Medical Device Development: An Innovative Approach
Medical Device Development: An Innovative Approach
Managing medical device development projects for energy-driven devices can vary greatly from managing the development of other devices.
To clarify before moving forward, when we say “energy-driven device” we mean any medical device that requires power or electricity to function (including battery-powered devices).
In working with top medical device engineers from around the world, a consistent theme resonates among engineers who aren’t currently working on energy-driven devices:
I am not currently working on a device that is energy driven, but I see the road map and I know it is coming.
The resulting conversations with these engineers typically revolve around the development process for an energy-driven device, which usually follows this pattern:
- The company spends millions of dollars to develop a piece of capital equipment.
- Then, resources are funneled toward developing the distal end of the device.
- Finally, the company begins to ideate the interconnect solution that will tie the capital equipment to the device.
The purpose behind this discussion is to spur thinking about the whole picture prior to originating the development process.
In this blog post, we’ll talk about the value of approaching energy-driven medical device development with a holistic view of the entire system—from the capital equipment to the cables and components that connect it to the device itself.
A recurring problem: Was your “medical” electrical connector actually designed for a fork truck?
When working on your last energy-driven medical device did you ask yourself: What was the origin of the connector we’re designing into our device?
Before continuing, stop and think about your device and ask yourself the following three questions:
- Does my device need the same features and construction as a connector that will be used in a heavy-duty equipment or a fork truck?
- Does my device need the same features and construction as a connector that will be used in a high-end automobile or commercial vehicle?
- Does my medical device need the same features and construction as a connector that will be used in a military or defense application?
Your answer was most likely no.
Not only no, but an emphatic NO!
Though this may never be a problem for you, at ATL, we’ve helped rework numerous devices that include an interconnect solution that was designed for a non-medical application—like a fork truck.
This is inefficient for many reasons, the two biggest being: performance and cost.
When you are designing a device, you are creating something for a specific medical application with unique requirements in mind.
None of those requirements have anything to do with fork trucks.
In order for your energy-driven device to function properly, you need to make sure that the interconnect solution you incorporate into your medical device delivers the required power from the capital equipment to the device itself.
Though industrial manufacturers produce very high-end connectors that work great for fork trucks and F-16s they don’t provide you the exact connector for your medical device needs.
And because of this, your device performance suffers.
Using a connector whose origin was intended for anything other than your medical device could prove detrimental to the long-term success and competitiveness of the device.
Considering the modern-day challenges of the medical device market and how they impact pricing (e.g., an aging population, healthcare spending, coverage and reimbursement, and the medical device tax), it is safe to say that your medical device, whether reusable or disposable will carry with it the constraint of cost.
To highlight how using an interconnect solution that was not designed for your device can impact cost, let’s compare the price of your medical device with the items listed in the three questions above.
According to a report from the US National Library of Medicine, atrial fibrillation equipment costs range anywhere from $6,637 to $22,284—well below either of the applications listed above.
Can your medical device compete if it includes a connector that was developed and priced to be built into a fork truck, luxury car, or fighter jet?
Depending on the connector you choose, this is exactly what you are deciding to do.
If you’re contemplating whether or not a custom interconnect solution is more expensive than an off-the-shelf option, consider this: A custom interconnect solution is typically designed to have fewer components and fewer un-utilized features, so that it delivers exactly what you need.
This eliminates costs and ensures that the solution is right for your device.
The increasing demands of energy-driven medical devices.
As new medical devices continue to push the envelope, engineers are being asked to do more and more.
Whether the challenge is:
- Incorporating a camera onto a catheter for better visualization during a procedure,
- Improving the amount and quality of information driven through a connector by increasing the number of conductors while maintaining the physical size of the connector,
- Implementing tactics to prevent illegal reuse of the device,
- Or finding ways to lower the cost of the whole device while maintaining or increasing performance
Engineers have tackled it head on to create the superior medical devices currently being used in the market today.
These challenges and increasing demands have uncovered a need for a new way of approaching the energy-driven medical device development process.
A process that considers every piece of the device during design and development.
Improving the development of energy-driven minimally invasive surgery devices.
With the minimally invasive surgery device market shifting further toward energy-driven technology and robotics, approaching device development with an eye toward the interconnect solution is vital.
If you don’t incorporate the interconnect solution into the design of the device, you could face the problem of having to find an expensive, sub-optimal off-the-shelf connector and cable assembly to fit your device after-the-fact.
These sub-optimal connectors and cables have the potential to cause performance issues, such as loss of power or signal.
Developing your minimally invasive surgery device with the interconnect solution in mind helps prevent a scramble to find a connector or cable to fit the device and it helps mitigate the risks associated with using components that weren’t designed for your specific application.
Improving the development of energy-driven electrophysiology medical devices.
Given the nature of electrophysiology medical devices, the interconnect solution has always been considered a crucial element of the device itself—after all, these devices require power in order to properly work.
So why do so many electrophysiology device projects depend on post-hoc cable assemblies instead of custom-engineered solutions?
When an electrophysiology medical device isn’t designed with the interconnect in mind, the device can experience performance issues—such as loss of image quality and decreased signal integrity—that impact patient outcomes.
Keeping the interconnect solution top-of-mind while developing your electrophysiology device helps prevent these performance issues.
[Video] As mapping and imaging devices continue to push the limits, how does that impact device design and development?
Accelerating energy-driven medical device development with prototyping.
When used strategically, prototyping can be an effective way to accelerate the device development process and decrease time-to-market because it enables you to validate your ideas faster than a drawing or specification sheet.
The ability to validate ideas faster can lead to better team alignment during the development process as well as improved voice-of-customer input, as prototypes can be shown to colleagues and healthcare practitioners and feedback can be collected and used.
Strategic prototyping can also help you identify design problems and opportunities early on, which enables you to streamline your development process and save your organization time and resources that may have been wasted pursuing a flawed concept.
The key to improving energy-driven medical device development: Focus on the interconnect.
So, how can you improve the development process of energy-driven medical devices to ensure that they reach peak performance?
By treating the interconnect solution like every other piece of the device: as something that should be designed, not purchased off-the-shelf.
Developing a custom interconnect solution helps you ensure that the connector and cable meet your exact requirements a while also eliminating the negative risks and costs associated with purchasing components off-the-shelf.
Your connector needs to be a connector designed for your medical device not a fork truck.
How to approach the 5 phases of the medical device development process with an eye toward the interconnect.
So, how do you approach medical device development with a focus on the interconnect?
In the sections below, we walk through the different stages of the medical device development process and provide examples of how this can be done.
[Video] Which phases of the medical device design and development process does ATL typically help customers execute?
Please note that the medical device development process is different for every organization and every device and that the information presented here is intended for general educational purposes.
For more information regarding the complexities and regulatory requirements surrounding the medical device development process, please consult the ISO 13485 guidance document and/or the FDA’s website.
Phase 1: Planning and Analysis
Before any device can be developed, there must be a plan in place that outlines how the device will go from an idea to a reality and how everything will be documented.
This plan should include information related to the design and development stages that the device will pass through, the resources needed to complete the project, the responsibility of the parties involved, the method for documenting project inputs, and much more.
It’s during this phase that project inputs related to function, usability, safety, and other fields must also be collected.
There are two big reasons that keeping the interconnect in mind—or even including an interconnect expert—during this phase can be advantageous.
First, depending on the function of the device, the interconnect can be complex.
Understanding how the intricacies of a device interconnect system can impact documentation, validation, and resource requirements can help you establish a more robust project plan.
Second, introducing electricity into a device inherently adds another layer of safety concern that must be considered and planned-for.
Knowing the safety regulations and requirements surrounding electrical medical equipment (e.g., IEC 60601) puts you in a better position to address and manage device safety risk throughout the development process.
Phase 2: Concept and Feasibility
For a device project to be successful, it must be attainable given the constraints of the organization and the market.
After the project plan has been established, the team must determine whether or not the device will be functionally and financially feasible.
This is typically done through a mix of market analysis, financial modeling, and prototyping—which enables teams to get a concept in their hand for testing.
Understanding the resources required to produce a functional interconnect system and the various options for creating interconnect prototypes can help accelerate the team through this project phase.
Phase 3: Verification
Once the device has been identified as feasible and the dust of concepting and iterating has settled, the project enters the verification phase.
During this phase, the device design outputs are measured against the previously defined inputs using methods and acceptance criteria determined by the organization.
Another requirement of this phase is that the design outputs must be confirmed to meet design inputs when the device is connected to another device.
As energy-driven devices are commonly connected to other devices (e.g., capital equipment, computers, monitors, etc.), this is a vital point that cannot be overlooked during the medical device development process.
Knowing the methodologies behind this verification step is key to project success.
Phase 4: Validation
During the validation phase, initial production units are produced and measured to ensure that the device is capable of meeting the application requirements.
If clinical evaluations are required for device commercialization, this evaluation happens during the validation phase.
Also, similar to the verification phase, during validation the device must be confirmed to meet application requirements even when it is connected to another device.
The manufacturing and assembly processes for interconnect solutions can differ greatly from those of fluid-delivery and device guidance systems.
Ensuring that the interconnect solution consistently provides the correct amount of power or transmits the correct data is vital not only to passing the validation phase—it’s also vital to the function of the device in the operating room.
Knowing how the interconnect solution is manufactured and assembled can help improve process development and validation efforts.
Phase 5: Manufacturing Handoff
After establishing the manufacturing processes and validating them to ensure that the product meets the application requirements, the project is ready to be transferred to the manufacturing team.
During this phase, the development and manufacturing team must ensure that they have the proper resources to manufacture the device according to the correct specifications.
Having an in-depth understanding of the interconnect solution that was developed for the device can help you identify resource needs (e.g., you may need specially trained technicians who can solder fine wires to a flex PCB) and potential manufacturing constraints (e.g., your facility may only be able to produce 1,000 pieces per week when you actually need 2,000 per week) before they become an issue.
For a custom interconnect solution to perform at the highest level, we recommend working with an interconnect expert.
If you want to learn more about integrating the interconnect solution into your next device, check out our Medical Device Development eBook.