 In most regulated industries remediation is a cost of doing business. Unfortunately the medical device industry is no different. While remediation won’t hit every business, the fact of the matter is as regulations continue to change and or grow more companies will find themselves in a spot where they are having to change their processes and procedures in order to remain in compliance. In 2021 we wrote about the keys to success, identifying six (6) key areas of focus to help one get through remediation and come out on the other end still in tact and moving forward. As the medical device industry continues to evolve, so must our approach to solving problems we face. As such, understanding the reasons why a device company may experience failure as they go through remediation is key to learning from others mistakes so we don’t repeat them when it comes our turn. WHY THINGS GO SIDEWAYS the top 11 reasons why remediation goes wrong for medical device OEMs:
When looking at this list the biggest take away is the starting point. Once it has been determined remediation is necessary, whether through regulatory intervention or internal, understanding what occurred to get us there in the first place is critical. If we misdiagnose the root cause of the problem within our operations our ability to successfully navigate through the rest of remediation is be hampered significantly. For this reason its wise to spend as much time as possible sorting through the cause and effects of your operation to accurately determine the root cause leading to remediation. Rushing this process will inevitably cause unnecessary challenges on the back end. SOLVING THE PROBLEM The quickest way to overcome a business challenge is to get help from those who are experienced in besting your beast! The team at Square-1 Engineering is comprised of a variety of technical and project management professionals who are subject matter experts in NPD, Quality, Compliance (and yes - remediation) and Manufacturing Engineering. Learn more about how we can solve your compliance problems while besting your remediation beast! 
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EU MDR/ IVDR PROPOSED PUSH1/25/2023  DID YOU KNOW On January 6, 2023 the European Commission, a political and regulatory steering committee consisting of a group of 27 Commissioners, known as 'the College', adopted a proposal to give more time to device OEMs to certify medical devices under EU MDR to mitigate the risk of shortages. The proposal, which now needs to be adopted by the European Parliament, could push out MDR requirements several years. Higher risk devices such as pacemakers and joint implants would have a shorter transition period till December 2027, whereas lower risk devices, such as syringes or reusable surgical instruments wouldn't be until December 2028. WHAT DOES THIS MEAN FOR YOU? Regardless of EU Parliament's decision to potentially extend MDR, device OEMs should consider the following as we hedge through 2023: 1. Strategies for US product approval and or commercialization will continue to increase as OEMs seek alternative pathways to potentially avoid EU MDR compliance. 2. As a result of #1, support to aide OEMs in their go-to-market strategy will intensify causing a shortage for resources, while potentially lengthening the process to get to approvals (supply & demand constraints - notified bodies and consulting firms experience increases in demand causing support shortages). This will be especially true with remediation work. 3. The idea of putting off or slowing MDR related efforts in the interim to re-focus on other activities may provide momentary relief, however it also creates a long-term liability in the business. This liability comes with a variety of future unknowns: regulatory landscape, inflation, cost of resources, CRO and notified body constraints, etc. If you must achieve MDR compliance our recommendation is to get it done and over with in the present. 4. Work associated with achieving MDR compliance can be easily underestimated, especially if you have legacy product where your CE mark was granted pre mid 2000s. The burden to meet MDR requirements may be steep, which is all the more reason to avoid procrastinating said efforts as outlined in #4.  SOLVING THE PROBLEM The quickest way to overcome a business challenge is to get help from those who are experienced in besting your beast! The team at Square-1 Engineering is comprised of a variety of technical and project management professionals who are subject matter experts in the areas of NPD, Quality, Compliance (and yes - remediation) and Manufacturing Engineering. Learn more about how we can solve your compliance problems while besting your EU MDR beast! Learn about Square-1 Engineering's mission and what it means to be fearless! Orange County unemployment rate is 2.9 percent as of July, 2022, as such the talent scarcity is creating gaps between the supply and demand of skilled MedTech professionals. Given these challenges we’re all facing we recently asked the online community the following question:
Which part of your business has the hardest time finding and hiring talent? I suppose EU MDR is to blame for this as the majority of respondents indicated RA QA personnel are the hardest to find. There’s another distinction worth noting that’s adding fuel to the fire. The cost of living (COLA) in Orange County is 54% higher than the national average. As a result, this has a direct impact on the sheer number of people who can afford to live in OC, which decreases the size of the employment pool. Add into the mix issues the overall State is experiencing like a 250k net migration loss along with relatively new industry regulations like EU MDR and you have a perfect storm where demand is grossly outpacing supply. Pete Nalbach, GM of SeaSpine in Irvine, CA shared some interesting insights about the present hiring, employment and talent situation: Pete indicated and I’m paraphrasing a bit “…candidates have options. This means they only accept jobs they really want which in turn gets a higher engaged employee for the company in the long term” What’s your solution to the talent shortage? The results are in from our Square-1 Engineering online poll...."What are the top 2 most frequent reasons warning letters/ citations are issued by the FDA?"
Listen in as our managing director, Travis Smith, covers the results of he poll while sharing commentary from the medical device community. Need help dealing with an audit or warning letter? Learn more about our support capabilities at https://lnkd.in/g7NX_8pw #poll #fda #capa #complaints #regulatory #quality #medtech #square1engineering  Our client, a Class III medical device company, was issued an FDA 483 warning letter due to product field failures and QMS issues posing life threatening risks to implant patients. The Square-1 Engineering subject matter experts (SME team) were brought in to identify & correct systems and process issues across six (6) functional departments and two (2) manufacturing locations domestically. As you can guess our clients’ situation was dire due to several implant failures in the field. We invite you to download the case study below to learn how we saved our client $4.5M while successfully concluding the remediation project. 
Getting Ahead of Compliance Work5/17/2022 EU MDR got you down? Is the mountain of compliance work you have in front of you taking away from other projects?
It's time you got some help! Learn more HERE #compliance #consulting #qualityengineering #regulatoryaffairs Want to get through your remediation project successfully? Doing these two things helps dramatically increase your chances of success. #fearlessmedtech #remediation #fda #medicaldevice #medtech #quality #compliance #QMS About the AuthorTravis Smith is the founder and managing director of Square-1 Engineering, a life sciences consulting firm, providing end to end technical project services to companies which design, develop and or manufacture products in Southern California. He successfully served the life sciences marketplace in SoCal for over 15 years specializing in engineering services, consulting, project outsourcing and leadership development. In 2019 he was recognized as a ‘40 Under 40’ honoree by the Greater Irvine Chamber of Commerce as a top leader in Orange County, CA. Archives
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