The Medical Device Entrepreneurship Journey
How to Do More With Less: Cost Cutting Development Strategies
On 1st July 2021, Villgro Africa held its second iteration of the Innovators Forum, a forum committed to building resilience through investment in biomedical and diagnostics innovation and manufacturing in Kenya. Titled “How To Design and Manufacture Ventilators in Kenya,” the discussion served as an accelerated case study on the development, approval and manufacturing of medical devices.
The conversation was rich, covering the many triumphs and challenges encountered by the brave souls who have ventured into the uncharted territory of medical device development — and did so in the middle of the COVID-19 pandemic, which has been marked by global supply chain upheavals. It was therefore no surprise that one of the challenges highlighted was the difficulty and cost of obtaining components and test equipment. The discussion brought to light the need for cost control, especially in the early proof-of-concept stage. Several opportunities for improvement were identified for the very new Kenyan medtech ecosystem. The following thoughts address the opportunity for cost-cutting in the prototyping stage, which could enable entrepreneurs to move faster towards their commercialization goals.
To keep the cost of developing a proof of concept low, entrepreneurs can (and definitely should) start their rapid prototyping with low-fidelity prototypes that are inexpensive and simply help communicate their ideas to users for quick feedback.
At the very beginning of a design/development process, these low-fidelity prototypes could be made out of inexpensive, easy-to-obtain materials such as wood, PVC pipes, duct tape, plastic sheets, etc. In the case of user interfaces, they can be simple PowerPoint mockups illustrating user interaction. As the user needs are better understood through feedback and observation, more functional and complete models can then be fabricated.
During the next stage, it may be that specific functionality needs to be proved out by building specific engineering models. These are often sub-systems that can be tested in isolation of the complete system. In the case of ventilators, a good example would be putting together a system to mix oxygen and medical air to test which type of valves and electronic drivers are flexible enough to meet user requirements. This level of development is very engineering heavy and although, ultimately, the functionality meets a user need, the purpose of the prototype is simply to prove technical feasibility.
At this point, things become less straight forward because, although it is not yet essential to have medical-grade components, the testing often has to be done with high-end components that will mimic the ultimate medical-grade functionality. These will often need to be imported, since the medical device supply chain is currently not fully supported locally. To reduce the cost of development, innovators can look into organizational assistance from bodies such as the Kenya Association of Manufacturers (KAM) that have access to the most current information on government subsidies and incentives for manufacturers. In the example of ventilators, KAM is able to work with innovators on duty remission for raw materials. This can result in tax savings that provide entrepreneurs additional funds for development.
Developing medical devices from initial concept to the point of bringing it to market is a long and complex process. By focusing on the larger picture and understanding the purpose of each step in the process, innovators can learn to prioritize in ways that reduce their costs without hindering their progress. By using a rapid prototyping approach and using appropriate levels of complexity in prototypes, innovators can have a more cost-effective development strategy. Additionally, government subsidies and incentives can further help by reducing the cost of expensive high-tech components.