Emotional subject. Valuation will happen as we provide medical services to more and more people.

Mark Proulx, CQA, cSSBB Adrianna Davies When Johnson and Johnson comes knocking on your door wanting to purchase your company! LOL

Have to consider the medical necessity for the device and the market segment it will be applicable for.

Ken Powell Conduct a simple economic/value in use analysis of your new product compared to existing products/techniques and quantitate its value. There are other important qualitative factors (patient safety, eliminating infection, reduced length of stay, etc.) to consider that can be quantified and put in the analysis. I have done it so many times it seems a basic and simple exercise.

Aaron Liang Being at a medtech startup, I think the best validation is when the organization can reach its mission goals. For example, if a startup's mission is to bring innovative technology to set a new standard of care for a therapeutic intervention where there exists a gap in treatment options, then the validation of its efforts or success will be when physicians and patients adopt their technology and use it to improve patient health. Certainly the more widespread the market adoption, the stronger the validation of what they are doing and things will flow from there.

Santiago Ruiz-Valdepeñas (...)
There are several things you can do to work on early validation:
- Interview doctors, nurses , patients, etc, as soon as possible, and get them to simulate their real use of a visually realistic prototype. If you find it necessary to explain anything, that's a bad sign.
- If the device is complex, launch less critical features first. Maybe in a slightly different context/aplication, maybe even outside medical. Hidden opportunities for your technology?
- Ultimately, medical device development requires a higher degree of analytical, scientific work on every aspect of design, to ensure that quality goes beyond trial and error.
- On the bright side, medical devices are not as subject to intangibles (taste, fashion, image) as other industries. If your device solves an important health issue and is fairly usable by health professionals and patients, the incentive to buy is much more objective, measurable and powerful than random gadgets, services or apps.

Santiago Ruiz-Valdepeñas Great topic! Starting lean and having early adopters that will accept unfinished, imperfect products gives us insight in many industries, but there is no way we can do the same with such safety critical products like medical devices, so early validation is a big challenge in our industry.

(continues)

Bahareh Kashizadeh Market assessment is necessary .

Paul Kirkby Anything that's meets the end user needs with clinical application that suit s the costs and budget

Tapan Mukerji Human factors engineering and usability

Market validation is simply checking three "enough"s.
Are there "enough" people who want your product "enough" that willing to pay "enough" for it?

Along with Usability, User Need validation including claims covered in product brochure and as required clinical evaluation (by literature or actual field tests)

Does it meet the user needs, is it unique/novel, is there competition, is there a market for it, how successful will it be in the marketplace - gather evidence to support all.

Roman Liberson The market evaluation, to my maind, includes: 1) number of customers/clients. It is not the same as patients, as not always the patient is a payer. I mean medical insurance programs and companies. Reimbersement clearence - codes and predicate devices may assist. 2) real price for first distributor - this it your client in the case that final customer would be supported in payment by reimbursement.

Market orientation is must

Shadow clinicians or patients using your product - make sure that it solves their problem and make sure that you fully understand what that problem is. Repeat this with different groups encompassing different skill levels and ideally in more than one country to highlight potential problems.

Prakash Pcgoliya What about validation for components like FEP Teflon tube with R/O stripes manufactured by us ...?
Is it customer,device manufacturer ...?

Marco Farina, Ph.D. If the Value propositions are correct and the device receives the FDA/CE clearance......who will pay the device? Who is the payer? In US you have to prove to CMS that the device is more efficient of the "gold standard" otherwise no reimbursement. This means no market unless you convince private insurances to reimburse it.

This relates to having marketing the medical devices the have just been cleared by the FDA .