Who are r u j e’ s Resources
We are a “Consortium” with over 100 years of experience, and have served over 200 clients collectively. Each are specialists in our respective fields. We each operate as independent businesses. All with stellar credentials and are highly recommended as an optional resource to ruje’s clients as needed throughout the product development process. Consortium business members have no financial, business or legal commitments to each other and are completely independent business entity referrals.
Griff Industries, Inc.: Mike Griffin owner Manufactures and markets disposable and re-usable medical products for operating room, surgi center, and Dental office applications along with consumer products.
In addition, our company offers prototype and production mold building and plastic injection molding services. We perform second operations, clean room assembly, ultrasonic welding, and packaging services. We are an FDA registered manufacturing organization operating out of a 17,000 square foot facility in Lancaster California. Visit our web site at www.griffindustries.com
Quality & Regulatory: George Austria Develops, implements and provides documentation for Quality Conformance with FDA’s and QSR requirements. George identifies and qualifies regulatoryrequirements both in the US and EU.George’s expertise includes managing and maintaining Quality Systems. Conformance with the requirements of ISO 13485 :2003, and FDA’s Quality Systems Regulations (QSR) organizations that manufacture Class I, II and III medical devices. At Safe Zone Global George designed and produced strategic products that support and promote optimum sharps handling in all preoperative environments. He holds numerous medical device patents. As VP and co-owner George was instrumental in the successful negotiation and sale of Safe Zone Global and their complete product line to Aspen Medical.
Fusion Fabrications: Andrew Pilgrim owner Under the direction of Andrew Pilgrim, Fusion Fabrication provides alpha and beta prototypes in plastic, wood, and metal. Fusion Fab. 3D prints in FDM, SLA, SLS, or traditional CNC manufacturing processes.The company has serviced multiple industries, including the medical, automotive, and consumer market. As a mechanical design engineer Andrew takes parts from inception to the initial 3D printed preliminary prototype, the alpha and beta comprehensive prototypes onto preparation for mass production injection molding. In addition he brings his experience in finite element analysis for determining theoretical failures prior to production. As well as sheet metal design and manufacturing, part design for traditional milling, and lathe operations.
Researcher: Tom Donnelly PhD is a seasoned research professional, providing insightful medical market research in a timely and cost efficient manner. Tom is an experienced moderator and qualitative analyst, and trained statistical analyst. He is a former psychology professor and academic researcher.
Tom has provided his clients with innovative design, execution and interpretation of marketing research to deliver fresh consumer insights and market knowledge to clients worldwide. Tom uses Sawtooth and SSI CBC survey analyzing software tools. Industries he’s serviced include healthcare pharmaceutical, biotech and medical devices, consumer packaged goods, food beverage, financial and insurance services, IT, lotteries and gaming, travel, tourism and entertainment and others.
About r u a n e j e t e r
- Ruane Jeter is the founder of r u j e Product Development.
- Graduate of the prestigious Interlochen Arts Academy.
- Graduate of Cleveland Institute of Art at Case Western Reserve University with a degree in Industrial Design, and double major in both Product and Auto design respectively.
- Apprenticed with internationally renowned product and interior designer Kay Uwe Witte founder of XO Design Group GmbH in Offenbach Germany. She also worked for Mattise & Patzak Design firm in Darmstadt Germany.
- Known for her design and patent of the First toaster with digital graphic touch interface display for selecting brown-ness while simultaneously lowering the bread into the toaster, offering a clean sleek design with no external manual levers or knobs protruding from the toaster housing.
- Products designed by Ruane Jeter have proven to be innovative and successful in the marketplace for over twenty-five years and have collectively sold millions of dollars worldwide.
- She has designed products for several companies ranging in size from startup’s to Fortune 500. Industries that include Food Catering Equipment, Consumer Products, Window Door & Hardware and Medical Device, where she has spent over half of her career. Designing for various modalities within the medical device arena such as Surgical, Pharmaceutical, Sharps Safety & Disposal and Mobile Point of Care.
Products designed by Ruane Jeter have been published in: AORN medical journal, for the Sandel Safety Scalpel™, The Change-A-Blade™ surgical scalpel was featured on the front page of Surgical Products Magazine and cheered for it’s blade versatility and excellent tactile-ergo feel. Also, in Nightclub and Bar Magazine for the Vinum Conservator TM Wine Preserving Machine. In addition, Ruane has been written about in Susan Casey’s book Women Invent, Patricia Carter Sluby’s book The Entrepreneurial Spirit of African-American Inventors and in Upscale Magazine’s the Modern Inventor series. Products designed by Ruane Jeter have been used in the entertainment industry as props, movies such as A History of Violence and Dallas Buyers Club. She has numerous patents, with several pending. (For a comprehensive list of Ruane Jeter’s patents go to www.google.com/patents).
Ruane has designed Sandel Medical Industries/Ansell’s surgical scalpel lines, the Sandel Safety Scalpel TM, the Change-A-Blade™, the Z-Tray™ and the Keep –It-Up™ System of disposable “sterile-field” products comprised of a magnet drape, scope holder, tubing holders passing tray, suture saddle bag, GC Devon-Products/Kendell-Healthcare’s disposable sharps line, 5 quart, 2 & 3 gallon Sharps-A-Gator ™, Howard Medical Industries point of care medication delivery cart line HI-Care E ™, HI-Care X™ and the HI-Care Cart Accessory Pak. Second generation Pinnacle Carts models 45 and 15. Becton Dickinson’s second generation drug delivery devices for the Redipen™, Pen II™, Syringe Infuser™, Accuspray ™, Syringe Plunger Rods, Needle Hubs & Caps and Rubber Septum’s, bulk Prefilled syringe Packaging and Product family integration across platforms. Cambro Manufacturing’s high temperature gasket lid line the GripLid™, Cambro’s gastronome pan carriers the Ultra Pan Carriers® S-Series, Cambro’s dolly & dish caddy the Camdolly™ Cambro’s beer and water server the Laguna™ Pitcher, and the banquet tray holder, Reflectolite/Truth Hardware’s internal and external patio door handle sets and more.
Synopsis of Ruane Jeter’s Experience Ruane has experience applying design principles and concepts to products across several business models. She Managed Sandel Medical Industries R&D department for 4 years, managing all new product development projects from design research, concept development, prototyping, end user testing and analysis, final end user verification, through manufacturing product validation and transfer. She has also guided and mentored subordinate designers and engineers.
Ruane spearheaded relationships and connections with research vendors, physicians, nurses and tech’s, needed to perform domestic & international feedback, capturing critical criteria/deliverables for product improvements and new development initiatives for Howard Medical, BectonDickinson, and Sandel Medical. Ruane has implemented inter-departmental control processes and procedures to solidify accuracy and expedition. Lead teams in exploring customer feedback data gathering, deciphering and (depending on the company) used either a Workshop Collaborative Space or DFSS /Design for Six Sigma tools for targeting multi level deliverables. She collaborates with human factors engineers, experiential and ethnographic teams during projects relating visual, tactile-audio, tactile-dexterity and graphic interactions to the products.
Ruane’s forte is research driven concept development coupled with on-site/in the field hand sketches capturing the end users immediate input, then translating/designing those customer needs & wants/deliverables into product features. Throughout Ruane’s career she has not only done the industrial design on products she has developed, she has engineered numerous internal and external mechanical mechanisms and components. Such as the redesign of BD’s liquid dry injection pen. Ruane designed a fold and snap together Syringe. It allows a simultaneous ratchet & hinge interaction to occur in conjunction with a lever that lowers turning a cam, which releases a preloaded spring, that forces a plunger and stoppers up inside a medicine vial. This releases a liquid that reconstitutes/mixes a lyophilized drug for injection into the human belly or thigh area. This mechanism-design changed the patient from using a crude amount of Hand Force onto a hard surface to activate the syringe, to a Cam Driven Activation System where the patient simply unfolds the syringe and snaps it together. Ruane’s design received positive patient consensus for achieving a smaller compact easier to use, easier to carry and store device.
Ruane has orchestrated and run analytical team brainstorming sessions exploring multi level customer deliverables, as well as run team interrogations analyzing concepts and approach methods of competitive products, scrutinizing design thinking and concept development for best functionality, ergonomic ease of use, overall performance and appeal on all out going development projects.
She has performed in depth design & development research at hospitals throughout the U.S. for Howard Medical Industries largest customer the U. S. Veterans Administration, interviewing hospital BCMA Coordinator’s, RN’s, LPN’s, and Tech’s regarding their needs and wants for Howard Medical’s next generation of mobile medication delivery carts “The Pinnacle Line” used throughout the VA system.
Ruane has coordinated in-house LAP’s/ Local Assessment Panels (Focus groups of local professionals in the field), and user preference testing with outside research houses as part of design verification. She has worked domestically & internationally with Marketing, Sales, Quality Assurance & Regulatory., design & Engineering Vendors, Mechanical & Mechatronics Engineer’s,Toolmakers, Molders, Process Engineers, Manufacturers, Assemblers and fulfillment houses. For eighteen yrs. she has worked within the constructs of design control. Adhering to various standard ISO, 13485, CAPA, ASTM, ANSI, GD&T, NSF, CE, CMDR and human factors engineering standards, as well as IEC 62366 & ANSI, AAMI HE74-75. Providing support documentation to Quality Assurance & Regulatory Affairs for 510K’s, DHF’s, DMF’s, etc.. She has established critical post-testing deliverables, collaborated with in-house labs & out-sourced testing agencies on recommended test methods and specific requirements for documentation of test results.
With over two decades of experience
Ruane is an expert in the field of product design and development. With her finger always on the
pulse of emerging technologies, coupled with her passion for design excellences,
Ruane delivers high quality products to industry.