As originally asked by Joel Steinberg, MD, PhD.

This is a challenge. The typical innovator, often a physician, may not have the entrepreneurial skills or funds to commercialize the device. So where to look? So called incubators typically offer rental space, not skills or funding. And the busy physician will usually prefer to find local talent as a practical means to collaborate. Most sources of capital, VC’s and angels, expect an established company to approach them. So what are the options for the innovator, the inventor, to make the transition from concept or early prototype, to form a company?

Burrell (Bo) Clawson
I research patents & design products to get a patented competitive position: Over 30 patents.
Scott, “High Tech” gets headlines. Great newer, better solid products with established markets do not get written up or have high profile and consequently take inordinate time to find the right funding source as I’ve seen it.

It is easy to see this when you go to raise capital as I am doing. We show our OTC cleared & patented POC test with virtually no competitor having a sealed kit for hospital Pyxis ADC use or any OTC kits and over 100 million kits/year used clinically and we have explained the details clearly (& verifiably). Product superiority is not an issue.

Investors scan so many prospective investments, I have heard it said that you get 20 seconds to make a great impression or it hits the trash bin.

If you get beyond the 20 second scan, most investors have had losses before and some probably seek to find their concept criteria in a company as opposed to finding a great product that can meet or exceed profit goals.

It is never easy.

Scott Blakley
President of Grabcessories By LiveWell: Providing Seniors, Caregivers & Their Families Quality Bathroom Safety Products
Thats the challenge in Ohio – At least in Cleveland most all organizations are caught up in the “high-tech” buzz. There are very innovative products that are not high-tech but patented and directly on trend in growing markets that get ignored. It’s like when dotcoms were hot. Everyone wanted to invest in them and ignored some really terrific investment opportunities sort of “panning for the big gold nugget”. High Tech is terrific but too many investors pass up other great deals out there. It is a wide open market for smart investors willing to capitalize on patented, non-high tech innovations in growing markets.

Roger Anderson
Helping people form companies, and companies form the future.
Lots of great stuff here and I hope it continues. The question I hear Joel asking is – How does a busy physician get his “pocket company” going while keeping his day job?

The same situation occurs to professors who have great research and are not looking to leave the bench.

Joel – one limitation you have put forth – they must be local – will limit your choices but should not be a disaster.

My advice, get to know your BIO community. There are many people at the meetings who are or know the kind of experienced executive you are seeking.

You may also want to contact Safeguard Scientifics (VC firm) located just outside Philly. Don’t go in looking for an investment, go in looking for referrals to people they would be open to hearing from one the plan is in place.

Go to pitch competitions, entrepreneur gatherings, and networking meetings. Try to connect with Angel investor groups. You are looking for people not money at this stage. With that focus, you are more likely to get a few minutes time. It’s the difference between talking to a movie director about how he/she shot a particular scene in their last film and asking them to read your screenplay.

I will also send you a few names of people I know in your area by private email. I hope to see great things soon.

Steven R. Rakitin
Medical Device Software, V&V and Compliance
Joel,

Getting funding for a device innovation is a challenging process. I have worked with many early-stage startups and recently came across the MD Idea Lab at UMASS Boston. [http://www.mdidealab.com|leo://plh/http%3A*3*3www%2Emdidealab%2Ecom/ZNkV?_t=tracking_disc]

This incubator not only does all of the things you would expect, but also provides mentors and consultants to help develop device innovations into tangible products that can then be pitched to VCs.

I hope this helps…

Regards,

-Steve Rakitin-
Software Quality Consulting
www.swqual.com

Donald Zinn
Pharmaceutical / Biotech Serial Entrepreneur, BD&L Oncology, Osteoporosis, Infectious Disease, Cardio
[email protected]
Hi Sanjay,
Have you tried delivering of other large market peptides? The insulin market is extremely crowded and the regulatory process is full of pitfalls such as precise delivery ranges, very difficult transdermally as 11 human clinical trials has likely taught you. I would suggest PTH, as the FDA begins to frown heavily on anti-resorptives. The rapidly growing osteoporosis market is looking for safer , more effective, bone building therapies. Why re-invent the wheel when PTH is a perfect opportunity for a transdermal company especially here in the US where the consumer is needle shy.

W. Bradley Worthington MD
OPIOID FREE ANALGESIA
Jagu
Have a patent,world wide with specific claims
FDA approval
CE stamp
TGA in Australia
The device is a simple patient controlled and empowering modification
of a simple TENS device that has been shown to be clinically effective
in acute, chronic, and neuropathic cancer pain.Also has potential to dramatically change
percutaneous neuromodulation with applications in urological and neuropathological pathophysologic conditions( Parkinson’s,bladder dysfunction, to name a few)
Single use electrode design also patented.
Also covered by a separate patent for use in functional bracing and fitments.
Additional applications in active transdermal delivery that can be used in combination.
Happy to further discuss with interested parties previously successful in the neuromodulation space.
Regards,
W.Bradley Worhington MD
Senior Medical Advisor
Gradient Technologies

Jagu Barot
Design & Development Engineer, Quality Engineer, Manufacturing/Project Engineer
First, define what is your interest: Make money, make name, or serve the need.

Do you have FDA approval to market the device (implant may take four years of clinical trials with NO guarantee that it will be approved)? Is it substantially equivalent to the existing device (it is less hassle for FDA approval)?

Is it a device or a system? Does it involve electronics? How do you know it works? What field is it in? Is it disposable or re-usable? If it is a system, does it have any consumables?

Do you have a patent? There are all kinds of funding available. What is in it for them? How different is it than what is existing on the market?

I do not have sufficient info to put you in touch with right people.

Burrell (Bo) Clawson
I research patents & design products to get a patented competitive position: Over 30 patents.
“First to File” brings the US into agreement with other countries in the WIPO, so it is probably good. Inventors are supposed to file within 12 months anyway or lose the right to file, hence it encourages everyone to file quickly. Given the low cost of the Provisional application now allowed, that is not as onerous as a full application.

My patent attorney did recommend learning enough about the Provisional Appl to make sure what you say in the document is said in the right way and that everything is correct and useful for your full application as you will be held to what you say in the Provisional application.

It might be good to let your patent attorney provide an outline & review your Provisional Appl. so you don’t “box” yourself into a corner you don’t want. Wording in the patent office can mean things which are specific to patents and sometimes it is not obvious.

Donald Zinn
Pharmaceutical / Biotech Serial Entrepreneur, BD&L Oncology, Osteoporosis, Infectious Disease, Cardio
[email protected]
That brings up another very important point, welcome to the era of first to file!

Joe Vosters
President at Bill-Ray Home Mobility, LLC
Great information on this thread coming from many angles. A product doesn’t have to be hi-tech as long as it can solve a need in the marketplace and have some IP protection. Don’t forget the distribution channels as that has been the challenge with my bed mobility product (Friendly Beds). Would like to discuss marketing relationships with others in the DME world- please contact me at 920-915-8433.

Donald Zinn
Pharmaceutical / Biotech Serial Entrepreneur, BD&L Oncology, Osteoporosis, Infectious Disease, Cardio
[email protected]
If the idea is patentable, serves an unmet medical need, has a need based un/under-served market, is logistically and financially feasible (does not weigh a ton or cost $1M per dose) that’s when you find a serial entrepreneur, Corporate partner with a built in VC such as GSK’s SR1, talented consultants or a VC with an in-house business accelerator (home to many Entrepreneur in Residence). Let me know if you need specifics.
Don
1-269-569-2794

Heather Thompson
Creating B-to-B content for medical device and digital health publications.
I promise I’m not trying to sell you anything, but I did have a chance to interview Ximedica last year. They are a contract manufacturing company that has begun a sort-of incubator program for inventions that align with their product offerings. They have set aside space on their own manufacturing floor for inventor partners to work and they provide R&D, business services, etc. I wouldn’t be surprised if other contract manufacturers begin to do the same.

Merrill Weber
Co-Founder, CEO, and President at VOTIS Subdermal Imaging Technologies, Ltd.
Hi, Joel, what field is yoru device in?

Paul Zalesky
Medical Specialty Consultant
David – the terms I’ve found most useful with prospective investors / partners are “outstanding unmet need” = the real opportunity.

David Hajicek
Owner / Luthier at Hajicek Guitars
Great discussion. I would add one thing; Is the product one that is really needed, which can be sold and which can survive the competition of other technologies?

Obviously, nobody has a crystal ball. But one needs to be brutally realistic about the prospects of a new product/device. Not negative, but honest. There may be little reason for a start-up to develop something simply because the originator of the idea thought it would be cool to do and nobody else is doing it. There may be good reasons nobody else is doing it. ;>)

The originator of the ideas tends to have rose colored glasses on. This is good as you need to be optimistic and enthusiastic about the chance for success. But before you get too far down the road, the realistic estimate needs to be done.

Also, you may run into nay-sayers and ‘experts’ who will shoot you down. This needs to be judged realistically too. They may lack the experience or vision to understand what you want to do or have their agendas of their own. So it is your vision and your gut feelings that need to be true and honest.

Also, be honest and honorable with the people you work with on your project. Don’t promise what you don’t intend to or can’t deliver. Trust the judgement of those you work with. This should go without saying. But I have seen a number of start-ups fail because of this.

Scott Blakley
President of Grabcessories By LiveWell: Providing Seniors, Caregivers & Their Families Quality Bathroom Safety Products
I found that it all starts with having the right vision, business model, and a clear (realistic) vision for how the product/venture makes $. Then you have to be able to confidently articulate this to others in a simple way they can understand it. The last is where many fall off. Either the personality or confidence to articulate OR too in love with the product to think through how it will make $. The ability to articulate how your product/venture makes $ is absolutely critical to gaining advocates for supporting your business. I was blessed with a team of individuals that believed in my vision: 1) CFO from an equity group who donated his time to help me create pro-formas for the business plan 2) an engineering firm who believed in me, my products and my ability to generate $ worked until I could pay him 3) A Graphic Designer who created my packaging/logos and waited until I could pay her 4) A Web Desinger who worked for free. All of these people worked for free because they saw the potential – a great litmus test to let you know if you have a compelling vision and you are articulating correctly how it will generate $. You don’t have to guaranteed everyone equity. People are generally supportive if you have done the work and they know you are credible. It does not come easy. You have to put the time in and show your passion/talent first for others to believe, follow and assist you.

Joel Steinberg, MD, PhD
Nocturnist/hospitalist at Memorial Hospital of Salem County
Wow. Such thoughtful responses to my query. Thank you. Here’s where I am.

I’ve been using a specialized leg compression device for 25 years to enhance blood supply of legs (diabetics and the elderly) to save them from amputation. Time to commercialize it, via design upgrades. Located in the southern NJ/greater Phila. area, I am seeking local talent (experienced medical device entrepreneur/CEO type, with fund raising experience, etc.) to build a team/company and move forward. I know the medical market pretty well and know what and who the competition will be (more competition via the politics of medicine than from potentially competitive devices).

I am having meetings with local people that will hopefully provide that ‘aha’ moment and we’ll run with my plan to success. As one said, you have a ‘game changing’ device. I remain open to all input. So if anyone out there can provide specific direction, it would be most welcomed.

Stephen Shue
—
Talented physician innovators/ inventors always waiting for talented entrepreneurs/ organizers to take actual action in help and work together to make things work.
No silver raining from the blue sky but dig it with substantial efforts, talent and team up.

Lou Cabana
Principal at LRC CONSULTANCY LIMITED
Even after determining the market size, profit, and revenue, you must consider the competition. If the market is owned by 2 or 3 major players, you will have a very difficult road to market entry. A complete SWOT analysis assessing the reality of the proposition is paramount. Ask yourself what is the “value add” this idea will carry to the market, be realistic about the opportunity. In all likelihood you will be sparring with the big boys who are making margins in excess of 50%, and do not like competition in the least.