<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

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
5 min read

COVID-19: MedTech Confronts the Pandemic

By Thomas Wallick on 4/6/20 3:50 PM

Covid-19 continues to spread across the globe, and, like the rest of the world, the MedtTech industry is strategizing the best ways to deal with the pandemic. SmartTRAK's analysts continue to monitor the effect COVID-19 is having on the Life Sciences industry, sifting through the noise to present the most relevant news to its subscribers and report on the impact the global 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:

OTA COVID-19 Webinar

  • OTA Special Webinar COVID-19: Preparedness in Orthopaedic Trauma OTA Panel Discussion was held 4/2/10. Panel included 9 OTA Trauma surgeons. For a recording of the Webinar, go to: COVID-19: Preparedness in Orthopaedic Trauma OTA Panel Discussion.
  • As a result of COVID-19 and stay at home orders, trauma surgeons are seeing a definite decrease in volumes, with polytrauma being almost negligible in certain cities. Geriatric fractures have decreased but to a lesser extent according to the OTA COVID-19 Webinar discussion.
  • According to the OTA webinar panel discussions, trauma surgeons are taking resource allocation into consideration when assessing fracture care of the clavicle, humeral shaft or fibula and deciding whether to treat conservatively vs. operate in areas with COVID-19 surges.

COVID-19 Risks to Clinical Trials
The impact of COVID-19 has been immense. This article reviews eight significant risks COVID-19 poses to clinical trials and how to mitigate them.

COVID-19: Projections of Peak and Procedure Returns
The Institute for Health Metrics and Evaluation is now projecting lower overall hospital resource needs in the US and predicts the peak will be April 15. Based on this, WFS estimates elective procedures will be depressed through June.

Continue Reading
4 min read

COVID-19: Increasing Impact on the Life Sciences Industry

By Thomas Wallick on 3/30/20 1:11 PM

As the COVID-19 pandemic progresses, the MedTech industry is continuing to see a multitude of changes and disruptions worldwide. SmartTRAK's analysts continue to monitor the effect COVID-19 is having on the Life Sciences industry, sifting through the noise to present the most relevant news to its subscribers and report on the impact the global 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 SmartTRAK:

Surgeon Survey: COVID-19 Impact

  • A survey of 50 orthopedic surgeons reported ~40% are still seeing both new and existing pts, while a third is only seeing pts for emergency or urgent issues. Telemedicine adoption has accelerated w/ 32% of survey takers noting some recent use. Canaccord Genuity Industry Report
  • According to a 50-surgeon survey, postponements of orthopedic procedures have led to a sharp decline in pt volumes, w/ respondents indicating a 58% avg decline in March and an anticipated 77% avg decline in April. Canaccord Genuity Industry Report
  • According to a 50-surgeon survey, 60% indicated that their organizations had already made formal decisions to defer or postpone orthopedic procedures, w/ ~33% indicating that over 90% of their entire practice was deferrable. Canaccord Genuity Industry Report

COVID-19: NV Procedure Impact
  • SmartTRAK physician checks suggest elective procedure volumes for aneurysm cases will pick up in H219, assuming social isolation and other non- pharmaceutical interventions effectively reduce the spread of COVID-19 and healthcare demand.
  • SmartTRAK is hearing from neurointerventionalists that COVID-19 is affecting elective procedure volumes for aneurysm cases, but those patients are being rescheduled—not canceled. Mechanical thrombectomy procedures have not been impacted to date.
Continue Reading

    Recent Articles