https://medicaldevice.how/observations daily 0.75 2023-12-21 https://medicaldevice.how/observations/the-rules-of-acquisition monthly 0.5 2023-12-21 https://images.squarespace-cdn.com/content/v1/648e5927ea6935509064afa6/3a883b61-a1bb-4c10-9df4-7452ff987d69/PIVOT.jpg Observations - The Rules of Acquisition Abiomed itself has been around for a while, it was founded in 1981. They initially focused on creating an artificial heart, and they implanted the first ever in 2001. In 2004 a new CEO came in, Mike Minogue, and he didn’t think the artificial heart market was the best, so he had the company pivot and focus on heart recovery devices. https://images.squarespace-cdn.com/content/v1/648e5927ea6935509064afa6/867b1e69-192b-44bd-88a0-111bebeff64b/ferengi.jpg Observations - The Rules of Acquisition Rule of Acquisition 402: Keep your friends close, keep the FDA closer. https://medicaldevice.how/observations/translating-an-fda-warning-letternbsp-what-the-fda-really-means monthly 0.5 2023-11-29 https://images.squarespace-cdn.com/content/v1/648e5927ea6935509064afa6/a31b750f-6422-4580-afbc-a65b2eac2700/they+are+who+we+thought.png Observations - Translating an FDA Warning Letter:  What the FDA Really Means - WFRM: Yup, this is a medical device, and we found some issues. Dan’s Comment: Adulterated is a very general term. It means that there is some sort of issue, could be more administrative and paperwork related, or it could be an actual product problem. I would expect that a majority of medical devices are “adulterated,” in that if you went through the entire DHF, you could find an issue. Not that it means there is an issue with the device, but when you generate thousands of pages of documents for a DHF, there are bound to be mistakes. But once it gets to the level where the FDA says it is adulterated, you better pay attention. https://images.squarespace-cdn.com/content/v1/648e5927ea6935509064afa6/1e5f0136-9e93-41bf-a936-ed3019e764f8/we+have+a+problem.jpg Observations - Translating an FDA Warning Letter:  What the FDA Really Means - WFRM: Yeah, so it is true that you have this device registered as a medical device, but it does a whole lot more than you told us it would, and that’s an issue. And those things are related to life-threatening conditions, so this is kinda a big deal. Dan’s Comment: You don’t want FDA saying that you have an issue related to your device and “life-threating condition[s].” https://images.squarespace-cdn.com/content/v1/648e5927ea6935509064afa6/4f07c6c6-013c-49c8-9849-89c59c809d94/really.gif Observations - Translating an FDA Warning Letter:  What the FDA Really Means - WFRM: We disagree. Dan’s Comment: Essentially the FDA is saying that Abiomed was gaslighting them in their response. I really do love the final sentence of the paragraph, does not require any translation, “We disagree.” https://images.squarespace-cdn.com/content/v1/648e5927ea6935509064afa6/66df5c56-a924-42c7-9705-ef2c134100c5/kinda+a+big+deal.jpg Observations - Translating an FDA Warning Letter:  What the FDA Really Means - WFRM: You told us that this functionality is just a little nice to have, you know, something to help out the caregiver and make their life a little easier. That’s nice. But you’re just wrong, and we have the receipts to prove it. Dan’s Comments: Again, FDA is pushing the “life-threating condition” part of this, and telling Abiomed that this is a big deal. https://images.squarespace-cdn.com/content/v1/648e5927ea6935509064afa6/5e24de4b-c60f-4289-b362-6bd0c90377f5/here+you+go.jpg Observations - Translating an FDA Warning Letter:  What the FDA Really Means - WFRM: Since it is not an approved device, you need to go through the process to get it approved, and here is exactly where you can do that. We know that you already know how to do this, but here is a gentle little reminder. Dan’s Comments: I always love this in a Warning Letter. It’s kinda like when you apply for a job and upload your resume, but they still make you type in the whole resume anyway. https://images.squarespace-cdn.com/content/v1/648e5927ea6935509064afa6/ecdd53bd-8d37-452a-84cb-92fe2b9a3e9b/just+do+better.jpg Observations - Translating an FDA Warning Letter:  What the FDA Really Means - WFRM: Really good job on having the correct content in your procedures, but you didn’t even follow your procedures. Good start, but you can do better. Dan Comment: The FDA will point out any time you don’t follow your own procedure, especially when it deals with “Life-threatening conditions.” They then provided two examples that are pretty black and white. When there are clear requirements in your procedure and you don’t follow it, you better have a pretty good reason why. https://images.squarespace-cdn.com/content/v1/648e5927ea6935509064afa6/122a54b0-06b8-46b6-ada6-9f17c876dbfa/just+stop.gif Observations - Translating an FDA Warning Letter:  What the FDA Really Means - WFRM: Just stop. Your procedure was clear as to when escalate something, you just didn’t follow your procedure. Don’t tell me it’s not raining while holding an umbrella. Dan’s Comment: This is the FDA getting a little angry here. The FDA is telling them that they are wrong. They then proceed to give two more examples, more than what they found in the inspection, on how they didn’t follow procedure. This is a case for when your company made a mistake, just acknowledge you made a mistake. Don’t try to blame your procedures when you didn’t do the right thing. If Abiomed responded that the procedures were clear, but that taking additional efforts to make sure they are followed, that would have at least reduced the number of issues in this Warning Letter. https://images.squarespace-cdn.com/content/v1/648e5927ea6935509064afa6/0b074a94-0831-490d-9cc3-9e6778dc1992/sorry+i+annoyed+you.jpg Observations - Translating an FDA Warning Letter:  What the FDA Really Means - WFRM: Why are we doing your job? It is your job to determine if a product needs to be recalled. It should not take us coming in here to inspect you to recall your product. Dan’s Comment: While it was good for them to do the recall and show the FDA they are trying to improve things, you don’t want to be doing recalls because the FDA told you to do one. https://images.squarespace-cdn.com/content/v1/648e5927ea6935509064afa6/e9565e10-d8be-41ab-a0ab-bca7c47f0663/dont+make+this+worse.gif Observations - Translating an FDA Warning Letter:  What the FDA Really Means - WFRM: Ok great, you did something to fix the problem, but you didn’t do enough. If you are going to make these updates to the manufacturing process, you need to make sure you didn’t make it worse or introduce something else. Dan’s Comments: This is a big thing for all design and process changes. If you change one thing, you need to make sure that it didn’t affect anything else. Especially in a case like this where you have identified high risks around the issue. https://images.squarespace-cdn.com/content/v1/648e5927ea6935509064afa6/a41adf53-58b8-4002-ab0c-873996809b4e/comon+man.jpg Observations - Translating an FDA Warning Letter:  What the FDA Really Means - WFRM: We are not idiots. You told us this was no big deal, but then your own engineers documented that this was a big deal, and even used an exclamation mark! Dan’s Comment: This is bad. At this point the FDA is really enjoying telling Abiomed how often they are wrong. Essentially the FDA pointed out that Abiomed told them having burrs is not a big deal since they shouldn’t come loose. However, the FDA pointed out that in another document it was stated that burrs are “always unacceptable!” You can’t have it both ways. https://images.squarespace-cdn.com/content/v1/648e5927ea6935509064afa6/6970f1d8-07cc-4c7f-8226-0f541a70bc06/spongebob.gif Observations - Translating an FDA Warning Letter:  What the FDA Really Means - WFRM: What the heck? You guys are just making it up as you go along. You don’t like to follow your procedures. And it took us to point out that to you, leading to MDRs being submitted almost 2.5 years late. Please, please, just follow your procedures. Your procedure specifically says that even if there is “Use Error” it is still reportable. You can’t just say that it’s not our fault in a complaint investigation and not file an MDR. You are wrong. Dan’s Comment: MDR reporting is often an easy low hanging fruit for inspectors. But in this case the FDA essentially called them out for finding reasons to not report a malfunction, and that is not kosher. Abiomed did do the right thing by eventually reporting the MDRs, but they reported it during the audit. https://images.squarespace-cdn.com/content/v1/648e5927ea6935509064afa6/e868f0a7-4f37-488d-b287-b8c1328904fd/documents.png Observations - Translating an FDA Warning Letter:  What the FDA Really Means - WFRM: You sent us a 470-page response to read, and it didn’t even include everything we needed to see! Great you found these records to review, but we need to know if this is a big deal or not. Dan’s Comment: 470 pages is a lot to read. And they sent FDA a lot, but they didn’t get to the core of the problem. Abiomed did all these product reviews, but do they need to take any actions based upon their investigation. Abiomed did not make that conclusion. FDA cares about that a lot. https://images.squarespace-cdn.com/content/v1/648e5927ea6935509064afa6/8e5458d1-625d-42c4-93fd-a5c2ae4b9eff/failure+to+communicated.png Observations - Translating an FDA Warning Letter:  What the FDA Really Means - WFRM: You need to work on your communication skills. You don’t like to tell us about MDRs, and you don’t like to tell us when you do recalls. Please, just please call us when you have an issue. We promise we won’t ghost you. Dan’s Comments: This is always a tricky thing with field bulletin type things. A company thinks they are doing the right thing by informing people about these issues and how to prevent them, and they are. But if you do anything in the field to reduce the risk, that is a recall. And you need to let the FDA know. This gets back to the findings at the start where they did not do any Health Hazard Evaluations. That process would determine if a correction notice needs to be sent out. If they had done something like that it could have helped here, but sadly they did not. https://images.squarespace-cdn.com/content/v1/648e5927ea6935509064afa6/725302ff-0b8a-4d1c-8ef3-daa24f54a23a/thor.gif Observations - Translating an FDA Warning Letter:  What the FDA Really Means - WFRM: By the way, we are the federal government, and we will come down on you like the Hammer of Thor if we need to. Dan’s Comment: They put this in every Warning Letter, but it’s a nice little reminder that the FDA has a lot of power if they want to use it. https://images.squarespace-cdn.com/content/v1/648e5927ea6935509064afa6/f6098195-492a-4fc1-abbd-a473004adf7c/clean+up.jpg Observations - Translating an FDA Warning Letter:  What the FDA Really Means - WFRM: We are not that good, and we can’t find all the issues we have. With everything we have found, we know you have major issues, and you need to clean up your act. Dan’s Comment: This is also a boilerplate paragraph, but it’s a reminder that the company needs to look at the big picture. https://medicaldevice.how/observations/level-up-your-design-inputs monthly 0.5 2023-10-31 https://images.squarespace-cdn.com/content/v1/648e5927ea6935509064afa6/5991b2d3-c27f-482a-80c9-0e4d9bbdeb52/big+system+v.png Observations - “Level” Up Your Design Inputs! For medical device design, a core concept is the System V. This is not a medical device concept but a general design and systems engineering concept and it aligns very well with medical device regulations and standards. You can see from the chart on the left that I have labeled the different levels of requirements, but those names don’t matter. What really matters is understanding where within the requirement hierarchy a requirement sits. https://images.squarespace-cdn.com/content/v1/648e5927ea6935509064afa6/73f7abbc-5556-40a7-9195-fde7bd66324e/2+to+3+level+gif.gif Observations - “Level” Up Your Design Inputs! In the example to the left, you can see that the same information is captured, just at different points along the requirements hierarchy. Both options are completely fine, and which one to use honestly comes down to preference. I prefer the three-level option, as it really gives you more traceability, as you can then directly link the 10.0mm width directly to requirement related to female mouth size, while in the two-level example it is more inferred. There are other ways to still maintain that linkage, but with the multiple levels it essentially forces engineers to lay it out. https://images.squarespace-cdn.com/content/v1/648e5927ea6935509064afa6/4877f123-c768-49b7-bdf8-4a8f0f7153fa/stakeholder+need+gif.gif Observations - “Level” Up Your Design Inputs! All requirements need to come from some sort of a top-level requirement, from the traditional design process those will be User Needs. But for these compliance requirements, you should not cascade them from a User Need. That is because the FDA QSR and ISO 13485 are very clear that User Needs need to be validated. Take a look at the two examples to the left: https://images.squarespace-cdn.com/content/v1/648e5927ea6935509064afa6/fd6d1362-ead1-4fd3-a849-b2699eec666d/yoda.jpg Observations - “Level” Up Your Design Inputs! Don’t be afraid to ask the question why, and really understand where they are coming from. They might just say, “… because that is the way we have always done it.” That might be a true answer, and a reason, but it is not a good reason. https://medicaldevice.how/observations/new-fda-draft-guidance-fda-provides-510k-cheat-code monthly 0.5 2023-09-19 https://images.squarespace-cdn.com/content/v1/648e5927ea6935509064afa6/dbb8fd28-22c6-471e-935e-2f4e5e22619b/v+idagram+fda+draft.png Observations - New FDA Draft Guidance: FDA Provides 510(k) Cheat Code You can see in the chart that it touches on all things across the design spectrum, and if you are somewhat new to medical devices, probably identifies some things that you may not be aware of. For instance, if a firm does not have much experience in implants, they may not account for the possibility of a patient being exposed to strong magnetic fields in an MRI machine. Also, real time and accelerated shelf-life testing for polymers, and other examples which are good for firms without much medical device experience. https://medicaldevice.how/observations/nyt12miyszmat106af4kr6zafodle5 monthly 0.5 2023-09-07 https://images.squarespace-cdn.com/content/v1/648e5927ea6935509064afa6/4b6f3d6b-10da-4fbd-9cb2-86589101d2b3/User+Need+Cat.jpg Observations - Schrödinger’s User Needs The gist of the thought experiment was, if the box was not opened the cat was both alive and dead at the same time. I’m sure I did a bad job summarizing it, but if you want to know more, I defer to your personal astrophysicist, Neil deGrasse Tyson. https://images.squarespace-cdn.com/content/v1/648e5927ea6935509064afa6/510d917a-f95c-4bfc-ac96-2229d4a30831/waterfall.png Observations - Schrödinger’s User Needs The FDA Design Controls Guidance has a very robust section on design inputs, but it also does not discuss user needs. It discusses how bad user needs can lead to bad design inputs and a bad design, but again does not talk about what is needed for a good user need. Just like the regulations, it just kind of assumes they exist. The celebrated waterfall image in the guidance shows that user needs are validated against the medical device, but it does not get into what a user need is. https://medicaldevice.how/observations/you-dont-need-to-do-design-verification-testing monthly 0.5 2023-08-28 https://images.squarespace-cdn.com/content/v1/648e5927ea6935509064afa6/0a5cd3e3-101e-4522-834a-6052cb3c48c2/Stool.png Observations - You don’t need to do design verification testing.  That final functional design verification testing is really the summation of all the design verification activities that were completed on the device. This is going to include analysis, inspection and characterization testing (this has other names like engineering studies, prototype testing, etc…). Those activities essentially hold up the final design verification testing. For example, analysis is required to determine the worst-case configuration of the product and inspection is utilized to confirm that the design meets the requirements of applicable standards. Lastly, characterization testing is done early to potentially be an input into the design requirements, and gain insight on how the device is performing. https://medicaldevice.how/observations/help-do-i-need-to-complete-design-verification-before-starting-design-validation monthly 0.5 2023-08-21 https://images.squarespace-cdn.com/content/v1/648e5927ea6935509064afa6/44cc06dd-3740-4b74-ae13-444a4ff57225/HELP.jpg Observations - Help! Do I need to complete design verification before starting design validation? - We’ll, it depends. But let’s get into what it depends upon… https://medicaldevice.how/observations/conjoined-squares-of-decisions monthly 0.5 2023-08-28 https://images.squarespace-cdn.com/content/v1/648e5927ea6935509064afa6/525b5f59-7eac-4fd9-9bee-020f72080f47/image-asset.jpg Observations - Conjoined Squares of Decisions - Make it stand out Whatever it is, the way you tell your story online can make all the difference. https://images.squarespace-cdn.com/content/v1/648e5927ea6935509064afa6/eb1982ab-8afd-4312-addc-e89bc4781543/Conjoined+squares+small.png Observations - Conjoined Squares of Decisions - Square: Low Compliance Risk, Low Business Risk High Compliance Risk, Low Business Risk Low Compliance Risk, High Business Risk High Compliance Risk, High Business Risk https://medicaldevice.how/observations/vix3h0cvt2gxwqn1p6wpasojmtme7k monthly 0.5 2023-07-10 https://medicaldevice.how/observations/13485-ways-to-leave-your-lover monthly 0.5 2023-06-20 https://medicaldevice.how/observations/category/13485 monthly 0.5 https://medicaldevice.how/home daily 1.0 2024-06-24 https://images.squarespace-cdn.com/content/v1/633b294d82b30f28aa639469/ec6f9f0f-a669-41c8-bff6-732f71e883c5/Arc.png https://images.squarespace-cdn.com/content/v1/633b294d82b30f28aa639469/ec6f9f0f-a669-41c8-bff6-732f71e883c5/Arc.png https://images.squarespace-cdn.com/content/v1/648e5927ea6935509064afa6/60420efe-c4fd-491f-acb8-352b91c819e9/Golden+Ratio.png https://medicaldevice.how/career-coaching daily 0.75 2024-06-20 https://images.squarespace-cdn.com/content/v1/633b294d82b30f28aa639469/ec6f9f0f-a669-41c8-bff6-732f71e883c5/Arc.png https://images.squarespace-cdn.com/content/v1/648e5927ea6935509064afa6/1695219973445-2VWQ9T4V2G7U1VBV3MMI/image-asset.jpeg https://medicaldevice.how/images daily 0.75 2026-01-06 https://medicaldevice.how/device-intelligence daily 0.75 2026-04-01 https://medicaldevice.how/device-intelligence/project-four-l3zw3-dk9py-xcmem-e2jgd-yfph7 monthly 0.5 2025-09-02 https://images.squarespace-cdn.com/content/v1/5ec321c2af33de48734cc929/1755893744462-UP0JG6EZDZMJ14UV0WXL/imgg-demo-ENjOSIkh.png https://images.squarespace-cdn.com/content/v1/5ec321c2af33de48734cc929/1755893744456-HUG1A2SZXM9F5TN3ASCW/imgg-demo-EzhmSujY.png https://medicaldevice.how/device-intelligence/project-three-sng7y-jkgxx-kmlk5-64gk3-b68cg monthly 0.5 2025-09-02 https://images.squarespace-cdn.com/content/v1/5ec321c2af33de48734cc929/1755893744456-HUG1A2SZXM9F5TN3ASCW/imgg-demo-EzhmSujY.png Device Intelligence - The Brightline Project https://images.squarespace-cdn.com/content/v1/5ec321c2af33de48734cc929/1755893744474-69X94EHJPE32L69KGLZQ/imgg-demo-N1g6iaei.png Device Intelligence - The Brightline Project https://images.squarespace-cdn.com/content/v1/5ec321c2af33de48734cc929/1755893744462-UP0JG6EZDZMJ14UV0WXL/imgg-demo-ENjOSIkh.png Device Intelligence - The Brightline Project https://images.squarespace-cdn.com/content/v1/5ec321c2af33de48734cc929/1755893744449-YO3VO30LBIUVFJ42HZBJ/imgg-demo-JBF3SmQJ.png Device Intelligence - The Brightline Project https://images.squarespace-cdn.com/content/v1/5ec321c2af33de48734cc929/1755893744479-ZH3VW35CQKFTHHC50QUZ/imgg-demo-8xM9d6Tc.png Device Intelligence - The Brightline Project https://images.squarespace-cdn.com/content/v1/5ec321c2af33de48734cc929/1755893744468-T7XN9012Y4QL91IEYRVI/imgg-demo-7J1jaCXI.png Device Intelligence - The Brightline Project https://medicaldevice.how/device-intelligence/project-two-ky966-n329z-nnx53-2grpr-4jfha monthly 0.5 2025-09-02 https://images.squarespace-cdn.com/content/v1/5ec321c2af33de48734cc929/1755893274858-C40HNJV2MQ6XR88Y2TBI/imgg-demo-iGikAGoV.png Device Intelligence - The Echo Project https://images.squarespace-cdn.com/content/v1/5ec321c2af33de48734cc929/1755893274872-MOOC5ZQG1WH3DVP76BAH/imgg-demo-N1g6iaei.png Device Intelligence - The Echo Project https://images.squarespace-cdn.com/content/v1/5ec321c2af33de48734cc929/1755893274844-3M01PK08N2BMSS41FVKN/imgg-demo-JBF3SmQJ.png Device Intelligence - The Echo Project https://images.squarespace-cdn.com/content/v1/5ec321c2af33de48734cc929/1755893274878-NM68B7A2BKVVTMJLDJDY/imgg-demo-8xM9d6Tc.png Device Intelligence - The Echo Project https://images.squarespace-cdn.com/content/v1/5ec321c2af33de48734cc929/1755893274865-YJED7MWUUCA4AIQ7AYEX/imgg-demo-7J1jaCXI.png Device Intelligence - The Echo Project https://images.squarespace-cdn.com/content/v1/5ec321c2af33de48734cc929/1755893274851-ZT6G62Y16HT52UMIIM3F/imgg-demo-a3mKUH6c.png Device Intelligence - The Echo Project https://medicaldevice.how/device-intelligence/project-one-f5w4d-z9nem-s3jda-x8w73-kts33 monthly 0.5 2025-09-02 https://images.squarespace-cdn.com/content/v1/5ec321c2af33de48734cc929/1755893069267-1GSFBZR1TD5GPYRR2DS4/imgg-demo-iGikAGoV.png Device Intelligence - The Atlas Project https://images.squarespace-cdn.com/content/v1/5ec321c2af33de48734cc929/1755893069282-VXJ00WE21SHIQ39Q6SW9/imgg-demo-N1g6iaei.png Device Intelligence - The Atlas Project https://images.squarespace-cdn.com/content/v1/5ec321c2af33de48734cc929/1755893069253-YA4QXBCV4J7WTYAX2N86/imgg-demo-JBF3SmQJ.png Device Intelligence - The Atlas Project https://images.squarespace-cdn.com/content/v1/5ec321c2af33de48734cc929/1755893069289-P1UXPAKWHT8I0N1PLL69/imgg-demo-8xM9d6Tc.png Device Intelligence - The Atlas Project https://images.squarespace-cdn.com/content/v1/5ec321c2af33de48734cc929/1755893069275-3J11RWQAY7G300MMP3S0/imgg-demo-7J1jaCXI.png Device Intelligence - The Atlas Project https://images.squarespace-cdn.com/content/v1/5ec321c2af33de48734cc929/1755893069260-TMJVU19AKAS19N344QLD/imgg-demo-a3mKUH6c.png Device Intelligence - The Atlas Project