Just last month, Luxoft attended the only international medical device gathering with medical software design, agile development and compliance discussions all in one place. The 8thannual Software Design for Medical Devices Global (SDMD), located in Munich, Germany, was a four-day event from February 19th-22st that brought medical device development professionals together to openly talk about the newest technology and share their success stories.
Attended by healthcare companies and IT solution providers, we were able to connect with industry leaders about their software development concerns, including UX analysis and data security. And exploring SDMD gave me eye-opening observations on what the industry is doing, and what companies need to do to drive change in the industry – both now and in the future.
Let’s dive into my 5 key takeaways on what healthcare companies need to do to stay competitive and keep up with industry pressure:
1. Decrease time to market
Under increasing market pressures with rapidly changing expectations on medical device usability and applications, traditional software development and testing methods are too slow and expensive for companies who want to stay competitive and adapt to new market trends. Forcing consumers to wait several years for release is just no longer acceptable.
So how do companies achieve a faster product development cycle – encompassing software, hardware and everything in between – while maintaining quality and staying compliant with industry regulations?
New prototyping tools, automated programming environments and incorporating agile practices help development and testing teams address the challenge. But the approach that works best is likely a combination of a few carefully selected and validated processes that are very specific to each project and company.
2. Focus on patient usability needs as more devices become on the go
Businesses can gain a competitive advantage just by understanding patients’ and clinicians’ usability needs and preferences. When new products have similar functionality and costs as more well-known devices used in the past, it positively influences a buyer’s decision to purchase.
That being said, the sheer variety of medical devices is enormous. It’s hard to claim such a general statement about purchasing habits is 100% accurate, especially for specialized devices in hospitals, such as bedside monitors. These devices should always feel familiar to users, especially during emergencies where quick thinking is key. This is probably why most of the discussions at the event centered around portable and mobile-based solutions, where user expectations regarding user experience (UX) tend to be less conservative.
Whichever case it may be, UX research is always important in order to create user-friendly and user-centric devices.
3. Focus critically on cybersecurity
Cybersecurity will likely become a top priority for medical device manufacturers in the near future. Most current research focuses on the probability of cyberattacks and assessing impact, rather than real actions medical device manufacturers can take to address the problem. However, as IoT-connected medical devices become more prominent and patient data security becomes more of a concern, demands to securely process, share and store data will force cybersecurity into the limelight.
In fact, any medical device used nowadays may have undiscovered vulnerabilities in its design and/or code. It may be wise for manufacturers to consider auditing their existing software from a cybersecurity standpoint, and to strictly follow code design rules to minimize the probability of cyber exploits in future devices.
4. Improve test automation practices
Product quality is always one of the top concerns medical device manufacturers have, hence the significant time and budget spent on verification and validation (V&V). And as it turns out, it’s an even bigger challenge when a device interacts with other devices in order to share data. A tremendous effort is required to re-execute thousands of manual use cases with every new product or patch release, aligning each to a required QA process.
Therefore, every R&D manager dreams of adopting a reliable and scalable test automation framework that covers most integration and system tests. In addition, connectivity and interoperability testing also need to be a part of the normal QA process. This ensures all interacting medical devices correctly process and display patient data at any given time.
There will never be one breakthrough approach or framework (whether developed in-house or by a third party) that serves all testing needs. Every medical device company needs to continuously assess their own needs and discover a unique process that works best for their business.
5. Evaluate the impact of artificial intelligence & machine learning and how they fit into compliance
Emerging technologies are constantly knocking on every medical device manufacturer’s door. But due to regulatory compliance concerns, healthcare has yet to fully submerge itself into the AI and machine learning world. Although it still may be some time before full adoption, eventually patient care systems will take complete advantage of what these technologies have to offer. As AI integration is already present in other high-tech industries, it’s safe to say healthcare will definitely follow suit.
Entering the future, one step at a time
While a worthwhile event, there was admittedly a lack of engineering leads, which I believe left a noticeable gap in the content. Existing practical device software development challenges were not touched on as much as I think they should have been, as mostly consultants, entrepreneurs, UX and business development personnel drove the agenda. Overall, it was an engaging event that will help drive future change…and I’m happy to be a part of it.
And Luxoft is here for you. We rapidly streamline your processes while improving communication between the 4 big P’s: providers, payers, pharma and patients. As experts in both technology and healthcare, we understand your business needs and how they must meet the demands of your patients.
So it’s time to step into the digital realm – contact us
Andrei Shastin, Director of Account Management, Luxoft