 right now, I’m most concerned with….”</p>
<p>Both said regulatory practices.</p>
<p>They said regulatory practices for CRT are having an adverse effect on how efficiently new products can be developed and brought to market. In some cases, the expense of putting a product through layers and layers of testing becomes so high that manufacturers abandon the idea. They realize they’ll never sell enough units to make the product viable.</p>
<p>I understand the need for regulatory policies and quality standards to govern safe use. No one wants to play by anything goes rules.</p>
<p>But CRT is called complex for good reason. The number of people who use CRT is minuscule statistically, but their need is profound. They can’t make do with something mass produced, packed into a box with a few instructions, and set onto a retail shelf.</p>
<p>CRT consumers desperately need their technology, and they don’t always have time to wait.</p>
<p>Last summer, S. 204 passed the U.S. Senate. Formally, it’s the Trickett Wendler, Frank Mongiello, Jordan McLinn and Matthew Bellina Right to Try Act of 2017. It basically allows certain drugs that have passed phase 1 testing to be available to patients with terminal illnesses. The reasoning is that patients who have exhausted other treatment options should have the chance to try experimental medications that have passed some, but not all of the U.S. Food & Drug Administration’s (FDA) regulatory requirements.</p>
<p>Wendler passed away in 2016 from ALS; Numotion has named an annual service and advocacy award in her honor. Mongiello and Bellina also have ALS. Jordan McLinn is a second grader with muscular dystrophy.</p>
<p>Right to Try legislation is not without controversy. Opponents say it gives patients and families false hope. Advocates argue that earlier access to experimental drugs won’t help everyone, but could save some.</p>
<p>I wonder what a “right to try” CRT model could look like. Maybe it would allow certain electronics or seating to be provided to clients in critical cases before the FDA has given final approval. CRT isn’t a cure, but it plays a crucial role in positioning that can impact respiration, pressure distribution, bowel and bladder management, etc. Electronics could give clients more control over their positioning and communications, and could facilitate interaction with their environments.</p>
<p>I don’t know what that model would look like. But common sense says regulatory processes aren’t meant to deprive us of technology when we need it most. If we cannot yet control the disease, can we use CRT to impact its path or timing? It’s worth considering.</p>
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