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Medical Device Failure

Transcript: The need: The product of our case study is a defibrillator, which is a product that attempts to treat a heart that is afflicted with either Cardiac dysrhythmia, Ventricular fibrillation, or pulseless ventricular tachycardia, by dispensing thereputic doses of electricity to regulate the heartbeat. The Solution: A medical device company, Guidant LLC, created an Implantable Cardioverter Defrillator (ICD). This product was designed to be implanted in patients with a high risk for sudden cardiac death. The ICD can detect cardio abnormalities and correct them without need for an external defibrillator. What went wrong? Due to poor wiring, the ICD's would short circuit and arch, causing malfunctions that prevented the device from delivering its electric charge to the patient's heart. Prior to 2002, several failures occured in the Ventak Prizm AVT model. Guidant continued to market the product but ordered immediate and total redesign. They claimed that doing so would eliminate all risk. However, by May 30, 2005, two more deaths and 45 additional failures had occured. Upon further testing, Guidant discovered that its newer Contak Renewal Model had a high risk of failure On June 17, 2005, Guidant issued a recall of numerous defibrillator models 50,000 Americans were suddenly forced to live in fear of the inability to receive assistance in the event of heart failure A massive class-action suit was held against the company, headed by U.S. District Attorney Frank J. Magill The Justice Department forced Guidant to pay $296 million in damages and plea guilty for several misdimeanors for lying to the FDA BUT WAIT... THERES MORE In April 2010 U.S. District Court Judge Donovan Frank (that name just keeps popping up), heeding the requests of many affected by the case, ordered a harsher punishment for Guidant, claiming that the previous settlement did "not adequately address Guidant's history and the criminal conduct at issue". Frank suggested placing Guidant and its parent company, Boston Scientific, on probation, but couldn't say whether their executives would have criminal charges levied against them We say... The FDA needs stricter approval requirements and a more rigid system of testing. Stricter regulation would ensure patient safety and help promote the idea that consumers ought to be able to purchase as safe and reliable a product as possible Guidant: From Defibrillation to Disaster By Ben Robinson and Colin Shaffer

Medical Device

Transcript: The FDA, St. Jude Medical, and the Heart Rhythm Society do not recommend routine removal of any leads due to the risks of explantation surgery. What it was suppose to do Medical device Why was it a failure? An ICD (implantable cardioverter defibrillator) is an electronic device that constantly monitors your heart rhythm. When it detects a very fast, abnormal heart rhythm, it delivers energy to the heart muscle. This causes the heart to beat in a normal rhythm again. Impantable Cardioverter Defibrillator It was the cause a major sudden death and could be countered by delivering a potent shock to the heart that essentially depolarized the entire heart and in a sense reset it. Out of 1,053people 20% were in risk of having a faulty ICD. The FDA have had 28 reports in the last 3 years which wasn't read and they finally made a recall when Joshua ICD was faulty and made the news. "Thanks to the pioneering work of Michel Mirowski and colleagues, patients at high risk for SCD can be treated effectively with an ICD" The ICD monitors the heart rhythm, identifies abnormal heart rhythms and determines the appropriate therapy to return your heartbeat to a normal heart rhythm. how it looks implanted A number of diseases other than dilated cardiomyopathy have been associated with an increased incidence of sudden cardiac death When it came out by Jessica Alba The heartbeat started raising which shocked the heart too much and some wires had cracks on them. Since they tried to improve to become smaller instead they had glitches. What is an ICD? Early models of this products were made in the late 1950's and early 1960's but was not fully developed and altered until the early 1980's. Results of Failure

Medical Device

Transcript: Alex Taylor Employer Brand & Service Development Professional JAM Recruitment November 2019 Let's Disturb the Medical Device Market! Is talent availability hampering your business? We can help. Driving your Recruitment Brand to Premium As a senior leader in your business we want to support you to leverage your employer brand to its full potential, ensuring you have access to the best talent in your market. We realised some time ago that the basic recruitment contingent model no longer offered enough support to our partners. We are partnering progressive organisations to offer true consultancy & support in a vastly changed recruitment market. Understand Employer Value Proposition Discover, understand & promote your employer value proposition ensuring you can target your key audience Employer Brand Understand your current employer value proposition and take your recruitment brand on a journey NUMBER OF ENGAGED PEOPLE FUTURE Assistance to understand where you are, and support to help you move where you want to go. Digital Marketing Global Talent Engagement Recruiters need to be digital marketing experts these days to ensure we know where to look to find the global talent that you need. Nowhere is this more evident than in the medical device world where the customer base and opportunities ensure a truly global market. Advance Promotion & Targeting Haldex Video & Case Study Talent Mapping, Pipelining & Benchmarking Target Candidate Knowing who's out there, where they are & what will engage them Extended Talent Network Skills & behaviours Desires Target Organisations Target Candidate Skills & behaviours Desires Extended Talent Network Extended Talent Network Extended Talent Network Markets can be mapped covertly or talent engaged to fully understand motivations Journey to best practice Support where you need it on journey Tomorrow 2019 Today 2020 A true business partner that can support you on the journey to best practice A flexible partner you can access when needed Meet & define the areas where we can support Work in collaboration to improve your offer A new world & partner Improve Recruitment Experience CONSULTANCY & SERVICES Bespoke flexible consultancy to help you where you need it most. Candidate Experience Candidate Experience What is your current candidate journey? What would you like your client journey to look & feel like? What is the market saying about your journey on Indeed, Glassdoor, Great Place to Work & Vault? Most importantly how do you improve both your journey and your ratings? Job Role & Behaviour Design Best Practice Support We can help to ensure you have the best formats, processes and methodologies across a number of recruitment and HR fields. Standardised Role Descriptions & Templates Clarification of behaviours & person specifications Organisational structure & succession Competitor Analysis Competitor Analysis What are your competitors doing? What are your competitors paying? What are your competitors offering? What are your competitors locations? How are your competitors approaching market? What are your competitors review like? Why aren't they experiencing the same issues you are? What is their recruitment strategy? Unknown answers, wouldn't it help with strategy if these were known facts with data to help you direct your decisions. Accurate Benchmark Data Professional Benchmarking Geographical Mapping including live data on salaries & offerings Competitor Analysis Real time live data on your competition & their offerings Recruitment Process Design Hiring Manager Training DEVELOPING HIRING MANAGERS SKILLS Workshops to help develop your hiring teams giving them skills & understanding they need in today's market Professional interview training Increasing diversity, understanding unconscious bias Behavioural Recruitment & Psychometric testing Succession Planning Contingent Support Specialist industry professionals to support on the hard to fill & long term open roles When you do need assistance to source a hard to fill role be rest assured there is specialist professional help and experience to back you whether that be role or expertise based. Steve Evans Dedicated Specialist Consultant UK & Europe Steve Evans Steve has 20 years’ experience in the recruitment industry in a variety of disciplines – including Manufacturing / Engineering, Design, IT, Legal, Finance, and HR – and across a number of sectors – including Medical Devices, Aerospace & Defence, Automotive and IT. He works with clients such as Quanta Dialysis Technologies, Owen Mumford, L3 and Lockheed Martin. He is very successful filling their job orders, due to his in-depth understanding of technical skills, the current candidate landscape and the open communication he has with his clients. It is following this successful formula that has allowed Steve to excel in recruiting for many different industries and disciplines. “In the current candidate driven landscape it is vital that clients work closely with Professional Recruiters on

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