Villgro Africa’s incubation program supports emerging companies in the health and life sciences that are providing a range of products and services, from digital platforms to service provision to medical hardware development. Although starting a business, especially one that is trying to do something new, is often an uphill battle, the task of designing, creating, building and selling hardware poses a unique challenge.
There are many reasons for this, not only because designing something that people can use means designing something that fits the huge variety of people in this world (there is no standard human), but also because hardware generally takes a significant amount of time before it can enter the market. This requires patient capital that ensures a hardware device has enough funding to take the long journey from idea → prototype → regulatory approval → completed device → market. Additionally, the African context in particular is not yet well set up to support the device development process, with importation currently the primary form of acquiring medical devices.
Although the need for patient capital is key in enabling success of med-tech startups, it is also true that any investor will provide capital only to startups that prove themselves to be good investments. The enabling environment needs to include more than just capital for development, so we must ask ourselves what is needed to create an environment where hardware startups can become investable.
When a group of us designed a ventilator in 2019 to 2020, it very quickly became clear that there wasn’t a pathway within the Kenyan regulatory system to approve medical devices or equipment. There was one created specifically for ventilators due to the urgency of the COVID-19 pandemic, but for the vast majority of devices, the most common way to get regulatory approval is to get a CE mark or FDA approval and then bring the device back into the country.
There are beginning to be encouraging signs of change in this area, including the Africa Medical Device Forum and the African Medical Agency, but it’s taking some time. Those of us who are working on developing or supporting medical device technology development in Africa need to join conversations to facilitate a robust medical device regulatory environment, as well as harmonisation across national borders.
Local manufacturing of medical devices on the African continent is hard to find. Revital Healthcare in Kilifi, Kenya is one of the few in this region. Manufacturing infrastructure is needed for commercialisation of devices currently in research and development. The needs include facilities that meet requirements for Good Manufacturing Practice (GMP) and ISO 13485, the medical device manufacturing standard. The availability of manufacturing infrastructure would encourage more entrepreneurs to tackle development, knowing they have a path to realisation of their innovations.
Government tax subsidies and development grants to enable and encourage private manufacturers to upgrade to ISO certified manufacturing facilities could provide a commercial pathway. Additionally, programs to train manufacturers in quality management systems (QMS) and GMP would build capacity towards medical device standards.
In order to be price competitive with devices from China and India, local developers and manufacturers would benefit from some assistance with supply chain optimisation. This could be in the form of aggregated purchasing programs to get volume discounts, government subsidies and/or setting up of industries to build common inputs for electronics and mechanical systems.
Additionally, the use of Design for Manufacture, Assembly and Test (DFMA-T) techniques represents an opportunity, especially during the last stages of the development process to optimise total cost of the product. This can be done by taking into account the intended use of the device and recommending the most cost-effective components, as well as ensuring that the product can be manufactured, assembled and tested with high yields and at the lowest cost possible.
Both development and manufacturing/industrial engineers need to get more hands-on, practical training either within the university system through project-based learning or as they get started in the workforce. In this way, we can build the capacity to successfully design, develop and manufacture medical devices locally. Building a life-long learning mentality is important because technology is changing fast and engineers need to keep pace with the latest developments in technology.
Partnership with either government, private industry and/or other stakeholders is an essential aspect of getting a device into the market. With the government stamp of approval on a medical device, for example, it is possible to supply to public hospitals that are bound by certain restrictions and represents a significant segment of the healthcare market. The healthcare system, both private and public, would benefit greatly by partnering with med-tech entrepreneurs because they could help define the problem space and have input into locally appropriate devices that solve clinical problems with solutions that take into account the local environment.
With these five things in place, med-tech innovators would be empowered and encouraged, lowering the barrier to entry into the medical hardware development space without lowering the standards of quality and efficacy. As we learned from the COVID-19 pandemic, relying on international markets for our healthcare advancement is not always realistic or responsible. We need to do everything we can to encourage local innovators to create solutions that are conceptualised and realised within the context it will be used.
Wambui Nyabero is Villgro Africa’s Chief Technology Officer. She provides support and technical assistance to emerging companies, especially those working in health-tech, specifically in the area of med-tech hardware devices.