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What we know to be true is root cause analysis (RCA) plays a vital role in the development, manufacturing, and use of medical devices. When we are able to successfully identify and address the underlying causes of failures or errors, using RCA as a tool in your operation helps to improve the safety, reliability, and effectiveness of medical devices. When done correctly, RCA has a significant impact on medical devices by enhancing patient safety, improving design and manufacturing processes, ensuring regulatory compliance, driving product improvement and iteration, mitigating risks, and supporting post-market surveillance efforts. While all of this may sound common sense, what's most important is when RCA is used and done correctly. In this episode of Medtech Snapshot we're joined by Quality Executive Robert Lahaderne to talk Root Cause Analysis (RCA)! Hear how Robert shares his perspective on the impact Root Cause makes to a medical device organization when it is done correct versus when it is done incorrectly and how rushing through FMEAs and hazard analysis creating unnecessary challenges down the road. #rootcauseanalysis #rootcause #medicaldevice #medtech #fmea #hazardanalysis #patientsafety #riskmanagement Get Medical Device Project Support Today 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 Manufacturing Engineering. Learn more about how we can solve your work and project problems today to get you back on track!
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Our LinkedIn poll concluded with some interesting findings and a fair amount of debate. It's estimated 75% of medical device start-ups fail or never make it to the market. Understanding the primary factors which drive these outcomes makes or breaks the difference in a start-ups success. As our respondents weighed in it was clear the primary factor which gets in the way of a start-up meeting up with success is in fact its own people. 48% of voters identified this as the primary reason for failure, many of which current have or have had in the past direct experience operating in a management role within start-ups.  The debate ragged on within the poll as some people felt like the product (ie technology) played a larger part in the failure of the company as it's ability to meet a core, and perhaps large, clinical need drove a variety of things including funding, market acceptance, etc. In the end the old saying still rings true - the people we surround ourselves with makes all the difference. Could You Live Fearlessly?2/15/2021  Imagine a life that is totally different from the one we know today. A life where disease and medical disorders are not commonplace. A life where medical afflictions no longer claim lives. It’s a wild thought, we know. It is our utopia! Now think about this utopia in comparison to where we are at today. In 2019, roughly 58 million people died worldwide of which 74% of those deaths (or 43 million people) were the result of noncommunicable diseases like heart disease, stroke and COPD. Imagine what the world would be like if all of those people, our family, friends and colleagues, were still with us. It’s a sobering and certainly emotional thought! But how could we ever achieve such a utopian life existence? Enter Square-1 Engineering and the greater life science industry. As I write this I’ll humbly admit there will inevitably be people who read these statements and think we’re absurd or even delusional for thinking we could ever achieve a life without disease and medical disorders. That said, it would also be prudent to note the purpose of this statement is not about our company, it’s not a sales pitch or a ‘look at what we’re doing’ ploy. It’s about an unrealized opportunity we need your help with as we believe it to be our responsibility to spread the word. Our utopia is indeed possible and it will take all of us, both within the life sciences industry and outside, to work together towards a greater goal. This greater goal, which we’ve defined by Square-1’s company vision, is to achieve a life where ‘medical technology has created a new quality of life empowering people to live fearlessly’. Fearlessly! Our company, like many others, is on a quest to change the world as we know it for the better. How are we going to do this you ask? We’ll achieve this through the advancement of medical technology. Along with many other companies in the life science industry, our focus is to drive change and innovation so that we can continue to inch closure to a state in the future where the way we live as people is better than today. Hopefully without disease and medical disorder. Imagine again if all heath care afflictions were in fact eradicated. The fear many of us live with as a result of the daily health issues we struggle with would also cease to exist. Rather than harboring fear we could spend our time focused on a life filled with optimistic gratefulness. We know our ambitions are colossal, even unimaginable at times yet this is exactly what keeps us going. It’s for this reason we’ve made it our mission to put all our time and energy into advancing medical technologies to improve patient lives today so we can in the future meet our utopia, a world rid of disease and disorder. Could you live fearlessly? Join us on our mission and learn more about some of the great companies who are pushing the boundaries of what’s possible in order to create a better tomorrow. A fearless tomorrow. Our utopia! Medtronic: https://www.medtronic.com/us-en/about/mission.html Edwards Lifesciences: https://www.edwards.com/aboutus/credo# Staar Surgical: https://staar.com/our-mission Square-1 Engineering: http://www.sqr1services.com/vision-mission.html Axonics Modulation Technologies: https://www.axonics.com/about-axonics/who-we-are Diality: https://www.diality.com/diality #fearlessmedtech   Executive Summary: Businesses of all sizes must make strategic decisions to ensure its operations and outputs are optimized, functioning at an effective level to help them grow, increase speed to market, improve ROI, etc. One tool which helps to achieve those metrics, and more, is outsourcing. For the purposes of this paper we’re define ‘outsourcing’ as the act of packaging internal work to be sent outside to an external supplier to facilitate on behalf of the company, now client. There are many positive attributes of outsourcing, yet there are a bevy of deltas which accompany outsourcing if the client doesn’t carefully vet and manage their suppliers. Outsourcing, a valuable strategic business tool, is best experienced where expectations are managed while relationships are allowed to develop overtime. This produces fruitful outcomes for both client and supplier. Author: Travis Smith Contributor(s): Bill Colone, Achilles Young To view the full article click on the download link below: 
 Are you dealing with the rollercoaster highs and lows associated with being a consultant? (aka gig, freelancer, solopreneur, etc.)  About the AuthorTravis Smith is the founder and managing director of Square-1 Engineering, a medical device consulting firm, providing end to end engineering and compliance services. He successfully served the life sciences marketplace in SoCal for over 15 years and has been recognized as a ‘40 Under 40’ honoree by the Greater Irvine Chamber of Commerce as a top leader in Orange County, CA. Categories
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