Nova Biomedical needed high-volume production capability to produce disposable strips for its glucose monitoring system, which is currently distributed as the Logic Blood Glucose Monitor by BD. An outside engineering firm designed and built manufacturing equipment to fit its requirements.

How are some medical device companies developing next-generation designs? And how are they bridging the gap between a niche idea and an innovative premium product? In many cases, external technology partnerships are transforming concepts into reality.

Even if the personnel were available, new projects always seem to be at odds with those already taking place. Innovation is not defined by the sophistication of the technology but by the cleverness of the design used to solve the problem.

AT A GLANCE

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Robert R. Andrews is medical division manager for the commercial group at Foster-Miller Inc., a QinetiQ company, 358C Second 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 contacted at (781) 684-4639 or randrews@foster-miller.com.

By Robert R. Andrews
Demand for high-quality medical products and devices is influenced by an increasing need for preventive care and a focus on health care cost containment. Medical manufacturers are challenged to deliver products quickly while ensuring safety and effectiveness. For many companies, the lack of internal technical resources and pressure to save money often present barriers to entry as a market leader with higher-margin products. Companies achieve market leadership and remain competitive because of their ability to bridge the gap between a niche idea and an innovative premium product. External technology partnerships play an instrumental role in filling the gap by transforming concepts into the products of tomorrow.

As competition gets tougher, medical product companies need to look beyond their own internal operations and engage with technology sources that have diversified knowledge and experience to implement innovative solutions. Simply put, leading medical product manufacturers are quickly learning that the intelligent use of outside engineering resources minimizes the effect of competing internal priorities, facilitates development of innovative products, and reduces time-to-market.

Practical Innovation

The window of time a medical manufacturer has the market to itself has been shortened by the ability of competitors to unveil their own products sooner. As a result, medical manufacturers with an eye to market penetration need to develop innovative approaches to meet their customer’s most compelling needs. Working with an external engineering firm experienced in medical technologies can be an effective approach to unlocking innovation. This firm must be skilled in creating ideas or building on their clients own ideas, using practical applied knowledge to turn concepts into a tangible standard-setting medical product or process.

In the initial phases, a firm should be able to advise its client if the concept fits the market and answer questions from the perspective of the end-users. Novel ideas and major product improvements are most likely to come from the end-users, and it is critical to understand and anticipate customer needs. Other issues that are critical in the early stages include potential development costs, design for manufacturing, the regulatory pathway, and having a reimbursement rate strategy.

When C.R. Bard was looking to create a one-hand biopsy tool, the risk and reward of being first to market were evident. But for the company, the clearest path to get there was to partner their efforts with technological brainpower. The external project team had expertise in medical product design, materials, and mechanism development, helping the company gain quicker industry acceptance and market leadership. The end result was a process to create a more ergonomic biopsy tool that surgeons can operate with one hand and that could be marketed under the existing 510(k).

Multidisciplinary 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. Another practice is to draw upon multiple but unrelated disciplines when beginning to solve complex problems. More often than not, engineering challenges cannot be resolved within the confines of a single discipline.
This was the approach taken during development of next-generation blood bags for the U.S. Army that enable lyophilization (freeze-drying) of blood products. The main goal was to design and develop a product to collect, lyophilize, store, and re-constitute blood for combat care of enlisted personnel. An external firm with expertise in microbiology, plastics engineering, mechanical engineering, and package engineering worked with Walter Reed Hospital to develop an approach that applied breathable polymers to enhance water vapor transmission during lyophilization. The project was a success, bringing to fruition a unique product that allowed platelets and plasma to be collected, lyophilized, stored, and transported in the same blood bag.

The use of one bag for processing eliminates product risk and the labor costs of transferring contents to other containers. This system also provides virus protection by not exposing the blood products to the external environment during processing. A key feature of the device is an internal port that opens automatically under a vacuum to permit the removal of water vapor. The port permanently seals upon removal of the vacuum. The bag can be stored at ambient conditions, and the blood products can be reconstituted when desired. Bag test lyophilizations show high drying rates and 100 percent protein recovery.

Time-to-Market

When C.R. Bard was looking to create a one-hand biopsy tool, the risk and reward of being first to market were evident. An external project team helped the company create an ergonomic device that could be marketed under the existing 510(k) and gain quicker industry acceptance and market leadership.

Cost pressure from managed care entities and the lengthy FDA approval process are prime considerations in bringing a truly breakthrough product rapidly to market. Properly applied technology solves these initial business hurdles and continues to evolve a product or process in a way that sustains industry advantage. But how the technology is applied separates the leaders from the rest of the market. Whether a company is looking to improve an existing process, conceive and develop a new product, transform a prototype into operating equipment, or even add short-term manpower requirements, utilizing an external technology partner can ultimately speed the process to commercial viability.
Many times viable solutions are not immediately obvious to internal teams due to time constraints and a lack of the right engineering talent. Even if the personnel were available, new projects always seem to be at odds with those already taking place. These scenarios force companies to seek alternative options to get products out faster.

Rather than hire full-time employees, which is an expensive proposition, or bringing on temporary staff with its inherent risks, top companies are more often contracting with outside engineering teams capable of handling multidisciplinary aspects of medical product development. In addition, outside technical expertise is often well versed in all aspects of medical product manufacturing and can more readily strategize an end-to-end solution due to a wealth of project experience.

If a company attempts to develop a product that falls outside its area of expertise, the use of outside engineering experts can accelerate time-to-market by overcoming obstacles that may cause project delays. What’s more, external personnel resources have a multidisciplinary approach to problem solving that is essential for mitigating potential market risk. A highly experienced and skilled project team can bring expertise in industrial design, market research, as well as concept, materials, and product development, and can be better leveraged to find the best practical solution. Utilizing personnel with different industry backgrounds can facilitate application of technologies not common to the medical industry. Engineers and scientists from different disciplines can look at problems from different perspectives and provide unique insight.

Device developer Nova Biomedical needed high-volume production capability to produce its innovative and proprietary disposable strips that are part of the sub-micro liter glucose monitoring system diabetics self-administer to check blood sugar levels. The unique strips contain a miniaturized biosensor to convey blood to an electronic reader or meter. The challenge for the company was the lack of available equipment that met Nova Biomedical’s specific manufacturing needs. As a solution, Nova Biomedical turned to an outside engineering firm to design and build customized manufacturing equipment to fit its product requirements.

Within nine months, two units were designed, built, and installed in the manufacturing facility. As the production requirements rose, additional units were built and installed within the next year. The engineering firm brought to bear expertise in program management, mechanical engineering, automation, and equipment fabrication to bring the project to a successful completion. Nova Biomedical now possesses the necessary capacity to meet market demand.

The glucose metering system is currently distributed by BD as the Logic Blood Glucose Monitor and by Medtronic as part of the award-winning Paradigm Link Diabetes Management System.

Ensuring Confidentiality

It may seem like a paradox, but using an external technology partner to develop the “next” medical innovation may actually help a company keep the technology proprietary for a longer period. In other words, an outside firm can help keep a client company’s secrets quiet. Why is this? In a highly competitive environment, medical manufacturers experience employee turnover, and internal knowledge may not stay internal. When competitors look to “cherry pick” for new talent, the first step is to target employees who work for the competition, not employees who work for an external technology partner.
While outside firms can help medical companies diminish staffing risk by coming equipped with the right skills, manpower, and technology, there are many things to keep in mind to execute projects smoothly. First, the reputation and integrity of a technology partner is paramount, and the organization should be trusted and experienced to ensure strict confidentiality. Getting stakeholder buy-in prior to a signed contract is essential, along with a non-disclosure agreement to protect technological secrecy or determine patent rights.

Summary

The greatest challenges to medical manufacturing are staying on top of new technologies and harnessing the creativity of diverse talent to develop the “next” innovation. True innovation is driven by fulfilling customer needs using superior and truly novel approaches. 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 design used to solve the problem. Leading companies also realize that reaching a new goal may require the helping hand of a trustworthy and competent technology partner to quicken time-to-market while simultaneously managing risk.

ONLINE

For additional information on the technologies discussed in this article, see Medical Design Technology online at www.mdtmag.com or Foster-Miller Inc. at www.foster-miller.com.