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Turnkey regenerative therapy standardization, remote patient follow-up and telemedicine solution designed to contribute substantively to management of the elective orthopedic surgery backlog.ObjectivesAn analysis recently published in JBJS concludes that it may take up to 16 months until health-care systems can return to performing the pre-pandemic volume of elective orthopedic surgery. Even in optimistic scenarios, there will be a cumulative global backlog of millions of surgical cases after the end of elective surgery deferment. To many, it may seem impossible to close the gap and planning for postpandemic recovery requires addressing the backlog reactively and proactively. However, enhancement of patient surgical throughput alone will not be sufficient.Greater utilization of remote patient monitoring and telemedicine can be valuable in overseeing patients in the backlog. Tools and protocols for an efficient and successful virtual orthopedic visit are being developed with, for example, patients being provided with virtual visit checklists so that they can confirm a number of items prior to the virtual examination.Alternative ambulatory treatments options can also make a substantive contribution. Despite that fact that regenerative medicine therapies for musculoskeletal conditions have been available for a number of years, many specialists are hesitant to fully embrace this therapeutic approach because of what they perceive as a lack of standardization which undermines their confidence in the clinical outcome. For example, systems used for the preparation of PRP are highly variable and the majority of publications do not report on platelet concentration. Therefore, if regenerative medicine is to attain its therapeutic potential, there is a need for standardization on various levels to optimize both outcomes for patients and returns for clinics. Key focus areas should be:Continuous but burden-free capture of longitudinal patient outcomes and requisite clinical protocol data.Detailed characterization of the regenerative therapy delivered.Comparative analytics to correlate treatment factors and clinical profile to patient outcomes.Compelling but fair and evidence-based communication of protocol results to prospective patients.Integration with other approaches for surgical backlog management, such as telemedicine.Regen Med’s inCytes™ platform can form the core of such a solution.ComponentsEvidence-based, regulatory-compliant Observational Protocols (OP’s) approved by an expert Clinical/Scientific Advisory Board.Web-based patient compilation of flexible ePRO surveys for remote engagement, feedback, and benchmarking.Logistics for characterization of regenerative medicine therapies in a qualified laboratory.inCytes™ Circles to aggregate clinical data with collaborators through AWS Cloud.Visual report builder correlating custom clinical data points against patient outcomes.Alerts for outlier patients.Configuration of a telemedicine platform and integration with other systems.Account management to provide support, including monitoring performance, patient engagement and communication, compliance rates, and new user training.ImplementationSelection of one or more condition-specific protocols.Completion of ePRO and e-Form design.Telemedicine configuration where needed.Activation of regenerative therapy characterization.Opening of patient enrolment.Creation of inCytes Circle(s) and invitation of additional members.Scheduling of patient engagement and education/training.Initial Comparative Analysis Meeting.Key performance indicatorsNumber of patients enrolled.Quantification of outcome/satisfaction improvement.Robustness of regenerative therapy characterization system.Pertinence of education and training.

According to the most recent KPMG/RAPS survey of 230 medical device manufacturers, 83% of respondents cited the clinical evaluation report (CER) requirements of the EU’s new Medical Device Regulation (MDR) as a challenge. While the 12-month delay to the date of application of the MDR provides invaluable breathing space for manufacturers to get in line with the revised post-marketing clinical follow-up (PMCF) and post-marketing surveillance (PMS) requirements, continued social distancing related to COVID-19 make data collection using traditional approaches more difficult.This scenario provides the opportunity for renewed focus with the objective of exploiting the extra time to gain broader advantage. Because PMS/PMCF must comprise performance data from humans and must extend over the entire lifetime of devices, coupling these activities to product lifecycle management would produce strategic sales/marketing and growth benefits.The generation of RWE, real world (clinical) evidence, is one approach that is gaining recognition. Regen Med’s inCytes™ platform allows delegation of remote data input to patients using any type of device, thereby overcoming historic hurdles, including data collection compliance by investigators as well as new barriers, such as COVID-19 social distancing. The capability to construct observational protocols using a combination of standard PROM’s and custom queries, to implement ad hoc scoring systems and to form Circles among multiple users, in addition to remote data entry by patients, has attracted numerous device manufacturers to Regen Med’s Solution.