What is Stable-Technology™?
- Stable-Technology™ devices are 510K FDA cleared devices, however their design specifications are no longer patent protected.
- Stable-Technology™ devices utilize a Premarket Notification process [510(k)]. This means the manufacturer made a pre-marketing submission to the FDA to demonstrate that the device to be marketed is safe and effective by proving substantial equivalence (SE) to a legally marketed device (predicate device) that is not subject to Premarket Approval (PMA).
- Stable-Technology™ devices comprise approximately 70% of the orthopedic devices marketed today.
What does OrthoDirectUSA (ODUSA) do?
- OrthoDirectUSA is a consulting group that connects the Provider directly with the OEM manufacturer.
- OrthoDirectUSA helps Providers take back the responsibility of managing their orthopedic implant service without relying on support from traditional sales representatives.
- A Direct-Access, wholesale, procurement model is enacted, allowing the Provider to purchase Stable-Technology products directly from the manufacturer.
- Procurement prices are significantly below their current spend with reductions in the 50%-80% range. These Direct-Access prices are not possible under today’s sales rep dependent business model.
Who is OrthoDirectUSA?
- OrthoDirectUSA will help the Provider take back control of their orthopedic implant service by implementing the fundamental principles of Value Based Purchasing (VBP).
- OrthoDirectUSA enables the Provider to replace the commercial sales representative for ALL Stable-Technology devices by training the Provider‘s most important asset, their people.
- OrthoDirectUSA’s product is the transformation of how the Provider procures, maintains, and consumes orthopedic products. This “Process Change” is achieved by instituting our adult learning development / change management protocol through the Operating Room Device Technician (ORDT) Curriculum.
- On-site Mentors (24/7) will teach, train and coach hospital surgical technicians and supporting departmental personnel in the systems and processes necessary to work directly with implant manufacturers.
- ODUSA’s Mentors will not leave the Provider until the transformation process is completed. This will generally be a 12-24 month period.
What does ORDT mean? What is their Job?
- ORDT – Operating Room Device Technician
- The ORDT plays the central role in the daily implementation of the Value Based Purchasing process.
- Ensure that all instruments and implants are ready and available for each surgical procedure.
- Ensure adequate training of the orthopedic team on implant systems.
- Provide the technical competence and support for all implant systems.
- Manage onsite orthopedic inventory.
- Interface with manufacturers regarding product availability, repairs, complaints, etc.
How is the ORDT trained?
- Training takes place using a hybrid adult learning system created, taught, and maintained by ODUSA.
- Learning is pursed with both instructor led training sessions and using and on-line Learning Management System (LMS).
- Topics of study include methodologies used to implement a Value Based System using a Direct-Access procurement model, organizational dynamics, change management, clinical anatomy, and operating room techniques.
What is VBP?
- In the healthcare delivery system, VBP is a payment methodology that rewards qualify of care through payment incentives and transparency
- Value can be broadly defined as a function of: Quality, Efficiency, Safety, Cost, and Education. All departments in the Value Chain participating in achieving these efficiencies.
- Value Based Purchasing (VBP) is the payment methodology that rewards quality care through payment incentives and transparency.
- VBP keeps value for the patient as the focus. Competition, choice, and price transparency are the central tenants of VBP.
How is OrthoDirectUSA compensated?
- ODUSA receives no compensation from any manufacturer who participates in selling Stable-Technology that the Provider chooses to purchase direct.
- ODUSA derives its fees on a consulting basis from the Provider.
What is the goal for the Provider?
- By adopting the ORDT process, the Provider will be less dependent upon outside support from traditional sales representatives, thereby improving over-all service line profitability while process quality is continuously improved.
- Removing the sales rep is the single most strategic decision the Provider can make to lower their implant spend. Through this action the Provider is reliant on its own capabilities and skills versus outside sales organizations, saving money while increasing services and benefits to patients.
- The Provider will establish an ‘in-house’ implant service team lead by ORDTs that will be capable and competent to manage the orthopedic implant needs of the institution, at a level equal to the standards provided by today’s skilled orthopedic representatives for Stable-Technology devices.
- Ultimately, this initiative will transform Provider processes to become more informed and knowledgeable value based buyers of orthopedic devices. “Teach you to fish not give you a fish.”
- Manufacturers become willing to sell the Provider more products at Direct-Access prices if they understand that NO traditional sales support is necessary.
How does this affect you – the Surgeon?
- By utilizing Stable-Technology, the Provider will be able to allocate resources to purchase more advanced technologies and expand services that can positively impact the quality of care for more patients.
- In short, this initiative will provide more value for more people in the surrounding area, which should increase the volume of patients.
Can I still use what I want?
- Yes… this is NOT an all or nothing proposition. Actually this initiative will give you, the surgeon, MORE CHOICE and MORE CONTROL.
- More complex procedures and other special circumstances will continue to be serviced in the manner currently in effect, i.e., the surgeon will choose what implant in these instances that is best for the care of the patient.
- By reducing procurement costs for Stable-Technology, the Provider can invest in technology that will expand services to better serve your patients.
How much can we save?
- The Provider can reduce their implant spend by 50-80% from current costs utilizing Direct-Access purchasing for Stable-Technology implants.
How do we know the products are quality products?
- All Stable-Technology products are high quality, and most importantly, time-tested designs that have a record of proven success.
- All companies are registered with the FDA and all devices have been 510k cleared by the FDA and are substantially equivalent to the products currently being used by the provider.
- Many of these products have a prolonged clinical experience in the U.S. market.
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