6 min reading time

I get a surprising number of inquiries from startups in the business of needles: Disposing of them, how to avoid getting punctured, how to make them less painful for children, and other concepts including doing away with them completely.

See:
Sharps Terminator at http://sharpsterminator.com
Buzzy at https://buzzyhelps.com/ (she was on “Shark Tank”)
Comfortably Numb:
“Pain-free needle” at
Needlestick Safety at http://needlesticksafety.org/the-problem

Did you know there are more than 150 needle manufacturers in China alone? Are the economics of needles such that they need to be produced at the lowest possible cost?

So, today’s post is crowdsourcing information about needles.

• Which companies are making strides in needle innovation (disposal, safety, pain, other)?

• How will the biggest needle players respond if patentable innovations beat them to market?

• What other needle market facts will add to the conversation?

Thanks in advance for sharing your knowledge with the group!

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Discussions

What will Trump’s victory mean for the medical devices industry?

Medical Device Access in developing nations?

Is the consumer ready for genetic testing for pre-dispositions to diseases?

Impact of MEDDEV 2.7.1 Rev. 4 on Clinical Evaluation Report Updates

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VIDEO REPLAY, SLIDES, and TRANSCRIPT READY

A few weeks back, Jon Speer from greenlight.guru discussed the changes ISO made in its long awaited revision to 13485, the global standard for medical device quality management systems.

This is the first revision of the standard since 2003, and it represents some major changes including the inclusion of risk management throughout the QMS, greater emphasis on quality management throughout the entire product lifecycle and supply chain, and much more.

The content is now free for all at http://medgroup.biz/iso13485

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Make it a great week.

Joe Hage
Medical Devices Group Leader

P.S. I’m offering a special discount to hundreds of 10x full-conference alumni through Thanksgiving. See http://medgroup.biz/10x and email me for details.

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HILARIO CASTILLO
Registered Nurse/Entrepreneur
We are developing a syringe needle technology that will decrease needle stick injuries and reduce the amount of time wasted in medication administer to in certain acute care settings. We just received the patent.

Lewis Owens
Independent specialist consultant & community volunteer
We have just launched our patented and unique prefilled safety syringe system – UniSafe. Patient centric focus, details here : http://ondrugdelivery.com/publications/73/Owen_Mumford.pdf

Javier Campos Mora
Sales & Marketing Specialist, Experienced Biomedical Engineer
I have experience in Latin American & Caribbean Market, I think the big deal its to try to sensitize the health care workers and procurement to take care of the patient vs the cost of different needles

Amy Baxter
Founder & CEO at Pain Care Labs (formerly MMJ Labs)
Ken, thanks for the link! There is a Tricorder XPrize – finalists presented at Exponential Med this year. I was able to give a “Future of Pain Management” talk, will post when the video is available. I believe a significant investment in painless needles will be a critical innovation space in the next ten years, as some molecules will simply be too big to administer without needles, and some tests will never be amenable to fingersticks or noninvasive methods – and 63% of those born after 1995 fear needles to the point of avoiding healthcare.

Ken Powell
President
Amy – Great work. As you know, there is now a “needle-free” flu vaccine and buccal swabs can be used for DNA analysis (sequencing). I followed so many companies that tried to eliminate capillary sticks for diabetic patients including contacts, infrared, patches, gluco-watches and many others. Due to the need for IV or IM injectable pharmaceuticals and venous blood collection for subsequent diagnostic procedures, needles will be a requisite component of the health care delivery system for the foreseeable future. Over 70% of all clinical decisions are based on a diagnostic test result, which highlights the critical nature of diagnostics. I remember watching the original Star Trek in the late 60s and we aren’t even close to a “Tri-Corder” used by McCoy. Also, given all our pharma research, knowledge and spending, we still haven’t cured the common cold either. That doesn’t mean we should stop, just keep working!

Ken Powell
President
I forgot to include the link to Dr. Jagger’s NJEM article that started everything for myself and my former employer. Here it is: http://www.nejm.org/doi/full/10.1056/NEJM198808043190506

Amy Baxter
Founder & CEO at Pain Care Labs (formerly MMJ Labs)
Needle fear has jumped almost 30% in the last 20 years. I just submitted a paper today establishing one hypothesis: kids get 6x more injections in their lifetimes, but now they get them when they’re old enough to remember, more shots equals more fear. The thing for needle companies, and those developing Biologics, is that the peak of fear is in children born around 1995 and later. as this cohort advances in to the public health arena, avoidance of needles will impact businesses who depend on using needles to make their money. I began MMJ labs to fund Buzzy needle relief device R&D- a quarter million people have now used it for needle procedures. I’m giving a webinar 12/1 at 1est to certify “needle fear friendly” clinicians in evidence-based methods to deal with people who avoid, faint, or dislike needles.

Ken Powell
President
After renewing my BD “Business Development” function (acquisitions, IP, etc) in 1986 I discovered a startling 1988 article that affected my former employer BD (the largest global sharps supplier) in an extraordinary way. It was written by Dr. Janine Jaeger in the NEJM. I had an opportunity to meet both her and Dr. Lorraine Day at a Washington conference on infectious disease transmission. I went on to lead the development of sharps related prevention devices that began at 2 BD divisions, became corporate, then a global business. This is quite the story and not enough room to go into the complete details, such as the Needle Safety Prevention law signed by President Clinton. If you would like to hear more, please email me and we can discuss in detail. It is quite the story because it led to BD’s involvement in MRSA, by Expert Witness Testimony in the Royal Court of Justice in London and their acquisition of Care Fusion. It is a very unique and compelling story.

Krishnan V.
Business Head | Medical Devices| INSEAD
Wenting Wang ….

Bill Hays
Procurement Specialist at Kaiser Permanente
Tangent : Spencer Jones makes the comment of sampling for diabetes patients from a venous line, but caution must be exercised that the glucometer is able to sample venous blood accurately. Many glucometers are calculated for capillary blood and hence using a venous sample might give an inaccurate reading.

Matt Valego
Senior Executive: Medical Devices l Sales, Marketing, Business Development, Corporate Accounts
Having come from one of the largest needle and syringe manufacturers, I will say we were always looking for the next best technology. When looking at proforma financials on those projects it required significant volume to cover the capital investment. Thus we had to look for technology that was easily adopted, manufacturable, and shows improved clinician safety with no change or improvement for the patient experience. Not an easy task. It is a mistake to think that the large companies are actively trying to prevent new technology from entering the market though.

Dr. Gudrun Reinschmidt
Innovation entsteht aus vertrauensvollem Umgang miteinander – Unterschiedlichkeit wird als Komplementarität verstanden.
The German company Sarstedt had already invented a safety device to collect used needles in the nineties.

John Mullin
Director of Sales, North America at sfm medical devices GmbH
I just got involved in the Needle space in the last year when I started working for sfm Medical devices http://sfm.de/en/
As a contract manufacturer, I have found that the USA based needle suppliers (Contract Manufacturers) have dramatically under-served the market

Brian Marckx
Director of Research. Senior Equity Research Analyst – Medical Devices/MedTech/Diagnostics.
In terms of insulin needles, a relatively unknown small company called Valeritas (ticker VLRX) makes a simple insulin patch that is improving insulin compliance. One reason is because many type 2 diabetics have needle-phobia and their product helps to address that.

Spencer Jones
Founder and CTO at Lineus Medical
BVAD Tech – Dual Lumen Peripheral IV – Allows blood sampling through peripheral access. No more lancet pricks and reduced needle sticks for diabetic patients in the hospital. https://youtu.be/XRC1jtD6-f8

Muhammad Sadiq
Founder and Senior Technical Officer at Active Needle Technology Ltd. / STEM Ambassador
@ Active Needle Technology (www.activeneedle.com), we are developing needles that do exactly what is required of them i.e. safety, efficiency and effectiveness.

David Tuch
CEO at Lightpoint Medical
Have a look at Active Needle Technology

Ted Hibbs
Quality Engineer at CME America LLC
I have performed many phlebotomies in my day, and IMHO, it is easy to teach, but a true art to do it well. Tricks I have found useful include:
1. Inspect the tip of the needle before use. If it is bent, broken, etc., discard and try another.
2. Speed is key. A quick jab to the correct depth is nearly painless; slow advancement always hurts. See “true art” above.
3. Get it right the first time. Confidence, anchoring well, and knowing what you’re doing are key. See “true art” above.
4. Talk with your patient. Ask them questions. Keep them talking and engaged. If they have time to stop and think, then they focus on the wrong thing (the needle). If they’re talking about the weather, family, etc., then they are distracted, and you can monitor their reaction and distraction. See “true art” above.
I hope this helps someone be better at being on the “dull end” of the needle, and help the person on the “sharp end”. If it even helps one person, then it has been worth it.

Segeun Kim
YOUNGLIM.Co.,Ltd
My company has manufacturing the needle safe disposal system in Korea.
We exhibit in the medical exhibition for many years in Korea, China, Germany, Vietnam and Thailand.
But the many people didn’t want to this type system.
They said to us that high price, uncomfortable, didn’t process someone needle.
I think that the many hospital is uninteresting about the injury of medical people, they are interested only the patients.

Segeun Kim
YOUNGLIM.Co.,Ltd
Our company has manufacturing the needle safe disposal system. I exhibited many exhibition for many years.
But, The many hospitals might did not interesting this type system.