April 27, 2015

What matters to you about device instructions?

Friends at the FDA called. 

Yes, I have friends there. 

They were looking for thoughts on device labeling and wondered if I could ask around. 

Sure, what are friends for? 

I would love to help funnel back thoughts to them from the DOC, not just my 2¢. It is all very informal but I hope, maybe, we can help them organize their thinking if they get to more formal asking. 

Willing to help?

Here is the little of what I know, labels are the instructions on how to use a device, what it is intended to do and what to do if there is a problem.  

RAPS aka Regulatory Affairs Professionals Society notes that unlike drugs devices do not have standardized labeling. “Under 21 CFR 801, medical device manufacturers are required to label their products with certain information, but the format and layout of that information is for the most part left up to the discretion of the manufacturer.” 1

Given that devices range from fairly simple to very complex it may make sense not to have a one size fits all standard. My BG meter is not the same level of sophistication as the CAT scanner at hospital, even if both are medial devices.

In this case FDA is asking about home-use devices. In the diabetes world that is a wide range of things from meters, insulin pens, pumps, CGMs, uploading software and more.

In a recent document FDA said this about home-use device labels:
Medical device labeling provides safety information, instructions for use, and/or other necessary information to the user. This labeling can be essential for home-use devices, which are much more likely to be used by lay users, who frequently have not been trained to use such medical devices and who are especially reliant on the instructions for use and other information provided by the device label and package insert.  2

AdvaMed the medical device association in 2013 said, "The development of a standardized Table of Contents (TOC) for device Instructions for Use (IFU) may be a useful tool if adequate allowances are made for the broad range of device types, users and environments."  3

So there we have the RAPS, FDA and AdvaMed, A.K.A. a bowl of Alphabits of regulatory professionals, regulators and industry. 

Notice a key group missing? Me too - Users, AKA patients. Maybe that is why they called. 

Here is my ask - take this quick survey. I made it up - none of it is their's. I’ll summarize the results for my friends at FDA and if you would like to see those too, share your contact information at the end of the survey and I send you what I send them. 




Help a Dad asking for better education.

Tom Karlya, aka Diabetes Dad reached out and asked for help getting the word out on a North Carolina diabetes education ask.

I'm happy to help share.

The effort is to help provide education about the symptoms of diabetes so that kids are not sent home entering DKA with a suspected flu or other childhood bug. Tom outlines the issue better than I. Like so many advocacy issues this popped up at the last second. All the more reason we need a strong advocacy database.


April 24, 2015

From E&C, 21 Century Cures

Never to late to send a CGM message. Here

21st Century Cures Legislative Phase Continues

NIH and FDA to Testify at 21st Century Cures Legislative Hearing NEXT THURSDAY – Discussion Draft To Be Released Next Week

WASHINGTON, DC - After nearly a year of listening to patients, innovators, researchers, providers, and regulators, 21st Century Cures next week will take the next step in the legislative phase with a hearing, “Legislative Hearing on 21st Century Cures,” on Thursday, April 30, 2015, at 10:00 a.m. in room 2123 of the Rayburn House Office Building. Subcommittee members will discuss a forthcoming bipartisan discussion draft of this highly anticipated legislation, the product of a yearlong listening session and bipartisan negotiations. 
The committee has held eight hearings and issued several white papers in this initiative since its launch last year. Committee members, both in Washington, D.C., and across the country, have also hosted more than two-dozen roundtables to generate ideas for this initiative. Staff continues to work together around the clock as they have for the past several months and legislative text will be made available in the coming days.
Dr. Kathy Hudson, Deputy Director for Science, Outreach, and Policy at the National Institutes of Health, Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research at the Food and Drug Administration, and Dr. Jeff Shuren, Director of the Center for Devices and Radiological Health at the FDA will testify. 
The Majority Memorandum, legislative text, and witness testimony will be available here as they are posted.

April 22, 2015

Two minute ask, How about CGM Coverage?

The House Energy and Commerce Committee is currently working on the bipartisan 21st Century Cures initiative. Help members of the Committee understand that CGM 21 is century technology that needs 21 century coverage. Now is the time, as Chair Rep Fred Upton says: “I am hopeful we’ll have an agreement by the end of the month.”

We are making it easy:

We have a list of Energy & Commerce Members and Tweet about CGM Coverage.

News on the initiative:
Chairman Fred Upton (R-MI) and Rep. Diana DeGette (D-CO) this week traveled to Southwest Michigan to talk about their nonpartisan 21st Century Cures initiative in Upton’s home district. The two launched 21st Century Cures last spring and have spent the past year gathering ideas from patients and experts across the country for how to improve the complete health care innovation infrastructure in the United States. 
“There is great excitement and anticipation building over the next phase of 21st Century Cures. Our teams have spent countless hours negotiating over the last few months on policy language and they continue to work by the hour in this landmark effort to provide folks more cures and treatments,” said Upton. “I am hopeful that we’ll have an agreement by the end of the month and the legislative phase can swiftly progress. This is an exciting time.”


April 17, 2015

Testing Tuesday - Not Blood Testing (unless you have a better idea on how to that)

From my good friend Joyce Lee and our merry band of innovators:

Initiating a Collaborative Innovation Network for Healthcare Transformation in Type 1 Diabetes

We #makehealth!
We are a group of patients, caregivers, healthcare providers, designers, innovators, advocates, quality improvement specialists, technologists, and engineers who are passionate about transforming healthcare for type 1 diabetes.

Be part of this crowd sourced effort!

This collaboration was inspired by the work we have been doing for the T1D Exchange and the C3N Project. See Storify #1; see Storify #2 to take a peek at what we have been up to!

Why is the page called Testing Tuesday? (http://testingtuesday.org)

Testing Tuesday Projects are projects, collaborations, improvements in healthcare that we can do to start the transformation now! Watch this video by Mike Evans to learn about how we chose the name!

April 14, 2015

IBM Watson Teaming up With Medtronic. Will Your Pump Kick Butt at Chess?

... or maybe Jeopardy? 

Medtronic is teaming up with IMB's Watson. The full press release is here. I thought these comments were the most interesting part:

"Devices alone cannot transform diabetes care. The combination of leadership technologies, big data, informatics and world-class patient management are all required to drive effective results in diabetes care," said Hooman Hakami, executive vice president and president of the Diabetes Group at Medtronic. "Medtronic and IBM intend to bring these capabilities together to pioneer a new level of care that will improve outcomes and lower cost so people living with diabetes can enjoy greater freedom and better health." 

"We are building a secure, open innovation platform that could change the face of diabetes management," said John E. Kelly III, IBM senior vice president, solutions portfolio and research. "Medtronic and IBM can marry the power of analytics, cognitive computing and patient engagement with the world's most sophisticated diabetes management devices to truly change how people with diabetes live."

Maybe it will be DEWY.

See: Of Fantasy Diabetes Devices, Sheldon & Dewy.

Source: http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&ID=2034597

April 7, 2015

PRESS RELEASE: DreaMed Diabetes and Medtronic Enter Strategic Collaboration

PETAH TIKVA, Israel, Apr 06, 2015 (BUSINESS WIRE) -- DreaMed Diabetes, developer of diabetes treatment and management solutions, announced today that it had signed an exclusive worldwide development and license agreement with Medtronic, the world's premier medical technology and services company, for the development and marketing of products incorporating DreaMed’s MD-Logic Artificial Pancreas algorithm in Medtronic’s insulin pumps.
Under the terms of the agreement, DreaMed Diabetes will receive undisclosed royalties from future sales of each device utilizing MD-Logic. Medtronic will be responsible for all development and marketing of such devices. In addition, Medtronic has made a minority investment in DreaMed Diabetes of $2 million.
DreaMed Diabetes’s CE approved GlucoSitter™, which is based on the MD-Logic Artificial Pancreas algorithm, is a fully-automated, artificial-pancreas system for controlling glucose levels. The system links the glucose sensor with the insulin pump through computerized control algorithms. It uses data of glucose levels from a continuous glucose sensor, analyzes them and directs the insulin pump to deliver the correct dose of insulin that should be released to the body in order to maintain balanced blood glucose. In effect, the software continuously monitors glucose levels, and defines precisely when and how to adjust insulin levels. more: http://www.marketwatch.com/story/dreamed-diabetes-and-medtronic-enter-strategic-collaboration-2015-04-06