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StarFish Medical October Newsletter
featuring Industry Insights, FDA News, How StarFish got its name,
Zephyr Sleep interview, and Using touchscreens in medical devices

Message from the President


Ever wonder why we're called StarFish? Check out my video for the key "points".



Also in this issue: a great new blog on the use of touchscreens in medical devices, Industry Insights, FDA Guidances, and results from our September survey.

As always, thanks for reading.


Scott Phillips, President

A touchy subject: The (mis)use of touchscreens in medical device development

Picture this: you are in a meeting with your client setting requirements for their new medical device and the subject of the user interface comes up (and I mean the interface, not the GUI). Of course the client wants a sexy solution to his/her device, therefore a touchscreen must be the solution.
READ MORE »


Busy end of the year for FDA

In August and September, the FDA issued several final guidances and drafts that will impact medical device companies at different stages of the product development and manufacturing.
READ MORE »

Finding and Accessing Alternative Funding for Your Medical Device Development Program
Mark Drlik, StarFish Medical Mechanical Engineer, speaks tonight, Tuesday October 1, 2013 5:00 p.m. - 7:00 p.m.  Part of the MDCC Educational Series.

CEO Q&A

Zephyr Sleep Technologies

 
Survey Results

What are readers seeking? 

 
Medical Industry News

Insights from StarFish staff

Paul Cataford, Zephyr Sleep Technologies CEO, talks about the North American roll-out of MATRx™ - the company’s Medical Device for determining whether oral appliance therapy will treat Obstructive Sleep Apnea.  We caught up with him on the road for an update.

READ MORE »

 

Our first newsletter survey garnered responses from a variety of readers, with about a third each from General/Corporate managers and Research & Development.  There was a similar split between Startup/Pre-revenue organizations and Manufacturers of Finished Medical Devices.

READ MORE »
 

FDA Operations during the Federal Government Shutdown

As of October 1 and continuing until the enactment of an FY 2014 appropriation or Continuing Resolution, FDA operations will be limited to the following:

o       Emergency work involving the safety of human life or the protection of property;

o       Criminal law enforcement work; and

o       Activities funded by 2013 Medical Device User Fee carryover.

During this time, FDA will not have legal authority to accept 2014 user fees.   
This means that until operations resume, FDA will NOT collect any 2014 user fees and will NOT be able to accept any regulatory submissions for FY 2014 that require a fee payment. 




Busy end of the year for FDA (cont'd)

The agency clarified expectations in regards to GLP compliance in animal testing and the UDI requirements in manufacturing. Two of the guidances address clinical trials - specifically IRB responsibilities and oversight of Clinical Investigators. For software engineers, key guidances cover wireless technology and mobile apps.

I highly recommend that you review all guidances that may impact your operations. For more information, check out Kenneth MacCallum's blog on 6 Areas to Watch in FDA's Wireless Guideline for Medical Device Development, this issue's Industry Insights from Vincent Crabtree and the Links to FDA website provided below.

Vesna Janic
Director of Quality/Regulatory at StarFish Medical




A touchy subject: (cont'd)

Furthermore, it has to be sleek and shiny so it must be capacitive and further still, he/she wants a massive screen size. Most people with smartphones demand this kind of interactivity and sleekness be implemented into their devices, forgetting about the whole reason for the screen in the first place: to tie the interaction between the user and their device.

When it comes to interfaces, whether they are a hard plastic button or a digital one on a screen, less is always more in medical devices. Listening to your users who live and breathe these devices everyday instead of marketing's penchant for shiny things (and we designers love shiny things!) is always a wise choice. A good example of this came out a few years back during a research session with ultrasound technicians at a hospital. We wondered why they still preferred to use their older style ultrasound carts with the trackball and big tactile buttons instead of the new, much sleeker looking carts with touchscreens. They explained that while the new carts were nicer to look at, they missed a big mark when it came to the workflow of a typical ultrasound tech: they don't look at where their fingers are during a screening and therefore rely on tactile feedback to tell them what they are doing. As we all know this is an area that touchscreens fall short: ever tried to text someone on your smartphone without looking at it? Practically impossible. Therefore out into the hall of shame (literally), go the sleek carts, joining the hospital's other unused medical devices.

So let's say you get past this and touchscreens are the definite choice, then there is the issue of technology. Many wonder why most medical devices still opt for the resistive flavour over capacitive. This really comes down to numbers. While resistive screens are generally the older, uglier and clumsier sibling of capacitive screens, they are more established and therefore reliable sources of reputable suppliers are more readily available. In order to obtain regulatory approval for your device you'd prefer to source parts that will be available for a minimum of 5-7 years to minimize production disruptions. Sourcing a cap touch screen that will still be available in that timeframe is difficult in an industry where most touch screen users are companies such as large smartphone manufacturers whose product lines change more often than the weather.  This is improving as capacitive touch screen technology matures, more stable supply chains materialize and better long term solutions become available for medical device manufacturers.

Then finally there is the issue of practicality. While it is true that nowadays touchscreens are often the cheaper solution, is it wise to introduce another layer of software abstraction into a potentially life-supporting application that used to be simply done by reliable hardware and big tactile buttons? A good example that comes to mind was Hospira's Symbiq infusion pump system recall in which incorrect inputs to patient's drug metering quantities could potentially have catastrophic results such as patient death. In this case, one of the issues was improper finger-to-touchscreen calibration, a non-existent problem with a physical tactile button setup. We must also consider the ergonomic challenges, such as the lack of tactile feedback and how the hand and fingers shadow certain bits of information when the user reaches for a function (although that's a whole other story for a later date).

Having said all that, touchscreens do have their significant advantages such as: cleanability (a huge plus in most clinical settings), ease of interface reconfiguration (especially when you're still in the development stage) and durability (no mechanical elements). Just make sure that when a client brings up the question of touchscreens it's for the right reasons and not just to up the bling factor.

Paul Charlebois is a StarFish Medical Industrial Designer.  He welcomes reader comments and practices less is always more Product Definition and Product Development for medical device development.




CEO Q&A - Zephyr Sleep Technologies (cont'd)

What's the headline for Zephyr Sleep Technologies, Paul?
Our first product, MATRx™, is installed in 50 clinics and more than 1,000 tests have been performed in the US since our FDA 510 (k) Clearance in March 2012.  We hope to be in 100 by the end of the year.

Very impressive. How did you achieve such wide distribution?
We started out with an exclusive distribution partner, but have now engaged five new independent marketing reps and two new distribution partners.

How about Canada?
We've signed RHS (http://rhscanada.com/) to distribute in Canada – after we get our Health Canada approval — which we hope will take place prior to Q1 2014.

What's the reaction from early users?
The MATRx™ system is working well and finding its way into the workflow of sleep clinics and hospitals. That's the toughest challenge for disruptive technologies like ours.

What do users like best?
It's a great test for the medical practitioners in determining a viable alternative to CPAP – which everyone, especially patients, are looking for. The MATRx saves the medical system time, energy, and money and leads to better quality of care.

How's the press?
Great. Our manuscript has recently been published and will appear in the October Edition of Journal Sleep from the American Academy of Sleep Medicine (AASM). The peer-reviewed Journal Sleep is the field's leading scientific journal and includes the latest findings related to sleep and sleep disorders.

Read more about Zephyr Sleep Technologies, the MATRx™ system, and StarFish Medical in our new online case study.

 


Survey Results - What are readers seeking? (cont'd)

About 90% work for companies currently manufacturing or developing medical devices. And 90% want a limited edition StarFish Medical F-455 Circuit Racer plane model kit. 84% think it is easy to find the information they seek. 95% think the newsletter information is clear. One reader suggests: “You might try bolder / more contrasting headings.

What are they seeking? Company News, Industry Insights, and Tips/Q&A lead the pack. Partner News follows closely.

Favorite format for information? PDFs and whitepapers are tops. Email and Newsletters are close behind. Videos, blogs, websites and webinars round out the top choices.

Industry Events There is no clear preference among industry events; 35% do not plan to attend any events in 2014. MD+DI Medical Device + Diagnostic Industry is the most widely read publication followed by Medical Device Technology. Fast Company and Inc. score as high as industry media, Fierce Medical and Qmed.

Thanks to everyone who participated. Look forward to more Company News, Industry Insights, Tips/Q&A and Partner News starting with this issue.

 


Medical Industry News (cont'd)

FDA issues final guidance on mobile medical apps

The FDA will be exercising discretion for software that poses minimal risk to the patient, where developers / manufacturers will not be required to register with the FDA or submit 510(k) premarket notifications. Typical apps that fall in this category:

  • Help patients/users self-manage their disease or condition without providing specific treatment suggestions
  • Provide patients with simple tools to organize and track their health information
  • Provide easy access to information related to health conditions or treatments
  • Help patients document, show or communicate potential medical conditions to health care providers
  • Automate simple tasks for health care providers
  • Enable patients or providers to interact with Personal Health Records (PHR) or Electronic Health Record (EHR) systems.

However, Apps that are extensions, control or are accessories to other medical devices must be regulated in the conventional way. In the same manner, Apps which require hardware attachments such as sensors and Apps which display, analyze or recommend treatments based on medical data in its original format, must also be regulated. For more information, see the full guidance.

 

FDA Finalizes New System To Identify Medical Devices: Unique Item Codes And Searchable Database To Come

This is hot on the heels of the Unique Device Identifier (UDI) which most Medical Devices must carry if they are to be distributed in the United States.  As part of the UDI system, the FDA is also creating the Global Unique Device Identification Database (GUDID) which will include a standard set of basic identifying elements for each device with a UDI. Most of this information will be made available to the public so that users of a medical device can easily look up information about the device.

When fully implemented, the UDI system will:

  • Provide a standardized identifier that will allow manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls and reduce counterfeiting by providing the foundations for a secure distribution chain
  • Provide a standard and clear way to document device use in patient records, facilitating analysis of existing devices in use
  • Improve accuracy of reporting, reviewing and analyzing adverse events so that problem devices can be identified and corrected more quickly
  • Facilitate the quick and accurate identification of a specific device, and obtain important information on the device characteristics, helping Healthcare professionals reduce errors
 

New rapid blood test can differentiate between bacterial and viral infections

An important step to reduce the over prescription of antibiotics and help manage illness caused by antibiotic resistant bacteria. The United States' Centers for Disease Control & Prevention (CDC) says that over 2 million Americans are infected with antibiotic resistant bacteria each year, resulting in 23,000 deaths. This is a definitely a hot topic as the UK (under the NIHR scheme), US (under the SBIR) and Canada (under the CIHR) are all offering innovation grants to come up with technology and solutions to help manage antibiotic resistant bacteria.

 

Phonebloks: The smartphone for the rest of your life

When a phone goes obsolete, it is usually only part of the system which required upgrading. For example, Faster broadband, High density resolution display, quality camera – these are typical reasons for upgrading a Smartphone (so marketing tells us), but at the same time the fundamental operation – to talk to people – remains constant. Wouldn't it be better if we could replace only the obsolete parts of the phone, like fitting a bigger engine, up-rated suspension and bigger brakes to a standard car to make a Hot Rod? And would we ever be able to apply this approach to Medical Devices, both technically and in such a heavily regulated environment?