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Contract Designer Turns Company's Innovative Concept into Successful Product

Contract Designer Turns Company's Innovative Concept into Successful Product

Most businesses start with great product ideas. To stay in business, however, new companies need to transform these ideas into commercially viable products, and do so in a timely manner. But the product design and development process can be an especially risky endeavor for start-ups. It takes time to build an in-house engineering team with the necessary skills, and most companies cannot afford that time. As a result, many start-up companies turn to experienced partners to help navigate them through the design and development process.

Endius Inc., a medical device manufacturer based in Plainville, MA, aspired to revolutionize endoscopic surgical procedures for sinus and spinal surgery with the introduction of a steerable instrument that could turn corners and maintain sufficient force for grasping and cutting tissue at the target area. As a start-up with limited resources, Endius did not have a multidisciplined engineering team to execute this plan. Endius president and CEO Thomas Davison realized that building a team with the broad range of skills required to turn the concept into a marketable product would take more time than his company had.

Endius Inc. created this tool for endoscopic procedures for sinus and spinal surgery. The innovative device was brought to market quickly with the help of the product development firm Product Genesis.

"Time is money, and we needed to bring the product out fast," recalls Davison. "Building a team could have worked, but it was not the fastest way to bring the product to market." Davison approached Product Genesis (Cambridge, MA), a product development firm specializing in moving technology from concepts to market-ready medical devices.

Davison's plan was to outsource the entire product development process to a cohesive team of professionals knowledgeable in electrical, mechanical, software, and human factors engineering, as well as industrial design.

During the initial meetings between the two companies, Davison presented a business plan that called for a disposable instrument that could sell for less than $200, while the Endius-designed prototype had a materials cost in excess of $1000. Confident that it could handle the challenge, Product Genesis provided Davison with a draft development plan outlining the scope of work, a budget estimate, and a development schedule.

Going from Concept to Reality

Endius believed that its revolutionary technology, properly integrated into surgical instruments, would reduce the need for some invasive sinus and spinal surgeries. The challenge for the Product Genesis design team was to translate this vision into reality. The device had to be flexible enough to navigate twisting body cavities with a high degree of accuracy, yet also be stiff enough to permit the surgeon to grasp and cut tissue effectively. Achieving its cost-of-goods and time-to-market goals were key to Endius's success. Both goals were achieved through an award-winning design.

The early Endius prototype was reviewed by the Product Genesis team and evaluated for both merit and shortcomings. Brainstorming sessions were held at Product Genesis to uncover possible approaches to each element of the instrument. More than 25 concepts were explored for the steerable portion of the device alone. Detailed trade-off matrices were used to rank concepts according to a predetermined set of attributes and criteria. Among the criteria used in the evaluation were disposable cost, tip flexibility, safety, reliability, ease of manufacture, ease of use, permanent tool cost, and development risk. The matrices allow solutions to be based on quantifiable measurements and analysis. This process minimizes risk and often eliminates redesign later during the detailed design phase.

Foam models, 3-D databases in ProEngineer, and SLA prototypes followed for testing outside of the design lab. Critical to the success of the program was acceptance by surgeons. Their input regarding performance, ergonomics, and the usage model was collected and integrated into the decision matrices to ensure the selected product concept was appropriate for the target market.

The team's research and design efforts resulted in the design of a stack of injection-molded vertebrae with centrally located pivots known as the FlexTip. The tip is moved by pulling on nitinol wires threaded through one side of the vertebrae. A thumbwheel is used to flex the jaw of the device, while a triggerlike component actuates the jaws of the forceps. The jaw actuation wire passes through the center of the device. The use of nitinol wire helped overcome the critical challenge of achieving the necessary range of motion while maintaining rigidity during use.

To reduce production costs, the control system for the steerable forceps is embedded within the injection-molded body and comprises a minimal number of molded parts. The use of injection-molded parts for the spine pieces, body, trigger, and thumbwheel enabled Endius to achieve the target cost necessary for the device to be commercially viable as a disposable product. In addition the design simplicity of the main housing helped to keep the manufacturing process efficient and the parts count low.

Building a Future

The steerable forceps are the first in a line of minimally invasive surgical products to be introduced by Endius. According to the manufacturer, the product is gaining wide acceptance in the medical marketplace. Due to its success, Endius plans to expand its product offerings with two to three other devices that make use of the steerable FlexTip technology. According to Davison, Endius plans to continue using Product Genesis's engineering capabilities as they come up with new products to be designed and developed.

Reflecting on the strategic partnership between the two companies, Davison says that the successful collaboration of Endius and Product Genesis demonstrates the benefits of using outside sources to support product development efforts. "We may have still been interviewing mechanical engineers when Product Genesis was already building prototypes for trials. Now we are generating revenues even earlier than we had anticipated. And that's what this is all about, finding and taking the fastest path to market with a product you can sell."

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