New Medical Device Company

S

Sandman2002

Hi everyone,

This is my first post. I have enjoyed much of the content over the last few days. Thank You.

I'm starting a medical device company in the US. I'm in the process of recruiting some key players to grow the company. For the time being I'm on my own. I'm currently working with a great engineering firm that is full service and may be able to do everything for me...which is preferable. We have a good handle on manufacturing and FDA. But, In order for for me to feel comfortable with the next phase. I need to wrap my head around a few key components. Currently I'm looking for some leads on convenience kit assembler and contract syringe fillers that could handle small batches of 20,000 / year but grow to 1,000,000+ as we grow. Im also looking for insurance agent in the medical device space. If anyone has a great consultant or specific company they have had trusting relationships with I would love any recommendation.
 
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Wes Bucey

Prophet of Profit
Hi everyone,

This is my first post. I have enjoyed much of the content over the last few days. Thank You.

I'm starting a medical device company in the US. I'm in the process of recruiting some key players to grow the company. For the time being I'm on my own. I'm currently working with a great engineering firm that is full service and may be able to do everything for me...which is preferable. We have a good handle on manufacturing and FDA. But, In order for for me to feel comfortable with the next phase. I need to wrap my head around a few key components. Currently I'm looking for some leads on convenience kit assembler and contract syringe fillers that could handle small batches of 20,000 / year but grow to 1,000,000+ as we grow. Im also looking for insurance agent in the medical device space. If anyone has a great consultant or specific company they have had trusting relationships with I would love any recommendation.
Do you have patents of your own or do you expect to have the engineering company create designs for new products?

I've worked with a number of startup companies - some have products but no idea of a market or marketing plan. Some have everything together but start up capital. Are you savvy about dealing with the FDA and getting ISO 13485 for sales to foreign markets? Ready for CE?
 
S

Sandman2002

We have 2 preliminary patents which will be broken into three separate patents. We have a working prototype, and are on hopefully our last rev. The device will be a class 1 Accessory, a convenience kit. We have raised series A funds through FDA and are aligning ourselves for round two fundraising for sales and Marketing. We are focused on US markets at this time. I have a good handle on the market and distribution, but are budgeted and are looking for a VP of Sales
 
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