Archimedic Blog
The Latest Medtech Insights from Archimedic.
Many organizations believe that the Q-Sub process should be completed after a design is relatively mature. The belief is that sufficient technical detail needs to be shared to gain substantive feedbac...
Picture this -- you've raced to the airport and found yourself at the end of a massive security line. You do the truffle shuffle with shoes off, belt off, keys out, laptop out, while the security agen...
I know what you're thinking - this is a sales pitch in disguise. Not the case. The intention of this article is to help you understand when to steer clear of outsourcing. And there are plenty of those...
 Consider this analogy..  You are driving across the US, planning for a week to travel from coast to coast. With elevated gas prices you want to optimize for fuel consumption. Without much thought or...
Most of the time, quality (as in “quality management”) is only considered after a design concept is mature, if not finalized. Design control, document control, risk management – they are considered ch...
Defining the right use case, ensuring a positive user experience, and mitigating user related risks are critical parts of the medical device design process. Interfacing with users (often) is a smart t...
Most medical device companies operate using the waterfall method. But most medical device companies don’t operate as quickly as they could or should.
The waterfall goes like this:
- Write down your ...
What is your manufacturing strategy? There are several options to consider. Sometimes it makes sense to engage a large CMO early, whereas other times it makes sense to launch manufacturing with a smal...
Most companies run product development under the Hero model. This is where a highly experienced medical device developer gives play-by-play direction on product development activities. This can work s...
Medtech teams have a critical decision to make at the early stages. Should the strategy be to build a robust in-house team or leverage outsourced experts to achieve medtech milestones. Here's an hones...
When developing a new medical product, have you ever heard a medtech investor or exec say, "Take your time. We'll get there when we get there.."? Us either.
There's always urgency. And for good reaso...
Most companies avoid primary market research. They believe that in-house tribal knowledge is enough to make the key product and business decisions. Research would just tell the team what they already ...
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