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. Raghu Vadlamudi, chief research and technology director at Donatelle, 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?
Raghu Vadlamudi: Some of the latest trends include innovative material handling techniques to minimize over-drying, and automated manufacturing work cells to handle parts with minimal weight (sub milligram range). Molding machine manufacturers are rising up to the challenges of providing equipment with small shot capacities to improve process consistency.
 
Barbella: What are customers demanding or expecting of their micromolded products and have these demands/expectations changed in recent years?
Vadlamudi: Customer expectations have not changed much in regards to the micromolded products. Consistent quality, delivery and reduced cost are the demands of our customers.
 
Barbella: How have advances in materials impacted micromolding technology?
Vadlamudi: There really hasn’t been a lot of work in developing materials suitable for micromolding at this time.
 
Barbella: Please discuss the challenges and complexities involved in micromolding tooling design. How can these challenges be overcome?
Vadlamudi: Designing tools might not be that challenging with the CAD packages that are available, but it is tough to machine the micro features in the molds with conventional machining techniques. These challenges can be overcome by understanding the type of equipment or the process to employ in machining these features. Mold cavities can be manufactured with micro laser and EDM technologies.
 
Barbella: Design for Manufacturability is critically important in micromolding. How is this different than conventional DfM?
Vadlamudi: A knowledge base for micromolding doesn’t exist, and the material manufacturers don’t provide design guides and processing guides for micromolding. Companies are learning by trial and error, which in turn makes it difficult to utilize traditional DFM techniques.
 
Barbella: Are machine learning and AI playing a role in medical device micromolding? If so, how?
Vadlamudi: Machine learning and AI will play an important role in the future of micromolding by employing closed loop systems and providing feedback to the equipment to compensate, if needed, in regular production as well as speed up the development cycles.
 
Barbella: Is there a limit to how small a micromolded part can be?  
Vadlamudi: The limit to a micromolded part comes from the equipment that’s needed to build the molds and mold the parts. In addition to the equipment capabilities, the need for knowledgeable and skilled personnel is of paramount importance. Donatelle currently manufactures parts with 100 micron thickness that weigh less than a tenth of a milligram.
 
Barbella: How might the medtech micromolding industry evolve over the next five years?
Vadlamudi: There will be advancements in material handling equipment and in processing equipment with smaller shot capacities (to obtain consistency from shot to shot). There will also be developments in materials that will allow molding thinner wall sections. Molding equipment with integrated with robots and inspection systems will become commonplace in the medtech micromolding industry.