Stephen Wilcox

Stephen B. Wilcox, Ph.D., FIDSA

I thought I would begin this blog with a discussion of a New Yorker article.

What does this have to do with medical-device usability?  Let me explain.

I’ve spent the last 25 years or so mostly working with medical-device development teams in new product development, and I can report that one thing nearly every team does at some point is “brainstorm”. The purpose of brainstorming is to add the magic of “new ideas” to the mix.  No matter how careful you are; no matter how much intellectual horsepower you bring to...

March 7th, 2012

It's no secret that China's domestic medical technology industry is a juggernaut in the making. Yet more evidence is provided by Helen Zhang, Associate Editor of China Medical Device Manufacturer, in a post on the medtechinsider blog. A number of life science sectors represent an investment gold mine, she writes in her article titled "Investors Seize Opportunities in China's Healthcare Industry."

Financial expert Wang Guochang introduced the recent 2012 China-International Supreme Forum of Medical Industry Investment and Financing by noting that more than 100 healthcare entities attracted a collective investment amount of RMB 25 billion in 2011. The medical technology industry was the fourth largest recipient of investment capital in the country, he told...

March 7th, 2012

Stuart KartenAs the Connected Health movement gains traction, there are many products developed to help people track and improve their health and fitness. Connected Health products let their users monitor vital signs, track calories consumed and burned, or connect easily to loved ones, doctors and caregivers. But in return, many devices ask people to change their behaviors—to wear new devices, input data, and track information.

Leaders in the Connected Health space admit this field is in its infancy and question when its connected, mobile devices will surge beyond a small market of quantified selfers and early adopters, into the mainstream. I think this will happen when more Connected Health product manufacturers pay as much attention to their end users as they do to their...

March 5th, 2012

This Week in Devices

  • "By 2017, mobile technology will be a key enabler of healthcare delivery, reaching every corner of the globe," reports an article by EMDT, which includes insights on mobile health from Jeanine Vos, executive director of mHealth at GSMA. 
  • An implantable sensor featured on medtechinsider provides surgeons with detailed, real-time information from a surgery site could lead to more accurate assessments of a patient’s recovery. 
  • To bring additional attention to the possibility of medical device hacking, a McAfee research architect has announced a means of remotely inducing a lethal attack on an insulin pump user, reports MPMN.
  • Is Boston Scientific in line for a private equity takeover? asks Massdevice.
  • ...
March 5th, 2012

For this feature, Bill White, Senior Consultant, Quality System Strategies LLC discusses how to go beyond compliance to achieve real value from quality manuals.

1. How can we get maximum value from our quality manual?

The quality manual should aim beyond just documentation of compliance.  Success in a quality management system can happen only if "quality is everyone's business."  If the quality manual is just a document pulled out by the quality staff for discussions with auditors, it cannot provide maximum value for the organization.  It needs to be a document for everyone.

2. How do we make our quality manual a document for everyone?

There are a few key actions:

  • Make it understandable. Use everyday language and not "qualityspeak."
  • Make it short enough to read in an hour or less. Don't try to include all quality management system details.  Save details for the next level of...
March 1st, 2012

Proto Labs has released a book “Injection Molding for Dummies,” written by Tom Tremblay. The group worked with the “For Dummies” people at Wiley & Sons Inc. to create an easy-to-understand guide to the injection molding process. And it pays off.

Is it everything you ever wanted to know about injection molding? Actually, yes, depending on your job description. The book provides a very thorough overview of the process designed to help medical device designers, for example, get enough information about the process to help them talk to molders intelligently. Proto Labs provides CNC machined and injection molded parts. Its Firstcut and Protomold services use proprietary computing technologies and automated manufacturing systems to provide prototypes and...

February 29th, 2012

In 2011, the latest versions of IEC 60601-2-25 ed. 2.0, Electrocardiographs; and IEC 60601-2-27 ed. 3.0, Electrocardiographic Monitoring Equipment, were released. Both standards have the identical test for defibrillation protection, and they have been significantly revised from their previous versions for this test. A new switch, named S3 in the standard has been added, a resistor value has been changed from 470k to 390k, and the circuit topology has been changed, for the common mode test. For both common and differential mode tests, the test requires that the test pulses be delivered in a proscribed time period of 20 seconds between pulses. For the common mode test, five pulses of each polarity are delivered with 20 seconds between pulses. For the differential mode test, the test is repeated for each lead wire in turn, until all lead wires are tested.

February 28th, 2012

Bill BIll BettenBetten recently attended the 5th International Advanced Technologies and Treatments for Diabetes (yep, the poor guy just had to go to Barcelona). Afterwards, he was kind enough to provide MD+DI with his observations from the event, highlighting trends in the sector.

What were some diabetes trends that you noticed?

A keynote talk was given on “What Next for Diabetes Technology: Strategic Directions for the Next 10 Years,” by J. Pickup of London. The five highlighted buzzwords included cost effectiveness, nanomedicine, mobile health, optical sensing, and closed-loop insulin delivery. A point that he made is that insulin pumps, for...

February 28th, 2012

When was the last time your company spent money on market data? How much did it spend and—perhaps most important—what did you do with the data? Research is useless unless it inspires timely action.

But access to actionable data is rare in the medical device industry. Research reports can be obtained, sure. But often the materials that companies pay $1000–$4000 for comprises charts and analysis cobbled from public data, and perhaps a survey. The analysis of such reports might be interesting, but they provide only a snapshot.

What is really needed is a system that helps build a business plan. A universally recognized data source with the capability to capture a complete view of the medtech industry has been a key missing ingredient. That’s why UBM Canon decided to seek...

February 24th, 2012

The hype over “bioabsorbable” stents has heightened after Abbott’s vascular stents obtained a CE mark last year and will reportedly soon be available in Europe. But, here in Japan, a very small company has already developed its own version of bioabsorbable stents. The Japanese stents garnered a CE mark in 2007, and are now sold in 11 European countries and Turkey.  

It’s amazing that the virtually unknown Kyoto-based company is in the vanguard on bioabsorbable stent development.
When I interviewed company president and co-developer of these novel stents, he showed great pride and confidence in his stents, but he also suggested he wanted to keep a low profile in the U.S. Why is that? He replied jokingly, “We don’t want to be like Gulliver in Brobdingnag, [the fictional land in Jonathan Swift's satirical novel Gulliver's Travels occupied by giants.]”
For more about what he has to say about...

February 21st, 2012