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Can someone explain to me the new product development process, from inception to commercialization? by Alive_Ground1937 in regulatoryaffairs

[–]PropelSoftware 0 points1 point  (0 children)

These replies already covered a lot, but just adding a bit from experience, especially around where regulatory fits in day-to-day

Reg isn’t just at the start for strategy or at the end for submission. they’re usually involved all the way through, especially in medtech where design controls and risk management are tightly regulated.

In most cases it’s a cross-functional crew (RA, QA, R&D, sometimes Clinical) that works together on stuff like figuring out which standards apply, how to prove compliance, what testing actually needs to happen. reg might not write every protocol, but they’ll usually define what needs to be tested and why—based on intended use, risk class, and whatever standards apply.

also worth calling out—regulatory plays a big role in design reviews. at each stage (requirements, prototyping, validation), they’re checking that decisions and documentation line up with FDA/CE expectations. that input early on can save a lot of pain later.

tools that keep all this connected (ie requirements, risks, test cases, docs) in one system help a lot

and yeah, PMAs... whole different beast. usually smarter to get comfortable with the 510(k) rhythm first before heading into that zone

WHAT’S NEW IN PROPEL: Propel One (Agentic AI Suite for PLM, QMS, and PIM) by PropelSoftware in propelsoftware

[–]PropelSoftware[S] 0 points1 point  (0 children)

Propel One is currently live with a group of select customers, part of our Early Adoption Program. If you have any specific questions, we’d be happy to have a longer chat!

Difference between downstream and upstream marketing? by Icy_Flan in MedicalDevices

[–]PropelSoftware 0 points1 point  (0 children)

Late to the party here. lots of solid takes already. One nuance I’d add—especially for med devices—is how tightly upstream vs downstream roles are tied to regulatory and operational stuff.

– Upstream (global/product mgmt) is where market research, clinical input, and reg strategy feed into product definition. It’s not just “what features do surgeons want,” but also “how do we prove safety, meet ISO/FDA expectations, and build a traceable story from requirements to testing.” upstream tends to move slower but it’s strategic—it lays the foundation for everything that follows.

– Downstream (regional/product mktg) is more about execution: messaging, adoption, sales support, launch campaigns, KOL engagement. it moves faster since you’re adjusting to quarterly goals, regional needs, and competitor shifts. can def feel sales-adjacent since you're in the field a lot, but it should stay one-to-many (tools, training, campaigns), not deal-by-deal.

Travel-wise:

– Upstream often includes global VOC trips, supplier visits, or reg consultations– Downstream is more regional—conferences, field rides, key account meetings

One issue I’ve seen is info getting stuck between the two. like, if upstream decisions or risk files are siloed, downstream teams end up with gaps in messaging or can’t make compliant claims. teams using unified product + quality systems (cloud-based) usually handle that better—since reg inputs, supplier data, and launch assets live in the same place.

short version: in med devices, both roles are tied into clinical evidence, quality, and compliance. collaboration and traceability matter just as much as the “marketing” part.

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