From the Affordable Care Act to sophisticated consumers and wearable technologies, a number of industry dynamics that weren’t a factor 10 years ago are very much a reality today. In a Q&A with MedTech Intelligence, Kenneth Fine, president and cofounder of Proven Process, sheds some light on how these increasing pressures are affecting medical device design and how product development teams should be collaborating in today’s environment.

MedTech Intelligence: How have medical device design challenges evolved over the past decade?

Ken Fine: Several things have occurred in design for medical devices that have made matters more challenging:

1. The developmental time frame has increased pressure for faster cycles. These shorter timeframes are somewhat related to the expectation that new technologies should be available faster.
2. Technology is evolving fast. End-customers are getting accustomed to technologies in the consumer field that have sophisticated user interfaces, and they’re expecting medical devices to possess a lot of these technological characteristics. So while it isn’t always possible to use a consumer product in the medical device industry (for quality and regulatory reasons), customers still expect that experience. This presents a technological challenge.
3. The regulatory landscape is always changing (which is not new over the last 10 years). However, there are issues that we previously didn’t have to worry about, including cybersecurity, and other areas that the regulatory agencies are starting to address, such as whether a software application should be considered a medical device.
4. From a political point of view, Obamacare has put a lot of pressure on the development of products. Ten years ago, companies could come out with a “me-too” product, obtain approval, and sell it to the market. Now, with healthcare and cost savings initiatives, medical devices truly need to add value compared to what’s on the market before they can meet the hurdles on the way to obtaining regulatory reimbursement, etc. There’s a lot more novelty and thought in the process of how devices are going to improve healthcare, reduce cost and be able to better manage a patient’s health.

MTI: How are these challenges affecting the design for manufacturability process?

Fine: The challenges are affecting the design for manufacturing process in similar ways. Again, consumers expect (both patients and users) very slick and inexpensive technology. In DFM, we’re seeing a lot more emphasis in the early stages to make sure there’s cost value; We do value mapping of the design as well as the processes.

For manufacturability, we see [companies] trying to adopt devices already being manufactured, and we see DFM activities introduced earlier into the lifecycle. Even in feasibility phases, when we’re just conceptualizing and determining what technologies we’re going to use, part of our review and vetting process is the maturity or the manufacturability of the technology. Even if one technology might be slicker than another, or it provides some benefits, the cost to manufacture and the ability to manufacture weigh very heavily on that decision. That’s our very first phase, along with design input. In the prototype phases our manufacturing process engineers develop the processes and evaluate the designs, while also trying to reduce component counts; identify common components; ensure that anything custom can actually be manufactured; and identify where in the world we’re going to actually make something. This is all happening early in the design process.

MTI: What product development team members should be present to position the design of the product for success?

Fine: We’re not unique in this area. We always take a multidisciplinary team approach to a product, which includes a core set of technologists, whether electrical, mechanical, software or biomedical engineers. We also consider how the device is going to be used. The team always has someone with human factors experience, as well as a member with clinical engineering expertise. We want the interfaces of where the device is going to be used and how it is going to be used to be integral parts of the team, and that happens right at the beginning.

Very early on, we also include process engineers, quality engineers and reliability engineers on the team. Depending on the product, we’ll have medical advisors, too. And there’s always a system engineer, because the weakest part of the design often occurs at the interfaces between the various elements of the design.

We usually have a core team that is fully dedicated, and then we have other engineers who may be participating in more than one program. We have the types of people who will reach out and touch the environment that the device is going to be in; and then we have the engineers who will make sure the pieces fit together, so that at the end of the day, there really are no surprises. There’s never an abrupt transition from one group to the other—people are participating at varying levels throughout the entire lifecycle.

In Part II of this interview, Fine and his colleague Michael Kanis discuss how product development teams should be integrating quality throughout the design process.  The article will be published next week.