Biomet Compliance Data Download Software
Kirby Apodaca
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Background: Suboptimal adherence to data collection procedures or a study intervention is often the cause of a failed clinical trial. Data from connected sensors, including wearables, referred to here as biometric monitoring technologies (BioMeTs), are capable of capturing adherence to both digital therapeutics and digital data collection procedures, thereby providing the opportunity to identify the determinants of adherence and thereafter, methods to maximize adherence.
Objective: We aim to describe the methods and definitions by which adherence has been captured and reported using BioMeTs in recent years. Identifying key gaps allowed us to make recommendations regarding minimum reporting requirements and consistency of definitions for BioMeT-based adherence data.
Methods: We conducted a systematic review of studies published between 2014 and 2019, which deployed a BioMeT outside the clinical or laboratory setting for which a quantitative, nonsurrogate, sensor-based measurement of adherence was reported. After systematically screening the manuscripts for eligibility, we extracted details regarding study design, participants, the BioMeT or BioMeTs used, and the definition and units of adherence. The primary definitions of adherence were categorized as a continuous variable based on duration (highest resolution), a continuous variable based on the number of measurements completed, or a categorical variable (lowest resolution).
Results: Our PubMed search terms identified 940 manuscripts; 100 (10.6%) met our eligibility criteria and contained descriptions of 110 BioMeTs. During literature screening, we found that 30% (53/177) of the studies that used a BioMeT outside of the clinical or laboratory setting failed to report a sensor-based, nonsurrogate, quantitative measurement of adherence. We identified 37 unique definitions of adherence reported for the 110 BioMeTs and observed that uniformity of adherence definitions was associated with the resolution of the data reported. When adherence was reported as a continuous time-based variable, the same definition of adherence was adopted for 92% (46/50) of the tools. However, when adherence data were simplified to a categorical variable, we observed 25 unique definitions of adherence reported for 37 tools.
Conclusions: We recommend that quantitative, nonsurrogate, sensor-based adherence data be reported for all BioMeTs when feasible; a clear description of the sensor or sensors used to capture adherence data, the algorithm or algorithms that convert sample-level measurements to a metric of adherence, and the analytic validation data demonstrating that BioMeT-generated adherence is an accurate and reliable measurement of actual use be provided when available; and primary adherence data be reported as a continuous variable followed by categorical definitions if needed, and that the categories adopted are supported by clinical validation data and/or consistent with previous reports.
Zimmer Biomet has established anti-bribery and anti-corruption policies and procedures that cover, among other things, interactions with healthcare providers and government officials. These policies and procedures are reinforced by a robust training program as well as periodic auditing and monitoring. Zimmer Biomet has a zero-tolerance policy when it comes to bribery and corruption.
The Zimmer Biomet Code of Business Conduct and Ethics embodies our commitment to the highest ethical standards and compliance with all applicable laws and regulations. It reinforces our commitment to acting ethically and with integrity in all that we do and guides positive interactions with customers and with people in the communities in which we live and work.
The Speak Up Hotline is available 24 hours a day, seven days a week. All reports are received by a trained operator at an independent third party provider hired by Zimmer Biomet. Reports are confidential and may be made anonymously, if permitted by law. Zimmer Biomet will investigate and follow up on all Speak Up Hotline reports received.
There are three regional compliance teams supporting the business in the Americas; Asia Pacific (APAC); and Europe, Middle East & Africa (EMEA), as well as global compliance teams responsible for compliance operations, investigations, monitoring, third party due diligence and trade compliance. Collectively, the teams work to ensure Zimmer Biomet team members have the training, tools, and guidance necessary to perform their jobs in a legal, ethical, and compliant manner.
Prior to joining Zimmer Biomet in 2010, Angela worked for Covidien in Singapore, Lloyds TSB Bank plc in London, and Texas Instruments in its European and Asia Pacific regional offices. She has extensive international legal and compliance experience in the healthcare, financial services and technology sectors.
Dominica leads the Asia Pacific Legal and Compliance team, responsible for managing and overseeing all legal and compliance matters; and implementing global legal and compliance initiatives in the region. She joined Zimmer Biomet in 2010, based in Sydney, Australia, and has served in several regional Legal capacities, providing legal counsel to all APAC markets, with a recent focus on the Australia/New Zealand, India, and South Asia businesses.
Mathias leads the Europe, Middle East and Africa Compliance team, where he is responsible for managing and overseeing all compliance matters as well as implementing global compliance initiatives in the region. He joined Zimmer Biomet in September 2023 and is based in Zug, Switzerland.
Prior to Zimmer Biomet, Mathias served as General Counsel, Legal and Compliance International at Cardinal Health. He also held key roles at Novo Nordisk and Novartis Pharma AG. Mathias is a qualified Swiss and German attorney, holds a Master of Law degree from Universit de Montral/Canada and a PhD from the Universit de Lausanne, Centre du Droit Compar et Europen/Switzerland.
Benjamin is responsible for the global Compliance functions, which include the compliance monitoring, investigations, operations and third-party compliance teams. He also oversees efforts to drive continuous improvements to the Compliance program.
Benji joined ZB in February 2014. Previously, he was in private practice, focused on white collar criminal defense, government investigations, and corporate compliance matters. Benji received his Bachelor of Arts degree from Princeton University and his J.D. from Columbia Law School.
Dan is Vice President, Global Compliance Investigations at Zimmer Biomet, a role he assumed in January 2024. Since joining Zimmer Biomet in 2015, Dan has held several positions, including most recently overseeing the Global Third Party Compliance and Global Operations teams. He was previously a part of the APAC Legal & Compliance function. Before joining Zimmer Biomet, Dan spent five years at an international law firm based in Washington, D.C., where he focused on civil and criminal litigation, government investigations and corporate compliance matters. He received a Bachelor of Arts degree in economics and political science from the University of Wisconsin-Madison and a J.D. from the University of Chicago Law School.
Steve leads the Global Trade Compliance team at Zimmer Biomet. Prior to joining the company in July 2019, he retired from the U.S. Customs and Border Protection (CBP) Office of Trade in Washington, D.C., where he began his career as a customs inspector. He then served as Acting Executive Director, Trade Policy and Programs, before becoming Deputy Executive Director, Office of Trade, where he provided oversight and direction for five divisions. He is based in Warsaw, Indiana.
Roberta joined Zimmer Biomet in December 2023. In her role, she leads the Global Compliance Monitoring, Audit & Analytics team, where she is responsible for overseeing the execution of the annual compliance monitoring and audit plan, as well as the compliance data analytics program, with a focus on improving detection and deterrence of misconduct and addressing key high-risk areas. Before Zimmer Biomet, Roberta was Head of Third Party and Corporate Compliance Audit for Gilead Sciences. She has previously worked for Genetech, Nestle Skin Health, S.A. and PwC in internal audit, forensic accounting, and compliance roles. Roberta is a graduate of Bocconi University in Milan, Italy and is a Certified Fraud Examiner.
The real-time guidance helps ensure that surgical instruments and implants are accurately positioned as per the pre-operative plan. Thus, for surgeons, this system is a significant leap forward in improving surgical precision and provides detailed pre-operative planning and intra-operative guidance, which in turn helps minimize the risk of complications.
The precision level is important for handling the complexity of surgical procedures and helps improve the overall patient outcome by optimizing the fit and positioning of implants. The robotic system also possibly reduces the chances of implant misalignment, which could lead to premature wear or the need for revision surgery.
The adoption of robotic systems such as the ROSA Shoulder System signals a shift in market requirements owing to an increased emphasis on precision medicine and personalized healthcare solutions. Therefore, companies within the medical device sector should invest in research and development of similar technologies as it can potentially lead to collaborations, partnerships and growth in the healthcare ecosystem. Furthermore, the efficiency of the system can help ensure reduced surgery times and potentially quicker recovery periods, thus enhancing patient satisfaction and quality of life.
Although there are many benefits of using the ROSA Shoulder System, its implementation is difficult. The high cost can be a barrier to adoption for many healthcare facilities, particularly those in underserved regions. Moreover, the successful integration of these technologies requires comprehensive training for surgeons as well as surgical teams, thus highlighting the requirement for on-going education and support from manufacturers.
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