After losing four babies, Jamie McDonald was overjoyed to learn she was expecting twins. But her happiness abruptly ended when she gave birth to the tiny pair at 24 weeks. “We felt pretty positive we were never going to bring them home,” she recounted to “The Doctors” syndicated talk show.
 
McDonald’s babies—Everly and Maverick—weighed 1.9 pounds at birth and both were diagnosed with patent ductus arteriosus (PDA), a potentially life-threatening congenital heart condition triggered by an opening between two cardiac blood vessels. The sixth most common defect, PDA occurs in 5-10 percent of all children born with congenital heart disease, and is twice as likely to occur in girls than boys.
 
The condition is treatable with therapy, minimally-invasive catheter-based interventions, and minimally-invasive surgical solutions. Doctors chose the latter option for Everly and Maverick, implanting a pea-sized wire mesh device between their pulmonary arteries and aortas to prevent blood from mixing and straining their tiny hearts and lungs.
 
The device, made by Abbott Laboratories, is inserted through a small leg incision and guided to the afflicted cardiac vessels. Manufacturing such a diminutive object most certainly entailed micromolding, a type of injection molding that produces extremely tiny parts, often with micron tolerances. The process uses special equipment that can produce intricate designs and details.
 
Medical Product Outsourcing’s October feature, “Little Big Parts,” addresses the latest trends and challenges shaping the fast-growing medical micromolding market. Scott Herbert, founder and president of Rapidwerks Inc., was among the various experts interviewed for the story. His full input is provided in the following Q&A.
 
Michael Barbella: What are the latest innovations in micromolding technology?
Scott Herbert: [There are] many new concepts in the world of micromolding specifically around rapid tooling. The key is fast-working prototypes that represent production like products. 
 
Barbella: What market forces are fueling the need for micromolding technology and services?
Herbert: The medical field across the board is fueling smaller designs. The need to reduce size and increase capabilities is crucial. 
 
Barbella: How is the need for smaller, more complex medical devices/components challenging micromolding suppliers and providers? 
Herbert: The challenge is multi-faceted, creating tool designs that will produce functional components is key additionally without the need of expensive assembly procedures ie: welding or glue process.  
 
Barbella: What factors must be taken into consideration in designing tooling for micromolded parts?
Herbert: Key factors would consist of what is the end game, what are you trying to achieve and in what specific material. 
 
Barbella: Should micromolding tooling design be outsourced? Why or why not?
Herbert: Some tools can be outsourced and some should not be. It really comes down to the application and the material selected. Coupled with tolerances, this will dictate outsourced or captive tools. 
 
Barbella: What are customers demanding or expecting in their micromolded products?
Herbert: Smaller and smaller cavity features. Some are realistic and some are not when it comes to mainstream micromolding. Its easy to make one or two of something super small, however in the real world and volume, it's sometimes not realistic. 
 
Barbella: How are minimally invasive and point-of-care applications affecting micromolded device design and development?
Herbert: The applications are growing and tripling … the demand is great.