Able to monitor key risk factors in kidney disease, the test uses an integrated software and hardware platform that produces a reliable readout from a single drop of blood.
The innovation has recently caught the attention of investors and healthcare providers as Kalium prepares its first products for commercialisation. Tom shared his insights on the art of product development in medtech with us this month.
There is a misconception that regulation leads to standardisation that in turn stifles innovation. In fact, the opposite is true – because each Medtech manufacturer needs complete control of their own device design to ensure safety and reliability, standardisation is often impractical. This gives the Medtech industry freedom to innovate with technology and product design while regulatory approval provides assurances of safety and efficacy to clinicians and patients.
When investors ask about the impact of healthcare regulation I remind them that our industry is considerably less-regulated than some others, for example aviation or nuclear. For context, with over 5,000 submissions reviewed by the US Food and Drug Administration (FDA) each year, and a similar number in Europe, the industry has a pretty good understanding of what works and what doesn’t.
Compared to software-as-a-service (SaaS) or business-to-consumer (B2C) innovation, it’s important to recognise that Medtech offers a different operational model. The potential overall returns in Medtech can be higher, but it may take a little longer to reach commercialisation.
This means that we like to work with investors who can see the long-term potential and have funds structured to support this – typically multi-stage venture capital investors, corporate venture capital or angel investors who are not obliged to deliver returns to their own investors within a very short time frame. We also work with strategic investors who have their own reasons for wanting our technology to be available to the market.
The neat thing about Medtech is that once a product is in use, it’s often naturally resistant to competition due to hard-to-replicate technology, deep integration into clinical workflows and established distribution chains. One of our advisors, Bill Moffitt, led i-STAT Corporation to develop their eponymous portable blood test in the 1990s and that product is still in regular use in hospitals today – with Abbott Laboratories enjoying a full 20 years of sales (and counting!) since acquiring the technology.
The pandemic was challenging for our whole industry. In our case we went from closing our first investment round to closing down our lab in the space of a week in early 2020. Lab scientists can’t do their jobs remotely so we had to put a lot of projects on hold until later in the year when the situation stabilised. Then we found that all our material and equipment suppliers were busy supporting manufacturers of lateral flow tests and PPE with large contracts and we had to fight to get any attention whatsoever.
Because we’re focused on long-term disease management, rather than infectious disease diagnostics, we tried not to get distracted by Covid-specific opportunities. In fact, we saw a number of diagnostics companies go through an extreme boom and bust cycle in 2021 as overwhelming demand evaporated as the pandemic subsided, and some of those companies never recovered.
One positive for us was the acceleration of the shift towards remote patient monitoring, and the increased empowerment we all now have when it comes to monitoring our health. This genie is finally out of the bottle.
The art lies in running a tightly controlled development process. The cost of re-design increases exponentially as a product moves through the process to the point where, ultimately, regulatory approval enforces a total design freeze. That’s the only version of the product you’ll be selling, unlike B2C products or SaaS where features can be iterated based on customer feedback.
However, the art is not in limiting design freedom or preventing innovation. It’s about making sure that user and other stakeholder needs are really well understood before coming up with concepts, and that technological innovations are proven to work before being wrapped into a final product design, so as to avoid rework or regulatory delays. This comes with experience, underpinned by an engineering mindset.
Through the Enterprise Hub, I regularly discuss these challenges with other entrepreneurs in the Medtech space, and this exchange of perspectives has helped us navigate challenges such as planning clinical studies, engaging with regulators and identifying the best investors in our space. The wider ecosystem of the Royal Academy of Engineering is also a fantastic resource for us to tap into, with active participation from many successful people in medical and healthcare technologies.
David Branagh is the founder and CEO of Raidmed. He has led the company’s engineering team in developing a low-cost thermal imaging system that diabetics can use at home for the early detection of foot ulcers. David says:
‘With Medtech product development, there is a fine balance to be maintained between innovation and compliance. A complex regulatory landscape needs to be considered when developing your engineering and product approaches. The ultimate goal is to deliver safe, compliant innovations that enable improved patient outcomes.
‘Along the way, innovators should be ready for unexpected opportunities and, if relevant, embrace them. Keep an open mind, be flexible and ready to seize such moments that will enable you to add value and further develop your product.’
Dr Elijah Nazarzadeh is the CEO of Nebu~Flow. Nebu~Flow technology unlocks the delivery of next-generation inhaled drugs and the delivery of hard-to-nebulise medicines. Elijah, has developed the company’s technology, leading its business development and fundraising activities. He says:
‘When developing in the MedTech space, make sure that you include all the necessary requirements in the product. Then verify and validate these for regulatory purposes. This can future-proof the product and reduce iterations or further regulatory requirements when it comes to making next steps and market segmentation.
‘While doing all of these on a budget is the main challenge. The time it takes to develop a design and validate it, while considering the requirements of the stake holders – which can be conflicting – is the main art in finding the right balance and achieving the desired goals.’
Kalium Health aims to make it quicker and easier for patients to monitor and manage unstable blood electrolyte levels that can become life-threatening, especially for those with kidney disease. Its first product is a handheld test device for monitoring blood potassium level with clinical accuracy.
The University of Cambridge spin-out is developing the device in response to patients’ request for an alternative to current methods, which involve hospital-based tests requiring a venous blood sample. These are often considered inconvenient, expensive and can lead to delays with treatment. In contrast, Kalium’s device will provide users with real-time results in any setting.
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