Lately, I have been wondering if the Medtech industry is missing out on software that can add value and accelerate data collection processes in R&D. Since the 90´s, the Pharma industry has used digital solutions in clinical studies during development of new products. At first, the shift from analog to digital was driven by necessity and regulations. Compliance became troublesome using analog methods. One can argue that the Medtech industry has not been able to follow suit and is still somewhat an analog driven industry. Especially when it comes to clinical evidence and data collection. This might come down to different factors. Such as lower buy-power (due to lower margins), alternative regulations, and pricing of Pharma solutions. Whatever the reason - I believe the Medtech industry has been missing out.
Today, the value of good data cannot be understated. The possibility of having traceable data in product development could open up new doors for the MedTech industry. That being said, regulations are changing in the medical device industry (e.g. the new MDR). Clinical evidence is becoming increasingly relevant, and traceability of such data is key. Furthermore, the new GDPR will force Medtech organizations to consider the way they collect such data. Larger Medtech organizations are moving faster towards continuous digital data collection in R&D. Smaller organizations are less observative though. I encourage start-ups to grab the value sitting right in front of them. The value of a traceable data for your device can prove vital when it comes down to investments (due diligence), future acquisitions, CE-marking, or marketing.
The wave of SaaS systems for secure data collection in Medtech R&D provides organizations with a variety of options at competitive prices. Which, renders the before-mentioned purchase power irrelevant. Are you interested in learning how SMART-TRIAL could benefit your organization? Let's have a chat, and allow us to share various case-stories, to see if you can relate.