Case Study: Medical Devices
Helping to Visualize Success
- A head-mounted, vein-imaging system that lets clinicians visualize more peripheral veins than they can with standard clinical technique.
- Reduces IV needles stick attempts, referrals to central lines, complications and costs.
- Medical devices
- From concept development, prototyping, and product verification through complete contract manufacturing and support
- A physician had noted frustration with accurately locating veins among those administering hypodermic shots and IVs, especially for small children and patients that are darker-skinned, elderly, obese or those with compromised vasculature
- Based on published white papers on wave length/reflectivity of blood vessels, he came up with an idea that could help: a head–mounted unit that would cost-effectively facilitate vein location without changing standard clinical practice. He approached Enercon to develop and commercialize his proof-of-concept product. The end product had to be:
- Lightweight and portable enough to use at bedside
- Able to fit all medical staff
- Battery-powered, but able to last a full shift and easily rechargeable
- Comfortable and unimposing enough not to interfere with the administration of needle sticks, while offering a field of vision that encompasses patient anatomy and surroundings
- Easy to clean in order to meet sanitary requirements
- Compliant with all U.S. and EU regulations
The Human Factor
Following are the key inputs that guided Enercon’s design of the product:
- Workable weight balance
- Must maintain current user practice (mimics clinical practice)
- Easily identifiable on/off buttons (adequate size and contrast)
- Easy attachment into battery charger and storage
- Must not entangle hair
- No unusual noises
- Easy to clean with all hospital disinfectants
- No high temperatures generated
- Comfortable to ear with eyeglasses
Enercon worked closely with company to design and develop the head-mounted display system. The key steps were:
- Table-mounted version served as proof of concept, then followed with head-mounted version (patentable approach)
- Product was developed by conducting:
- Marketing studies
- Clinical studies
- Human factor analysis (see sidebar at right)
- Executed industrial design, accommodating all issues of packaging, weight, safety, battery life and regulatory compliance
- Developed prototype head-mounted unit, including three PCB’s, battery pack, illumination source, digital signal processing, camera & power management.
- Prototype housing made using rapid prototyping methods to allow for quick turn build and evaluation
PRODUCT DEVELOPMENT PHASE
- Established supply chain (qualified tooling suppliers)
- Developed tooling for injection-molded housing
- Product branding, marketing plan and collateral materials: literature, user manuals and documentation
- Enercon supported 510k submission documentation (regulatory approval for medical devices)
DISTRIBUTION & SUPPORT SERVICES
Enercon has, from the beginning, served as virtual manufacturing partner, providing all support services, from direct shipping of customer-branded product, to service depot warranty support.
- Product recently introduced to the market as an affordable yet profitable solution to a clear need in the medical community: to improve the success rate of IV needle sticks, leading to faster treatment, better outcomes and a higher level of patient satisfaction.
- First manifestation of company's vision for a line of products that 'redefine vascular imaging.'
"The enthusiastic early response to our first product from practitioners has been very encouraging to us as a business. We have been extremely pleased with our partnership with Enercon: their technical expertise and program management skills are impeccable."