welcome

You will have received a link to access this Private Circles Page (PCP).  In consideration of your colleagues, be judicious in sharing that link.  Each PCP provides resources relating to specific clinical/scientific theme, divided into three access categories:

Open access

Immediately accessible to any PCP visitor.

Limited Authorization

Accessible by providing a valid name and e-mail address.

Manual Authorization

Accessible only after confirmation by RegenMed and the project owner.

Please reach out any time to the individuals identified at the bottom of the page.

Open Access

FAQ's

GENERAL
Why Are OREF and RegenMed Launching This Initiative?

MOTIV™ allows providers to develop, own and benefit from real-world evidence.

Properly defined and structured real-world data – clinical data arising in the everyday surgical and medical practices – can represent important clinical, scientific and financial value.  When statistically significant and “fit-for-purpose”, the resulting real-world evidence datasets can support regulatory submissions, product development, clinical-decision making, value-based care, and AI-model training.

While randomized controlled trials will remain the research “gold standard”, they suffer from major disadvantages: cost, complexity, delay, inaccessibility of underlying data, publication only of “successful” results, and actual or perceived bias.  Due to their expense, only drug companies and academic medical centers can support RCTs. [1]  As a result, clinically relevant or trustworthy RCTs for most treatment protocols are difficult to find.  

The science and clinical realities of musculoskeletal surgery and medicine are rapidly advancing.  Outpatient total joint replacements, rare MSK disease diagnoses and treatments, independent practice groups, biologics, modern forms of education and training, value-based care – these have important implications for practitioners and patients alike.  MOTIV™ will develop verifiable and clinically-relevant datasets to help support providers and patients in the context of these evolving trends.

[1]     Recent NIH grant cutbacks are already severely affecting major research centers.  This only makes real-world evidence datasets that much more important.

What Are The Benefits To My Practice?

There are clinical, financial and reputational benefits:

  1. Support clinical decision-making, as well as evidence-based standards of care for procedures.
  2. Enable all physicians to participate in meaningful research without interruption of normal clinical flow.
  3. Clinically relevant and fresh datasets for conference presentations, articles, newsletters.
  4. Training and education.
  5. Deeper patient education.
  6. Support for reimbursement, narrow network participation, value-based care and SDoH requirements.
  7. Opportunity to collaborate with other MOTIV™ participants on areas of common clinical/scientific interest.
  8. Ownership and monetization of your datasets.  New income source; growing balance sheet value.
  9. Development of, and support of, proprietary intellectual property.
We Are Already Collecting Data.  Why Do So Again?

Providers of course already enter and/or collect healthcare data through multiple platforms.  These are generally geared to fee-for-service reimbursement, some to research.  Although data entry represents substantial expense and burden, it rarely generates meaningful clinical, let alone financial, return on investment.  

Meanwhile, the healthcare data analytics market is valued at $70 billion, and is growing at 20% annually.  Providers receive little if any of that value.  (Large hospital systems like Mayo and Duke Health are realizing this, and are monetizing their clinical data.)

Deriving genuine clinical value from data requires asking clinically relevant questions (as opposed to mere medical codes).  Deriving financial value requires unambiguous ownership of statistically significant datasets.  Generating demonstrable return on investment requires minimal cost and burden.  Circles meet all of these criteria.

Finally, medical reimbursement is moving inexorably away from fee-for-service to value-based care models.  Current data collection platforms are poorly designed to meet VBC requirements.

We Already Have A Research Program.  How Is This Different?

Even for the largest medical institutions, research presents several serious challenges:

  1. Staffing and systems expense, coupled with reduced grant and donation availability.
  2. In an era of medical information “overload”, difficulty in publishing results which are scientifically or clinically impactful.  
  3. Even within the institution, inability to effect clinical translation of research results.
  4. A single “study” can take many months if not years to develop and publish.
  5. Even published datasets have gaps, unverifiable entries, manipulations, or other weaknesses.
  6. Vulnerability to assertions of bias due to direct or indirect funding sources.
  7. Difficulties in publication.
  8. “Poor” results are rarely published, resulting in loss of credibility.
  9. Clinical, scientific or financial return on investment is rarely measured or even clearly defined.

The most meaningful research leads to demonstrable impact in everyday patient care.  Circles are a low-cost, efficient and scalable platform for doing so.

Do We Own Our MOTIV™ Data?

Ownership, and allocation of all license fees attributable to each Circles Dataset are

  1. 50% to Investigator Entity(ies) participating in the Circle;
  2. 35% to OREF, and
  3. 15% to RegenMed.
MOTIV™ — SPECIFIC DEFINITIONS
What Is An “Investigator Entity”?

In the context of MOTIV™, an Investigator Entity is any legal entity comprising one or more Investigators contributing real-world data to a Circle.  It is the Investigator Entity which executes the MOTIV™ Circles Agreement with OREF and RegenMed.  An Investigator Entity may be a large academic medical center or a sole practitioner.  As discussed below, the Investigator Entity decides how to allocate its 50% Circles Dataset ownership and licensee fee allocations among any Investigators affiliated with the Investigator Entity.

What Is An Observational Protocol?

An Observational Protocol (OP) is analogous to a RCT study protocol.  It is defined by a single anatomical region, a single diagnosis/pathology, a single treatment protocol, and standard or custom outcomes surveys and scoring bundles.  Each OP also has various Attributes associated with it, including relevant medical codes (ICD, CPT, HCPCS, etc.)

An OP typically comprises separate surveys for patients, clinicians, and third parties when specified (e.g., laboratories).  Each OP is designed to be as efficient as possible for any party answering OP survey questions.  For example, an OP clinical survey is designed to be completed in thirty seconds or less. (This is possible because OP clinical surveys re designed to capture only clinically/scientifically relevant data.)

What Is A Circle?

A Circle is the group of Investigators (practitioners) collecting real-world data against a single OP.  Those Investigators may be within or outside of institutional or even national borders.

What Is A MOTIV™ Principal Investigator?

A MOTIV™ Principal Investigator (PI) is responsible for preparing an Observational Protocol to be submitted to the OREF Observational Protocol Review Committee.  RegenMed provides support in the preparation of OPs.  A MOTIV PI may also serve as a Investigator Entity PI.

What Is An Investigator Entity Principal Investigator?

A Investigator Entity Principal Investigator is the Investigator affiliated with an Investigator Entity authorized by the Investigator Entity to add questions to the Observational Protocol.  He/she also will typically co-moderate Circle Hours and other educational events with all Investigator Entity Investigators.

What Is The MOTIV™ Observational Protocol Review Committee?

Each Observational Protocol proposed by a MOTIV™ Principal Investigator is peer-reviewed by an anonymous three-member Observational Review Committee selected by OREF on the basis of their clinical/scientific expertise relating to the specific OP under review.

What Is An Investigator?

An Investigator is typically a clinically-active physician treating patients in the context of the corresponding Observational Protocol.  It may also be, for example, a laboratory technician, physical therapist or other healthcare professional involved in the treatment path specified in the OP.

What Is A  MOTIV™ Circles Dataset?

A MOTIV™ Circles Dataset is the licensable asset.  It results from the following sequence:

  1. The establishment of an Observational Protocol by the MOTIV™ Principal Investigator.  
  2. The review and approval of that OP by the OREF Observational Protocol Review Committee.    
  3. The implementation of the approved OP by one or more Investigator Entities.
  4. The negotiation by RegenMed and OREF of a licensing transaction covering specific data ataributes and time parameters of interest to a particular licensee.  
  5. The creation by RegenMed of the licensed MOTIV™ Circles Dataset, pulling from all available MOTIV™ data corresponding to the dataset attributes negotiated with the licensee.  
  6. Note that data originating from a single Investigator Entity, or even from all Investigator Entities in a single MOTIV™ Circle, may be combined with other MOTIV™ Circles data to create one or more MOTIV™ Circles Datasets from which an Investigator Entity will receive license fee allocations.
What Is A Circle Hour?

A Circle Hour is a secure livestreamed video conference among Circle Investigators.  As desired by the Investigator Entity, attendance may be limited to Investigator Entity Investigators, or open to all Circle Investigators.  A Circle Hour is typically moderated by a Principal Investigator as well as representatives from OREF and RegenMed.  

Although attendance is optional, most Investigators appreciate the opportunity to review preliminary correlations suggested by rapidly accumulating Circles data, exchange best practices and even propose new questions or Observational Protocols.

PROCESS AND USER EXPERIENCE
How And When Can I Access Circles Data?

The underlying Circles technical platform and associated processes enable access to and review of Circles data at any time, from any device, for no additional charge.  In addition, an Investigator Entity can download its raw data file at any time, also without additional charge.

How Do I Join A MOTIV™ Circle?

Most MOTIV™ Observational Protocols, once approved by the OREF Observational Protocol Review Committee, are available to academic medical centers, independent provider groups, community hospitals, and even credentialed sole practitioners.

If We Leave, Can We Keep Our Data?

Yes.  An Investigator Entity may download raw exports of any data it has contributed to a Circle at any time, without additional charge.  Moreover, the Investigator Entity remains entitled to its 50% of any License Fees attributable to Datapoints contributed by the Investigator Entity while it was a Circle Member.

How Much Burden Is This Clinically and Administratively?

Very little.  The patented Circles technical infrastructure and associated processes provided by RegenMed ensure no interruption of normal clinical flow, and excellent physician and patient user experience.  There is no need for additional staff or systems.

Who Decides What Data To Capture?

For a given MOTIV™ Circle, the final Observational Protocol questions are determined by the MOTIV™ Principal Investigator for that Circle, as peer reviewed by the OREF Observational Review Committee.  An Investigator Entity may add questions to that peer-reviewed OP based on its own clinical setting.  However, we recommend against OP “bloat”, which leads to poor compliance by participating Investigators as well as patients.  Too many questions also raise the risk of confounding data results.

RETURN ON INVESTMENT
What Does Participation Cost?

The sole Investigator Entity costs for MOTIV™ participation are:

  1. A one-time charge of $3,500 for the encoding of a customized Circle for an Investigator Entity and any number of its affiliated Investigators. [2]
  2. $35 per month per Subscriber.  A Subscriber is any individual affiliated with the Investigator Entity which wishes access to the Circles platform for purposes of data entry and review.  A Subscription may be cancelled at any time upon 30 days’ notice.
  3. $5 per longitudinal Case.  Thus, a one-time payment of $5 covers all data collected for a single patient in the context of a single Circle regardless of the duration of such data capture. [3]

[2]     RegenMed’s normal charge of encoding customized Circles is $4,250.  It has been reduced to $3,500 through December 31, 2025 for MOTIV™ Investigator Entities.

[3]     Thus, a single $5 payment can cover five years or more of outcomes capture.

How Will MOTIV™ Datasets Be Monetized?

Typically, healthcare datasets are monetized through licensing transactions.  Licensees include product manufacturers, life science companies, payers, research centers, data aggregators, [4] and, increasingly, AI models. [5]

License amounts depend heavily on data quality, statistical significance, fit-for-use value to the licensee.  MOTIV™ Circles Datasets are designed and assembled to maximize not only clinical value, but licensing value.

[4]     For example, IQVIA and dozens of others.

[5]     There are already an estimated 2,100 healthcare AI models.

How Is An Investigator Entity’s Share of License Fees Calculated and Paid?

Each answer to an Observational Protocol question is a Datapoint.  The technical platform underlying Circles tracks each Datapoint, and its attribution to a Investigator Entity as well as any Investigator affiliated with the Investigator Entity.  Thus, RegenMed is able to identify the Investigator Entity and Investigator attribution of each Datapoint comprising a licensed Circles Dataset.  On this basis, it can calculate the 50% of license fees associated with that Circles Dataset allocable to the Investigator Entity, as well as the portion of that 50% notionally allocable to each Investigator affiliated with the Investigator Entity. [6]

[6]     “Notionally”, because the entire 50% allocable to a Investigator Entity is remitted to such Investigator Entity, which has the discretion to allocate it among its Investigators as previously agreed among them.

Materials

Material — Name
Document — MOTIV™ Overview
View document
Document — Introduction to MOTIV™ TKA Program
View document
Document — FDA Final Rule
View document
Document — FDA Guidance On Real-World Evidence
View document
Article — Why Physicians Should Own Their Data
Read article

Limited Authorization

Materials

Material — Name
Document — Memorandum for Investigators
Request document
Document — Total Knee Arthroplasty Protocol
Request document
White Paper — Key Clinical Issues in TKA and THA
Request document
White Paper — Key Clinical Issues in TKA Robotics
Request document
White Paper — Key Clinical Issues in Kinematic Alignment
Request document
White Paper — Circles for Spinal Muscular Atrophy
Request document
White Paper — Circles for Osteogenesis Imperfecta
Request document
White Paper — Circles For Pediatric Musculoskeletal Care
Request document

Manual Authorization