COVID-19 has affected every area of life. The medical device development industry is no exception. Some changes have been delays to clinical trials and disrupted regulatory processes. Due to the need for certain devices, others have taken less priority . In the European Union, the Medical Device Regulation application date has been postponed for one year. This proposal was approved April 3, 2020. 

While some devices have been postponed, other devices that have been deemed vital for the treatment of COVID-19 have had expedited pre-market review in order to speed up production for use to treat COVID-19.

Industries that are unrelated to the healthcare field, such as Tesla and Ford, have been called upon to aid with the manufacture of medical devices that would bridge the gap in the shortage of materials required to treat COVID-19, such as ventilators. 

I have very mixed emotions about the COVID-19 crisis, because it has begun to adversely affect people that I know personally. However, from a research and biotech standpoint, I hope that we don't miss out on a historic opportunity.  Crises force us into translational and implementation science thinking, minus the usually minutiae of scientific and statistical rigor that sometimes becomes a burden.  I mean, ultimately, isn't medical science about saving and preserving the quality of life?

During this crisis, NASA's Jet Propulsion Lab taking a lead on developing ventilators, as well as car manufacturers, Ford, GM and Telsa, has made a great impression on me.  First, it show that engineering is engineering and science and science; all the specialization that's conjured up in the business industry is in many ways arbitrary.  If we can reconfigure automobile plants or rocket simulation laboratories to design high level ventilators, why don't businesses do this more often to respond to national and global needs?  Why isn't our government more proactive in incentivizing these kinds of changes?

Actually, before COVID-19, I DID take medical devices for granted, hardly giving them any thought.  Today, I can articulate the difference between a face mask and a ventilator.  One year ago, if you asked me what PPE stood I might have said, "Is it a new to measure on-base percentage?"  On the grant front, from both NIH and NSF, I have seen more investment into SBIR and STTR efforts to commercialize device and technology development to address COVID-19.  Collaboration with private industry is being strongly encouraged for many of the RFAs asking for creative responses to quelling the virus.

What other changes are we seeing in the medical devices industry due to covid19?

Due to covid19, many companies in the medical devices industry have had to shift supply chains from international to domestic. There have been difficulties on importing international medical devices due to health concerns as well as political friction. On a global scale, many countries are increasing domestic production of medical devices, as the previous posts have mentioned, with companies in the automobile industry such as Ford and Tesla also helping. But in addition to other industries realizing the importance of producing medical devices during covid19, the medical device industry in the U.S. has had to face the reality of such a large dependence on international imports.

Another interesting shift in medical device manufacturing is the increase in automation and robotics, as fewer employees are allowed to be in the same room together. There is a greater emphasis on robotics/automation within the medical devices industry, as robots are not susceptible to covid19. In some countries, the sanitation of public spaces is performed by robots and healthcare workers are assisted with robotic technologies as workdays become longer and there are shortages of staff. Here is some more information on how robotics/automation has helped the medical device industry and helped us battle covid19: https://www.a3automate.org/a3-special-report-how-robots-and-automation-are-fighting-covid-19/

I think one of the biggest impacts is the limited supply of components to manufacturing especially from Asia. The crisis has impacted organizations to underproduce with plant shutdowns. Supply chains will need to deal with more inventory and multiple suppliers to minimize disruptions. Carrying costs will increase as a result.

The lesson learned in my opinion is that companies have tried lean out the supply chain so much, that critical medical devices, pharmaceuticals and healthcare products could jeopardize human lives.

COVID19 has in some ways helped and continue to help use in our methods and technology. As mentions in previous posts, companies and people who originally had nothing to do with the medical industry have now gotten involved in the medical device industry - I think this is a good thing.

Because we now have engineers from other industries putting their knowledge, experience, and expertise in developing and manufacturing, for instance, ventilators, we're seeing new methods and materials that we had never thought of before. For example, one of the car manufacturers found that the motors used in car seat ventilation could actually be used in ventilators. In another example, we have 3D printed parts and tools now. The vast engineering and materials science knowledge that is now coming into the medical device industry due to COVID19 related issues is actually helping further develop the ever growing medical device industry.

Because the coronavirus that causes COVID-19 is spread primarily through droplets in the air, PPE is critical to protect medical staff and other patients from contracting the respiratory disease. And as medical facilities all over the world required more PPE, equipment vendors were pushed well beyond their normal capacity.

That forced hospitals to look at the sources for their equipment supply. Many took for granted that products manufactured overseas would always be available, and hospital supply chain leaders  have since turned a more critical eye toward the entire value-chain.

Now and in the future, prioritizing local sourcing—both distributing and manufacturing—is important to simplify shipping routes and ensure that this vital equipment will be available in a crisis.

One of the biggest impacts of Covid-19 on the medical device industry was on stopping essential clinical studies that halted the development of many devices for different companies. This was reflected through decreased stock value for some organizations. However, there were other organizations that were able to increase device development in response to Covid-19, which highlights the importance of an organization's adaptability to current events around the environment. Medtronic is an organization that set a great example when they released their design documentation for the ventilators being produced by them so that other companies could help in production of ventilators to meet the high demand during the early onset of Coronavirus in the United States. Overall, my main takeaway of this situation is that organizations learned how to adapt to the situation and were able to make a positive contribution to society while maintaining and taking on new business goals. 

Posted by: @orleron

We are meeting in an interesting time, to say the least.  As a disease, covid19 has many elements to its treatment and many of those elements use medical devices.  There are ventilators and syringes, which we all think about constantly, but also remember that cotton swabs and oxygen masks are also classified as medical devices.  Things that we take for granted may be part of this well-regulated industry.

Do some searching around and report back here with thoughts on how covid19 is changing the way medical devices are made, used, and/or developed.

 

 

COVID has changed how almost every company out there operates. motor vehicle manufactures had to step in and make ventilators for those sick patients that their lives depended on them. While companies that create medical devices might have had a downfall with producing medical devices that are not essential to help patients affected by the virus, pharmaceutical companies and their manufactures have been operating non-stop. that's a different type of medical devices, utilizing machines and testing the vaccines to help cure the world and stop the spread of the virus. Thats a different kind of medical devices that are higher in demand nowadays 

Posted by: @orleron

We are meeting in an interesting time, to say the least.  As a disease, covid19 has many elements to its treatment and many of those elements use medical devices.  There are ventilators and syringes, which we all think about constantly, but also remember that cotton swabs and oxygen masks are also classified as medical devices.  Things that we take for granted may be part of this well-regulated industry.

Do some searching around and report back here with thoughts on how covid19 is changing the way medical devices are made, used, and/or developed.

 

 

There is no doubt that COVID 19 has changed the trajectory of the medical device industry for the foreseeable future. However, during the pandemic there was obviously a spike in the use and therefore the demand for common medical devices also known as personal protective equipment(PPE). Also, there has been increase in the development of COVID 19 diagnostic tools for at home and laboratory use. For instance, at the Ohio State University Wexner Medical Center    the researchers were instrumental in producing the viral transport media (VTM) liquid needed in COVID 19 test kits. In my opinion this is a trend that will continue as long as COVID 19 is still prevalent in our culture. 

https://wexnermedical.osu.edu/blog/what-covid-19-has-changed-for-hospital-supply-chains

Working in a hospital I see how covid has changed the way in which cotton swabs and oxygen masks are utilized; just medical devices, in general, are used in the hospital. At the hospital in which I work the primary concern is the sterilization of all medical devices and the turnaround time to prepare so that they can be utilized by another patient. In the case of cotton swabs. They are not reused however, with covid, more attention to detail is being utilized with the disbursement of them throughout clinics. Where you may have been able to obtain swabs that were covered but not necessarily in sterilized packaging that is now of the uttermost importance. Especially because covid can live on surfaces outside of the body, no matter how short-lived it is. When we exam the likelihood of nosocomial infection and the increased rate currently being experienced due to covid, this explains the extra precautions that are being taken in the cases of medical device usage and covid. Us being a well-regulated industry is what allows us to continue to have someone of a clamp on and minimize the spread of nosocomial infection during this particular time in our nation and yet still be able to produce medical devices of solid quality during covid. 

COVID-19 has impacted nearly every aspect of life.  It was a global problem that presented problems for most industries.  The medical device industry was impacted greatly.  The pandemic especially highlighted the failures of the medical device supply chain to operate effectively during a crisis. It was under these circumstances that the idea of a crisis-responsive design framework has developed.  Certain medical devices became absolutely vital in the fight against COVID.  As a result of a massive increase in demand for N95 masks, syringes, ventilators, etc., the failures of the supply chain were amplified.  Large scale production of those devices is done by a small number of organizations that rely heavily on a global supply chain.  That supply chain was essentially got off during the height of the pandemic.  Small and middle size manufacturing operations would begin at the request of the federal government granting emergency manufacturing protocols for organizations not accustomed to manufacturing medical devices; examples include Tesla and Ford.  The need far outweighed the risk of failures in the manufacturing processes.  There is risk in not providing devices to the quality of the medical industry.  Crisis-responsive design framework allows for the temporary streamlining of the process of medical device manufacturing in 3 specific areas.  Those three areas are: 

1. Problem definition and needs assessment

2. Solution definition, verification, and validation

3. Regulatory approval and implementation

The pandemic taught us that we were ill prepared to handle maintaining critically necessary supply chains.  The need for medical devices essentially pushed accountability to the side.  Accountability is very present in the traditional framework of medical device development.  Crisis-driven design framework allows for collaboration of industry, medicine, and regulatory agencies at every step.  That drastically reduces the time to production for small and mid sized manufacturing.  It will allow us to have a framework in place to combat any future global emergencies.  

AUTHOR=Antonini Marc-Joseph, Plana Deborah, Srinivasan Shriya, Atta Lyla, Achanta Aditya, Yang Helen, Cramer Avilash K., Freake Jacob, Sinha Michael S., Yu Sherry H., LeBoeuf Nicole R., Linville-Engler Ben, Sorger Peter K.

TITLE=A Crisis-Responsive Framework for Medical Device Development Applied to the COVID-19 Pandemic

JOURNAL=Frontiers in Digital Health

VOLUME=3

YEAR=2021

PAGES=25

URL= https://www.frontiersin.org/article/10.3389/fdgth.2021.617106

DOI=10.3389/fdgth.2021.617106

ISSN=2673-253X

@ssbufford Thank you for highlighting the impact the new normal is having inside our hospitals.  As a classroom teacher I feel the impact of the pandemic on my job every day.  Desk shields, masks, disinfectant wipes are part of my day now.  The extra steps necessary in a hospital far outweigh the demands in my classroom.  Stopping the spread of disease is even more important today.  I wonder how we can continue to learn from this new normal to make these processes more efficient and safe.  I also wonder how soon after herd immunity is reached will we be able to leave some of these habits behind.  How many of these habits are here to stay?

Covid-19 has impacted the healthcare industry in a huge way! Whether its vaccines, medical devices, or drugs this virus has made researchers, nurses, doctors, technicians, and companies develop new resources to help diagnose/treat these disease. The medical equipment being developed has been created at faster pace. More ventilators inside the hospitals are being used, and masks are being developed at a faster rate. Oxygen masks are developed to help those have respiratory issues which is an cause of the virus. The FDA, and other companies are having to verify these devices at a faster rate as well making sure that these devices are safe to use to improve the quality of life. I believe that the vaccination has had a negative impact on individuals but a positive impact on the healthcare industry, because more devices are being developed and sold, causing them to receive more funds. However, when resources are short due to the high request for these medical devices, this could cause a problem. In contrast when the resources are available for the medical devices, these devices could be sold at a higher rate because they are in such high demand due to the Covid-19 virus.