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Upcoming Events
September 9th 2010 07:30 AM
- Successful Office Kaizen Events
September 9th 2010 08:00 AM
- Sup 1: Fundamentals of Leadership for Manufacturers - St Paul
September 9th 2010 09:00 AM
- Sup 2: The Next Stage for Improving Performance for Manufacturers-Plymouth
September 9th 2010 01:00 PM
- Sup 1: Fundamentals of Leadership for Manufacturing - Plymouth
September 14th 2010 08:00 AM
- Results-Driven Sales Incentives
September 14th 2010 08:00 AM
- Fraud and Misconduct at Investigator Sites
September 14th 2010 01:00 PM
- Failure Mode and Effects Analysis (FMEA)
September 21st 2010 08:00 AM
- Project Monitoring- The Earned Value Method
September 21st 2010 08:00 AM
- Project Monitoring: The Earned Value Method & Project Management
September 21st 2010 01:00 PM
- Project Management for Product Development
Article Index
Medical Device Product Recall PreventionArticle by: Thomas Pepin All activities associated with a field action are in direct response to a product or system failure. It is every medical device company's goal to never execute a field action. They are very costly, from direct cost of execution to lost customer loyalty, and may result in suspended new product approvals from FDA and other regulatory agencies. All of the above can have severe adverse impact on a company's long-term survivability. |
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Clincian of the Month: Jennifer MaloneyArticle by: Pamela Wolfe Brazil, Costa Rica, Dominican Republic, México. In December in Minnesota, these are the exotic destinations we crave for a little bit of R&R to ease our winter blues. For Jennifer Maloney, working with Latin American countries is a daily event, as the Senior Clinical Research Specialist for Latin America Operations at Medtronic. |
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Companies in the News: St. Jude, ev3, and AGA MedicalArticle by: Medical Device Alliance ev3 Inc. Receives FDA Clearance to Market EverCross and NanoCross Peripheral Angioplasty Balloons ev3 Inc. (Nasdaq: EVVV),a global endovascular device company, announced today that it has received 510(k) clearance |
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Medical Device Product Recall Prevention |
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All activities associated with a field action are in direct response to a product or system failure. It is every medical device company's goal to never execute a field action. They are very costly, from direct cost of execution to lost customer loyalty, and may result in suspended new product approvals from FDA and other regulatory agencies. All of the above can have severe adverse impact on a company's long-term survivability. Prevention is key to field action avoidance. Strict adherence to an integrated and FDA / ISO compliant quality system is the bedrock for success. An integrated quality system includes comprehensive tools for product design through manufacturing and distribution, supported with extensive and relevant clinical testing. Successful and sustained implementation of an effective Quality System is contingent on leadership from the boardroom to first line supervision. Company officers and other upper management staff guide the mission, vision, values and strategic behavior of the entire organization. Tactical leadership at the line level affects and influences daily compliance with the processes and procedures. Line leadership is often viewed as an entry level training position for future company leaders. Root Causes for product recalls span a range of topics from fundamental technical design issues that were either overlooked or overruled (for the sake of time and money) to fundamental execution of the quality and or production system at the line level. Minor or major non-conformance to process procedures due to inadequate training, attention to detail, or ineffective tools and systems will eventually be discovered during a CAPA (Corrective and Preventative Action) investigation into product complaints from the field. Effective line leadership is the kingpin; the core of tactical execution of the quality system. It is imperative that they be given tools, staff and sufficient authority to lead their portion of the operation. Multimillion dollar decisions are made in the board room. Conversely, multimillion dollar activities for the conversion of product design to process and finished goods occur at the line leadership level. Both contribute to effective deployment of the Quality System for the development and delivery of Safe and Efficacious devices for human use.
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Clincian of the Month: Jennifer Maloney |
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Brazil, Costa Rica, Dominican Republic, México. In December in Minnesota, these are the exotic destinations we crave for a little bit of R&R to ease our winter blues. For Jennifer Maloney, working with Latin American countries is a daily event, as the Senior Clinical Research Specialist for Latin America Operations at Medtronic.  Jennifer began her career with Medtronic in 2003 in their regulatory affairs department, supporting all aspects for Latin American countries. This was her first opportunity to work within international markets for cardiac rhythm management, cardiac surgery and vascular products. She was assigned thick dossiers and was expected to make sure all of the pieces were present. However, she never got the opportunity to read the information and did not know the product. In 2005, Jennifer joined the clinical research team, and the abstract became concrete. She was able to see details in terms of knowing what therapy the patient was getting and the real value of that therapy. Not to mention, Jennifer was able to use her fluency in Spanish to her advantage. Although the daily scope of her work compares to those with a similar title, including writing protocols, designing CFRs and maintaining databases, there is also a very unique element, the international component of language and cultural differences. Jennifer is on the phone with different countries all day long and has a very broad array of clinical projects. At any time she may be working on 8-12 multi-center trials in multiple countries, conversing back and forth in Spanish and Portuguese. Her trial responsibilities range from site initiation through study close-out. Managing these relationships via phone creates an added element of complexity. Jennifer's team is often thousands of miles away and in various time zones. The team has to have a strong level of mutual trust to ensure the study is progressing as it should. She needs to be an expert listener with the ability to sense their stress level and have a sixth sense regarding how things are going. Jennifer has to give them direction and prioritization, hoping they will follow through. Recently, Jennifer received her CCRA certification through ACRP, which she feels is one of the highlights of her career. The certification conveys a higher level of trust within these long-distance relationships since she is considered an expert within her field. Once a quarter, Jennifer travels to the Latin American region for conferences, meetings, study start-ups and site visits. The face to face contact is invaluable for solidifying professional relationships. A significant cultural difference is that one doesn't walk into a meeting, make initial introductions and get down to business as we might in the US. In Latin America, you first need to sit down and develop a relationship to conduct business successfully. It can be difficult to navigate cultural differences, and not impose the expectations one might at home. These countries have their own flow and rhythm. Our expectations should be adapted to reflect this, and patience is required. As Jennifer stated, "Good data doesn't grow on trees", and you can't expect miracles. During these quarterly visits, one of Jennifer's aims is to identify exemplary physicians with research interest. She is responsible for seeking them out and connecting them to ongoing studies in the US and Europe. One of the biggest misconceptions Jennifer has had to overcome is common belief that the healthcare in Latin America is second rate due to many of the locations being in third world countries. In fact, many of the physicians are trained in the US and the healthcare facilities are often first rate with excellent resources. Building a successful cross-cultural team involves hard work. The Latin American team at Medtronic is lean, and broke away from the Emerging Markets group about 6 months ago due to having immense potential. Within the large structure of Medtronic, the team is very entrepreneurial. Jennifer can be involved in all facets of the process from idea to internal completion. This also allows her the freedom to build external relationships to support projects. Ideally, in each country she has a physician and a CRA/coordinator she relies upon to complete her network team structure. Having been involved in the Latin American markets for the past five years, Jennifer has overcome many cultural barriers and knows each individual country's capabilities and resources. She now knows which centers to work with and who can deliver as promised. Using her network, she partners with physicians to bring research ideas into Medtronic. Additionally, she often assists other departments in finding sites for their studies within Latin America. Jennifer is pleased to be part of the Latin American team. In her opinion, everyone gives 100% and does not ever forget that patients come first. She gets real satisfaction in knowing the team's efforts enable them to reach patients who normally wouldn't be aware of or treated using new therapies. When this all comes together, and good physicians willing to work on the study and develop the protocol are able to connect with patients, there is a sense of excitement. Jennifer feels the most valuable lessons she has learned from working within cross-cultural markets are that you need to rely on your team, build solid trust and manage expectations to ensure success.
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Companies in the News: St. Jude, ev3, and AGA Medical |
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ev3 Inc. Receives FDA Clearance to Market EverCross and NanoCross Peripheral Angioplasty Balloons ev3 Inc. (Nasdaq: EVVV),a global endovascular device company, announced today that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) to market its EverCross 0.035" and NanoCross 0.014" peripheral angioplasty ballooncatheters. ev3 expects to begin full commercialization of the EverCross andNanoCross peripheral balloon catheters globally in January 2009. Robert Palmisano, ev3's president and chief executive officer commented,"We are looking forward to launching the EverCross and NanoCross balloons this January. Based on our experience to date, we believe both balloons will enhance customer ease of use and offer significantly better margins than our current distributed product. The ability too offer our own peripheral balloon catheter also provides access to key international markets, including Europe, where we do not currently sell balloons." The EverCross and NanoCross peripheral balloon catheters are designed too offer improved overall performance in peripheral angioplasty procedures. Among several new features, both catheters offer innovative beveled tip profiles for best-in-class lesion entry and a broad range of sizes, including the only 200 mm length .035" balloon available worldwide. The EverCross balloons also offer Rated Burst Pressures that compete in the high pressure balloon market without compromising ease of use. St. Jude Medical heart device approved in Europe St. Jude Medical Inc. has received regulatory approval in Europe for its AnalyST implantable cardioverter defibrillator, the St. Paul-based med-tech manufacturer said Wednesday. A implantable cardioverter defibrillator is a surgically inserted electronic device that constantly monitors your heart rate and rhythm, according to the Cleveland Clinic Heart and Vascular Institute. St. Jude says its Analyst ST device allows physicians to better monitor heart disease progression. That's because the device continuously monitors specific changes in the heart's electrical system. The Analyst ST is still awaiting U.S. Food and Drug Administration approval. AGA Medical Receives European CE Mark Approval for AMPLATZER(R) Cardiac Plug - Device will enable minimally-invasive transcatheter closure of cardiac structures. AGA Medical Corporation announced today that it received European CE Mark (Conformite Europeenne) approval for its AMPLATZER® Cardiac Plug (ACP). The ACP provides an innovative, minimally invasive solution for closing cardiac structures not involving the septal wall. One such intended use will be for the non-surgical occlusion of the left atrial appendage. "The ACP is an important addition to the interventional tools we have for structural heart repair. The design and conformability of the device as well as its ease of deliverability will allow us to effectively occlude challenging anatomy such as the left atrial appendage," said Bernhard Meier, MD, FACC, FESC, professor and chairman of cardiology, University Hospital, Bern, Switzerland. "Scientific data suggests a strong link between atrial fibrillation and formation of thrombus in the left atrial appendage, which can increase the risk of stroke to 5 percent per year. Physicians have limited options to minimize stroke risk other than anticoagulants which are often associated with adverse side effects." Made of flexible braided Nitinol mesh, the ACP is designed to provide occlusion with full cross-sectional coverage. The ACP self-orients to the cardiac wall, covering the hole of the structure to be occluded. It leverages the proven microscrew technology platform used in all AGA Medical devices to provide physicians with simple, controlled and precise delivery. This allows the ACP to be recaptured and repositioned if necessary, ensuring a customized delivery and fit for each patient's unique anatomic structure. AGA Medical will immediately begin marketing of the ACP in Europe and plans to support the broad adoption of left atrial appendage occlusion for atrial fibrillation. It will also introduce a physician clinical training program utilizing the latest medical simulation technology. The company has filed for an Investigational Device Exemption (IDE) with the U.S. Food and Drug Administration (FDA) for clearance to begin a clinical trial in the United States in the first half of 2009.
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