Design and Build
The key components ( items 1 to 9) have been allocated to leading manufacturing companies in our cohort.
These companies will be responsible for the manufacturing of the complete sub- assemblies and managing production internally and with their tier 1 and tier 2 suppliers.
All sub-assemblies will be sent to MCR Manufacturing in Rosslyn where the Nuffield 200 copy will be fully assembled, and every completed unit individually tested under the quality supervision of Robin Whittle of New Age. Robin has been a ventilator technician for 40 years and has an intimate understanding of the Nuffield 200.
Design and manufacturing status of the various parts;
Item 1– this critical valve will be managed by Robert Bosch. The production drawings are 100% complete including the bill of materials. Prototyping can immediately commence. Several specialist companies such as Capewell for springs and ADV plastics will be involved with this very technical valve.
Item 2 – this critical valve will be managed by Executive Engineering in Cape Town. The production drawings are 100% complete including the bill of materials. Prototyping can immediately commence. Essential O-rings will be supplied by Bearing Man Group(BMG)
Item 3– this valve block will be managed by BMG Gauteng. The production drawings are 100% complete including the bill of materials. Prototyping can immediately commence.
Items 4 and 5 (timer valves) are being designed and manufactured by MCR manufacturing in Rosslyn. These timers are exceptionally complex, and they are being modified slightly to facilitate manufacture. The designs will be complete by the end of 2 April 2020.
AA Springs, Sasphin and Mastermech are some of the tier 1 suppliers.
Items 6– this manifold will be manufactured by Reef Engineering in Alrode. The production drawings are 100% complete including the bill of materials. Prototyping can immediately commence.
Items 7– this critical valve will be managed by Paramount Group . The production drawings are 100% complete including the bill of materials. Prototyping can immediately commence.
Items 8– this gauge is tricky. Rhomberg Instruments in Cape Town can produce 80% of the gauge however they are dependent on China for some critical parts. Rhomberg have 50 gauges immediately available and “can” have essential components from China in 4 weeks. As we have serious concerns about foreign supply chains we are working intimately with Prof Carlos Van Zyl of Nelson Mandela University in PE to develop a very user friendly and easy to build manometer in lieu of the cmH20 gauge. We are running these 2 options concurrently. We are paying much attention to this essential product and are confident that we will find a solution without delaying product launch.
Item 9- this may look like a simple on off switch, however the product, it is complex and full of small parts.
The aim is to produce in the short term about 5000 ventilators
For more information
Today RSA has 4000 ventilators available in private hospitals and 2000 in government hospitals. The estimate, depending on how we can flatten the curve, that more than 30.000 ventilators will be needed.
South African manufacturers and suppliers have come together and decided to build the Nuffield 200 type vent for the following reasons;
- It is a time-tested product that is still made by Penlon today. (The UK govt is relying on this product for their internal Covid crisis management)
- The IP has long expired and will avoid legal repercussions.
- In copying this design testing, approvals and regulatory issues will be minimised.
- Whilst the capabilities of this ventilator is rather limited in relation to modern units, the functionality is acceptable given the physiology of Covit patients.
- Skilled medical personnel will also become scarce as the crisis intensifies and the unit is relatively easy to operate.
- It is totally mechanical; devoid of electrical parts.
- It can effectively be made with 100% local inputs. (Many new alternate ventilator designs are scoring high on innovation, however fail on supply chain as they are reliant on difficult to procure imported specialist parts).
- By working with auto component companies, they immediately appreciate the following; quality, volume production, reactivity and cost down!!
In order to assist with the overall project management, and critical path monitoring (Gantt charts), a team has been put in place that will be headed by Elizabeth Wolmarans of Aveti consultants. Elizabeth has much experience with the development of medical devices and the associated regulations. We have also been sponsored by Microsoft with project management software, which will ensure that all parties are working from a common platform.
Project Milestones and Cost Estimates
- Prototyping complete in 3 weeks
- Production to commence in 5 weeks
- Within 7 weeks production will be at a level of 125 units per day
- Target volume phase one; 5000 units
- Total Target volume phase 2 as we incorporate other African markets – 30000 units
- We are aiming to produce this unit for approximately USD$2500 per unit. Current price of a Nuffield unit in excess of ZAR 300 000.
Not the Ventilator alone
The South African Emergency Ventilator Project has not only focused on the ventilator alone, and has addressed the entire system that is needed to make a ventilator work namely;
- A filtration and drying system needed to convert industrial compressed air into medical air. There is a huge medical air supply shortage in the hospitals (design 95% complete and ready to commence manufacture)
- The manufacture of O2/ Medical air blenders that are required with all types of ventilators. (design 100% complete and ready to commence manufacture)
- A nebulizer system to keep the patients lungs sufficiently moist. Normal O2/medical air is exceptionally dry and can dehydrate the mucus and create critically dangerous stiff lungs. (design 100% complete and ready to commence manufacture. Technical development has been managed by Sinapi Bio Medical. Manufacturer still to be selected)
- Patients pipes and fittings including a filtration system to capture the covid infected exhalation air. (Work in progress)
- The manufacture of a universal “patients valve” that moves the gases in and out under controlled pressure and has an emergency pressure release valve in case of over pressure(design 100% complete and ready to manufacture)
All of the above is necessary to make the Nuffield 200 work as well as most of the other innovations that are being presented to the market.