Healthcare analytics, AI solutions for biological big data, providing an AI platform for the biotech, life sciences, medical and pharmaceutical industries, as well as for related technological approaches, i.e., curation and text analysis with machine learning and other activities related to AI applications to these industries.
Skin Regeneration Therapy One of First Tissue Engineering Products Evaluated by FDA
Reporter: Irina Robu, PhD
Under the provisions of 21st Century Cures Act the U.S. Food and Drug Administration approved StrataGraft regenerative skin tissue as the first product designated as a Regenerative Medicine Advanced Therapy (RMAT) produced by Mallinckrodt Pharmaceuticals. StrataGraft is shaped using unmodified NIKS cells grown under standard operating procedures since the continuous NIKS skin cell line has been thoroughly characterized. StrataGraft products are virus-free, non-tumorigenic, and offer batch-to-batch genetic consistency.
Passed in 2016, the 21st Century act allows FDA to grant accelerated review approval to products which meet an RMAT designation. The RMAT designation includes debates of whether priority review and/or accelerated approval would be suitable based on intermediate endpoints that would be reasonably likely to predict long-term clinical benefit.
The designation includes products
defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or products;
intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition; and
preliminary clinical evidence indicates the drug has the potential to address unmet medical needs for such disease or condition.
According to Steven Romano, M.D., Chief Scientific Officer and Executive Vice President, Mallinckrodt “We are very pleased the FDA has determined StrataGraft meets the criteria for RMAT designation, as this offers the possibility of priority review and/or accelerated approval. The company tissue-based therapy is under evaluation in a Phase 3 trial to assess its efficacy and safety in the advancement of autologous skin regeneration of complex skin defects due to thermal burns that contain intact dermal elements.
21st Century Cures Act reforms to the Food and Drug Administration’s (FDA) regulation of the medical device and pharmaceutical industries – Medical Device Overview: Major FDA Reform Bill Becomes Law
Reporter: Aviva Lev-Ari, PhD, RN
HIGHLIGHTS
The 21st Century Cures Act seeks to expedite development of, and provide priority review for, “breakthrough” devices
The act requires FDA to provide training on the meaning and implementation of the least burdensome review standard, and requires an audit of the results
The act expressly excludes certain categories of medical software from FDA regulation
Major provisions of the act related to medical device regulation found in Subtitle F are listed, below.
President Obama recently signed the 996-page 21st Century Cures Act to implement a variety of reforms to the Food and Drug Administration’s (FDA) regulation of the medical device and pharmaceutical industries.
This alert summarizes the major provisions of the act related to medical device regulation found in Subtitle F.
For more information, please contact the Barnes & Thornburg LLP attorney with whom you work or one of the following attorneys in the firm’s Food, Drug & Device Group: Lynn Tyler at (317) 231-7392 or lynn.tyler@btlaw.com; Beth Davis at (404) 264-4025 or beth.davis@btlaw.com; or Alicia Raines Barr at (317) 231-7398 or alicia.rainesbarr@btlaw.com.
Medtronic Receives FDA Approval for World’s First Hybrid Closed Loop System for People with Type 1 Diabetes
The MiniMed® 670G System Features the Company’s Most Advanced SmartGuard(TM) Algorithm To-Date
DUBLIN – Sept. 28, 2016 – Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it has received U.S. Food and Drug Administration (FDA) approval of its MiniMed® 670G system – the first Hybrid Closed Loop insulin delivery system approved anywhere in the world. Featuring the company’s most advanced algorithm – SmartGuard(TM) HCL – the system is the latest innovation in Medtronic’s phased approach toward developing a fully automated, closed loop system. Medtronic is committed to simplifying and improving diabetes management through the advancement of smart algorithms that achieve greater glucose control with reduced patient input. Through SmartGuard HCL, the system builds on Medtronic’s industry leading algorithms to offer therapy customization so patients and providers can choose from increasing levels of automation that best fit their diabetes management needs.
“With SmartGuard HCL, the ability to automate basal insulin dosing 24 hours a day is a much-anticipated advancement in the diabetes community for the profound impact it may have on managing diabetes – particularly for minimizing glucose variability and maximizing time in the target range,” said Richard M. Bergenstal, M.D., principal investigator of the pivotal study and executive director of the Park Nicollet International Diabetes Center in Minneapolis. “The data from the pivotal trial were compelling and I am confident that this therapy will be well-received by both the clinical and patient community.”
“This significant milestone represents an important step forward in the management of type 1 diabetes and will improve the quality of life for those living with this chronic disease,” said Derek Rapp, president and CEO of JDRF, the leading global organization funding type 1 diabetes research. “We are very encouraged by the speed in which this groundbreaking technology was approved by the FDA, and we are proud of the role JDRF played in achieving this exciting breakthrough. Medtronic and JDRF are committed to ensuring appropriate patient access to this therapy.”
The MiniMed 670G system features the Guardian® Sensor, Medtronic’s newest and most advanced glucose sensor with enhanced accuracy and performance, and a longer 7-day life. The Guardian Sensor, the first and only sensor approved by the FDA to control a hybrid closed loop system, incorporates diagnostic technology that continuously monitors sensor health. Driven by the SmartGuard HCL, the system delivers a variable rate of insulin 24 hours a day based on the personalized needs of the patient, maximizing the time glucose levels are within the target range. It is designed to learn what an individual’s insulin needs are and to take action to minimize both high and low glucose levels. As a result, the system requires minimal input – patients only need to enter mealtime carbohydrates, accept bolus correction recommendations, and periodically calibrate the sensor.
“The FDA approval of the world’s first hybrid closed loop system is a culmination of many years of hard work and close collaboration with the clinical and patient communities to generate the body of evidence needed to advance this technology for those living with diabetes,” said Francine Kaufman, M.D., chief medical officer of the Diabetes Group at Medtronic. “We appreciate the unprecedented speed by which the agency approved our PMA submission to help bring this advanced insulin pump therapy so quickly to U.S. patients living with this challenging disease. We are committed to preparing for commercial launch as quickly as possible while ensuring we provide the most successful rollout of this novel therapy.”
The system is approved for the treatment of people with type 1 diabetes fourteen years of age and older with ongoing studies to expand the indication to additional patient populations. Medtronic will begin commercial release of the MiniMed 670G system in the spring of 2017 with system availability increasing over time. This timeline ensures payer coverage, market and manufacturing readiness, as well as appropriate training of employees, clinicians, educators and patients on the new system. As the company moves toward initial commercial release and subsequently to full production, users of the MiniMed 630G system will be eligible for a Priority Access Program to the MiniMed 670G system as their experience with our newest hardware platform will facilitate an optimal transition. Regulatory approval of the MiniMed 670G is expected outside of the U.S. in the summer of 2017. More details can be found athttp://www.medtronicdiabetes.com/products/priority-access.
MiniMed® 670G System Click the thumbnail above for a larger image.
About the Diabetes Group at Medtronic (www.medtronicdiabetes.com) Medtronic is working together with the global community to change the way people manage diabetes. The company aims to transform diabetes care by expanding access, integrating care and improving outcomes, so people living with diabetes can enjoy greater freedom and better health.
About Medtronic Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world’s largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 88,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
Johnson & Johnson has entered into a definitive agreement to acquire Abiomed in a deal valued at approximately $16.6 billion. The boards of directors of both companies have unanimously approved the transaction.
Johnson & Johnson agreed to an upfront payment of $380 per share. Abiomed shareholders will also receive a non-tradeable contingent value of up to $35 per share if certain milestones are met. For example, if the company receives FDA premarket application approval for the use of its Impella heart pumps to treat ST-elevation myocardial infarction (STEMI) patients without cardiogenic shock by Jan. 1, 2028, each shareholder will receive $7.50 per share. If Impella devices receive a Class 1 recommendation for the treatment of high-risk percutaneous coronary intervention or STEMI patients with or without cardiogenic shock by Dec. 31, 2029, shareholders will receive an additional $10 per share.
“The addition of Abiomed is an important step in the execution of our strategic priorities and our vision for the new Johnson & Johnson focused on pharmaceutical and MedTech,” Johnson & Johnson CEO Joaquin Duato said in a prepared statement. “We have committed to enhancing our position in MedTech by entering high-growth segments. The addition of Abiomed provides a strategic platform to advance breakthrough treatments in cardiovascular disease and helps more patients around the world while driving value for our shareholders.”
Michael R. Minogue, Abiomed’s chairman, president and CEO, said in the same statement. “It will enable us to leverage Johnson & Johnson’s global scale, commercial strength and clinical expertise to accelerate our mission of making heart recovery the global standard of care.”
This acquisition is expected to be finalized by the end of the first quarter of 2023.
Abiomed Impella® Therapy Receives FDA Approval for Cardiogenic Shock After Heart Attack or Heart Surgery
Entire Family of Impella Left Side Heart Pumps FDA Approved To Enable Heart Recovery
DANVERS, Mass., April 07, 2016 (GLOBE NEWSWIRE) — Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough heart support technologies, today announced that it has received U.S. Food and Drug Administration (FDA) Pre-Market Approval (PMA) for its Impella 2.5™, Impella CP®, Impella 5.0™ and Impella LD™ heart pumps to provide treatment of ongoing cardiogenic shock. In this setting, the Impella heart pumps stabilize the patient’s hemodynamics, unload the left ventricle, perfuse the end organs and allow for recovery of the native heart. This latest approval adds to the prior FDA indication of Impella 2.5 for high risk percutaneous coronary intervention (PCI), or Protected PCI™, received in March 2015.
With this approval, these are the first and only percutaneous temporary ventricular support devices that are FDA-approved as safe and effective for the cardiogenic shock indication, as stated below:
The Impella 2.5, Impella CP, Impella 5.0 and Impella LD catheters, in conjunction with the Automated Impella Controller console, are intended for short-term use (<4 days for the Impella 2.5 and Impella CP and <6 days for the Impella 5.0 and Impella LD) and indicated for the treatment of ongoing cardiogenic shock that occurs immediately (<48 hours) following acute myocardial infarction (AMI) or open heart surgery as a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures with or without an intra-aortic balloon pump. The intent of the Impella system therapy is to reduce ventricular work and to provide the circulatory support necessary to allow heart recovery and early assessment of residual myocardial function.
The product labeling also allows for the clinical decision to leave Impella 2.5, Impella CP, Impella 5.0 and Impella LD in place beyond the intended duration of four to six days due to unforeseen circumstances.
The Impella products offer the unique ability to both stabilize the patient’s hemodynamics before or during a PCI procedure and unload the heart, which allows the muscle to rest and potentially recover its native function. Heart recovery is the ideal option for a patient’s quality of life and as documented in several clinical papers, has the ability to save costs for the healthcare system1,2,3.
Cardiogenic shock is a life-threatening condition in which the heart is suddenly unable to pump enough blood and oxygen to support the body’s vital organs. For this approval, it typically occurs during or after a heart attack or acute myocardial infarction (AMI) or cardiopulmonary bypass surgery as a result of a weakened or damaged heart muscle. Despite advancements in medical technology, critical care guidelines and interventional techniques, AMI cardiogenic shock and post-cardiotomy cardiogenic shock (PCCS) carry a high mortality risk and has shown an incremental but consistent increase in occurrence in recent years in the United States.
“This approval sets a new standard for the entire cardiovascular community as clinicians continue to seek education and new approaches to effectively treat severely ill cardiac patients with limited options and high mortality risk,” said William O’Neill, M.D., medical director of the Center for Structural Heart Disease at Henry Ford Hospital. “The Impella heart pumps offer the ability to provide percutaneous hemodynamic stability to high-risk patients in need of rapid and effective treatment by unloading the heart, perfusing the end organs and ultimately, allowing for the opportunity to recover native heart function.”
“Abiomed would like to recognize our customers, physicians, nurses, scientists, regulators and employees for their last fifteen years of circulatory support research and clinical applications. This FDA approval marks a significant milestone in the treatment of heart disease. The new medical field of heart muscle recovery has begun,” said Michael R. Minogue, President, Chairman and Chief Executive Officer of Abiomed. “Today, Abiomed only treats around 5% of this AMI cardiogenic shock patient population, which suffers one of the highest mortality risks of any patient in the heart hospital. Tomorrow, Abiomed will be able to educate and directly partner with our customers and establish appropriate protocols to improve the patient outcomes focused on native heart recovery.”
Abiomed Data Supporting FDA Approval
The data submitted to the FDA in support of the PMA included an analysis of 415 patients from the RECOVER 1 study and the U.S. Impella registry (cVAD Registry™), as well as an Impella literature review including 692 patients treated with Impella from 17 clinical studies. A safety analysis reviewed over 24,000 Impella treated patients using the FDA medical device reporting (“MDR”) database, which draws from seven years of U.S. experience with Impella.
In addition, the Company also provided a benchmark analysis of Impella patients in the real-world Impella cVAD registry vs. these same patient groups in the Abiomed AB5000/BVS 5000 Registry. The Abiomed BVS 5000 product was the first ventricular assist device (VAD) ever approved by the FDA in 1991 based on 83 patient PMA study. In 2003, the AB5000 Ventricle received FDA approval and this also included a PMA study with 60 patients.
For this approval, the data source for this benchmark analysis was a registry (“AB/BVS Registry”) that contained 2,152 patients that received the AB5000 and BVS 5000 devices, which were originally approved for heart recovery. The analysis examined by the FDA used 204 patients that received the AB5000 device for the same indications. This analysis demonstrated significantly better outcomes with Impella in these patients.
The Company believes this is the most comprehensive review ever submitted to the FDA for circulatory support in the cardiogenic shock population.
Maini B, Gregory D, Scotti DJ, Buyantseva L. Percutaneous cardiac assist devices compared with surgical hemodynamic support alternatives: Cost-Effectiveness in the Emergent Setting.Catheter Cardiovasc Interv. 2014 May 1;83(6):E183-92.
Cheung A, Danter M, Gregory D. TCT-385 Comparative Economic Outcomes in Cardiogenic Shock Patients Managed with the Minimally Invasive Impella or Extracorporeal Life Support. J Am Coll Cardiol. 2012;60(17_S):. doi:10.1016/j.jacc.2012.08.413.
Gregory D, Scotti DJ, de Lissovoy G, Palacios I, Dixon, Maini B, O’Neill W. A value-based analysis of hemodynamic support strategies for high-risk heart failure patients undergoing a percutaneous coronary intervention. Am Health Drug Benefits. 2013 Mar;6(2):88-99
ABOUT IMPELLA
Impella 2.5 received FDA PMA approval for high risk PCI in March 2015, is supported by clinical guidelines, and is reimbursed by the Centers for Medicare & Medicaid Services (CMS) under ICD-9-CM code 37.68 for multiple indications. The Impella RP® device received Humanitarian Device Exemption (HDE) approval in January 2015. The Impella product portfolio, which is comprised of Impella 2.5, Impella CP, Impella 5.0, Impella LD, and Impella RP, has supported over 35,000 patients in the United States.
The ABIOMED logo, ABIOMED, Impella, Impella CP, and Impella RP are registered trademarks of Abiomed, Inc. in the U.S.A. and certain foreign countries. Impella 2.5, Impella 5.0, Impella LD, and Protected PCI are trademarks of Abiomed, Inc.
ABOUT ABIOMED
Based in Danvers, Massachusetts, Abiomed, Inc. is a leading provider of medical devices that provide circulatory support. Our products are designed to enable the heart to rest by improving blood flow and/or performing the pumping of the heart. For additional information, please visit: www.abiomed.com
FORWARD-LOOKING STATEMENTS
This release includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “plan,” “could,” “may,” “will,” “believe,” “estimate,” “forecast,” “goal,” “project,” and other words of similar meaning. These forward-looking statements address various matters including, the Company’s guidance for fiscal 2016 revenue. Each forward-looking statement contained in this press release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, uncertainties associated with development, testing and related regulatory approvals, including the potential for future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological change, government regulation, litigation matters, future capital needs and uncertainty of additional financing, and the risks identified under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended March 31, 2015 and the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2015, each filed with the Securities and Exchange Commission, as well as other information the Company files with the SEC. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this release and the Company undertakes no obligation to update or revise any of these statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.
For more information, please contact: Aimee Genzler Director, Corporate Communications 978-646-1553 agenzler@abiomed.com Ingrid Goldberg Director, Investor Relations igoldberg@abiomed.com
Article ID #203: Problem of Science Doctorate Programs. Published on 4/12/2016
WordCloud Image Produced by Adam Tubman
The Problem in Biomedical Education
Henry Bourne (UCSF)
Dr. Henry Bourne has trained graduate students and postdocs at UCSF for over 40 years. In his iBiology talk, he discusses the imminent need for change in graduate education. With time to degrees getting longer, the biomedical community needs to create experimental graduate programs to find more effective and low cost ways to train future scientists and run successful laboratories. If we don’t start looking for solutions, the future of the biomedical enterprise will grow increasingly unstable.
Henry Bourne is Professor Emeritus and former chair of the Department of Pharmacology at the University of California – San Francisco. His research focused on trimeric G-proteins, G-protein coupled receptors, and the cellular signals responsible for polarity and direction-finding of human leukocytes. He is the author of several books including a memoir, Ambition and Delight, and has written extensively about graduate training and biomedical workforce issues. Now Dr. Bourne’s research focuses on the organization and founding of US biomedical research in the early 20th century.
Nursing School Doesn’t Have to be so DAMN Hard! CPP=MAP-ICP Normal range should be greater than 70 mmHg How to calculate, regulate, and manage CPP or cerebra…
Human Factor Engineering: New Regulations Impact Drug Delivery, Device Design And Human Interaction
Curator: Stephen J. Williams, Ph.D.
Institute of Medicine report brought medical errors to the forefront of healthcare and the American public (Kohn, Corrigan, & Donaldson, 1999) and estimated that between
44,000 and 98,000 Americans die each year as a result of medical errors
An obstetric nurse connects a bag of pain medication intended for an epidural catheter to the mother’s intravenous (IV) line, resulting in a fatal cardiac arrest. Newborns in a neonatal intensive care unit are given full-dose heparin instead of low-dose flushes, leading to threedeaths from intracranial bleeding. An elderly man experiences cardiac arrest while hospitalized, but when the code blue team arrives, they are unable to administer a potentially life-saving shock because the defibrillator pads and the defibrillator itself cannot be physically connected.
Human factors engineering is the discipline that attempts to identify and address these issues. It is the discipline that takes into account human strengths and limitations in the design of interactive systems that involve people, tools and technology, and work environments to ensure safety, effectiveness, and ease of use.
Several drug delivery devices are on a draft list of med tech that will be subject to a final guidance calling for the application of human factors and usability engineering to medical devices. The guidance calls called for validation testing of devices, to be collected through interviews, observation, knowledge testing, and in some cases, usability testing of a device under actual conditions of use. The drug delivery devices on the list include anesthesia machines, autoinjectors, dialysis systems, infusion pumps (including implanted ones), hemodialysis systems, insulin pumps and negative pressure wound therapy devices intended for home use. Studieshave consistently shown that patients struggle to properly use drug delivery devices such as autoinjectors, which are becoming increasingly prevalent due to the rise of self-administered injectable biologics. The trend toward home healthcare is another driver of usability issues on the patient side, while professionals sometimes struggle with unclear interfaces or instructions for use.
Human–factors engineering, also called ergonomics, or human engineering, science dealing with the application of information on physical and psychological characteristics to the design of devices and systems for human use. ( for more detail see source@ Britannica.com)
The term human-factors engineering is used to designate equally a body of knowledge, a process, and a profession. As a body of knowledge, human-factors engineering is a collection of data and principles about human characteristics, capabilities, and limitations in relation to machines, jobs, and environments. As a process, it refers to the design of machines, machine systems, work methods, and environments to take into account the safety, comfort, and productiveness of human users and operators. As a profession, human-factors engineering includes a range of scientists and engineers from several disciplines that are concerned with individuals and small groups at work.
The terms human-factors engineering and human engineering are used interchangeably on the North American continent. In Europe, Japan, and most of the rest of the world the prevalent term is ergonomics, a word made up of the Greek words, ergon, meaning “work,” and nomos, meaning “law.” Despite minor differences in emphasis, the terms human-factors engineering and ergonomics may be considered synonymous. Human factors and human engineering were used in the 1920s and ’30s to refer to problems of human relations in industry, an older connotation that has gradually dropped out of use. Some small specialized groups prefer such labels as bioastronautics, biodynamics, bioengineering, and manned-systems technology; these represent special emphases whose differences are much smaller than the similarities in their aims and goals.
The data and principles of human-factors engineering are concerned with human performance, behaviour, and training in man-machine systems; the design and development of man-machine systems; and systems-related biological or medical research. Because of its broad scope, human-factors engineering draws upon parts of such social or physiological sciences as anatomy, anthropometry, applied physiology, environmental medicine, psychology, sociology, and toxicology, as well as parts of engineering, industrial design, and operations research.
Two general premises characterize the approach of the human-factors engineer in practical design work. The first is that the engineer must solve the problems of integrating humans into machine systems by rigorous scientific methods and not rely on logic, intuition, or common sense. In the past the typical engineer tended either to ignore the complex and unpredictable nature of human behaviour or to deal with it summarily with educated guesses. Human-factors engineers have tried to show that with appropriate techniques it is possible to identify man-machine mismatches and that it is usually possible to find workable solutions to these mismatches through the use of methods developed in the behavioral sciences.
The second important premise of the human-factors approach is that, typically, design decisions cannot be made without a great deal of trial and error. There are only a few thousand human-factors engineers out of the thousands of thousands of engineers in the world who are designing novel machines, machine systems, and environments much faster than behavioral scientists can accumulate data on how humans will respond to them. More problems, therefore, are created than there are ready answers for them, and the human-factors specialist is almost invariably forced to resort to trying things out with various degrees of rigour to find solutions. Thus, while human-factors engineering aims at substituting scientific method for guesswork, its specific techniques are usually empirical rather than theoretical.
The Man-Machine Model: Human-factors engineers regard humans as an element in systems
The simple man-machine model provides a convenient way for organizing some of the major concerns of human engineering: the selection and design of machine displays and controls; the layout and design of workplaces; design for maintainability; and the work environment.
Components of the Man-Machine Model
human operator first has to sense what is referred to as a machine display, a signal that tells him something about the condition or the functioning of the machine
Having sensed the display, the operator interprets it, perhaps performs some computation, and reaches a decision. In so doing, the worker may use a number of human abilities, Psychologists commonly refer to these activities as higher mental functions; human-factors engineers generally refer to them as information processing.
Having reached a decision, the human operator normally takes some action. This action is usually exercised on some kind of a control—a pushbutton, lever, crank, pedal, switch, or handle.
action upon one or more of these controls exerts an influence on the machine and on its output, which in turn changes the display, so that the cycle is continuously repeated
Driving an automobile is a familiar example of a simple man-machine system. In driving, the operator receives inputs from outside the vehicle (sounds and visual cues from traffic, obstructions, and signals) and from displays inside the vehicle (such as the speedometer, fuel indicator, and temperature gauge). The driver continually evaluates this information, decides on courses of action, and translates those decisions into actions upon the vehicle’s controls—principally the accelerator, steering wheel, and brake. Finally, the driver is influenced by such environmental factors as noise, fumes, and temperature.
How BD Uses Human Factors to Design Drug-Delivery Systems
Posted in Design Services by Jamie Hartford on August 30, 2013
Human factors testing has been vital to the success of the company’s BD Physioject Disposable Autoinjector.
The BD Physioject Disposable Autoinjector offers users a 360° view of the drug injection process and features a one-touch injection button.
Improving the administration and compliance of drug delivery is a common lifecycle strategy employed to enhance short- and long-term product adoption in the biotechnology and pharmaceutical industries. With increased competition in the industry and heightened regulatory requirements for end-user safety, significant advances in product improvements have been achieved in the injectable market, for both healthcare professionals and patients. Injection devices that facilitate preparation, ease administration, and ensure safety are increasingly prevalent in the marketplace.
Traditionally, human factors engineering addresses individualized aspects of development for each self-injection device, including the following:
Task analysis and design.
Device evaluation and usability.
Patient acceptance, compliance, and concurrence.
Anticipated training and education requirements.
System resilience and failure.
To achieve this, human factors scientists and engineers study the disease, patient, and desired outcome across multiple domains, including cognitive and organizational psychology, industrial and systems engineering, human performance, and economic theory—including formative usability testing that starts with the exploratory stage of the device and continues through all stages of conceptual design. Validation testing performed with real users is conducted as the final stage of the process.
To design the BD Physioject Disposable Autoinjector System , BD conducted multiple human factors studies and clinical studies to assess all aspects of performance safety, efficiency, patient acceptance, and ease of use, including pain perception compared with prefilled syringes.5 The studies provided essential insights regarding the overall user-product interface and highlighted that patients had a strong and positive response to both the product design and the user experience.
As a result of human factors testing, the BD Physioject Disposable Autoinjector System provides multiple features designed to aide in patient safety and ease of use, allowing the patient to control the start of the injection once the autoinjector is placed on the skin and the cap is removed. Specific design features included in the BD Physioject Disposable Autoinjector System include the following:
Ergonomic design that is easy to handle and use, especially in patients with limited dexterity.
A 360° view of the drug and injection process, allowing the patient to confirm full dose delivery.
A simple, one-touch injection button for activation.
A hidden needle before and during injection to reduce needle-stick anxiety.
A protected needle before and after injection to reduce the risk of needle stick injury.
YouTube VIDEO: Integrating Human Factors Engineering (HFE) into Drug Delivery
Notes:
The following is a slideshare presentation on Parental Drug Delivery Issues in the Future
The Dangers of Medical Devices
The FDA receives on average 100,000 medical device incident reports per year, and more than a third involve user error.
In an FDA recall study, 44% of medical device recalls are due to design problems, and user error is often linked to the poor design of a product.
Drug developers need to take safe drug dosage into consideration, and this consideration requires the application of thorough processes for Risk Management and Human Factors Engineering (HFE).
Although unintended, medical devices can sometimes harm patients or the people administering the healthcare. The potential harm arises from two main sources:
failure of the device and
actions of the user or user-related errors. A number of factors can lead to these user-induced errors, including medical devices are often used under stressful conditions and users may think differently than the device designer.
Instead of blaming test participants for use errors, look more carefully at your device’s design.
Great posting on reasons typical design flaws creep up in medical devices and where a company should integrate fixes in product design. Posted in Design Services by Jamie Hartford on July 8, 2013
YouTube VIDEO: Integrating Human Factors Engineering into Medical Devices
Notes:
Regulatory Considerations
Unlike other medication dosage forms, combination products require user interaction
Combination products are unique in that their safety profile and product efficacy depends on user interaction
Human Factors Review: FDA Outlines Highest Priority Devices
The US Food and Drug Administration (FDA) on Tuesday released new draft guidance to inform medical device manufacturers which device types should have human factors data included in premarket submissions, as well final guidance from 2011 on applying human factors and usability engineering to medical devices.
FDA said it believes these device types have “clear potential for serious harm resulting from use error and that review of human factors data in premarket submissions will help FDA evaluate the safety and effectiveness and substantial equivalence of these devices.”
Manufacturers should provide FDA with a report that summarizes the human factors or usability engineering processes they have followed, including any preliminary analyses and evaluations and human factors validation testing, results and conclusions, FDA says.
The list was based on knowledge obtained through Medical Device Reporting (MDRs) and recall data, and includes:
Auto injectors (when CDRH is lead Center; e.g., KZE, KZH, NSC )
Automated external defibrillators
Duodenoscopes (on the reprocessing; e.g., FDT) with elevator channels
Gastroenterology-urology endoscopic ultrasound systems (on the reprocessing; e.g., ODG) with elevator channels
Hemodialysis and peritoneal dialysis systems (e.g., FKP, FKT, FKX, KDI, KPF ODX, ONW)
Implanted infusion pumps (e.g., LKK, MDY)
Infusion pumps (e.g., FRN, LZH, MEA, MRZ )
Insulin delivery systems (e.g., LZG, OPP)
Negative-pressure wound therapy (e.g., OKO, OMP) intended for home use
Robotic catheter manipulation systems (e.g., DXX)
Robotic surgery devices (e.g., NAY)
Ventilators (e.g., CBK, NOU, ONZ)
Ventricular assist devices (e.g., DSQ, PCK)
Final Guidance
In addition to the draft list, FDA finalized guidance from 2011 on applying human factors and usability engineering to medical devices.
The agency said it received over 600 comments on the draft guidance, which deals mostly with design and user interface, “which were generally supportive of the draft guidance document, but requested clarification in a number of areas. The most frequent types of comments requested revisions to the language or structure of the document, or clarification on risk mitigation and human factors testing methods, user populations for testing, training of test participants, determining the appropriate sample size in human factors testing, reporting of testing results in premarket submissions, and collecting human factors data as part of a clinical study.”
In response to these comments, FDA said it revised the guidance, which supersedes guidance from 2000 entitled “Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management,” to clarify “the points identified and restructured the information for better readability and comprehension.”
Details
The goal of the guidance, according to FDA, is to ensure that the device user interface has been designed such that use errors that occur during use of the device that could cause harm or degrade medical treatment are either eliminated or reduced to the extent possible.
FDA said the most effective strategies to employ during device design to reduce or eliminate use-related hazards involve modifications to the device user interface, which should be logical and intuitive.
In its conclusion, FDA also outlined the ways that device manufacturers were able to save money through the use of human factors engineering (HFE) and usability engineering (UE).
GAINESVILLE, Fla. — Applied Genetic Technologies Corporation (AGTC), a biotechnology company researching adeno-associated virus (AAV)-based gene therapies for the treatment of rare diseases, is expanding into the rapidly growing north central Florida biotech corridor.
The company, which was founded on technology developed at the University of Florida, is opening a combined use corporate office and laboratory facility in Alachua, Fla. AGTC’s portion of the new multi-tenant facility is expected to accommodate up to about 75 people and consists of approximately 20,000 square feet including state-of-the-art lab and office space as well as space for future expansion, the company announced this morning.
“The new facility will help us to accelerate our research and development efforts for novel AAV-based gene therapies for rare diseases and house critical corporate functions including finance, quality assurance and project management, while providing ample space as we continue to bring new talent to our team,” Sue Washer, president and chief executive officer of AGTC said in a statement.
AGTC’s lead product candidates focus on X-linked retinoschisis, achromatopsia and X-linked retinitis pigmentosa, which are inherited orphan diseases of the eye, caused by mutations in single genes that significantly affect visual function and currently lack effective medical treatments. Retinoschisis is a condition in which an area of the retina has separated into two layers. The part of the retina that is affected by retinoschisis will have suboptimal vision, according to the University of Michigan’s Kellogg Eye Center. Achromatopsia is a condition of the eye that is characterized by an absence (partial or total) of color vision. People with the complete form of achromatopsia are unable to perceive any colors and can only see black, white and shades of gray.
AGTC is also pursuing pre-clinical development of treatments for wet AMD using the company’s experience in ophthalmology to expand into disease indications with larger markets.
In August, AGTC’s research was bolstered by a $1 billion deal withBiogen (BIIB) to support the company’s gene-based therapies. As part of the deal, Biogen holds a license to AGTC’s XLRS and XLRP programs and an additional three licenses, BioSpace (DHX) reported in August.
David Day, assistant vice president & director of the Office of Technology Licensing at the University of Florida, touted the growth of the biotech sector in north central Florida.
“AGTC’s progress in developing novel treatments for rare diseases without adequate therapeutic options is a particularly good model for the entire biotechnology sector,” Day said in a statement.
Medtronic recalled its dual chamber pacemakers (Adapta, Versa, Sensia, Relia, Attesta, Sphera, and Vitatron A, E, G, and Q series) due to a possible software error that can stop pacing.
Steps to minimise replacement of cardiac implantable electronic devices
Much can and should be done to maximise the longevity of existing devices
Imagine spending £3000 on a new watch with a battery embedded in the mechanism that cannot be replaced or recharged. Although the battery is predicted to last 10 years or more, after six years you discover that it is running flat and you’re advised to replace the watch immediately, even though it may keep good time for a year or more.
This mirrors the dilemma faced by all patients with cardiac implantable electronic devices such as pacemakers and implantable cardioverter defibrillators (ICD). But for them the stakes are much higher as replacing the battery exposes them to a risk of serious complications, including life threatening infection.
Over half of all patients with pacemakers require a replacement procedure because the batteries have reached their expected life.1 Some 11-16% need multiple replacements.2 The situation is worse for recipients of an ICD, since the risks of infection at the time of implant and device replacement are higher than with pacemakers and the batteries have a shorter life.3
What is the risk of infection?
With no standard definition or reporting system, infection rates vary widely, and the commonly quoted risk of 0.5% for new implants and 1-5% for replacement procedures may be wrong.4 Infection, even if it seems superficial, usually necessitates extraction of the entire system. Simply treating the infection with antibiotics results in a much poorer outcome.5 The increased risk of infection associated with battery replacement makes it critical that we prolong the life of implantable devices as much as possible. The health economic grounds for minimising the number of replacements are also compelling.6
The current financial model discourages the development of longer life devices. Increasing longevity would reduce profits for manufacturers, implanting physicians, and their institutions. With financial disincentives for both manufacturers and purchasers it is hardly surprising that longer life devices do not exist.
Patients are often assumed to prefer smaller devices, but when offered the choice, over 90% would opt for a larger, longer lasting device over a smaller one that would require more frequent operations to change the battery.7 And given the risks that patients are exposed to during replacement, there is an urgent need to improve longevity by developing longer life batteries and using those in current devices more prudently.
What can be done now?
At present the main drive to improving longevity of pacemakers has been through programming changes aimed at reducing the amount of pacing8 or minimising the drain of current during pacing—for example, using high impedance leads. But devices are usually replaced when there is still substantial life left in the battery. For example, when a pacemaker reaches elective replacement indication, it is usually 3-12 months before it will reach its end of life. And even then, the battery may continue to function for several months. Early replacement may be reasonable for high risk patients (such as those who are entirely dependent on their pacemaker). However, we could delay replacement of the pulse generator until the batteries are virtually depleted in lower risk patients. The increasingly popular innovation of home monitoring of devices would facilitate this.
For ICDs the waste is even more striking; devices reach their elective replacement indication when they are still capable of delivering at least six full energy shocks. Each shock reduces the battery longevity by about 30 days. So for patients who receive no shock therapy we are prematurely discarding a device costing up to £25 000 (€33 000; $36 000), which could last at least another six months (current devices last four to seven years on average). We need to review the timing of replacement of implantable devices in all patients.
Kinderman M, Schwaab B, Berg M, Frohlig G. Longevity of dual chamber pacemakers: device and patient related determinants. Pacing Clin Electrophysiol2001;24:810-5.
Kurtz SM, Ochoa JA, Lau E, et al. Implantation trends and patient profiles for pacemakers and implantable cardioverter defibrillators in the United States: 1993-2006. Pacing Clin Electrophysiol2010;33:705-11.
Ramachandra I. Impact of ICD battery longevity on need for device replacements–insights from a Veterans Affairs database. Pacing Clin Electrophysiol2010;33:314-9.
Boriani G, Braunschweig F, Deharo JC, Leyva F, Lubinski A, Lazzaro C. Impact of extending device longevity on the long-term costs of implantable cardioverter defibrillator therapy: a modelling study with a 15-year time horizon.Europace2013;15:1453-62.
Wild DM, Fisher JD, Kim SG, Ferrick KJ, Gross JN, Palma EC. Pacemakers and implantable cardioverter defibrillators: device longevity is more important than smaller size: the patient’s viewpoint. Pacing Clin Electrophysiol2004;27:1526-9.
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