The medical device manufacturing industry is among the world’s fastest growing industry sectors. According to research, the majority of companies operating in this market are optimistic about the future of the industry in 2016. And for good reason: the medical electronics and healthcare IT market hit the $100 billion mark by the end of 2015, and with the ageing of global population, increased health awareness and rampant growing of healthcare costs, it certainly doesn’t look like it’s about to slow down.
The future is definitely looking bright for medical device manufacturers. However, dig just a bit deeper, and you’ll find that developers of healthcare electronics will have to face several major issues, and keep pace with accelerating trends in coming years. Let’s take a look at the challenges ahead for medical device developers, and the market trends that can be expected to continue in 2016.
Continued trends in the medical device industry
Patient experience & value to be incorporated in the development lifecycle
A new, more integrated, value-based approach is disrupting traditional business models. Medical developers are looking to integrate marketing and sales with engineering, design & manufacturing in order to deliver value for their customers and stakeholders (which include patients, physicians as well as regulatory bodies) by understanding how exactly their medical products are being used in practice.
Remote and virtual healthcare
The way healthcare is delivered, accessed and perceived is changing. Due to increasing health awareness, lifestyle products promoting and supporting a healthier way of life are converging with traditional medical products. Devices and mobile apps for fitness and wellness, such as smartphones with activity trackers, smart watches, wearables and body diagnosis scales can be expected to become more popular, and could enter the world of healthcare (in other words, your doctor may well prescribe you a smartphone app in 2016). Remote patient monitoring and e-visits are expected to grow in significance, further expanding software/IT opportunities on the medical device market. As the PwC Health Research Institute’s annual report notes:
“In 2016, millions of American consumers will have their first video consults, be prescribed their first health apps and use their smartphones as diagnostic tools for the first time.” – PwC: Top health industry issues of 2016
Streamlining medical device lifecycles & healthcare
The cost of healthcare is rapidly increasing throughout the world. At the same time, companies involved in the development of solutions for diagnosis, imaging, treatment, monitoring and therapeutics are looking to capitalize on cost-sensitive emerging markets. Therefore, increasing the efficiency of all healthcare systems and reducing costs seems to be an essential trend that can only be expected to continue in 2016.
The emergence and increasing popularity of remote healthcare and mobile health devices can be expected to support the reduction of costs. Collecting, managing and analyzing big data to find ways to tighten up waste is expected to support this trend, placing significant emphasis on healthcare software and IT infrastructure.
New & ongoing challenges for medical developers
Adapting to the above trends is by itself a crucial challenge for developers of medical devices. In addition to these, however, the following concerns will mean a bit of headache for these companies:
Reliability, safety, security, quality control
Quite naturally, product quality is a primary concern among medical device developers. Avoiding recalls (resulting in a loss of reputation as well as significant financial damage) is of primary importance, and the use of adequate processes to ensure product safety, reliability and security is stipulated by standards and regulations imposed by various governments and international regulatory bodies. To make matters even more difficult, these regulations are constantly being updated:
Changing regulations & compliance
Changing legislation remains to be one of the main causes of concern for medical device developers. Evolving regulations on the security, privacy, reliability and safety of medical devices can have a significant impact on the internal processes, as well as the profitability of development companies. Upcoming changes to Europe’s medical device regulatory process are expected to take effect in 2017, leaving developers with the challenge of preparing for these adjustments well in advance.
Managing data, mobile devices, IoT-integration
While opening up new areas of innovation, the Internet of Things also brings technical challenges for medical device developers. Collecting, securely managing, and simply making sense of the vast amounts of data that sensors in IoT-enabled devices gather is going to be a difficult task. Due to the sensitivity of the information, special care will have to be taken to securely transmit and store data in the cloud, and to avoid breaches.
Overall, 2016 is certainly looking interesting for medical developers. Adapting to a rapidly changing market landscape, and overcoming emerging challenges to keep pace with and take advantage of rapid development will require a great deal of flexibility, and innovative business management solutions & tools. As the Application Lifecycle Management platform of choice for many ingenious medical device developers, codeBeamer ALM can help future-proof your medical electronics development processes. codeBeamer supports dispersed development, scaled Agile, and the parallel lifecycles of IoT innovation.
Interested in how Medtronic, DATATRAK, NewYork–Presbyterian Hospital, and several other leading medical companies are using codeBeamer ALM to streamline their innovation? Get in touch with us for a quick chat or a free 1-on-1 demo, or simply start your free 30-day trial of codeBeamer ALM.
Join us ad Medtec Europe 2016, 12-14 April in Stuttgart! Look for Intland Software’s booth numbered 3A55.