ORTHOX Frequently Asked Questions
Q: CAN OUR COMPANY APPLY TO THE PROGRAM IF WE’VE YET TO RECEIVE FDA CLEARANCE FOR OUR TECHNOLOGY?
A: Yes, you can still apply. Each year our cohorts represent a good mix of companies that have already received FDA clearance or don’t need it and companies that have pre-FDA clearance. If your technology needs clearance and has yet to receive it, we will help you move through IRB approval with an independent IRB or whatever IRB is used by our participating OrthoForum member practice.
Q: IN WHAT STAGE OF DEVELOPMENT DO WE NEED TO BE TO QUALIFY FOR THE PROGRAM?
A: The two general requirements are:
Your company needs to have data of some sort indicating your innovation works. Ideally, that would be in the form of a pilot project or clinical study conducted at another clinical site. Short of that, the better data you can provide, the stronger your application will be.
Your company needs to have raised at least $500K of external capital.
These two requirements, of course, are intended to mitigate the program’s risk. OrthoForum practices will be investing a significant amount of time with our cohort companies, and we want that time to be invested in companies that are financially stable and have validated technologies.
In terms of stage of development, cohort companies are required to be able to onboard patients into their pilot projects or clinical studies within six months of entering the program.
Q: HOW MANY PILOT PROJECTS OR CLINICAL STUDIES WILL WE RECEIVE IN THE ORTHOX PROGRAM, AND WHERE ARE THE PHYSICIAN PRACTICES BASED?
A: Each cohort company invited to participate in the program is guaranteed at least two pilot projects or clinical studies, though companies may receive more than two. The two pilots or clinical studies can be separate, or simply two different sites in a multi-site study. In terms of site locations, The OrthoForum has 96 independent orthopedic practices spanning the U.S. When an invitation is extended to your company to participate, you’ll be notified of your “sponsoring” physician practices so you can factor that into your decision on participation.
Q: WILL WE NEED TO COMPENSATE THE PHYSICIAN PRACTICES FOR THEIR WORK WITH US?
A: The general essence of the OrthoX program is there’s no economic exchange between the cohort company and its sponsoring sites. That is, physician practices don’t have to pay to pilot solutions with companies that are otherwise conducting paid pilots. And conversely, cohort companies aren’t required to compensate physician practices for clinical studies. A few exceptions to this:
Cohort companies are expected to provide any supplies or equipment used in pilot projects and clinical studies and are also expected to cover any third-party IRB fees, when applicable.
Occasionally our practices will agree to compensate cohort companies to pilot solutions that are already in the market, especially if there’s corresponding reimbursement that can be achieved by the sites. If being compensated for the pilot is important to your participation, please indicate that in your application, as well as whether reimbursement by CMS currently exists for your solution.
Occasionally our practices will require reimbursement from cohort companies for clinical studies, especially if the study requires significant time from a clinician that would otherwise take that person away from “billable time” in his or her practice.
When an invitation is extended to your company to participate, you’ll know the economic terms of your participation and can thus factor that into your decision on participation.
Q: HOW DO INVESTMENTS WORK IN THE ORTHOX PROGRAM?
A: Each cohort company will receive a $700K cash investment from UHV on market-rate terms. That means that if your company is in the middle of an open capital round when you enter the program, UHV will simply “tag along” as part of that round on the same terms. If you’re between rounds, the $700K cash investment will be through a SAFE or convertible note in which only the cap and discount rate will need to be negotiated.
In addition to the $700K investment position you’ll offer in exchange for cash, each cohort company is required to pay 10% of that amount (or $70K) to OrthoX as a program participation fee. In terms of what you’ll receive in exchange for the $70K participation fee, it can be summarized as:
At least two pilot projects or clinical studies (referenced above) for which you don’t have to compensate the physician practices. HealthTech Arkansas’s clinical trials manager will work with you to help you develop the scope of your pilot or clinical study, develop a protocol (if applicable), and engage you with your participating sites to help you facilitate and execute your studies.
The suite of services The OrthoForum will provide to each company: the ability to host a webinar for their membership (4,100 physicians), to present alongside other OrthoX cohort companies at a Demo Day to be held at the annual OrthoForum conference, to “push” content through The OrthoForum newsletter and other channels, access to OrthoForum operational data, and representation on the OrthoForum website.
Access to educational content and connections to subject matter experts in the areas of regulatory clearance, intellectual property law, reimbursement/value-based care, capital formation/fundraising, value analysis/procurement and sales/business development.
Exclusive price discounts from program partners available only to OrthoX cohort companies.
Q: CAN WE PROPOSE DIFFERENT TYPES OF PILOT PROJECTS OR CLINICAL STUDIES IN OUR APPLICATION?
A: Yes! In your application, please outline whatever types of pilots or studies will be impactful for your company and which you anticipate being impactful for our participating physician practices. Giving choices to physician practices on the types of studies they can conduct is a bonus. Often, our participating sites will work with cohort companies to creatively design studies incorporating the company’s technology to solve real problems and challenges in the sites’ clinical practices. All parties work together to design and execute mutually beneficial pilot projects and clinical studies.
Q: WHEN CAN WE EXPECT TO HEAR FROM THE ORTHOX PROGRAM ABOUT THE STATUS OF OUR APPLICATION?
A: Applications open April 1, 2024, with an open, “rolling” application period. Applications will be reviewed on an ongoing basis, and each company will hear from OrthoX organizers within one month of their application as to its status. Some companies will be invited to interview by Zoom with a screening committee comprised of HTA, UHV, and physician practice representatives. For companies that receive commitments from at least two OrthoForum member practices to pilot the company’s innovations, UHV will consummate an investment in the company, and HTA representatives will work with the company to structure and facilitate the pilot projects or clinical studies.
Q: HOW LONG WILL THE APPLICATION TAKE ME TO COMPLETE, AND WHAT SHOULD BE EMPHASIZED IN THE APPLICATION?
A: The online application has just 17 questions, and we limit the number of characters in the responses. So overall, it shouldn’t take you more than 20 minutes or so to complete. All the questions are important, but we’d ask you to especially focus on the question that asks you to outline the types of pilot projects or clinical studies you wish to conduct in the OrthoX program. The more detail you can provide in this answer, the better position OrthoForum practices will be in to assess whether they can provide a value-added experience in the program for your company. The application includes an option to upload any relevant attachments; please upload any files you think would help explain your services further, such as a slide deck, videos, pictures, etc.
Q: IS THE PROGRAM VIRTUAL?
A: Nearly so. You’ll need to attend The OrthoForum’s annual conference, to be held in Q1, 2025. Beyond that, you’ll visit your sites for whatever in-person work needed (clinician training, etc.) to conduct your pilot project or clinical study, just as you would with any given pilot or clinical study.
The in-depth curriculum will also be delivered virtually. Topical areas to be led by subject matter experts include regulatory clearance, intellectual property law, reimbursement/value-based care, value analysis/procurement, fundraising/capital formation, and sales/business development.
Q: IF WE DON’T RECEIVE AN INVITATION TO PARTICIPATE IN THE PROGRAM, CAN WE APPLY AGAIN?
A: Definitely! Our past experience with these types of accelerators is that many of our cohort companies are likely to receive an invitation after applying multiple times to the program. As your company makes progress, your value prop to OrthoForum practices often becomes stronger. We ask that you please wait at least a year before applying again.