General Discussion

Share tips and best practices, show what you've created and inspire others

45 Topics

Tim Hickle
Tim HickleDirector of Content and Community
posted in Getting Started

Meet The Community - Introduce Yourself!

Hey everybody!My name is Tim Hickle and I’m our Director of Content and Community here at Greenlight Guru. You are going to see me from time-to-time sharing content and sharing moderating duties with our world-class Community Manager, Etienne.I wanted to start a thread where we can introduce ourselves and share the human side of our community.A little about me: I’m a born-and-raised Hoosier (That means “Person from Indiana” for those of you not from the States) who loves basketball and a good nonfiction book. When I’m not working or parenting, you’re likely to find me listening to a podcast or watching Ted Lasso. My wife is named Kristen and we have an almost-two-year-old named Myles who is NOT the most efficient co-worker I have, but who is definitely my favorite. Feel free to share a little bit about yourself, your interests, hobbies, and family! Whatever makes you, “you!” 

40
becki.hiebert
1 day ago
Etienne
EtienneCommunity Manager
published in General Discussion

What is your favorite MedTech software?

For brainstorming: 💥 Strategy💥 I mean the software. we like sticky note and whiteboard sessions, but nobody likes inputting the mess back into Excel afterwards. It takes weeks... (Eh, what else do we pay Project Managers to do, amirite?) Instead, what if your team could asynchronously put those sticky notes into an Impact/Effort table, and turn it into a list with weighted scores (or tag them to become User Needs or Design Inputs later) automagically? Strategy does that, and a lot more. Specifically built for cross-functional MedTech teams. Plus there's an option for early access. Link in the comments.   For physical design: 💥 Solidworks💥 I know, mechanical engineers are biased - but I've searched microfilm, NX Ideas, AutoCAD, and paper drawings... Those are hours of my life I'll never get back. SolidWorks beats them all. Plus, in 2021, when I had nothing more than an idea and an LLC, but SolidWorks gave me a free year of Pro + Simulation... Yeah, I'm biased... And their Entreprene

922
Etienne
7 days ago
Etienne
EtienneCommunity Manager
posted in Ask Me Anything (AMA) sessions

AMA on IEC 62304

Here’s the video to this weeks AMA session!  

0
Etienne
2 months ago
Etienne
EtienneCommunity Manager
posted in Ask Me Anything (AMA) sessions

AMA on Packaging with Roy Morgan

Roy, thank you for sharing your expertise with us on Packaging & Sterilization! His last piece of advice was really good - fail early, fail often, and fail cheap. We could stand to apply this to how we build out our packaging activities! I hope you enjoy this conversation with Roy!  

0
Etienne
3 months ago
radhikapandya
radhikapandyaEmployee
posted in General Discussion

2023 MedTech Industry Benchmark Survey

Hello MedTech Community! I need your help. Take part in this industry survey  for medical device executives, QA/RA, and product development professionals to help us uncover trends and day-to-day operations of successful medical device companies worldwide. The survey should take less than 10 minutes to complete and all answers are kept completely anonymous. In return for taking the survey, you can receive free, early access to the research report before it’s released to the public. You can also enter your name into a drawing to win our prize of $100 for you, $100 to give. Donations will be made to Project Cure in the winner’s name.Click here to get started!  

1
Etienne
3 months ago
Brian Matcheski
Brian MatcheskiParticipating Frequently
posted in Ask Me Anything (AMA) sessions

Follow up question from the AMA-Clinical Evaluation Reporting

@Keith Kallmes @EtienneThanks for hosting the AMA session today!   One question that I wanted to ask during the session was about the age of literature used in a CER.   New research is great, when available, but what If one finds a high quality article published in a journal, say 10+, 20+ years ago.   How can you frame the article to support its current relevance?  and how old is too old for literature to include it in a evaluation report?Thanks,Brian

1
K
3 months ago
Etienne
EtienneCommunity Manager
posted in Ask Me Anything (AMA) sessions

AMA recording: Mike Baca on Quality Leadership

Thank you to everyone who participated in the AMA on Quality Leadership with Mike Baca from White Rook Consulting! Great conversation, and if you were not able to attend, I highly recommend watching the recording.  If you have any questions, please reach out to me, @Etienne  All the best!

0
Etienne
3 months ago
Etienne
EtienneCommunity Manager
posted in Ask Me Anything (AMA) sessions

AMA Recording: Bryant Foster on Human Factors

Thank you to everyone who participated in the AMA on Human Factors with Bryant Foster from Research Collective! Great conversation, and I especially want to thank everyone for your patience with the technical difficulties.  If you have any questions, please reach out to me, @Etienne  All the best!

0
Etienne
3 months ago
Etienne
EtienneCommunity Manager
posted in General Discussion

Let's read this book, "Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Feds Hit-List"

 A friend of mine gave me this book by Howard Root, Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Feds Hit-List. So far I’ve been impressed with how easy the book is to read - but it also goes into detail about things like indications for use vs. intended use, and off-label promo vs. off-label use… And how to prepare both your company and yourself to go to trial and defend both your device and how it was developed and marketed. This book will expose you to the sides of a medical device company that most of us do not think about very often, but will likely have to interact with at some point.I thought it would be fun if some of us read the book together and then tried to get Howard on for a live podcast!Here’s a link to Amazon if you want to get the book. Love to hear any thoughts you all might have!

0
Etienne
3 months ago
Etienne
EtienneCommunity Manager
posted in Ask Me Anything (AMA) sessions

RoundTable discussion on Clinical Affairs

RoundTable on Clinical Affairs We hope you enjoyed this RoundTable discussion on Clinical Affairs!Let us know what you think - we look forward to more discussion in the future.Thanks,@Etienne Community Manager 

3
L
4 months ago
T
twhitecentrixNew Participant
asked in Ask Me Anything (AMA) sessions

IFU - notice to user to report

Annex I, 23.4. Information in the instructions for use(z) a notice to the user and/or patient that any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is establishedIs actual practice and expectation to include a canned statement to this effect in every IFU?

1
Niki
4 months ago
Etienne
EtienneCommunity Manager
posted in Ask Me Anything (AMA) sessions

AMA on EUMDR with Chandler Thames

What questions do you have on EUMDR? Drop them in the thread below and we’ll make sure they are addressed on the call with Chandler!  

4
A
4 months ago
Etienne
EtienneCommunity Manager
posted in Ask Me Anything (AMA) sessions

AMA on Design Assurance with Orla Connaughton

Between Product Development and Quality Assurance, there are a few tasks related to Design Controls that are done by… Design Assurance. Whether or not they where the title, the functional owner of most Design Controls tasks need to be able to toggle between Product Development and Quality - it’s a unique hat (or set of hats) to wear. We hope this discussion is helpful as you approach the Roles and Responsibilities of someone working in Design Assurance! Thanks,@Etienne

0
Etienne
4 months ago
Etienne
EtienneCommunity Manager
posted in Ask Me Anything (AMA) sessions

AMA on Packaging & Sterilization

Let’s talk packaging & sterilization! I don’t know about you, but this is one of those topics that some manufacturing and product development engineers try to push to the bottom of their priority list, and “kick the can down the road” until they absolutely HAVE to address it. Which can quickly turn into an “all hands on-deck” situation.Instead of putting it off, let’s talk about all your packaging and sterilization questions.EDIT: I just found out that Roy (our expert) will be unable to make it, and with the Virtual Summit going on right now I’m not able to get a back up expert on Packing and Sterilization… SO! If you still have specific questions, please drop them in the comments below, and I will make sure they are answered by the end of the week!Thank you for your patience and especially your participation!All the best,Etienne Nichols

0
Etienne
5 months ago
Etienne
EtienneCommunity Manager
posted in Ask Me Anything (AMA) sessions

AMA on Supplier Management

We invited Greg Lyons from LGD Ventures for an exclusive AMA (ask me anything) session to talk Supplier Management! If you have run into problems, send a message directly to @Etienne and let us know!

5
Etienne
5 months ago
P
PaulQSCNew Participant
asked in Ask Me Anything (AMA) sessions

OEMs and Distributors

Do OEMs and Distributors need to be on the “Approved Supplier List?”

2
G
5 months ago
Etienne
EtienneCommunity Manager
posted in Ask Me Anything (AMA) sessions

AMA on Combination Products

We invited Shannon Hoste from Agilis for an exclusive AMA (ask me anything) session to talk Combination Products. If you have run into problems, send a message directly to @Etienne and let us know!

2
M
5 months ago
Etienne
EtienneCommunity Manager
posted in Ask Me Anything (AMA) sessions

AMA on Cloud Validation

Thank you all for the discussion in our RoundTable discussion of intermittent SaMD Validation of Cloud Platforms!If you missed the discussion, you can view it below:If you have run into problems, send a message directly to @Etienne and let us know! 

3
DavidShanes
5 months ago
Etienne
EtienneCommunity Manager
posted in Ask Me Anything (AMA) sessions

AMA on IVDR

We invited Kyle Rose from RookQS for an exclusive AMA (ask me anything) session on the topic of the recent the IVDR.If you have run into problems, send a message directly to @Etienne and let us know!

2
Etienne
5 months ago
Niki
NikiEmployee
posted in General Discussion

Phone App in 510k

How do I add details about the phone application into the 510k for a medical device? Any best practices?

1
Etienne
5 months ago
Etienne
EtienneCommunity Manager
posted in Ask Me Anything (AMA) sessions

AMA on UDI

We invited Gary Saner from Reed Tech for an exclusive AMA (ask me anything) session to talk UDI.Please let us know if you have any issues accessing the recording. We hope this was a beneficial session and we’re looking forward to seeing you next week! All the best,Etienne Nichols

8
M
6 months ago
Etienne
EtienneCommunity Manager
posted in Ask Me Anything (AMA) sessions

AMA on Sterilization

This week we’ve invited Jody Birks from the Eagle Medical for an exclusive AMA (ask me anything) session on Sterilization.If you’re not signed up yet, be sure and RSVP here.What challenges are you currently facing as you work through your sterilization process? What feels unclear?Ask us anything!Leave your questions in the comment section below - this will give your question the greatest likelihood of being answered.P.S. There is an interactive video element to this AMA that you can participate in. The link to join the Zoom meeting will be provided on the day of the event!If you have run into problems, send a message directly to @Etienne and let us know!Link to Zoom meeting.

19
J
6 months ago
Etienne
EtienneCommunity Manager
posted in Ask Me Anything (AMA) sessions

AMA on ASQ Certification

This week we’ve invited Shawn Findlater from the VirtualQE for an exclusive AMA (ask me anything) session on ASQ Certification.If you have run into problems, send a message directly to @Etienne and let us know!

3
M
6 months ago
Etienne
EtienneCommunity Manager
posted in Getting Started

Community Feedback!

What do you think so far of our community? Isn’t it so adorable, it’s my baby, and I love it so much… But I want it to be YOUR community, so please give any and all constructive feedback!What do you think of the topics? How was the intro email? Is there anything missing that you expected? Are there any things you would change with the usability or navigation so far?  What did I miss??I know you’re busy, but I want to hear it all - tell me now so I can make your life easier later!Thank you!

7
jesseca.lyons
6 months ago
Etienne
EtienneCommunity Manager
posted in Getting Started

Welcome our New Members!

Welcome to the community, everybody! 👋🏼I want to help you get the most out of the community, so check out the Getting Started page.Also, feel free to introduce yourself here - I’d love to hear more about what you do and what your goals are! This is your cohort of new members, so that automatically makes you friends, right? 😂I look forward to getting to know you! @vesone, @KrzysztofNazar, @keliyew, @odejesus, @vanessashebola, @Greg Lyons, @BenB, @TrueQuality2022_Eli, @JimSkinner, @jjmifsud, @mattdneal, @Chris, @Namratha Kumara

2
Etienne
6 months ago

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