Sign in to view Ryan’s full profile
Welcome back
By clicking Continue to join or sign in, you agree to LinkedIn’s User Agreement, Privacy Policy, and Cookie Policy.
New to LinkedIn? Join now
or
By clicking Continue to join or sign in, you agree to LinkedIn’s User Agreement, Privacy Policy, and Cookie Policy.
New to LinkedIn? Join now
Minneapolis, Minnesota, United States
Contact Info
Sign in to view Ryan’s full profile
Welcome back
By clicking Continue to join or sign in, you agree to LinkedIn’s User Agreement, Privacy Policy, and Cookie Policy.
New to LinkedIn? Join now
or
By clicking Continue to join or sign in, you agree to LinkedIn’s User Agreement, Privacy Policy, and Cookie Policy.
New to LinkedIn? Join now
358 followers
346 connections
Sign in to view Ryan’s full profile
Welcome back
By clicking Continue to join or sign in, you agree to LinkedIn’s User Agreement, Privacy Policy, and Cookie Policy.
New to LinkedIn? Join now
or
By clicking Continue to join or sign in, you agree to LinkedIn’s User Agreement, Privacy Policy, and Cookie Policy.
New to LinkedIn? Join now
View mutual connections with Ryan
Welcome back
By clicking Continue to join or sign in, you agree to LinkedIn’s User Agreement, Privacy Policy, and Cookie Policy.
New to LinkedIn? Join now
or
By clicking Continue to join or sign in, you agree to LinkedIn’s User Agreement, Privacy Policy, and Cookie Policy.
New to LinkedIn? Join now
View mutual connections with Ryan
Welcome back
By clicking Continue to join or sign in, you agree to LinkedIn’s User Agreement, Privacy Policy, and Cookie Policy.
New to LinkedIn? Join now
or
By clicking Continue to join or sign in, you agree to LinkedIn’s User Agreement, Privacy Policy, and Cookie Policy.
New to LinkedIn? Join now
Sign in to view Ryan’s full profile
Welcome back
By clicking Continue to join or sign in, you agree to LinkedIn’s User Agreement, Privacy Policy, and Cookie Policy.
New to LinkedIn? Join now
or
By clicking Continue to join or sign in, you agree to LinkedIn’s User Agreement, Privacy Policy, and Cookie Policy.
New to LinkedIn? Join now
Activity
Sign in to view Ryan’s full profile
Welcome back
By clicking Continue to join or sign in, you agree to LinkedIn’s User Agreement, Privacy Policy, and Cookie Policy.
New to LinkedIn? Join now
or
By clicking Continue to join or sign in, you agree to LinkedIn’s User Agreement, Privacy Policy, and Cookie Policy.
New to LinkedIn? Join now
-
See how EarliTec is unlocking healthcare trust: CTO Sreenivasan (Sreeni) Narayanan reveals crucial lessons in embracing explainable AI models. #AI…
See how EarliTec is unlocking healthcare trust: CTO Sreenivasan (Sreeni) Narayanan reveals crucial lessons in embracing explainable AI models. #AI…
Liked by Ryan Bormann
Experience & Education
-
EarliTec Diagnostics Inc.
******** ** ******* *** **********
-
***** ******
******** ** *******
-
******
******** ** *******
-
**** ***** **********
*********** ******* ********** ***********
-
View Ryan’s full experience
See their title, tenure and more.
Welcome back
By clicking Continue to join or sign in, you agree to LinkedIn’s User Agreement, Privacy Policy, and Cookie Policy.
New to LinkedIn? Join now
or
By clicking Continue to join or sign in, you agree to LinkedIn’s User Agreement, Privacy Policy, and Cookie Policy.
View Ryan’s full profile
Sign in
Stay updated on your professional world
By clicking Continue to join or sign in, you agree to LinkedIn’s User Agreement, Privacy Policy, and Cookie Policy.
New to LinkedIn? Join now
Other similar profiles
-
Ella Swanson-Hysell
St Paul, MNConnect -
Sew-Wah Tay
Minneapolis, MNConnect -
Michael Fox
Greater BostonConnect -
Bob Kritta
warehouse professional at Cummins Power Generation
St Paul, MNConnect -
Thomas Kemnitz
Private Practice
San Jose, CAConnect -
Norm Goranowski
Financial Analyst at Housing & Dining Services, University of Minnesota
St Paul, MNConnect -
douglas harmening
Utilities Professional
Minneapolis, MNConnect -
Jay Brezall
Senior Tech. at Mc Candless T/C
Denver, COConnect -
Dan Magistad
Sales person at Walters Recycling and Refuse, Inc.
St Paul, MNConnect -
Mona Mahlum
United StatesConnect -
Denise Hillmann
Business Office Manager at Pro Maintenance Inc
Buffalo Lake, MNConnect -
Tara Kolberg
Intensive Care Nurse at UNIVERSITY OF NEW MEXICO HOSPITALS
Albuquerque, NMConnect -
Lindy Bakeberg
Interior Designer, Realtor
Jordan, MNConnect -
Kelly Leines
District Manager at Mannington Mills, Inc.
Elk River, MNConnect -
Brandon Moss, MBA
Atlanta Metropolitan AreaConnect -
Ben Bakeberg
Middle School Principal at Jordan Public Schools
Jordan, MNConnect -
Joseph Mateo
Greater Minneapolis-St. Paul AreaConnect -
Allison Bruckner
Operations Manager at JJ Swanson Advisory Group
Hopkins, MNConnect -
Garima Mehta
Data Scientist at EarliTec Diagnostics, Inc.
Seattle, WAConnect -
Thomas Ressemann
Minneapolis, MNConnect
Explore more posts
-
Marnie Smith
Thank you to everyone that attended my webinar on 6/25 about the QMSR changes! You had some great questions and I was happy to share my perspectives. If you haven't had a chance to dive deep on it, here is FDA's ruling: https://lnkd.in/ex8SWZNm Of particular interest is the last 3 pages which previews what it will look like, although the preamble has some great stuff in there too. Check it out! #QMSR #NPG #Quality
18
-
Kevin Ashton
What to do when the test itself is the failure? How many times have you investigated product failures to find out that it was not the manufacturing process, but the test method that was the source of the error? If your experiences are similar to mine, you'll know that this is a frequent problem. Understanding and controlling a test system is not a given; it's a scientific endeavor. While working for a medical-biologicals company, I was assigned to investigate a potency failure of a biological component. The failures were intermittent, and results would sometimes not confirm on repeat testing. I started the investigation not with looking at the component that failed, but rather with studying the measurement system scientifically to determine its accuracy. This type of study is called a Measurement Systems Analysis (MSA). I discovered that there was a large amount of measurement variation, and we had standards that were not controlled for stability. As the standards grew older, their degradation caused the truly good product to test out of spec. The resolution was two-fold: replace standards at a certain age, and measure multiple replicates of product to assess potency. There were other methods in my company that were also failing to achieve their purpose. The strong results we got from my first investigation inspired the company to remediate all the test methods. I was fortunate to be able to train and lead a team of 10 extraordinary scientists and engineers to comb through dozens of test methods and complete MSA's. Several test methods were adjusted to reduce variation and improve accuracy of results. The cost savings from eliminating false failures and extensive investigations paid for the MSA work within the first year. It was a great decision by management to dedicate these resources to prevent problems that were sure to happen! Measurement devices of all types can fail to achieve their purpose: Vision systems can fail to accurately identify the edge of an object. Laser systems can fail to identify a shiny surface. In the world of biologics, we have the additional complexity of controlling conditions for biochemical reactions and instability of standards. The answer is MSA: understand measurement variation so that you can design measurement processes to overcome that variation. Study - Design - Achieve. Brilliant! If you have high costs from investigation and measurement systems that have errors, contact me! I teach, train, coach, and apply MSA, scientific studies, and statistics to scientists and engineers to help companies maximize profitability by achieving quality excellence.
2
-
Tom Quinn
Authority to change performance standards The performance standards in the FDCA and 21CFR are the backbone of patients safety. Performance Standards are developed, updated, changed exclusively by the FDA The finished device manufacturer then submit their performance standards policy to the FDA in a PMA or 510k submission for review by the FDA and approval or clearance. Who has the authority to change the performance standards? The Congress and the secretary, not courts, not lawyers, not the public, only the Congress and the secretary using the FDCA or posting in the federal register and following the regulation requirements for changing the performance standards. Again, no other person, company, agency and courts, can change the performance standards. Finished device manufacturers who change performance standards requirements, after filing , have adulterated their devices, for example the intended use. The authority to change performance standards requirements falls solely with the FDA under the FDCA. Denying portions of the performance standards after receiving approval or clearance of a device also adulterates a device and could be a serious violation of the law, FDCA. All the discussions on manuals and software go through the performance standards. Compliance goes through the performance standards. Enforcement goes through the performance standards. Failure to file a PMA or 510k is another serious violation of the FDCA. Why am I saying all of this? I hope no one gets into litigation but with Philips on the warpath it’s best to make informed decisions on how to defend yourself in litigation. Violations of 21CFR to control a service or parts market through litigation can be a crime the DOJ might want to look at. In addition, as Philips filing show, Philips treats litigation like a commercial trade secret not excluding the FDA requirements from litigation filings. We know why Philips does this. Trade secrets starts after adequate manuals and software for a lay person. So what’s a trade secret? Philips were is you case? Don’t become another notch on Philips or any other unscrupulous OEM gun belt. Don’t pay lawyers for what you can do for free. Demand adequate manuals and software now. Whew! I’m tired now.
1
-
Chris Bouchee (B.S. MatSci)
The first step to a remediation plan is to do a thorough gap analysis of the regulations/audit findings and the QMS. This is critical to developing the plan for getting back into compliance. Next, adjust the QMS policies and procedures to gain compliance and then execute closing the gaps! Let us custom tailor a solution for you! #compliance #remediation #MEC #customsolutions
3
-
Tom Quinn
Another source of information in litigation In case you’re in litigation get the Pre Market Approval (PMA) and 510k clearances to see what the OEM told the FDA. Class 1 least likely to be inherently dangerous to patients. Class 2 devices generally only require one PMA before using 510k clearances as substantial equivalent for devices Class 3 use the PMA. In litigation FDA filing are essential in any litigation. The secrets are there
2
-
Joseph Sener
Setting up your operation with appropriate listening systems will facilitate the management review process. This should be far more than a periodic meeting. It should be an ongoing process that monitors the operations and key metrics for notification of management and for acting when key thresholds have been met.
4
-
Garth Conrad
Have you ever wondered about the likelihood of receiving a 483 Observation (aka finding/nonconformance) during an FDA Inspection? I recently came across this question and decided to dig into the data to find some hard facts. According to data from datadashboard.fda.gov (Inspections), the probability of receiving a 483 observation at the end of an FDA Inspection for Medical Device companies is approximately 50%. (higher or lower than you anticipated?) The reasons for receiving a 483 observation during an FDA Inspection can vary depending on the effectiveness of your people, processes, and systems. Typically, these observations can be categorized into two main areas: (1) inadequate translation of requirements into procedures and (2) lack of adequate evidence to demonstrate compliance with established procedures. Ensuring that you have qualified resources in place and fostering a strong quality culture within your facility can help promote compliance and reduce the chances of receiving 483 observations during FDA Inspections. Now, here's a question for you: How do your company's results compare to the industry average? #dataanalytics #fdainspection #483Observations
81
2 Comments -
Grace Fu Palma
Starting from October 8, 2024, usability engineering documents need to be submitted for medical device applications in accordance with the new guideline, “Registration Review Guideline for Medical Device Usability Engineering (2024, NO.13)”, published in Mar 2024. A risk-based approach is adopted when determining what human factors information to include in a marketing submission. The devices are regulated under two categories: those with high use-related risk and those with medium or low use-related risk. CMD can assist in assessing document sufficiency or the need for a summative usability test in China. Please email info@chinameddevice.com for more information and request our webinar slides or recordings. #usability #engineering #FDA #NMPA #Chinamarket #USmarket #medicaldevice #humanfactors
9
-
Rene' Hardee
Medical Device Manufacturers - have you looked at the FDA eSTAR v.5.0 yet? If not, you may be in for quite the shock... eSTAR is a required template that medical device manufactures need to utilize to make a submission to the FDA. The cybersecurity portion of this required template went from only 2 attachment fields in v.4.0 to 12 attachment fields and 9 additional questions to answer in v.5.0! Manufactures need to pro-actively review these cybersecurity deliverables and make the necessary changes 𝐍𝐎𝐖 to their product development processes to output the required cybersecurity artifacts the FDA is looking for. Do not wait til the end of product development to create these documents or you will suffer the consequences of unnecessary scrambling, poor cybersecurity management, and risk a Refuse to Accept (RTA) for your submission! #medicaldevice #estar #fda #cybersecurity
45
2 Comments -
Daniel DeFranco
This is a great reference chart. Another thing to keep in mind is the setting when having these discussions. ISO 13485 and 21 CFR 820 use different acronyms so the auditor is going to be looking for the information that pertains to their standard. You may explain that you use one file to meet both requirements, but you're going to want to be comfortable explaining how you accomplish that.
-
Tom Quinn
Understandings what you are under 21CFR 21CFR 820 definitions If you perform any of the functions below you are a manufacturer. I know the push back from this statement is coming but you are manufacturers in the eyes of the FDA. Period end of discussion. Have you installed any medical device? You’re a manufacturer Same for the other requirements to be classified as a manufacturer which is what you want your be. Understanding 21CFR and the benefits of 21CFR will improve patient safety, increase your business profile, decrease your litigation liability and much more. CDRH has made the definition of a manufacturer in many policy documents. Most of you in the installation, service, resale and other duties could be manufacturers, assemblers, servicers, owners, users, installers, or others. All require access to manuals and software upon request and require you to provide these documents and software to the owner upon resale. 21CFR 820 definitions (o) Manufacturer means any person who designs, manufactures, fabricates, assembles, or processes a finished device. Manufacturer includes but is not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions.
3
2 Comments -
Nilesh Billade, Ph.D., P.E.
Testing medical devices at worst-case assembly tolerance conditions presents a formidable challenge in ensuring their reliability and safety. In the intricate world of medical technology, where precision is paramount and margins for error are minimal, assessing devices under the most extreme assembly scenarios is crucial. Sterile barrier systems are critical components of medical devices, particularly those intended for use in invasive procedures or sterile environments. Just like with the devices themselves, ensuring the integrity and reliability of sterile barrier systems under worst-case assembly tolerance conditions is paramount. Moreover, navigating the complex regulatory landscape adds another layer of complexity. Regulatory standards (such as the ISO 11607-series) often mandate rigorous testing of sterile barrier systems to ensure compliance with stringent requirements for maintaining sterility throughout the device's lifecycle. This includes testing under worst-case conditions to simulate the most challenging scenarios that the device may encounter during manufacturing, handling, and storage. In these scenarios, computational modeling & simulation based approaches provide precise control over simulation parameters, allowing engineers to precisely define worst-case scenarios with accuracy that may be challenging to achieve in physical testing. This level of control enables thorough exploration of a wide range of assembly tolerances and environmental conditions to identify potential failure modes and weak points. Additionally, these approaches offer significant advantages in the form of cost-effectiveness, rapid iterative design optimization, insight into failure mechanisms, future-proofing and regulatory compliance. https://bit.ly/4cDosAV #insilico #medtech #regulatoryaffairs #medicaldevice #FDA #HealthcareInnovation #sterilepackaging #medicalpackaging #sterilemedicalpackaging #healthcarepackaging #sterilization #medicalsafety #packagingsolutions #sterileproducts #sterilebarriersystems #medicaldevicespackaging #cleanroompackaging #packagingdesign #HealthCare
31
-
Ryan Tee
The Final Deadline of May 26, 2024 for Compliance with Article 120 3c of the MDR is approaching! Companies must ensure they meet the requirements to avoid losing their certification. Non-compliance means automatic invalidation of device certificates, as mandated by the MDR itself. To ensure your device(s) stay(s) certified, please confirm the following: ✅Directive Compliance ✅Device Design Confirmity ✅Device Risk Management ✅Quality Systems Compliance ✅Application To Notified Body There's no flexibility when it comes to these requirements. As the deadline approaches, make sure your products comply fully. Don't let non-compliance be the reason for losing your certification. Good luck to all companies! #RegulatoryAffairs #EUMDR
10
-
Woodrow Starnes
Good evening Linkedin, I apologize but there will be no new post for MedTech Compliance Chronicles this week. As many of you likely know, there are some important EU MDR deadlines coming up this month that are keeping me quite busy at my day job. For that reason and to continue to deliver well thought out, quality posts at a sustainable pace, I will post every other week. This will enable me a full week to research the topic and a full week to write the post. Next week we will begin the new schedule with a post on Monitoring and Measurement. See you then! #MedicalDevices #FDACompliance #QualityAssurance #ProcessValidation
5
-
Nika Mendelev
Wrong place. Wrong time. Wrong side of history. It's the perfect moment to recalibrate your internal compass. #SelfImprovement #Leadership #GrowthMindset #CareerDevelopment #Resilience #Adaptability #MindsetMatters #PersonalGrowth #Reflect #ProfessionalGrowth #SelfAwareness #westandwithisrael
3
-
Chris Whelan
Dear Risk Community, ISO TR 24971:2020 C.4 Risk Control explicitly mentions "economic practicability". I rarely hear this as part of the discussion at a quality or risk management level, but it should be right next to benefit-risk in assessing a product. The best way to eliminate risk is to eliminate the product. If risk control measures mean that no-one will buy it, you've eliminated risk but you've also eliminated benefit! A key distinction made in the report, which was obviously made by the authors in anticipation of mis-use of this clause, is that "economic practicability should not be used as a rationale for the acceptance of unnecessary risk". So can we use economic practicability or not? Yes, we can, but not to justify *unnecessary* risk i.e. risk that is not necessary to deliver the benefit. What do you think?
22
7 Comments -
Nishant Varma
If I had an FDA cleared medical device ready to be marketed to hospital groups in the US for the first time, here is what I would consider doing to bring on my very first customer... - Identify a major hospital group for collaboration on an initial pilot - Meet with the OBGYN department head of that group (e.g. Chair, Chief, Division Director etc) to introduce the device (assume you gain clinical buy-in) - Discuss parameters of an early pilot (what data needs to be collected by providers to support approval at the system level) - Offer a discount to support the pilot (or devices free of charge). Justified if this is the very first user (early adopter) in the country - Work with procurement/ value analysis to agree a free of charge evaluation (trial period, contract, vendor set-up, protocol, on-going pricing etc) - Obtain a zero charge PO to mark the start of the pilot - Provide initial and on-going on-site education to support the clinical teams using your device - Regularly engage with providers to monitor initial uses and obtain feedback (this might come via a clinical champion) - On completion of the pilot, have your clinical champion collate provider feedback for submission to the new product committee (or a committee of this type) - Assuming the above is a success and their experience is consistent with the benefits you initially articulated, you should have your first customer and orders to follow Ultimately, there will be nuance to the above list, but thinking about this process is a good start. Hospital and system internal approval processes will vary considerably. We know that healthcare systems are slow to adopt new technologies. In the obstetrics space especially. Target early adopters and key opinion leaders. Consider your distribution strategy - how will you move from your first customer to national adoption? If you need help with any of the above or would like to talk through, drop me a message. I spent many years building our US business from scratch and I now share that journey, knowledge, and network with others through OBG Access I'm enjoying working with exciting start ups in the medical device space, especially clinician-inventors, like my father who wanted to solve a clinical problem and will leave a lasting impact on his field. Maybe there's one more adventure left... #FDAClearance #MedicalDevices #Innovation #Obstetrics #Maternity #WomensHealth #Sales #Business #USLaunch
46
5 Comments -
Patrick Gora
The FDA recently issued a draft guidance emphasizing the assessment of how medical devices affect tissue temperature. This guidance is crucial for device manufacturers submitting premarket applications to the FDA, outlining necessary documentation to support evaluations of thermal impacts. It covers devices using electromagnetic energy (like radiofrequency and microwave), ultrasound, electroporation, contact-based temperature changes, and those with electrical components potentially heating tissue. This update reflects FDA's commitment to enhancing device safety and efficacy through clear regulatory standards. You can find the full draft guidance document here: https://lnkd.in/gieUDG2K #FDA #medicaldevices #thermaleffects #regulatoryguidance #healthcare
1
-
Hank Kohl
Many devices require users to service them on-site rather than return them to the manufacturer. Therefore, it’s critical to design and manufacture your medical device knowing that it may not always be serviced in an optimal setting. For example, if your product design doesn't consider simple field replacements, such as cables or screws, it could play a significant role in the device's uptime. To that end, consider the manufacturing and serviceability aspects of your design before finalizing it for production. This proactive approach ensures that your design is optimized for both manufacturing efficiency and ease of maintenance once in use. That way, you safeguard your product’s UX, and give your users the flexibility to service a medical device on the spot without disrupting their work or product availability. #mpe #medtech #medicaldevice #medicaltechnology
16
1 Comment -
Peter Shearstone
I’m looking forward to joining product compliance engineers, innovators, safety advocates and continuous improvement experts at the 20th Institute of Electrical and Electronics Engineers (IEEE) International Product Safety Engineering Society’s (PSES) International Symposium on Product Compliance Engineering (ISPCE) 2024 April 30-May 2 in Chicago. The event will include discussions and presentations on different engineering disciplines, which have become a growing area of interest to business leaders. On April 30, I’ll have the honor of delivering this year’s keynote presentation, titled “Changing the Compliance Paradigm in Large Global Companies” in the spirit of sharing best practices and lessons learned over the past 30 years. I’ll provide a suggested roadmap on how to approach the formidable challenge of changing the compliance paradigm in a large, complex, international organization. I’ll also discuss our greatest opportunity and challenge - demonstrating the benefits that earlier Compliance involvement bring to the product development process, and how it can positively affect business results, reduce the amount of time to receive compliance and go to market, and provides customers with better products. The work that the IEEE PSES and ISPCE 2024 are doing with my Thermo Fisher Scientific colleagues Mark Pearson, Regan Arndt and Ken Kapur, among others - as well as their dedicated counterparts at other companies - are powering the compliance engineering profession across the globe, and the benefits it will bring customers and companies. #thermofisher #QualityProfessionals #QualityAssurance #RegulatoryAffairs #QARA #Regulatory #Quality #IEEE #ISPCE #Compliance
175
8 Comments
Explore collaborative articles
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
Explore MoreOthers named Ryan Bormann in United States
-
Ryan Bormann
Business Intelligence Lead at Humana
Louisville, KY -
Ryan Bormann
Patent Attorney
Indianapolis, IN -
Ryan Bormann
Las Vegas, NV -
Ryan Bormann
Austin, TX
7 others named Ryan Bormann in United States are on LinkedIn
See others named Ryan Bormann