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. Steve Raiken, president of RenyMed, 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? 
Steve Raiken: Micromolding has become much more mainstream as tool making and machine technology has improved. Micro surgical, micro electronics, drone technologies, and new personal care products are all relying on engineered micromolded parts.

Barbella: What are customers demanding or expecting of their micromolded products and have these demands/expectations changed in recent years? 
Raiken: Customers are looking for suppliers with a higher level of expertise, experience, and confidence in micro part and tooling design.

Barbella: How have advances in materials impacted micromolding technology? 
Raiken: New implantable grade materials and silicone technologies have been well received.

Barbella: Please discuss the challenges and complexities involved in micromolding tooling design. How can these challenges be overcome? 
Raiken: The main challenge is to eliminate as much of a cold runner as possible so the control of the injection molding machine delivery system/shut off nozzles are maximized. Part handling post-molding can become a big issue and requires a new way of part handling. In addition, air evacuation from the tooling is a high priority.

Barbella: Design for Manufacturability is critically important in micromolding. How is this different than conventional DFM?
Raiken: There needs to be a full understanding of the part geometry and function, the parts should be as simple as possible, and designed with limited undercutting. Micro features can be molded in with coining and other special micromolding techniques. 

Barbella: Are machine learning and AI playing a role in medical device micromolding? If so, how? 
Raiken: Micromolding with full automation operates most efficiently in a “lights out” environment if possible. AI helps this as well as working in a smart factory. Smart machines are a necessity in micromolding as shot to shot repeatability is of paramount importance.

Barbella: Is there a limit to how small a micro molded part can be?
Raiken: The parts may be too small to handle post molding—any amount of static will cause the smallest micro parts to become “sticky” and will cling to anything, even in a glass jar.  

Barbella: What medtech speciality (cardiology, wearables, orthopedics, etc.) presents the greatest challenge in producing micromolded parts and why? Which present the greatest opportunity? 
Raiken: New personal healthcare tracking and diagnostic devices will require micro parts that are molded in a commodity system. Part cost and supplier margins will be minimized and a highly automated micro system will be needed to maximize high volumes.

Barbella: What regulatory requirements/changes have impacted medtech micromolding and how?  
Raiken: As with all medical devices, FDA is now very watchful for patient safety. ISO 13485 and excellent clean room molding systems are standard.

Barbella: How might the medtech micromolding industry evolve over the next five years? 
Raiken: Personal/home healthcare devices and wearables that associate with smart phones will become much more mainstream.