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Medical Device Development in a World of Growing Complexity

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Recently, we’ve been surveying a number of reports and articles forecasting the future of medical devices. Specifically, the future trends emerging in interventional cardiology, structural heart, neuromodulation and drug/device combination products.

Some of the individual market segment takeaways include:

  • Improvements in cardiac mapping are combining with advances in ablation technologies to improve patient outcomes while simultaneously shortening procedural times, elevating throughput in the cardiology lab.
  • Real-time, visual guidance using intravascular imaging, fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) technologies, are finding their way into interventional cardiology and will continue to expand into other, vascular-accessible interventions.
  • Advances in neuromodulation are combining with miniaturization technologies to usher in a new era in pain management, sympathetic/parasympathetic nervous system modulation, sensory enhancement and potentially, mobility.
  • Advances in transcatheter aortic valve replacement (TAVR) are rapidly displacing open heart procedures for valve replacement, greatly reducing the risk for infection while dramatically improving patient recovery times.

The incorporation of devices for the targeted delivery of precision therapeutics is opening new frontiers for immunotherapies, novel compounds (that may be systemically toxic, but highly efficacious), personalized medicine and access across the blood-brain barrier.

We can speak directly to the accuracy of these prognostications. Why? Because the Rev.1 Engineering team has been intimately involved in the engineering and development of many of these innovations!

Additional complexities extend to nearly all devices, including the Internet of Things, accompanying data streams and processing demands, cybersecurity concerns and potential applications for Artificial Intelligence. Taken together, this growing complexity is changing the way medical devices are engineered, developed and tested.

Concurrently, as information technology and patient-centric consumerism seep into medical device, and reimbursement shifts from fee-for-service to value-based payments, product life cycles will inevitably compress. Time, or more accurately, timeliness, will truly be the essence of success in medical device development.

So how does one embrace complexity while simultaneously increasing their speed of development without breaking the bank on the technical and engineering headcount necessary to support the breadth of these emerging technologies?

Fundamentally, there’s no replacement for experienced developers, disciplined Program Management and a rigorous approach to Design for Risk Management along the Critical Path. These binary elements are either world-class or they’re not, and if they are not, that’s a good place to draw one’s focus on immediate needs for improvement.

If these elements are, in fact, world-class and in place, the differentiating, final input for achieving high-speed innovation of commercially viable devices is the orchestrated application of talent. Below is an example drawn from a real development project we’ve been working on for the past 12 months.

While over the course of this development project, you’ll notice that an average of approximately three engineering Full-Time Equivalents (FTEs) ushered the project along. Please note, how, at the earliest stages of development and innovation (pre-design freeze), eight, ten, up to twelve individual engineers worked on the project, as required, based upon their individual expertise.

Even as the project matured, at any given time, an average of eight engineers contributed to the development process while the expense allocation remained at around three FTEs. This precise application of the right resources, in the right sequence, at the right time drives remarkable speed and efficiencies.

This final element can be a challenge to create and implement. For very large companies, rigid organizational structure, internal accounting procedures, and shifting priorities can make this approach difficult to implement. Conversely, small companies (> 80% of medical device companies operating in the U.S. have 50 or fewer employees) may struggle to afford the requisite breadth of core competencies (in terms of skill sets and individual knowledge workers) necessary to competitively develop this coming wave of complex devices.

By embracing these four critical elements (highly experienced engineers, disciplined Program Management, rigorous Design for Risk Management along the Critical Path, and the orchestrated application of talent), REV.1 Engineering has consistently demonstrated we’re 2X Faster than traditional, internal development. As product life cycles compress, speed of commercialization will grow in importance for creating a continuous, competitive advantage.