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."
Medical device companies: how to prepare for Brexit
Over the last decade, medical device businesses have been no strangers to regulatory changes and new compliance requirements. Companies with devices in the EU market have been working hard to achieve conformity with the requirements of the EU Medical Device Regulation 2017/745 (MDR) and In Vitro Diagnostic Regulation 2017/746 (IVDR), but the UK’s exit from the EU, effective as of 1st January 2021, demands yet another change: to comply with the new UK regulatory regime.
The Medicines and Medical Devices Act passed into law on 11 February 2021 does just that; it enables the UK to build its own regulatory system, although when this new framework will be fully in place is not yet known.
The transition to the UK’s new regulatory regime officially began on the 1st of January 2021, and with it a series of deadlines and phases that medical device manufacturers exporting to GB and Northern Ireland would do well to take close notice of. During the transition period, the UK Medical Devices Regulations (UK MDR) 2002, not to be confused with the EU MDR, will continue to apply in England, Scotland and Wales, whilst CE marked medical devices will still be accepted up to 30th June 2023.
The conformity assessment processes defined in the UK MDR 2002 (as amended) will require that medical devices carry the UKCA mark for entry in the GB market or the UKNI mark for entry in Northern Ireland (where the devices are not CE marked for the EU). In Northern Ireland, where the rules for placing a device on the market differ, the EU MDR and IVDR will apply in 2021 and 2022 respectively, in line with the EU’s implementation timeline.
This easing-in period of transition is valuable time that should be used productively by manufacturers to ensure that they get up to speed, keep up with relevant updates and prepare strategies and product portfolio for the next phase. To do this, businesses should make sure they consider the following areas as they assess their strategy for UK market access:
Potential Overlap with EU MDR and IVDR
Medical device manufacturers have been working to implement measures to ensure they comply with EU MDR and IVDR for quite some time. The experience, processes and objective evidence that they have gathered in these efforts are certain to be of use when applying for UKCA marking.
Product portfolios and new product pipelines should be evaluated against both overall compliance risk and commercial and strategic value. By identifying the regulatory compliance status for each product for the UK market and the efforts required to maintain that compliance, manufacturers can plan to use the grace period up to June 2023 to complete their activities. These plans should also be evaluated in consideration of the commercial importance of the individual products to help prioritise the workload. This may well result in the decision to discontinue certain products in the UK or to introduce new products on the UK market ahead of other markets.
Engage with Approved Bodies
This activity cannot take place too soon; as of the 1st of January 2021, UK organisations that were acting as EU Notified Bodies have become Approved Bodies in the UK, while EU Notified Bodies are no longer able to provide conformity assessments under the UK regulations. As there are currently only three UK Approved Bodies offering this service, there is a very real risk that latecomers will struggle to find a UK Approved Body to carry out the conformity assessment required to attain their UKCA mark in time.
Just as EU Notified Bodies are no longer relevant to pursuing UK certifications, UK-based Authorised Representatives are no longer valid when CE marking against the MDR or IVDR. Manufacturers using UK-based EU Authorised Representatives must switch to an EU-based Authorised Representative.
For the UK market, the role of the EU Authorised Representative is also no longer applicable. Non-UK manufacturers must have a UK-based Responsible Person (UKRP), which is equivalent to the EU Authorised Representative in terms of roles and responsibilities. Only one UKRP may be appointed, unlike EU Authorised Representatives, and they must have a registered place of business in the UK in order to register with the MHRA. Approved Bodies may be able to provide details of organisations acting as UKRPs and once this role has been assigned it will be critical for manufacturers to determine exact procedures for managing documentation and that clear communication channels are established.
Labelling and Import/Export
New UK regulations require that medical devices bear a UKCA mark in addition to the name and address of the UKRP for non-UK based manufacturers. Manufacturers who use the same products/packs for the EU and UK markets will need to consider the impact of adding more content to their labels in terms of usability for the supply chain and end-users.
While CE marking and certificates will continue to be recognised by the UK until June 2023, import/export administration is likely to change and become more burdensome. Manufacturers using separate products for GB (UKCA) and the EU and Northern Ireland (CE marked) will need to plan for how to ensure that the CE marked product is not shipped to GB post June 2023. Ensuring that processes and resources are in place to deal with developing situations will help manufacturers hit the ground running.
Many businesses will find that clinical investigations are carried out across multiple sites, some of which are outside the UK. In these instances, manufacturers will do well to have a plan for implementation and management of investigations, in compliance with local requirements. It is likely that the MHRA will also continue to update their requirements for clinical trials in the UK.
Data Protection and Standards
New tensions are emerging between the EU and the UK concerning UK data protection rules and the EU’s General Data Protection Regulation (GDPR), suggesting that maintaining ‘equivalency’ may involve a number of different phases.
Compliance with applicable standards also requires close attention; the list of designated standards for medical devices issued by the UK’s Department for Health and Social Care is based on the list of harmonised standards published in the Official Journal of the EU, which in turn are harmonised to the MDD, AIMDD and IVDD. More recently published standards, however, have not been harmonised to the latter European directives and are thus not in the UK’s designated list, despite being considered state of the art. It would be prudent for manufacturers to monitor the state-of-the-art standards and apply where applicable, rather than rely on superseded and outdated standards.
As the UK moves into a new regulatory regime, medical device manufacturers who have already invested time and resources to comply with EU MDR and IVDR can use this to attain their UKCA mark. However, a dynamic compliance environment combined with the new onus relating to export policies means that close attention needs to be paid on numerous fronts. Keeping pace with this changing environment will ensure that manufacturers face the future with confidence and do not lose important space on their markets.