<img height="1" width="1" style="display:none" src="https://www.facebook.com/tr?id=1000083763474443&amp;ev=PageView&amp;noscript=1">

SmartTRAK Life Sciences News and Analysis Blog

5 min read

International Medtech News Roundup: Updates from Around the Globe

By Thomas Wallick on 6/29/20 9:18 AM

As the international response to COVID-19 shifts to preparing for a potential second wave, the Medtech industry pushes forward with the development and approval of new devices. The following is just a small sampling of the past week's international updates that were curated, compiled, reviewed and posted throughout the day by the expert analysts at SmartTRAK. They sift through the noise to discover the latest international news, industry trends, financial data and competitor developments in the global Life Sciences industry.

Pandemic Reserve in Germany

In Germany, as a result of the past months, BVMed proposed to the Minister of Health to build stock for masks and protective equipment for 6 months to be used in pandemics.

How To Build Wound Care Knowledge

The Odense University Hospital in Denmark built up a blended learning concept in wound care for nurses to support them in gaining confidence when carrying out wound care. E-learning modules, study visits and workshops are mixed to address the needs.

Medical Device Promotion in France

In France, The National Agency for the Safety of Medicines and Health Products (ANSM) published a guideline on how advertising visas should be handled for medical devices during the state of emergency (until July 10, 2020) and through the year.

Restricted China Export Boost Local Market

Freight costs have increased dramatically during the COVID-19 outbreak. Chinese medical dressing export are mainly low cost, less advanced dressings. Manufacturers are now looking more to grow sales on their local China market, to replace imported more advanced dressings.

Continue Reading
4 min read

Meet Joe Mish - Director of Sales

By Thomas Wallick on 6/11/20 4:19 PM


We are pleased to announce that Joe Mish has joined the team at SmartTRAK as Director of Sales. Joe has 10+ years experience in medical device sales, with concentration on Joint Replacement and Spine & Robotic Technologies. Prior to joining SmartTRAK, Joe sold and implemented analytic software to manage value-based care and bundled payment, working with Stryker, LDR/ZimmerBiomet and Stryker Performance Solutions.

Meet Joe Mish:

What is your role with SmartTRAK? I will be joining the commercial team as Director of Sales.

What do you like about SmartTRAK? I’ll give you two perspectives here. First, with regards to the technology, I love the value proposition to our current and prospective customers. With the world being so volatile and business being severely disrupted (especially for surgery and device companies) being able to offer a solution to reduce risk, improve profitability and productivity makes this a fantastic time to partner with organization’s and build strong, long-lasting relationships. This was truly a deciding factor in making a career/company change. Second, with regards to the company, I love the people. Coming from multiple large Fortune 500 companies with very specific cultures, individuals and team comradery is often and easily overlooked. I have been so impressed with the professionalism, transparency and family vibe from every person I have engaged with and I have only been on board for a week! This feels like a very special group of incredibly talented people and I am honored to be a part of it.

Continue Reading
7 min read

COVID-19: Vaccines, Testing and the Future for MedTech

By Thomas Wallick on 5/26/20 8:00 AM

With social distancing and travel restrictions easing worldwide, and WHO warning of a possible second peak of the pandemic, the work continues on potential vaccines to prevent COVID-19 and treatments for those already affected by the virus. The following is a small sampling of the COVID-19 updates compiled, reviewed and posted in real-time by our SmartTRAK analysts, who are constantly monitoring the situation and sifting through the noise to present the most relevant news to our subscribers:

Remdesivir Shortens Recovery Times in COVID-19 

Preliminary results of a double-blind, randomized, placebo-controlled trial of IV remdesivier in adults hospitalized w/ COVID-19 and lower respiratory tract infection showed remdesivir was superior to placebo in shortening recovery times (11 days vs 15 days; p=0.001). NEJM

Orthopedic Surgery During COVID-19

This JBJS article discusses medically necessary orthopaedic surgery during the COVID-19 pandemic and recommends safe surgical practices and a classification to guide tx. JBJS

US Plans Massive COVID-19 Testing Effort to Deliver Vaccine by YE20

The US plans a massive testing effort involving more than 100K volunteers and ~6 of the most promising vaccine candidates in an effort to deliver a safe and effective one by YE20, compressing what is typically 10 yrs of vaccine development/testing into a matter of months. Reuters

COVID-19: Vaccine Shows Promise in Early Trial

Moderna reports preliminary data suggests its COVID-19 vaccine is safe and appears to be eliciting an immune response in test subjects. The FDA has given the Company approval to begin a Phase II study w/ ~600 volunteers. A Phase III study may begin by July. NPR

Continue Reading
7 min read

COVID-19: Restrictions Ease as Vaccine Development Ramps Up

By Thomas Wallick on 5/18/20 3:29 PM

As restrictions begin to ease around the world, the Life Sciences industry prepares to deal with the impending ramifications. While progress is being made on vaccines and treatments as new surgery guidelines are developed, the potential long term consequences of the pandemic must be addressed. The following is a small sampling of the COVID-19 updates compiled, reviewed and posted in real-time by our SmartTRAK analysts, who are constantly monitoring the situation and sifting through the noise to present the most relevant news to our subscribers:

COVID-19: WFS Call on Reopening America

During a Wells Fargo call, Dr. Ashish Jah, Dir of Harvard Global Health Institute, projected the US economy will ramp up to 80% open by fall w/ an increase of elective procedures in the summer to 100% or higher. He doesn’t anticipate a fall return of COVID halting procedures.

Impact of COVID-19 on Spine Procedures

Based on conversations with healthcare and industry professionals, SmartTRAK expects deferred spine procedures to reschedule more quickly than many other procedures due to the non-elective nature of spine cases – particularly those w/ neurological deficit or progressive pain.

Pfizer's COVID-19 Vaccine in Human Trials

Pfizer working alongside German drugmaker BioNTech injected its potential COVID-19 vaccine in first human participants last week and hopes to test up to 360 people in its clinical trial. If the vaccine is found safe and efficacious it could be available starting in Oct. CNBC.com

Continue Reading
6 min read

COVID-19 Updates: MedTech Fights Back

By Thomas Wallick on 5/11/20 8:57 PM

While some countries are slowly emerging from their lockdowns, the MedTech industry continues to face unprecedented challenges as it adapts to the changing landscape. SmartTRAK's analysts are constantly monitoring the effect COVID-19 is having on the Life Sciences industry, sifting through the noise to present the most relevant news to its subscribers. Our analysts continue to publish real-time updates throughout the day, detailing what you need to know about the impact the international healthcare crisis is having on the industry at large.

Following is a selection of the COVID-19 updates from the past week as compiled by the analysts at SmartTRAK:

COVID-19: Advamed Issues New Code of Ethics Guidance

Advamed announced the availability of its new “Code of Ethics Compliance Guidance Related to the COVID-19 Response” to help its members and other MedTech companies develop and implement processes supporting rapid decision making and mitigate any related compliance risks.

MedTech Europe 

MedTech Europe, the European trade association representing the medical technology industries, issued a statement around COVID-19 calling attention to the supply situation of medical devices. They also highlighted that some contracts need to be revised and analyzed.

COVID-19: FDA Removes Respirators Manufactured in China

In a letter to healthcare providers, the FDA announced it removed a number of EAU disposable filtering facepiece respirators manufactured in China. The products pulled failed to demonstrate a minimum particulate filtration efficiency of 95% in testing conducted at NIOSH. fda.gov

Continue Reading
6 min read

COVID-19: The MedDevice Industry Navigates Uncharted Waters

By Thomas Wallick on 5/4/20 6:12 PM

The world-wide medical community continues to search for ways to stem the spread of the COVID-19 virus and deal with its impact. Progress is being made on vaccines and treatments as new surgery guidelines are developed. The following is a small sampling of the COVID-19 updates compiled, reviewed and posted in real-time by our SmartTRAK analysts, who are constantly monitoring the situation and sifting through the noise to present the most relevant news to our subscribers:

AAHKS Survey Shows COVID-19's Effect on MedDevice Industry
Results from a survey of AAHKS Industry Partners indicates an increasing shift to web-based prof ed through 2021, and for H220, a significant emphasis on outpt care, COVID-19 safety measures, and the need for increased availability of instruments and implants. J of Arthroplasty

More Signs COVID-19 Vaccines Coming

There are add’l signs a COVID-19 vaccine could be available in late 2020/early 2021. JNJ and Catalent are preparing for 24/7 manufacturing of JNJ’s investigational vaccine candidate. Also, Pfizer believes it may have a vaccine for emergency use by late Q3/early Q4. Seeking Alpha

FDA Allows Emergency Use of Potential COVID-19 Treatment

The FDA issued emergency use authorization for Remdesivir, an investigation ant-viral drug, for the treatment of suspected or lab-confirmed COVID-19 in adults and children hospitalized for severe conditions. FDA.gov

Continue Reading
5 min read

COVID-19 Updates: The State of MedTech as Reopening Begins

By Thomas Wallick on 4/27/20 3:35 PM

The Covid-19 crisis continues to impact the world-wide medical community. As some parts of the world take steps toward reopening, a more complete picture is forming of the effects on the global Life Sciences industry. SmartTRAK's analysts are constantly monitoring data and sifting through the noise to present the most relevant news to its subscribers in real-time updates throughout the day.

Following is a small sampling of the hundreds of COVID-19 updates from the past week that were compiled, reviewed and posted by our analysts on SmartTRAK:

Mesoblast MSC Product Initially Proves Successful in COVID-19 Related ARDS 

Mesoblast announced 83% survival in ventilator-dependent COVID-19 pts w/ moderate/severe acute respiratory distress syndrome (ARDS) treated w/ two IV infusions of remestemcel-L (allogenic MSCs) w/in the first five days.

Impact of COVID-19 on CAS in the US
SmartTRAK took a preliminary look at the impact of the COVID-19 pandemic on procedure volumes & capital equipment placement of orthopedic and spine enabling technologies, with projected recovery into 2021. Impact of COVID-19 on US Orthopedic and Spine Computer-Assisted Surgery

Impact of COVID-19 on Advanced Wound Care
SmartTRAK assessed the impact of COVID-19 on the NPWT Market. Single-use volumes are expected to drop during the first three quarters of 2020 due primarily to the drop in elective surgical procedures but will rebound in Q420. Impact of COVID-19 on US Advanced Wound Care

Continue Reading
5 min read

COVID-19: The Life Sciences Industry Rises to the Challenge

By Thomas Wallick on 4/20/20 3:29 PM

As the Covid-19 epidemic continues, the medical community world-wide struggles to cope with its impact. SmartTRAK's analysts are constantly monitoring the effect COVID-19 is having on the Life Sciences industry, sifting through the noise to present the most relevant news to its subscribers. Our analysts continue to publish real-time updates throughout the day, detailing what you need to know about the impact the international healthcare crisis is having on the industry at large.

Following is a selection of the COVID-19 updates from the past week as compiled by the analysts at SmartTRAK:

New CMS Guidelines for Providing Non-COVID-19 Care
CMS issued guidance on providing a gradual process for restarting non-COVID-19 care in areas w/ low incidence of the disease including coordination w/ local and state public health officials and readiness assessment in terms of staff, supply and testing capabilities. CMS.gov

AHA & Others Develop Joint Guidelines for Resuming Elective Procedures
AHA, ACS, ASA and AORN have developed joint guidelines to help providers determine their readiness to resume elective procedures including a sustained reduction in COVID-19 cases in their geographic area for at least 14 days and having the appropriate resources. AHA.org

Switzerland Easing Restrictions While Others Extend Theirs
Switzerland announced a 3-step plan for easing restrictions due to COVID-19 including allowing hospitals to perform elective procedures. The UK, however, extended its lockdown for 3 more weeks similar to extensions in Italy, Spain, and France. CIDRAP

Continue Reading
9 min read

Swim with the Sharks: A Deep Dive in the Biologic Association Think Tank

By Freddy Buntoum on 4/17/20 2:23 PM

The Biologic Association kicked off its very 1st Summit (Feb 5-7, 2020 in Carlsbad, CA) with what turned out to be a big crowd-pleaser. Initially set up as a “by invitation only” attendance, the Summit’s opening program, “Biologic Association Think Tank” raised such a high level of interest that everyone in attendance was ultimately let into the session.

The format for the Think Tank was quite similar to the hugely popular television show “Shark Tank.” Only in this session, the “school of fish” (contestants/presenters) included a lineup of industry and/or academic researchers in the field of Orthobiologics who gave presentations on their respective lead product candidates.

Continue Reading
6 min read

COVID-19: MedTech Navigates the Pandemic

By Thomas Wallick on 4/13/20 1:31 PM

As Covid-19 tightens its grip on the global community, the impact on the world economy grows. SmartTRAK's analysts are constantly monitoring the effect COVID-19 is having on the Life Sciences industry, sifting through the noise to present the most relevant news to its subscribers. Our analysts continue to publish real-time updates throughout the day, detailing what you need to know about the impact the international healthcare crisis is having on the industry at large.

Following is a selection of the COVID-19 updates from the past week as compiled by the analysts at SmartTRAK:

COVID-19 Could Travel in Air Up to 13 Feet
New research published by the CDC showed COVID-19 was detected in air up to 4 m (~13 feet) from pts in a study that tested surface and air samples from a hospital w/ COVID-19 pts in Wuhan, China. The virus was detected on floors, computer mice, doorknobs, bed rails & trash cans.

COVID-19: Roadmap for Reopening the US

A report by former FDA commissioner Scott Gottlieb, MD and colleagues at the American Enterprise Institute provides a roadmap for navigating through the COVID-19 pandemic in the US and outlines steps needed to start reopening America for businesses and families. AEI

DSM Launches Site to Support COVID-19 Efforts
With COVID-19 disrupting supply chains and causing shortages, DSM has launched a web page that brings together designs and resources for people looking to help alleviate the supply issues using 3D printing technology.

Continue Reading
  • There are no suggestions because the search field is empty.

Follow Us on Social Media

Recent Articles