9 min reading time

Some group members reach me at the earliest stages of their start-ups.

They have limited (or no) funds.
They have the germ of an idea.
They have a product but no marketing strategy, investors, etc. etc.

I’m sure many of us would like to help … and while I may donate an hour here or there … that’s not going to make a big enough difference for someone looking for serious direction, mentorship, and counsel.

Very few of us can afford to tackle their fundamental challenges with the near-certainty of no compensation. Is there a practical way to help them?

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Steven R. Rakitin
Medical Device Software, V&V and Compliance
I have worked with many start-ups who often need a lot of help. The way I provide help is to focus on the product development process. This process needs to comply with the Design Controls section of the Quality System Regulation. By working collaboratively with the team, we establish a reasonable set of product development procedures (SOPs) that are designed to both comply with the QSR and allow for flexibility and innovation. Building a solid foundation with an essential set of product development SOPs is one way to help those who need a lot of help…

Regards

-Steve Rakitin-
Software Quality Consulting, Inc.

Mark Rich
Enterprise Account Executive | Building Brand Loyalty | Cloud Contact Center | SaaS
I am interested to work with unfunded early stage companies on commercialization strategy. Compensation would be in the form of Equity and a Board Member. .

IORDAN STAVAR
President at Worldwide Independent Inventors Association ( WIIA )
We provide free posting of inventions on www.worldwideinvention.com

Sandra Horton
Business Development/Finance App Solutions, Marketing/Social Media, Virtual Admin
My Company LPI is offering Application Only Working Capital Loans, and others as well. I am available to help with the loan process. Our loans are specific to Licensed Doctors. Please call or email me for more information.

Jerrold Shapiro
President and CEO, Fem-Medical LLC
Jean, the conservative current funding environment may keep truly innovative medical devices from being developed. Investors want to see a clear path to an exit, with discrete milestones along the way at what they call “valuation inflection points” such as regulatory clearance, sales to first customers, etc. Here in Massachusetts, we have a state agency that is supposed to help life science companies endure the “cash flow valley of death” between submitting all the required clinical and other data to the FDA, and FDA 510(k) clearance to market your product, however, the company has to raise the first $300,000 themselves before they can qualify for the state’s matching funds.

The JOBS Act provides a funding vehicle for companies that need early money for prototypes, clinical studies, etc. but the SEC will probably take until 2014 to issue the rules for crowd funded securities, so raising early money is still a challenge.

Do any of you know whether patient groups or foundations will fund the early stages of developing a medical device treatment for their disease? There are many patient advocacy groups that raise money for research, but which ones support commercialization of an idea into a product?

Jean Bigoney
Regulatory Affairs Specialist.
Jerrold, I hear what you are saying. And believe me, I know first hand how different medical device companies have to be owing to the highly regulated nature of the sector. Still there are general aspects that these agencies should be able to help out with things like business plans and access to funding. I agree that not all of the individuals who volunteer or who take these government jobs are the best possible candidates for helping entrepeneurs. It’s the luck of the draw; I also know individuals who volunteer their time who used to own small medical device companies so at least it is worth a try.

The greater issue as I see it is that the rules of the game make it imperative that someone with the germ of an idea assemble a small army before proceeding very far. Having the idea is great. Getting a prototype costs money. Having the required testing done costs more money. Going through clinical trials costs a LOT of money. Getting design and production set up according to FDA requirements takes time and money. And that is only your ticket to enter the regulatory arena; now you get to sit back and wait while the FDA considers your submission.

I think many entrepeneurs underestimate the effort it takes to get an idea or product to be a success in a highly regulated market, particularly if they have an existing product which is very similar to a regulated product. When they find out, many abandon the untertaking. It is a shame, because we may be losing out on new devices that could improve the quality of life or save lives. So hats off to those who offer their time to help these fledging companies make it.

Shashindra Singh
Senior Investment Banker
I have a basic practical breakthrough product, with a unique concept. Would like to know, how can an inventor , convince a seed investor , with his concept being not compromised, if the inventor has no funds to go for IP.

Diane Marie Kabbaz
SELF EMPLOYED
Hi Joe! I think that you are obviously very selfless, and, Care about those of us who fall into that “entry level” category. Having been a recruiter for physicians, as well as a short stint with Haldane & Associates, I walk around shaking my head quite a bit. I find it to be a real shocker on how the whole hiring process is handled. Of course, it is just my opinion, however, such an important role is undertaken by the sales force. To me, that is the lifeline of the success or failure of a company, Pardon my frankness, but it appears to be handled in a rather haphazard, impersonal way. I sit back and wonder how a recruiter, who doesn’t reside in the same city, has never met me, nor even had a phone conversation with me could possibly have any feeling about my aptitude, personality, successes, likes & dislikes, my passion for sales, drive, determination and positive mental attitude. True … I did get Certified, but have no experience. I am much like many of you years ago. Joe, I actually had a recruiter, (the only one I had an actual one on one conversation with–after much pleading on behalf of the defendant) lol – He told me flat out that I was too old & would be considered a liability. Never mind the fact that I’ve consistently took it upon myself to start from ground zero at every career I’ve ever undertaken – or the fact that within months, I was making six figures – countless times much more than their “top” producer! When I do something, I either absorb all I can from everyone I can – a regular 🙂 sponge – OR If I have No Interest, I waste No Time! I have begged recruiters to do a little work – sell me – Just Get Me In Front Of A Decision Maker —- I’ll Do The Rest! I’m looking for any advice. I’m almost to the point of telling Mr. or Ms. prospective Mgr. “Look – I’ll pay You, until I produce!” I have Never Accepted “no” for an answer, and don’t intend to start at this late age!!!! lol I would love to know the stats on how many of these “young” people, who are just starting out their life, actually stay with these companies for longer than 2 – 3 years.

Well I have only two things more to add: 1) I come from a family whose genetic predisposition is to live a very, very, L O N G L I F E!
2) My Cup Is Always Half Full – However I Will Spill It On The Next so-called Recruiter who is Brave enough to tell me that no one will ever hire me

ps: My personal friend who happens to be a Thoracic Surgeon said, “Diane, All you have to do is be YOU, kiddo!”

Srinivas K Rao
Consultant Orthopaedics at ESI Hospital,Hyderabad
I have couple of novel devices.They have gone thru’ the design and development.I am looking for incubation centers / parks connected with universities or biotech parks in USA, who can provide me with 2000 square feet of manufacturing facility ( GMP ) and help me with the regulatory affairs(FDA class 510 K – Predicate devices )

A brief abstract is given below
” Bioplats is an integrated developer, manufacturer of regenerative biomaterials and bioimplants processed from organic source. Bioplats®’s key biomaterial platform technologies include the tissue technologies, for advanced wound care devices and novel biomimetic bone substitutes

Advanced wound care devices: These devices made in the form of a transparent sheet, is used for external applications– chronic wounds such as diabetic foot ulcers, venous leg ulcers and acute wounds such as burns, plastic surgery and scar revision.

Novel bone graft substitute : These novel bioceramic devices developed by
Nanostructure processing of inorganic and organic biomaterial with ultra fine structure. These devices with excellent mechanical and biological properties are for orthopaedic and dental implant applications.”

IORDAN STAVAR
President at Worldwide Independent Inventors Association ( WIIA )
Maria Corrales : thanks ,good advice 🙂

Martha Moyer
Executive Director at Seth Moyer Support Microboard, Inc.
Well, I am in a little different boat. My adult son with autism uses a medical device to clean out his bowels (his bowels are completely nonfunctioning) developed by a paraplegic so he could toilet himself. It is a simple device that cleans out the whole bowel system with a pulsating manner. It has saved the life of my son. Of and on we have been able to get either medical insurance or Medicare to pay for it but now we can’t seem to find any way of getting this paid for by either Medicare, private insurance or Medicaid, which my son has. I thought we were making progress with Medicaid but they reconsidered when they saw we would need denials from Medicare and private insurance first. My son has used this remarkable device for close to 15 years so it is not a new concept. The company still exists and supplies my son with the disposables. However, I have had to become a Home and Community Based Medicaid Waiver provider for my son so I am able to pay for it with administrative funds. Since I support just one person, my son, money is very tight and Texas, where we live, is not willing to budge. The manufacturer is Piemed. com. Ideas please! I think the manufacturer recently joined here.

Perry Mykleby
Customer Activation, Engagement & Retention
@Julie, I agree re: Edison Nation. They are entrepreneur-friendly, and have a winning model for getting great ideas to market painlessly.

If you sign up, use group named “Yakata” for a free submission.

Martin Fekete
President/CEO at Divergent Health, LLC.
All excellent ideas and suggestions presented here. One last comment is the local Small Business Administration or Chamber of Commerce. My experience, is these local offices are manned by retired businessmen and offer these free of charge in many instances. Just another resource when resources are scarce.

Marc Alessi
CEO at SynchroPET / Partner Shelter Rock Strategies
I NEED HELP! SynchroPET is a start up biomedical device OEM, with a platform PET Scan Technology out of Brookhaven National Labs, we are looking for experienced managers, sales people, and a contract manufacturer/design willing to take a risk with us. www.synchropet.com

Julie Wheelan
Founder & CEO at Untether – Brand Growth & Innovation Consulting
Check out Edison Nation Medical (www.EdisonNationMedical.com), which is a collaboration between Edison Nation and Carolinas Healthcare System. Helping inventors bring their ideas to life is exactly what this company does!! And the ideas can be at any stage of development — from just a “germ” of an idea all the way to the point that the idea is ready for manufacturing.

There are plenty of shady product innovation companies out there, but Edison Nation actually has a very reputable and trustworthy track-record. In addition to the medical division, Edison Nation also operates EdisonNation.com (an online community for innovators); Everyday Edisons, an Emmy® Award-winning series on public television; and Inventors Digest, a top trade publication dedicated to the study of business and innovation.

Ann Dehmlow
Registered Nurse at SEDOL
I would love to communicate with a fellow medical device inventor!

Sandy Ingold
Inventor-Medical Shorthand Keypad (LION)
Hi Ann, I have been in the medical field for 36 yrs and I also invented a medical device. I would love to chat with a co-inventor. Can I send you an invite?
Sandy

Ann Dehmlow
Registered Nurse at SEDOL
I am a nurse with a medical device I was trying to find help with getting to market. I just kept asking questions to everyone one I met via every resource I could, took notes, researched, followed up, followed through and via help of some very helpful, knowledgeable, giving people, I am on my way to helping those people I designed this device for. I am smart enough to know I would not be able to do this without help from many, many sources. I am a nurse, not a business person. I do not know what questions I need to ask, or of whom. I do not have the business connections or speak the “language”that would get me in to see the right people without the help of people like you. I will never be able to return the help, favors, or whatever you want to call it, to all of these people. I just hope they already know how I feel. I thank them every time we communicate, whatever way that may be. Please consider helping another small business start up like me. I may be nothing to you but and hour or two, but it will make a world of difference to that person. And to those to have helped me that maybe reading this, Thanks again. It is much appreciated

Jai Shankar
Partner, The JJ Team
Good to see the comments of Help from various members in this Group. It can go a long way in helping people with great ideas.

Tapan Mukerji
Medical Device/Digital Health Business Development, Start-Up Advisory Services, US and India
We are ready to offer help for innovative projects in Oncology area. We have our non-profit arm to explore grant funding opportunities and our exclusive R&D company to take the product thru’ design, development, commercialization and regulatory procedures.