Meet The Community - Introduce Yourself!

  • 18 January 2022
  • 35 replies
  • 373 views

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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!” 


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Hey everyone, my name is Etienne Nichols and I am the Community Manager and Medical Device Guru at Greenlight Guru! 

I’m originally from Oklahoma (everyone who meets me eventually finds that out) but now live in Cincinnati, Ohio near my wife’s family. We have 3 kids and a German Shepherd dog that we consider to be our first kid. 

Some of my favorite things to do are snowboarding, mountain biking, and reading books that expand my horizons and challenge me to think deeper about a given subject. Now that we have kids I don’t do any of these activities as much as I would like, but so far I’ve enjoyed and am thankful for every season of life that has come my way. 

I’m excited for the chance to meet and work with everyone here!

Greetings All,

I’m Mark Alpert, the Director of Quality at GG. Our team focuses on the internal quality and information security management system processes across the company. We have integrated ISO 9001 and ISO 27001 (and ISO 31000) into one comprehensive QMS. Many assume we are certified to ISO 13485 as all of you are. But, alas, we are developers of a SaaS based cloud solution, not a manufacturer of medical devices. The cool thing is GG is home too many medical device experts ensuring our application fully supports all of your regulatory needs. 

I live in MA. and enjoy time with the family, most racquet sports, sailing or a good book. My wife has been trying to teach me how to binge watch a TV series, not sure I’ll ever get really good at that one.

I’m looking forward to interacting with you and sharing my passion for product and process quality.  

Userlevel 1

Hello all!

I am Amar Vamsi Krishna, the Lead Systems Engineer at NextStep Robotics - a rehab robotics startup in Baltimore. Fun story about my name - it is entirely my first name! I have no last name. I am the only one in my entire extended family with three first names and no last name!!!  I am from Bangalore, India and have been living in Maryland the last 6 years. I recently got engaged and live with my fiance (who still refers to me as her lazy boyfriend). 
 

I have newfound love towards history, culture, and behavioral economics. Outside of work, you can find me trying to understand the world a little better - mainly through different podcases. Feel very guilty looking at the pile of very interesting books (I keep buying them at the cute bookstore nearby) that I don’t get the time to read. Really looking forward to the warmer weather and safer times to do more outdoorsy things. 

Userlevel 1

Hi all!

My name is George Zack.  I am a co-founder of and principal at Two Harbors Consulting.  We are a small (as in we are small - only four of us) business performance, process improvement consulting company.  About 2/3rds of our engagements are in the medical device space, with a significant portion of that being in the Medical Device Discovery Appraisal Program (you may have heard of this referred to as MDDAP or VIP or the Case for Quality).  I am happy to discuss that program or related efforts with any of you.

In addition to our involvement in that program, we are working with clients in healthcare, public school systems, software shops, manufacturing, defense, communications, staffing and IT.  We leverage not only the regulations for devices you are all probably familiar with (like 820) but other models for improvement (CMMI, DMM, VSM techniques, Agile approaches, etc).  

We have enjoyed partnering with GLG in that we often speak a similar message:  we are seeking to have our business partners achieve higher quality outcomes over compliance.  Which is also to say, that is not saying compliance is not important - but it is not enough.  

I look forward to further conversations and partnering with you.  

GZ

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Hi Everyone!

I am Ankitha Nair and I am the RA/QA Lead at Aidar Health, Inc. At Aidar Health, we aim to empower personalized care and have developed a FDA cleared and CE marked, handheld, wireless monitoring system, MouthLab, that captures all your vital signs (including lung functions) within 60s for this.

My stint at Aidar started out as a biomedical engineer, when we were a small team of 4, but as our team is slowly growing, I transitioned into the quality and regulatory space and got introduced to the GG team, who have been AMAZING in this entire process. Now, I am not going to be looking back. 

A little about me...I was born in Bahrain, grew up in Thailand, did my UG in India and then landed in US for my masters. I love travelling (road trips especially), casual photography using my drone (exploring the world from above), diy stuff, and watching all kinds of sports, majorly football (or as it is called here, soccer). Hala Madrid!!

I look forward to interacting with others here!

-Ankitha

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Hello all! I’m excited to engage with this community!

I am Shannon Hoste. I’m the president at Agilis Consulting (a Human Factors, Instructional Design, Risk Management consulting firm) and assistant professor at Pathway for Patient Health, Quality Science Education program. 

On a personal level, I’m a boy mom. My guys currently range from elementary to university. One of my favorite pictures of them is below. This one was taken when ‘the dab’ was on the way out. 

We all love a good adventure and have moved around a bit: US, Brazil, PacNW, Mid-atlantic, Great Lakes and now the Ohio Valley.

Like several of the previous posts, I am an advid reader as well; even though, my library is outpacing my time to read. I’ve taken to working in audio books and I try to alternate between one to learn and one to relax (typically scifi or historical fiction). 

In my 25+ yr career I have seen the power of a techanical community and what can grow from open discussions. I cannot wait to see where we go here!

 

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Hello to you all!  I’m Rebecca and am VP RAQA at Oxford Endovascular based in...Oxford, UK.  However I live in a town between Liverpool and Manchester.  At Oxford Endovascular we are developing a second generation flow diverter to treat brain aneurysms and on schedule to move into human studies in 2023.  In 2021 we were named one of the 10 coolest Health Startups in the UK.  😎

I’ve been in the Medical Devices industry for more than 25 years, a materials engineer who started out at the UK Regulatory Authority MHRA and then quickly transitioned into industry working for 15 years in American global multinationals working in leadership positions in RA, QA and Clinicals.  

For the past 10 years I’ve been working in start ups and had my first experience implementing Greenlight Guru in 2015 with a prior company Phagenesis Ltd.  I’ve been a huge advocate ever since and enjoy engaging with the GG Community. 

I love travelling and have lived in Belgium and Switzerland, thanks to the opportunities provided by former companies.  The past couple of years have been tough not leaving the UK, my other half is a Chief Executive in the NHS so until the restrictions on quarantine on return were lifted we were confined to “the island”.  However just back from our first post-pandemic trip to Venice which has been so energising and so wonderful.

Other than travel then I’m passionate about gardening, biodiversity in our garden, hiking, renovating our home (we moved 6 months ago), live music and since Dec 2020 a total bore regarding Peloton and Power Zone training.  

Looking forward to engaging with the community!

Hi everyone,

My name is Steven Poon (aka ‘spoon’), and I am an independent consultant working in the fields of medical devices and combination products, based in the UK. I’ve been in the industry over a decade now, having worked on both sides of the fence at design consultancies, device manufacturers and pharmaceutical companies before going independent.

I live with my wife, young son and two cats (one of whom we refer to as our first son and actually thinks he is a dog). Outside of work projects and spending time raising a young family, I’ll usually be down at my local CrossFit box. My other interests lie in F1, cooking, rugby (union) and travelling.

I look forward to the interactions and lively discussions we’ll have in this community.

SPOON

Greetings GG Community,

Thank you for the opportunity to participate in this forum.  The topics fit in well with my back ground and current industry.  Speaking of back ground, mine started in Quality with the automotive industry and migrated to the medical device arena, where I’ve been the past 14 years.  In med device, I’m accountable for both the Quality and  Regulatory responsibilities.  So, looking forward to future sessions..!!

Hi Everyone!  I’m Mike Cremeans and I lead the Life Sciences Practice at Hylant, and live in Cleveland Ohio.  Now, for those “seasoned professionals” out there, the river caught on fire in 1969 and has been cleaned up a long time ago!  Cleveland is actually a great place to live, raise a family and is part of a thriving environment of highly innovative companies in the Midwest.

Technical Stuff:  I consider myself a problem solver and connector and try to keep people out of trouble as an outsourced Chief Risk Officer. I also happen to be in the insurance business, specializing in FDA-Regulated companies. Many of us use "risk management" to describe our businesses; however, I start at a very high level, trying to understand the organization's strategic goals and then creating plans to manage the "enterprise risks" that a company faces. The risks could include employees, investors, supply chain, contractual, product liability & personal liability.  I’ve also been described as “the most interesting man who talks about the most boring topic - insurance”  

 

I don’t always talk about insurance, but when I do, it’s not boring

Enough of the comedy.  I am the proud father of four girls and four grandchildren.  I hope we have a chance to meet someday, perhaps at the True Quality Event in San Diego!

I have a few women in my life

Here’s the grandkids.

Grandkids!

 

Hi everybody! I’m Jim Grey, and I lead the software engineers and testers who build and maintain the GG QMS. I’m looking forward to meeting as many of you as I can at True Quality! I’d love to know all about the work you’re doing and how Greenlight Guru helps you get it done.

I’m a lifelong Hoosier and a 33-year veteran of the software industry in central Indiana. I’m married with seven children -- all adults now, with just two still at home - the empty nest is in sight!

In my spare time I make photographs with my large collection of vintage film cameras, and I write. When the weather’s nice I love to ride my vintage three speed bicycle. Last summer, I rode it all the way across Indiana on US 40! Here’s a selfie from the ride -- I got rained on that day.

 

Greetings and salutations, 

 

It’s a pleasure to join this community. 

 

Highlights:

  • I’ve worked in the Healthcare industry for 13 years. 
  • I’m new to the medical device industry. 
  • I am in the Pacific Northwest (PNW) of the USA.

 

I believe in process, organization, and documentation. 

  • Process does not have to be a burden or roadblock. Process encourages efficiency and consistency. The difference lies in the implementation, adoption and execution. 
  • Organization is a superpower. When someone struggles to organize, process can help structure the chaos. 
  • Clear, correct, concise, consistent and verifiable documentation will be read, understood and applied. 

 

I’m a fan of GG in general. I indulge in GG’s podcasts, blogs and have an extreme fondness for GG’s team members. Morgan, Etienne and Wade are absolute rock stars. I like of the concept and intent for this GG community.

 

I plan to be a lurker in the community and make use of AMAs. Thank you in advance, for what I will learn from you in the not-so-distant future.

 

Sincerely,

 

Laura

Hello GG Community!

I’m Lin Arnsdorf, Senior Product Manager at Greenlight Guru. I’m a clinician by trade and, after working in the hospital for many years, I hopped over to the MedTech industry where I helped to take many low risk medical devices to from concept to commercialization. Once upon a time, I was a customer of Greenlight and that is where I became one of their biggest fans. I credit so much of our ability to rapidly become ISO 13485 certified to my relationship with GG. 

I was born and raised in Portland, Maine. I have lived in Boston, San Diego and now Bainbridge Island, an island in the Puget Sound about 30 minutes west of Seattle. Our life here is full of outdoor activities. We love to kayak, hike and snowboard. My husband is a professional photographer so we travel many, many places to shoot. My son graduated from college last year and now attends Montana State, where he’s following in his Father’s footsteps and studying film and photography. In my side hustle I paint, draw had dabble in graphic design. Creativity is definitely part of my little family’s DNA!

I am very excited to meet and connect with you all at True Quality 2022 in San Diego. Come find me ask me about my absolute FAVORITE place to grab a fish taco while you’re in sunny SD. You will not be disappointed!

 

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Hi All, 

 

My name is Ashkon Rasooli and I am the Director of Quality at Big Health. Big Health is a digital therapeutics company. Digital Therapeutics are in their infancy and it is therefore a very exciting and groundbreaking field to be in. It is a SaMD and as such having the appropriate eQMS tool is of utmost importance. 

In terms of my background, I have always focused on software as a medical device or IN the medical device. I have held a variety of roles from product management to system engineering, software engineering and testing, but mostly QMS.  I am interested in connecting with the industry professionals as well as the GG team to brainstorm the best ways to address the SaMD development challenges.

I am located in Sunny Orange County, CA, just down the freeway from San Diego. Looking forward to meeting you all!

 

Ashkon

 

 

Hello all, nice to meet you! I’ve followed greenlight guru for a while and its great to see their success. About me: I work in regulatory affairs for a diabetes mgmt. company called Lifescan. I’m working with Software as a Medical Device (SaMD) and have worked with other types of Class I and II devices. Much of my work experience is also in Quality, eQMS, CAPA and Validation. 

Here is a photo of my wife and I at the strawberry festival here in South Carolina where we live: 

   

Hi all,

I’m Paul Lamoreux and I’m the VP Product Development and Quality at Lumos Labs Medical. We are division of Lumos Labs, the makers of Lumosity Brain Games. We’re the brain games folks! Lumos Labs Medical packages select brain games into SaMDs that target symptoms of particular cognitive conditions. We’re currently in our first clinical trial and we’re looking forward to introducing many effective digital therapeutic products over the coming years.

I actually started my career in the medical devices arena back in the 1980s building products to capture body motion measurements to inform doctors on the patterns of skeletal motion to help diagnose maladies using non-invasive techniques. I moved on to some consumer products revolving around body motion during a golf swing. I’ve worked on a lot of other different projects since then, but I’m happy and excited to be back in the medical device field again. 

I’m from Oakland, CA (go A’s!) and now live in San Francisco with my wife and three kids. One daughter in college and identical twin boys who will be seniors in high school in the fall (yay, double college applications). In my spare time I’m an amateur sports photographer and an avid windsurfer and golfer. I live on the East Coast for the summers if I possibly can, since SF summers are a little on the brutal side (chilly, windy, foggy). 

Looking forward to meeting folks next week at True Quality in San Diego!

 

The kids in 2005:

 

The kids now:

 

A couple sports photos:

 

Hello, my name is Ida and I am an Electronic Document Specialist and Scrum Master at BeanStock Ventures. My background is in Quality. I have been all over the Quality lab, from manufacturing Quality, to performance Quality. I am so glad that my journey has led me to BSV, and I am honored that I get to implement GreenLight Guru for BSV.

 

Anyone who has talked to me at the GG Green Carpet knows that my bread and butter are cats.

 

So enough about me, here’s some cat pictures.

Faust, a very distinguished young man
Pepper, an eccentric and grumpy old lady

 

Userlevel 1

hello all, better late than never!

Michael Bocchinfuso here. Quality Engineer at Koios Medical, a SaMD company. 

Our decision support product, Koios DS Breast, utilizes machine learning to improve diagnostic accuracy, assisting doctors in determining how to classify cancerous or potentially cancerous breast lesions found in ultrasound images.

I have been using Greenlight Guru since starting with Koios in summer 2019 in almost all of its aspects and modules - from quality events to internal audits to document control and now training. It is great to see GG not just growing as a product, but as a company that is continuously improving and evolving.

A lifelong New Yorker, I began my professional career as an electrical design engineer in aerospace, then took a role in quality for a dental x-ray equipment manufacturer, and now SaMD.

Outside of the quality/regulatory world, I am an enthusiastic runner (currently training for my second marathon - Chicago - and my 11th half marathon is next week), and enjoy craft beer and board games. My lovely fiancee Jennifer luckily shares the same hobbies as me. Here’s us at the 2021 New York City marathon, hamming it up for the cameras as we passed our friends from our running team.

 

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Hello Everyone,

 

My name is Justin Turner and am the Director of Quality and OrthoGrid Systems based out of Salt Lake City. 

 

We produce a SaMD that assists with total hip replacements and trauma surgeries, but also corrects the distortion from the Fluoroscopic X-ray images from the live image feed from a C-Arm.

 

My time outside of work is all about my kids, movies and punk rock shows. 

Hi everyone, 

My name is Melinda Ayvazian. I am the Director of Research and Development at Pega Medical in Laval, Quebec, Canada. 

I am a Mechanical Engineer with over ten years of professional experience in the total product life cycle of innovative medical devices in the biomedical field. We act as the OEM to our line of pediatric devices and offer our turnkey services for Design, Testing and Regulatory Approvals to all health-allied professionals.

I have a wonderful husband, two year old daughter and Pitbull mix. 

 

Hello everyone,

My name is Francisco Rodriguez and I am a Chemical Engineer currently working as a QA Specialist for Healgen Scientific.

I have only been working in the Medical Devices industry for as long as I have been working with Healgen, however, I do have years of experience working in Quality and Manufacturing in other industries, so I know a thing or two about Quality in general that I am bringing over to the field.

So far I have been enjoying this field and attending True Quality helped me learn so much more about it, so I truly enjoyed it.

Hello! 

I work for Sonic Incytes, a small company in Vancouver, BC. We are working on a portable ultrasound based system for liver health assessments. I am a biomedical and electrical engineer by training and currently work on clinical trials and testing. I have been working in ultrasound and ultrasound elastography for about 15 years.

I am trying to learn as much as possible about quality and regulatory to move projects from the research side to the commercial side.

I really love to be outside, hiking, climbing, kayaking. I don’t have kids or pets, but here is some pictures to entice everyone to come visit Vancouver. 

Come Skiing!
Or kayaking!

 

Hello everyone!  I'm Fran Cruz, and I have the great privilege of managing the Customer Success team here at Greenlight Guru.  I get to watch as 100s of medical device companies bring their life-changing products to market, so it's a really rewarding role.  

I live in Boulder, CO, with my husband, 3-year old daughter, and 11-year old dog.  We love hiking, skiing, and generally spending time outside.  I'm originally from Boston, so I'm naturally a Boston sports fan.  I hope that isn't a divisive trait here in the community :)

In my spare time, I like to ride my Peloton, bake sweet treats, travel to exotic places (it’s rare these days!), and practice my Italian by reading awful romance novels.

Looking forward to getting to know you!

I have loved over three decades of experience and a unique combination of legal, medical, home health, brain injury and medically fragile childcare. I am formally credentialed in Business, Law, Nutrition. Currently I am enrolled in Villanova University NCMA credentials in legal/contract management, class of 2022. I have experience and resources in the Biotechnology, Medical/Pharmaceutical and the Nutraceutical industry.

I believe in the human element and meaningful support of any effort or project. You never win alone, and you always win with others. You can only serve others in a way that makes the community effort better. Bad grades early in elementary school led to my mother explaining to me that “the world needs ditch diggers too.” My father taught me that you can do many things in life. Whatever it is, do it right or do not do it at all. If you need to burrow something, return it in better shape than how you got it.

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Holiday House Publishing Award Lincoln Elementary Competition, Saint Joseph MI.

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Bill is a resident of Carlsbad, CA and shares his love of business development consulting with his pit crew and wife Angela. “Together we enjoy feline foster placements for SPOT.org Saving Pets One at a Time. Together we permanently foster MJ who ended up being a pure-bred Bombay ‘parlor panther” and one of the most unique creatures in intelligence, strength, and agility. The stories are endless.”

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Hello everyone 👋

I’m Jon, originally from Iceland but have been living in Denmark since 2008. I am a Biomedical Engineer and specialised in informatics and clinical data management.

I’ve been working in the clinical research industry for more than a decade now, and for the past nine years I’ve dedicated my career in developing smart software solutions to facilitate the clinical data collection for MedTech.

In 2013 I co-founded SMART-TRIAL with one goal in mind - to enable all MedTech companies to collect high-quality clinical data in compliance with industry regulations.

I live in Copenhagen. I am a foodie, amateur chef, father of (soon to be) two sons, and getting married to my fiancee (who’s also Icelandic) now in July 2022 in Iceland. I’ve got the black belt in Karate, but luckily haven’t had to use that for any serious self-defence so far 😛

Here’s a recent photo of us in the Tivoli in Copenhagen

I look forward to learn and share knowledge with everyone in the community!

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