By Robert R. Andrews
![](/ProductImages/0509/PD59FF01a.jpg") |
| Medical device manufacturers sought outside expertise when designing a one-handed biopsy tool… |
Medical manufacturers targeting market leadership are able to provide innovative solutions to meet their customer’s most compelling needs. To get products out quickly, most companies are utilizing outside technology sources to leverage diversified knowledge and experience.
Simply put, working with an external engineering firm is a cost- and time- effective approach to unlocking innovation. In fact, relationships that couple an OEM’s own ideas with the practical applied knowledge of an engineering firm is the latest trend for turning concepts into one-of-a kind products that quickly reach the market and edge out the competition. The following two case studies illustrate this point.
Unlocking Innovation
For more than 95 years, C. R. Bard Inc. has committed its resources to creating innovative products and services that meet the needs of healthcare providers and patients. So when the company was looking to be first-to-market with a one-handed biopsy tool, it partnered with an outside firm. To successfully develop C.R. Bard’s concept, the engineering firm approached the product from the end user’s perspective to ensure practical application and market viability.
By using expertise in medical product design, materials, and mechanism development, the firm helped the company roll out an ergonomic biopsy tool that surgeons can operate with one hand. The joint team also was able to design the product to meet the requirements of the existing 510(k), helping C.R. Bard gain quicker industry acceptance and market leadership.
![](/ProductImages/0509/PD59FF01Ba.jpg") |
| …and a new generation blood bag for the U.S. Army. |
The primary challenge was leveraging the right expertise to evolve a solution that supported one-handed functionality. Successful implementation came from the knowledge of varied, but unrelated disciplines, such as ergonomics and human behavior, to design a handheld diagnostic device able to perform biopsies.
What resulted is a simple design where all mechanisms fit into the handle. Because of this, the handle required a solid housing made of a rigid material but also a flexible grip made of a resilient material. Both elastomeric and rigid polymers were selected to accommodate a design that could be replicated through injection molding.
The unique features of the biopsy tool are its low-force operability and ergonomic design. It also has a lockout function that promotes easy handling. The product can be either cocked and/or triggered by the surgeon from either the top or side of the tool with one hand. To make the tool reliable/safe, a safety latch was built right into the handle.
ADVERTISEMENT
Multi-Discipline Approach
External technology resources with a wide breadth of engineering disciplines encourage new ways of thinking. They can help steer a company away from covering old ground and establish new parameters right from the start to minimize unnecessary costs and risks. This was the lesson learned during development of a next-generation blood bag for the U.S. Army to enable lyophilization (freeze-drying) of blood products. In this case, an external firm was selected to work with Walter Reed Hospital to design and develop a product to collect, lyophilize, store, and re-constitute blood products for combat care of military personnel.
By leveraging microbiology, plastics, mechanical, and packaging engineering expertise, the manufacturer reached its goal. The biggest challenge was preventing blood waste or loss that occurred due to cracking PVC at -40°C. By conducting heat sealing tests on various PVC and polyurethane grades, breathable polyurethane (less than 10 microns thick) was selected to form the bag because it offered the highest rate of drying and virus resistance. The new bag allowed the lyophilizing process to take place at -20°C.
To overcome the challenge of blood contamination, a system was created that eliminates contact through development of a container with a hole in its lid. Basically, the blood bag has a membrane on the outside and an inner lining, separated by a heat-sealed valve that opens automatically under a vacuum to permit the removal of water vapor. After lyophilization, the valve is permanently sealed and the membrane removed. This system provides virus protection by prohibiting blood exposure during processing. Testing has shown high drying rates and 100 percent protein recovery.
More recently, the engineering team has applied impulse heat-seal technology to create a method for sealing the bag in place on the lyophilizer. Additionally, the process specifically controls bag expansion due to differential pressures. And while the unique blood bag has already achieved many of its goals ahead of time, development by the outsourcing team continues to find ways to get the process working closer to ambient temperatures. Originally the bags needed to be lyophilized at –20°C, but now the team has got it to almost 0°C. Continued progress is expected.
The greatest challenge to medical manufacturing is staying on top of new technologies, and harnessing the creativity of diverse talent to develop the “next” innovation. True innovation is reached by meeting customer needs by way of a superior and novel approach. Smart companies never lose sight of the end-user when considering new product development. Innovation is not defined by the sophistication of the technology, but by the cleverness of the least complicated and lowest cost design used to solve the problem.
About the AuthorRobert R. Andrews is medical division manager for the commercial group at Foster-Miller Inc., a QinetiQ company, 358C 2nd Ave., Waltham, MA 02451. He has more than 25 years of medical device experience managing product development and operations. He has 10 issued U.S. medical device patents. He received an MBA from Bryant College and a master’s degree in plastics engineering from The University of Lowell. He can be reached at 781-684-4639 or randrews@foster-miller.com.