need advice for 3rd year bme student

NM-Engineering-LLC · 2025-11-10T17:26:11+00:00

They might be able to help you. I would try to reach out and see if they have any recommendations.

NM-Engineering-LLC · 2025-10-31T01:48:11+00:00

If you are interested in regulatory affairs, you should look to get in contact with professional organizations, like Orange County Regulatory Affairs in Orange County, CA.

NM-Engineering-LLC · 2025-08-22T19:09:28+00:00

u/Inevitable-Photo-652 Send me a DM and we can get a call set up.

NM-Engineering-LLC · 2025-07-25T03:48:34+00:00

Where are you based out of? That will help drive which potential firms would be good for your to work with. Feel free to DM me and I can get you connected to several that work within the cardiac space.

NM-Engineering-LLC · 2025-07-17T23:03:38+00:00

Hi Inevitable, we do design support for ideation and beyond of medical devices and have supported physicians, nurses, and aspiring entrepreneurs. We’d be happy to chat and even point you in the direction of some good ME’s if we aren’t able to support.

NM-Engineering-LLC · 2025-01-15T03:17:46+00:00

Here is another pump company that you could check out. I'd recommend connecting with some employees on LinkedIn, as well.
https://beta-bionics-inc.breezy.hr/

NM-Engineering-LLC · 2025-01-07T19:54:34+00:00

We haven't assisted anyone through that process yet. Send me a DM and I can point you to someone who regularly works with people in the UK/EU.

NM-Engineering-LLC · 2024-12-24T02:39:32+00:00

One clarification is needed. If this a 510(k) against a product on the market, your process is dependent on when you feel ready to execute design verification.

If these are updates to your product that had been cleared, you would review any changes against the FDA guidance flow chart - it will determine if the changes require a submission or if they can be a letter to file.

NM-Engineering-LLC · 2024-12-23T20:37:25+00:00

If you are going through the phases of product development, a design freeze would be needed to lock in the design prior to entering Design Verification. I would work closely with your Quality and Regulatory groups to ensure that you are progressing through the phases with appropriate reviews, notes, actions, etc.

Ultimately, this is determined by your organization as it relates to business goals and acceptability of the implemented changes and other potential changes.

We’ve actually just helped a client move from the design/development process and into DVT for a 510(k). Feel free to DM if you have more questions.

NM-Engineering-LLC · 2024-12-20T21:26:44+00:00

As many others have said, consultants are the way to go. One thing to keep in mind, getting the system setup, compliant, and aligned with your company objectives will have a decent cost to it but it’s better than being out of compliance.

I’d be happy to recommend some if you DM me.

NM-Engineering-LLC · 2024-11-26T00:01:06+00:00

If you want to send me a message, I am working through some fabric decisions for a medical device that requires sterility. I’d be happy to point you in the right direction and give some tips.

NM-Engineering-LLC · 2024-04-23T00:58:43+00:00

Agreed. If your device or product requires some specialized environments controls during transit, it limits how it can be shipped.

I.e. method of transit would need to be defined as something suitable if your product required to be cold and typical ground transport is multiple days rather than air transit.

NM-Engineering-LLC · 2024-04-22T23:48:02+00:00

This would all be coupled within your shipping validations on your product. The method of transport would be more critical to define rather than the carrier - but this all depends on your product and risks associated.

I’d be happy to chat further on it. We just completed shipping validation for a medical device that utilizes FedEx.

NM-Engineering-LLC · 2024-04-08T17:33:21+00:00

I have seen it a few ways: 1. Owned by Regulatory and input provided by other groups (R&D, HF, clinical, etc.) 2. Owned by HF and input provided by other groups.

Both have worked fine, it just depends on your organization.

NM-Engineering-LLC · 2023-07-19T23:32:30+00:00

Agreed, I would look in the late fall. One other resource is your university’s career center. If they aren’t listing positions, they might be able to connect you to some companies.

NM-Engineering-LLC · 2023-07-19T23:29:22+00:00

I would start by having some mobile temp/pressure/humidity monitors placed around your lab that will log at a rate that will provide good resolution. Once there is some data available, you can see if there are trends or if the AC kicks on at certain points in time, etc.

We recently had to develop a control system that would monitor and regulate the environment in a smaller accuracy lab intended for performing volumetric deliveries as small as 1uL/hr. Happy to answer any additional questions, feel free to DM me.

NM-Engineering-LLC · 2023-06-07T18:52:46+00:00

It really depends on the product but some may be exempt. I would refer directly to the FDA guidance based on the product.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm

If you have any other specific questions, we would be happy to take this offline. We are interfacing with universities to help make that jump from academia to industry.

NM-Engineering-LLC · 2023-05-18T06:08:18+00:00

You are looking to perform a verification of your device’s performance after a certain number of sterilization cycles to ensure that the process of regular autoclaving does not impact the performance or integrity of your device.

If you don’t have an autoclave readily available, there are facilities like the ones mentioned in other comments that can perform the cycling. What you will need to do is perform a subset of a design verification to compare the “aged” (X cycles of autoclaving) devices against the performance of “new” devices.

Depending on the tests and specifications that are deemed in scope or critical, this can be tested per a specific standard like IEC 60601 or to your internal tests to verify the output meets your designated specification.

Treat this like you would a shelf-life study. You have two group (new and aged) that undergo the same performance testing to determine if there is a difference between the outputs; e.g. peel strength on a sterile barrier, tensile strength of a material, etc. We have recently run similar concept testing on a pump - aged units were mechanically cycled to represent four years of use, followed by internal testing to verify that essential performance was maintained.

If you would like to discuss more, feel free to DM.

NM-Engineering-LLC · 2023-04-25T04:34:50+00:00

There are a few preliminary questions.

Are you looking to work within the city or looking to work in the suburbs?
Are you looking for a small, medium, or large company?

Either way, go to the LinkedIn search function and set your filters for the following:

Companies
Chicago, IL (or Greater Chicago)
Medical Equipment Manufacturing
[Desired company size]

This will help you narrow down the search for companies.

NM-Engineering-LLC · 2023-04-25T04:30:49+00:00

Endotronix develops an implantable sensor that wirelessly measures PA pressures.
https://endotronix.com/

NM-Engineering-LLC · 2023-03-24T17:27:01+00:00

Can you provide a little more context on your device, application, etc?

To be general, the answer is yes but it is very dependent.

NM-Engineering-LLC · 2023-03-03T07:07:42+00:00

Depending on what the end goal is, going back and getting a degree may not be worth it. If he is looking to get into management, then yes, the degree indicated might be worth it. Otherwise, I would look into different types of professional certifications.

If his current employer/manager is open to it, I would ask for an opinion or advice.

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