The Abbott stent that saves lives and inspired a new app
In 2016, athletic 40-year-old Matthew Shields suffered an unexpected widowmaker heart attack while running before work. Victims of widowmaker heart attacks, also known as a STEMI (ST-segment elevation myocardial infarction), have very low survival rates - people who have cardiac arrests outside of hospitals have just a 6 per cent chance of survival, and in the case of widowmaker attacks it's even lower.
However Matthew survived, after undergoing a two-hour operation to be fitted with a stent. This profound experience inspired him to make it his mission to help improve the quality of care for people with cardiovascular disease, and as a result he's developed a cloud-based app that can track stents.
"I was incredibly lucky to survive the ambulance ride to emergency surgery, and I remained fully conscious seeing my dying heart on the screen in the emergency room" Matthew says. "All to watch a medical implant be inserted through my arm into my heart to save my life."
"Waking up the following morning in the ICU, I made a conscious decision that if I was able to get out of hospital and not die, if I would do one thing with the rest of my life, I would dedicate it to healthcare and making sure people do not go through what just happened to me."
Doctors told him that as his heart had gone without oxygen for a long time, he would need either a pacemaker or a heart transplant. He was fitted with a XIENCE stent, manufactured by American multinational Abbott, a pioneer in medical devices since 1888.
"The implant stays inside your body forever, and you need medication for the rest of your life. You're not able to do things you previously took for granted and your life is very different. Fortunately, I later found out, I could push my body to return to the normal outdoor activities I loved."
The months that followed were very slow paced; just walking to the letterbox was a challenge. "People often don't know that once heart muscle is damaged from a lack of oxygen it can't be repaired. This is why time is everything when people suffer a heart attack and every second counts."
"For me, learning I had a medical implant inside my body was an artifact of surviving a widowmaker heart attack. This precious medical device would be there to help me stay alive forever."
Matthew, who works for the Australian Commonwealth Scientific and Industrial Research Organisation (CSIRO), decided to visit the Abbott production facility in Temecula, California, to find out more about how the device works.
"The level of quality and care that was engineered into these medical devices was beyond my expectations. When I returned to wilderness trekking in the remote mountains of New Zealand, I felt confident the product was not going to fail."
Matthew then set about creating a tracking app for stents like his. Working for the CSIRO, he had experience of creating monitoring apps, and applied the same methodology to this project. "However, we needed a platform" he explains. "After visiting the development team at Salesforce in San Francisco I was confident that my vision could be realised. Later on in the development cycle I attended the Dreamforce event, meeting other app developers and company founders. Then I knew that what I’d created solved a hole in the market."
The MyLM app connects hospitals with manufacturers to keep track of their inventory. "Managing hospital supplies is a balancing act" Matthew says. "Some medical devices have expiration dates, but always need to be on hand for emergencies. Specialist items like medical implants need to be ordered in advance, and parts like stents are kept on hand. Others arrive just in time for an emergency when they’re needed in an urgent operation."
"Hospitals are constantly juggling their supply levels and arrival dates, and it’s so easy for something to slip and throw everything out possibly affecting costs or often patient outcomes. A mismanaged hospital supply chain also affects manufacturers, as they’re the organizations fulfilling orders for hospitals. Manufacturers need to be kept in the loop as well to deliver urgent and temperamental goods on time."
MyLM is hosted on the Salesforce app exchange, which Matthew says allows for a faster rollout and greater accessibility on more devices. Logging products in the app is completely contactless, using scanners to log the movement of medical supplies.
This aspect is particularly important with Covid-19 causing disruptions to supply chains. "Secure contactless tracking removes the need to quarantine goods and reduces the possibility of outbreaks in high risk areas such as hospitals" Matthew says.
"Improving medical supply chains is also a boost to manufacturers. Hospitals can establish an ongoing relationship with manufacturers of medical supplies, better monitoring their stock levels and ordering more as soon as supply drops."
Matthew says the current focus is on the Australian market, but there are plans to expand globally in 2022.
His ultimate goal is to have a worldwide impact on the outcomes of patients with coronary artery disease. "There were nearly 18 million people globally who died because of this last year" he says. "For MyLM to be adopted on this scale we challenge hospitals to adopt our technology and see the benefits. Global medical device manufacturers are looking for real time information on the status of their medical devices. This is now a reality with MyLM."
It's an ambition that is driving him personally too. "The events that unfolded after my heart attack shattered my life to pieces. Amazingly since pieces were put back together, I have now created a life which is greater than the sum of these broken parts."
The challenges to vaccine distribution affecting everyone
While it is comforting to know that vaccines against COVID-19 are showing remarkable efficacy, the world still faces intractable challenges with vaccine distribution. Specifically, the sheer number of vaccines required and the complexity of global supply chains are sure to present problems we have neither experienced nor even imagined.
Current projections estimate that we could need 12-15 billion doses of vaccine, but the largest vaccine manufacturers produce less than half this volume in a year. To understand the scale of the problem, imagine stacking one billion pennies – you would have a stack that is 950 miles high. Now, think of that times ten. This is a massive problem that one nation can’t solve alone.
Even if we have a vaccine – can we make enough? Based on current projections, Pfizer expects to produce up to 1.3 billion doses this year. Moderna is working to expand its capacity to one billion units this year. Serum Institute of India, the world’s largest vaccine producer, is likely to produce 60% of the 3 billion doses committed by AstraZeneca, Johnson & Johnson and Sanofi. This leaves us about 7 billion doses short.
Expanding vaccine production for most regions in the world is complicated and time-consuming. Unlike many traditional manufacturing operations that can expand relatively quickly and with limited regulation, pharmaceutical production must meet current good manufacturing practice (CGMP) guidelines. So, not only does it take time to transition from R&D to commercial manufacturing, but it could also take an additional six months to achieve CGMP certification.
The problem becomes even more complex when considering the co-products required. Glass vials and syringes are just two of the most essential co-products needed to produce a vaccine. Last year, before COVID-19, global demand for glass vials was 12 billion. Even if it is safe to dispense ten doses per vial, there is certain to be significant pressure on world supply of the materials needed to package and distribute a vaccine.
It is imperative drug manufacturers and their raw material suppliers have clear visibility of production plans and raw material availability if there is any hope of optimizing scarce resources and maximising production yield.
It is widely known by now that temperature is a critical factor for the COVID-19 vaccine. Even the regions with the most developed logistics infrastructures and resources needed to support a cold-chain network are sure to struggle with distribution.
For the United States alone, State and local health agencies have determined distribution costs will exceed $8.4 billion, including $3 billion for workforce recruitment and training; $1.2 billion for cold-chain, $1 billion vaccination sites and $0.5 billion IT upgrades.
The complexity of the problem increases further when considering countries such as India that do not have cold-chain logistics networks that meet vaccine requirements. Despite India’s network of 28,000 cold-chain units, none are capable of transporting vaccines below -25°Celsius. While India’s Serum Institute has licensed to manufacture AstraZeneca’s vaccine, which can reportedly be stored in standard refrigerated environments, even a regular vaccine cold chain poses major challenges.
Furthermore, security will undoubtedly become a significant concern that global authorities must address with a coordinated solution. According to the Pharmaceutical Security Institute, theft and counterfeiting of pharmaceutical products rose nearly 70% over the past five years. As with any valuable and scarce product, counterfeits will emerge. Suppliers and producers are actively working on innovative approaches to limit black-market interference. Corning, for example, is equipping vials with black-light verification to curb counterfeiting.
Clearly, this is a global problem that will require an unprecedented level of collaboration and coordination.
Disconnected information systems
While it is unreasonable to expect every country around the world will suddenly adopt a standard technology that would provide immediate, accurate and available information for everyone, it is not unreasonable to think that we can align on a standard taxonomy that can serve as a Rosetta Stone for collaboration.
A shared view of the situation (inventory, raw materials, delivery, defects) will provide every nation with the necessary information to make life-saving decisions, such as resource pooling, stock allocations and population coverage.
By allowing one central authority, such as the World Health Organization, to organize and align global leaders to a single collaboration standard, such as GS1, and a standard sharing protocol, such as DSCSA, then every supply chain participant will have the ability to predict, plan and execute in a way that maximises global health.
Political influence and social equality
As if we don’t have enough stress and churn in today’s geopolitical environment, we must now include the challenge of “vaccine nationalism.” While this might not appear to be a supply chain problem, per se, it is a critical challenge that will hinge on supply chain capabilities.
In response to the critical supply issues the world experienced with SARS-CoV-2, the World Health Organization, Gavi, the Vaccine Alliance and the Coalition for Epidemic Preparedness Innovations (CEPI) formed Covax: a coalition dedicated to equitable distribution of 2 billion doses of approved vaccines to its 172 member countries. Covax is currently facilitating a purchasing pool and has made commitments to buy massive quantities of approved vaccines when they become available.
However, several political powerhouse countries, such as the United States and Russia, are not participating. Instead, they are striking bilateral deals with drug manufacturers – essentially, competing with the rest of the world to secure a national supply. Allocating scarce resources is never easy, but when availability could mean the difference between life and death, it becomes almost impossible.
Global production, distribution and social equality present dependent yet conflicting realities that will demand global supply chains provide complete transparency and an immutable chain of custody imperative to vaccine distribution.
The technology is available today – we just need to use it. We have the ability to track every batch, pallet, box, vile and dose along the supply chain. We have the ability to know with absolute certainty that the vaccine is approved, where and when it was manufactured, how it was handled and whether it was compromised at any point in the supply chain. Modern blockchain technologies should be applied so that every nation, institution, regulator, doctor and patient can have confidence in knowing that they are making an impact in eradicating COVID-19.