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Posts Tagged ‘Medical device’


Reducing the Burden of Tuberculosis Treatment

Reporter: Irina Robu, PhD

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.

 SOURCE

http://news.mit.edu/2019/stomach-device-antibiotics-tuberculosis-0313?utm_source=&utm_medium=&utm_campaign=&hootPostID=a4ebcfad3e9982776b3c1883db19141c

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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.

 

References:

 

https://www.nytimes.com/2017/03/22/well/live/sperm-counts-via-your-cellphone.html?em_pos=small&emc=edit_hh_20170324&nl=well&nl_art=7&nlid=65713389&ref=headline&te=1&_r=1

 

http://www.npr.org/sections/health-shots/2017/03/22/520837557/a-smartphone-can-accurately-test-sperm-count

 

https://www.ncbi.nlm.nih.gov/pubmed/28330865

 

http://www.sciencealert.com/new-smartphone-microscope-lets-men-check-the-health-of-their-own-sperm

 

https://www.newscientist.com/article/2097618-are-your-sperm-up-to-scratch-phone-microscope-lets-you-check/

 

https://www.dezeen.com/2017/01/19/yo-fertility-kit-men-test-sperm-count-smartphone-design-technology-apps/

 

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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.

 

FDA says drug delivery devices need human factors validation testing

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.

 

Humanfactors 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.

source@ Britannica.com

The human-factors approach to design

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.

HFgeneralpic

 

 

 

 

 

 

 

 

 

 

 

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

  1. 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
  2. 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.
  3. 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.
  4. 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.

 

hfactorconsideroutcomes

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.

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:

  1. failure of the device and
  2. 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.

Human Factors: Identifying the Root Causes of Use Errors

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

Posted 02 February 2016By Zachary Brennan on http://www.raps.org/Regulatory-Focus/News/2016/02/02/24233/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:

  • Ablation generators (associated with ablation systems, e.g., LPB, OAD, OAE, OCM, OCL)
  • Anesthesia machines (e.g., BSZ)
  • Artificial pancreas systems (e.g., OZO, OZP, OZQ)
  • 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).

– See more at: http://www.raps.org/Regulatory-Focus/News/2016/02/02/24233/Human-Factors-Review-FDA-Outlines-Highest-Priority-Devices/#sthash.cDTr9INl.dpuf

 

Please see an FDA PowerPoint on Human Factors Regulatory Issues for Combination Drug/Device Products here: MFStory_RAPS 2011 – HF of ComboProds_v4

 

 

 

 

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Materialise Partners with University of Michigan and Tissue Regeneration Services for Clinical Trials of 3D Printed Tracheal Splint

Reported by: 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.

Source
http://3dprint.com/109725/materialise-uom-trs-partners/

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The red tape challenge

reporter and curator: Dror Nir, PhD

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.
On this issue, I bring you the following post:
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.
R1
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:
  1. 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.
  2. Living with the quality system: Each SOP and work instruction has to be followed, and typically forms need to be filled, signed and filed.
Information Overload

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.

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The Biomedical Engineering Society (BMES) Boston Industry Chapter, Boston University Biomedical Engineering Department & Healthcare PioneersTM

Reporter: Aviva Lev-Ari, PhD, RN

present:

Medical Device Innovation – Logistics of Innovation and Case Studies 

Thursday, October 24th, 2013 5:30 – 9:00 PM

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

Agenda:

5:30 – 6:00pm                     Registration/Networking/Refreshments

6:00 – 6:15 pm                    Opening Remarks, BMES and HCP Leadership Team

6:15 – 7:30 pm                    Panel: “Medical Device Innovation”

7:30 – 8:00 pm                    Question & Answer Segment

8:00- 9:00 pm                     Networking/Refreshments

 

For SPONSORSHIP OPPORTUNITIES please call (347) 903-4362

 

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Reporter: Aviva Lev-Ari, PhD, RN

BIOMEDevice Boston Conference 2013
April 10-11 2013, Boston, MA

 

New conference format for 2013…

Don’t miss out on 2013’s new and improved BIOMEDevice Boston Conference.

Choose from six seminar sessions across the two day conference that will deliver crucial insights and guidance on biomedical regulations, design engineering, new biomaterial innovations and product development for the medical device industry.

Six Solution Packed Seminars

April 10, 2013 April 11, 2013
10:00-11:45am Seminar 1
Advanced Technology and Device Innovation
Seminar 4
Accelerating Speed to Market 
1:00-2:45pm Seminar 2
Intelligent Design for Implantable Devices
Seminar 5
FDA Regulatory Guidance and Updates
3:15-5:00pm Seminar 3
New Innovations in Drug Device Combination Products
Seminar 6
Human Factors: Enhancing Usability and Managing Risk

Conference Speakers



Jay Crowley, Senior Advisor Patient Safety, FDA

Jay Crowley is Senior Advisor for Patient Safety, in FDA’s Center for Devices and Radiological Health. He is interested in developing and implementing new methods and techniques for identifying and resolving problems with the use of medical devices. Jay has held variety of positions over his 25 years at FDA. Currently, Jay has responsibility for implementing the Unique Device Identification requirements of the 2007 FDA Amendments Act and 2012 FDA Safety and Innovation Act. He holds a master’s degree in risk analysis and a bachelor’s degree in mechanical engineering.





Emmanuel Nyakako
, Senior VP of Global Quality & Regulatory Affairs, Zimmer Inc

 




Matthew Myers, PhD, Research Physicist, FDA 

Matthew R. Myers received his doctorate in Applied Mathematics from the University of Arizona. He worked in the research and development laboratory of Corning Glass Works, where he performed mathematical modeling of fiber drawing and other processes involving molten glass. Dr. Myers was later employed as an acoustics consultant with BBN Systems and Technologies. In 1990, Dr. Myers joined the Center for Devices and Radiological Health of the U. S. FDA. He has performed mathematical modeling in the areas of drug delivery, cardiovascular implants, virus transport, and most recently, therapeutic ultrasound. His current research areas include noninvasive methods for pre-clinical testing of focused-ultrasound surgery devices, and modeling of debris retention in reusable medical devices. Dr. Myers also performs consulting reviews on device submissions involving fluid flow and acoustic wave propagation, most recently applications to treat Parkinson’s disease and Essential Tremor with therapeutic ultrasound.




Dr. Thomas J Webster, Associate Professor, Divisions of Engineering and Orthopaedic Surgery, Brown University 

Thomas J. Webster’s degrees are in chemical engineering from the University of Pittsburgh (B.S., 1995) and in biomedical engineering from Rensselaer Polytechnic Institute (M.S., 1997; Ph.D., 2000). He is currently the Department Chair and Professor of Chemical Engineering at Northeastern University in Boston. He has graduated/supervised over 109 visiting faculty, clinical fellows, post-doctoral students, and thesis completing B.S., M.S., and Ph.D. students. To date, his lab group has generated over 9 textbooks, 48 book chapters, 306 invited presentations, at least 403 peer-reviewed literature articles, at least 567 conference presentations, and 32 provisional or full patents. His H index is 47. Some of these patents led to the formation of 9 companies. He has received numerous honors including, but not limited to: 2002, Biomedical Engineering Society Rita Schaffer Young Investigator Award; 2005, Coulter Foundation Young Investigator Award; 2011, Oustanding Leadership Award for the Biomedical Engineering Society (BMES); and Fellow, American Institute for Medical and Biological Engineering.




John (Barr) Weiner, Associate Director of Policy, Office of Combination Products, FDA 

John Barlow Weiner is the Associate Director for Policy in the Food and Drug Administration’s Office of Combination Products, which is tasked with the classification and assignment for regulation of therapeutic products (drugs, devices, biological products, and combination products), and with ensuring the sound and consistent regulation of combination products. Prior to joining OCP, Mr. Weiner was an Associate Chief Counsel in FDA’s Office of Chief Counsel, advising the agency on various issues including regulation of drugs and cross-cutting topics including the regulation of products that use nanotechnology. Before coming to FDA, Mr. Weiner was in private practice in the areas of food and drug, environmental, and related aspects of public international and trade law. He has published and lectured on topics in all three areas. Mr. Weiner received a BA from Princeton University and a JD with honors from the Columbia University School of Law.




Olivia Hecht
, Senior Marketing Manager, Wireless & Networking, Philips Healthcare

Olivia Hecht is currently Sr. Manager of Technology and Platforms Integration, for Philips Healthcare Patient Care and Clinical Informatics. She came to the healthcare industry with over 20 years in the information technology sector working in product management and product marketing for companies such as Bay Networks, an early innovator in network infrastructure; RSA Security, a leader in enterprise security; and Legra Systems, a start up manufacturer of enterprise Wi-Fi equipment. She has a Masters degree from the Massachusetts Institute of Technology and Bachelor of Science in Biology.




Joel Kent, Regulatory Affairs Manager, GE Healthcare 

Joel Kent, RAC (Canada, EU and US) is currently Manager, Regulatory Affairs for GE Healthcare, Healthcare Systems Patient Care Solutions business. He has 18 years experience in regulatory affairs covering a variety of medical devices. He holds a Bachelor of Science degree in Electrical and Biomedical Engineering from Duke University and a Master of Science in Biomedical Engineering, Worcester Polytechnic Institute. Mr. Kent has nine publications related to pulse oximetry and gastric tonometry and has been granted two US and Japanese Patents for Remote Sensing Tonometric Catheter Apparatus and Method. He is a lecturer at Northeastern University, Boston, MA and is an IEEE Senior Member and American Society for Quality (ASQ) Senior Member. In addition, he is a Regulatory Affairs Professional Society (RAPS) member serving as Vice-Chair of the RAPS Boston Chapter and member of the RAPS 2008-2011 Annual Conference Committee and RAPS Annual Conference Preconference workshop committee on Latin America Medical Device Regulations in 2012. Speaking engagements have included the RAPS Annual Conferences, Medical Devices Summit East 2011, 2012 and 2013 and the 11th annual AdvaMed Emerging Growth Company Council conference.




Pat Baird, Product Design Owner, Baxter Healthcare

Pat Baird is a Product Design Owner at Baxter Healthcare, with oversight responsibility for over $400M in installed medical devices. His previous roles included software developer, function manager, program manager, and engineering department manager. Drawing on 20 years’ experience in product development, he has published and presented over 30 papers on topics such as software development, change management, stakeholder management, and risk management. He is currently the co-chair of the AAMI Infusion Pump Standards committee, chair of the Assurance Case Technical Information Report Working Group, a US representative to the IEC standards committee, founder of the Infusion Systems Safety Council and the Coalition of Organizations Reporting Adverse Events. He has earned multiple industry awards for his work to advance patient safety. He recently completed a Masters in Healthcare Quality and Patient Safety at Northwestern University in Chicago.




Dr. Eric Ledet, Associate Professor, Rensselaer Polytechnic Institute

Eric Ledet is an Associate Professor in the Department of Biomedical Engineering at Rensselaer Polytechnic Institute where he has taught medical device design and maintained an active research program in orthopaedic biomechanics for the last 9 years. Prior to joining RPI, he served as Director of the Orthopaedic Research Program at the Albany Medical College for 9 years. He has served as a consultant to medical device companies for 15 years and is currently principal partner in three medical device startup companies. He earned a bachelor’s degree in mechanical engineering from the University of Arizona and a Master of Science and doctorate in biomedical engineering from Rensselaer Polytechnic Institute.




Judith K Meritz, Associate General Counsel, Covidien




Jeffrey Morang
, Human Factors Engineer and User Experience Analyst, Siemens Healthcare Diagnostics

Jeffrey Morang is a Human Factors Engineer for the Point of Care line of instruments at Siemens Healthcare Diagnostics. Jeff received his MS in Human Factors and Ergonomics from San Jose State University. Jeff has experience as a researcher in aeronautical human factors, focusing on human perceptual and cognitive performance, for the Virtual Airspace Modeling and Simulation Project at the NASA Ames Research Center. After graduation, he joined Future Combat Systems project at British Aerospace Systems responsible for mapping soldier roles and assessing their cognitive and physical workloads using real-time usability testing methods. Jeff has brought that expertise to his current position at Siemens where his team is responsible for employing a synergistic design and testing methodology on behalf of a variety of end users in the relatively new area of healthcare called Point of Care.




George Papandreou, VP Quality, Lutonix, CR Bard 

George Papandreou, Ph.D., is Vice President of Quality at Lutonix, a subsidiary of C.R. Bard. In his current position, George is working on drug-coated balloons for the treatment of peripheral artery disease. George has extensive experience in formulation, analytical characterization and process development. He has a proven record in the commercialization of advanced drug delivery concepts, such as drug/device combination products, and has contributed in the approval of novel therapeutic solutions, such as the CYPHER® Sirolimus-eluting Coronary Stent. He has defined the strategy to address Chemistry Manufacturing and Controls issues, and has significant expertise in troubleshooting complex technical and quality issues during research, development and manufacturing of drug products. George has earned a Ph.D. in organic chemistry, and has co-authored of over 35 publications, as well as applied and issued patents.




Eric Roden
, Associate Director, Operational Excellence, B. Braun Medical 




Marjorie Shulman
, Director, 510(K) Premarket Notification Staff, FDA




Rahul Sapreshker, Associate Professor- Electrical Engineering & Computer Science, MIT


Roger Narayan, Professor, Biomedical Engineering, North Carolina State University

Dr. Roger Narayan is a Professor in the Joint Department of Biomedical Engineering at the University of North Carolina and North Carolina State University. He is an author of over one hundred publications as well as several book chapters on processing and characterization of biomedical materials. He currently serves as an editorial board member for several academic journals, including as editor-in-chief of Materials Science and Engineering C: Materials for Biological Applications (Elsevier). Dr. Narayan has been elected as Fellow of ASM International, AAAS, and AIMBE.


 

 

 

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