国际医疗器械设计与制造技术展览会

Dedicated to design & manufacturing for medical device

September 25-27,2024 | SWEECC H1&H2

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Developing Raw Technology

During the MD&M Minneapolis 2019 conference, Perry Parendo of Perry's Solutions spoke about best project management practices for engineers. Afterward, a sidebar conversation began regarding new technology exploration. MD+DI asked Parendo a few questions on how engineers could approach what he calls “raw technology.”

Do engineers employed by medical device companies have enough time and internal support to develop raw technology? If not, what are some best practices to better support such work?

Parendo: Time available really depends on the company. A start up needs cash flow, so it can only develop stretch technologies with a risk-tolerant investor. In large corporate organizations, they need to be dedicated resources. Splitting time between a near-term revenue project and a pure-technology project is impossible to balance. The time available for new technology will suffer significantly.

To support technology work, companies need to dedicate a percentage of R&D spending for technology projects that contain dedicated resources. Collaboration between groups is always expected, but these dedicated technology groups need to be focused on their appropriate time horizon. Prioritization comes in the form of full-time, dedicated resources.

Does it depend upon the size of company? Are there suggestions for large companies and for smaller companies for developing raw technology?

Parendo: It certainly is impacted by the size of company. A small company needs to have parallel path project plans. These companies cannot afford a dead-end project, so they need to ensure a certain level of confidence of completing a cash flow producing product. The probability for revenue needs to be at a certain level to proceed.

For a larger company, they have the ability to stretch technology expectations. With multiple products in the pipeline, the new technologies can be implemented when they mature. Additionally, they can develop technology without a specific end use and allow product plans to evolve.

Does a company need an in-house R&D department to conduct such work?

Parendo: The need for an in-house R&D group depends on the work to be done. I always talk about R&D in subgroups. It can be “big R” or “little r” work. “Big R” is a significant new technology, while “little r” is uncertain expansions of existing technologies. “Big R” might be best with an outside firm as they are breaking a lot of established internal rules. “Little r” projects can certainly be done internally, with a dedicated team, as they are comparable to the rules that already exist for current products. Similarly, we can distinguish between “big D” or “little d” work. “Big D” could include a new platform project using known technologies or complex and emerging new products where the scope contains uncertainty. Doing “big D” or “little r” work should be in-house for the core technology. Because “little d” work can be scoped clearly, this is ideal to be farmed out to another organization or could be done internally with an existing engineering team.

Who else should be involved in developing raw technology?

Parendo: Early on, a mix of leading-edge thinkers from a variety of technical and business areas is acceptable. However, that is only to scope a set of stretch objectives. Once the effort is going, too many people are a distraction and a potential constraint on thinking and thus limiting options. The team should have little long-term accountability to a cost center, so that excessive rules are not added that could risk the accomplishment of the goals. They also should not be a permanent team, as that just condenses what should be out-of-the-box thinking.

Should tech development be left to suppliers?

Parendo: Suppliers can do some “big D” and “little d” work, but bigger advances are likely from a different organization. If the supplier is big enough they may have some “little r” work, but most get too locked in to existing capabilities and wanting to maintain those limitations. Thus, most raw technology development should be done with well-funded organizations. However, this will be limited to the components they supply. Product advancement still will be limited if research is exclusively done at suppliers.

What comes first—the technological advance or the unmet healthcare market need?

Parendo: Without a technology capability, needs cannot be met. However, without some sense of needs, how can we forecast the next important technology? As with many things, it is a continuous cycle between need and technology. Using both perspectives well, we can maximize the capabilities of an R&D organization.

Are there rules for managing technology development?

Parendo: There are certainly rules to be addressed. However they are quite different than most traditional product development rules. Technology break-through projects have uncertainty in outcomes, incremental budgets, and narrow requirements. That is the essence of the management changes required for “big R” and “little r” projects.

Is technology failure really bad, or can engineers/companies learn something from it?

Parendo: Failure is required to advance technology. But it is intelligent and managed failure. Limit expenditures getting to critical test points in order to avoid wasting resources in a rabbit hole. But a failure is simply an opportunity to learn. I was involved with a multi-million dollar R&D effort once with significant stretch objectives. At one project review, we spent a considerable time discussing outlier data! Could we leverage it? Could we recreate it? Why did it happen? What could we learn from this? The group was comfortable thinking in this challenging way, where a typical product development group would be more likely to diminish or ignore such information.

Do you start with established technology first to bring a product to market and then update it later with technological advances?

Parendo: Long term, I believe that is best. That develops the market need and can help finance the technology development. Potentially confusing new technology in a new market application is an excessive complication that could negatively impact customer acceptance. Using established technology in a new market can help comprehension and acceptance. After market growth begins, there is incentive to learn the new technology and to appreciate the benefits and advantages it provides.

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