MedTech innovation saves lives. The companies that develop them, and the brilliant minds behind these products, are responsible for the devices that keep families together. Due to their importance, MedTech products come under a lot of scrutiny from a quality and regulatory perspective.
For medical device developers, speed and safety are the two most important factors when it comes to MedTech innovation. Devices need to perform, hit the market quickly, follow rules and regulations, and keep patients safe.
But how do we accomplish all of those important measures in such a short window of time, and still ensure we're bringing effective devices to market? In this post, we’ll cover all the stages of developing your next medical technology device from patient safety to regulatory compliance.
MedTech Innovation For Patient Safety
The biggest threat to safety in medical devices and software is human error. Like most IT processes, the more automation you can have, the better. It's not that humans are inherently bad – we just all make mistakes sometimes.
For MedTech innovation to happen safely, in the case of software or devices, IT engineers need to start with the end in mind. Development teams should be brainstorming to explore every possible way the device or software platform can malfunction. Taking this proactive approach not only keeps patients safer, but it will save your team time and money in bringing your new product to market.
Teams also need to analyze any potential hazards misusing the device or software could cause. If a device installed within the biological systems of a patient fails, the results could be catastrophic. Developers need to plan extensively for these scenarios. They also need to plan for the controls that will be in place to minimize their damage.
Teams can help ensure the safety of their designs during the product development of medical devices. Conducting proper product risk analysis and periodic surveillance reviews during this process goes a long way toward ensuring the safety of new medical software and devices.
Medical Device Recalls
One of the biggest issues affecting medical device safety is product recalls. In 2019, the majority of these recalls were due to software-related errors. This shows that there is a lot of room for improvement in the way MedTech software arrives on the market. Teams working toward MedTech innovation need to figure out ways to implement much tighter Quality Assurance measures when it comes to developing software.
Efficient MedTech Innovation
Naturally, we want safe products when it comes to medical software and devices. But the nature of the industry also dictates that we develop efficient products, and we do it at optimal speeds so that they can be brought to market quickly.
There are some hurdles to this process, which MedTech companies can handle in a variety of ways:
1. Regulatory Compliance
Government bodies impose regulations on the MedTech industry to control risks. Engineering methods, design practices, and other processes all fall under the umbrella of these rules and regulations. The main goals of these regulations are twofold.
The first is transparency. Government bodies in both the U.S. and Canada implement legislation to make the MedTech innovation process as transparent as possible. The good news is that this aspect actually helps with efficiency.
The more transparent a team's processes are, the fewer surprises there are that can pop up while bringing the device to market. Therefore, process maturity and transparency actually helps improve the profitability of medical device developers in the long run.
The second, and certainly not less important, reason for these regulations is safety.
There are three main pieces of legislation governing international MedTech innovation
- IEC/ISO 62304:2006 Medical device software — Software life cycle processes
- IEC 82304-1:2016 Health software — Part 1: General requirements for product safety
- ISO 14971:2012 Medical devices — Application of risk management to medical devices
The idea is that by using three overarching pieces of legislation we can ensure consistency and accuracy in product development. If a medical device is deemed compliant, it will begin its journey to market.
MedTech companies have an opportunity to optimize the efficiency of their process at this point. For decades, compliance was considered an afterthought, adding significant overhead once the actual development of the product was already completed.
Instead, what successful development teams aim to do today is to build quality into their processes, and implement routine compliance checks throughout the development process. Proactive controls throughout every stage of the development process (essentially implementing a system of continuous compliance) save MedTech companies time and money.
2. Digital Controls
Controls, or the methods for handling issues, need to be in place at every stage of the process. This is the best way to achieve efficient design and compliance.
The challenge, then, is how do we manage all of these individual controls? Digitalizing controls makes the process much easier for development engineers and MedTech IT personnel.
With digital controls, engineers free up time to focus on adding value. Less time is spent on redundancies and more time is spent on core tasks.
Revisions and updates can also be logged and timestamped digitally – and automatically. This makes for a "short and sweet" history of every product on its way through the development process. If bugs occur, they can be easily traced back to their source and quickly resolved.
Finally, digital controls help achieve consistency. No matter where in the world your team is located, data and processes can remain consistent throughout the product life cycle.
3. Risk Management
Measures, processes, and approaches to assess product risk management are essential to the design process. But risk management can be a challenging part of the development journey. A lot of this has to do with geographic isolation.
A few experts in product risk analysis are located thousands of miles away, on another continent, from the rest of the development teams. Setting up a shared, central development hub with digital controls for your MedTech innovation process is a way around this hurdle.
By implementing digital controls, your entire development process can be played out on one easy-to-use dashboard. This brings product analysts back "into the loop". They're closer to the rest of your design team even though, geographically, they may still be far away.
Now, your entire team can work together toward the common goal of eliminating patient safety risks. All relevant information is accessible to all stakeholders – similarly, audit preparation is greatly facilitated, as audit reports can simply be pulled from the system. As a result, patient safety and efficiency of design both improve dramatically.
Full Speed Ahead
MedTech innovation needs to be done carefully. But that doesn't mean it has to be done slowly and without efficiency. By implementing modern digital tooling, many of the traditional pitfalls of medical device development can be avoided while also optimizing product delivery time & costs.
Read our case study to find out how Medtronic, this global innovation leader, has implemented digital tooling to support their (Agile) MedTech delivery processes: