Here at the Medical Device Technology Exchange (MDTX) event, there are several workshop and sessions covering a vast range of engineering topics. Like everything else in the current of world of engineering, the massive trend is integration. The medical device industry has been flooded with technology and systems from other engineering industries, which are creating new device categories and opening the door to new opportunities. Based off our speakers’ topic list, here are the trends I am most looking forward to at MDTX.
1. What are the rules I need to follow for medical devices?
The first thing one wonders about, beyond the design of a device, is the steps necessary to get cleared by governing bodies like the FDA. It is quite difficult to get approval for one’s device and, considering the hurdles in front of design companies today, it’s amazing that there are any advancements at all in the medical industry.
For example, at our last MDTX event I was surprised to learn that medical apps are not regulated. This answers the question of why there are so many “health” apps available for your smartphone, but so little medical devices for smartphones. The latest Apple Watch is one of the few commercially wearable devices that has FDA approval, and even that approval was only in the medical second-class device category, which regulates devices that can be sold over the counter. I look forward to conferences, like the ones from Greenlight Guru and Macadamian Technologies, to help highlight the regulation steps for medical devices.
2. Is 3D printing really going to change the medical world?
3D printing has blown up quickly and has changed the manufacturing world in ways not many expected. My college professor told me one day you would be able to order something online and print it at home. We aren’t there yet, but we aren’t far off either. In the engineering world, 3D printing has become a go-to for prototyping. It makes sense as it is a quick and easy way to test out product ideas before mass production.
In the medical device world, 3D printing can open other doors in relation to safe and sterile products. Our medical devices are required to be made of out materials that do not harm humans. Silicon, for example, is a material used for implants and medical devices. However, the construction of these devices with particular materials can be complicated and burdensome. 3D printing can allow for the production of complicated shapes with materials specifically designed for medical applications. The question is, what resources are available today for 3D printing on a mass production scale?
3. What are the necessary design considerations with regard to modern tech innovations?
There are several new tech innovations entering the medical industry. These include automation, advanced data sensors, network connectivity, and advanced manufacturing. Several of the topics at MDTX will cover how to design with a new world of innovations at your disposal.
We as engineers can no longer design for a single purpose. Our devices need to be future-proof, and one way to make certain of their longevity is to consider how to integrate the appropriate design aspects into your plans. Build your devices so they connect to future 5G networks, or else so that they can collect data for 10 years. These design considerations will help ensure your device has a long shelf life.
4. How can simulation help my medical device design? The human body is a difficult system to replicate. Each person is different and, in the past, our only resource to test medical devices was actual patients. However, that is changing as the power of computation has increased. With the new computer aided design (CAD) systems, simulation tools, and augmented and virtual reality, engineers can now accurately replicate parts of the human body to properly simulate medical devices.
This aids designers in ensuring the proper functioning of their medical devices in humans. Several of the speakers at MDTX will be highlighting the latest advancements in CAD and simulation and how they pertain to the ever-changing medical industry.
5. How is IoT going to change the medical device world?
The Internet of Things is now in full adoption across several manufacturing industries. Companies are currently adding sensors for data collection and implementing cloud analytics to help improve their processes. This has resulted in predictive maintenance, less downtime, and higher production efficiency. IoT will be a different tool in the medical industry. One aspect will be in the collection of patients’ data.
Devices will become an access point and provide important information to their physicians. These devices will connect to the cloud, connecting patients to emergency services and constant health monitoring. IoT will also provide opportunities to medical device companies to help improve their production process and ensure their devices are built correctly and safely. IoT provides a networked and connected process that helps manufacturers be more informed of how their devices are produced.