on 2 June 2014 | By Ryan Kasun
The FDA, as part of the transparency initiative, has developed a Total Product Life Cycle (TPLC) report capability on their website (www.fda.gov). The intention behind this new report is to provide existing data to medical device manufacturers that will enable them to...
Read Moreon 19 May 2014 | By Ryan Kasun
Even though Risk Management and Usability Engineering are clearly two separate processes with unique requirements, they are interdependent and must communicate with each other during the entire product lifecycle. Risk Management identifies the risk of a medical device’s...
Read Moreon 5 May 2014 | By Ryan Kasun
The process of submitting a 510(k), demonstrating that your device is substantially equivalent to a device that is already cleared, can be daunting. Typically designed to be a 90-day review by the FDA, the entire process could take several months if adequate information is not...
Read Moreon 21 April 2014 | By Ryan Kasun
Having a documented regulatory strategy developed early during a new product’s development life cycle and updated periodically is critical for a new product’s market success. An inaccurate or lack of regulatory strategy can lead to the product not being cleared for market in the...
Read Moreon 24 March 2014 | By Ryan Kasun
In the medical device arena, recalls are a fact of life and competitors love to find out that you’ve had one. Regardless of recall classification (Class I, II, or III), a recall procedure is instrumental in working in concert with a company’s post-market surveillance and...
Read Moreon 10 March 2014 | By Ryan Kasun
Each year, the FDA issues hundreds of warning letters to medical device companies for reasons ranging from manufacturing practice violations to breaches in labeling and misbranding. Companies responding well to the FDA’s demand for prompt compliance will ultimately return to the...
Read Moreon 21 February 2014 | By Ryan Kasun
On February 18, the FDA issued the final guidance document for the Pre-Submission Program and Meetings with FDA Staff. The Pre-Submission process is a way for industry to get feedback from the FDA prior to the submission of a premarket application (PMA, 510(k), HDE, IDE, de...
Read Moreon 13 February 2014 | By Ryan Kasun
Innovative ideas for medical devices are often costly for manufacturers to make and for patients to own. However, not all innovative medical devices will cost you an arm and a leg.
Read Moreon 30 January 2014 | By Ryan Kasun
In an effort to help get safe and effective medical devices to market more quickly, the FDA publishes a list of proposed guidance documents each year. Here is FDA’s prioritized list of things you can expect to see in 2014:
Read Moreon 22 January 2014 | By Ryan Kasun
On Friday, January 10, 2014 the FDA issued a final rule, which amends the premarket approval (PMA) regulations. The final rule requires “submission of information on pediatric subpopulations that suffer from the disease or condition that a device is intended to treat”. 1 The...
Read Moreon 10 January 2014 | By Ryan Kasun
How well do you know the logistics of the 510(k) process? Today’s blog is interactive, as well as educational! Take this quiz (no cheating!). Comment on the post to tell me how many answers you got right!
Read Moreon 9 January 2014 | By Ryan Kasun
As if 3D printers for rapid prototyping weren’t cool enough, researchers at the University of Wollongong and St. Vincent’s Hospital Melbourne, part of Australian Research Council Centre of Excellence for Electromaterials Science (ACES), have been using 3D printing to make some...
Read Moreon 9 January 2014 | By Ryan Kasun
As part of FDA’s Performance Goals and Procedures adopted under MDUFA III (The Medical Device User Fee Act of 2012), the FDA agreed to participate with the medical device industry in an independent assessment of the process for the review of medical device submissions. The key...
Read Moreon 2 January 2014 | By Ryan Kasun
Trans∙hu∙man∙ism /tranz’hyoomənizm// Noun The belief or theory that the human race can evolve beyond its current physical and mental limitations, especially by means of science and technology.1
Read Moreon 20 December 2013 | By Ryan Kasun
This past weekend I travelled to the Chicago-land area to attend my brother’s graduation from Northern Illinois University and commissioning into the US Army. He will be reporting to Fort Leonard Wood, Missouri for officer training as part of the Army Corps of Engineers. This...
Read Moreon 12 December 2013 | By Ryan Kasun
I recently worked on a project that involved writing a regulatory strategy for a device used on animals. This was a new area for me and I got interested in learning even more about the topic afterwards. I was curious as to how big of a market veterinary devices were, as well as...
Read Moreon 2 December 2013 | By Ryan Kasun
You probably think you know yourself pretty well, right? Of course. You’re a (circle all that apply) super cool/ witty/ charming/ good-looking/ intelligent person, and humble about it too, but what does your DNA say about you? DNA is an incredibly complex storage structure for...
Read Moreon 14 November 2013 | By Ryan Kasun
I read a really interesting article this week written by Josh Rising called "The Loophole That Keeps Precarious Medical Devices in Use". The articles explains how when the Medical Device Amendments of 1976 were implemented, dozens of marketed medical devices were left...
Read Moreon 7 November 2013 | By Ryan Kasun
As quality professionals, we are always looking for ways to improve the quality of products, and reduce the cost of quality mishaps. But how do you actually climb to the top of that mountain of high quality while still maintaining a marketable product?
Read Moreon 6 November 2013 | By Ryan Kasun
Can you imagine what a GPS for blind people would be like? We may not be there yet, but a research project at the University of Arkansas could be the next best thing. Dr. Cang Ye and his team are making over the standard white cane often used by the visually impaired into a...
Read Moreon 31 October 2013 | By Ryan Kasun
Of all of the seminars I attended at the RAPS 2013 Conference in Boston, the Medical Devices Single Audit Program ("MDSAP") was arguably the best. The overview of MDSAP - done well by Kim Trautman of the FDA and Mike Ward from Health Canada - was thorough and well done; however,...
Read Moreon 24 October 2013 | By Ryan Kasun
Over the years, major advances in blood transfusion safety measures have drastically reduced the risk of viral transmission via allogeneic blood. Although correlation doesn’t necessarily imply causation, it’s tempting to believe that this may have something to do with the...
Read Moreon 24 October 2013 | By Ryan Kasun
Upon my nightly adventures of surfing the World Wide Web I came across this article on the Popular Science website announcing the FDA’s approval of the Medtronic MiniMed 530G Insulin pump, praisingly dubbed the first artificial pancreas. The Medtronic device was officially...
Read Moreon 18 October 2013 | By Ryan Kasun
As the government shutdown dragged onward, nobody was watching the outcomes more than medical device manufacturers. For device manufacturers – there was and still is a lot at stake. And make no mistake – the medical device tax is part of the hot debate in Washington right now....
Read Moreon 18 October 2013 | By Ryan Kasun
The standard treatment for patients with cancer of the larynx is to have a tracheostomy tube installed. Tracheostomy tubes are Class II devices, under 21 CFR 868.5800. According to ProTip CEO Maurice Beranger, this technology has not changed in 140 years. Tracheostomy tubes...
Read Moreon 15 October 2013 | By Ryan Kasun
On October 1st, 2013, the Government of the United States began shutting down operations due to an impasse in congress regarding government funding appropriations. Practically speaking for the medical device industry, the shutdown puts businesses, medical professionals, and,...
Read Moreon 11 October 2013 | By Ryan Kasun
Advancements in biotechnology have made things of science fiction into reality. Back in the 70’s, bionic body parts were thought to be donned only by the Six Million Dollar Man1 and The Bionic Woman2. Fast forward forty years and bionic body parts are more science than fiction....
Read Moreon 11 October 2013 | By Ryan Kasun
In the world in we live, where communication is becoming further removed from face to face interaction, medicine is utilizing telecommunications technologies to advance treatment and care for patients.
Read Moreon 11 October 2013 | By Ryan Kasun
The Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA) has launched a new initiative targeted at giving the patients a voice in the agency’s decision making process on medical devices. I became aware of this effort by the FDA when...
Read Moreon 2 October 2013 | By Ryan Kasun
Sometimes changes in process can have a dramatic effect on product registration. There are several events that can cause a re-registration of a registered medical device. A new product name, part number, material, manufacturing site, country of origin, business name or...
Read Moreon 1 October 2013 | By Ryan Kasun
Earlier this year I joined a running club, Steel City Road Runners (come run with us!). I’m still a newbie, but I really enjoy the challenge that running provides. This past week, the Boston Marathon announced to applicants who would be awarded the last 5,000 spots in the 2014...
Read Moreon 27 September 2013 | By Ryan Kasun
This week must be the week of the FDA publications. In the same week the UDI final rule and guidance were published, the FDA has also released the guidance document on the FDA's plan for enforcement regarding Mobile Medical Applications. The FDA's final thoughts on how they'll...
Read Moreon 25 September 2013 | By Ryan Kasun
The rule and guidance document for Unique Device Identifiers ("UDI") on medical devices and some combination product that contain devices has been released.
Read Moreon 19 September 2013 | By Ryan Kasun
The European marketing approval system for medical devices is less stringent than other regions of the world and because of that, at times it is viewed as a more attractive market for device manufacturers. However over the past few months, a new proposal has come up in Europe...
Read Moreon 18 September 2013 | By Ryan Kasun
As you might expect, here at RQS the responsibilities and duties of providing our clients with the support they need often involves traveling for on-site visits. For the time being, most of the travel takes place within the greater metropolitan area of the cities in which we...
Read Moreon 17 September 2013 | By Ryan Kasun
What do Jean Grey and Professor Xavier of X-Men, Vulcan “mind-melds” from Star Trek, the Six-Million Dollar Man, Darth Vader and Jedi mind tricks from George Lucas’ Star Wars, The Bionic Woman adapted from Martin Caidin’s Cyborg, Inspector Gadget, Replicants from the 1980’s...
Read Moreon 11 September 2013 | By Ryan Kasun
It used to be much easier to have an international device on the market that complies with the regulations of the multi-country international market. With a properly localized multi-language Instructions for Use, the regulations of most international countries were met with one...
Read Moreon 5 September 2013 | By Ryan Kasun
On the news this morning, I heard a story that got me thinking about risk management. The headline was “Eight N.H. patients possibly exposed to fatal brain disease”. Further research about the situation reveals just how complex this case is.
Read Moreon 30 August 2013 | By Ryan Kasun
With the growing use of incorporating wireless technology into medical devices, the FDA has issued a final guidance Radio Frequency Wireless Technology in Medical Devices. This guidance document is meant to cover a wide range of medical devices that use wireless technology from...
Read Moreon 30 August 2013 | By Ryan Kasun
Today, when I was thinking of a blog topic, I had a moment of clarity. I realized that I regularly peruse the news and media for evidence of how machines and medical devices help humans, improve human life, and how humans utilize machines and technology to help solve problems. I...
Read Moreon 30 August 2013 | By Ryan Kasun
In my Bioethics course during my undergraduate years, we had discussed the curious case of Henrietta Lacks: a 31 year old African American mother who contributed to numerous modern day medical advancements upon her death without her or her family’s knowledge. I noticed that...
Read Moreon 22 August 2013 | By Ryan Kasun
Every once in a while, when I’m not running, I like to take my bike down to the river trails of downtown Pittsburgh. I throw my bike rack on my car, strap it in, and I’m ready to go. Being as I only used my bike rack about ten times since I got it, I was surprised when I went to...
Read Moreon 22 August 2013 | By Ryan Kasun
I am in TopSail North Carolina this week enjoying the ocean, sun and family! (Yes: in that order)
Read Moreon 22 August 2013 | By Ryan Kasun
A few notable posts pertaining to mobile medical applications came through my Twitter feed / Inbox recently, so I wanted to share!
Read Moreon 22 August 2013 | By Ryan Kasun
Why is it that when you drop the A-bomb (audit) people just seem to instinctively cringe. Is this a learned behavior or one that has been passed down since men began assessing each other for acceptance?
Read Moreon 9 August 2013 | By Ryan Kasun
Please join RQS for a happy hour networking event! Drinks and appetizers will be provided and prizes will be given away to winning attendees during the event.
Read Moreon 9 August 2013 | By Ryan Kasun
I read an interesting article on the RAPS website this morning about a new initiative set by the FDA to clean-up certain guidance documents. This means finalizing draft guidance documents, withdrawing or updating/revising outdated guidance documents. This initiative is taking...
Read Moreon 5 August 2013 | By Ryan Kasun
Earlier last month, FDA released a new draft guidance that addresses many questions and answers pertaining to the sometimes tricky world of medical device reporting for medical device manufacturers. (1-4) The draft guidance, “Draft Guidance on Medical Device Reporting for...
Read Moreon 1 August 2013 | By Ryan Kasun
While doing my usual read-through of the headlines on USA Today, I recently came across an article about a USA Today investigation examining the works of Matt Cahill, a supplement designer with a dark history in developing risky products. As an individual who tries to maintain a...
Read Moreon 26 July 2013 | By Ryan Kasun
Recently, I had the opportunity to attend a Risk Management Conference hosted by the FDAnews. At the beginning of the conference, we all went around the room and introduced ourselves, and indicated why we were there. Not surprisingly, a majority of people were there to have a...
Read Moreon 24 July 2013 | By Ryan Kasun
So you think you’re a bargain shopper, huh? Did you secretly get a rush when you had a coupon for that high-end toothpaste AND found it on sale? Most bargain shopping comes with few, if any, downsides. (Ok, so maybe you had to evict a family of angry possums from that couch you...
Read Moreon 24 July 2013 | By Ryan Kasun
One of the ways that I try to stay in touch with the world of medical device regulations is by subscribing to the CDRH (Center for Devices and Radiological Health) mailing lists (http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/ucm135906.htm)....
Read Moreon 19 July 2013 | By Ryan Kasun
Complaints from end users to medical device manufacturers are unfortunately a common occurrence. Medical device manufacturers are expected to handle these complaints efficiently and effectively by keeping the end user or patient’s safety in mind. However not a lot of people...
Read Moreon 19 July 2013 | By Ryan Kasun
The latest mobile medical application news on the industry's collective mind is the issuance of an "It has come to our attention..." letter sent to Biosense Technologies in India, essentially questioning why Biosense has not obtained 510(k) clearance for their uChek mobile...
Read Moreon 11 July 2013 | By Ryan Kasun
As a recent college graduate working in the medical device industry, I quickly learned that life as an engineer is different than what is envisioned and different than what is taught in the hundreds of undergraduate programs across the nation. Today, students graduate with...
Read Moreon 10 July 2013 | By Ryan Kasun
As of June 30th, Croatia has now been formally added to the list of EU governed / regulated countries making for a total of 27 European Union countries.
Read Moreon 10 July 2013 | By Ryan Kasun
As a University of Pittsburgh graduate, I was excited to read in the spring issue of Pitt Magazine about a promising advance in cancer prevention research at my alma mater. Immunologist Olivera Finn and her research team at Pitt have been studying potential cancer prevention...
Read Moreon 10 July 2013 | By Ryan Kasun
In today's world of always looking for ways to get something done faster there appears to be one area where speed has begun to do some harm. This area happens to be related to production equivalence. Quite simply, production equivalence is the evidence that a manufacturer...
Read Moreon 28 June 2013 | By Ryan Kasun
My recent work has involved providing regulatory assistance to software medical devices. One thing I have been learning about is how security and privacy is handled with these types of products. Often times I have experienced clients grouping regulatory affairs with privacy and...
Read Moreon 28 June 2013 | By Ryan Kasun
For today's show-and-tell, I'm bringing a picture of me at FDA:
Read Moreon 27 June 2013 | By Ryan Kasun
The Food and Drug Administration (FDA) recently released its new data set for the Inspections Database. 1-2 The Inspections Database makes available the most recent inspection (up to two years of inspections) of a company. The final inspection classification for clinical trial...
Read Moreon 27 June 2013 | By Ryan Kasun
Over the last few months, several of the potential clients I’ve met with have been start-up device companies. Typically, I find that start-ups will have a fantastic product idea that can positively impact countless lives – but, often, they do not have a clear plan for how they...
Read Moreon 19 June 2013 | By Ryan Kasun
This weekend my family and I are going to go to the Congenital Heart Walk at 9:45 a.m. at the boathouse in North Park. This walk is to raise awareness for Congenital Heart Defects, America’s #1 birth defect. Regulatory and Quality Solutions is a sponsor of this event; it is very...
Read Moreon 14 June 2013 | By Ryan Kasun
How much time to you spend searching FDA’s website? Looking for predicates, collecting adverse event reports from the MAUDE database, searching for guidance documents, etc. I’m sure I don’t need to dig into the details, you have felt this pain too if you have spent any...
Read Moreon 14 June 2013 | By Ryan Kasun
Every time I visit my optometrist I see advertisements for colored contact lenses. I’m pretty happy with the green I’ve got so I’ve never tried another color. Did you know that contact lenses, even the purely decorative ones that don’t correct your vision, are considered medical...
Read Moreon 14 June 2013 | By Ryan Kasun
Recently I went trolling through the FDA website and stumbled upon an article entitled "Wanted: Consumers to Report Problems (http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm354560.htm#report). It's a great article that at its core, is a plea to the consumers of medical...
Read Moreon 14 June 2013 | By Ryan Kasun
An AGILE software development process allows for adaptive development through incremental changes in the software. This means that there are more releases and upgrades of the software in the field. Within the AGILE process there is time allotted for the integration phase. This...
Read Moreon 6 June 2013 | By Ryan Kasun
After reading Steve’s blog, "Why RQS Cares- The Race for the Place" and learning more about Race for the Place/The Gathering Place, I knew that I wanted to participate in this event. Soon thereafter, I was registered and ready to participate in RQS Cares’ first Ohio-based...
Read Moreon 3 June 2013 | By Ryan Kasun
RQS team members pride ourselves on focusing on customer success, and it is with that in mind that I am honored to announce our most recent 510(K) submission was approved this week! We are proud to obtain clearance, but swell with pride because of how we obtained it.
Read Moreon 29 May 2013 | By Ryan Kasun
Could it get much worse for mobile medical applications and their developers trying to utilize phones and tablets as point-of-care medical devices? OK, surely it could, but this story can't make it any easier.
Read Moreon 29 May 2013 | By Ryan Kasun
The FDA is looking for industry input for the revision of FDA 510(k) Memorandum #K97-1 “Deciding When to Submit a 510(k) for a Change to an Existing Device,” January 10, 1997. This is a critical go-to document for the average Regulatory Engineer, so I have been thinking about...
Read Moreon 23 May 2013 | By Ryan Kasun
In my last post “Who’s watching your MedWatching”, I commented on some of the common issues manufacturers have with their MDR and complaint handling systems. It’s useful to know what people are doing wrong, but I think it is equally important to know how to solve those issues....
Read Moreon 23 May 2013 | By Ryan Kasun
I saw an episode of Elementary a couple weeks ago in which a hired assassin killed someone by hacking into his pacemaker and cranking up the voltage to cause a heart attack. Initially I thought maybe crime shows were just stepping up their game, trying to find more creative ways...
Read Moreon 23 May 2013 | By Ryan Kasun
Why is it that Internal Audits are forgotten, or even worse feared? Why is it so many organizations of today place so much focus on the creation of Quality Procedures, Work Instructions, Forms, etc. but do not place the same focus on conducting internal audits of the quality...
Read Moreon 17 May 2013 | By Ryan Kasun
In school I was always taught that the medical device development process followed the waterfall model. However since entering the work force I have started to see other methods of development for different types of devices. I have recently been working with software medical...
Read Moreon 16 May 2013 | By Ryan Kasun
At the beginning of this month, MedCon 2013 was hosted in Cincinnati, OH by Xavier University. The three day conference was held Wednesday May 1st, 2013 through Friday May 3rd, 2013.
Read Moreon 13 May 2013 | By Ryan Kasun
Today we feature a post from Deb Gimbel on why RQS Cares has chosen to support the Congenital Heart Walk. Seven years ago, my niece Riley was born with a congenital heart defect known as complete heart block, which is an interference in the signals between the heart chambers,...
Read Moreon 9 May 2013 | By Ryan Kasun
Last month Serbia changed its localization so that The Instructions for Use and labeling of medical devices must be written in the Serbian language. There was no grace period for this change, it was effective immediately. Conversely, Korea has also indicated that their...
Read Moreon 8 May 2013 | By Ryan Kasun
I was blessed enough this weekend to run the Pittsburgh Half-Marathon with my wife, her dad, and her cousin. I had such a blast running in my favorite city in gorgeous weather with 30,000 other crazy people!
Read Moreon 6 May 2013 | By Ryan Kasun
Today we feature a post from Steve Keverline on why RQS Cares has chosen to support The Race for The Place. My father, sister and I stood in the hospital room by my mother’s side. We were anxious to learn the cause of her recent dizzy spells and loss of appetite. She had a CT...
Read Moreon 3 May 2013 | By Ryan Kasun
This past weekend I had a really great discussion with some neighborhood friends that really didn't know much of my background (where had I grown up, gone to school, etc.) and the question came up "what did you study in college?" This is a question that I'm sure everyone has...
Read Moreon 3 May 2013 | By Ryan Kasun
Last year, FDA received almost one million adverse event reports from manufacturers1. Needless to say, the Office of Surveillance and Biometrics has been very busy, and so have manufacturers.
Read Moreon 1 May 2013 | By Ryan Kasun
I’ve always had a rocky relationship with my alarm clock, specifically the snooze button. In my current clock it’s built into the base (not the display, where all the cool buttons hang out), and it’s angled, narrow and difficult to locate in a semi-conscious state. I pretty much...
Read Moreon 25 April 2013 | By Ryan Kasun
FDA issued a new draft guidance document on biocompatibility on Tuesday April 23, entitled Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. It is intended to replace the ODE General Program Memorandum #G95-1. G95-1...
Read Moreon 24 April 2013 | By Ryan Kasun
Make some noise people - the FDA may be making labeling easier on the medical device and biological product industries by way of harmonized symbols!
Read Moreon 23 April 2013 | By Ryan Kasun
Automated external defibrillators (AEDs) can save the lives of individuals suffering from a cardiac arrest event. Sudden cardiac arrest can happen to anyone and at any time. According to the American Red Cross, over 350,000 people will suffer from sudden cardiac arrest this...
Read Moreon 22 April 2013 | By Ryan Kasun
RQS is happy to announce that RQS Cares is organizing a group for the Congenital Heart Walk event occurring on June 22nd, 2013 in Allison Park, PA. The race serves as a community gathering and fundraising event for ACHA, an organization to improve the quality of life and extend...
Read Moreon 22 April 2013 | By Ryan Kasun
RQS is happy to announce that RQS Cares is organizing a group for the Race for the Place 5K run / 1 mile walk event occurring on June 2nd, 2013 in Beachwood, OH. The race serves as a fundraising event for The Gathering Place - an organization focused on supporting, educating,...
Read Moreon 18 April 2013 | By Ryan Kasun
The culture of a company is what drives the organization – it can change and adapt, but ultimately, if a strong management team doesn’t drive a company’s culture – the company risks losing its identity. For medical device companies, establishing a culture around the Quality...
Read Moreon 17 April 2013 | By Ryan Kasun
Collaborative development, or for the purposes of this post we'll call it "crowd sourcing", seems to be discussed and used more frequently in the current business environment. Obviously, crowd sourced projects have been around for a long while (Wikipedia is just one well-known...
Read Moreon 16 April 2013 | By Ryan Kasun
Recently I had to get my annual mammogram. They were running behind like doctor’s offices sometimes do - there were seven women in dressing gowns in the waiting room with me. After a few awkward moments, we all started to talk to each other. Every single one of the ladies talked...
Read Moreon 11 April 2013 | By Ryan Kasun
For over 200 years, the US has operated under a “first to invent” rule. This means that if two innovators independently submit a patent for the same exact invention, the person who can prove that they invented it first is the one who is awarded the patent.
Read Moreon 10 April 2013 | By Ryan Kasun
If you’ve ever spent any appreciable amount of time in a hospital or other medical care facility, you may have been driven temporarily insane by the never-ending chorus of medical device alarms. I was recently reminded of a few nights I spent in the hospital with my dad a year...
Read Moreon 10 April 2013 | By Ryan Kasun
This morning I was welcomed by receiving an email from the FDA CDRH News stating that new guidance was released regarding user fees and refunds for pre-market notification submissions 510(k)s. Some of the takeaways I had were:
Read Moreon 5 April 2013 | By Ryan Kasun
I came across an FDA guidance document – not entirely recent; however, I found it very interesting and worth sharing. It is on voluntary submissions of audit reports done by auditing bodies outside of the FDA.
Read Moreon 5 April 2013 | By Ryan Kasun
I recently had the opportunity to receive some training in auditing of medical device companies. In this training I was able to gain experience from an auditor's perspective as well as an auditee's perspective on how an audit is performed. This training was important to me...
Read Moreon 3 April 2013 | By Ryan Kasun
As a somewhat rabid hockey fan there are a few days during the year that are considered sacred holidays: every playoff game, first day of free agency, and the trade deadline. My mind is on hockey because the trade deadline happens to be today. Outside of my insatiable desire to...
Read Moreon 2 April 2013 | By Ryan Kasun
Bipartisan support, in today’s world of politics, might seem a little hard to believe. However, the U.S. Senate passed an amendment that repeals the medical device tax last month (Thursday, March 21, 2013). The bill was passed by a bipartisan vote of 79 to 20. 1 This impressive...
Read Moreon 28 March 2013 | By Ryan Kasun
Last week I saw several articles published about a new device that is going to shake up the Craniomaxillofacial device market, and the Orthopedic market is next on the list. 3D Printing – chances are you’ve just started hearing about it, mostly concerning gun controls laws for...
Read Moreon 26 March 2013 | By Ryan Kasun
The season is upon us. Unfortunately, the season is not spring…winter still seems to be lingering. However, the season of March Madness is in full swing! Everyone’s bracket selections are in, and we wait to find out who is the National Champion.
Read Moreon 22 March 2013 | By Ryan Kasun
Regulatory and Quality Solutions is featured in another publication this week! Our President, Maria Fagan, has written an article focused on the top five tips on how to successfully address FDA warning letters. The article is featured in MedCity News and can be found here. FDA...
Read Moreon 20 March 2013 | By Ryan Kasun
Last week I had the opportunity to attend the Human Factors & Ergonomics Society Health Care Symposium. Since I work on medical devices, I mainly went to the presentations in the medical devices track and found them to be very interesting and educational. The opening keynote...
Read Moreon 20 March 2013 | By Ryan Kasun
It seems that for one reason or another supplier controls are a requirement that slips through the cracks of even some of the largest medical device organizations. Those of us in the medical device field should know better since 21 CFR Part 820 clearly includes requirements that...
Read Moreon 15 March 2013 | By Ryan Kasun
In the March 2013 edition of the Pittsburgh Tech Council's TEQ Magazine, Jonathan Kersting highlights Regulatory and Quality Solutions' growth over the past 5 years. See here for the blog post that recounts the article. The "e-zine" can be found here.
Read Moreon 15 March 2013 | By Ryan Kasun
They’re just as frightening as Lions and Tigers and Bears, but how much do you know about them? Are they in your medical devices?
Read Moreon 14 March 2013 | By Ryan Kasun
My son has a friend that was born deaf. When he was a small child, he had surgery to get cochlear implants. With the implants, he is able to hear. When his younger brother was also born deaf, his parents found that they carried a recessive gene that causes deafness. Both boys...
Read Moreon 11 March 2013 | By Ryan Kasun
What do adhesive bandages, blood-pressure monitoring cuffs, sanitary napkins, ventilator bellows, wheel chair cushions, and dental dams all have in common?
Read Moreon 5 March 2013 | By Ryan Kasun
In the medical device field the name of the game is Compliance. The reason for V&V testing is compliance. Prior to distribution you need to provide evidence of compliance. Everywhere you turn there are rules where the medical device manufacturer or distributor must provide...
Read Moreon 4 March 2013 | By Ryan Kasun
I have a teenager that just passed his Driver’s Test. As he pulls out of our driveway, I see the freedom, the possibilities, the trouble that he could get into. Although a bit poetic and a bit melancholy, it’s also a bit exciting. His father and I cautiously trust him – he’s a...
Read Moreon 1 March 2013 | By Ryan Kasun
This week, the FDA faces between 5.1 to 5.3% of their budget being cut this week ($210 million of a $4.1 billion budget). I’ll be interested to see what areas of the FDA are impacted by these budget cuts, and what that means for medical device manufacturers. Proposed to be...
Read Moreon 26 February 2013 | By Ryan Kasun
Some may think the FDA does not take what industry has to say to heart or feel that there is no point in commenting on a proposed rule, because their feedback is left unread.
Read Moreon 26 February 2013 | By Ryan Kasun
I heard an interesting new term today (new to me at least!) that I thought greatly impacts the line of work I am in. Regulatory science is "the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated...
Read Moreon 22 February 2013 | By Ryan Kasun
Over the past few years, there have been some really great technologies that have changed the way we live our lives. Smartphones are the easiest example. Life would be a lot different if I didn’t have instant access to my e-mail, the weather, the spinning schedule at my gym, or...
Read Moreon 20 February 2013 | By Ryan Kasun
Throughout our daily lives, we assess risk. At the grocery store, driving to work, giving advice to our kids and buying a car are all examples of internal risk analyses. How can we be sure that we’ve considered everything? Do we know that we’ve given every aspect the proper...
Read Moreon 19 February 2013 | By Ryan Kasun
Up until the time when I joined the RQS team in November all I had ever truly worked on was Quality. Coming out of college I worked for a plastics bottling manufacturer in process development and quality control. My next job was design V&V closely followed by design quality...
Read Moreon 18 February 2013 | By Ryan Kasun
Recently I came across a FoxNews article (‘Medical breakthroughs on the horizon for 2013’ by Dr. David Samadi) that got me excited. The reason why I pursued the medical device industry was to be in a field that impacted people; a field that matters. I don’t care who you are –...
Read Moreon 12 February 2013 | By Ryan Kasun
After many years of adamantly claiming not to have a “hometown,” hating the 100% humidity-filled summers (that I still despise), and trying to be indifferent about anything “Southern,” I have finally come to peace with my Southern roots and my “Southernisms.” It wasn’t until I...
Read Moreon 12 February 2013 | By Ryan Kasun
Something very exciting is happening this week in Green Bay, Wisconsin. The 2013 Men's and Women's Curling Nationals are taking place all week. What's even more exciting is that this year the semi-final and final games will be on national television. In the past there has only...
Read Moreon 8 February 2013 | By Ryan Kasun
We in the medical device industry throw the term CAPA around like it's a word that is common-place in our society (though, here in Pittsburgh, you'll get a lot of confused looks if you tell someone you've opened a CAPA as it is a local performing arts school. That's a strange...
Read Moreon 7 February 2013 | By Ryan Kasun
You may have heard that last year there were two new releases of EN standards: EN ISO 14971:2012 and EN ISO 13485:2012. What does this mean to you? What are the changes? How much does this affect the way you do business? Compliance to standards can be somewhat overwhelming....
Read Moreon 7 February 2013 | By Ryan Kasun
The FDA received funding to increase its workforce at the CDRH for 2012 and 2013. They have set aggressive goals to improve the turnaround times for 510K approval. They have instituted programs to retain their employees and to increase the reviewer to manager ratio. My...
Read Moreon 5 February 2013 | By Ryan Kasun
Coming to your commercial break at the 2014 Super Bowl at Met-Life Stadium - the automated compliance robot!
Read Moreon 4 February 2013 | By Ryan Kasun
'Tis the season for auditing. The beginning of this year, just like years in the past, seems to have brought the New Year's Resolution that audits will be scheduled and conducted to correct the sins of the previous year and take a fresh look at the upcoming year. To this point...
Read Moreon 31 January 2013 | By Ryan Kasun
On January 18, 2013, the FDA announced their final rule on current good manufacturing practices for Combination products. These Guidance Documents will tell companies when submissions would be required for any post-approval changes to a combination product. First off, what are...
Read Moreon 30 January 2013 | By Ryan Kasun
Last week, the FDA issued a final rule(1-2) on combination products(3) and the applicable current good manufacturing practice (CGMP) requirements. The final rule actualizes the proposed rule that was issued many moons ago, in September 2009 without significant changes. Four...
Read Moreon 28 January 2013 | By Ryan Kasun
In addition to the Refuse to Accept Policy for 510(k)s Guidance document I discussed in my previous post, the FDA also issued a guidance titled Acceptance and Filing Reviews for Premarket Approval Applications (PMAs) at the same time.
Read Moreon 28 January 2013 | By Ryan Kasun
With the recent announcement of 510(k) clearance of a retinal examining attachment and companion app can we now declare the outcry against the FDA finished?
Read Moreon 25 January 2013 | By Ryan Kasun
My mom works as an x-ray technician at a small orthopedic office in Chicago-land. Recently, the office ordered a new x-ray machine to replace their old and outdated equipment. My mom was very eager to use the new equipment, and was very happy to have an upgrade. However, after a...
Read Moreon 23 January 2013 | By Ryan Kasun
There have been a bunch of countries recently that have changed their regulations to require a native language registration label on medical devices. These labels must call out a specific set of information including manufacturing location and address, and the Registration...
Read Moreon 23 January 2013 | By Ryan Kasun
There are some things in life that never change. So, if they never change, let’s learn the rules. A teacher once told me “once you know the rules, embrace them.”
Read Moreon 21 January 2013 | By Ryan Kasun
I constantly find myself trying to draw parallels between my work life and personal life in almost everything I do and while I work in Quality and Regulatory for medical device manufacturers, I enjoy spending downtime playing fantasy football. Being that this weekend was the...
Read Moreon 18 January 2013 | By Ryan Kasun
One of the more personal aspects of why I work in regulatory and quality is because of my dad. As a youth, he experienced a hip injury. Combine that with a condition (don't ask - I never remember its fancy medical name) that causes weak capillaries, and that resulted in a...
Read Moreon 16 January 2013 | By Ryan Kasun
The other night, while I was drinking a refreshing beverage (neither shaken, nor stirred) and completely engulfed in an iconic (British) action-espionage movie, I began thinking of fingerprints (thanks to the movie's protagonist using spiffy spy gear to trick the baddies!) and...
Read Moreon 14 January 2013 | By Ryan Kasun
A few quick notes I wanted to post while clearing my inbox of my "informative reading" emails from last week:
Read Moreon 14 January 2013 | By Ryan Kasun
So I wasn't kidding last week about wearable tech, which made the biggest splash at CES 2013, an annual consumer electronics expo. Coverage thanks to CNET.com.
Read Moreon 14 January 2013 | By Ryan Kasun
There has been much controversy about the new RTA FDA Guidance document titled "Refuse to Accept Policy for 510(k)s". The draft of this guidance was issued for review in August of 2012 and was recently released at the end of that year. However companies are still talking about...
Read Moreon 10 January 2013 | By Ryan Kasun
January is usually that time of year where I start day dreaming about a vacation somewhere warm and sunny. California is always on the list. California has a lot more to offer than just its beautiful beaches and amazing sights. A recent article on the biomedical industry had...
Read Moreon 9 January 2013 | By Ryan Kasun
I wanted to write about an interesting event that a group of us at RQS had this weekend. One of our employees, Kathy Callan, is a professionally trained Fashion Consultant. Kathy is one of those people that always looks put together. She is walking evidence of her talent and...
Read Moreon 8 January 2013 | By Ryan Kasun
Training is an integral part of what we do at RQS, whether it’s one on one or in a more formal setting. Recently, as I talked with staff members at one organization, I realized that we needed to do a basic class on documents that make up the Quality Management System. As process...
Read Moreon 7 January 2013 | By Ryan Kasun
2012 brought many new challenges to my life. Some dealt with changes in my professional career, some dealt with personal losses of friends and family, but none were greater than becoming a parent for the first time. Being in Quality I'm accustomed to having some semblance of...
Read Moreon 4 January 2013 | By Ryan Kasun
Often enough, I'll hear or say, "It's just a bandage" (to avoid the popular brand-name bandage) in response to a solution that won't truly fix a problem or is just a temporary measure or bridge to the better solution. I had a thought today that it might apply to our current use...
Read Moreon 3 January 2013 | By Ryan Kasun
Happy New Year - I hope that all of our blog readers had a wonderful holiday and brought in 2013 with warm and welcoming arms!
Read Moreon 1 January 2013 | By Ryan Kasun
Every New Year, many of us take stock of our lives and make resolutions to live differently. We see January 1st as an opportunity for a fresh start. Whether it’s the chance to renew a friendship, correct a mistake, or take an opportunity that we may have previously missed,...
Read Moreon 28 December 2012 | By Ryan Kasun
Quite appropriate for the season, I found a little "gift" in my documents folder - a list of Regulatory Intelligence Sources! If I'm remembering correctly, these links may have come from the RAPS Online University program. This week's post: Alerts, Updates, and Newsletter...
Read Moreon 27 December 2012 | By Ryan Kasun
Have you ever received a gift that you didn’t really want? Was it an ugly sweater from Great Aunt Margie, or a holiday pillow that didn’t quite match with your décor? People always say, it’s the thought that counts… but if that was the case, gift receipts would not be so...
Read Moreon 21 December 2012 | By Ryan Kasun
I'll admit, I'm a sucker for the "Best of " everything for whatever reason. Why do I need to watch a mash-up of Gangam Style, Walk Off the Earth, and "Call Me Maybe"? The answer is "I don't", but I love it all. Sports stories, worst media sensationalist stories (such as today's...
Read Moreon 20 December 2012 | By Ryan Kasun
Seven years ago today, I waited by the phone. Waiting for the news that my niece had been born. This wait was much different for me than previous births. This was a nervous and unsure wait.
Read Moreon 20 December 2012 | By Ryan Kasun
As a native Clevelander and lifelong (i.e. 47 years) Northeast Ohio resident, I have heard my fair share of “Mistake on the Lake (Erie)” jokes. Yes, it’s true the Cuyahoga River caught fire in 1969, the city has suffered from loss of jobs due to de-industrialization, there have...
Read Moreon 19 December 2012 | By Ryan Kasun
When I first heard the words “biodegradable” and “electronic devices” together, especially in the context of nanotechnology and the medical field, the idea smacked ever so slightly of science fiction. You know, the sort of advancement that belongs in an era of teleportation and...
Read Moreon 18 December 2012 | By Ryan Kasun
In recent years, my father has picked up a new hobby of star-gazing. What started out, as I believe, as an excuse to get out of the house and away from the mother-in-law, has slowly turned into a full-fledged astronomical geekfest (no pun intended). So, for Christmas this year,...
Read Moreon 17 December 2012 | By Ryan Kasun
During this holiday season, when presents are being packaged and shipped at high volumes, I thought it would be appropriate to talk about the importance of labeling.
Read Moreon 17 December 2012 | By Ryan Kasun
I was going to write about China Labeling this week, but I didn't feel like it!
Read Moreon 13 December 2012 | By Ryan Kasun
I sat down tonight, as I do every night that I write a blog post, and I started reading the prior posts from my colleagues. I had every intention of writing on a different topic tonight, but something struck a chord with me when I looked through the blogs. They all had something...
Read Moreon 12 December 2012 | By Ryan Kasun
I’ve been working in regulatory for a company in which biocompatibility of device materials has been pretty straightforward and understood by all for many years. Annex A in ISO 10993-1 and FDA General Program Memorandum - #G95-1 is all you need. Check the chart for our device...
Read Moreon 11 December 2012 | By Ryan Kasun
My teenager works at a local eatery – I thoroughly believe the saying, “A good teenager is a tired teenager”. Besides, there is a lot to be learned from being in the work force.
Read Moreon 10 December 2012 | By Ryan Kasun
Let me start my blog off by stating that I personally love tracking politics. Presidential election years are my favorite, with all the debates, mudslinging, scandals and whatnot that comes with the elections. It's pretty much like watching your favorite reality tv show....
Read Moreon 10 December 2012 | By Ryan Kasun
In a bit of a change for today's post, I'm going to highlight some of the big news items that came through my inbox last week:
Read Moreon 6 December 2012 | By Ryan Kasun
Well how about that - software developers are making it easy on me to write this series with yet another 510(k) clearance announced this week. The latest in cleared mobile health devices? The AliveCor mobile heart monitor.
Read Moreon 5 December 2012 | By Ryan Kasun
About a week ago I read an article in Mechanical Engineering magazine that I found inspirational from several perspectives. Design-2-Part online magazine also covers the same story in this article.
Read Moreon 4 December 2012 | By Ryan Kasun
Yesterday, the United States Court of Appeals for the Second Circuit (based in NYC) made a 2-to-1 decision on United States v. Caronia (just one of many criminal cases pertaining to off-label use). This case even contained a supplemental briefing that had the litigants brief the...
Read Moreon 3 December 2012 | By Ryan Kasun
This past Thursday (11/29) several RQS employees were fortunate enough to attend the kick-off event for the Women in Bio Pittsburgh chapter which featured keynote speaker Alexandra Drane. Alexandra is the founder and Chief Visionary Officer at Eliza Corporation. The event was...
Read Moreon 30 November 2012 | By Ryan Kasun
In a fantastic case of science-fiction-meets-reality, Qualcomm created the X Prize Foundation to challenge developers and innovators to create a Star Trek Tricorder. The prize? $10M!
Read Moreon 29 November 2012 | By Ryan Kasun
Thanksgiving night I was standing outside in the cold in a line that wrapped halfway around Target. My motivation for this spontaneous Black Friday door-buster shopping was peer pressure, but I was also excited to take advantage of the great prices. Even though I wasn't in the...
Read Moreon 29 November 2012 | By Ryan Kasun
When people ask my opinion of the most difficult country to register medical devices internationally, I would have to say it is China. China is considered to be an “emerging market”- it is getting more and more lucrative to register there as the population gets larger and...
Read Moreon 27 November 2012 | By Ryan Kasun
Last week, I had a computer issue...not a big issue, more like an annoyance. Nevertheless, I dutifully called our IT support and after a couple of hours of investigation, we determined that the problem could be solved by one of two solutions; change the battery or change the...
Read Moreon 27 November 2012 | By Ryan Kasun
Why is it that anytime a project is underway that it seems as if quality is an afterthought? Why are Regulatory and Quality (R&Q) Engineers typically considered to only support the deliverables at the end of a projects launch? How can this be when they are working our tails off...
Read Moreon 21 November 2012 | By Ryan Kasun
Early in product development, it’s easy to be overly optimistic about designing a user-friendly device. The risk management process tends to be a reality check of sorts, often resulting in a tradeoff of usability for safety with the intent of mitigating risks. Design changes are...
Read Moreon 20 November 2012 | By Ryan Kasun
When you think of video gamers or computer gamers, what typically comes to mind? Out of the many images, word associations, and stereotypes that may have just gone through your head, I am confident that the words, “future robotic surgeon” were not included.
Read Moreon 20 November 2012 | By Ryan Kasun
My focus lately has wildly been on healthy eating, various diets and finding the true source of where our food comes from; behind the labeling/packaging, behind the marketing....what am I really eating? Prior to this new obsession food has always just been...food. Something I...
Read Moreon 20 November 2012 | By Ryan Kasun
On November 29th the Women in Bio (WIB) Pittsburgh chapter will be having its official launch event with guest speaker Alexandra Drane. This will be an interesting informational and networking event that a number of RQS employees are planning to attend. It is encouraging to see...
Read Moreon 16 November 2012 | By Ryan Kasun
In an odd turn of coincidence, I have been involved in more discussions regarding mobile security this week than I have in the life of the RQS blog. I took it as a sign that I should write about it.
Read Moreon 16 November 2012 | By Ryan Kasun
One challenge that many regulatory professionals face is finding applicable and relevant data to conduct their day-to-day activities. Regulatory intelligence is important in the constantly evolving healthcare industry for activities such as submissions, pre- and post-market risk...
Read Moreon 15 November 2012 | By Ryan Kasun
I have to admit, school doesn't teach you everything. During my first week at RQS, I was working with a client, and we were discussing labeling. She said I needed to get the bomb. Then, if I explode the bomb, everything will be good, and I'll have what I need. I left her office...
Read Moreon 14 November 2012 | By Ryan Kasun
Several years ago a good friend who knows my interest in human factors and engineering psychology gave me a book called Set Phasers on Stun and Other True Tales of Design, Technology, and Human Error, by Steven Casey. I started to read it again recently and wanted to share it...
Read Moreon 12 November 2012 | By Ryan Kasun
One of my favorite topics about the medical device industry and technology in general is innovation. Rebecca's post last week discussed the Medical Innovation Summit - "Innovative to the Bone" hosted by the Cleveland Clinic. Although I was unable to attend the event, I did find...
Read Moreon 9 November 2012 | By Ryan Kasun
To continue our product highlights within mobile health, we turn to Aycan's "Aycan Mobile" product which received clearance on September 12, 2012. A picture of its use on an iPad is shown on their website.
Read Moreon 9 November 2012 | By Ryan Kasun
Just the other day, I left work with high ambitions of going to the gym. However, when I walked out of the office, it was completely dark outside; it felt like the middle of the night. I instantly started second guessing my decision, I mean, it had to be almost bed time, right?...
Read Moreon 9 November 2012 | By Ryan Kasun
Quick note today as a training seminar came through my inbox.
Read Moreon 9 November 2012 | By Ryan Kasun
Last week, Regulatory and Quality Solutions participated in Cleveland Clinic’s 10th Annual Medical Innovation Summit – “Innovative to the Bone”! Each year, the Summit highlights different areas of specialization, with this year focusing on orthopaedics. It was our first year...
Read Moreon 7 November 2012 | By Ryan Kasun
When I was in high school, I was a speech geek. Every Saturday during the Forensics season I got up before the crack of dawn, met up with my speech and debate team, and drove to a different local school to compete in a public speaking tournament. The category I competed in...
Read Moreon 5 November 2012 | By Ryan Kasun
As a recently new professional in the medical device industry, I try to find any tips or tools I can use to gain more knowledge about the industry as a whole. Increasing my general knowledge of the field can only help me when I interact with other professionals. When thinking of...
Read Moreon 5 November 2012 | By Ryan Kasun
The topic of this week's post was a bit more challenging than normal. Ever since my inadvertent "reboot" of the Everyday Usability series, my brain was stuck in that frame of mind. Even today I struggled to break my mind from it.
Read Moreon 2 November 2012 | By Ryan Kasun
Trick-or-treating in my neighborhood was moved to Saturday this year because of Hurricane Sandy...therefore I needed a few Halloween jokes to keep me going until this weekend. Here you go:
Read Moreon 1 November 2012 | By Ryan Kasun
In the spirit of November’s highly anticipated Presidential Election, an important and multi-faceted question was raised during a recent RQS presentation. “How will the results of this year’s 2012 Presidential Election affect the medical device industry?”
Read Moreon 31 October 2012 | By Ryan Kasun
Have you ever felt like you were trying to do too many things at once and could really use a third hand? Like trying to answer the phone while carrying the groceries in (as the bags are breaking) while keeping the dog from escaping…. As our lives get increasingly busier, our...
Read Moreon 30 October 2012 | By Ryan Kasun
One issue that came up last week with a client was how to conduct a literature review and how important literature reviews were. I have experienced in some cases, companies that have a lot of man power behind the reviews but these companies do not have solid criteria for...
Read Moreon 26 October 2012 | By Ryan Kasun
This week my inbox was flooded by notifications of a great blog post from the Emergo group, outlining the changes set to occur to the medical device regulations in Europe. Changes such as:
Read Moreon 26 October 2012 | By Ryan Kasun
I couldn't resist the urge to post another picture in the Everyday Usability series after seeing this:
Read Moreon 26 October 2012 | By Ryan Kasun
I've often believed that the number of idioms and quirky phrases describing a particular characteristic, event, or circumstance is mostly equivalent to its frequency in everyday life.
Read Moreon 25 October 2012 | By Ryan Kasun
October is a very important month for women: It’s National Breast Cancer Awareness Month. There are many things to be proud of for how far we have come with treating breast cancer. The Susan G. Komen Foundation reports that the 5-year survival rate for female breast cancer...
Read Moreon 25 October 2012 | By Ryan Kasun
So you’re designing a new medical device and you want to gain a better understanding of how it will fit into your intended users’ workflow. Where do you start? Some common tools for user research that are particularly useful during early stages of design are contextual inquiry,...
Read Moreon 24 October 2012 | By Ryan Kasun
Last week, Regulatory and Quality Solutions, attended the first Great Lakes Venture Fair (GLVF). The fast-paced day-and-a-half event (Wednesday, October 17, 2012 and Thursday, October 18, 2012) was held in downtown Cleveland, OH and featured some of the highest potential...
Read Moreon 23 October 2012 | By Ryan Kasun
With recent clients I have been dealing more and more with new standards coming out or revisions being made to standards. This has got me thinking a lot about how to keep up with current standards. What is the best way of being notified of new releases of standards as well as...
Read Moreon 19 October 2012 | By Ryan Kasun
A good friend of mine in high-school was trying to understand the definition of a "hyperbole". Now, if Google would have been sophisticated enough at the time to include the "define:" feature, it would have returned the following for hyperbole: Exaggerated statements or claims...
Read Moreon 19 October 2012 | By Ryan Kasun
Every time I go home to visit my parents, one thing that comes up more often than not, is the fact that our local Blockbuster closed. It’s been about two years now, and they still can’t get over it. Me? I’m happy to rent from a RedBox, or even better, kick my feet back on the...
Read Moreon 17 October 2012 | By Ryan Kasun
The vast majority of us are familiar with Stan Lee and Steve Ditko’s Marvel comic book series, "The Amazing Spider-Man", where he would go web-slinging from here to there, in order to catch the baddies (of course, there is a lot more to this story than just that… but...
Read Moreon 16 October 2012 | By Ryan Kasun
I recently took a two week vacation to South Africa traveling to Cape Town, Prince Albert and various parts of the northern Western Cape. It was an absolutely amazing trip with many memories of time spent with my family. Traveling to a foreign country has shown me a lot of new...
Read Moreon 12 October 2012 | By Ryan Kasun
In the second of the two part series, we'll review support of the 2.3% tax of the medical device industry to go into effect on January 1, 2013. Earlier this week, I outlined why the industry sees this tax as an enormous burden and described actions already being taken to off-set...
Read Moreon 11 October 2012 | By Ryan Kasun
On Tuesday, I attended a Pittsburgh Technology Council event downtown titled “Medical Devices and the European Union: What does the Path of Entry Look Like?” which was sponsored by RQS! (We gave out stress balls in the shape of a pill!) I’ve posted a few times before regarding...
Read Moreon 11 October 2012 | By Ryan Kasun
Our neighbors located up the street from our Cleveland, OH location, at the Cleveland Clinic, have recently helped develop horse power into a whole new meaning. A Cleveland Clinic researcher found that one reason horses are more efficient at walking and running than humans, is...
Read Moreon 10 October 2012 | By Ryan Kasun
Since I’m in the middle of several usability testing projects right now, I thought this would be a great time to discuss some things to remember when moderating usability testing activities:
Read Moreon 9 October 2012 | By Ryan Kasun
Thanks to Sherri's earlier post, we've begun to explore the landscape of the medical devices industry in reaction to the 2.3% tax on revenue for medical device companies as a result of the Affordable Care Act. The tax is being implemented in part to fund the estimated 30 million...
Read Moreon 8 October 2012 | By Ryan Kasun
One major variable med tech companies are faced with today is the unknown of FDA reviewers. It seems like what works for one company doesn’t necessarily work for the rest. And why is this so?
Read Moreon 5 October 2012 | By Ryan Kasun
Part of the mission of the CDRH is to ensure medical devices are safe and effective. Based on the risk of the device and the agency’s familiarity with the device type, different levels of evidence are required to convince the FDA that a device is safe and effective.
Read Moreon 3 October 2012 | By Ryan Kasun
Many medical devices are meant to be used while in mobile situations. These devices could be wearable, carried in a user’s pocket or by hand, pushed like a cart, etc. Users of mobile medical devices expect them to be safe, reliable, durable, and easy to use while in motion or...
Read Moreon 3 October 2012 | By Ryan Kasun
After a recent statement by the EU health commissioner, it appears that FDASIA's influence may have gone abroad. As the medical device industry gears up and is adapting to the changes that FDASIA brings, it may also have to prepare itself for even more changes heading our way.
Read Moreon 1 October 2012 | By Ryan Kasun
Another thanks must go out to the Pittsburgh Technology Council for hosting RQS on their TechVibe Radio program. The PTC's CEO Audrey Russo and Director Visibility Initiatives Jonathan Kersting interviewed President Maria Fagan, Vice President Lisa Casavant, and Vice President...
Read Moreon 1 October 2012 | By Ryan Kasun
Mobile apps are absolutely exploding on the marketplace. It seems like so many business entrepreneurs are focusing on creating new apps that fit various needs such as games, music, organizational purposes and the list goes on. I recently read an article that discussed creating a...
Read Moreon 26 September 2012 | By Ryan Kasun
As if it isn’t challenging enough to design a medical device that can be used safely and effectively by a select group of individuals in a specific environment, the complexity increases when designing for international use by operators with diverse cultural backgrounds....
Read Moreon 26 September 2012 | By Ryan Kasun
I think it's high time we start profiling a few applications that have been approved for use by the FDA, discuss their functionality, and potentially profile the impending issues they may encounter.
Read Moreon 24 September 2012 | By Ryan Kasun
The Networking with Technology event hosted by the Pittsburgh Technology Council and Pittsburgh Social Exchange last Wednesday on September 19th was a success!
Read Moreon 20 September 2012 | By Ryan Kasun
Medical Device Companies are required to comply with various regulations, based on where products are marketed. As start-up businesses or established companies enter the medical device arena, sometimes quality systems and regulations are viewed as a painful part of doing...
Read Moreon 19 September 2012 | By Ryan Kasun
During recent usability testing of an updated medical device, I was reminded how important it is to set realistic expectations of medical device users when designing a product. Since the end users are the experts at what they do, it’s easy to think of them as having super-human...
Read Moreon 18 September 2012 | By Ryan Kasun
Several RQS employees will be attending the Networking with Technology event this Wednesday hosted by the Pittsburgh Technology Council and Pittsburgh Social Exchange. This event is taking place on Wednesday the 19th from 6:00-8:00 PM at the Rivers Club. The event will provide...
Read Moreon 13 September 2012 | By Ryan Kasun
Innovators are constantly being pulled in different directions on whether they should develop a product that ‘Stands Out’ or one that ‘Fits In’. It’s like middle school all over again! I’ll go through some of the challenges with choosing to develop a new state of the art device...
Read Moreon 12 September 2012 | By Ryan Kasun
Since this is my first contribution, let me give you the intro - my name is Mike Andreas and I am a Senior Quality Engineer with RQS. My background, aside from 5 years in the medical imaging industry, includes mechanical engineering, configuration management, and a lot of pizza....
Read Moreon 11 September 2012 | By Ryan Kasun
Hospital patients (and hospital staff) no longer have to grow weary of the constant due diligence of power cord avoidance (in fear of tripping on or becoming tangled in cords from the patient monitoring devices). Now, thanks to wireless medical devices, such as portable patient...
Read Moreon 10 September 2012 | By Ryan Kasun
I recently read an article that focused on describing what it takes for a company to create growth and improve its performance. So how can companies do more with less? This article describes several areas a company can focus on in order to become more successful in their...
Read Moreon 7 September 2012 | By Ryan Kasun
Thanks to the Pittsburgh Technology Council and their TechVibe Radio program, Regulatory and Quality Solutions will be on the radio this Saturday at noon. Hosted by the PTC's CEO Audrey Russo and Director Visibility Initiatives Jonathan Kersting, the radio program will provide a...
Read Moreon 6 September 2012 | By Ryan Kasun
We’ve heard it before: “There are two things certain in life: death and taxes.”
Read Moreon 5 September 2012 | By Ryan Kasun
Continuing our discussion about usability objectives from last Wednesday, a related question that comes up frequently is – What acceptance criteria should I use for my usability objectives? or Is it acceptable to have a usability objective of less than 100% success?
Read Moreon 5 September 2012 | By Ryan Kasun
Over the past 50 years, the advancement of technology has been beyond incredible. Although, we are not zipping around in flying cars, fearing the dreaded encounter with a hoverboard gang, or living amongst cyborgs, we are witnessing things never before thought possible. Such...
Read Moreon 4 September 2012 | By Ryan Kasun
Since I am a recent graduate and new to the work force, I wanted to discuss what exactly it takes to become a successful regulatory affairs consultant in the life science industry. Biospace wrote an article on this subject describing the five steps to becoming a successful...
Read Moreon 31 August 2012 | By Ryan Kasun
Pittsburgh Technology Council (PTC) is hosting a Breakfast Briefing on October 9th, 2012 to discuss important aspects on gaining approval and releasing medical device product in the European Union. The briefing will include a keynote by Paul Brooks of the British Standards...
Read Moreon 31 August 2012 | By Ryan Kasun
The core of strong organizations can be found in its mission and its vision. The Center for Devices and Radiological Health (CDRH), the body of the FDA dedicated to medical devices, strives, just like an private company, to be a strong organization. In an attempt to meet this...
Read Moreon 30 August 2012 | By Ryan Kasun
How long does it take to get device clearance through the 510(k) pathway? Does your 90 days seem to stretch into 160? What’s taking so long?
Read Moreon 29 August 2012 | By Ryan Kasun
Black and white. Yes and no. On and off. Absolutes. Extremes. Exactly what our sensationalist media involuntarily expects each of us to believe is absolute truth. And, thankfully, wisdom typically prevails with the ever-present maxim “The truth lies somewhere in between.”
Read Moreon 29 August 2012 | By Ryan Kasun
If you ever plan usability testing activities for a medical device, you may find yourself responsible for defining usability objectives. Today’s topic is - What makes a good usability objective?
Read Moreon 28 August 2012 | By Ryan Kasun
Recently, the little brother of my close childhood friend and his family experienced a dramatic, life-altering event. While serving in the US Army as a Commanding Officer of the Army Rangers, my friend’s little brother became a double amputee while on tour in Afghanistan.1,2...
Read Moreon 27 August 2012 | By Ryan Kasun
Yearly, the Pittsburgh Technology Council issues awards, the Tech 50 awards, for local technology companies to recognize the success and growth of the technology sector in the Pittsburgh region. RQS is pleased to announce that it has been nominated for a 2012 Tech 50 award in...
Read Moreon 27 August 2012 | By Ryan Kasun
Hello and welcome! This is the kickoff blog to RQS’s new daily blogging social media initiative. The purpose of this blog is to provide current, thought-provoking content about quality and regulatory affairs, life sciences and healthcare that impacts the Pittsburgh and Cleveland...
Read Moreon 24 August 2012 | By Ryan Kasun
As announced Thursday at a ceremony and reception hosted by Pittsburgh Business Times at the Duquesne Club, Regulatory and Quality Solutions was named the 4th fastest growing company overall in the Pittsburgh region, and 2nd fastest in the Professional Services category.
Read Moreon 5 April 2012 | By Ryan Kasun
Regulatory and Quality Solutions is in the news again, this time featured in the Pittsburgh Business Times. The article describes the Cleveland market and why it is an attractive location for the first branch office of RQS. The article can be found online here.
Read Moreon 5 April 2012 | By Ryan Kasun
Effective June 5, 2012, FDA will begin a voluntary pilot program to accept voluntary submissions of external audit reports compiled by one of the founding members of the Global Harmonization Task Force (GHTF). Said audit reports will be reviewed by the FDA to determine whether...
Read Moreon 4 April 2012 | By Ryan Kasun
BSI is hosting a webinar on April 24th, 2012 at 11:00 AM on the 7 common mistakes of medical device startups. I would anticipate that their information stems from their work as a notified body for manufacturers seeking market clearance for Europe (in which case, this information...
Read Moreon 18 January 2012 | By Ryan Kasun
After a small hiatus, the Mobile Medical Apps blog series is back! Today we'll take a look into wellness and weight-loss applications.
Read Moreon 2 December 2011 | By Ryan Kasun
Our third installment of the mobile medical apps series finally features a mobile medical app. This app in particular, the MediCal QAWeb Mobile app, is used to calibrate the screen of an iPad for diagnosis of medical images viewed on said iPad (both versions 1 and 2 according to...
Read Moreon 28 November 2011 | By Ryan Kasun
As with all software and technology, security is, and will always remain, a hot-button topic. It is even a point of contention for computer consumers - Mac vs. PC debates often will focus on how Mac's don't "need" virus protection (which is somewhat of a misnomer, but certainly...
Read Moreon 22 November 2011 | By Ryan Kasun
It has been predicted by many technology pundits that smartphones will be in everyone's hands within the next few years. Of course there will be different flavors of smartphones to adjust to different consumer ranges, but the way of the numpad flip-phones will be left to the...
Read Moreon 18 November 2011 | By Ryan Kasun
Well folks, our Everyday Usability photo series has come to an end with this final post. Today's blog post, in line with last week, is the nuance of language. For example, I "googled" the term "Usability" to be inspired by pictures of usability for the post. Alas, I needed the...
Read Moreon 24 October 2011 | By Ryan Kasun
As announced last Wednesday, October 19th, 2011, Regulatory and Quality Solutions LLC placed 25th of the 78 nominees for "Best Places to Work in Western Pennsylvania in 2011.
Read Moreon 24 October 2011 | By Ryan Kasun
For our penultimate edition of Everyday Usability, we take a look into what the future of Usability could look like. What better way to improve usability than to remove the physical interface altogether and implementing voice control of medical devices?
Read Moreon 11 October 2011 | By Ryan Kasun
Good morning blog folks! I greet you this morning with a familiar topic from the early part of this usability series: Colors! (or "Colours!" for those of our readers who favour the use of "u" in said words).
Read Moreon 10 October 2011 | By Ryan Kasun
Biotech's slow coup of the mobile industry never ceases to amaze me. In this latest piece of news, the addition of a simple (and cheap) ball lens to the iPhone camera creates a microscope strong enough to view details at the cellular level. It is being touted as the perfect...
Read Moreon 5 October 2011 | By Ryan Kasun
As some who know me would tell you, my mind happens to wander at times about a variety of topics. The subject of this mental galavant happened to be the current regulatory landscape in the United States - specifically the FDA's new outlook of regulation and greater enforcement.
Read Moreon 30 September 2011 | By Ryan Kasun
A great example of usability engineering is right in front of us every day (especially as we become a more technological society): electrical outlets!
Read Moreon 29 September 2011 | By Ryan Kasun
When designing medical devices it is important to identify use-related hazards as early in development as possible so that mitigations can be developed into user interface requirements, incorporated into the design, and then tested for effectiveness. The recently released draft...
Read Moreon 26 September 2011 | By Ryan Kasun
In light of the recent drafts of the FDA's regulation and guidance for controlling mobile apps, it is the Federal Trade Commission (FTC) handing down fines to app developers for false claims.
Read Moreon 20 September 2011 | By Ryan Kasun
Here in our tenth edition of Everyday Usability, we'll discuss the usability of bathrooms!
Read Moreon 19 September 2011 | By Ryan Kasun
My son was watching Disney's Beauty and the Beast in the car this weekend and I noticed, being the complete nerd that I am, that Belle and the Beast conducted a pretty good root cause analysis:
Read Moreon 8 September 2011 | By Ryan Kasun
Last week, I guided a client and their software developer through a notified body audit. Thankfully, this particular developer was well polished (albeit not ISO 13485:2003 certified) resulting in a smooth and quite impressive audit result. The length of the audit was far shorter...
Read Moreon 7 September 2011 | By Ryan Kasun
Yankees - Redsox. Democrats - Republicans. French - British. Google - Apple. They find themselves in perpetual disagreement; however, I'm sure there is one topic on which no one will disagree:
Read Moreon 1 September 2011 | By Ryan Kasun
Regulatory and Quality Solutions, LLC was recently announced as a nominee as one of the "Best Places to Work in Western Pennsylvania". The announcement of the winners will occur later in Fall 2011. The RQS blog will provide updates with any web-based news stories prior to the...
Read Moreon 1 September 2011 | By Ryan Kasun
On 8/29/2011, the FDA issued a Draft Guidance recommending changes to monitoring practices in clinical trials. The earlier 1988 Guidance recently was withdrawn and building on the spirit of ICH E6 (1996), the FDA recognizes the desirability of increased monitoring flexibility in...
Read Moreon 31 August 2011 | By Ryan Kasun
I was discussing quality system documentation with a colleague yesterday when it dawned on me that usability can (and should) apply to quality systems. An example I later identified is shown below:
Read Moreon 30 August 2011 | By Ryan Kasun
Mobile medical applications are revolutionizing the way that healthcare is delivered across the world. In fact, it is estimated that by 2015, 500 million smart phone users worldwide will be using a health care application (app) on their Smartphone or tablet [1]. Mobile medical...
Read Moreon 22 August 2011 | By Ryan Kasun
There must be something about the simplicity and innocence of children that is particularly inspiring when it comes to usability. Clearly, it is a frequent inspiration for this picture series and this week's post is no exception.
Read Moreon 18 August 2011 | By Ryan Kasun
In the July 29th to August 4th edition of the Pittsburgh Business Times, Kris B. Mamula writes about Ortho-Tag, Inc., a McKees Rocks company that has created an RFID (Radio Frequency Identification) tagging system for implants. The technology will revolutionize the information...
Read Moreon 15 August 2011 | By Ryan Kasun
Have you ever felt like an idiot for walking straight into a doo
Read Moreon 10 August 2011 | By Ryan Kasun
The Institute of Medicine (IOM) has released their latest report regarding their review of the 510K process as requested by the FDA. Recall the FDA requested that the IOM review the 510K process on several specific areas to assess the process with regard to protecting the public...
Read Moreon 9 August 2011 | By Ryan Kasun
Ever attempt to open a carton of milk, but end up splitting the lip of the carton? Of course, the frustrating battle ensues as you struggle to migrate that final sliver to the other side. Clearly, our pain was heard! Companies began to sell their milk with convenient plastic...
Read Moreon 8 August 2011 | By Ryan Kasun
Please join me in welcoming team member Scott Wright, Principal Regulatory and Quality Advisor, to RQS!
Read Moreon 2 August 2011 | By Ryan Kasun
The United States Food and Drug Administration (FDA), in an attempt to further the safety of the nation’s medical data systems, issued the final rule for the reclassification of medical device data systems (MDDS) on February 15th, 2011 and went into effect on April 18th, 2011....
Read Moreon 1 August 2011 | By Ryan Kasun
Prior to becoming a parent, I prepared for many things - diapers, late nights, regurgitation (to be light) - and have experienced them all (plus the many wonderful moments!) in my 13 months as a dad. What I wasn't consciously thinking about were toys - loads and loads of toys...
Read Moreon 25 July 2011 | By Ryan Kasun
Our VP, suffering from a terrible cold last winter, decided that the best remedy would be the DayQuil/NyQuil dual pack. Perfect, right?! Symptoms dealt with day and night with the added bonus of deep sleep. Alas, the development at Vicks clearly didn't realize that the NyQuil...
Read Moreon 20 July 2011 | By Ryan Kasun
The Double Wide Grill is an eclectic eatery on Carson Street in Pittsburgh's South Side Flats. Apart from its wonderful culinary offerings, it also offers a fantastic example of usability for this week's post (and, no, not all of these posts will be inspired by restaurants, I...
Read Moreon 17 July 2011 | By Ryan Kasun
Lisa Casavant, Vice President of Regulatory & Quality Solutions, was quoted in a recent article in the Pittsburgh Business Times. In the article, Casavant spoke on the impact of usability on the medical device industry. Usability has become a focus of the FDA and Europe as it is...
Read Moreon 12 July 2011 | By Ryan Kasun
Today begins Regulatory & Quality Solutions' first picture series titled "Everyday #Usability". The intent of the series is to post images from everyday life that emphasize the importance of usability. There will be examples of both poor and great usability. This week's post?...
Read Moreon 6 May 2011 | By Ryan Kasun
Regulatory & Quality Solutions adapts business model to economy
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