From Research to Product
Taking something from the Lab to a product for sale in the market takes considerable effort. If you are developing electronic medical devices, you can either partner with
Dialog Devices or we can help you strategise for your non-competing product.
Here are a few things to think about for your technology.
The Plan
As a scientist, you probably have a great technology, but poor understanding of the medical device market place. The journey is never the same for each technology, but we can help you in the following areas:-
Patenting
This is the first thing you need before searching for funding, and you may have to pay for it yourself. If you are in a University, then the University Tech transfer office should be able to help.
However, does your patent application 'A medical device to diagnose XXX' offer the maximum protection? Are you aware most national jurisdictions forbid patents which diagnose? We can help you in your patent strategy, maximising coverage, limiting others from developing work-arounds.
Share Allocation
Early strategising can be critical for the future of your innovation, but it depends what you want to do. Do you want to continue working for the University? If so, what implications does this have on your company? If you are prepared to leave research and work for the company full time, you should be incentivised. We can help you understand the limits.
Business Strategy
What does your company want to do? If you have a service to offer, this can fund the early stages of the companies embryonic development, such as patent costs.
Ideally, everyone wants to license. But if you have something completely new, there is no demonstrable market, so how do you minimise these barriers to licensing?
If you need to manufacture, what is the cost/benefit analysis to the company? We can help you develop the correct business strategy for your technology product.
Regulatory
Medical Devices are heavily regulated. If you are from an Engineering background (Biochemical/Electrical), then you may not be aware of the regulations required in order to trial your device in NHS hospitals to prove it works. We have planned, organised, ran and anlysed several clinical investigations, and can guide you through the minefield.
When you want to sell, you have to get regulatory clearence before you can sell - CE marking and FDA clearence (Not approval). Most people have heard of the FDA, but dont know what they do. If this is handled incorrectly, the FDA will charge over US$100,000 to review your application, whereas if handled correctly only a few thousand dollars. Ticking the FDA boxes is an art in itself, let us help you!
Reimbursement
You may not have considered who is going to pay to use your invention, but the term is 'reimbursement'. If the Doctors (as customers) will not be paid for fitting/using/diagnosing using your invention, then you will find it very difficult to get investment.
Reimbursement is complicated, and the UK is not the most attractive market. We can show you how the US reimbursement system works!
Raising Equity
When you have set up your company, what funding is available?
Research Council grants (BBSRC, EPSRC) are good because they do not dilute your equity, but ownership of IP must be shared. How do you maximise revenue from IP? In addition, many healtcare oriented (MRC, BBSRC) generally are only interested in fundamental (Cellular) research, and do not permit clinical investigations on humans....
Local Development Agency funding does not dilute equity, and does not share ownership of IP but wants to create jobs in the area, and requires match funded. Where can you obtain this match funding?
University Challenge Funding is ideal seed funding, but has certain requirements. How do you prepare and tick the boxes of their selection process?
Venture Capital Funding is needed for real commercialisation, to grow up from a lifestyle to a company capable of exiting. Different VCs want different things, depending on the amount they are prepared to invest, who to approach and what they want takes time to learn and understand. How do you get an investment round which will commercialise your product?
Next Steps
Contact us for an informal discussion.