Pilots and IRBs are essential to digital health entrepreneurs attempting to build a clinically-validated product and scale it within a health system.
But they are also a royal pain.
Done wrong, they could spell the demise of your business. Having undergone a couple of IRBs for my digital health company Litesprite, I have developed some tips that can help you go about it successfully.
Find research partners who have a good reputation and the skill to complete the IRB process for you
When possible, find partners that don’t require funding. This preserves the objectivity of the analysis and results – not to mention precious cash. An added bonus – your investors will appreciate your scrappiness and you’ll gain the reputation of being mindful of their purse strings.
If full partner funding is not an option, you can pay commercial entities for an IRB and individuals to conduct the analysis for you, but be aware that results derived from the paid approach will not be as strong.
IRBs are highly variable in their allowances so make sure you understand the IRB’s level of scrutiny and also the complete process and the documentation you will be asked for. Some are easy, peasy, and breezy. Others are like getting a root canal, getting your appendix out, and giving birth all at once.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
You may be required to meet HIPAA compliance standards, to change the study design, objectives, inclusion/exclusion criteria, or even your product. You will have to determine whether moving ahead with the study will still make sense or if it would change it so much that you will risk not getting the metrics you need.
Some organizations may charge a facilities fee, usually as part of grant applications. Even if your research or pilots are not grant-funded or don’t use the organization’s facilities, these fees may still be charged to go through their IRB process and/or to work with a researcher at the organization.
In some circumstances, it can add as much as an additional 70 percent to the total cost of the project. Take care to structure your pilots and make sure you have all the necessary paperwork and infrastructure (informed consents, patient releases, data privacy protocols) so that you can seek IRB approval later, should you wish to publish.
Know what success looks like
Plan pilots and trials with a clear understanding of the metrics you need so your solution will gain widespread adoption. Data collected from your pilots and studies should further your sales efforts. The more evidence you can present to your customers in a form they are comfortable with, the more quickly you will be able to realize sales and adoption.
Don’t shoot in the dark hoping you’ll hit your mark. Talk to potential customers and investors to ask what they need to see before they engage with you. Metrics don’t necessarily need to be clinical outcomes, they could include operational metrics like clinic wait times, increases of referrals, among others.
But it’s important to know what kind of organization you are piloting for.
When organizations have an immediate critical need or want to be considered industry thought leaders, they may be looking for solutions to implement and want to engage more directly and quickly, so they won’t even ask about metrics. Instead, they will jump right to deployment. If you find yourself in that position, run hard and fast and make that pilot happen. This is one of your early adopters so don’t let them get away.
Sometimes even after you ask, there’s no clear answer regarding metrics and outcomes. Know that it’s probably not you, it’s them. You aren’t dense or haven’t asked the wrong question. It is likely that the organization itself is truly clueless. In this case, “Run Forrest run!” This group has a long way to go before they can catch up with you.
Same advice if the group needs an RCT (randomized control trial). At this point of your development, you need groups that can get you into a deployment fast. Many digital health solutions can be properly and safely implemented without an RCT.
As documented by the RWJF, NIH, NSF, HHS, McKesson Foundation and RWJF, the model of an RCT can’t support the rapid cycles of innovations that occur in digital health. [Here’s a link to the day-long proceedings in 2011 out of which the previous report link emerged.] Put this RCT organization on the back burner and let them pay full freight for that jelly once you get to the right stage.
Consider creating your own metrics
As a true trailblazer, consider creating your own set of custom metrics. These can augment the information your customers want. For example, if you are developing a digital health solution to help with patient engagement, you could provide unique metrics around total time spent with your solution and the breakdown of activities. In some cases, this information maybe things the health system or organization may not even know they need — yet. By being proactive and creating a new metric, you come across as being supersmart.
Don’t end up in pilot purgatory
Know what purpose your pilots will serve – they can prove the efficacy of a new solution, act as a test of a new patient population, provide data for research publication, and/or allow an organization to test the solution with their patient population or clinical staff.
Given that the goal is to have a larger deployment upon completion of a successful pilot, it’s imperative that you have the conversation up front with your pilot partner about what will happen if the pilot hits all the notes. Ask them early about what a commercial rollout can look like.
If an organization is not able to quantify or give you a sense there is a clear set of next steps, consider passing on the pilot, even if it’s a marquee institution. Don’t end up in pilot purgatory and never get to a commercial scale deployment.
Find a research partner who thinks like you do and is enthusiastic to work with you
The biggest success factor for pilots or the IRB process is having partners who are excited and want to see the program succeed. They should be a super fan of yours from the start. And that is because they may have to do some heavy lifting for you, especially if you are early in your development.
A strong pilot with a small partner is better than a mediocre pilot with a branded institution. With each pilot and research study, potential customers and investors will ask, “What happened to that pilot with XXX?”
That is your time to throw down and shine and talk about the strong partnership that was established. The right answer will demonstrate not only the clinical relevance of your solution but your company’s ability to build a productive relationship with a partner.
I hope these tips will be helpful in your mission to change healthcare. Building a healthcare startup is a long journey and you don’t have time to suffer fools, indecisive fence sitters, or arrogant know-it-alls. Quickly scoop up as many enthusiastic superfans as you can and the rest of the herd will follow.
May the odds be ever in your favor.
Photo: Three Images, Getty Images
