MedTech Roundup

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

The importance of providing and fearlessly seeking feedback at Novasyte goes back to the Company's inception in 2008. This cultural priority is not simply a theory discussed at the annual company meeting, but a living, breathing, organically-developed reality of the day-to-day environment that allows for cross-departmental synergies to develop, relationships to grow, and issues to be resolved in real-time. 

Topics: Novasyte News, Med-Tech Industry Update, Quality Management System, San Diego, CA, Industry Trends, ISO Certification

On April 30, 2018, the California Supreme Court unanimously ruled to establish clearer distinctions between W-2 employees and 1099 independent contractors. Additionally, they made the process more difficult for employers to classify an employee as an independent contractor through an updated, more restrictive "ABC" test.

Topics: Novasyte News, Med-Tech Industry Update, Medical Device Industry, San Diego, CA, Industry Trends

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

 

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: 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