#1 Scope
A Statement of Work is drafted to define the deliverables, roles and responsibilities, and timeline of the project being considered. Both parties provide input into the document to ensure the accuracy and completeness of the desired work-plan.
#2 Perform
This is where the rubber meets the road and we get to work on the items described in the SOW. Lupine Medical is added to your development team as an additional resource that you can call on to do any number of activities, with a focus on the antimicrobial and anti-thrombic development and testing.
#3 Report
Data are compiled, organized and statistics performed. Preliminary results are shared with the sponsor. At major milestones including the close of product development phases, we provide reports, memos, and additional documentation to provide information for the design history file and regulatory submission.
Consulting
It’s challenging to sift through the many product and design ideas you or your organization produces. It’s even more challenging to determine which ideas are the most viable to move forward, and have the best chance for success from technical and regulatory perspectives. We at Lupine Medical have several patents related to medical combination devices and more than a decade of experience evaluating and developing new technologies from small startups and Fortune 500 companies. We’ve been there for every phase of product development, from invention to commercialization.
We understand the science, the design and development processes for a highly regulated device industry, the government regulations, the marketing, and the strategic planning needed to develop an idea into a product suitable for the medical device market. Tracking market climates and regulatory amendments, we get it done. Let us lead you through the product development process and find the best technology to create or improve your combination medical device. If you already have a technology in mind, let us help you optimize, test, and gain approval for your new technology.
Why Lupine?
Over the last twelve plus years, we’ve been designing and testing combination medical devices. We know from first-hand experience which labs are compatible with your critical testing phases, and where we can offer cost-effective in-house testing solutions. More importantly, we save you time by avoiding facilities that do not have the capabilities to perform testing to support your desired antimicrobial or anti-thrombic claims. Whether your product is a surgical scrub, a wound dressing or a coated implantable device, we have several select labs to choose from and will ensure that your product is being handled by industry leaders and experts in the field. When appropriate, we can use our existing library of blood compatibility tests, or design and validate new tests specific to your device or technology.