Archimedic转发了
How to land on the right Need Statement? Here's how Jorge and I break it down for our new #drugdelivery device. But first.. Feedback received from Edwina and Joris suggested.. ?? Gotta define WHO it's for? An important detail, right? Here's our WHO: Healthcare providers (HCPs) delivering drugs stored in vials. What are the problems? Lots. So, to help us think holistically through the problems, we're looking through the following 3 axes: Axis 1?? - Technical - Coring of vial septum that results in injected particulate - Extractables & leachables from materials contacting drug Axis 2?? - Regulatory - Performing tests to demonstrate safety/effectiveness - Meeting consensus standards Axis 3?? - Marketing - Inconvenience of multiple steps - Confusion of what needle / syringe to use with vial Those are just some of the problems / challenges associated with HCPs accessing and delivering drugs stored in vials. But the centerpiece of this analysis is -- injected particulate -- which can be a big problem for patients. Turns out that many of the problems we've listed directly contribute to this injected particulate. So, we've landed on the following Need Statement ?? "A low-cost drug delivery solution for healthcare providers that reduces the risk of injected foreign particulate." That's where we're aiming (for now).. Got some ?? feedback ?? for us? Drop it in the Comments. And big thanks for all the comments Mark, Ulrich, Drew, Mark, Penny, Zikria, Ramses, Edwina, Joris, and Scott from the last post. Keep it coming please! Archimedic #pharma #drugdelivery #medtech
For a need statement, perhaps add in a key need that will drive adoption (potential addition in caps): "An EASY-TO-USE low-cost drug delivery solution for healthcare providers that reduces the risk of injected foreign particulate."
Thank you for sharing! I really like the transparency. Are you designing your device to be a Closed System Transfer Device (CSTD) per NIOSH to support hospital pharmacy compounding (FDA product code ONB)?
I’m a bit confused by your statements. You say this is for HCPs delivering drugs from vials. But to address the issue of particles coming from the transfer, you’ll have to eliminate the transfer. Meaning, the manufacturer has to fill your device with the drug. Why would they do that? What’s their incentive? As Mark Brassil pointed out, all of these components are approved. Using a new “applicator” adds regulatory burden, requires changing manufacturing processes, and may even annoy customers who have to train their staff on the new device. While the user may be a HCP, your customer would be the drug manufacturer. And I don’t believe they see a problem that requires solving. Please help me understand if I got this wrong.
I would add the "clinical circle" to the other 3; and ask: What about the patient? You have addressed the interaction between the vial and the transfer syringe, and how the HCP might adopt a new solution; but the interaction between the syringe/needle and the patient plus the administration of the drug to the patient are very important factors depending on the drug you need to administer.
Great breakdown! Focusing on injected particulate as the centerpiece of your analysis is spot on.? It is often the case that the most pressing problem becomes clear only when examined from multiple angles, as you’ve done with the technical, regulatory, and usability aspects. Balancing those while keeping the end goal (a safer, more efficient solution for HCPs) is key to addressing the complex needs in drug delivery. Excited to see how this solution takes shape!
CTO @ Smart Reactors. Director @ Cerefuze Medical
1 个月"A low-cost drug delivery solution for healthcare providers that reduces the risk of injected foreign particulate." I’ll be real picky here. The “foreign particulate” you mention (septum materials and silicone oil) isn’t actually “foreign” – it is all listed on he BOM of an approved device for either the vial or the syringe/needle. There would be biocompatibility data for it even. In fact, things like silicone oil aren’t even particulate strictly speaking in that they aren’t solid and will dissolve/mix/suspend with other liquids. Extraneous matter perhaps? This is the term in ISO7886. When you go to measure particulate you will notice that the test methods are very different for extractables and leachables. USP788 for injectables has size ranges for particle counts (AAMI TIR 42 talks a little more broadly about how to assess this risk). You can be below the count size (e.g. nanometre particulate) and this method will determine that you are “ok”. So, you have to think about what size range particulate are you concerned about (and why?). Extractables and leachables are quantified by molecular level analyses for things that dissolve in the extraction solvent so wont detect particles at all and vice versa.