Funding, Deals & Partnerships: BIOLOGICS & MEDICAL DEVICES; BioMed e-Series; Medicine and Life Sciences Scientific Journal – http://PharmaceuticalIntelligence.com
Patients with type 2 diabetes may soon receive artificial pancreas and a smartphone app assistance
Curator and Reporter: Dr. Premalata Pati, Ph.D., Postdoc
In a brief, randomized crossover investigation, adults with type 2 diabetes and end-stage renal disease who needed dialysis benefited from an artificial pancreas. Tests conducted by the University of Cambridge and Inselspital, University Hospital of Bern, Switzerland, reveal that now the device can help patients safely and effectively monitor their blood sugar levels and reduce the risk of low blood sugar levels.
Diabetes is the most prevalent cause of kidney failure, accounting for just under one-third (30%) of all cases. As the number of people living with type 2 diabetes rises, so does the number of people who require dialysis or a kidney transplant. Kidney failure raises the risk of hypoglycemia and hyperglycemia, or unusually low or high blood sugar levels, which can lead to problems ranging from dizziness to falls and even coma.
Diabetes management in adults with renal failure is difficult for both the patients and the healthcare practitioners. Many components of their therapy, including blood sugar level targets and medications, are poorly understood. Because most oral diabetes drugs are not indicated for these patients, insulin injections are the most often utilized diabetic therapy-yet establishing optimum insulin dose regimes is difficult.
Patients living with type 2 diabetes and kidney failure are a particularly vulnerable group and managing their condition-trying to prevent potentially dangerous highs or lows of blood sugar levels – can be a challenge. There’s a real unmet need for new approaches to help them manage their condition safely and effectively.
The artificial pancreas is a compact, portable medical device that uses digital technology to automate insulin delivery to perform the role of a healthy pancreas in managing blood glucose levels. The system is worn on the outside of the body and consists of three functional components:
a glucose sensor
a computer algorithm for calculating the insulin dose
an insulin pump
The artificial pancreas directed insulin delivery on a Dana Diabecare RS pump using a Dexcom G6 transmitter linked to the Cambridge adaptive model predictive control algorithm, automatically administering faster-acting insulin aspart (Fiasp). The CamDiab CamAPS HX closed-loop app on an unlocked Android phone was used to manage the closed loop system, with a goal glucose of 126 mg/dL. The program calculated an insulin infusion rate based on the data from the G6 sensor every 8 to 12 minutes, which was then wirelessly routed to the insulin pump, with data automatically uploaded to the Diasend/Glooko data management platform.
The Case Study
Between October 2019 and November 2020, the team recruited 26 dialysis patients. Thirteen patients were randomly assigned to get the artificial pancreas first, followed by 13 patients who received normal insulin therapy initially. The researchers compared how long patients spent as outpatients in the target blood sugar range (5.6 to 10.0mmol/L) throughout a 20-day period.
Patients who used the artificial pancreas spent 53 % in the target range on average, compared to 38% who utilized the control treatment. When compared to the control therapy, this translated to approximately 3.5 more hours per day spent in the target range.
The artificial pancreas resulted in reduced mean blood sugar levels (10.1 vs. 11.6 mmol/L). The artificial pancreas cut the amount of time patients spent with potentially dangerously low blood sugar levels, known as ‘hypos.’
The artificial pancreas’ efficacy improved significantly over the research period as the algorithm evolved, and the time spent in the target blood sugar range climbed from 36% on day one to over 60% by the twentieth day. This conclusion emphasizes the need of employing an adaptive algorithm that can adapt to an individual’s fluctuating insulin requirements over time.
When asked if they would recommend the artificial pancreas to others, everyone who responded indicated they would. Nine out of ten (92%) said they spent less time controlling their diabetes with the artificial pancreas than they did during the control period, and a comparable amount (87%) said they were less concerned about their blood sugar levels when using it.
Other advantages of the artificial pancreas mentioned by study participants included fewer finger-prick blood sugar tests, less time spent managing their diabetes, resulting in more personal time and independence, and increased peace of mind and reassurance. One disadvantage was the pain of wearing the insulin pump and carrying the smartphone.
Not only did the artificial pancreas increase the amount of time patients spent within the target range for the blood sugar levels, but it also gave the users peace of mind. They were able to spend less time having to focus on managing their condition and worrying about the blood sugar levels, and more time getting on with their lives.
The team is currently testing the artificial pancreas in outpatient settings in persons with type 2 diabetes who do not require dialysis, as well as in difficult medical scenarios such as perioperative care.
“The artificial pancreas has the potential to become a fundamental part of integrated personalized care for people with complicated medical needs,” said Dr Lia Bally, who co-led the study in Bern.
The authors stated that the study’s shortcomings included a small sample size due to “Brexit-related study funding concerns and the COVID-19 epidemic.”
Boughton concluded:
We would like other clinicians to be aware that automated insulin delivery systems may be a safe and effective treatment option for people with type 2 diabetes and kidney failure in the future.
Retrospect on HistoScanning; an AI routinely used in diagnostic imaging for over a decade
Author and Curator: Dror Nir, PhD
3.2.7 Retrospect on HistoScanning: an AI routinely used in diagnostic imaging for over a decade, Volume 2 (Volume Two: Latest in Genomics Methodologies for Therapeutics: Gene Editing, NGS and BioInformatics, Simulations and the Genome Ontology), Part 2: CRISPR for Gene Editing and DNA Repair
This blog-post is a retrospect on over a decade of doing with HistoScanning; an AI medical-device for imaging-based tissue characterization.
Imaging-based tissue characterization by AI is offering a change in imaging paradigm; enhancing the visual information received when using diagnostic-imaging beyond that which the eye alone can see and at the same time simplifying and increasing the cost-effectiveness of patients clinical pathway.
In the case of HistoScanning, imaging is a combination of 3D-scanning by ultrasound with a real-time application of AI. The HistoScanning AI application comprises fast “patterns recognition” algorithms trained on ultrasound-scans and matched histopathology of cancer patients. It classifies millimetric tissue-volumes by identifying differences in the scattered ultrasound characterizing different mechanical and morphological properties of the different pathologies. A user-friendly interface displays the analysis results on the live ultrasound video image.
Users of AI in diagnostic-imaging of cancer patients expect it to improve their ability to:
Detect clinically significant cancer lesions with high sensitivity and specificity
Accurately position lesions within an organ
Accurately estimate the lesion volume
AND; help determine the pre-clinical level of lesion aggressiveness
The last being achieved through real-time guidance of needle biopsy towards the most suspicious locations.
Unlike most technologies that get obsolete as time passes, AI gets better. Availability of more processing power, better storage technologies, and faster memories translate to an ever-growing capacity of machines to learn. Moreover, the human-perception of AI is transforming fast from disbelief at the time HistoScanning was first launched, into total embracement.
During the last decade, 192 systems were put to use at the hands of urologists, radiologists, and gynecologists. Over 200 peer-reviewed, scientific-posters and white-papers were written by HistoScanning users sharing experiences and thoughts. Most of these papers are about HistoScanning for Prostate (PHS) which was launched as a medical-device in 2007. The real-time guided prostate-biopsy application was added to it in late 2013. I have mentioned several of these papers in blog-posts published in this open-access website, e.g. :
For people who are developing AI applications for health-care, retrospect on HistoScanning represents an excellent opportunity to better plan the life cycle of such products and what it would take to bring it to a level of wide adoption by global health systems.
It would require many pages to cover the lessons HistoScanning could teach each and all of us in detail. I will therefore briefly discuss the highlights:
Regulations: Clearance for HistoScanning by FDA required a PMA and was not achieved until today. The regulatory process in Europe was similar to that of ultrasound but getting harder in recent years.
Safety: During more than a decade and many thousands of procedures, no safety issue was brought up.
Learning curve: Many of the reports on HistoScanning conclude that in order to maximize its potential the sonographer must be experienced and well trained with using the system. Amongst else, it became clear that there is a strong correlation between the clinical added value of using HistoScanning and the quality of the ultrasound scan, which is dependant on the sonographer but also, in many cases, on the patient (e.g. his BMI)
Patient’s attitude: PMS reviews on HistoScanning shows that patients are generally excited about the opportunity of an AI application being involved in their diagnostic process. It seems to increase their confidence in the validity of the results and there was never a case of refusal to be exposed to the analysis. Also, some of the early adopters of PHS (HistoScanning for prostate) charged their patients privately for the service and patients were happy to accept that although there was no reimbursement of such cost by their health insurance.
Adoption by practitioners: To date, PHS did not achieve wide market adoption and users’ feedback on it are mixed, ranging from strong positive recommendation to very negative and dismissive. Close examination of the reasons for such a variety of experiences reveals that most of the reports are relying on small and largely varying samples. The reason for it being the relatively high complexity and cost of clinical trials aiming at measuring its performance. Moreover, without any available standards of assessing AI performance, what is good enough for one user can be totally insufficient for another. Realizing this led to recent efforts by some leading urologists to organize large patients’ registries related to routine-use of PHS.
Studies PHS on statistically reasonable number (611) of patients and concluded that “Our study results support supplementing the standard schematic transrectal ultrasound-guided biopsy with a few guided cores harvested using the ultrasound-based prostate HistoScanning true targeting approach in cases for which multiparametric magnetic resonance imaging is not available.”
First Surgical Robot Making Surgeon’s Life More Efficient
Reporter : Irina Robu, PhD
A team of microsurgeons and engineers, developed a high-precision robotic assistant called MUSA which is clinically and commercially available. The high precision robotic assistant is compatible with current operating techniques, workflow, instruments and other or instrument. Microsure is a medical device company in The Netherlands founded by Eindhoven University of Technology and Maastricht University Medical Center in 2016. Microsure’s focus is to improve patients’ quality of life through developing robot systems for microsurgery.
The Microsure’s MUSA enhances surgical performance by stabilizing and scaling down the surgeon’s movements during complex microsurgical procedures on sub-millimeter scale. The surgical robot, allows lymphatic surgery on lymph vessels smaller than 0.3 mm in diameter. Microsure received the ISO 13485 certificate which assures that Microsure is adhering to the highest standards in quality management and regulatory compliance procedures to develop, manufacture, and test its products and services.
MUSA provides superhuman precision for microsurgeons, enabling new interventions that are currently impossible to perform by hand.
Diabetes is a life-long condition where your body does not produce enough insulin (Type 1) or your body cannot use the insulin it has effectively. Since there is no cure for diabetes, the artificial pancreas system comes as a relief for patients that are suffering with this disease.
The artificial pancreas, MiniMed 670G hybrid closed loop system designed by Medtronic is the first FDA-approved device that measures glucose levels and delivers the appropriate dose of basal insulin. The system comprises Medtronic’s MiniMed 670G insulin pump that is strapped to the body, an infusion patch that delivers insulin via catheter from the pump and a sensor which measures glucose levels under the skin and can be worn for 7 days at a time. While the device regulates basal, or background, insulin, patients must still manually request bolus insulin at mealtimes.
The device is intended for people age 14 or older with Type 1 diabetes and is intended to regulate insulin levels with “little to no input” from the patient. The artificial pancreas measures blood sugar levels using a constant glucose monitor (CGM) and communicates the information to an insulin pump which calculates and releases the required amount of insulin into the body, just as the pancreas does in people without diabetes.
The 2016 FDA approval was done in just three months which is a record for any medical device. The agency evaluated data from a clinical trial in which 123 patients with Type 1 diabetes used the system’s hybrid closed-loop feature as repeatedly during a three-month period. The trial presented the device to be safe for use in those 14 and older, showing no serious adverse events. The system is on sale since spring 2017.
While further clinical research is needed to ensure that the strength of the device in different settings is consistent, several researchers support the view that “artificial pancreas systems are a safe and effective treatment approach for people with type 1 diabetes. Medtronic counts this device as a step toward a fully automated, closed-loop system.
Tuberculosis is one of the world’s deadliest infectious diseases, which requires six-month course of daily antibiotics. To help overcome that, a team of researchers led by MIT has devised a new way to deliver antibiotics, which they hope will make it easier to cure more patients and reduce health care costs. In their approach a coiled wire loaded with antibiotics is inserted into the patient’s stomach through a nasogastric tube. Once in the stomach, the device slowly releases antibiotics over one month, eliminating the need for patients to take pills every day.
The device is a thin, elastic wire made of nitinol that can change its shape based on temperature. The researchers can string up to 600 “pills” of various antibiotics along the wire, and the drugs are packaged in polymers whose composition can be adjusted to control the rate of drug release once the device go in the stomach. The wire is distributed to the patient’s stomach via a tube inserted through the nose, which is used regularly in hospitals for delivering medications and nutrients. When the wire reaches the higher temperatures of the stomach, it forms a coil, which stops it from passing further through the digestive system. The researchers then tested the device in pigs and found that this device could release different antibiotics at a constant rate for 28 days. Once all of the drugs are delivered, the device is recovered through the nasogastric tube using a magnet that can attract the coil.
Giovanni Traverso and Robert Langer have been working on a variety of pills and capsules that can remain in the stomach and slowly release medication after being swallowed. This type of drug delivery, can expand treatment to several chronic diseases that require daily doses of medication. One capsule that shows promise appears to be for delivering small amounts of drugs to treat HIV and malaria. After being swallowed, the capsule’s outer coating disintegrates, allowing six arms to expand, helping the device to lodge in the stomach. This device can carry about 300 milligrams of drugs which is enough for a week’s worth of HIV treatment but it falls short of the payload of 3 grams of antibiotics every day needed to treat tuberculosis.
The researchers in addition to David Collins, an economist analyzed the potential economic impact of this type of treatment. He determined that if the treatment is applied in India, costs could be reduced by about $8,000 per patient. I think that such an approach can be helpful for longer regimens required for the treatment of extensively drug-resistant TB and even hepatitis C and this approach can be an vital milestone toward addressing this problem.
Sperm Analysis by Smart Phone, Volume 2 (Volume Two: Latest in Genomics Methodologies for Therapeutics: Gene Editing, NGS and BioInformatics, Simulations and the Genome Ontology), Part 1: Next Generation Sequencing (NGS)
Sperm Analysis by Smart Phone
Reporter and Curator: Dr. Sudipta Saha, Ph.D.
Low sperm count and motility are markers for male infertility, a condition that is actually a neglected health issue worldwide, according to the World Health Organization. Researchers at Harvard Medical School have developed a very low cost device that can attach to a cell phone and provides a quick and easy semen analysis. The device is still under development, but a study of the machine’s capabilities concludes that it is just as accurate as the elaborate high cost computer-assisted semen analysis machines costing tens of thousands of dollars in measuring sperm concentration, sperm motility, total sperm count and total motile cells.
The Harvard team isn’t the first to develop an at-home fertility test for men, but they are the first to be able to determine sperm concentration as well as motility. The scientists compared the smart phone sperm tracker to current lab equipment by analyzing the same semen samples side by side. They analyzed over 350 semen samples of both infertile and fertile men. The smart phone system was able to identify abnormal sperm samples with 98 percent accuracy. The results of the study were published in the journal named Science Translational Medicine.
The device uses an optical attachment for magnification and a disposable microchip for handling the semen sample. With two lenses that require no manual focusing and an inexpensive battery, it slides onto the smart phone’s camera. Total cost for manufacturing the equipment: $4.45, including $3.59 for the optical attachment and 86 cents for the disposable micro-fluidic chip that contains the semen sample.
The software of the app is designed with a simple interface that guides the user through the test with onscreen prompts. After the sample is inserted, the app can photograph it, create a video and report the results in less than five seconds. The test results are stored on the phone so that semen quality can be monitored over time. The device is under consideration for approval from the Food and Drug Administration within the next two years.
With this device at home, a man can avoid the embarrassment and stress of providing a sample in a doctor’s clinic. The device could also be useful for men who get vasectomies, who are supposed to return to the urologist for semen analysis twice in the six months after the procedure. Compliance is typically poor, but with this device, a man could perform his own semen analysis at home and email the result to the urologist. This will make sperm analysis available in the privacy of our home and as easy as a home pregnancy test or blood sugar test.
The device costs about $5 to make in the lab and can be made available in the market at lower than $50 initially. This low cost could help provide much-needed infertility care in developing or underdeveloped nations, which often lack the resources for currently available diagnostics.
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).
Materialise Partners with University of Michigan and Tissue Regeneration Services for Clinical Trials of 3D Printed Tracheal Splint
Reporter: Irina Robu, PhD
Dr. Scott Hollister, a biomedical engineering professor at University of Michigan and Dr. Glenn Green, otolaryngologit at C.S. Mott Children’s Hospital invented a tracheal splint using 3D printing in 2012. The 3D printed trachea of a baby with tracheobronchomalacia (TBM),keeps the airway open until it can grow into a healty state and stay open on its own. The splint dissolves and is absorbed in the body and the process can take up to three years. Dr. Hollister and Dr. Green partnered with Materialise and Tissue Regeneration systems to commercialize the device, starting with clinical trial involving involving 30 patients at Mott Children’s Hospital sometime next year.
According to Dr. Green“This agreement is a critical step in our goal to make this treatment readily available for other children who suffer from this debilitating condition.We have continued to evolve and automate the design process for the splints, allowing us to achieve in two days what used to take us up to five days to accomplish. I feel incredibly privileged to be building products that surgeons can use to save lives.”
The bioresorbable splints will be manufactured by Plymouth, Michigan startup Tissue Regeneration Systems, which received its first commercial product clearance from the FDA in 2013 after several years of product development.
Large part of the time and cost for developing a new medical device or a new drug is allocated for achieving regulatory compliance. While quality and safety are desired, having to continually spend additional time and money throughout the product’s life cycle just on the proof of its quality and safety is painful to all, especially for the health systems which eventually have to pay for it.
It has almost become routine: under narratives of increased patient safety and improved efficiency new regulatory requirements are developed, resulting in increased requirements on the industry. The new European pharmacovigilance legislation and the upcoming European medical device regulatory updates are only two examples. Being part of the industry you have very limited impact on the regulations but have to comply with them anyway. That is – if you were to continue marketing your device or drug. Under certain circumstances the cost of meeting legal requirements is so great it may bring into question the viability of continuing certain business activities. This is especially the case for smaller companies or niche products.
It is clear, thus, that you have a huge incentive to try to achieve compliance with minimal effort. If we take a bird’s eye view on the challenge of reaching compliance, two major elements become evident:
The quality system is, in itself, a high maintenance object which consumes ongoing resources:
It needs to be revisited often due to changes in the regulatory system or in the business environment.
Each change may affect many components of the system and a quick modification may cause inconsistency.
Each modification needs to be accepted, signed-off formally by several people and be disseminated via formally recorded training.
The organization should withstand audits and inspections in regards to the quality system.
Living with the quality system: Each SOP and work instruction has to be followed, and typically forms need to be filled, signed and filed.
Young companies which are just embarking on the regulatory path often do not realize these two characteristics of the quality system. Quick fixes in the form of SOP texts copied from other organizations or generic templates are being used to get the initial certification. However, as the organization evolves it realizes that a quality system is not a one-time effort and cannot be glued on from external sources. It has to be streamlined and become part of the way that the organization lives and does business. Companies are enjoying the benefits of improved process design and automation on a large scale every day, in many areas. When recently did you see a delivery person arriving to a pickup without a Barcode reader, so that he does not need to fill any form manually? When was the last time that a software package was released without an automatic consistency check? So too your quality system and related processes may be dramatically engineered to serve you better.
Better efficiency in quality compliance should thus be achieved through careful analysis and optimization of two types of processes:
How do we better maintain the quality system? How do we make it easier to change the system, keep it consistent, train in it, etc.
The SOPs and work instructions: SOPs cannot be just imported from outside or suggested by a QA/RA consultant who does not know the organization very well. SOPs should be a true marriage between the legal and business requirements and should be the result of a careful consideration by all stakeholders. From my experience, the best SOPs are written by the process owner, with the guidance of the regulatory expert. For example: the R&D manager should be the one drafting the design control SOP, with input of the regulatory expert. Such a SOP is much more likely to fit the business needs, and also more likely to be followed by the process owner.
Yes, I realize that thinking this way is very often not what companies do when they rush compliance. I insist that this is what has to be done to achieve sustainable compliance. The good news is that, when companies do look at their quality system in this way, they see many opportunities for significant improvement. Some of those improvements are achieved through use of better IT tools. These tools would typically be in the area of document management and versioning, workflow automation, improved collaboration and electronic signatures. Like any other change, this also requires a vision and a certain effort. However, the long term business impact may be as significant as the difference between business success or failure.
Boston University- LSEB B01, 24 Cummington Street, Boston, MA 02215
New Opportunity for Exhibitors – get a booth at this evening’s conference directly in the auditorium for just $100. Purchase Tickets below.
Medical device innovation is a bridge between formal biomedical engineering education and a professional career, while translating scientific research to market. As we all know, bringing medical devices from concept to commercialization can be difficult. The Biomedical Engineering Society (BMES) Boston Industry Chapter and the Healthcare PioneersTM group are presenting an evening Forum (with a live video broadcast option for registered members) to address key success factors and discuss case studies in medical device innovation. Here are few of the questions we will be addressing:
• Intellectual property and how to protect it
• Business development
• Engaging doctors in medical device innovation
Panel Speakers:
Ms. Karin Gregory, MPH, managing partner at Furman Gregory Deptula LLC, will share her experience of over 30 years in the healthcare industry in addressing tips and pitfalls in bringing medical innovation to market.
Dominic J. F. Tong, M.D. CEO and Principal at Del Mar Medical & Radiology Services. Dr. Tong will talk about his experience as a medical director for multiple medical technology companies across the country, as well as about starting an academic spinoff in the field of medical imaging.
Gabriel Gruionu, PhD, co-owner and manager, Restore Surgical LLC and Medical Product Development. LLC. Dr. Gruionu will address the innovation social network in academia, how we can connect and align different key players for successful medical innovation inside and outside universities. He will illustrate his concepts with examples from three academic start-up companies from the US and Europe.
By sharing thoughtful process and best practices in presentation and question & answer formats, the speakers will provide insights into the wide range of issues any biomedical engineer should consider as they contribute as team members and leaders of new device and drug development programs.
When: Thursday, October 24th
Time: 5:30 pm – 9:00 pm
Where: Boston University- LSEB B01, 24 Cummington Street, Boston, MA 02215
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