Oct 26, 2016
Oct 25, 2016
|Developing a new device is not as easy |
as it used to be. You must understand
the entire product development
process to be successful
by Tom KraMer
President & CEO
Do you have a great idea for a new medical device? It's not as easy to get a product to market as it used to be. Following these five design research steps may successfully bring your device to market.
You Must Think About How Devices Get Purchased
Medical device technology today is fascinating. 3D printing tissue, robotic surgeons, and laser procedures are fabulous technologies that we all get excited about.
All too often however, medical device developers become so enthralled with their technology that they forget to think about how their device will be purchased. Who will make a purchasing decision, and what will the process be? It is good to know the answers to these questions if you want your device to even have a remote shot at success these days.
Oct 20, 2016
by David Jensen
Ever wish you could have a do-over? Wouldn’t it be nice to be able to go back in time to change or undo some event? Or what about going to a future time? Nothing illegal, maybe just to avoid the lines and hassle of getting a ticket to the next episode of Star Wars.
If you’re in quality management and an auditor hands you a list of inspection observations or a warning letter, the notion of going back in time might seem appealing.
Actually, Jules Verne and H.G. Wells aside, when it comes to quality management, the whole space-time continuum thing might not be so far-fetched. With the changing regulatory landscape and manufacturing processes, manufacturers are exploring more effective ways of managing quality. Companies hoping to sustain productivity and momentum while staying compliant are applying more of a closed-loop approach to quality, which, in essence, is a form of time travel.
Oct 19, 2016
|The sponsor-CRO relationship is not |
always a win-win but parties should
strive for a positive outcome.
by Craig Morgan
Head of Marketing
By 2020 72% of clinical trials are anticipated to be outsourced, up from just 23% in 2012. Sponsors are seeking cost reductions, access to specialized knowledge, and increased speed and agility. Meanwhile, CROs focus is on business goals related to economic outcomes for their owners, investors and shareholders. Each group is expecting deliverables and timelines to be met or exceeded for potentially different business reasons, leading to a traditional client/vendor-type relationship. Though alliances and partnerships are increasing, there continues to be a client/vendor mentality at the operational and management levels, which perpetuates a lack of trust and empowerment.
Oct 18, 2016
by Cindy Fazzi
Patch Adams, the physician famously played on the silver screen by Robin Williams, urged IT professionals to help build an ethical and nonviolent world during his keynote speech at the 2016 Masters Summit in Salt Lake City.
“The IT world offers the strongest possibility for a revolution. You’ve made the world your living room. Let’s do something,” said Adams, a family doctor, humanitarian, activist, author, and clown. He spoke to a standing-room only crowd about what he called the “most radical medical project in the world.”
More than 500 people attended the ninth Masters Summit, MasterControl’s premier annual educational conference for its customers. This year, it was held in Little America Hotel in Salt Lake City, from Oct. 11-13, 2016.
Oct 13, 2016
|Planning for disaster will |
keep your supply chain
from sliding into
The Dark Side.
by Ed Rusch
Vice President, Corporate Marketing
Hurricanes. Power outages. Socio - geopolitical upheavals. Train derailment. Road closures. Contamination in a supplier facility. Terrorism, cyber-attack, sabotage or industrial espionage. Labor unrest. Global pandemic. Fires, floods and natural disasters. These incidents are not a work of science fiction and the number of them that can negatively affect the supply chain are real and virtually limitless.
Sometimes there are advance warnings; sometimes not. Some events are highly unlikely ever to occur; others are probably just a matter of time. The severity of impact might affect only a small area, or an entire business sector, or it could be (or become) catastrophic.
Oct 6, 2016
|Efforts to promote safe, effective |
products go back 300 years!
by Lisa Weeks
Editor’s note: This is part one of a two-part series.
Fall is officially upon us, and we are settling into a new school year. As a child, I loved the beginning of school. It signified a fresh start—new teachers, new clothes, new school supplies. I'm dating myself here, but was there anything better than a brand spanking new Trapper Keeper®?
For those of you who don’t know, the Trapper Keeper was THE 80s school supply must-have: an ultra-cool 3-ring binder with an outer shell (the “keeper”) that held glossy primary-colored folders (the “trappers”) and featured a fold-over Velcro closure to keep it shut.
Oct 4, 2016
|21 CFR Part 11 is one of the FDA |
regulations and initiatives that
helped modernize compliance
for life science companies.
by Cindy Fazzi
Editor, MasterControl Insider
Not too long ago, regulatory compliance meant color-coded stamps for various documents, gigantic cabinets for storing files, and truckloads of paper documents for FDA submissions. The advent of 21 CFR Part 11 signaled the movement toward automation. It’s one of 16 regulations and initiatives that helped modernize the compliance process for life science companies.
Matt Lowe, a mechanical engineer and medical device industry veteran, describes the struggles of life science companies in the old days of manual processes in his newly released e-book, “Convergence of Compliance and Technology.”
In his first job as a product development engineer at a medical device firm, the change control process for getting a new drawing through the system resembled an obstacle course that required a lot of time, effort, and patience. The simple act of document submission was anything but simple.
Sep 29, 2016
|There's a treasure trove of PMS |
data you're probably not using.
By Lisa Weeks, Marketing Communications, MasterControl
Medical device companies are required to conduct postmarket surveillance (PMS) on their devices to maintain high product quality and safety. However, few companies realize the true value of the digital feedback they receive. In this post, we will explore current best practices for collecting and interpreting postmarketing intelligence, and discuss how you can use the information you acquire to gain a competitive advantage.
Sep 27, 2016
|These do's and don'ts will help you|
engage with customers compliantly.
by Lisa Weeks
Marketing Communications, MasterControl
Is the FDA starting to get serious about how medical devices and prescription drugs are being marketed on social media? Many experts think so, citing Kim Kardashian’s highly publicized misleading endorsement of the morning-sickness medication Diclegis® as an example. The offending post, which appeared on the reality star’s personal Instagram page, earned drug maker Duchésnay a warning letter, demanding an immediate retraction. The post was promptly removed—after it had garnered 450,000 likes from Kardashian’s over 42 million followers.
Sep 23, 2016
|The Medical Device Directive (MDD) |
is being recast as the Medical
Device Regulation. It's time to
learn some new rules.
by Linda Chatwin, Esq, RACUL, LLC Senior Customer Solutions Consultant
It’s coming – and at this point, nothing will stop it. The Medical Device Directive (MDD) is being recast to a regulation – the Medical Device Regulation (MDR). It has been over four years in the making and the EU countries have spent many hours (actually over four years) working to agree on its Consolidated Negotiated Text.
Since the MDR is now a regulation as opposed to a directive, the member states in the EU are bound to abide to it – giving it strength equivalent to the FDA’s CDRH regulations in the US. The EU is the world’s second-largest medical device economic area/region, and the regulation, felt to be long overdue, will regulate devices not only manufactured and marketed within the EU, but also devices that will be imported into the EU. The regulation includes rules for determining device classification, requirements for quality systems, obtaining pre-market authorization, and monitoring device performance in the field, including reporting of adverse events.
Sep 20, 2016
|Data integrity is important to the |
quality control laboratory because poor
practices can allow for substandard
product to reach patients.
by Joanna Gallant
Owner/President, JGTA, LLC
Because of the multitude of problems being found in regulatory agency inspections, data integrity is a hot issue for regulators around the world today. Data integrity is critically important to regulators for a variety of reasons, including patient safety, process and product quality. The integrity and trustworthiness of the data provides a baseline for the regulators opinion of the personnel and the company as a whole.
Data integrity is of particular interest in relation to the quality control laboratory and the handling of OOS results, because poor practices can allow for substandard product to be put into the hands of patients. But the same holds true for any other area that generates or controls data – including IT, R&D, manufacturing – any data integrity failures from these areas can also impact patient safety, product and process quality effects.