Epic Medical Concepts & Innovations (EMCI) is a medical device company that creates human health-advancing technologies by translating high-level scientific research and medical innovation into Internet of Things (IoT) market-ready devices.
How do they do it amidst the ever-growing thorn bush of regulation?
In part II of our conversation with EMCI’s Vice President & COO Peter B. Lucas, we investigate the opportunities and challenges facing medical device companies in the burgeoning IoT space.
Arena: It seems things change so quickly in IoT. Disruptive change can impact the market overnight. How does product lifecycle management (PLM) corral change and help companies move in a new direction quickly?
Lucas: This is the biggest fear of a medical device company — quickly changing standards. PLM is a must for such an implementation as we can immediately see exactly what the cascade of affected items and documents are when we make a change to one thing.
Arena: Are the pain points your IoT medical device company faces common?
Lucas: Currently the interconnection of medical devices is in total infancy. Most interaction is done through (believe it or not) TTL 5v pulses. This is essentially a binary connection (on/off), and does not allow for sophisticated data transfer. Our devices, for example, can accept a signal from an fMRI to respond to a pulse, and our device can send a signal to the fMRI that it has just performed a task.
You could call this an "interconnection" but that is the extent of the connection. Again, as tech advances and medical device companies expand collaboration, we expect that more and more interconnectivity will emerge.
Arena: How did Arena PLM help resolve your IoT business and technology challenges?
Lucas: Arena is very helpful across a broad range of issues. For us, the interconnection between Arena PLM BOMControl and Arena Quality is where the value really shows itself. We know when we change a specification on one part of one of our devices, immediately what other parts, products, procedures, and manufacturing processes are affected. We can jump straight from there into engineering and document change requests and orders, as those can interconnect with our CAPA process within Arena Quality.
We are also able to connect all of these different pieces of information together within Arena Projects and use it to manage the change, set deliverables and deadlines that can be tracked easily. Accountability is clear cut, and reports can be generated to show where the bottlenecks exist.
Arena: Is there a measurable ROI for EMCI that speaks to how Arena PLM helped deliver value to IoT companies?
Lucas: We have found that a change that would have taken a staff of 5-6 people full time for 60 days can be accomplished by a staff of 1-2 people in less than 30 days. This is a tremendous benefit for us, because we have a lot of projects going at any given time. Those people who would have all been tied up on a change can now work on advancing other product development projects.
Another metric that we watch is “incomplete quality processes”. These are often simple product enhancement processes, but you would be quite surprised how difficult it is to keep track of the progress of several dozen quality processes all happening simultaneously. Without Arena Quality, quality processes that don't get completed in a timely manner would get caught by external auditors rather than by the built-in features of Arena.
Click here to read part 1 of our conversation with EMCI.
Click here to contact Arena about how we can help your IoT company succeed.