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In medical device hardware development, embracing Agile methods presents exciting opportunities and unique challenges. Unlike software development, where Agile practices have been widely adopted and standardized (as seen in the AAMI TIR45 Guidance), the transition in the hardware sector has been slower.

Join us for a conversation between Michael Keer, Founder and Managing Partner of Product Realization group, and Ken Kapur, an expert in product compliance, about overcoming the biggest barriers to new product development and introduction: time and money. This interview has been edited for length and clarity.

Many companies, especially for high-complexity products such as energy storage and robotics, are moving away from outsourced manufacturing to establish their own internal operations. In fact, Kearney’s 10th Annual Reshoring Index finds that reshoring has substantially increased during the past decade.

Join us for a conversation between hardware expert David Graham, CEO of PowerBeam, a technology development firm, and Michael Keer, Founder and Managing Partner of Product Realization Group.

Wayne Miller is a seasoned executive with decades of experience designing and manufacturing products in the robotics, clean-tech, semiconductor, and consumer industries.

As part of PRG's Ask the Expert series, Michael Keer gives opinions on the role DFX plays in designing your product for scale versus prototype.

The product was great, worked fantastically, and sales proudly rushed it out to the customer. The customer said, "Oh, we needed that two years ago when we asked for it; now we've done things differently!" What difference would product management have made to this scenario?

As part of PRG's Ask the Expert series, Howard Edelman answers how to overcome the challenge of ad-hoc design, which we see in many products.

There are many challenges associated with taking an idea from concept to product, but the two that stand out for me are: 1. Plastic design and tooling take time 2. Finding the right manufacturing partner

As part of PRG's Ask the Expert series, Jay Feldis answers how to overcome the specifics of this challenge for medical devices which we see in many companies.

In today’s fiercely competitive and rapidly evolving business landscape, large companies, especially those developing hardware-based products, struggle with more complex operational frameworks and product development cycles.

The aftershocks of the pandemic compelled a sweeping reassessment of the hardware manufacturing landscape. Amid these shifts, three transformational themes have emerged: the restructuring of supply chains, the integration of cutting-edge technologies, and the necessity for upskilling. Continue reading to gain a deeper understanding.