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This is the tragic story of how poor healthcare device leadership could cost hundreds of lives due to locally-made quality ventilators being stymied by a government bureaucracy currently only able to certify them once the Covid-19 crisis is over. A Pietermaritzburg-based company has notched up to medical-grade-component-quality, ventilators it once produced, streamlining the process and overcoming customs bottlenecks for German made and other foreign components. They’re ready to produce 1500 portable units by the end of May 2020 and 10,000 units by end of June, fitting in with lockdown relaxation predictions and the expected ICU patient-peak. (It might be worth mentioning that, according to my anecdotal reports, ICU’s in the Cape Metropole’s two main tertiary hospitals are already nearly full, with plans afoot to convert operating theatres used for now-discontinued elective surgeries, into ICU’s). The company owners, Ubuntu types, see no purpose in prioritising local production, (overseas demand is huge), unless there is some fast-tracking and gelling of red tape outfits – working hard in silos but with no leadership co-ordination. The SA government accepted 1,000 FDA-approved ventilators from the US government, and these guys seriously doubt they were put through the same compulsory local certification process. Double standards perhaps – dysfunction certainly. – Chris Bateman
By Graham Raynor*
Thank you for allowing us ordinary folk the opportunity of listening to your webinar this afternoon – it is really good to listen to people who certainly have the knowledge base and intelligence and oratory skill to put across ideas well. I was particularly interested in the gentleman’s comments from the IRR and in particular when he noted that one of the objectives of the lock down was to allow the state time to prepare themselves for the potentially disastrous consequence on the medical profession, and that in fact, very little had been done to further this objective. I agree with what he said as our ventilator project is a practical example of this. For me this is no longer a story about ventilators, whose media relevance is probably passed, but one about lack of leadership at the top end of government and certainly John Steenhuisen’s comments that governments seeming desire to simply become tin pot dictators and not leaders with a purpose has been my experience on the regulatory aspect of our project. I ask your forgiveness for the long email to follow but it really was difficult for me to get my thoughts and frustrations across without really going into detail:
- Clifford has developed a fully portable ICU Ventilator. We have built a prototype to test the medical efficacy of the unit and have also built a pre-production model to test our manufacturing process. The unit is ready to go to market and we are ready to produce in scale.
- As a result of the Covid-19 crisis, Clifford commenced development of a ventilator that they had discontinued around 2005. The development consisted mainly of upgrading the control system as many of the control elements had become obsolete. Mechanically the unit remained essentially the same.
- After commencing development, the Department of Trade and Industry formed a working group known as the National Ventilator Project (NVP), to establish a set of specifications and choose a promising project that met with those specifications, to proceed on to developing the chosen project and scaling its manufacture
- Although details were thin at the time, the NVP undertook that they would fast track the certification via the South African Health Products Regulatory Authority (SAHPRA) which is a legal requirement to sell medical devices in South Africa
- Our bid to NVP was not successful. We had anticipated this result given that the specification of our machine far exceeded the requirements of NVP but we continued with our development regardless.
- While soldiering on with the development we engaged with numerous people and groups to ascertain the process for the SAHPRA certification including requesting NVP to assist us even if we had not been successful.
- As a result of our consultations it became clear that the fast tracking process referred only to SAHPRA’s commitment to analyse every application in the shortest possible time and that the onerous requirements of certification would either not be relaxed at all, or might be relaxed with regard to a small amount of requirements.
- The subsequent understanding of the requirements together with the significant costs and the time that would need to meet those requirements meant that there was no case for continuing with SAHPRA certification as the certification offered by them under this fast tracked process would be limited to an authority for use during the COVID-19 crisis. Given the time, energy and cost of acquiring this authority, the motivation to proceed plummeted simply because by the time we could achieve the authority, the crisis may well have abated or indeed disappeared altogether.
- We are in the process of applying for a US FDA Emergency Use Authorisation. This process is far more streamlined and acknowledges the need to get devices approved in time to deal with the crisis. The US FDA authority will not give us legal ability to market our devices in South Africa.
- We understand that the South African government has accepted a generous donation from the US Government of 1,000 ventilators. While applauding this initiative, we also wonder whether the ventilators being offered have been through the same rigorous specification and licensing requirements that we have to face.
- In conclusion, while we very much accept the requirement for regulatory oversight, we have a grave concern that there has been an abject lack of true leadership from the very top echelons of government to understand the nature of the problem and place co-ordinated mechanisms in place to ensure that a solution to the ventilator shortage is not hampered by a myriad of regulatory bureaucracy and different groups marching to their own set of rules. It is for this reason that we, as concerned citizens and businessman, have decided to withdraw from government’s call to arms from its citizens to come up with innovative and timely solutions to the crises that we are facing in South Africa and focus our energies on bringing the device to market outside of South Africa under the US FDA Emergency Use Authority.
A more detailed explanation of the above follows:
1. On 2 April 2020 we were invited to register our interest with the National Ventilator Project to design, develop and manufacture a ventilator for the anticipated shortages of these machines as a result of Covid-19. The National Ventilator Project was empowered by the Department of Trade and Industry to prepare a specification and adjudicate proposals from South African companies against those specifications. At this stage we had already commenced with our ventilator project. The timelines for this presentation and adjudication process were as follows:
- Launch: Friday 3 April 2020 (22:00)
- Information session: Monday 6 April 2020 (10:00)
- Close : Monday 6 April 2020 (23:00)
- Evaluations: Tuesday 7 April 2020 (evaluation panel)
- Presentations: Wednesday 8 April 2020 (selected proposals)
2. Once the specifications and the adjudication process was announced we made our submission to the National Ventilator Project. The specifications were based solely around their defined requirements for the ventilator as well as our ability to actually manufacture the ventilator. At this stage very little information was shared with us regarding the complexities of certification of the device with SAHPRA (South African Health Products Regulatory Authority). However one of the requirements was the ability to scale the manufacture of the devices which was noted as follows:
- Start production as soon as possible (latest end of April 2020)
- Providing a minimum of 1500 units by the end of May 2020
- Providing a minimum of 10 000 units by end of June 2020
3. During a Zoom information session with NVP held prior to the final submission date for the proposals, a lot of detail was shared with potential bidders, and particularly that the NVP’s process would be to choose the best submissions and then to assist in any way possible to get the device to market. At this stage very little was actually shared regarding any potential certification processes.
4. After we submitted our proposal we did not hear anything. I communicated a few times with NVP and received very vague responses. However in particular on 14 April after we had heard nothing of value from NVP, and we had became more concerned about the SAHPRA certification requirements, I was prompted to write to the NVP project leader and ask whether the non-successful bidders could at least rely on the NVP’s assistance to fast track the SAHPRA process as they had advised that they would do for the successful bidders from the proposal process. I received a response saying that the fast tracking process would only be for successful bidders but that he would check at the next steering committee meeting whether there was an appetite to assist a limited number of other options. In this regard I heard nothing further.
5. On 14 April we received a communication from NVP that they were still finalising the evaluation process with a conclusion that basically amounted to “ don’t call us, we’ll call you”.
6. On 22 April 2020 we were advised that we had not been successful. To date we have not been able to determine who was successful either from NVP or national media. It is only through contacts that we have made as a result of our involvement in this project that we have been able to establish the successful bidders.
7. Fortunately we had already made a call very early on that we were not going to halt our development to wait for NVP’s response and given that we were only advised on 22 April that we were not successful, this was a good decision otherwise we would have lost almost 2 weeks of development time. We also suspected right from the start that our proposal would not be successful as we were developing a fully portable ICU ventilator whereas the specifications of the NVP called for a simpler device – please let me emphasize that we have no issue with NVP for not choosing our proposal – we fully understand and accept that they had to apply their minds to their specifications and how the different proposals met those specifications and we respect and accept their decision to exclude our device on those grounds. We had also continued on the basis that the urgency of the requirement and the advice from NVP that there would be a fast tracked SAHPRA process and we believed that the accreditation process would not be a difficult and long winded affair.
8. During this time we also had the pleasure of being introduced to the Covid-19 Agile team which was made up of a team of people from Aerosud and assisted by various experts closely associated with the SAHPRA requirements. These experts would typically be involved in SAHPRA certifications under normal circumstances and would understand all the requirements, nuances and laws relating to the normal certification processes. The team was also exploring ways of getting funding or grants to facilitate the SAHPRA process. However what was clear at the time is that there really did not seem to be much guidance from SAHPRA as to the form of the fast tracking requirements.
9. Finally on 12 May we took part in a MS Teams meeting with representatives from SAHPRA who purported to give us an introduction to the process. However it simply turned into a session in which they advised how to fill in the relevant application forms with emphasis on the normal mistakes made in filling in these forms. In covering this topic, it became apparent to us that fast tracking did not mean the relaxation of any requirements of SAHPRA but that the applications themselves would be pushed through their systems of checks and balances at a faster pace. At around about this time the Covid-19 Agile team also advised us that based on their assessment of our project file and the stage of our development, that our project was suitable to proceed with the registration/certification process. For this purpose they allocated and introduced us to a consultant that was an expert in the SAHPRA registration and certification processes.
10. What we have learnt in the last week from this consultant is as follows:
a. The process is not a simple one and requires things such as Electromagnetic compliance testing and clinical trials
b. We would be required to get an ISO13485 certification although they are still waiting for SAHPRA’s decision on whether this is an absolute requirement. It seems that even if this is not an absolute requirement then ISO9001 will still be required
c. The costs of all of the above testing, applications and certifications will exceed a million rand.
d. The timing to get all of the requirements and tests in place would be many many months so even if SAHPRA actually fast tracks applications, the marathon required to get an application to their door which has any chance of success will be a long and drawn out process.
e. After doing all of these things, spending all of that money and wasting all of that time on getting all the requirements together, SAHPRA will only give an authorisation for its manufacture and distribution during the course of the Covid-19 crisis and they specifically state that it still remains the responsibility of the medical practitioner to asses the suitability of the device for use. It also seems that once the Covid-19 crisis has passed so will the authorisation – so take all the time, spend all the money, to get your application up to scratch and you will get an authorisation which is no longer valid for anything because potentially the Covid-19 threat has abated or even passed – in a word, NUTS!!!!!
11. Given the above it seems pointless us continuing with the SAHPRA process. The sad thing for us is that we have built our first prototype, fully tested it and made modifications for issues noted during testing. We have now built our pre-production unit to test the production processes and we are ready to push the button to commence production – all for naught in the South African context.
12. We are still continuing to apply for the FDA “Emergency Use Authority” but even if we are successful with that, it does not allow us to distribute in South Africa. While SAHPRA does place credence on FDA certification, it does not automatically give you a path to SAHPRA authority and all the requirements of testing and ISO certifications are still required – its just that the FDA authority would act as an additional confirmatory tick in the SAHPRA process.
13. The FDA approach has been very different. They simply want you to submit a project file to an email address and from that project file they will ascertain whether the evidence presented indicates that your skill, risk assessment, design and specifications indicate that you can produce a device that is not only successful in delivering results, but also will not have any negative implications. The success of their program is shown by the fact that, as of 3 May 2020, they have 51 ventilators listed on their website as having received their “Emergency Use Authorisation”
14. We read recently in the media that the South African Government has accepted a generous donation from the US government of 1,000 ventilators – we applaud both the SA and US governments for this initiative but cannot help but wonder whether these ventilators have any SAHPRA certification or authorisation. If they didn’t, but have subsequently received same, this speaks to the true nature of fast tracking that we thought was going to be the process. Even in the case were they do not have certification, the whole thinks reeks of a serious double standard whereby the benefactors of the raw deal are South African manufacturers, who at the behest of the South African Government, through the Department of Trade and Industry and their NVP project, have rolled up their sleeves, sweated and toiled to get to a viable and workable solution only to have the gates to the marketplace littered with thorns.
15. We have recently established that the NVP intends to open “Stream 2” of their project which will enable them to re-assess some of the applications that may have been excluded from the initial adjudication but that have progressed to the point that they may need re-assessment. I have been in contact with the project leader of “Stream 2” to confirm that this is the case and he has confirmed that we are on the radar of “Stream 2”. The reality is that if there is no change in the regulatory issues, we see no point in expending time and energy to continue along the “Stream 2” path.
The take out from all of the above is that I do not want to be seen as critical of the NVP, SAHPRA, the Covid-19 Agile team or any other people involved in the process – to the contrary, I believe that everyone has been working hard at their individual aspects of the requirements, but herein lies the problem. There has been a distinct lack of leadership from the very top levels. All of these different groups are running very hard on their treadmills, but in the absence of a coordinated, structured and well lead and managed approach from Government, and particularly the Ministry of Health, all the treadmill runners are creating buckets of sweat but in reality they are still in the same spot. What is required is true leadership that would co-ordinate all of these teams, get them out on the road running together so that we can get a finisher’s medal at the end of the race which we run in record time. Instead all the different parties are being left to run their own fiefdoms and islands within their own particular set of rules and guidelines and the end result is that nothing gets done or at best the process is so mired in bureaucracy that the timing of the end result makes the result irrelevant. True leadership has been shown by the US FDA were in record time they set up a standard, a process and implemented and hence their success in getting numerous suppliers listed and supplying a solution to the citizens of the USA. I am all for oversight and especially given that this is a medical device but we are in the trenches right now and it seems pointless to me, that when there is enemy fire overhead, that we debate amongst numerous different stakeholders which armaments to return fire with – we just grab the nearest available working weapon and get into the fight.
My final thoughts – thank you to my team who have worked tirelessly to get us to where we are, thank you to the NVP, Covid-19 Agile Team, SAHPRA and the myriads of people of which there are too many to mention who have done so much hard and valuable work to assist in the process, not only for us but for all of those out there trying to achieve the same goal, thank you for the efforts of the other manufacturers trying to achieve a solution (I don’t see you as competitors but brothers in the same fight). However unless there is some serious leadership intervention to truly fast track this process, to paraphrase Barack Obama in his final speech as US President, from a South African perspective its “Clifford Out”.
- Graham Raynor is co-owner of Clifford Machines
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