Customer Partners with Enercon to Develop & Manufacture a Direct Visualization System

• What is it?

The Direct Visualization System is an intuitive platform that enables simple, single-operator, direct visualization cholangioscopy for detection and treatment of large stones and strictures throughout the pancreatico-biliary system.

The System is comprised of:

1. The Catheter for imaging and illumination, navigation, irrigation and aspiration, and delivery of various devices
2. The Digital Controller [developed and manufactured by Enercon Technologies] that processes the video signal for display on an external monitor, provides dual LED illumination to the Catheter along with automatic light control and enables control of the light source through a front panel user interface.

• Why is this product important? 

Each year, more than one million people throughout the world undergo endoscopic retrograde cholangiopancreatography (ERCP) for conditions related to the liver, gallbladder, pancreas and bile ducts. The benefits of direct visualization cholangioscopy are well known and documented, but traditional approaches limited adoption due to the need for two operators and continual, costly capital scope repairs.

• Significant features of the camera/controller imaging system? 

Camera: The small area of the CMOS camera face (0.726mm x 0.726mm) allows this digital sensor to be mounted in the distal cap of the Catheter. This sensor features a total of 25,600 pixels (160 pixels x 160 pixels), an approximate 4X increase in the number of pixels compared to the previous generation probe. Unlike the previous probe, the digital imager eliminates dead space between pixels which is visualized as a honeycomb pattern by the physician. The field of view is 120˚ allowing the physician to visualize a larger region of interest.

Controller: The Controller provides the power and illumination for the Catheter, receives and decodes the video signal, performs custom image processing to generate standard video signals for display and provides a simple, easy to use interface for control of the light source. The Controller also features automatic light control (ALC).

• Clinical outcomes?
The clinical trial physician commented that the System is a dramatic improvement over the previous system, allowing him to view mucosal structure with impressive morphological detail.  He stated that the new system is a game changer and that the cases today altered patient management.  Overall, the system exceeded his expectations with regard to image quality, steering, deflection, suction and ease of set-up.

Caution: US Federal law restricts this device to sale by or on the order of a physician.

Helping Fulfill a Vision for Pediatric Ophthalmic Health

Product Highlights

• Ground-breaking portable digital vision screening device
• Allows pediatricians to accurately screen for vision abnormalities in children, even those too young to take conventional vision tests
• Contains embedded computer, keyboard, color display, digital camera, flash, battery & charging circuit, and focusing LEDs
• User data collection and upload of data for analysis via the built-in Ethernet port

Market

• Class 2 Medical Device

Lifecycle Stages

• From final design, prototyping, to full volume manufacturing, direct fulfillment and service depot support

Key Challenges

• Needed to be far more mobile, lightweight than previous design (4.5 vs. 30 lbs)
• Design to meet IEC-60601 standards for safety and emissions
• Device needed to increase processing power and functionality from original design
• Easy-to-use, portable
• Economical

Enercon Solutions

• Enercon took concept, then identified and corrected issues with product
• Modified design to solve safety, electromagnetic emissions, & static discharge issues
• Supported IEC-60601 re-testing of product
• Helped customer secure 510K approval

Enercon Services

• Product design and programming (Linux-based)
• Supply chain management
• Regulatory testing management & coordination
• Manufacturing and quality control

Results

• Seamless, direct fulfillment to end-users (pediatricians)
• Customer does not need to maintain or manage inventory
• Enercon maintains a supply of back-up product for ready fulfillment
• Service depot support

“The success of our product results from our listening to our customers, and Enercon in turn listening to us. Their experienced team worked closely with us, and were absolutely essential to getting our product to the market.”

-President & CEO

Reprogramming for Success

Product Highlights

• Public hygiene device subject to high-frequency use
• Battery-powered, ungrounded

Market

• Industrial Electronics

Lifecycle Stages

• Revamp existing product

Key Challenges

• Product was vulnerable to electrostatic discharge build-up, causing malfunction in arid environments
• Failure occurred in highly public place with multiple units, generated significant unnecessary expenses and end-customer dissatisfaction
• Customer faced the prospect of losing a high profile contract to a competitor

Enercon Solutions

• Customer enlisted Enercon to troubleshoot and redesign the electronics and software, while working on system improvements
• Enercon identified the problem and reproduced it in controlled laboratory environment, then:
  • Modified hardware
  • Wrote new firmware code (including an error-checking module)
  • Built prototype Printed Circuit Boards (PCBs)
• Enercon tested improved product first in lab, and then provided samples and made site visits for field-testing with Customer
• Enercon quickly and cost-effectively built components to retrofit hundreds of defective units, and provided Customer with the methodology to demonstrate that the problem had been fixed on-site

Results

• Customer retained end-user’s business
• Problem solved, has not resurfaced

Mobilizing Our Broad Range of Solutions

Product Highlights

For over twenty years, we have designed and manufactured vehicle driving controls to provide mobility to individuals with high-level disabilities. Our systems have also been utilized in unmanned military vehicles. Typical systems are integrated packages of both primary (accelerator/brakes/steering) and secondary controls (such as lights, windows and accessories)

Market

• Automotive
• Defense

Lifecycle Stages

From complete electrical and mechanical design through contract manufacturing. End products are highly configurable, composed of multiple controls and input devices that require a system level approach to design and manufacturing. Design services also include system re-fresh, with products currently at third generation architecture.

Key Challenges

• Mobility conversions are inherently difficult, requiring sophisticated programming of controllers to replicate the typical driving experience
• Each vehicle OEM has a different electrical architecture, and none provide aftermarket suppliers with any technical data, schematics, or other guidance that might help develop system interfaces
• Enercon needed to obtain, teardown, study and re-engineer products for each new OEM platform (new vehicle model or modified electrical system)

Enercon Solutions

• Customer has partnered with Enercon for greater efficiency and flexibility in keeping up with frequent OEM vehicle model changes
• Enercon provides finished product design and manufacturing
• Enercon ensures that all products meet strict redundant-system safety requirement (monitored by TÜV)

Enercon Services

• Complete development of all system architecture and design (electrical and mechanical). This includes:
  • Designing and building control modules and input devices (PCB assemblies)
  • Device programming
  • Enclosure design
  • Mechanical interfaces
  • Design testing and verification
• Product service and support

Results

• Customer has relied on Enercon as its key design and manufacturing partner for over 20 years
• Customer continues to be a world leader in sales of disability and autonomous driving controls

Riding the Demand Curve to Success

Overview

Demand Driven Inventory (DDI) is our Enercon optimized Vendor Managed Inventory (VMI) process. The goal is to reduce out-of-stock situations and minimize materials exposure, reducing expediting expenses, and better managing manufacturing workflows. DDI requires working together in close partnership to set safety stock levels and track daily changes in inventory levels—both receipts and unit movement.

DDI provides optimized responsiveness to changing demand, complete flexibility, and lowers the risk of stock outages and leftover obsolete product. At the same time, it enables us to manage production lines more efficiently, yielding lower overall costs.

The heart of DDI is to minimize inventory at each point of the supply chain and manufacturing process. Our process is based on KANBAN, a scheduling system that helps determine what to produce, when to produce it, and how much to produce. Product builds occur only when sales demand indicates a need to replenish stock. Materials, in turn, are procured only when the need to build dictates.

Enercon manages manufacturing, shipments and re-orders based on up-to-date consumption data and a level of safety stocks (i.e., number of weeks of supply) agreed on with the customer. DDI can benefit any customer that orders on a regular basis, as opposed to those that order once per year. This case study describes the experience of one of our customers, and summarizes the benefits received.

Product Highlights

• Enercon was integrally involved in the original designs, which included multiple PCBs.
• Enercon builds the PCBs and completes the integration of all components into the finished medical instrument.

Market

Medical devices

Key Challenges

Before using DDI, this customer issued purchase orders for product manufacture based on their forecast of demand. However, fluctuations in the demand curve left them with excess inventory at some times, while at other times, a lack of inventory meant they could fulfill orders only partially or not at all…leading to significant lost revenue.

They incurred substantial costs expediting product as well. We often had to build products immediately and ship them overnight—not just within the U.S., but internationally, too.

At Enercon, workflow planning suffered, leading to inefficiencies and challenges meeting all customers’ needs.

Enercon Solutions

• Once the customer agreed to have Enercon manage the inventory process with DDI, we worked together to facilitate daily monitoring of inventory–both receipts and usage—using automated reporting technology to minimize labor costs.
• A supply agreement set ground rules and expectations, including minimum and maximum safety stocks.
• We worked to anticipate consumption on a longer-term basis, which allowed us to purchase more efficiently, yielding greater leverage on pricing.
• Leaving the materials in their most basic, flexible form (e.g., rolled steel sheet rather than formed product enclosures) lowered customer’s exposure to materials. Unused raw components could be used for other customers or returned to the supplier with nominal or no restocking costs.

Results

• Customer funds tied up in inventory dropped by 50%.
• Stock outages, formerly a monthly occurrence, have been eliminated.
• Costs for expedited shipping dropped from $40,000 per year to zero.
• Customer reduced labor costs to manage inventory by 50%.
• Enercon reduced labor costs to manage inventory by 75%.

Illuminating Quality Closer to Home

Product Highlights

Compact, portable and feature-packed professional-grade LED fixtures developed for entertainment and display venues. Features include:

• Flicker-free, color-changeable light
• Output comparable to fixtures 4-5 times the size
• Patent-pending heat-sink technology

Market

• Entertainment

Lifecycle Stages

• Contract manufacturing & next-generation product design

Key Challenges

• Product originally sourced offshore for cost savings
• Customer contract manufacturer failed to maintain quality standards, with unacceptable and growing level of functional and cosmetic defects
• Company required extremely fast turnaround on conversion to domestic manufacture in order to meet near-term demand, while keeping manufacturing costs competitive

Enercon Solutions

• Re-designed the PCB (printed circuit board)
• Created and tested the new manufacturing process
• Established supply chain, produced and delivered revamped lighting products
• Now working with customer to implement product improvements to improve quality while lowering manufacturing costs

Results

• Enercon helped company convert from outsourcing to domestic production without skipping a beat in meeting customer demand
• Enercon now serves as a virtual extension of the company for design and manufacturing support on a growing range of products

“As a relatively small, fast-moving company, we find Enercon to be the ideal product design and manufacturing partner. They share our commitment to innovation, and have proved to us the advantages of trustworthy, cost-effective and high-quality sourcing close by to us. As we look to develop new products, we’ve decided offshoring is not worth the cost savings, given the uncertainty, supply chain issues, quality uncertainty, and lack of flexibility.”

-VP of Engineering

From Concept Sketch to Tested Success

Product

• Industrial Field Measurement Unit

Market

• Industrial Electronics

Lifecycle Stages

• From total ‘ground up’ product re-design through contract manufacturing

Key Challenges

• Core functional components of the customer’s existing product had not changed for many years
• Complete re-design was urgently needed to keep up with emerging competition. Product had to:
  • Be in compliance with applicable global standards
  • Meet the latest applicable industry test requirements
  • Be lightweight, compact, rugged and highly portable
  • Be manufactured at a cost that would yield competitive pricing

Enercon Solutions

• Enercon was given full, turnkey responsibility and complete freedom to develop a comprehensive, integrated contract manufacturing solution:
  • Designed new product from a loose concept sketch
  • Wrote detailed engineering specifications, including user-interface requirements
  • Handled prototyping and product performance verification
  • Produced electrical, mechanical hardware, firmware, and software design (including remote application compatible with Microsoft Windows) as well as product packaging
  • Launched production and seamlessly handled direct delivery of product with customer’s identity

Results

Using Enercon as its virtual product development and manufacturing division, customer has successfully refreshed this major offering of its product line without adding significant overhead costs.

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

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
• 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