MedTech Roundup

When it comes to electronic medical records, several words beginning with ‘F’ may come to mind.

You may be surprised to learn that, according to an article by Sarah Kliff, faxes still account for as much as 75 percent of all medical communication (Kliff, 2018). This is due to several factors. One of the main drivers is the lack of interoperability between competing electronic medical records systems.

So the fax machine survives, even though it is a dated technology widely despised by stakeholders throughout the healthcare spectrum.

Advantages to the fax machine include that it doesn’t require a login to access nor does it need months of training to operate. However, while these can be seen as benefits for end users, challenges arise when analyzing the security, traceability and confirmation of faxed documents.

Topics: Outsourcing Support, Medical Device Recall, Medical Device Recall Help, Med-Tech Industry Update, Medical Device Industry, Industry Trends, Industry Advancements, SMART recall program

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.

Topics: Medical Device Recall Help, Med-Tech Industry Update, Medical Device Industry, Industry Trends, Industry Advancements, White Paper

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.

Topics: Medical Device Recall Help, Med-Tech Industry Update, Medical Device Industry, Industry Trends, Industry Advancements, White Paper

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. 

Topics: Medical Device Recall Help, Med-Tech Industry Update, Medical Device Industry, Industry Trends, Industry Advancements, White Paper

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.

Topics: Medical Device Recall Help, Med-Tech Industry Update, Medical Device Industry, Industry Trends, Industry Advancements, SMART recall program, White Paper

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: Med-Tech Industry Update, Quality Management System, Medical Device Industry, Medical Device Field Action, San Diego, CA, Industry Trends, ISO Certification, Industry Advancements, 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: Medical Device Recall, Med-Tech Industry Update, Medical Device Industry, Medical Device Field Action, S.M.A.R.T Programs, Industry Trends, Industry Advancements, SMART recall program, White Paper

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: Medical Device Recall, Med-Tech Industry Update, Medical Device Industry, Medical Device Field Action, S.M.A.R.T Programs, Industry Trends, Industry Advancements, SMART recall program, White Paper

 

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: Medical Device Recall, Med-Tech Industry Update, Medical Device Industry, Medical Device Field Action, S.M.A.R.T Programs, Industry Trends, Industry Advancements, SMART recall program, White Paper

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.

Topics: Medical Device Recall Help, Med-Tech Industry Update, Medical Device Industry, Industry Trends, Industry Advancements, SMART recall program, White Paper