New scientific products are often innovative, forward-thinking and can even be life changing to many. But those seeking to bring them to market must prepare themselves for an uphill struggle.
Whether related to human or animal health and wellbeing, scientific products are always subject to stringent testing and must display a wealth of supporting evidence if they are ever to pass the relevant regulatory hurdles.
In the internet age, we’re all increasingly suspicious of pseudoscience and promises that defy reality. Still, it’s increasingly difficult to impress, and consumers expect new innovations, but only within the realms of what we already understand and know to be true.
Prepare yourself for a long journey
Such a balance can seem impossible to deliver, and it takes much time, effort and persistence to get right.
Indeed, it took several years of testing and research before my company, Tharos™, cleared all the hurdles while enabled us to launch Equinectar®, an enzyme-enriched feed supplement for performance racehorses.
From demonstrating the science behind it to raising the money needed to get it off the ground, the process has not been without its challenges. Moreover, it has been an intense learning experience.
Here are the most important lessons I learned along the way:
1. Analyse problems from different perspectives
You may be very much on top of your field, but it’s always worth speaking to people with alternative viewpoints who might ask different questions and have fresh ideas.
Listening to others – particularly those in different fields – and opening your mind to new ideas can bring great results.
You can then look to existing research and see if you can innovate. Sharing experience and ideas with others is often the best way to combine expertise and break new ground.
2. Prioritise the science
Many science-based products have relied on myths and assumption, rather than facts – something that people are little wiser to these days. So before you even consider setting up a company to push a scientific product, it’s crucial to have done the legwork to ensure the science is truly behind your solution.
Testing and proving the science behind any claim, of course, requires extensive research and testing – processes which do not tend to come cheap. Don’t be put off by these costs though, as they are truly essential. If it later emerges that your product is not upheld by science, all your time, effort and money will have been wasted anyway.
The need for money and investment to pay for the scientific research can understandably seem like a chicken and egg scenario. How can investors justify their financial backing without the proven science? And, how can you fund the science without some form of investment?
This is something we were hyper aware of. To prevent ourselves from stalling, we used our primary investment and the resources we had to work with some of the top gut health scientists we could find. We then commenced studies with several research institutions and universities.
As our scientific evidence mounted, we were able to attract more investors, which in turn allowed us to conduct more scientific research. Once we were confident in the science behind Equinectar® – and that we had the evidence to demonstrate it – we began to widen our team and prepare to bring it to market.
3. Up your credibility
Though it is a hugely important component, it takes more than scientific evidence to build confidence in your product.
We were a new company seeking to target the racehorse industry, which is not a sector immune from corruption. Our findings were significant, but people were nonetheless sceptical.
Before they took us seriously, they needed actually to see it in action, or hear about its merits from a respected source.
To tackle this, we worked with well-regarded vets and stables, and wrote and published papers in notable peer-reviewed journals.
The upside for us was that performance equine market is a small world. By presenting our findings to vets and trainers in Newmarket, we were able to reach many of the sector’s most influential people at once.
We first undertook bespoke, five year-long trials in stables, which allowed us to demonstrate improvements in both the performance and condition of the horses.
Then, we contributed these findings in the form of articles to peer-reviewed journals, which helped to further boost our case.
Seeking to influence a small market then, is a good place to start, and is a great way to gain traction and later expand. The scattergun approach on the other hand requires a lot of money to make a mark. So, it’s often best to start small.
4. Be cautious with patents
Just like the need for funding and scientific credibility, patents can offer another chicken and egg scenario. We had evidence to support our patent application but needed to secure a patent before publishing the details, or risk having our discovery stolen.
So, when contributing to journals, we were very wary about what information we submitted. Putting our ‘recipe’ into the public domain would have scuppered our attempt for a patent.
This is why it’s useful to have a skilled patent lawyer at hand. They can help you write your patents in order to speed-up the process and advise you what to publish, and what to keep under wraps.
5. Study the regulatory requirements
Scientific products need to pass certain stringent regulatory requirements, which means the process is going to take a very long time.
To judge how long the process will take, learn in advance what regulatory framework your product will be categorised under. This will also help you budget until you’re approved – you don’t want to go bankrupt before you’ve released a breakthrough product, after all.
Regulations may also influence your choice of ingredients during the development stage. We made sure that all the ingredients were included on the Generally Regarded as Safe (GRAS) list, which made it easier to gain approval from BETA and NOPS.
Using prohibited or restricted ingredients makes the approval process much more difficult.
Like most things in business, money will always be a key consideration. Specialist studies, trials, research and development, regulatory approval, patents and lawyers are necessary, but they all cost money.
You’ll also need to be able to pay for your team’s time, and support yourself throughout this process, which may take several years.
All said and done, one of the biggest barriers that prevents scientific products from making it market is the company running out of money. So, always keep track of your bank balance and carefully manage your cash flow.
About the author
This guide has been written exclusively for ByteStart by Professor John Hunter, founder of Tharos, an equine health company. He was a Consultant Physician at Addenbrooke’s Hospital, Cambridge, Visiting Professor of Medicine at Cranfield University.
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