The Challenges of Designing New Medical Devices to Create Value & Meet Regulatory Demands

Advances in manufacturing technologies, including micro molding¹ and additive manufacturing are meeting these needs. One excellent example here is the hearing aid sector,² where customization, miniaturization and improved functionality have converged. Indeed, In-The-Ear (ITE) hearing aids were, arguably, the first mass-produced product manufactured using AM processes. This is largely because their small size and the requirement for personalized geometry are a good fit for the capabilities ­— and the economics — of AM.Downsizing Devices & Increasing Innovation[CF1]

A key trend that has emerged over recent years is the miniaturization of medical devices. This has largely been driven by patient requirements, including the need for increased self-care and monitoring, leading to smaller devices that can be discretely worn while patients interact in their daily lives.

One obvious challenge that arises from making products smaller is that designers have to fit increased capability into decreased spaces, which leads to downstream challenges in efficiently manufacturing the designs.

Advances in manufacturing technologies, including micro molding¹ and additive manufacturing are meeting these needs. One excellent example here is the hearing aid sector,² where customization, miniaturization and improved functionality have converged. Indeed, In-The-Ear (ITE) hearing aids were, arguably, the first mass-produced product manufactured using AM processes. This is largely because their small size and the requirement for personalized geometry are a good fit for the capabilities ­— and the economics — of AM.

 [CF1]If possible to crop this image as shown here to minimize the black undergarment strap.Downsizing Devices & Increasing Innovation[CF1]

A key trend that has emerged over recent years is the miniaturization of medical devices. This has largely been driven by patient requirements, including the need for increased self-care and monitoring, leading to smaller devices that can be discretely worn while patients interact in their daily lives.

One obvious challenge that arises from making products smaller is that designers have to fit increased capability into decreased spaces, which leads to downstream challenges in efficiently manufacturing the designs.

Advances in manufacturing technologies, including micro molding¹ and additive manufacturing are meeting these needs. One excellent example here is the hearing aid sector,² where customization, miniaturization and improved functionality have converged. Indeed, In-The-Ear (ITE) hearing aids were, arguably, the first mass-produced product manufactured using AM processes. This is largely because their small size and the requirement for personalized geometry are a good fit for the capabilities ­— and the economics — of AM.

 [CF1]If possible to crop this image as shown here to minimize the black undergarment strap.Downsizing Devices & Increasing Innovation[CF1]

A key trend that has emerged over recent years is the miniaturization of medical devices. This has largely been driven by patient requirements, including the need for increased self-care and monitoring, leading to smaller devices that can be discretely worn while patients interact in their daily lives.

One obvious challenge that arises from making products smaller is that designers have to fit increased capability into decreased spaces, which leads to downstream challenges in efficiently manufacturing the designs.

Advances in manufacturing technologies, including micro molding¹ and additive manufacturing are meeting these needs. One excellent example here is the hearing aid sector,² where customization, miniaturization and improved functionality have converged. Indeed, In-The-Ear (ITE) hearing aids were, arguably, the first mass-produced product manufactured using AM processes. This is largely because their small size and the requirement for personalized geometry are a good fit for the capabilities ­— and the economics — of AM.

A key trend that has emerged over recent years is the miniaturization of medical devices. This has largely been driven by patient requirements, including the need for increased self-care and monitoring, leading to smaller devices that can be discretely worn while patients interact in their daily lives.

One obvious challenge that arises from making products smaller is that designers have to fit increased capability into decreased spaces, which leads to downstream challenges in efficiently manufacturing the designs.

Advances in manufacturing technologies, including micro molding¹ and additive manufacturing are meeting these needs. One excellent example here is the hearing aid sector,² where customization, miniaturization and improved functionality have converged. Indeed, In-The-Ear (ITE) hearing aids were, arguably, the first mass-produced product manufactured using AM processes. This is largely because their small size and the requirement for personalized geometry are a good fit for the capabilities ­— and the economics — of AM.