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Medical Devices

What are the best Methods for Root-Cause Analysis ?




Performing an investigation in case any type of deviation occurs is of fundamental importance nowadays and root-cause analysis methodologies play a fundamental role within the regulated environment.

Events and Casual Analysis

The Events and Casual analysis is a tool that describes the necessary events and causal factors for accident occurrence in a logical sequence. It is a classic method for root-cause analysis. From practical point of view, it is a chart which has the timeline as heart of the chart. Specific symbols are used to define the type of interconnections between the different events that led to the issue.

Other symbols that can be used to describe interconnections are these following:

This method is based on some principles, mainly the following:

  • All the negative events are caused to happen.
  • Undesirable events are caused by additional causes.
  • The root cause(s) can be determined by analyzing the cause-effect relationships around a primary effect.

Let me assume that the deviation we want to investigate is a non-conformity due to a missing records for a specific training on a defined QMS procedure.

Change Analysis : Kepner-Tregoe Method for root-cause determination

Another tool for root-cause analysis is the so-called Change Analysis, which Kepner-Tregoe method. In fact this methodology was developed by Benjamin Tregoe and Charles Kepner, whom performed extensive research on rational decision making and problem solving.

The Kepner Tregoe method is a problem analysis model in which the “problem” is disconnected from the “decision”. This method is basically based on four different steps:

  • Situational Analysis
  • Problem Analysis
  • Decision Analysis
  • Potential Problem Analysis

Situational Analysis

The situational analysis is the first step and the goal is to answer the question “What is happening?”. Specifically, this phase involves the identification of concerns, setting priorities and planning activities for the next steps. The main focus of the situational analysis is to set priorities and avoids to work on the wrong issue.

Problem Analysis

Problem analysis helps to answer the question “What Went Wrong?”. The problem analysis helps sharpen the focus on the right data and helps avoid the tendency to arrive at the wrong cause because irrelevant data or facts have been taken in considerations. The problem analysis includes the following:

Decision Analysis

The output of the problem analysis plus all the possible alternatives that could be identified to resolve the problems and the related risk assessment for each of the options identified are the key factors of a decision analysis. In any case the risk assessment is the core of this step and all the possible solutions shall be evaluated from risk point of view.

Potential Problem Analysis

Before rushing into action making your decision take hold throughout the organization, think about the various issues that may come up and how they will be dealt with. This is a preventive step to evaluate all the possible issues that might come up after all the corrective actions have been implemented.

Fault Tree Analysis: widely used tool for root-cause analysis

Fault tree analysis was initially developed for the aerospace sector and extensively used by the Boeing company before becoming a widely used method for root-cause analysis.

Fault tree diagrams (or negative analytical trees) are logic block diagrams that display the state of a system (top event) in terms of the states of its components (basic events).

From practical point of view, the fault trees are built using gates and blocks. Usually the most common gates are AND and OR. Then, there is a whole set of symbols that could either Gate Symbols or Events Symbols.

5 Whys

The 5 Whys is a widely used technique which is part of the Analyze phase of the Six Sigma DMAIC (Define, Measure, Analyze, Improve, Control) methodology. It is a great Six Sigma tool that does not involve any use of statistical tools. By repeatedly asking the question “Why” (five is a good rule of thumb), you can peel away the layers of symptoms which can lead to the root cause of a problem. Very often the ostensible reason for a problem will lead you to another question.

Failure Mode Effect Analysis

The failure mode effect analysis it is usually a tool used for risk assessment and analysis of risks, either for a process or for a product. However it is a method that it is used as well for root-cause analysis, because it correlates the specific failure with:

  • The effect that the specific failure could impart
  • The cause in relation to the specific failure.

The FMEA is using a preventive approach as it does not need a specific event to be used. Rather, it is a technique that is used to envision all the possible failure modes that could happen within a specific system, and the related potential effect and related root-cause.

Below a general template for a FMEA table


Medical Devices

Elcam Medical Joins Serenno Medical as Strategic Investor and Manufacturer of its Automatic Monitoring of Kidney Function Device




January 20, 2021

Serenno Medical, developer of medical devices for patient monitoring in a hospital setting, announced today that Elcam Medical, a leading producer of medical devices, has invested  $1.5 million in the Company and will also manufacture SentinelTM, Serenno’s urine output and intra-abdominal pressure digital monitoring device for the detection of acute kidney injury (AKI). Elcam Medical join existing investors Alon Medtech and serial medical device inventor, entrepreneur and investor, Dr. Shimon Eckhouse.

The partnership announced today combines Serenno’s unique solution with Elcam’s superior manufacturing experience to deliver high quality products at a competitive price, that will enable the use of Sentinel in a variety of hospital environments.

Continuous kidney function assessment allows the early detection of AKI, a common condition in hospitalized patients that significantly increases risk of mortality during and after hospitalization. Accurate measurement of urine output (UO) is clinically accepted as the best method for monitoring changes in kidney function. However, UO is currently monitored intermittently and manually by ICU staff, therefore acute changes in urine flow are difficult to detect. Thus, kidney injury is often detected relatively late, sometimes after it is impossible to prevent further progression.

Beyond the high death toll associated with kidney failure routinely in the ICU, the recent spread of COVID19 had greatly increased prevalence of, and death from AKI, while vastly increasing the demand and exposure risk on medical professionals and ICUs worldwide.

Sentinel offers a simple and cost-effective solution for the precise, continuous measurement of urine volume and flow rate in real time. The system promotes early detection of kidney injury, while there is still time to intervene and prevent further damage. It aims to automatically and accurately detect small changes in kidney function, allowing remote detection by the medical staff, thus reducing both patient and caregiver risk.

“The investment by Elcam Medical is a strong endorsement, and will allow us to swiftly move toward commercialization of our device,” said Tomer Lark, Serenno’s co-founder and CEO. “Elcam’s world class production capabilities and experience, will enable mass production and increased market access of Sentinel. Our plan is to begin deployment of the devices in several US hospitals towards the end of 2021, in the hope to eventually reduce kidney failure risk for every patient at ICUs.”

Dr. Shimon Eckhouse, Serenno’s Chairman, added, “We are pleased with Elcam’s investment, which marks the first commitment in Serenno’s larger planned current financial round. This partnership with Elcam is an excellent indication of the high degree of innovation and the significance of Serenno’s solution for the advancement of monitoring technologies. We are confident that Elcam’s leadership position in the global point-of-care market will play a critical role in bringing Serenno’s exciting technology to ICUs and patients around the world.”

“Our investment in Serenno and the establishment of a production line for its device is aligned with Elcam’s strategy to cooperate with promising Israeli startups to deliver products with added value for the patient,” said Igal Kohn, Elcam Medical’s CEO. “Elcam Medical has joined Serenno as a board member and we look forward to taking part in the Company’s continued successes.”


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Medical Devices

Best Coronary Stents from the Top Brands




The total coronary stent market comprises bare-metal stents, drug-eluting stents, covered stents, and bifurcated stents. Stents can be defined as small mesh tubes inserted into an artery to prevent it from collapsing and keep it open after an angioplasty surgery (percutaneous coronary intervention, or PCI). Following multiple clinical studies that presented evidence of over-stenting in the U.S market, the value of the overall market has decreased through 2019 and is expected to trend downwards over the coming years, outside of COVID-19-related fluctuations. We have identified the different types of stents and analyzed their benefits and draw-backs:

Top Companies for Coronary Stents by Market Share

1. Boston Scientific – The leading competitor in the coronary stent market was Boston Scientific. Most of the company’s success can be attributed to its strong position in the drug-eluting stents (DES) market, where it held the leading share.

The company currently offers the SYNERGY™ and REBEL™ BMS product line. SYNERGY™ is the first and only FDA-approved DES with abluminal bioabsorbable polymer coating available in the U.S. coronary stent market. REBEL™ is made of a platinum chromium alloy, which is designed to reduce device usage, procedure times, and radiation exposure.

2. Medtronic – Medtronic is the second-leading competitor and maintained a notable position in both the bare-metal stents (BMS) and drug-eluting stents (DES) markets. Through strategic acquisitions and aggressive bundling, Medtronic has increased its share across the interventional cardiology market in recent years.

The company currently offers the Resolute Onyx™ and Resolute Integrity™ DES product lines, as well as the Integrity™ BMS product line. Unlike Boston Scientific and Abbott’s DES devices, which use the everolimus drug, Medtronic’s DES devices use zotarolimus. 

3. Abbott  – Abbott is the third-leading competitor in the coronary stent market. Competition between Abbott and Medtronic has increased within the DES market, resulting in Abbott losing share in recent years.

The company currently offers the XIENCE™ and Multi-Link Vision™ product lines. Multi-Link Vision™ has been the leading BMS in the U.S. since its introduction. It is constructed of a cobalt-chromium alloy that is more radiopaque than stainless steel stents. This alloy is also stronger than stainless steel, which allows stent construction to be much thinner while still retaining its strength.

Coronary Stent Market Trends – By Type

1. Drug-eluting stents (DES) – All stents have a risk that scar tissue will form and narrow the artery again. This scar tissue can block blood flow. However, drug-eluting stents are coated with drugs that prevent scar tissue from growing into the artery. DES are used for an overwhelming majority of stenting procedures, due to the continued publication of clinical studies supporting their safety and efficacy as the gold standard for stenting procedures. With this clinical backing, the DES market sits at over $1 billion.

However, due to increased bundling and competitive pricing, significant ASP depreciation resulted in negative market value growth in 2019. Negative to flat growth is expected to continue for most of the next few years.  

2. Bare-metal stents (BMS) – “Bare-metal stents are mesh-like tubes of thin wire without a coating or covering. Ideally, bare-metal stents will be covered by a new layer of endothelial cells, sealing it into the vessel wall, within a few weeks after implant.” – DAIC.

Bare-metal stents were once the gold-standard choice for stenting procedures but have lost substantial share to drug-eluting stents. It is expected that the segment will continue to contract in market value in the upcoming years with decline rates in the double-digits. 

3. Covered stents – Covered stents are composed of fabric or graft material, such as polytetrafluoroethylene (PTFE), covering a metal stent. These devices are seldom used and are indicated for the treatment of free perforations of native coronary arteries or saphenous vein grafts, which would have been treated with a coronary artery bypass graft (CABG) procedure in the past.

The incidence rate of coronary perforation has historically been low. It is estimated to occur in less than 1% of percutaneous coronary intervention (PCI) procedures performed in the United States.

4. Bifurcated stents – Bifurcated stents represent a small fraction of the total market value. Tryton Medical’s TRYTON® Side Branch was the first dedicated bifurcated stent to be approved in the U.S. market, in March 2017. 

The segment was once expected to experience very rapid growth, due to the strategic alliance between Tryton and Cardinal Health. However, after the first year on the market, unit sales declined sharply, due to a lack of clinical studies for and efficacy of the stents.

Coronary Stent Market Analysis and Forecast

Overall, the U.S. Coronary Stent market size was valued at over $1 billion in 2020. This is not expected to increase by much over the next few years, as the market observed a loss of 22% resulting from the impacts of COVID19. This is expected to bounce back with growth over the next 2 years but then drop off again as stents become less used in surgeries.

Register to receive a free US Market Report Suite for Interventional Cardiology Devices  2020 – 2026 synopsis


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Medical Devices

Occlutech Announces Atrial Flow Regulator Has Received U.S. FDA Breakthrough Device Designation for Heart Failure




January 19, 2021

Occlutech, a Swiss-based privately-held company reported that the FDA has granted the Company a Breakthrough Device designation for its first-in-class, implantable Atrial Flow Regulator (AFR) for heart failure (HF) patients with preserved (HFpEF) or reduced (HFrEF) ejection fraction.

Heart failure (HF) is a serious condition characterized by the heart’s inability to pump an adequate blood supply to the body. Worldwide, HF affects over 30 million people, and the lifetime risk of HF increases with age, with over 50% of hospitalizations of persons aged 65 or older attributable to HF. Heart Failure Symptoms include fatigue, palpitations, and exertional dyspnea. HF may result from disorders of the pericardium, myocardium, endocardium, heart valves, great vessels, or specific metabolic abnormalities. These disorders affect the heart’s structure or function, which results in reduced cardiac output and/or elevated intracardiac pressures at rest or during exercise. When HF is left untreated, symptoms gradually worsen, resulting in increased morbidity, clinically driven hospitalizations, and higher mortality.

The AFR is for use in patients with Heart Failure with Preserved Ejection Fraction (HFpEF) or Reduced Ejection Fraction (HFrEF) and who, despite optimal medical therapy, experience worsening symptoms. The AFR maintains an interatrial shunt with a predetermined diameter allowing for controlled blood flow from the left to the right atrium enabling the left atrium to decompress and lower left atrial pressure. Reduced left atrial pressure has been shown to reduce heart failure symptoms and improve exercise tolerance.

Breakthrough Device Designations aim to accelerate the development, assessment, and approval of new treatments in severe diseases, including a prioritized review all the way through market approval.

“It is an important milestone for us to have received this second breakthrough designation for our AFR device.” says Sabine Bois, CEO Occlutech Group. “After receiving the first Breakthrough Device designation for pulmonary arterial hypertension (PAH) in December 2020, the heart failure (HF) indication addresses a substantial market with rapid growth and only limited options for the treatment for critically ill patients. We are looking forward to developing an important new therapy and working closely with the FDA on both indications.”

Occlutech is one of the leading companies in its field, with several major products including state-of-the-art PFO occluders, ASD occluders among others. Occlutech has sales of congenital and structural heart products in over 80 countries and maintains manufacturing and R&D facilities in Jena, Germany and Istanbul, Turkey. Occlutech has developed many novel products and technologies to improve treatment of patients in these and related areas.

The AFR is not approved in the United States.  Product availability is subject to local regulatory clearance. The AFR is under clinical investigation for use in patients with pulmonary arterial hypertension and use in these patients is limited by applicable national laws.


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StemVacs Cellular Immunotherapy: Positive Animal Data Reported in the 4T1 Breast Cancer Model




January 19, 2021

StemVacs cellular immunotherapy update: Therapeutics Solutions has reported positive animal data in the 4T1 breast cancer model using StemVacs cellular immunotherapy.

In a series of experiments, it was demonstrated that StemVacs™ administration resulted in a) regression of established breast cancer in mice; b) that regression was dependent on natural killer cells, and c) that immunity to breast cancer could be transferred by CD4 T cells to naïve mice.

Previously the Company announced positive safety data in 10 patients treated with StemVacs™1.  Additionally, the Company has filed an Investigational New Drug Application (IND) which is currently pending based on the Company responding to questions posed by the FDA.

“The current data, which conclusively demonstrates the induction of immunological memory to cancer, as well as the natural killer cell as a mechanism of action, will position us to provide the FDA responses to their questions from our submitted IND,” said Dr. James Veltmeyer, Chief Medical Officer of the Company and voted Top Doctor of San Diego. “Given the fact that we have human safety data from outside of the United States, combined with these new mechanistic findings, we are confident in a smooth interaction with the FDA as we get closer to clearing of our IND application.”

“It is known that numerous immunotherapies such as Herceptin® are dependent on the ability of natural killer cells to function properly,” said Famela Ramos, Vice President of Business Development. “The current data provides a scientific basis for us to collaborate with other immuno-oncology companies to identify and leverage possible synergies with other drugs that work via the natural killer pathway of the innate immune system.”

“Therapeutic Solutions International is a ‘science-driven’ organization,” said Timothy Dixon, President and CEO. “Having key opinion leaders such as Drs. Santosh Kesari and Francesco Marincola as advisors allows us to design and execute experiments with the highest level of academic rigor. We believe that the FDA and our scientific and medical peers will appreciate our philosophy.”


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