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How Ready Are You for the Next Crisis?

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During the COVID-19 pandemic, medical device and diagnostics companies and their partners have been responding with rapid solutions to meet urgent healthcare needs. Much has been learned from the quick response that could help the medical device industry prepare for future pandemics, disasters, and other potential supply-chain disruptions.

MD+DI will be exploring such lessons in the webinar series, How the Medtech Industry Can Respond to Crisis. The six individual webinars held the week of June 22 include:

These events aim to help attendees learn how to:

  • Develop a plan to respond to a pandemic, crisis, or other potential supply chain disruption.
  • Expedite the design process for urgently needed products.
  • Work with regulators on an expedited pathway.
  • Work with suppliers and other partners to prevent shortages of materials and components and ensure a stable supply chain.
  • Address critical needs for disinfection, sterile processing, and packaging.
  • And develop other best practices for responding to the next crisis.

Kicking off the week of webinars will be risk management experts from Grant Thornton, which has been advising both large and small medical device manufacturers on the COVID-19 pandemic and more. The firm has developed a Pandemic Risk Model to help companies take a risk-based approach to crisis planning. Speaking from Grant Thornton during the webinar, Respond and Restore: Best Practices for Responding to a Pandemic (and Other Crises), will be Yvette Connor, principal, regulatory and compliance solutions; Pat Shafer, managing director, regulatory risk and quality effectiveness; Lisa Walkush, principal, life sciences sector leader; and Andy Mechavich, director, human capital services.

According to the team: “Current risk management capabilities assume a normal probability of known risk factors to occur, but they miss the unexpected, low probability events that result in the most severe supply chain disruptions like the COVID-19 Pandemic.” The speakers will explore key impact zones, risk factors, and strategies for responding and restoring operations.

During another webinar, The UK Ventilator Challenge: A Developer's Story, Sagentia will share how it responded to the UK's Ventilator Challenge by developing a new ventilator in under 7 weeks. The company devised new ways of collaborating with supply-chain partners, competitors, regulators, and clinicians to develop a solution. Speakers Rob Morgan, VP – medical, and Carl Hewett, senior product development consultant, both with Sagentia, will share how their experiences could influence future product developments.

Nelson Laboratories and Sterigenics, leading providers of mission critical services in the healthcare industry, will share recent learnings and insights about novel approaches to decontamination/sterile processing of items such as personal protective equipment (PPE) in Method Development for Decontamination and Sterile Processing of Personal Protective Equipment (PPE). “The presentation will provide the audience with a complete picture of the challenges faced when working with novel methods for decontamination/sterilization for items that are meant to be single-use devices,” said Alpa Patel, principal scientist for Nelson Labs. Aaron DeMent, vice president of technical services, will join Patel to present the importance of testing all critical parameters even when developing accelerated or abbreviated test methods.

There are also steps medtech companies can take for a more secure components supply chain. Maxon and Tekscan, for instance, will share ideas in their respective Webinars, Preventing Component Shortages During a Crisis and Secrets to a Stable Sensor Supply: What You Should Consider, respectively.

Christian Fritz, director of business development and applications engineering for maxon USA, which provides motion control components, will examine how smart product design, collaboration with key partners, and crisis planning can lessen the impact of unplanned events. He will explore the benefits of modular components and discuss the concept of minimum viable product. Using maxon’s product and services offering as an example, Fritz will outline how a close collaboration with supply chain partners allows companies to overcome sourcing issues in times of rapidly rising demand.

“As we all move through these unprecedented times with the COVID-19 pandemic, we have learned the importance of critical mission readiness. I will share some proven strategies that can prevent component shortages and fulfill the increased demand of critical equipment and gear,” Fritz told MD+DI.

Charlie Malacaria, vice president of business development for Tekscan, which provides embedded components such as force sensors, will share how healthcare products manufacturers can reduce supply chain risks through a deeper understanding of component manufacturing. He will explore how insights into component manufacturing processes, application and engineering support, and company stability could help mediate possible risks. Attendees will also learn how assess the long-term stability of their suppliers.

Ensuring successful packaging designs while on an expedited timeline will also be covered in Medical Device Packaging as Told Through Design Control. Oliver Healthcare Packaging's Director of Product Marketing Jenn Goff will discuss why including packaging early during the design requirement process is so important, especially during times of crisis. The webinar will help product design engineers develop a deeper understanding of packaging’s role as well as experienced packaging engineers implement design control practices.

“Designing and developing sterile medical packaging is like telling a story—it’s a stream of chronological events that takes place," Goff told MD+DI. "In sterile medical packaging, it starts with the end-user’s needs and concludes with detailed documentation. The documentation shows how each user need was determined along the way, how it was translated into specific design inputs, and then how it was validated. Each event in the design control process is an important part of the story to ensure a compliant end product.”

Be sure to join us June 23-25 for these informative webinars:

RapidAI is Set to Acquire EndoVantage for an Undisclosed Sum

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M&A is still a thing during the COVID-19 Pandemic. Advanced stroke imaging firm, RapidAI is acquiring EndoVantage, developer of the Find, Track, and Treat comprehensive cerebral aneurysm management platform.

Menlo Park, CA-based RapidAI said this acquisition can help it expand its scope, from ischemic stroke to hemorrhagic stroke and now aneurysm.

EndoVantage was started at Mayo Clinic and Arizona State University has developed a powerful award-winning computational platform that provides comprehensive cerebral aneurysm management, automating the entire workflow from initial assessment, growth monitoring, to treatment planning.

It uses CTA and MRA scans to deliver results that help physicians find and track aneurysm progression, and leverages data from 3D rotational angiograms to deliver detailed 3D models of a patient’s vasculature and allow presurgical planning for the repair of the aneurysm.

“By adding the incredible technology developed by EndoVantage to the Rapid platform, we strengthen our position as the global leader in cerebrovascular imaging,” said Don Listwin, CEO of RapidAI, said in a release. “We can offer hospitals a complete portfolio of products—encompassing ischemic stroke, hemorrhagic stroke, and aneurysm—providing an end-to-end solution that will drive better patient outcomes across the spectrum of cerebrovascular disorders.”

The M&A scene has been shaky in medtech since the pandemic struck. In April, Alphatec announced it was pulling out of its agreement to acquire EOS Imaging because of negative impacts on the market caused by COVID-19.

The surgical spine specialist announced in late February that it would pick up EOS Imaging for $88 million, plus debt retirement for $33.9 million, in a combination of cash and equity.

Organovo Holdings also terminated its merger agreement with Tarveda Therapeutics. The San Diego, CA-based company originally submitted the proposal to merge with Tarveda Therapeutics late last year.

 

DoD Funds Clinical Trial of Seraph Blood Filter to Treat COVID-19

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The Department of Defense is funding a clinical trial of a COVID-19 treatment using ExThera Medical’s Seraph 100 Blood filter.  The device was selected to be in the multi-center randomized clinical trial because it showed encouraging preliminary results in critically ill COVID-19 patients at a military hospital in the U.S. and 14 other hospitals in Europe.

Investigators at the Uniformed Services University in Bethesda will run the trial of the Martinez, CA-based company’s device.

Initial reports indicate Seraph 100 stabilizes blood pressure and inflammatory biomarkers that correlate with poor patient outcome: IL-6, Ferritin, D-dimers, LDH, and Nt-proBNP, all decreased during Seraph 100 treatments of COVID-19 patients.

In a release about DoD’s funding,  it was stated that it appears as if the Seraph 100 helps improve patient outcomes by providing additional time for supportive care while reducing the sources of inflammation and possibly preventing further damage by reducing SARS-CoV-2 virus/RNA in the bloodstream.

In a March 26th release from Exthera, its president and CEO Robert Ward NAE said, “We are very pleased to confirm the feasibility of Seraph 100 treatment of COVID-19. Since Seraph 100 treatments have also consistently produced improved oxygenation/lung function, we believe that this feature together with virus reduction may be a useful combination for treating COVID-19, while simultaneously treating the dangerous secondary infections that can occur in COVID-19 patients.”

Here’s how Seraph works. As a patient's blood flows through the Seraph filter, it passes over tiny beads with receptors that mimic the receptors on human cells that pathogens target when they invade the body.

Harmful substances are quickly captured and adsorbed onto the surface of the beads and are thereby removed from the bloodstream. Seraph does not add anything to the blood, which is returned to the patient with blood cells and proteins intact. Seraph targets the pathogens that cause the infection, while it also binds and removes harmful substances generated by the pathogen and by the body’s response to the infection.

Seraph won Emergency Use Authorization from FDA for the treatment of COVID-19 in April, according to the company

DoD’s funding comes as medical devices are becoming more of a factor in the fight against COVID-19. Abiomed made some rumblings in this effort.

In April, the Danvers, MA-based company acquired Breethe, a developer of an extracorporeal membrane oxygenation system, for an undisclosed sum. The Baltimore, MD-based company’s technology has the potential to serve the needs of patients whose lungs can longer provide sufficient oxygenation, including patients suffering from cardiogenic shock, cardiac arrest or respiratory failure such as due to ARDS, H1N1, SARS, or COVID-19.

And recently, Abiomed won EUA for the Impella RP to include patients suffering from COVID-19 related right heart failure or decompensation, including pulmonary embolism.

New App Predicts Blood Glucose Levels 60 Minutes into the Future

Wladimir1804 - Adobe Stock Image Diabetes.jpeg

There's a new, AI-powered diabetes app that claims to accurately predict blood glucose levels sooner than the industry-leading continuous glucose monitoring (CGM) systems, which currently tout 20-minute glucose value prediction capabilities.

Bio Conscious Technologies said an in-house silico study of its Diabits AI algorithm demonstrated its ability to provide 60-minute blood glucose value predictions. The Vancouver, British Columbia-based company says the app is designed for people with diabetes who use a CGM to monitor their daily blood sugar fluctuations.

The ability to accurately predict glucose levels with the Diabits app helps users improve blood sugar management by increasing the time that they have to react. This enables proactive management of highs and lows to help them stay within a healthy glucose range for a longer time during the day and ultimately keep them healthier,” said Amir Hayeri, CEO of Bio Conscious Technologies. “Additionally, this information could be transmitted to a pump or a smart insulin pen to calculate the precise amount of insulin needed and the optimal time for injection. This can further minimize fluctuations and excursions beyond recommended glucose range.” 

Bio Conscious Technologies Inc.BloodGlucose.png

Details of Bio Conscious Technologies' Study

The in-house study used the Padova simulator provided by the Epsilon Group, included 30 virtual patients, and measured the predictive accuracy of the Diabits algorithm. Each virtual patient was entirely unique, and represented a possible profile of a real Diabits user's glucose metabolism, the company said.

The subjects were studied in four cohorts representing four distinct populations: adults with mixed hypoglycemia awareness, adults with impaired hypoglycemia awareness, pediatric patients with mixed hypoglycemia awareness, and pediatric patients with impaired hypoglycemia awareness. Patients also had simulated behaviors related to diabetes management such as a randomized meal and insulin schedule based on the patient’s weight, age, and amount of insulin necessary based on carbs consumed. For each patient, a total of 360 days of blood glucose behavior was simulated and insulin-on-board and carbs-on-board information were recorded.

Two different blood sugar prediction models were trained and tested for each patient. The first model, Production, is the algorithm which is used in Diabits today. The second model, ICE, is a more advanced version of Production which puts a more substantial weight on food, insulin, and exercise information. The results of the simulation showed that, in general, while the Production model is highly accurate, the ICE model will slightly outperform the Production model in most cases. As a result of this study, the ICE model was implemented into Diabits. Today, if a user inputs food or insulin information, the ICE model will be automatically selected and used for that user’s predictions. If a user does not input this additional information, the Production model is automatically selected.

Bio Conscious said it will release more detailed study results and data during the upcoming virtual meeting of the American Diabetes Association, which kicks off on Friday.

Medtech in a Minute: Bigfoot Steps Up the Funding Game, Fitbit Flow, and More

Fitbit Dives Deeper Into Medtech with Ventilator

FDA granted an emergency use authorization for the Fitbit Flow, a low-cost ventilator, for use during the COVID-19 pandemic. The company said the device builds on standard resuscitator bags, like those used by paramedics, with sophisticated instruments, sensors, and alarms that work together to support automated compressions and patient monitoring.

Advamed Takes a Stand Against Racial Injustice

It's rare that the head of one of the industry's most prominent trade associations takes a stand on a controversial social issue, but as the father of a black son, Scott Whitaker said he just couldn't stay silent about the recent protests sparked by the murder of George Floyd in Minneapolis, MN. Whitaker penned an open letter to the medtech community, urging the industry to stand up, listen, and act on, "eradicating the disease of racism in this country and around the world."

Bigfoot Steps Up Its Funding Game

Bigfoot Biomedical, the diabetes tech startup that wants to close the diabetes management loop, raised $55 million in a series C round led by its partner Abbott. The company is on track to file for FDA 510(k) clearance in 2020 to market the Bigfoot Unity System, part of a real-time, dose-decision support system for people with insulin-requiring diabetes who rely on multiple daily injection therapy.

Plastic Face Shields: Ingenious Methods and Designs

Plastic Face Shields: Ingenious Methods and Designs

Versatile COVID-19 Shield Now Available from Maguire Products

Versatile COVID-19 Shield Now Available from Maguire Products

Well-known within the plastics processing industry as a global supplier of auxiliary equipment, Maguire Products is branching out, as so many manufacturers have, under the influence of COVID-19. The company is now offering a flexible, PET-based shield designed for safe social distancing in workplaces, schools, and stores.

Jordan Defense Shield from Maguire Products
Lightweight, flexible, and transparent, the Jordan Defense Shield is the latest example of how the advantages of plastics have become prominent in the COVID-19 pandemic, according to Maguire Products.

The patent-pending Jordan Defense Shield is made from sturdy PET film. It is shipped as a roll with rods attached on either end, and can be installed and uninstalled in seconds, according to Maguire. Any size or type of space can be protected by unrolling the shield to the required length.

“The versatility of the Jordan Defense Shield eliminates the assembly effort required by the rigid sheet now widely offered as protection from COVID-19,” said Frank Kavanagh, Vice President of Sales and Marketing. “For deployment in restaurants and retail stores, where shielding needs are constantly shifting, our shields can be removed and relocated over and over, with appropriate changes in length.

The Jordan Defense Shield is the latest example of how the advantages of plastics have become prominent in the COVID-19 pandemic, added Kavanaugh. “The ease with which the Jordan Defense Shield can be deployed is attributable to the flexibility and light weight of plastics. The film is crystal-clear and, like all PET polyester, recyclable,” he added.

The Jordan Defense Shield is available worldwide. Discounts are available for bulk orders, and standard shipping is free in the contiguous United States.

How Ready Are You for the Next Crisis?

How Ready Are You for the Next Crisis?

During the COVID-19 pandemic, medical device and diagnostics companies and their partners have been responding with rapid solutions to meet urgent healthcare needs. Much has been learned from the quick response that could help the medical device industry prepare for future pandemics, disasters, and other potential supply-chain disruptions.

MD+DI will be exploring such lessons in the webinar series, “How the Medtech Industry Can Respond to Crisis.” Six individual webinars held the week of June 22 will help attendees learn how to:

  • Develop a plan to respond to a pandemic, crisis, or other potential supply chain disruption.
  • Expedite the design process for urgently needed products.
  • Work with regulators on an expedited pathway.
  • Work with suppliers and other partners to prevent shortages of materials and components and ensure a stable supply chain.
  • Address critical needs for disinfection, sterile processing, and packaging.
  • And develop other best practices for responding to the next crisis.

Kicking off the week of webinars will be risk management experts from Grant Thornton, which has been advising both large and small medical device manufacturers on the COVID-19 pandemic and more. The firm has developed a Pandemic Risk Model to help companies take a risk-based approach to crisis planning. Speaking from Grant Thornton during the webinar “Respond and Restore, Best Practices for Responding to a Pandemic (and Other Crises)” will be Yvette Connor, principal, regulatory and compliance solutions; Pat Shafer, managing director, regulatory risk and quality effectiveness; Lisa Walkush, principal, life sciences sector leader; and Andy Mechavich, director, human capital services.

According to the team: “Current risk management capabilities assume a normal probability of known risk factors to occur, but they miss the unexpected, low probability events that result in the most severe supply chain disruptions like the COVID-19 Pandemic.” The speakers will explore key impact zones and risk factors.

During another webinar, Sagentia will share how it responded to the UK's Ventilator Challenge by developing a new ventilator in under 7 weeks. The company devised new ways of collaborating with supply-chain partners, competitors, regulators, and clinicians to develop a solution. Speakers Rob Morgan, VP – medical, and Carl Hewett, senior product development consultant, both with Sagentia, will share how their experiences could influence future product developments.

Nelson Laboratories and Sterigenics, leading providers of mission critical services in the healthcare industry, will share recent learnings and insights about novel approaches to decontamination/sterile processing of items such as personal protective equipment (PPE) in Method Development for Decontamination and Sterile Processing of Personal Protective Equipment (PPE). “The presentation will provide the audience with a complete picture of the challenges faced when working with novel methods for decontamination/sterilization for items that are meant to be single use devices,” said Alpa Patel, Principal Scientist for Nelson Labs. Aaron DeMent, Vice President of Technical Services, will join Patel to present the importance of testing all critical parameters even when developing accelerated or abbreviated test methods.

There are also steps medtech companies can take for a more secure components supply chain. Maxon and Tekscan, for instance, will share ideas in their respective Webinars, “Preventing Component Shortages During a Crisis” and “Secrets to a Stable Sensor Supply: What You Should Consider,” respectively.

Christian Fritz, director of business development and applications engineering for maxon USA, which provides motion control components, will examine how smart product design, collaboration with key partners, and crisis planning can lessen the impact of unplanned events. For instance, modular off-the-shelf product platforms could help ease sourcing in an emergency, and Fritz will explore the concept of minimum viable product and how to leverage alternative variants.

Charlie Malacaria, vice president of business development for Tekscan, which provides embedded components such as force sensors, will share how healthcare products manufacturers can reduce supply chain risks through a deeper understanding of component manufacturing. He will explore how insights into component manufacturing processes, application and engineering support, and company stability could help mediate possible risks. Attendees will also learn how assess the long-term stability of their suppliers.

Ensuring successful packaging designs while on an expedited timeline will also be covered in “Medical Device Packaging as Told Through Design Control.” Oliver Healthcare Packaging's director of product marketing, Jenn Goff, will discuss why including packaging early during the design requirement process is so important, especially during times of crisis. The webinar will help product design engineers develop a deeper understanding of packaging’s role as well as experienced packaging engineers implement design control practices.

Please join us June 23-25 for these informative webinars:

AdvaMed CEO: We Can and Must Stand for the Cause of Equal Justice for All

Background image by Ahmet Aglamaz - Adobe Stock AdvaMed

As a journalist covering the medical device industry for more than a decade, I cannot recall the last time AdvaMed took a stand on a controversial social or political issue. The trade association is known for advocating on a range of policy issues impacting the industry but tends to avoid the really hot-button topics such as gun violence and police brutality.

Until now.

"For too many in this country, the fear of a similar fate [to that of George Floyd] has led to outrage, anger, and hopelessness. We are seeing this expressed in cities across the nation, and for good reason. We are proud of our industry’s employees and the countless others who are taking to the streets to exercise their constitutional right to peacefully protest and plead for long-overdue change," Scott Whitaker, president and CEO of AdvaMed, said in an open letter intended for the entire medtech community. "We must all stand up. We must all listen. We must all act."

Whitaker acknowledges in the letter that, as a healthcare organization, AdvaMed does not have the solution to a cultural crisis like the one we face today. But, he says, "together we can and we must stand with those who are hurting and suffering ... We can and we must listen to those who offer real solutions to the evil of racism—and then ensure that those who have the power to implement those solutions do so immediately."

In a separate comment on his LinkedIn post, Whitaker explains his reasons for speaking out about the current protests sparked by Floyd's murder, given that he is not typically inclined to engage in controversial social issues.

"Throughout the course of history, often the most meaningful advances have come when political leaders, of both parties, can no longer resist the change rightfully demanded by the people they represent. As a father of a black son, this is very personal to me, perhaps more personal than it should be," Whitaker said. "But I couldn’t allow this moment to pass without acknowledging it. Too many are suffering. Those who are suffering need to know we care and that we support the cause of equality for all."

He closed his letter by reminding the industry that the medical technology community is united in its common mission to improve and save lives.

"While we continue our single-minded pursuit of medical breakthroughs to treat and cure disease, we must also have a single-minded focus on eradicating the disease of racism in this country and around the world," he said.

Judging by the comments, Whitaker's letter was largely welcomed by industry peers who follow him on social media. One such comment came from  Orrin Marcella, the head of U.S. government affairs at GE Healthcare.

"As a father of black children as well, I'm struggling. I have been since August 9, 2014, the day Michael Brown was murdered in Missouri. That was the day my son was born in Washington, DC. But I should have been long before. All of us privileged white people should have," Marcella said. "This is not something for us to 'get past' but rather something we should feel and fight everyday until there are no more Michael Browns and George Floyds."

Patrick Hope, executive director of the Medical Imaging and Technology Alliance, also commented on Whitaker's letter saying, "We shouldn’t be silent when the stakes are this high."