Factors driving the adoption of human factors engineering include market demand for intuitive products, the world’s growing, aging population, mass customization of products, and greater patient engagement. User preference now is almost as important as clinical efficacy, as customer feedback and performance metrics affect how hospitals and other providers are compensated by insurance companies and Medicare.
Meeting patient needs in challenging medical circumstances requires patient-specific implants and specialized surgical instruments. These implants and instruments can require such small, intricate parts — often with features, geometries, or enclosed channels — that they would be impossible to produce without the industrial 3D-printing process of direct metal laser sintering (DMLS).
As the world's aging population will places increasing demands on the healthcare system, the challenge for medical device companies is to develop products and services to meet this demand, in a cost-conscious manner, in the face of what has been referred to as an impending “demographic storm.”
Overmolding is a two-part injection molding process entailing the production of a typically rigid substrate part (made of plastic or metal) that is partially or fully molded over a second, often softer, material to create a finished part. Substrates can be produced by numerous means, but the most common approach is to use a two-shot molding process: The substrate is molded in the first shot, and the overmold material is molded in the second shot.
As rapid prototyping has evolved, so have the ways in which metal is fabricated. You not only have traditional methods like CNC machining and die casting, but advanced processes like metal injection molding (MIM), magnesium thixomolding, and an additive manufacturing (3D printing) process called direct metal laser sintering (DMLS) that is increasingly being used to produce parts for medical applications.
Like many industries, the development path for medical devices differs with every product and its unique requirements. However, all medical devices have a series of FDA approval gates to clear and clinic trials to administer and analyze that often dictate a device’s path to market.
Every product places demands on materials, but demands in the medical industry can be particularly stringent. When medical products and devices don’t perform as they should, the consequences can be serious, immediate, and costly.