Case Study: Medical Devices

Helping to Visualize Success

Product Highlights
  • 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.
Market
  • Medical devices
Lifecycle Stages
  • From concept development, prototyping, and product verification through complete contract manufacturing and support
Key Challenges
  • 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:

  • Portability
  • Workable weight balance
  • Color
  • 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 Solutions

Enercon worked closely with company to design and develop the head-mounted display system. The key steps were:

CONCEPT PHASE

  • Table-mounted version served as proof of concept, then followed with head-mounted version (patentable approach)

PROTOTYPE PHASE

  • 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.

Results
  • 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."

-Company President


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