Timing truly is central to business success.
 
Microsoft, for example, could very well have been the world’s first trillion-dollar company had the public warmed to its tablet at the millennium’s dawning. Similarly, the world was not quite ready to embrace the future when Bell Labs unveiled its Picturephone in 1964 (imagine how different life would be today had it become commonplace back then).
 
Surprisingly, biotechnology firm Vaxxas hasn’t encountered that same dead end despite its invention being a bit ahead of its own time. The privately-held company is developing needle-free vaccination technology originally hatched by the Australian Institute of Bioengineering & Nanotechnology at The University of Queensland.
 
The technology uses a proprietary high-density micro-projection array patch (HD-MAP) to streamline and improve vaccine delivery. The postage stamp-sized silicon patch contains tens of thousands of projections 200-300 microns in length that release vaccine antigens directly to immune cells sitting just below the skin’s surface.
 
Preclinical studies have shown the Nanopatch to be considerably more effective than conventional vaccine delivery systems, with as little as 1/100th of its dose eliciting the same immune response as a “full” portion through intramuscular injection. Moreover, Nanopatch’s dry-coating technology eliminates the need for vaccine refrigeration during storage and transportation, thereby eliminating the resource burden of maintaining a cold chain.
 
“Based on our results, we believe that Vaxxas’ HD-MAP could offer a compelling solution that importantly could use less vaccine and potentially could be readily distributed without refrigeration for self-administration,” David A. Muller, Advance Queensland Industry Research Fellow, School of Chemistry and Molecular Biosciences, The University of Queensland, said last June. “This combination could make the HD-MAP extremely well suited to support the massive need for global population vaccination and indeed, we believe that HD-MAP offers a superior alternative to conventional needle-and-syringe.”
 
That superiority lies in the microscopic projections responsible for delivering vaccines. Those projections likely were created through micromolding, a highly specialized manufacturing process that produces extremely small, high-precision thermoplastic components with micron tolerances. This technique has become integral to medical device manufacturing of late as devices continue to shrink in size and scale. 
 
MPO’s feature “Big Shots” details the trends and market forces driving micromolding in the medical device industry. Scott Herbert, founder and president of Rapidwerks Inc., was among the more than one dozen experts interviewed for the feature. His full input is provided in the following Q&A:
 
Michael Barbella: What are the latest trends in micromolding technology and services?  
Scott Herbert: Smaller, quicker, faster equipment; more automation/less handling; and more vision system inspection inline.  

Barbella: What are customers demanding or expecting of their micromolded products and have these demands/expectations changed in recent years? 
Herbert: There really are no significant changes on the supply side—the customers are closing in on the technology currently available, which makes everyone’s job easier.

Barbella: How have advances in materials impacted micromolding technology? 
Herbert: Material changes haven’t occurred as much in the past five years as it has in the last 10.

Barbella: Please discuss the challenges and complexities involved in micromolding tooling design. How can these challenges be overcome?   
Herbert: Tool complexity can be a long conversation, as today’s challenges are multifaceted. From EDM, sinker or wire work all have a roll in the [product] fabrication process and challenges. Depending on the application, small pins or holes seem to be a challenge as well. Holding a pin steady—while often referred to as molding around a noodle—can be a challenge and difficult. How to hold a pin and how to mold a variety of plastics around the pin without disturbing it or moving it can be challenging. Disturbing its location or concentricity is often a challenge to any experienced micromolder. 

Barbella: Design for Manufacturability is critically important in micromolding. How is this different than conventional DfM? 
Herbert: Its not so different and yet it is—having to pay attention to detail especially when designing a tool to produce volume numbers. Incorporating automation or at least being prepared to upgrade or implement when needed is important as an option to double or triple capacity or throughput. 

Barbella: Are machine learning and AI playing a role in medical device micromolding? If so, how? 
Herbert: At the moment we have not seen much implementation in the AI area. But it would not shock me to see this coming very quickly.

Barbella: Is there a limit to how small a micro molded part can be? Please explain. 
Herbert: Without a doubt there is, everyone wants to be able to push the limits. However, the reality is that with conventional molding machines (micro) you have to have an ability to control volume. There is a maximum and a minimum within that volume. The question is how do you control this volume and to what degree? Making one part is not so challenging; making the same part in volume is. 

Barbella: What medtech speciality (cardiology, wearables, orthopedics, etc.) presents the greatest challenge in producing micromolded parts and why? Which present the greatest opportunity? 
Herbert: All areas—cardiology, wearables, and orthopedics—present challenges, but it really is dependent on the designer and the toolmaker coming together and creating a solution that is achievable for both. The key is giving a solution to the application and also having the tool that can be fabricated for that solution.  

Barbella: What regulatory requirements/changes have impacted medtech micromolding and how? 
Herbert: We have not had any significant changes impacting our micromolding to date.

Barbella: How might the medtech micromolding industry evolve over the next five years? 
Herbert: I see tooling being most affected over the coming years. “Get Small” as we say, and that is the driving factor in tool fabrication.