Tarek Elneil The risk management is the most critical in products development because it will improve the user safety, will comply with regulatory requirements and will be cost effective in the long run.

Aaron Liang I think at the end of the day, risk management should come out because if the risks are not properly managed within the design controls, the benefits accrued from ttm or abundance of features won't have sustained market power in the long run because those unacceptable risks (safety, regulatory, etc) will manifest in the field which are much more costly to address. That being said, things like features and ttm do matter in such a competitive market and I think the best approach is balance of all that ensures risks are managed at an acceptable level so the product can make it to market with the features for safe and effective use and iterate using clinical feedback from initial adoption.

Stephan van der Merwe Thanks Tarek and Aaron for your great input and feedback. The x 5 forces have their trade-offs!

Heather Campbell For diagnostic devices, the risk to the patient is inherently low. The most critical criteria in my experience is "Features", which I understand to mean product performance. Diagnostic sensitivity/specificity and convenient workflow are probably the two most important features.

Mateusz Pawelec I agree that risk analysis is an elementary feature - it determines the safety so there is no doubt that it needs to be done properly. however critical for success in my medtech product development criteria is also ”response to customer needs” – we always need to remember that we are producing for SOMEONE and Someone's needs.

Stephan van der Merwe Thank you Heather and Mateusz for your excellent input!

Clearly written and translated requirements derived from customer-facing product managers. Those clear requirements should state the intended use and who the target user will be, which will ultimately be fuel and fire for product and commercialization of such product.

What are your views on the role of industry consensus standards in product development and translational engineeering process?

Roman Liberson We are talkng about development problems? Only two - money and qualified stuff. If we are talking about project success - understading of real need and providing satisfacting product; regulation; reimbursement; good marketing; good strategic partner

Andrew Wilson MedTech Impact Conference 2016 gives the ability to demonstrate and showcase your product to 1,000s of doctors who can help commercialize your product and provide feedback. Depending on the medical device if a wearable etc. the ability to have a doctor who believes in your product to then recommend it to patients is a success in the making. Anyone looking to showcase a new device should consider this opportunity. I'd like to help new device companies commercialize their product - serious inquires only....

Peter Saalmann When I wanted to offer a new device I asked good and relyable clients (doctors) what they AND their patients need to have less problems with their disease (inflammatory chronical skin diseases) and then development started. When a prototype was ready it was presented on medical congresses to the doctors to get a feedback.
So R&D and marketing went hand in hand and when the first device was more or less ready it was given to well known University hospitals to get a study. Publications about this new device have always been useful for sales! All this feedback is important for QM as well as for marketing.

Materials and R&D cost go hand in hand. I call the combination of these two, the "True Cost". The end result being a "finished" product. Once the unit cost is determined, marketing costs then comes into play. Lastly, in regards to customers and patients, I feel features and safety prevail.