With increased pressures to reduce internal SG&A costs, accelerate the pace of business, and increase process efficacies, manufacturers are continually investing in third-party partnerships where innovation is at the forefront of service delivery.
Improving the patient experience and measuring their satisfaction is becoming increasingly
important to facilities and manufacturers. Not only is patient satisfaction one of the three essential dimensions of the Institute for Health Improvement (IHI) Triple Aim, but the scores are also key performance metrics under the 2016 Center for Medicare and Medicaid Services (CMS) Hospital Value-Based Purchasing (VBP) Program.
As a partner to many of the largest, global medtech companies for more than a decade, Novasyte has gained a strong understanding of the evolving healthcare landscape and trends in nurse staffing. With the consistent rotation of nurses in hospital systems, manufacturers are adapting to the staffing changes and optimizing their education methods to ensure successful medical device conversions.
For many medtech manufacturers, commercializing products into a new healthcare facility brings a series of opportunities and challenges, including:
- The need to provide proof of product efficacy and cost effectiveness,
- The need to deliver new product into the facility quickly,
- The need to align with facility leadership on the strategic direction to implement, and
- The need to train the facility’s end-users to support adoption.
In May 2018, the FDA released a report titled "FDA Report on the Quality, Safety and Effectiveness of Servicing of Medical Devices," issued by the Secretary of Health and Human Services and in accordance with The Food and Drug Administration Reauthorization Act (FDARA). The FDA examined product servicing by manufacturers, healthcare establishments and third-party providers who refurbish, recondition, rebuild, remarket, service and repair medical devices.
Topics: Industry Advancements, Industry Trends, San Diego, CA, ISO Certification, Quality Management System, Medical Device Field Action, Medical Device Industry, Med-Tech Industry Update, Field Technical
Organizations who have previously struggled with managing a recall internally, or perhaps do not have the time or resources to maintain the consignee data, develop a field strategy or create a centralized database, can trust Novasyte as their recall management partner.
Topics: White Paper, Industry Advancements, Industry Trends, Med-Tech Industry Update, Medical Device Industry, Medical Device Recall, Medical Device Field Action, S.M.A.R.T Programs, SMART recall program
It is easy to fall into the rhythm of receiving multiple spreadsheets from various sources – be it sales, regulatory, marketing or quality – and by having them in one place, feeling like the recall is “under control.” In working with more than half of the largest med-tech companies globally, Novasyte has discovered this is a common theme.
Despite the commonality of this approach, there are inherent associated risks with managing a recall across multiple spreadsheets. Here are the top four.
Topics: White Paper, SMART recall program, S.M.A.R.T Programs, Industry Advancements, Industry Trends, Med-Tech Industry Update, Medical Device Field Action, Medical Device Recall, Medical Device Industry
Prior to launching a field team to address the product need, it is critically important to assess the effectiveness of the field strategy as it could result in a significant, potentially unnecessary, budgetary hit.
Topics: White Paper, Industry Advancements, Industry Trends, Med-Tech Industry Update, Medical Device Field Action, Medical Device Industry, Medical Device Recall, SMART recall program, S.M.A.R.T Programs
This is never as simple as it sounds, and it may even sound obvious. That said, it is one of the critically important steps to ensuring a recall is executed accurately and timely.
Product recalls happen. Even to the most diligent organizations.
With the medical device landscape continually evolving, organizations must be agile and ready to respond to a recall at any moment. In looking at the annual number of medical device recalls in the graph below, one thing is known - recalls are not going away.
Topics: White Paper, SMART recall program, S.M.A.R.T Programs, Medical Device Recall, Medical Device Field Action, Medical Device Industry, Med-Tech Industry Update, Industry Trends, Industry Advancements