It seems my phone never stops these days. And the same happens to my colleagues. It is actually heart warming to see all the initiatives that are starting to support the COVID crisis, and to be part of some of these efforts. And of course the first support we can give in our line of work is some free advice, some things the innovators need to know, some technical details crisis teams are in need of.
Since early March we have been able to support the crisis management teams in three countries to have some better insight into product specifications, comparing foreign standards to their own, generating overviews of products approved in other jurisdictions such as China, and indicating reliable sources we’ve encountered earlier in the global supply chain. First efforts were on securing masks, medical versus PPE, or both. Where to find them, and what standard is sufficient for which purpose. In parallel the search for PCR kits, and more recently moving into finding reliable serological kits to conclude on persons effective immunity, as well as on new software techniques for detection and screening.
Humanitarian Exemption and emergency approval scenarios
We have experience with the Humanitarian Exemption routes in China, US, and EU, as well as in other countries around the world. We are happy to share this info and help you to find market access. Please contact my colleague Danielle Motta if you have specific questions regarding humanitarian exemption route and process.
Meanwhile, manufacturers started to jump in the vacuums; producing masks and ventilators, even if before the crisis they did not work in the Medtech environment. QA, QC and regulatory expectations being quite different from what they were used to in their normal line of business. Interesting to see that many want to move ahead to start producing, where some are looking ahead first, building plans, getting rapid certification in place. I’d say that is best practice, but reality concludes that even when notified bodies are willing to prioritise, PPE test capacity is limited, and cross border traffic to reach the test house in lockdown countries can be challenging. So, we move on, and with the best technical support from university and industry lab demonstrate performance of devices. Much will depend on whether authorities will use emergency approval scenarios, as formal routes to certification might be restricted. Not in the least because initial audits are not allowed to be performed remotely e.g. in the EU. It brings the challenge to national authorities, to crisis teams, to make decisions on who they trust, rather than on demonstrated safety and performance following well established rules and practices. In that sense, it appears to be easier to step into the world of ventilators than in protective masks; logical in a way, as the validation of the function of ventilators is a positive one, whilst validation of PPE masks is a negative to prove something is not happening. On the other hand, with new ventilators, the real challenge will come later once we might see results post treatment of the long-term effect specific ventilators might have on final recovery of patients. Material choices may ultimately display long term effects. But great to see successful initiatives, where new designs are explored, sometimes with the limitation to use materials and components that are produced in the same country, so supply will not be limited.
New technology for testing
New technology is being tested that has never been used in testing viruses and infection, new software techniques being applied to interpret lung scan to establish COVID-related damage to lung tissue. Some of the efforts focus on the restart of society and social life, others to support grave decisions on who might benefit most from IC treatment should there be any shortage of places to treat patients. What is the common denominator in all these projects we’re supporting, is the extreme levels of energy and motivation the developers are displaying? The sheer need of finding solutions brings the best out in people, as the Danish-French economist Ester Boserup argued, in her case on scarcity of food supplies, but it might equally be valid for sacristy in medical supplies: humanity will find solutions if you allow them the freedom to invent and apply the solutions. Necessity is the mother of inventions, and "the power of ingenuity would always outmatch that of demand". The positive drive, trying to help, do something, is great to connect with in times where many are numbed by daily flood of figures.
Society 2.0
Meanwhile, the world is rapidly evolving into society 2.0; or as some call it: the 1.5meter of 6-feet society. But truly getting into that new life, that prestigious groups of experts from e.g. the Imperial College and Harvard indicate will be around us for years to come, in a harmonica model of easing and tightening restrictions, depending on the capacity the healthcare system has. So clearly, we need Medtech to support our lives, not only when we would find ourselves as patients in the hospital, but also to get forward into ‘the new normal’.
Web-based learning
We’ve rapidly moved into virtual audits, internal audits, supplier audits, and even mock audits for companies preparing for EU-MDR, EU-IVDR or for example NMPA oversee inspections. And lessons learned are great input into the web-based learning. We’re becoming experts in recording ourselves for training purposes, in seeing ourselves in a corner of our screen during the many videocalls we have. A challenge perhaps to be hearing yourself, seeing yourself. But we all know that in this first phase, those that more rapidly adapt have a head start. But nice as that all might seem, and yes there are also benefits to being more at home I can confirm as frequent flyer (!), we will need to start preparing for the next phase. As some things just cannot be done remotely, such as the mentioned initial audits for EU-MDR and EU-IVDR, we have to be ready to schedule them on very short notice once travel restrictions are simultaneously lifted in the country where the auditor lives, and the country where the company is located. And at that time, we will have to be ready and prepared, as that might be the only window to get over the hurdle of the first audit. The good thing is that these days also our contacts at notified bodies work from home, and many are easier to reach than before the crisis when they were travelling and were engaged at manufacturing sites during audits and unannounced inspections. So, use that to discuss your plans for registrations and approvals, for design changes, and see what can be prepared remotely. And yes, a delay on Date of Application of the EU-MDR may be announced soon, but realise it is only that, allowing products currently on the market to stay available to support the healthcare system in time of crisis. Our deadlines will largely remain as they are: the end of the validity of our existing certificates.
One thing is clear. Our world is drastically changing, and not all givens will come back. But still, our customs and styles remain in place. In all the pro-bono work it is clear: the recipient of information will only be open to listen and engage if they have started the search for the information. Same as always, same as we see when raising kids or teaching a class. Only when there is a need to understand and a willingness to engage will there be room for connection. People need to find their own way and follow their own path. That’s why there is no single solution, and that’s why we’re continuing to build on-demand training to support people when they need the information.
Some of our most recent information sharing you will find in this listing:
And for all your unanswered questions, there is our FAQ Friday. Or pick up the phone or email and engage!
Connect. Communicate. Convey. Consult. Together we will conquer Corona….
I look forward to meeting you soon in one of the many virtual events on the horizon.
Stay safe!