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Type image caption here (optional)Michael Strøm is an international speaker, educator and men’s health shockwave specialist. He is the clinical director of The Academy of Shockwave Excellence, and starting in 2024, will be regularly conducting his own courses for international practitioners interested in learning about the use of shockwave for men’s health. Michael has designed several Circles to:1) help generate real-world data and outcomes against his specialized men’s health shockwave protocols and 2) enable other shockwave users to remotely contribute and benchmark their results from their home clinics. These aggregated real-world data will be the building blocks for real-world evidence, and that evidence is poised to help standardize protocols for shockwave users and their real-world patients. We are proud to work with evidence-based teachers and practitioners like Michael Strøm. Learn more about Michael Strøm's Circles below:Erectile Dysfunction CirclePeyronie’s Disease CircleChronic Pelvic Pain CircleIncontinence CircleContact us to learn more.

Type image caption here (optional)The recent IOF MAX Experience, organized by the Interventional Orthobiologics Foundation, brought together some of the world’s foremost experts on orthobiologics to share their proprietary real-world data and real-world evidence. Many of those experts proudly included a growing number of Circle founders, including: ‍Peter A. Everts, PhD, FRSM opened the show with some nuanced hypotheses for "Where will the Field of Orthobiologics be in 2030?". Those same hypotheses informed his launch of the Gulf Coast Biologics Knee and Shoulder Circles over a year ago.Imran Siddiqui, Research Director at Regenerative Orthopedics & Sports Medicine, presented statistically significant 1 year results from those same Circles. Numerous IOF members joined Dr. Everts and Siddiqui as expert co-investigators, including: Luga Podesta, MD, Glenn M. Flanagan II, Alberto J. Panero D.O., Shounuck Patel, DO, Walter I. Sussman, Gayan Poovendran MD,CAQSM, and Ariana De Mers. Special thanks as well to Dr. Chris Brown Mahoney for her statistical analyses, which is a critical component for elevating real-world "data" into "evidence". Lastly, IOF members and sponsors continue to launch and grow their own real-world studies in 2024. We present their headshots and studies proudly, as their proprietary real-world evidence are bound to play a role in future curriculums, standards and regulatory decisions.Contact us to learn more about Circles.

Generative AI (GAI) is considered the most important technical development since the establishment of the Internet. It has profound implications in healthcare. Research, product development, and clinical decision-making are a few major examples. At the same time, clinical-grade real-world data (RWD) is fast becoming the most important data category in healthcare. More than EMR, payer, RCT, and other types of data, RWD is essential to achieving value-based care, health equity and overall cost reduction in healthcare delivery. GAI/RWD use cases will include value-based care for payers, product development for manufacturers, scientific breakthroughs for researchers, and clinical decision support for providers. Circles represent proprietary and well-structured RWD databases which are ideal for a variety of GAI applications. They possess several important characteristics making them attractive for healthcare-related GAI applications: They are well-structured, enabling the efficient derivation of statistically significant correlations among scientific hypotheses, clinical interventions, and long-term outcomes. They are “fit-for-purpose”. Each Circle database corresponds to one or two well-defined endpoints representing clinically and statistically significant datasets. Data integrity, auditability, scalability, and regulatory compliance. Clear data ownership rights. Ease of integration with other private (e.g., EMR) or public (e.g., open access medical literature) data sources. Circles Founders and Members already capture value from their RWD through publication, study investigator fees, honoraria, and other channels. Their most important opportunity for value creation will likely come from Generative AI. For more information, see our Articles on the importance of real world data and Circles data monetization.

Type image caption here (optional)Quality medical care is the domain of the treating physician. Its fundamental elements include education, training, observational skills, and professional judgment. Those hard-won traits are then applied to the relevant data the clinician is able to assemble. Those data comprise the patient story, clinical assessments, imaging, and laboratory results. Ideally, these data are augmented by reference to evidence-based research and consultation with peers. However, the physician is often hindered in delivering quality care by administrative burdens, financial factors, information overload, time constraints, and limitations on meaningful collaboration, education, and training. Circles return the physician to the center of healthcare delivery. They provide her with the ability to diagnose, treat and monitor each patient on the basis of evidence-based standards of care. Critically, they enable him to do so in a cost-effective and minimally burdensome manner. This is the essence of value-based quality medicine, a dominant theme of 21st Century healthcare.Contact us to learn more.

Type image caption here (optional)The FDA has released draft guidance on the “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices”. The principles underlying this guidance have important – and advantageous – implications not only for device manufacturers but also for clinicians.The FDA states that real-world evidence (RWE) “may provide an efficient means of generating the necessary clinical evidence to support regulatory decisions”. However, the guidance also emphasizes that data quality, good clinical practice, proper study design, longitudinal outcomes data and other traditional methodological considerations remain critical.The FDA enumerates many potential sources of RWE. Nevertheless, it is clear from the guidance that only specific types of real-world data (RWD) surrounding a discrete category of clinical interventions, and causally correlated to longitudinal outcomes, will generate acceptable “study-specific derived dataset(s).”This means that busy clinicians and their patients are essential to developing the RWD which can be converted into RWE. It is those already over-worked clinicians who are best positioned to design, capture and analyze study-specific RWD. It is their patients who must report long-term outcomes against standardized assessment measures. The overriding question is: where is the time or incentive to do so?The technology and processes underlying each Circle is “fit-for-purpose”in the context of any RWE objective to comply with the FDA’s guidance. (Indeed, the U.S. patent underlying Circles is titled “Method and System For Processing Large Amounts of Real-World Evidence”.) Moreover, Circles eliminate administrative burden for clinicians in generating RWE, while developing accompanying ethical professional and financial incentives.Please contact us to find out more.