When it comes to medical device miniaturization, the usual design risks still apply.

David Fink, Ximedica

The rapid increase of miniaturization in medical device development is undeniable as medtech companies seek new ways to improve patient outcomes and overall healthcare quality.

A broad array of technology advances in consumer electronics, semiconductors, sensors and material science have driven the creation of the new miniature devices and systems, and the results have been extraordinary. Here are just a few:

• Medtronic’s Micra leadless pacing system is an excellent example of miniaturization to the benefit of patients, both in the treatment and delivery/placement of that treatment. Running leads to the heart has been an Achilles’ heel for pacemaker systems; shrinking the pacemakers and placing them inside the heart appears to be the answer.
• Wearables for the monitoring of health and wellness are another segment of devices that miniaturization is transforming. Smaller and more capable wearable sensor systems integrated into an effective connected health system could immeasurably impact healthcare in a positive way.

While miniaturization and all that comes with it is a vital factor in new device development, it cannot ignore crucial aspects of form. Simply put, device miniaturization is not insulated from the usual design risks. In fact, it’s making attention to them more important than ever. The negative impact of design can play in device errors by users is well documented. Regulators globally are increasingly focusing on it, and medical device creators have increasingly realized that they need to change their product development processes.

Here are three areas of medical device product development that especially need improvement now that devices are undergoing miniaturization:

1. Not taking human-centered engineering into account

Human-centered engineering and all its components of human factors, usability and risk assessment must now be embedded in the device development process — ideally from early concept development through the various phases of development.

The size may be much smaller, have greater functionality and markedly reduce the cost of a potential treatment. But if it does not consider the end-user, the risk of adoption and use error increases. Ideally, at the inception of the development program, the design team will be including not only the technical and manufacturing challenges of miniaturization but who will be using the product, how will it be used and where.

Think of what’s going on in the wearable devices field. Consider that many of these wearables will target an aging population. Older users may face problems of dexterity and peripheral neuropathy. They may not be able to effectively understand and interact with a user interface. Knowing those issues early in the miniaturization development process could inform concepts that could be tested in formative studies with potential users. The results could enable adjustments resulting in an optimal interface and user experience. It may be as easy as a more effective clasp mechanism for a wrist band for those with dexterity challenges or a simplified delivery system for an adhesive-backed miniature device.

2. Rushing toward ‘solutions’

Development teams often rush to potential design solutions early in a program based on experience or incomplete research at the risk of creating a significant use error that may or may not be identified later in the project. The adage of pay me now or pay me more later applies here as the expense in time and budget to remediate that error can be crippling. Too many innovative development programs fall prey to the drivers of a tight schedule to launch when in fact an early and objective assessment of risks to successful outcome can support prompt and effective corrections. Consider this issue in the context of timing where early successful intervention may be an investment in weeks or months against discovering a significant use error late in the development cycle. Late cycle design corrections can take months or years depending on the degree of change. Include the added cost in that discussion and significant compromises are often the result at the expense of a solid user-centered design.

3. Not doing the early work

Discipline in documenting who will use the product, and it is frequently more than one use group, the anticipated steps (flow) of how the product or like-product may be used and the environment it will be used in is a high priority. In the overall timeline of a development project, this does not need to be a daunting task.

There are great tools available such as contextual inquiry of users and observational research of users in their anticipated use environment. Executed well and objectively, these activities frequently uncover unmet user needs that translate to a more effective miniature design. For example, observing targeted users in their environment frequently identifies workarounds with existing products that are not identified in an interview or discussion. Those can be translated into user needs with a resulting design that can avoid a significant user error. More importantly, that improvement leads to greater product acceptance and post-launch revenue.

Design outfits and other outside companies that specialize in this area can be very beneficial, especially if they conduct this activity from an unbiased view. These early activities are often viewed as too costly or too time-consuming. In reality, the early work when well done creates a solid foundation of understanding of who, how and where the product will be used. That foundation informs much of the miniaturization concepting, design and verification activities that follow, including solid design decisions grounded in an understanding of end-use.

Identifying and correcting use errors early saves time and cost as opposed to later stages of verification or even post launch.

The impact of miniaturization on device design will fuel dramatic improvements in the quality and cost of healthcare and to the benefit of patients globally. That impact will be accentuated with an effective, efficient  and disciplined human centered engineering practice woven into the miniaturization development process.

David Fink is VP of strategic development at Ximedica. Fink has more than 40 years of successful new product development experience in the medical device industry ranging from early phase research, strategy and business development through detailed design to commercial launch. His role at Ximedica is working closely with client companies to effectively align their project needs with Ximedica’s extensive development capabilities. Prior experience includes more than 20 years at Covidien/Kendall, most recently serving as director of R&D, managing multiple development groups in the fields of cardiology, radiology, respiratory care and advanced wound care.