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Upcoming Events
November 20, 2008
- Statistics for Clinical Studies
Medical Announcements
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The Medical Device Alliance Newsletter covers topics including clinical trials best practices, quality and regulatory issues within the medical device community, and much more. Click Here
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Other Announcements
- Member Appreciation
The Medical Device Alliance would like to say thank you to new and renewing companies in September for being a part of the local medical community and part of the Medical Alliances' mission: Sharing Clinical, Quality & Regulatory Education Peer-to-Peer.
Lifecore Biomedical Inc
Integra Group
ASI DataMyte Inc
Lion Precision
RTD Company
Article Index
 Patient Recruiting - Who needs the education?
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Article by: Pamela Wolf Imagine for a minute that your world has just changed irrevocably. You have been diagnosed with a devastating disease. Your life now consists of medical appointments, diagnostic tests, the anxiety of waiting for results and wondering about your future. In addition to coping with the diagnosis, you are now worrying about the impact on loved ones. If you had a career, it may feel as if it is slowly slipping by the wayside. Read More |
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Local News - Advanced Circulatory Systems, St. Jude Medical, Acist Medical
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Article by: Medical Device Alliance NIH makes $1.5 million grant to Advanced Circulatory Systems The National Institutes of Health (NIH) granted $1.5 million to Advanced Circulatory Systems, the company announced yesterday. The money will be used to continue a study of two devices intended to help people survive cardiac arrest. Read More |
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Medical Device Manufacturing and the Regulations
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Article by: Thomas Pepin Product recall from the field - part 3. Previously, part 2 of the series addressed the components of a successful field action, and the importance that all assumptions must be supported with a formal technical reference. Now we will address execution of the field action and notification to the FDA. Read More |
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Patient Recruiting - Who needs the education?
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Imagine for a minute that your world has just changed irrevocably. You have been diagnosed with a devastating disease. Your life now consists of medical appointments, diagnostic tests, the anxiety of waiting for results and wondering about your future. In addition to coping with the diagnosis, you are now worrying about the impact on loved ones. If you had a career, it may feel as if it is slowly slipping by the wayside. The fundamental question running through your mind is, "what will it take for me to live, or is living even an option?" The medical professionals you have entrusted with your care are telling you things that will have a profound impact on the rest of your life. As they themselves are learning about your particular disease state, they try to inform you. They tell you about the possible treatments, the benefits and sometimes the side effects, and help you recognize the changes in your everyday life. You realize in order to move forward, you need to look at treatment options. The specialist you have chosen has an excellent reputation; they are well known as experts in their field and are also involved in research. You boldly head to your appointment. Because you and your specialist want the best possible outcome, you go over every option in detail. You may have already done some research on your own. You have some very real fears about various treatments and their long term effects. Together you discuss all this and try to synthesize a lot of information in a short period of time. Although none of the treatments seem to offer you the perfect outcome, you are leaning towards an option which is not the current standard. According to the specialist, statistically it is only 2-4% less effective overall, but should provide you a better quality of life. There is another option to consider, a clinical trial the practice is recruiting for. They think you would be a good candidate for the study. The possibility intrigues you. First, there is potential the treatment you will receive will be superior to the current standard. Second, since you are familiar with clinical trials, it would be your opportunity to contribute to medical science, and be a part of its advancement. Your specialist sends in the research nurse to talk to you. They give you the informed consent forms, and begin to review them with you. Their belief is this protocol will surpass the current treatment and become the standard, based upon the fact it has been used with some success in similar disease states. You begin to get an inkling of optimism. Then you remember your fears. What will this protocol do to my body? You ask the question, because it is important to you. The nurse gives you a generic answer "It should be the same as the other." You ask about outcomes with other patient populations and get no acceptable answer. You ask about your quality of life and any changes that might occur. Again, no good answer. Unbelievably, they have no more information than what is on the consent forms. You mention you are leaning towards a different treatment than the current standard, and want to know how this protocol compares with the option you are strongly considering. The research nurse openly verbalizes their opinion that you would be endangering your own health to consider anything other than the current standard. You press the point and want to know the comparison. You want statistics and information from past research and patients. Frustrated, they offer to confer with your specialist. They return 20 minutes later. They couldn't find your specialist but talked with another doctor in the practice who said "It should be fine." "It should be fine," what kind of response is that? You want details! You begin to question if you should participate in the study at all. You don't trust they relayed all the information about your particular situation to the second specialist. If this is the nurse that might be caring for you, your confidence is waning. Did their strong opinions need to be voiced, in contradiction to a specialist you trusted? Did they understand their pressure-sell tactics were not helping? Did they even listen to you? Did they realize this decision affects the rest of your life, not theirs? Did they know you were thinking this was only about the number of patients enrolled in the trial and not about your care? Unfortunately, this is often reality. Many patients who are approached for trials cannot get the answers they need to feel comfortable with participating. You can use retention strategies designed for common questions on time commitments, costs, and daily life requirements. Your strategy can include writing information about the patient like "has a little dog named Fluffy" to make a personal connection with them. However, these strategies have a real potential of failing, when the person presenting the information lacks knowledge the patient seeks. It is not enough to be familiar with consent and treatment or typical information on features and benefits for the patients. Recruiters need to be familiar with related studies. Patients need details as to why this study is being conducted. These steps would go a long way towards allaying patient specific questions and personal fears. Something to consider in relation to low patient enrollment numbers is how our society has changed. It seems we are developing serious health issues at a much earlier age. Longevity and maintaining quality of life are of utmost importance. Think of trying to enroll two cancer patients with the exact same diagnosis, except that one is 22 and the other is 82. The specific cares, concerns and fears will be different for each patient. In the internet era, medical information is just a click away. It is easy to locate sites which deal with particular diseases or conditions, via blogs or professional publications. The patient can learn about what they are facing. By increasing their knowledge base, they also increase their questions. It is well known that site coordinators and research nurses are often juggling multiple trials. Time is a rare commodity. Where then, do they get answers, without spending hours looking for journal articles and publications? The sponsor works hard to provide the site with information. Perhaps this is an area where the sponsor could provide additional detail. Ultimately, the person talking with the patient needs to make sure they can they be effective in addressing the patient's individual concerns. In the end, it is the patient's choice to participate in any study. They need to be able to obtain sufficient information in order to make a choice, and be confident it is the right decision. We need to be sensitive to the fact we are assisting them with making a decision which will affect their future. As research professionals, we cannot discount their individuality. We must recognize each person is unique in their needs and desires for their life regardless of the hand that fate has dealt them.
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Local News - Advanced Circulatory Systems, St. Jude Medical, Acist Medical
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NIH makes $1.5 million grant to Advanced Circulatory Systems The National Institutes of Health (NIH) granted $1.5 million to Advanced Circulatory Systems, the company announced yesterday. The money will be used to continue a study of two devices intended to help people survive cardiac arrest. The devices are a compression and decompression pump and a device that increases blood flow to the heart and brain during CPR. Both are manufactured by Advanced Circulatory Systems, a privately held provider of circulation technologies in Eden Prairie. Six sites, in Minneapolis; St. Paul; Whatcom County, Wash.; Oshkosh, Wis.; suburban Detroit and Livingston County, Mich., are included in the study. The study compares results of CPR when performed with the two devices, and without them. St. Jude Medical gets approvals for Angio-Seal, cardiac monitor St. Jude Medical Inc. won approvals on both sides of the Atlantic for a pair of new products. The U.S. Food and Drug Administration and the European Commission have approved a vascular closure device of St. Jude's for use in the United States and Europe. The device, called the Angio-Seal Evolution, uses collagen to close punctures in the femoral artery that are made in catheterization procedures to diagnose blockages and other cardiovascular problems. Catheterization involves inserting a small tube in the femoral artery and threading it through blood vessels to problem areas. After the treatment, the opening in the femoral artery must be closed, and patients must lie still for several hours to prevent bleeding from the puncture. The Commission also approved an implantable cardiac monitor made by St. Jude for use in Europe. The cardiac monitor, called the SJM Confirm, is implanted under a patient's skin on the chest and monitors the heart for atrial fibrillation and other heart rhythm irregularities. St. Jude (NYSE: STJ), a medical device company in St. Paul, will announce its third-quarter earnings on Wednesday. The company's stock was trading at $38.19 in midday trading. Acist Medical Systems Inc. opened its expanded headquarters Tuesday. Eden Prairie-based Acist, which has developed injection systems for improving the quality of medical scans and X-ray images, has built a 75,000-square-foot space, which encompasses its expanded corporate headquarters as well as a manufacturing facility. The new campus houses research departments, engineering laboratories, manufacturing, technical and customer service, as well as other corporate functions, a release detailed. Minnesota First Lady Mary Pawlenty and Eden Prairie Mayor Phil Young joined Fulvio Renoldi Bracco, chairman and CEO of Acist, which is owned by Italian firm The Bracco Group, for a ribbon-cutting event. Acist Medical Systems employs 135 people locally and more than 220 worldwide. It has regional offices in Europe and Asia.
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Medical Device Manufacturing and the Regulations
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Product recall from the field - part 3. Previously, part 2 of the series addressed the components of a successful field action, and the importance that all assumptions must be supported with a formal technical reference. Now we will address execution of the field action and notification to the FDA. All field actions are subject to 21 CFR part 7 and 806 regulations. The level of risk, as documented in the Health Hazard Evaluation, will be used by FDA to determine the field action classification with Class I being the most serious, resulting in death or serious injury, and Class III as the least serious. The FDA requires notification of a field action within 10 days of implementation. The most conservative interpretation is 10 days from field action approval with the least being 10 days from initiation of the field action communication. The FDA notification is documented per the guidance of 21 CFR part 806. FDA will then review the submitted material and determine the field action classification. Class I actions will typically require a formal press release for large scale notification to the public. The FDA's primary objective is to protect the public. FDA will post the field action notice on their fda.gov web site. Class I actions will result in e-mail notifications to a subscription list that includes all health care organization risk managers. Assume the field action plan, with all communication material, has been assembled and fully approved by senior management. It is now time to arrange for a formal communication meeting with your field staff to inform them of the upcoming field action. This is critical to assure there will be no surprises with your customers. Some companies will administer the field action with the direct assistance of the sales force; they know the customers and have the relationships to meet with them and explain the field action details. In many cases, it is necessary to obtain signed confirmation from the customer. It is customary to use a controlled form of direct delivery with a signed delivery receipt. The FDA then requires monthly status updates. Upon completion of the field action, all relevant material and records will be assembled into a master field action file and archived as a permanent record. A close out letter will be sent to FDA for review. Upon satisfactory review by FDA, a close out letter will issued. This concludes the series - Product Recall from the Field. If you have suggestions regarding future regulatory topics, or if you would like to contribute to the Medical Device Alliance Newsletter, feel free to send an email to Kirby Sneen at ksneen@mfrall.com.
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Pamela Wolf specializes in the areas of strategic organizational growth and management. She has over 15 years of expertise in healthcare and scientific related positions within corporate and entrepreneurial environments. Her background encompasses roles in R&D, Quality, Regulatory and Clinical Research for medical products and pharmaceuticals. For more information, Pamela can be reached at peejwolfe@comcast.net.
The Medical Device Alliance has captured a synopsis of local medical device companies in business journals and publications. Please send your press releases to ksneen@mfrall.com or call 763.533.8239.