Strategy development stage is sort of the ultimate proving ground…
…having framed a concept as a solution to a need is only half the battle.
At that point what we really have to put in place are a set of pathways through the major
gates, like regulatory, reimbursement, quality, IP, and to come up with a plan to navigate
through that in order to find a path to market.
So this planning the strategy is really thinking about how do I build value?
And how do I build something which is a business that actually allows me to actually get this
to patient care?
Intellectual Property is really the blocking and tackling of device development.
So as you begin to start taking your product to market, other people are going to be learning
about it and seeing what’s going on.
And so if you've had those years of head start against competitors, you'll have your portfolio
built up and that will keep other competitors at bay.
With R&D the easy pitfall is always to just go build the product that you're envisioning
right away when the more important thing is to think of the white hot risks and the risk
that is potentially going to kill the project from a technical point of view.
And just build something that answers that question.
The world has changed in terms of which are the biggest problems.
There is no question right now that reimbursement, getting things paid for, is the top barrier.
If you look at where the healthcare system is going is there's just not going to be the
type of spending that there once was.
Regulatory strategy is something we did spend a lot of time on.
We were trying to reduce the, sort of the barriers to get this product out to market
and thinking creatively of how we could do that.
I think if you look at it in terms of functional challenges, it always comes down to great
clinical data.
I wish we’d moved faster with our current technology; to iterate faster, get clinical
data and then iterate again as quickly as possible
Quality is really the unsung hero of medical technology and medical development.
I love quality.
… think of quality as you know stop signs.
A lot of people think of stop signs as a bad thing.
But you know if we lived in a society where there were no stop signs, you'd think you'd
be going really fast but you'd have complete gridlock.
most innovators can get pretty comfortable matching a concept to a need.
In some ways the harder part is to determine whether there is sufficient value in the concept
to form the basis to have an impact in the marketplace.
Know your audience, put yourself in their shoes.
Know exactly their vantage point.
Be cynical about it.
Be mindful of the non-verbal cues or the things that are on people's mind and no one speaks
about.
Previously you could take a product to a physician or clinician and sell them on the benefits
of that product directly.
Now, you have to go to the clinician to make them a product champion, and then that clinician
has to take it to the value analysis committee who most oftentimes makes the decision, not
only based upon the benefits to the patients but the cost to the product compared to other
therapies.
I thought about competitive advantage a lot early on.
You have to know what you're good at and exploit it.
whatever that competitive advantage it is, it has to be enough to build a business around.
It has to be able to sustain you through the costs of the other facets of doing that business.
I think that the most important thing to look out for in the strategy development stage
is make sure you’re making well-informed decisions with expert input…
it’s quite easy to get discouraged if you’re not an expert in something, and you investigate
it on your own and it seems very daunting or difficult.
It’s not like you have to know everything, but it’s really important to know what you
don’t know, and find a those who do.
build the right team, get the right advisors on board, and then buckle up and go as fast
and hard as you can.
It's a lot of work, but it's a lot of fun.