Webinar Recording Available On-Demand
By: Sandra K. Rodriguez, Market Analyst, Axendia
The Internet of Medical Things (IoMT) and the transition to outcomes based reimbursements are changing the way medical device companies approach new product development. IoMT and connected healthcare can enable the transition to patient-centered, preventative care. IoMT connected devices are going to play an important role in supporting improved quality of care, patient outcomes, and also improving the business of healthcare in the outcome economy. Yet with smart, connected products comes a new level of complexity throughout the total product lifecycle
In a recent FDANews webinar, I was joined by David Wolf and Jordan Reynolds, both Senior Managers with Kalypso. We discussed the impact the increased number of connected IoMT devices is having on outcome based healthcare models, the potential benefits and pitfalls, and how to best leverage PLM solutions and IoT in a changing healthcare environment.
Medical device manufacturers are applying advanced technologies to support the development of complex, high quality, smart connected devices. Jordan Reynolds added, “These include the ability to develop products that can be monitored in real time, that can be updated in real time, and that can be controlled in real time by the manufacturing organization that’s responsible for the product. These are really the three elements of IoT and Analytics technologies that, when coordinated together, are giving manufacturers the capability to enable an outcome-driven patient care model.”
In the Life Sciences industry, manufacturers are considering Product Lifecycle Management (PLM) strategies in support of the FDA’s Case for Quality (CfQ) when starting their Internet of Medical Things (IoMT) journey. David Wolf pointed out, “Some of the most important CfQ metrics are centered around pre-production, production and post-production which will be used by the FDA to prioritize audit and pre-market approval inspections. These Key Process Indicators (KPI’s) utilize PLM systems as the backbone when aggregating product changes over the product lifecycle, calculating non-conformances in order to determine if they got it right the first time, trending complaints, evaluating service records, understanding adverse event reports and when calculating failure rates. Not only can companies reduce the number of recalls and warning letters by harmonizing PLM and QMS, they can also significantly reduce the cost of poor quality and better unsure the safety and efficacy of their products. PLM & QMS are used as the backbone for compliance, help ensure better product quality and can be used as a very important input to the IoMT and predictive analytics processes.”
We also discuss:
- How IoMT and Big Data foster an environment that is conducive to Predicative Analytics and Machine Learning
- What medical device companies are already doing to compete in a new ecosystem that includes at-home patient monitoring
- How Cybersecurity threats are being mitigated
To learn more about how the Internet of Medical Things (IoMT) Supports Improved Patient Outcomes, access the on-demand webinar here.