consistency in processes, products, and people. In addition to providing a framework for quality measures, SOP’s can improve efficiency by keeping everyone on task and ensuring that preventative maintenance needs are up to date.

These documents can also serve as training documents for new hires or performance checklists for current employees. But most importantly, when something goes awry, these documents provide a basis for exploring the root cause of the problem. Ultimately, regulatory bodies that provide oversight for medical devices want to see the stringent protocols during device development. They want a solid framework to rely on if there are problems with devices down the road.

When Do You Need an SOP for a Medical Device?

The medical device industry is full of regulatory hurdles. Maintaining compliance with all the governing bodies is paramount during each phase of device development. That means that you’ll be creating SOPs for different purposes. The short answer is that any time there is a process, your company should create an SOP to document that process. Here are some common examples of when an SOP might be solicited for your device: 1) Document Control, 2) Manufacturing Processes, 3) Transporting Devices, 4) Storing Devices, 5) Supplier Management, 6) Reporting Defects or Other Problems, 7) Risk Management, 8) Design Controls, 9) Biocompatibility, 10) Publications, 11) Registrations, 12) Training, 13) Clinical Investigations, 14) Clinical Evaluation, and 15) Post-Market Surveillance.

Imagine yourself caring the “SOP torch” during the creation of SOPs. The Olympic torch heralds the start of the Olympic Games and transmits a message of peace and friendship along its route. You too can send a message that correctly written SOPs can create peace and friendship within your organization.

Each SOP should aim to document how activities are performed. Care should be taken to ensure that the SOP addresses quality assurance and regulatory compliance needs and outlines a process for validating results and calibrating equipment.

Global Strategic Solutions is committed to promoting safety in health care through diligent risk management for device manufacturers. Learn more today.

How to Write an Effective SOP that can Light the Torch in Your Organization

Not all SOPs are created equally. Some contain ambiguous language that can be difficult to understand. Some fundamentally miss key steps. And some are incomplete. So, that begs the question, when writing an SOP, how can you ensure that it is effective?

The most practical approach is to write from the end user’s point of view. While the author of the SOP might be the subject matter expert, those who will rely on this document are anything but experts with the device. That requires the ability to be objective. Follow these suggestions: 1) Write clearly and concisely. 2) Use common language and provide definitions when technical language is required. 3) Stick to a step-by-step format. 4) Use directive language like “identify,” “evaluate,” or “investigate.” 5) Aim for precision, giving exact measurements when possible. 6) Format for easy reading.

A trick that I use in Word is to check the readability statistics. Go to Home, Editor, and Document Statistics. Check both the Flesch-Kincaid Grade Level and Flesch Reading Ease and adjust to your audience.

Use a Clear Format

One thing that can make a significant difference when writing SOPs is sticking to a clear format. Not only will this help each SOP be clear and effective, but it also promotes consistency from one SOP to another. SOPs can be very long, but the list below is a good start.

 ●      Header: Include the title, document number, and version for easy reference.

●      Purpose: Write a concise summary of the document’s purpose in one or two sentences.

●      Scope: Defines the audience for the SOP.

●      References and Documents

●      Definitions: Spells out definitions for acronyms and technical language uses therein.

●      Roles and Responsibilities: Defines who is responsible for what.

●      Procedure: Generally outlined in a step-by-step process.

●      Appendices: Flow charts and other visual aids.

●      Revision History: A record of changes.

●      Approval Signatures: Documentation that appropriate parties have reviewed and signed off on the SOP.

Global Strategic Solutions, LLC has been involved in creating, revising, or editing hundreds of SOPs. If you need help, let’s talk.

Mistakes to Avoid When Creating an SOP

Standard operating procedures are detailed, and that’s why it can get confusing when creating them. The goal is to keep them clear, concise, and on target. You should generally try to avoid including more than what is necessary. Some people try to copy regulatory guidelines word-for-word, making sure that they cover all their bases. In reality, this just bloats the SOP with distracting information and obscures the true purpose of the document. You should also avoid adding too many different roles and responsibilities under one SOP. If things become muddled, consider creating separate documents for each role.

Related: Creation of Sufficient Clinical Evidence

Another common mistake is that company’s overlook version control records. The truth is that things change over time, and it’s imperative to keep an accurate record of those changes for historical purposes.

Final Thoughts on Writing an SOP for a Medical Device

Writing SOPs should be an engrained process for any medical device company. It’s not a one-and-done activity. You’ll likely need to create dozens of these documents to cover every facet of your business as well as every device in your development program. Understanding the purpose of the SOP and how to write clearly and effectively is key to getting the green light during your device approval process. We recommend choosing a standard format and keeping it simple with clear language and easy-to-read formatting. If you need help,

Global Strategic Solutions is your partner in managing medical device risk. Learn more today.

David R Rutledge, Pharm.D., FCCP, FAHA, President & CEO

David.Rutledge@GlobalStrategicSolutions.com, https://globalstrategicsolutions.com/ +1 (630) 846-0350 cell

Some of the medical device technologies in use today might seem more like they fit in a futuristic science fiction movie. Neuroscientists are exploring opportunities to use virtual reality and mind-controlled devices. Children’s hospitals embrace a new way to provide emotional support to their young patients. Cardiac patients can wear a garment to shock their heart back into a healthy rhythm. Anti-choking devices bring calmness to a choking emergency. Finally, medicinal contact lenses may soon replace eye drops. These are just a few innovative ways that technology is changing healthcare for the better.

1. Mind-Controlled Exoskeleton that Helps Disabled Walk

Spinal cord injuries are the leading cause of accidental paralysis, permanently confining patients to wheelchairs. In the United States alone, more than 250,000 people live without using their legs. Traffic accidents, sports injuries, and falls are the most common reasons they end up in the chair, and the majority of them are young–under 50 years old.

The medical community currently has no cure for restoring the function of a damaged spinal cord, meaning that there is no medical cure for paralysis. But thanks to advancements in technology, these patients may be able to walk again. Systems like mind-controlled orthosis (brace) along with virtual reality (VR) training environments for walk-empowering activities, or Mindwalker, use a brain-neural-computer-interface (BNCI) to bypass the spinal cord and send brain signals to the legs to coordinate movement.

Across the European Union and the United States, we have seen many advancements in technologies like this.

ABLE Human Motion is perfecting an exoskeleton prosthesis designed to help people with spinal cord injuries and lower limb paralysis walk again. ABLE’s medical startup mission is to help people with paralyzing disabilities live better and to enhance the quality of their lives. The most notable fact about ABLE Human Motion is that the company went from exoskeleton prosthesis conceptualization to a working prototype within 3 years.

2. ROBIN: Emotional Support Robots in Children’s Hospitals

More than three million children spend lengthy and sometimes frequent stays in hospitals. Before the COVID-19 pandemic, it was very isolating and depressing for young children who were not old enough to process these big feelings. But one thing that is helping is emotional support robots which have recently been trialed in children’s hospitals around the world to help these young patients cope with stress and depression. 

One robot, Robin, was originally developed in 2018 to establisher peer-to-peer interactions and foster communication with children. And clinical trials were positive, with one nine-week study showing a 26% improvement in joy and a 34% reduction of stress in the average juvenile patient. I just love the big WALL-E eyes and sleek plastic body.

Robin appeals to children using AI-based interactions to build emotional connections. It can play games, tell stories, and make patients laugh with jokes. But most importantly, it can adjust its behavior to interact in an age-appropriate way so that the patient sees a peer instead of a scared parent or a clinical doctor. The robot helps children feel less isolated and makes medical procedures easier by distracting the young patients.

3. Biomedical Vest that Shows Heart-Related Problems

One particularly interesting category of medical devices is wearables. This includes everything from internet-connected yoga pants that monitor biometric data as you work out to products like the LifeVest®, a personal defibrillator worn by certain cardiac patients. LifeVest continuously monitors cardiac activity and can provide a life-saving shock treatment if the patient falls into an abnormal rhythm. It is essentially a wearable cardioverter defibrillator (WCD).

This device is for anyone at high risk for sudden cardiac death, such as some patients who are just returning to normal daily activities following a heart attack, bypass surgery, cardiac stent placement, or patients with severe heart failure. While AEDs are common in certain situations, patients must rely on a bystander to recognize the emergency and locate and use the automated external defibrillator (AED) within a few minutes.

Comparatively, with devices like LifeVest, no intervention is needed. The device can recognize a problem before anyone else is aware and immediately deliver appropriate shock treatments up to five times in an attempt to restore a normal heart rhythm. The device can alert a patient prior to delivering a treatment shock, thus allowing a conscious patient to delay the treatment. If the patient becomes unconscious, the device is designed to release a Blue™ gel over the therapy electrodes and deliver an electrical shock to restore normal rhythm.

4. The Dechoker, Anti-Choking Device

Choking is not an uncommon emergency. A few thousand people die from a lack of oxygen due to choking every year, and there are several thousand more non-fatal choking accidents.

Traditionally, the best way to clear the airway of someone who was choking was to perform a Heimlich maneuver, which can be difficult depending on the size of the victim and rescuer and, even when performed successfully, can cause broken ribs.

The Dechoker is a simple device that can clear an airway for anyone 12 months and older. It works using negative pressure and has been successful in clinical trials and real-life emergencies since its approval a few years ago.

Another device, the LifeVac Choking Rescue device, is also available. I purchased this for our family off of Amazon.

Device manufacturers expect that the results of clinical trials will assist in making decisions to update current resuscitation guidelines for choking emergencies.

5. Contact Lens Medicine Dispersal

Several medications are applied to the eyes. But the biggest challenge is that the eyes wash out most of the medicine in a short amount of time. The typical dose is often completely gone after just thirty minutes. Contact lenses, which do not have to be corrective, can hold the medicine in place longer.

These lenses are being considered for use to deliver antibiotics, anti-inflammatories, and anti-allergy medicines. The prediction for the future is that medicinal contact lenses may entirely replace eye drops.

The important thing to note with this technology is that the lens manufacturers are not simply soaking the lenses in medicine. Doses are administered through controlled release using technology built into the lens structure.

The photo shows a patient inserting a medicated contact lens. (Photo:

Jeff Etheridge/Auburn University)

It makes sense that chronic dosing could yield more benefits than the periodic use of eye drops, not to mention the added convenience of potentially being able to forget about medicating for days at a time.

What’s in Your Strategy?

The clinical, regulatory, and quality expectations for cutting-edge medical devices around the world are increasing. Global Strategic Solutions, LLC located in the Silicon Valley area of California uses innovative technologies to conduct and systematically analyze the medical literature using proven methods that regulatory bodies accept. Additionally, we have expert clinical and regulatory strategists along with senior medical writing personnel to assist with your market application. Although changes are occurring all over the world, Europe is where the medical device revolution exists today. We have experts available now.

Final Thoughts on Cutting-Edge Medical Devices

This is only a small sampling of what is possible with the help of technology. We expect to see radical transformations in patient care and treatment efficacy using artificial intelligence and virtual reality technologies. Conditions that have previously been considered incurable or irreversible may have a second chance. Paraplegics confined to a wheelchair may be able to walk again using mind-controlled technology, and AI provides the perfect emotional companion for sick children living in hospitals. It won’t be too much longer before these technologies will be in our homes.

David R Rutledge, Pharm.D., FCCP, FAHA

President & CEO, Global Strategic Solutions, LLC, Silicon Valley in California.

www.GlobalStrategicSolutions.com    +1 (630) 846-0350 cell David.Rutledge@GlobalStrategicSolutions.com

While Kai-Lin was ambling along a crowded sidewalk, the breeze whispered, “You’re scared and cannot do this.” Kai-Lin, an evolving leader at the fictional medical device company, Mythical Medical, overheard this as a cruel, merciless, penetrating scream, not a weak, pathetic, faint murmur. She needed help to prepare for an upcoming audit and contacted me shortly after that.

The first time you prepare for an audit, it stimulates your private, rarely apparent insecure behavior. You find yourself with hallucinations of being hopelessly and woefully inadequate. Never let your insecurities limit your potential.

On the one hand, you have delusions of sound, fundamentally euphoric ideas that convince you that you can handle it, no problem. These debilitating symptoms blur the line between what is real and what isn’t, making it difficult to enter the audit room; unless you prepare in a simplistic, unsophisticated, rational, and unneurotic manner.

There are two rooms. One is the backroom where employees and consultants gather to create strategies and gather documents that the auditor wants to see during the audit process. There are processes in place for the back room, but for this exercise, we will focus on the other room—the audit room where the auditor is.

Let’s Keep It Simple

My first audit training session with Kai-Lin would set the stage for future success. I was unsuspecting then how easy it would be for her to go off script once a relaxed, comfortable environment was created in the audit room.

Whether it is responding to an audit required for (i) pre-approval, (ii) routine surveillance, (iii) compliance follow-up, or (iv) for-cause, this four-step, 15-minutes each preparation process can chill and soothe the hot seat that is waiting for you in the audit room.

To set the stage, we needed a technique to stay in character, but be flexible to go out of character when urgent teaching points came up. I would lay a Montblanc ballpoint pen on the table that signified, in character. I would reach out and take it away as the signal to go out of character. A simple visual.

Be An Active Listener

Speak less, listen more. Some people are just born to be active listeners. Unfortunately, most need to learn this skill. Kai-Lin was not the exception. She excelled at partial listening, lack of interest, and deep-rooted beliefs, but rarely showed pre-judgment, intolerance, or negativity towards speakers. I needed to address this before the real four-step training started.

The pen went down to the table. “Can you tell me your name?” I asked. “Kai-Lin Liu,” she said confidently and with an air of assertiveness.

I picked up the pen. “That was actually a yes or no question,” I replied. As an auditor, I had not asked her to say her name. What followed was a brief conversation that would transform her into a recognized, influential leader within the audit room. To drill that point firmly into her brain neurons, I started every four-step audit training session with that simple question. Kai-Lin needed to actively listen to every question and only answer the question. Stay in your lane and speak to what is relevant to your job responsibilities. This was not the time to develop a relationship or bond with the auditor. We discussed how to introduce herself at the appropriate time and to properly exchange business cards. Although there are other active listening skills to learn, during an audit just answer the question. No more.

Lesson #1 – Do you understand the issue you are being brought in to discuss?

I explained to Kai-Lin that this would be four simple lessons, but that she would have to pass each before being allowed to the audit room. The first session focused on do you know the audit exception you are being brought in to address. Sometimes there are no exceptions, but the auditor wants to understand certain procedures that are in place. A very common audit question is, “Please tell me in your own words about this procedure.” Procedures or Standard Operating Procedures (SOPs) are approved documents that can be brought into the room. It is a best practice to point to a figure (or two) and within two to three minutes highlight the essence of the SOP. If an exception was found that you are being asked to address, now is the time to briefly and factually state the exception along with the results of the investigation. This is not the time to be defensive or point fingers. The popular, widespread BLAME GAME should never be played in the audit room.

I reminded Kai-Lin that she would leave each lesson with a homework assignment. Practice on your own. Once you are confident that you know and can articulate why you are being brought into the audit room, lesson #2 can begin.

Lesson #2 – Do you believe it?

Each session began with a brief role-play of the previous lessons. This lesson is to wrestle, struggle, and grapple with what was done or written that the auditor knows about.

This may seem like a simple, obvious next step, but it profoundly can affect the outcome of your meeting. There are times when you cannot get there, and you will need to be a good corporate citizen, within the law, of course, and you will have to confidently convey that the internal investigation that was performed was correct and all the right steps were taken for you to believe it. If you cannot pass this step, you should not be taken into the audit room. I saw the challenge that she accepted. Kai-Lin wanted to be in the audit room and would do her homework assignments magnificently. She was brilliant and a perfect student.

Lesson #3 – Do you have and know the evidence?

The third, 15-minute meeting with Kai-Lin was to assess whether or not she had the actual objective evidence necessary to address the exception (or to show how the SOP is working). This simply will come with putting in more time to understand the evidence presented to the auditor. There are a number of thinking moves that are integral to developing knowledge and understanding. Although the training was for Kai-Lin, anyone in her organization could follow this audit preparation coaching. She paused and mentioned others on her broader team that could benefit, and we set up times for several members to participate.

The top three thinking moves that Kai-Lin needed to learn were (i) making connections, (ii) considering different viewpoints, and (iii) forming convincing conclusions based on the evidence. I mentioned to Kai-Lin that there are three places to go to in order to pass this lesson. First, be by yourself and ponder the evidence. Ask tough questions. Challenge yourself privately and then verbalize what the evidence is suggesting. Second, gather your friendly colleagues and present to them. Ask them to poke holes in your thought process and reasoning, but verbalize your responses to your friends. Finally, identify “the critics” within the organization and practice with them. This will naturally cause conflict, so don’t take it personally. Obviously, it is hard not to take it personally. I reminded Kai-Lin that it is better to make mistakes and be vulnerable outside the audit room. She should look at this as a “gift” that was being given to her.

You likely will need to uncover complexities you did not think about, going below the surface of things you thought you knew. After her voyage or journey to those three locations, when challenged, she should be ready to pass this lesson.

Lesson #4 – Can you put it all together?

We briefly reviewed all the previous lessons during our in character, pen on the table session. Kai-Lin was dazzling. She was well on her way. Then, we began the last session.

The purpose of this meeting with Kai-Lin is to evaluate if she could “in the moment” in front of me, the “mock” auditor, speak confidently as she describes the exception (or the SOP), verbalize and agree to what was done, and then speak to the evidence that supports it. This could be considered the final exam.

During this final session, we reviewed all four questions and Kai-Lin had all the talking points down. An element here that I threw in was what I refer to as curve balls—trying to distract or shake her. I wanted Kai-Lin to remember to stay in her lane and to speak only to areas that she was directly responsible for. It’s okay to say, “That’s not my area.”

I rattled off likely questions that she should not attempt to answer:

(i) How many critical suppliers do you have? Quality owns this in Mythical Medical, not your department.
(ii) How often do you audit your critical suppliers? Quality determines this, not you.
(iii) Is your supplier of X (solution or material supplier) a critical supplier? Quality does this, not you.
(iv) How does Mythical Medical process invoices? Procurement and finance take this question.
(v) How do you determine the selling price of your device? –They should not be asking this.
(vi) What international standard was followed during the development of X product? Bring R&D in for this one.
(vii) Can you speak to the sterilization methods that are used? That’s for the manufacturing engineers to address.

I thought this last piece of training was useful and reinforced the point to ensure Kai-Lin stayed in her lane in the audit room. I would be proved wrong.

The day of the audit

The day of the audit came and there was excitement and expectations in the backroom as preparations were being made. The usual opening meeting occurred flawlessly with introductions and reviewing the upcoming agenda. Then, the meeting was closed and employees were being escorted from the backroom into the audit room per the agreed-upon schedule of events.

Kai-Lin’s turn came and we all had confidence in her, although this was her first time to actually be in the audit room in front of an auditor. She was there for almost an hour doing remarkably. Extraordinarily, actually.

But then, the sly, sneaky auditor, still plagued by an unresolved issue previously noted within another department, asked her about the process for selecting suppliers. Kai-Lin’s department used suppliers. A legitimate question, per se. What followed was a sincere, but inaccurate answer. “We change suppliers all the time. We cannot keep up with them. Sometimes I wonder how they stay in business.” She smiled and let out a very brief, quiet chuckle.

The backroom was monitoring the audit room. Several leaders and the majority of employees gasped, sneered, gulped, and were taken back.

The somewhat reserved, organized audit preparation machine just went off the tracks as Kai-Lin left her lane and represented another department and their processes inaccurately.

The birth of a crisis with the all too familiar calamity had just occurred, and Kai-Lin was completely unaware as she left the audit room. The BLAME GAME had just started, outside of the audit room, and there were more than enough players ready to participate.

Auditors are trained to do their job and that job was done today. The clever, devious, scheming auditor had another “rabbit hole” to go down in order to find more facts that just did not seem to be adding up. A previous employee had been interviewed, and the evidence the auditor had before him was not consistent with what he heard. The frequency of new suppliers being brought on board at Mythical Medical might just explain the auditor’s suspicions about the facts. The auditor, now acting more like a purebred bloodhound, had just found the proverbial scent that had eluded the audit trail up to that point.

Kai-Lin comes back into the audit backroom

What happened to Kai-Lin today can be fixed. There were so very many things that she did correctly. In fact, she was a model employee as she prepared for the audit. Yes, she learned about staying in her lane during an audit, even when the auditor, doing their job, tries to disarm you to obtain more, not so readily apparent, information.

When the closing meeting occurred, the auditor pointed out a major nonconformity that was discovered. There was a lack of quality control over Mythical Medical’s suppliers in general, critical suppliers specifically. Several employees privately singled out Kai-Lin as the reason the auditor discovered that major nonconformity. It crushed Kai-Lin. She felt like she let down the organization. She was heartbroken. There may have been tears. But, had she let Mythical Medical down?

During the chaos in the backroom, the President of Mythical Medical stood up and looked, with a laser-like focus, around the room. Senior leaders know. Mostly they know from experience. What was said that day, set the company towards a path of greatness that few companies experience. In those companies, it seems to always start at the top.

“It’s been a long day. We will get through this together. Here at Mythical Medical where you can be anything, let’s be kind today. Kai-Lin, I know how you must feel. I have an embarrassing audit story for you and the rest of the team. You all need to hear it, but let’s get through this audit. I became a better leader because of it, and you will too, Kai-Lin. We have a lot of work yet to do. Tomorrow morning, we have two choices. Go back to sleep and dream, or get up and catch your dreams.”

That extra glance given to Kai-Lin would become an invitation to destiny.

There were a lot of discussions and assignments made. Kai-Lin, as in her nature, stepped up and became part of the solution. The audit eventually ended many months later. Mythical Medical was a stronger, more grounded company.

Sometimes there are people that can relate, in fact, even connect in moments of failure. They know that an expert in anything was once a beginner. No matter what happens, life goes on with new opportunities on the horizon. Although unknown to Kai-Lin, opportunities to continue to grow as a leader were already set in motion but remained unrevealed, hidden to her.

Final Thoughts

Audits and inspections occur all over the world. These four, simple audit training steps can easily be implemented in your organization. Global Strategic Solutions, LLC, has the expertise to assist you in preparing for upcoming audits. If your organization is preparing for EU MDR audits, here are three additional secrets for a successful audit readiness plan.

David R Rutledge, Pharm.D., FCCP, FAHA, President & CEO, Global Strategic Solutions, LLC, Silicon Valley in California.

+1 (630) 846-0350 cell.

Disclaimer: 

This is just a bit of fun. The purpose of articles like these is for the free exchange of questions, ideas, or comments regarding issues of global interest involving medical regulations. It is not to be considered legal advice. These are just opinions and not advice; opinions may change over time, too. Use it at your own risk. This disclaimer will occasionally be posted or updated throughout the year.