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

Subscribe to our Medical newsletter

Stay connected with the latest developments and innovations in medical technology.

Subscribe

The vast landscape of the medical technology industry continues to evolve and adapt in line with ever-changing regulatory frameworks that provide guidance and standards for the development of all medical devices. As a result, med-tech companies operating within this space face an increasing number of challenges that can affect business growth and value creation.

In addressing some of these challenges here, there is also optimism about the opportunities that they create for new innovations in this market. 

Downsizing Devices & Increasing Innovation

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.


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.


 [CF1]If possible to crop this image as shown here to minimize the black undergarment strap.

Material Selection

Another key challenge that has to be addressed in developing innovative solutions for medical devices is material selection. Material usage is highly regulated and changing guidelines, particularly for existing products, present challenges in terms of re-design and manufacturing and assembly processes.

Any new material for medical applications will necessarily undergo vigorous testing and scrutiny, so it is vital to understand its chemical composition, chemical safety assessments and ability to reliably assemble new materials.

However, this can also bring new opportunities for product optimization, especially if approached collaboratively across the entire value chain. Working in partnership with material experts — who share similar goals and understand the issues — can alleviate the pain and accommodate even the most demanding applications.

 

A flexible approach with more flexible materials

There is undoubtedly increasing focus on safety and materials of concern from global regulatory bodies. One current material type of interest in this regard is Thermoplastic Elastomers (TPEs), specifically as an alternative to PVC materials. The benefits of TPEs are many, including that they have both thermoplastic and elastomeric properties, require little compounding with no need for reinforcing agents or stabilizers, and demonstrate advantages typical of both rubbery materials and plastic materials.A key characteristic of TPE is its resilience with the ability to stretch and return to its original shape. As it is DEHP-free, and plasticizer-free, TPEs offer a viable alternative to plasticized PVC tubing. Medical device manufacturers looking to use TPE will typically be assembling TPE to itself as well as to other materials, which brings the different substrate into scope.

 

For TPE to TPE assemblies, the high degree of non-polarity requires assembly with non-polar solvents or a different means of assembly. To join TPE with polar substrates — like PC or ABS — the solvent welding does not work properly. The difference in polarity of the non-polar TPE and the polar substrate will not support proper polymer-to-polymer connection. While there is no single universal solution for all surfaces, there are innovative adhesive and substrate pre-treatment solutions available to assist in the connection of difficult-to-bond materials.

 

Beyond enabling the assembly of different substrates, adhesives have also been selected by medical device manufactures to lower manufacturing costs. Adhesives, in place of solvent, can increase operational efficiency by reducing scrap, decreasing cycle times, automating production, and enable in-line QC testing. Moreover, adhesives have also been specified in support of sustainability and safety initiatives.

Have you faced any of the challenges raised here? Are you willing to share solutions?  

 

 

Interested in smart medical devices? Check out this published article: The Increasing Role of Self-Care Medical Devices for Healthcare & Treatment

About the author

Jason Spencer is Henkel’s Global Key Account Head for Medical within the Adhesive Technology business unit, where he is focused on setting broad strategic guidance and leading a team of professionals in delivering high-quality products proven to help reduce costs in the assembly of medical devices.

With over 20 years’ experience in industrial manufacturing and 8 years focused in the medical device sector, Spencer possesses a deep understanding of the medical market needs, and challenges of medical device manufacturers. Spencer joined Henkel in 1997 as an Account Representative and has worked in various roles including Key Account Manager, Business Director, Global Business Director and Global Market Development.
With a proven professional track record of delivering reliable solutions, Jason is committed to helping customers achieve their goals through optimizing current processes and developing new assembly techniques while maintaining safety and superior performance.
Based in North Carolina, Jason holds a Technology Bachelor’s degree from State University of New York College at Oswego and MBA from the University of North Carolina at Charlotte.

Contact us

Please fill out the form below and we'll respond shortly.

There are some errors, please correct them below
What would you like to request?
This field is required
This field is required
Salutation
This field is required
This field is required
This field is required
This field is required
This field is invalid