Sunday, November 27, 2022

The Pandemic Fallout: Covid-19's Impact on Medtech

Pandemic Fallout

In December 2019, Covid-19 took the world by storm as it rampaged across the earth. Originating from Wuhan, China, the virus damaged life as we knew it. It hindered the economy across all sectors, notably the medical field, from supply shortages to patient care quality declining. The pandemic fallout centered mainly around the medical sector as we witnessed the medtech industry scrambling to get their wits about them to solve every issue. One could argue that specific measures could have been put in place in case of a pandemic long before Covid-19.

Pandemic Fallout: How Medical Facilities Came Up Short

The Covid-19 virus sent the world into a tailspin. It crippled the medical field as the workers rushed to patch the holes that had become glaringly apparent. Issues arose at the medical supplies chain, patient care, and governmental guidelines levels.

Medical Supplies Chain

The pandemic fallout mainly concerned the medical supply chain. This extensive network of systems, components, and processes ensures the manufacturing and distribution of medicines and other healthcare supplies. In addition, it provides patients with their medical necessities. The world witnessed an unprecedented demand for medical supplies all over the world, from personal protective equipment (P.P.E.) to vaccines.

A 2020 Supplyframe study outlined the obstacles that the industry faced. One year under the stress of Covid-19 was enough to impact businesses in healthcare and manufacturing profoundly. According to the survey, three aspects threaten the supply chain:

1. Supply shortages:

Fifteen percent of the participants viewed the supply shortage as the most considerable medtech supply chain risk. The World Health Organization (WHO) grouped the critical items suffering shortage into three these categories:

  • Personal Protective Equipment (i.e., examination gloves, surgical gloves, face shield, etc.)
  • Diagnostic equipment (i.e., lab screening test kit, lab confirmation test kit, etc.)
  • Clinical care equipment (i.e., pulse oximeter, nasal oxygen cannula with prongs, etc.)

2. Lack of alternatives:

Twelve percent of the participants thought a lack of alternatives was the most significant contributor. At the time, a medical product that did the job did not have a standby alternative. The most common example is the N95 mask. It was the most effective at respiratory protection against the virus. Unfortunately, the quantity was insufficient to meet the demand, and there was no alternative.

3. Delays in Production issues:

Twelve percent believed production delays would be the most significant hurdle to cross. Even though automation has taken over most factories, production has been delayed. The workers had to quarantine and abide by the Centers for Disease Control and Prevention (C.D.C.) guidelines.

Patient Care Quality

The pandemic fallout greatly impacted patients. The guidelines to mitigate the pandemic’s effects hurt the quality of care. The C.D.C. required individuals to forgo any unnecessary physical meetings and consultations. Hospitals and clinics had difficulty keeping their patients safe while running their operations smoothly. As a result, some locations had to shut down, reducing people’s accessibility to medical care. Furthermore, hospitals saw an unprecedented influx of patients, which is understandable given the circumstances. It resulted in limited places for those who needed other types of medical care.

Governmental Guidelines and Requirements

Customary clinical trials for drugs, including vaccines, revolves are four main phases.

  • Phase I: The purpose is to gauge the safety and dosage best for human application. It includes 20 to 100 volunteers, preferably with the disease/condition. The duration of this phase is of several months. Almost 30 percent of the drugs fail this phase.
  • Phase II:The goal is to test the efficacy and note any side effects over several months. It involves up to several hundred individuals with the disease/condition. The rate of failure for this phase is approximately 67 percent.
  • Phase III:This phase can last anywhere from 1 to 4 years. They observe the drug’s efficacy and monitor any adverse reactions in 300 to 3,000 volunteers carrying the disease/condition. The rate of success here ranges between 25 and 30 percent.
  • Phase IV: they coordinate a final test for the drug’s safety and efficacy on several thousand volunteers with the disease/conditions for effectiveness and safety.

On average, vaccines take anywhere between ten to 15 years to develop. The Covid-19 vaccine, however, took almost a year to develop. Note that no corners were cut in terms of rigorous testing and assessment. The rushed production highlighted the finance and manufacturing issues that circumvent vaccine production.

Pandemic Fallout: How the Broken Pieces Were Mended

Individuals in positions of power took action to try and fix what, thanks to the pandemic fallout, turned out to be broken.

Medical Supply Chain

Medtech stakeholders looked beyond their usual means for ways to supplement efficiencies. Some methods they resorted to were collaborations with companies from outside sectors and open-source equipment design.

The W.H.O. offered repurposing as a temporary solution. The organization called on manufacturers to temporarily repurpose their facilities to meet the shortages.  

  • Personal Protective Equipment (i.e., textile factories, electronics assembly plants, prototyping shops including 3D printing, etc.)
  • Diagnostic equipment (i.e., pharmaceutical preparations, pilot biotech plants, etc.)
  • Clinical care equipment (i.e., automotive production lines, manufacturing technology, innovation centers, etc.)

Patient Care

As far as patient care went, medical professionals had to resort to telemedicine to continue their business as normally as possible. Consultations that didn’t necessarily need to be in person were conducted virtually. Furthermore, we collectively experienced significant trauma. Thus, most of us, who were financially capable, sought mental health treatment in the pandemic fallout. The U.S. Food and Drug Association (F.D.A.) issued guidelines regarding digital devices for mental health. The association decided not to enforce specific regulatory requirements (i.e., Unique Device Identification standards, listing/registration requirements, etc.) and be lenient about which products do not necessitate F.D.A. oversight. So, if the product is low risk, the F.D.A. is willing to limit excessive contact between patients and providers. It also expanded digital health therapeutic device availability and psychiatric conditions.

Conditions covered by computerized behavioral therapy:

  • Obsessive Compulsive Disorder
  • Generalized Anxiety Disorder
  • Insomnia Disorder
  • Major Depressive Disorder
  • Substance Use Disorder (SUD)
  • Post-traumatic Stress Disorder
  • Autism Spectrum Disorder
  • Attention Deficit Hyperactivity Disorder

Low-Risk General Wellness and Digital Health Products that do not require F.D.A. oversight:

  • General wellness functions to track, promote, or encourage choices contributing to a healthy lifestyle.
  • General wellness functions to help users embrace or accept complicated feelings
  • Software functions that display messages to support individuals who may suffer from anxiety while recovering from a substance use disorder
  • Software functions that use questionnaires or checklists to help in the diagnosis and management of psychiatric conditions and, when appropriate, encourage users to consult healthcare providers

Furthermore, we witnessed the birth of telemedicine. Healthcare providers in the pandemic fallout resorted to virtual medical meetings and consultations. This method is cheap, convenient, and quick to connect patients and providers without the risk of transferring the contagion.

New Start-ups

Between the supply chain issues and the vaccine production, there was a big gap that small medtech start-ups rushed to filled, notably diagnostic testing opportunities.

Colorimetrix

This start-up worked on experiments that involved a drop of blood from a finger prick, reminiscent of traditional blood sugar testing. This minute amount of blood is combined with a solution in a test tube. Afterward, a mobile app scans it. Subsequently, an algorithm runs the scan and alerts the test subject of the anti-bodies presence.

Digid

This start-up concerned itself with a less invasive test. This one included saliva test kits. The kit is washed in a test liquid and put on a Biosensor chip. A small reader process the chip and immediately transmits the data to the server.

ixLayer

this company is working on a cloud technology infrastructure. It concerns itself with test scalability. The aim is to create a simplified approach to managing testing, monitoring, and patient followup

Advitos

Since there weren’t enough vaccines, Advitos stepped in to help COVID-19 patients with multi-organ malfunction. This medtech firm specializes in multi-organ support of the kidneys, lungs, and liver. The system works to balance the acid-base in the body and extracts waste from the body.

Pandemic Fallout: As We Advance

The pandemic fallout has slowed down. But that does not mean that we can sit back and relax. This tragedy has devastated the population and exposed some vulnerabilities in the medtech industry. The work wouldn’t end until a plan is implemented if such devastation were to happen again.

According to the Supplyframe study mentioned above:

  • 16 percent of the participants recommended a supply chain redesign to source locally
  • 14 percent suggested improving the qualifications of suppliers and the review process
  • 13 percent advocated enhancing the visibility of supplier inventory, capacity, and lead times
  • 12 percent endorsed restructuring supply chains with second sources

For now, and until the end of the COVID-19 public health emergency, medtech companies are somewhat protected. But nothing ever lasts, especially F.D.A.’s temporary amendments to its guidelines. Some companies may have lapsed in product safety practices in the whirlwind of meeting the demand. So, the concerned entities must act fast to remedy this. Furthermore, the F.D.A. clarified what is expected of the concerned parties when transitioning to “normal” procedures.

Concerning patient care in the pandemic fallout, things will return to normal eventually. Now, however, we’ve seen the potential of telemedicine. This aspect could be a game-changer regarding the healthcare of disabled people. It is a step further into giving further options to become as independent as reasonably possible.

Final Thoughts

The pandemic left us all in shambles. It crippled the economy and almost brought the medical sector to its knees. In the beginning, the medical supply chain suffered the most as the demand far exceeded the supply. Providers and suppliers rushed to equip the workers with adequate equipment to get them and their patients through these challenging times. Recognizing the severity of the situation, government agencies such as the F.D.A. have temporarily relaxed their requirement for the greater good. Furthermore, we witnessed the increase in the popularity of telemedicine as hospitals and clinics had to abide by C.D.C. guidelines but refused to leave their patients hanging. Finally, medtech start-ups started coming out of the woodwork to fill in the gap that became glaringly obvious in the pandemic fallout with innovative and promising products.

The pandemic changed life as we knew it, and the medical sector was as quick as it could be to accommodate the never-experienced-before influx of patients. However, their lack of preparedness is understandable, but it is unacceptable in no way, shape, or form. These organizations and companies have the authority to establish protocols in case of disasters preemptively. And yet, they were scarily unprepared to handle a pandemic despite the historical evidence of how previous ones impacted the world (i.e., the black plague).


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