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Reduction of operating expenses is a strategic imperative in all businesses. This is nowhere more true than in healthcare. Whether a large hospital system, an independent provider group, a product manufacturer, or a payer, continuing to drive financial efficiency is critical to survival. Reduced valuations, inability to grow, layoffs and even bankruptcies of every category of healthcare company are everyday occurrences.Data collection and analysis represent a major cost center for each of these categories. It is increasingly difficult to justify expensive EMR systems, research platforms, internal servers — and the personnel and vendor costs associated with them. “Data” was supposed to constitute a positive return on investment. In fact, not only is that ROI proving to be negative, it is so negative as to threaten financial stability of the entity. Healthcare data are undoubtedly important. Indeed, the right datasets are more important than ever. Validated fit-for-purpose datasets lead to better and more predictable clinical outcomes, to product development, to value-based care, to health equity. As such they can represent a profit center. Moreover, those datasets can be developed for a fraction of the price currently paid by healthcare companies. For the type of datasets which make a difference, modern technology enables superior substantial cost reduction and superior user experience for clinicians, support staff, researchers, and patients.Contact us to learn more.

Type image caption here (optional)Many provider groups and product manufacturers recognize the inherent value of validated, well-structured datasets generated in the busy clinical setting. (The FDA, payers and others refer to such datasets as real-world evidence.) A major category of thoughtfully-designed and executed real-world evidence programs is intellectual property – inventions, patents, trade secrets, and copyrights. Most large hospital systems now have “innovation centers”, “tech transfer departments” and similar units designed to generate license revenues. They generally fail, however, to tap into RWE, the richest source of such IP. Moreover, their revenue shares for clinician inventors, and complex IP processes, may often stifle rather than incentivize marketable inventions. Meanwhile, independent practice groups are now in an equally strong position to develop and capture IP value through real-world evidence programs. They can do so on their own, accumulating and curating fit-for-purpose RWE until its clinical significance warrants licensing and monetization. Alternatively, they can partner with product manufacturers in establishing an RWE program designed to maximize specific IP objectives from the beginning.In all cases, Circles represent a robust yet low-cost platform, with excellent user experience, for designing and implementing RWE programs leading to IP value. Contact us to learn more.

Addressing Strategic ImperativesIntroduction OTC product demand is driven by perceived safety and efficacy among healthcare professionals and consumers. Moreover, legal/regulatory compliance is an increasingly important issue for manufacturers. [1]Well-structured datasets comprising real-world evidence(RWE) are foundational to meeting both categories of requirements.Through its HCP and consumer customers, an OTC product manufacturer can generate a large amount of RWE comprising substantial clinical, scientific, and commercial value. OTC category leaders recognize this value, and have established programs to achieve it. [2]Through Circles, RegenMed supports product manufacturers globally in developing RWE programs delivering demonstrable and sustained return on investment.Circles: Not A Cost Center, But A Strategic ImperativeRWE is a strategic imperative for OTC product manufacturers. [3] As an important signal of emerging trends, the FDA states that RWE “may provide an efficient means of generating the necessary clinical evidence to support regulatory decisions”.Thus, RWE can be an important element of value-based care, new product development, reimbursement, HCP and patient engagement, health equity and evidence-based support for marketing claims.However, the FDA also emphasizes that RWE must be “fit for purpose”. In other words, it must start with well-defined endpoints, be causally correlated to longitudinal outcomes, represent validated data, and otherwise conform to traditional parameters of properly designed and executed studies.Circles-based RWE programs meet these criteria. They are efficient, cost-effective, flexible and scalable. As such, they can advance one or more strategic objectives for any OTC product manufacturer, regardless of size and market position:Financial: New product development. Improvement of existing products. IP capture. Support for new indications. Reimbursement.Competitive Differentiation: Publication. Conference Presentations. Research. Deeper HCP and patient engagement.Brand Extension: Recruitment and collaboration among HCP influencers and their peers. Evidence-based content for patient groups.Legal/Regulatory Compliance: Regulatory submissions. Marketing claims. Adverse event reporting. Safety/efficacy reports for specific formulations.Critically, an OTC product manufacturer owns the Circles-based RWE which it and its customers generate. It therefore maintains control over the resultant product development, publication, and other value creation opportunities. See here and here for more information.Learn MoreWhat Is A CircleValue PropositionsJoin/Start A CircleProcesses For PhysiciansOwnership, Publication, MonetizationContact UsEndnotes1 See for example here, here, and here.2 See for example the sunscreen study materials disseminated by Johnson&Johnson.3 Real World Evidence, FDA, February 2023. Registries for Evaluating Patient Outcomes: A User’s Guide, HHS/AHRQ, September 2020. Creating Value From Next-Generation Real-World Evidence, McKinsey July 2020. Use of Real-World Evidence to Support Regulatory Decision-Making For Medical Devices, FDA, December2023.‍Copyright © 2024 Regenerative Medicine LLC

Addressing Strategic ImperativesIntroductionFor a number of reasons, the domination by large hospital systems of healthcare delivery may be slowing if not reversing.Conversely, physician owned hospitals, ambulatory surgery centers, and other independent clinical practices are assuming a greater role.This is not surprising given the desire of physicians for independence – not only financial but also in matters of clinical judgment. The growth of physician-controlled practices is also driven by the preference of patients for personalized care, the national focus on value-based care, and governmental policy initiatives.There is however a fundamental challenge for independent practices – they are by definition owned by physicians. Physicians are trained – and want – to provide patient care, not deal with business issues.Most of the strategic issues for independent provider groups are the same as for other businesses: financial stability, recruitment of qualified personnel, competitive differentiation, growth, predicting the future, and preparing for it. Circles: Not A Cost Center, But A Strategic ImperativeIn healthcare, more than most other industries, data are fundamental. They are at the center of reimbursement, product development, value-based care, and legal/regulatory compliance.However, meaningful use, CPT codes, RVUs, and similar data requirements have imposed large costs and administrative burdens on providers. Paradoxically, these data-driven initiatives have often reduced compensation to clinicians. They also reduce the time clinicians can spend on patient care.Meanwhile, real-world evidence is emerging as the most important healthcare data category in the 21st century. [1] Critically, the most valuable sources of real- world evidence arise from everyday clinical interventions and correlated long-term outcomes. Independent provider groups are in a position to capture, own and monetize that real-world evidence.As emphasized by the FDA, however, real-world evidence depends on aggregated real-world datasets which are validated, well-structured, “fit-for-purpose”, and statistically significant. The technical platform and processes underlying each Circle ensure that these parameters are met – with minimum burden for the busy clinician.Moreover, independent provider groups own and control the real-world data and evidence generated by Circles. That ownership and control can advance several strategic objectives:Financial: Database licensing revenues. Clinical study fees. Internal product development and monetization. New service lines. Reimbursement.Competitive Differentiation: Publication. Conference Presentations. Research. Deeper patient engagement.Personnel: Recruitment/retention of physicians and researchers. Minimal burden for clinicians and office staff.Legal/Regulatory Compliance: Support expanded access, quality improvement, off-label, and other clinical initiatives.Brand Extension: Inherent collaboration with clinical peers and experts on clinical/scientific topics of common interest.‍Learn MoreWhat Is A CircleValue PropositionsJoin/Start A CircleProcesses For PhysiciansOwnership, Publication, MonetizationContact Us‍EndnotesReal World Evidence, FDA, February 2023. Registries for Evaluating Patient Outcomes: A User’sGuide, HHS/AHRQ, September 2020. Creating Value From Next-Generation Real-World Evidence, McKinsey July 2020. See Deloitte Insights, 2018.Copyright © 2024 Regenerative Medicine LLC

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.