How does a startup best meet the QMS and ISO 13485:2016 requirements for bringing a new medical device to market in Canada?

A 0.31 second Google search located this: http://i.cdn.turner.com/nascar/.element/pdf/2.0/sect/kyn/NASCAR_Prospective_Licensing_Application.pdf

First off, stop calling it an idea. (might be just that, but in licencing efforts you don't want to call it that). Second, what do you mean time is of the essence? This already started sounding risky. With that said, I believe you have two options, assuming that you can spend the next quarter reaching out and performing poorly in presentations and pitches to executives for licencing deals. 1. Learn the art of pitching and presenting, in my blog I have listed some books, one of them is presentations like Steve Jobs. Check it out here: unthinkeverything.blogspot.com (books are listed on the right) and hopefully secure a deal. The risk with this is that if you don't is time wasted. 2. Figure out a creative way to launch your innovation yourself, even if is simply to test for validation. It can be relatively inexpensive to do this (you didn't provide information on your patented idea so I can't help you on that yet). The upside of you launching your product or validation effort yourself is that it gives you exposure, it gives you business experience and most importantly it adds tangible value to your idea no longer putting you on the spot putting a random price point for it. This also makes it easier for you to approach companies and executives and if the licensing deal doesn't go through you have a business out of it. The reality is that if another business can make profit off a license, so can the owner of the product itself. Just have to figure out how.

If the person doesn't have a patent, trademark, or copyright on the thing you want to copy, then you can copy as much as you want. Current IP law in the USA is "first to file" (see: https://en.wikipedia.org/wiki/First_to_file_and_first_to_invent) If the person has any of those things, and you want to copy them legally then you have to ask them for a licence. If the person has any of those things, but doesn't have the money to sue you for infringement, then you might be able to copy it with legal repercussion. That wouldn't be very cool though.

I am a patent attorney generally on the patent owner's side. Signing such a clause should make you nervous. You don't want to be responsible for the major company's infringement. The major company is likely getting more benefit out of using your software than your company is making by selling licenses. The previous gentleman's answer is incorrect. Anyone can be sued for patent infringement if they make, sell, or *use* the claimed invention. It depends on the claims in the asserted patent. Based on experience, it's much more likely that the larger entity would be sued for infringement. A patent infringement case could cost anywhere between $350k-$5M+ USD. http://www.cnet.com/news/how-much-is-that-patent-lawsuit-going-to-cost-you/ In order to properly answer your question, I would need to know why you feel it's "very unlikely" that someone would sue the major company for using your software. If the major company won't back down on this provision, the best thing you can do is determine if you need IP (defense) insurance. If a patent attorney determines that it is necessary, raise the price of your license and get IP insurance.

This is always a question of who wants whom more. I've seen deals where the percentage was in single digits. The thing is, I've seen both deals where a LICENSEE ended up with a single digit percentage and deals where a LICENSOR ended up with a single digit percentage. It all comes down to your ability to convince the other side that you are bringing in so much to the table that the other side should get a smaller piece of the pie. Essentially, this depends on these factors: - whether you are well-known in the industry; - whether the other side is well-known in the industry; - the level of uniqueness of your product (if you've developed another minor variation of a product that already exists on the market, chances are the distributor will want a larger piece of the pie); - your level of desperation (it's one thing when you partner up with someone else who will commercialize your product simply because you can make more money by investing your time building new stuff; it's another thing when you have no realistic way to commercialize the product yourself, and if you don't find someone who can do it for you quickly, you'll starve...) MOST IMPORTANTLY, no matter what number you agree to, make sure you read the contract extremely carefully. Contracts can create rights and contracts can destroy rights. Contracts are more powerful than any rights vested in you by IP laws. So, the bottom line is: - Know EXACTLY what you are trying to get out of your contract; - Get your contract reviewed by an experienced lawyer, but make sure you tell the lawyer what it is you're trying to get out of the contract. Lawyers are not going to create "the right deal" for you. We're not going to tell you whether you should be getting 9% or 90% of the revenue. We're going to make sure that you understand whether the contract you are about to sign reflects what you think the terms of the contract are. You're welcome to schedule a call if you would like to discuss this in more detail. Cheers, Andrei