Memo to EU Member States: Don’t Derail UDI
WELL, THAT WAS FAST. At its March 2013 meeting in Nice, France, the International Medical Device Regulators Forum (IMDRF) announced that it would release guidance on a unique device identification (UDI) system for public consultation in the “near future.” That is usually code for, &ldq...
Medical Packaging Innovators Form a Community
WORK-AROUNDS HAVE SAVED MY LIFE in publishing more than a few times, but
in the medical realm—where lives literally are at stake—they are not always a good
idea. This point was brought home during a conversation about sterile medical packaging
that I had at MEDTEC Europe....
And for My Next Trick, I Will Make Your Implanted Electronic Device Disappear
With apologies to Paul Simon and minus the layers of ambiguity that infuse his pop masterpiece, it does seem like we are living in the age of miracles and wonder, when “medicine is magical and magical is art.” Consider transient electronics.
Once upon a time, built-in obsolescence had...
Editorial: Wachstum trifft auf Fachkräftemangel
Der Arbeitsmarkt sowie die Karrieremöglichkeiten in der Medizintechnik-Industrie sind hervorragend. Hier trifft Wachstum auf Fachkräftemangel. In der Entwicklung sind insbesondere Ingenieure der Medizintechnik, Elektro- und Maschinenbauingenieure sowie Biotechnologen, Biologen und Chem...
The Good, the Bad and the Ugly
There was plenty to talk about at MedTech Forum 2012, from the new medical device regulations to business models that are “changing fast and forever,” to quote Chris Llewellyn from McKinsey & Co. Here are some random thoughts inspired by the meeting, organised by Eucomed and the Eu...
Medtech’s Prime Directive
Thanks to Google, I was reminded the other day of the 45th anniversary of the first Star Trek TV show. Not being a Trekkie, I don’t have the show's milestones committed to memory. So thank you, Google and your delightful doodle, for bringing that to mind. There is much to lampoon about the o...
Tech Barbarians at the Medtech Gates
Some 40,000 medical-related apps are available for download, and countless more are on the way, which begs the question: How do you reconcile the regulatory requirements that govern medical devices with the fas...
Illegal Implants, Ill-Conceived Laws
We knew that the Poly Implant Prothèse (Pip) breast implant scandal would affect device regulations, but there was uncertainty about its scope. The so-called Pip resolution, drafted by the Environment an...
Cell phones have become our lifelines, and not just metaphorically. Smartphone users are expected to download some 44 million mobile health, or m-health, apps in 2012, according to Juniper Research. By 2017, th...
Pip Implant Scandal: Fix What’s Broke. Then Stop.
Here are two headlines you don’t want to read: “Medical Devices and Chinese Toys Share Same Level of Safety Checks” and “The Terrifying Story of How a Former French Butcher Earned Millio...
What it Costs to Operate a Medical Device Plant: Total Geographically Variable Operating Cost Ranking
Source: The Boyd Company Inc.
What it Costs to Operate a Medical Device Plant: The Highs and Lows
(1) Includes all major geographically-variable operating costs for a 325-worker medical devices plant.
(2) Includes property and sales/VAT taxes.
Source: The Boyd Company Inc.
The Relative Costs of Doing Business
Did you know that it costs approximately twice as much to operate a medical device manufacturing facility in Munich as it does in Sioux Falls, South Dakota, USA? Running that plant in Sioux Falls will set you b...
Don’t Stop Thinking about Tomorrow
“Nobody, including myself, would dispute that the medtech industry is a bastion of strength compared with other industry sectors in the current state of economic turmoil,” writes Joerg Kruetten, Exe...
Scavengers of the Heart
In my lifetime, artificial pacemaker technology has evolved from an external device with vacuum tubes that powered up via a wall socket to today’s tiny implantable devices with batteries that run for five...
The Innovation Paradox
Penny wise, pound foolish . . . I’ve always enjoyed the stark simplicity of that expression, which encapsulates an enduring truth. How this myopic mindset engenders an innovation paradox in the medical te...
A Patently Absurd Situation
There is a European Patent Office, but, as I am sure you are painfully aware, there is no single European patent. Instead, as noted recently in the Financial Times, there is simply a “basket of national p...
Plaidoyer en faveur d’un brevet unique
Innover ou mourir : jamais cette expression n’a sonné aussi juste. Et ce n’est pas pure vue de l’esprit que de formuler un tel dilemme à propos des mécanismes de protectio...
The Formal Objection of the European Commission to 11 medical device standards has caused a certain amount of consternation and even alarm. The initiative has the potential to seriously undermine the EU regulat...
I Was Just Thinking…
Now that we have landed squarely in 2011, I thought it might be an opportune moment to put together a to-do list for Europe’s medtech community. Here goes.
Learn Mandarin. Not content with being the world’s factory, China is ramping up innovation initiatives. The Medical Technology Inno...
The Celtic Tiger Is Alive and Well and Living in Galway
It was not a good year for Ireland, to be sure, but the commotion surrounding bailouts and bubbles did drown out some encouraging news. Specifically, Ireland’s medical technology sector and associated supply chain, much of which is clustered in and around Galway, fared remarkably wel...
Being old is cheap. It’s dying that’s expensive. With that curt observation, Sweder van Wijnbergen, PhD, got my full attention as he delivered the keynote speech at the Eucomed MedTech Forum in Brussels in October. A noted economist who earned his doctorate at Massachusetts Insti...
One Day, You Will Spit on Your iPhone
Remember when a phone was just for calling people? How quaint. We are living in the age of convergence, and healthcare, more than any other technology, exemplifies that in the minds of many. That is one of the perhaps surprising results of a survey conducted by Cambridge Consultants.
When asked whi...
A Matter of Life and Death
“Surveys of patients with terminal illness find that their top priorities include, in addition to avoiding suffering, being with family, having the touch of others, being mentally aware, and not becoming a burden to others. Our system of technological medical care has utterly failed to meet th...
It was 20 years ago…
…NOT TODAY, GRANTED, and that does muddle the cadence of the sentence, but at my age it’s difficult to resist a Beatles reference. Be that as it may, Medical Device Technology (MDT) magazine was launched two decades ago in January 1990. It was followed shortly by International Medical D...