The 5 Costly Mistakes You Can Make
When Developing a Medical Device Carrying Case
The ever-increasing sophistication of medical devices has created a greater need for collaboration between medical device manufacturers and their carrying case manufacturer. What may initially appear to be a minor, case design oversight can result in a costly flaw that diminishes a device’s quality, limits functionality, or even jeopardizes the health of a patient. Because medical devices are indispensable in preventing, diagnosing, treating, and rehabilitating illnesses, injuries, and diseases, it is vital to avoid the following mistakes when it comes to the development of custom carry cases.
1. Separating the Design of the Carrying Case from the Design of the Medical Device
Manufacturers can easily fall into the trap of focusing solely on the development of a medical device without careful consideration of the case design. Yet, designing a case as an afterthought, in a siloed environment, can lead to a variety of unwanted consequences, such as schedule delays, regulation risks, and more. A misplaced indication window on a case can hinder the actual functionality of a device.A less-than-durable case may not be able to protect a device’s delicate components. Even the seemingly minor detail of sharp corners versus contoured corners creates unexpected challenges for users, such as hindering the ability to place a device in a case. The development of cost-effective, well-integrated, custom carrying cases requires direct collaboration between a custom case manufacturer and the device manufacturer from the earliest stages of the project. By partnering early in the design process, device manufacturers gain a much greater ability to facilitate superior case design integration and optimize the case development process.
Manufacturers can easily fall into the trap of focusing solely on the development of a medical device without careful consideration of the case design. Yet, designing a case as an afterthought, in a siloed environment, can lead to a variety of unwanted consequences, such as schedule delays, regulation risks, and more. A misplaced indication window on a case can hinder the actual functionality of a device.A less-than-durable case may not be able to protect a device’s delicate components. Even the seemingly minor detail of sharp corners versus contoured corners creates unexpected challenges for users, such as hindering the ability to place a device in a case. The development of cost-effective, well-integrated, custom carrying cases requires direct collaboration between a custom case manufacturer and the device manufacturer from the earliest stages of the project. By partnering early in the design process, device manufacturers gain a much greater ability to facilitate superior case design integration and optimize the case development process.
Perfect fit of device and its custom case
2. Ignoring User Functionality Aspects
To design customized case for medical devices, it’s essential to remember that it should both protect the product and serve the end user. For this reason, a designer should carefully analyze all usage scenarios when designing a case. For example, a defibrillator case used in an EMS environment needs to be rugged, quick to open, and easy to clean. However, there’s far more to consider.
The device’s function, in relation to the case, should also be carefully considered because of its role in life-altering situations. Could the case prevent the easy viewing of a display screen or hinder the ability to change out a battery? In challenging, emergency situations, when every second counts, an emergency medical technician (EMT) requires a device case that is optimized for usage, not one that creates barriers to helping a patient.
To design customized case for medical devices, it’s essential to remember that it should both protect the product and serve the end user. For this reason, a designer should carefully analyze all usage scenarios when designing a case. For example, a defibrillator case used in an EMS environment needs to be rugged, quick to open, and easy to clean. However, there’s far more to consider.
The device’s function, in relation to the case, should also be carefully considered because of its role in life-altering situations. Could the case prevent the easy viewing of a display screen or hinder the ability to change out a battery? In challenging, emergency situations, when every second counts, an emergency medical technician (EMT) requires a device case that is optimized for usage, not one that creates barriers to helping a patient.
Integrated indication & activation window
3. Not Defining Test Requirements and Standards
Medical devices, along with their cases, must meet a variety of healthcare industry test requirements and standards. Because of this, an important step in product design is identifying compliance requirements. For instance, wearable devices where the case is continuously in contact with a patient’s skin will need to pass the Vitro Cytotoxicity test (under ISO 10993-5), the Primary Skin Irritant and Cumulative Skin Irritant test, and the Skin Sensitization test (under ISO 10993-10).
Compliance and regulations, like functionality, are important considerations that should be defined at the start of product development. This will not only prevent last-minute product design changes and product recalls; it is essential to keeping the production of a device on track and on budget.
Medical devices, along with their cases, must meet a variety of healthcare industry test requirements and standards. Because of this, an important step in product design is identifying compliance requirements. For instance, wearable devices where the case is continuously in contact with a patient’s skin will need to pass the Vitro Cytotoxicity test (under ISO 10993-5), the Primary Skin Irritant and Cumulative Skin Irritant test, and the Skin Sensitization test (under ISO 10993-10).
Compliance and regulations, like functionality, are important considerations that should be defined at the start of product development. This will not only prevent last-minute product design changes and product recalls; it is essential to keeping the production of a device on track and on budget.
4. Choosing the Wrong Material
Just like a medical device, a medical device carrying case must be fabricated from materials that match its usage and environment. If a product will be utilized in a dirty environment, the case’s materials should be able to withstand repeated exposure to the harsh compounds used in cleaning solutions. Is there the possibility of exposure to excessive heat or fire? Fire retardant materials will be necessary in protecting the device. Even the color of the materials can make a significant difference in the functionality and durability of a case and the device.
Of course, cases are fabricated from more than one material. Each material should be carefully selected, and the combination of materials should work together in a consistent, cohesive way to optimize the function of the medical device.
Just like a medical device, a medical device carrying case must be fabricated from materials that match its usage and environment. If a product will be utilized in a dirty environment, the case’s materials should be able to withstand repeated exposure to the harsh compounds used in cleaning solutions. Is there the possibility of exposure to excessive heat or fire? Fire retardant materials will be necessary in protecting the device. Even the color of the materials can make a significant difference in the functionality and durability of a case and the device.
Of course, cases are fabricated from more than one material. Each material should be carefully selected, and the combination of materials should work together in a consistent, cohesive way to optimize the function of the medical device.
Choosing the right materials for cleaning and maintaining the device
5. Selecting the Wrong Production Technology
Even if a case is designed with functionality in mind from the optimal materials, things can still go awry if the technology used to manufacture the case can’t support mass production. Delivery time, cost, and chemical properties can easily be overlooked in a go-to-market strategy, resulting in having to go back to the proverbial drawing board to rethink materials, source a new
manufacturer, or even redesign a case.
While these mistakes are common, there is a single solution to prevent them. By partnering with a specialized designer and manufacturer of professional carrying solutions, you can get a case truly designed for your product. Functionality, protection, compliance, and durability are optimized to ensure you have a case built to the highest standards. With the investment of time, money, and resources necessary to create today’s advanced medical devices, choosing to work with an expert is simply a smart business decision.
Even if a case is designed with functionality in mind from the optimal materials, things can still go awry if the technology used to manufacture the case can’t support mass production. Delivery time, cost, and chemical properties can easily be overlooked in a go-to-market strategy, resulting in having to go back to the proverbial drawing board to rethink materials, source a new
manufacturer, or even redesign a case.
While these mistakes are common, there is a single solution to prevent them. By partnering with a specialized designer and manufacturer of professional carrying solutions, you can get a case truly designed for your product. Functionality, protection, compliance, and durability are optimized to ensure you have a case built to the highest standards. With the investment of time, money, and resources necessary to create today’s advanced medical devices, choosing to work with an expert is simply a smart business decision.
Partner with an Expert
At Shell-Case, we begin each custom case project by conducting a thorough needs-based analysis to define compliance standards, specifications, and end-user requirements. From there, a plan is constructed to design and manufacture the best carrying solution for the product. Our commitment to quality methodology ensures that we conform to the highest international standard and processes. Once a prototype is approved, preproduction and production processes are monitored from start to finish, ensuring that the case complies with the highest standards.Ready to turn your ideas into a customized carrying case that meets your needs—and the needs of your product’s end users?
Let’s talk.
At Shell-Case, we begin each custom case project by conducting a thorough needs-based analysis to define compliance standards, specifications, and end-user requirements. From there, a plan is constructed to design and manufacture the best carrying solution for the product. Our commitment to quality methodology ensures that we conform to the highest international standard and processes. Once a prototype is approved, preproduction and production processes are monitored from start to finish, ensuring that the case complies with the highest standards.Ready to turn your ideas into a customized carrying case that meets your needs—and the needs of your product’s end users?
Let’s talk.