From breakthroughs in personalized medicine, genomics, and medical devices, healthcare and life science companies are finding ways to advance human health more cost-effectively. Yet increased regulatory requirements challenge innovative companies to get to market quickly. Arena makes audits easier and faster with a cloud-based solution that consolidates all compliance information into one centralized system. The secret? The solution streamlines management of bill of materials (BOM), the design history file (DHF), the device master record (DMR), and change orders.
Arena customer Epic Medical Concepts & Innovations (EMCI) is a premier, quintessential medical-device developer that creates human health-advancing, market-dominating products. EMCI seeks and develops disruptive technologies in a wide array of medical disciplines. EMCI translates high-level scientific research and medical innovation into market-ready devices.
According to EMCI’s Vice President & COO Peter B. Lucas, the company is unique in that its business spans from large-scale production of devices already in the market to development of its own technologies. The strategic-minded Lucas, who is responsible for both project management oversight of new product development (NPD) and for all day-to-day operations, has a deep knowledge of the Internet of Things (IoT) market. In this two part blog posts series, we asked Lucas to discuss the opportunities and challenges IoT companies face.
Arena: Why is the IoT market exciting to Epic Medical Concepts & Innovations?
Lucas: Sharing information is always exciting and useful. As the world becomes more connected, we find new ways to leverage big data. The more interconnection we have between pieces of technology, the more useful that big data can be in identifying trends, improving response times, and locating problems before they become BIG problems. The idea that our medical devices could communicate with the lab hardware in which they operate in a meaningful, real-time manner is really exciting. It manifests into improving medical outcomes and finding new breakthroughs, especially for EMCI in the area of cognitive neuroscience.
Arena: It seems like IoT can theoretically touch every industry. Products that you once could not imagine having electronic components, now do. Can you elaborate on the endless opportunities this offers medical device companies?
Lucas: We are working on a system right now that is designed to track physical patient records in a way that will greatly reduce errors, speed retrieval time, and give doctors instant access to exactly what they need. Because this is a specimen rather than a paper record, it can't be digitized, so we are developing a method for tracking this material in a hospital setting (for a lot of reasons I can't expound any further on this tech as it's in development). We envision these systems eventually sitting in hospitals all across the country and having the ability to communicate with each other. This not only allows for a patient’s records to be accessed even if they change hospitals, but allows research scientists to look at a cross section of aggregated records across a demographic of interest... something that is impossible today.
Arena: What are the greatest challenges IoT companies face — from a manufacturing/operational/supply chain/collaboration standpoint — and why do they need Arena PLM?
Lucas: I believe the biggest challenge for IoT is standards. In an emerging field, it's always difficult for everyone to agree on how things will communicate with each other — what types of data can/will be shared, and how security will be handled. This is certainly even more important in medical devices with HIPAA regulations. There will be a need for close collaboration between industry leaders in order to create open standards for communication, security, and methodology. Updating a medical device's firmware is more than modifying the program. It requires testing, validation, and in some cases, review by regulatory agencies. This means we are highly sensitive to any meandering of tech standards, and avoid areas in which there is no clear route. With Arena PLM, manufacturers and industry leaders alike can view each other's information in real time, thereby allowing open discussion about these issues and identifying roadblocks early.
Stay tuned next week for Part II of this conversation with EMCI on the IoT market.