Serial medical device entrepreneur Dr. Yuri Sokolov asks the group, “What comprises product market validation today?”

He assembled this list for today’s discussion. (I think it’s missing a thing or two.)

1. Meeting regulatory requirements – confirmed by appropriate regulatory bodies;
2. Meeting user requirements – by target users;
3. Meeting other customer requirements – confirmed by target customers;
4. Acceptance by opinion-makers and recommenders in the field – confirmed by them;
5. Confirming the price – by prospects;
6. Issuing quotes to prospects;
7. Obtaining purchase orders;
8. Producing and delivering the product/service to customers – as specified;
9. Collecting payments from customers – per terms of payment;
10. Having the early customers delighted with the product/service and recommending it to others – generating buzz in social media, on the show floor, etc.

Do you agree with the list? What would you add or take away, and why?

Yuri’s LinkedIn profile: http://bit.ly/Dr-Yuri

++++++++++

FREE UDI / GUDID WEBINAR FOR MANUFACTURERS: July 31 at noon Eastern Time

Are you planning to use the FDA’s GUDID web interface or another solution for all your devices?

The http://medgroup.biz/UDI-goes-in-effect-Sept-24 event is appropriate for: Regulatory, Manufacturing, Operations, Supply Chain Logistics, Compliance, and Distributors with UDI Submission Responsibilities.

We’ll record and transcribe the session so sign up even if you can’t make the live event. We’ll email you when the replay is ready.

++++++++++

Discussions You May Have Missed

Are remote monitoring devices protected enough from hackers?
http://bit.ly/hacked-remotely

Does Quality System Remediation (483 or Warning Letter) strain your R&D and NPI?
http://bit.ly/483-strain

A comparative analysis between single vendors vs. multiple vendors for hospitals?
http://bit.ly/single-vs-multiple

Asking FDA for a letter regarding allowable use of device during exhibits?
http://bit.ly/allowable-use

++++++++++

Make it a great week.

Joe Hage
Medical Devices Group Leader

P.S. When you register now for the UDI webinar, we’ll send you links to the first two events in the series. http://medgroup.biz/UDI-goes-in-effect-Sept-24