When Elon Musk unveiled his ‘bionic pig’ in an on-line event in September there was much hype and more than a few raised eyebrows. Did this herald a substantial step forward in the realm of brain-machine interfaces? Or was it another publicity stunt?
Gertrude the pig roots for attention
As Gertrude the pig snuffled around her pen accompanied by a live feed of electronic beeps, Musk announced the creature had a removable chip inserted into her skull two months previously. The beeps we could hear were her brainwaves, the “neural activity triggered by her snout as she looked for food”. We were witnessing the prototype of a ‘FitBit for the human brain’.
Inevitably, Musk went way beyond this in his predictions about the potential and objectives of his company, Neuralink. With this technology, he claimed, he would develop mass-market brain-computer interfaces that would essentially allow humans to control systems and objects with their minds alone; curing depression, spinal injuries and neurological disorders for good measure.
Is Neuralink a game-changer?
The amount of investment the company has attracted is impressive - topping “$150m in funding (including $100m from Musk himself)”. But, it seems, on closer examination, that there was little that was genuinely groundbreaking in the technology he presented.
Instead, what really got some commentators interested was preliminary ‘FDA approval’ the project had received.
“The FDA approval might be the most exciting aspect. Given recent reports that the company culture is chaotic and clashes with a normal pace of science, regulatory oversight will be crucial to making sure that this product does not endanger people.”
Here was, at least evidence of concrete moves towards a functioning, saleable product and not just the entrepreneurial fever-dream that Musk’s projects so often resemble.
What investors really want to see
All this is a reminder that flamboyant announcements are one thing, but actually getting an original, compliant and profitable product out at the other end of a med tech development process, is another.
A bit of theatre and a well-rehearsed pitch might be important for getting your message across to investors. But it’s no substitute for evidencing a sound business case, market knowledge, and the pragmatism and good governance that is going to get your project over the line.
How to develop a medical device; the 5 phases of med-tech development
5 tips for winning med-tech investment if you’re not Elon Musk
1. Assemble the right mix of people with the right mix of skills to take you through from concept to launch
You need the technical skills and ability to innovate fast, but also the ability to build teams and sustain a competitive advantage. A management team with a track record of building successful companies and new products from scratch will give investors’ confidence.
2. Be realistic, clear and focused about the objectives of the technology and device that you are developing
What is the unmet need that your product is responding to? Is your USP a genuine technological innovation, or an improved take on an existing product? Have a good handle on the answers to the following questions:
- Why is this medical device necessary?
- Does it have a proven clinical need?
- What are the rival products on the market and why is yours different?
- Who is the end-user of the medical device?
- Who will purchase this medical device?
- What is the market size for the device?
3. If you can have a prototype developed, this will really help
It doesn’t have to be in its final functioning state. But it should be enough to demonstrate proof of concept to potential investors. This and your ‘elevator pitch’ will be an impactful way of demonstrating that you have a vision of the product and a clear sense of the gap in the market it will fill.
4. Ensure you have a documented plan and regulatory strategy for developing a medical device
Being able to demonstrate that you’re preparing to develop the device in a compliant way is vital. This plan should demonstrate your understanding of the required design controls and the validation activities that you will need to perform and document if you’re going to get to market and realise ROI as quickly as possible. Have you got someone on board who can help you navigate and speak around those specific challenges?
5. Sort out your QMS
As mentioned above, medical device development is a uniquely risky business. Investors need to know you’ve got those risks covered, yet still have the ability to adapt, scale and respond quickly to opportunities and challenges as they arise. Having agile, digital Quality Management tools in place to control your documentation from the outset will also go a long way to persuading investors you’re aware and equipped for the challenge. In fact, if you’ve built, or are in the process of building out prototypes to accompany your pitch, you should already be documenting and cataloguing the work you’re doing in this kind of exhaustive way.
A final thought - document your brainwaves…
Not everyone has a bionic pig to raise their profile, and not everyone has $100m of their own money to sink into a project. For most people embarking on developing a medical device, it will be your ability to persuade investors that you’ve got the ideas and discipline to bring a compliant product to market that will keep your fundraising on track.