Medical device start-ups should be familiar with the FDA Design Control regulations and it is their responsibility to have a design control framework in place. That means our regulatory group can generate design control documents, but they should be merged with the client's
existing quality system. We understand the
FDA Design Control regulations, and our team will ensure that the compliance documents are integral to the overall development process, not an afterthought.
Image: Kathryn Kukulka, Regulatory Affairs Director Patent news - Stanford University states that $20 billion was spent on patent litigation and patent purchases over the last two years. In the last decade, patent lawsuits have nearly tripled, contributing to what some are referring to as a "patent tax", which can add as much as 20 percent to R&D costs. The problem is compounded by patents granted for ideas that already exist, like
Apple's recent design patent for a rectangle with rounded corners. We will discuss the clout of design patents in our next issue of OMNInews.
Innovation is a subject we discuss a lot at Omnica. Most design and engineering firms could make the same statement, but not in this case, since one of the exceptional ways we innovate is rare in the product development world. The singular service I'm referring to is pre-development, the critical proof-of-concept and feasibility activities prior to design and engineering. We call it "Phase 0".
Our
R&D and science group excels in answering the client question, "
We're not sure this is going to work. Can you help us determine if it is possible to take this idea and leverage it into a manufacturable medical device?" This is not the same as asking for help with a new iteration or a next generation product. The client wants to know if their intellectual property, new technology, or rudimentary prototype represents a rabbit hole or a new opportunity.
Image: R&D FixtureThe customer who hires us for this type of specialized activity wants to limit their time and financial exposure by exploring unproven, concept-type projects, in an ordered and scientific manner before they commit to a full-blown development program. We have performed this service for both start-ups and well-established firms like Tecan, J&J Ethicon, Medtronic Minimed, Volcano Therapeutics, Alcon, SafeShot Technologies, and others.
OMNICA News and Announcements . . .
A New Look at Omnica - If you have not visited Omnica recently and are in the Irvine area, accept my invitation to see our newly remodeled entry and meeting areas. After years of the same look 90s look, we felt it was time get with the 21st century. As Rex might say, "It looks pretty slick". But some things haven't changed. We are still a world class product development firm with the personnel and resources to do the complex jobs others cannot.
Omnica Calendar March Quiz- Which fighter jets are zooming over Manhattan on our March calendar page? As a hint, it starts with an "F" - I seriously shouldn't say any more. Email the right answer, and I'll reward you with a Starbucks coffee card. If you did not receive your 2013 Omnica calendar, it's not too late. Contact me and I'll send one to your address.
