My group is making realistic, full-sized, medical models that provide a high-fidelity surgical experience.
Used for medical schools' education and training, these durable, soft, silicone models can mimic nearly any organ or system (including normal, diseased, or patient specific) with tumors, bleed when incised, be scoped, sutured, etc.
I can’t help but think there may be potential for use or interactivity with some medical device items – but the students don’t know to ask, and both this group and I have little experience with what is available and where there may be opportunity to augment student learning.
Any ideas? Thanks so much! Barbara Duffy, firstname.lastname@example.org. P.S. We need more awesome groups like this!
I'm new to my orthopedic implants and associated instrument company and inherited a 510(k) in review. In this 510(k) and those cleared in the last year, we had no discussion on usability 62366-1. We also didn't discuss evidence for biocompatibility beyond materials standards, and predicate comparison.
That was not the case in my previous company (external communicating devices, short-term).
Can you help me understand why these devices are being treated differently?
Hiring managers and recruiters, you can list your opportunities at https://medgroup.biz/jobs anytime this month for just $39 using code OCTOBER. Candidates, visit https://medgroup.biz/jobs to create a profile, upload your resume, search by keyword and location (city/state or ZIP), and sign up for job alerts (available at this time only in the US, Canada, UK, and Australia). Good luck! +++ Discussions You May Have Missed Got a question? This is a free resource for all members. Ask yours at medicaldevicesgroup.net/question/add.
Live event: October 25 at noon New York timeThe live event will be Thursday, October 25 at noon, New York time. As always, if you can't make the live event, no prob. We record it and give you the slides afterward. And when you click here to register, I send you to his 2015 presentation, since watched thousands of times. Coincidentally, Rob is in Amsterdam today, teaching this exact same content – for $600, I might add. So, seriously, come. It's a gift. Rob writes, "FDA made a lot of changes to the 510(k) process since our last webinar together, Joe. I can cover some imminent changes and assemble a completely updated presentation, with new tips and tricks I learned from doing dozens of pre-subs since then. See you on the 25th? +++
When it rains, it pours!Here's another freebie for you, courtesy of greenlight.guru, another name you probably recognize by now. FDA invited us(!) to an FDA live announcement on Thursday, October 18, starting at 11:45 a.m. New York time, for an hour. FDA will discuss new draft guidance, entitled "Computer Software Assurance for Manufacturing, Operations, and Quality System Software." +++
Hiring managers and recruiters, you can list your opportunities at https://medgroup.biz/jobs anytime this month for just $39 using code OCTOBER. Candidates, visit https://medgroup.biz/jobs to create a profile, upload your resume, search by keyword and location (city/state or ZIP), and sign up for job alerts (available at this time only in the US, Canada, UK, and Australia). Good luck! +++
Discussions You May Have MissedGot a question? This is a free resource for all members. Ask yours at medicaldevicesgroup.net/question/add. Clément Vallois, Project leader at Fresenius Kabi, has a question about "Finished good article codes" Saurabh Dubey, Regulatory Affairs & Quality System at Syngene International Limited, asks for "Help with 510(k), GTIN, and GUDID" Tom Bowen, President at Bowen Medical, wonders if you have to "Sacrifice accuracy of blood pressure cuffs to low cost disposables" +++
Thank you for being part of our Medical Devices Group community!Make it a great week. Joe Hage Medical Devices Group Leader P.S. If you can't afford the time to attend the entire 10x for ENGINEERS conference – no problem! Come only for Dr. Black's talk on Wednesday night. Stay for the reception! Register now.
We're new to the FDA medical device, and we're looking to implement an eQMS system into our workflow. We've looked at Greenlight Guru, MasterControl, and Enzyme. Was hoping to get some feedback from the folks here regarding the pros/cons of these products. Also, are there any others that you'd recommend?
Dear colleagues, what are your "tips and tricks" to limit the number of article codes for your finished products?
How do you manage the different power cords, languages for software interface, languages for IFU, duration for authorization time, labeling differences, and more?
Thanks in advance, and best regards.
“Let's forget about how many of you have invested in Bitcoin. How many have just heard of Bitcoin or blockchain?” began Jad Mubaslat, founder of Bitquick, and Industrial and Human Factors engineer.
“How many of you understand it?” he continued. (Not so many hands went up and – I won't lie – I had to watch his presentation more than once to "get it.")
“Blockchain is not going to completely revolutionize how you build medical devices, but it is going to revolutionize how that data flows in the background, and how effective your medical devices can be, and how they can take advantage of the data going around.”
Jad explained what a blockchain is, how it fits into healthcare, and answered the question, "Do you need one?"
If you have an interest in blockchain and how it may affect your business, give a listen.
I made the video and slides free for everyone – even had it transcribed for your download. 😊
This time next week I'm boarding a plane to San Diego to spend quality time with group members eager to make new connections and keep abreast of the latest thinking in medical device design, development, manufacturing, and commercialization.
I got a lot of positive reviews on the agenda.
We can accommodate another dozen or so folks – so please reply to this email if there's even a chance you might attend. (I have to finalize food and beverage numbers with the Hyatt by Friday.)
The event is geared equally for senior and junior levels. If you're senior, you'll return with ideas the team can use. If junior, you'll return with specifics lessons, materials, and action items to do your job better.
Our keynote speaker is Lance Black, Medical Device Innovation Lead at Texas Medical Center
He served in the U.S. Air Force, where he completed a residency in family medicine with additional training in aerospace medicine. He had the opportunity to deploy twice during his service, first as Chief of the Medical Staff at Manas Transit Base in Kyrgyzstan, and then as a Squadron Flight Surgeon in Okinawa, Japan.
During his time in Manas, Lance helped to create a mobile modular medical facility aimed to uplift the surrounding defunct healthcare system. In Japan, he responded to in-flight emergencies and orchestrated protocols ensuring the safety of F-22 pilots and their crew.
His work with wounded warrior amputees during his military career and his background in biological engineering prompted him to refocus his efforts from patient care to the design and development of medical devices.
Following the completion of his commitment to the military, Lance attended Georgia Tech’s Masters of Biomedical Innovation and Development program to include one year in their Masters of Industrial Design program.
Now as Medical Device Innovation Lead, Lance focuses on the resident companies of TMCx by supporting their efforts in developing innovative health care technologies.
His Keynote Topic:
How the world’s largest medical center invests in medical device innovation (and how you can benefit!)
Did you know Texas Medical Center is the world’s largest? And did you know they spend millions annually on medical device innovation with players ranging from industry titans to the smallest start-ups?
Then come listen to Dr. Black and learn how TMC – potentially one of your biggest customers – looks at innovation and how it fosters it among companies like yours!
P.P.S. Special thanks to RTI - The Industrial Internet of Things Connectivity Company. Their 10x sponsorship made it possible for us to make some seating available for students and those in transition. Thank you!
See something you like? Click away!
Hiring managers and recruiters, let's get these nice people some jobs!
List your opportunities at https://medgroup.biz/jobs anytime this month for just $39 using code OCTOBER.
Candidates, make yourselves at home. You can:
- Create a profile;
- Upload your resume;
- Run searches by keyword and location (city/state or ZIP); and,
- Sign up for job alerts (available at this time only in the US, Canada, UK, and Australia).
Discussions You May Have Missed
Got a question? This is a free resource for all members. Ask yours at medicaldevicesgroup.net/question/add.
Valeria Fast Wouterlood, Training and Development Manager at Venn Life Sciences, asks for "A question about annual safety reporting medical devices (pre-marketing)."
Kasper Friis, Head of UX & Design at Technolution A/S, asks, "How do you make sure that people will love your product?"
Thank you for being part of our Medical Devices Group community!
Make it a great week.
Medical Devices Group Leader
P.S. If you can't afford the time to attend the entire 10x for ENGINEERS conference – no problem! Come only for Dr. Black's talk on Wednesday night. Stay for the reception! Register now.
There are many resources available on QSR, design controls and standards, etc; but there is a gap in understanding how these protocols should be designed to follow these regulations.
Let’s say I am designing a PCB and have to write a protocol to test it. I would include measuring voltages and current at different stages.
But there is much more to consider, even before I plug in the device (like shorts and loose solder connections). Many companies have a team to take care of this, but in a start-up that may not be practical.
My question: What's a good approach when just starting out in protocol design?
I just came across a legal manufacturer in EU with CE Certificate granted to their devices but without having ISO13485 certificate.
I ran through MDD 93/42/EEC and it seems there is no stated requirement that a legal manufacturer needs to obtain certification for their QMS. That is, as long as their QMS is in accordance to recognized harmonised standards, and subject to an NB assessment/audit.
Do you arrive at the same conclusion, that they'd be able to get CE certified in this situation?
It wasn't until I transcribed Dr. Howard Levin's presentation from our last 10x for ENGINEERS event did I realize how much his past 15 years he packed into 25 minutes.
It was fantastic presentation for anyone who ever works in bringing a medical device concept to market.The video, slides, and transcript are immediately available for you now at https://medgroup.biz/Howard-Levin.
For credentials, Howard's company Coridea issued 120 US patents, raised $100 million, and returned more than 1.4 billion to investors.
Have I got your attention? Some key takeaways but srsly, download it:
• A university gets a patent on a concept constructed with "academic engineering" (different than "real engineering"). When they find the idea, as written, is unworkable, they've effectively shut everyone else out from expediting the innovation to market.
• A device may be good for mankind but not for business. You, as a medical device design engineer, get pitched more ideas than you can execute. How do you choose?
• If you consider taking equity as a form of payment, how do you minimize the risk there's no payout at all?
• "Breakthrough therapies tend to start in academics; better tools developed by industry or clinicians."
• Determine if the physician wants help developing clinical data and generating
IP for acquisition versus help manufacturing the device you'll make money on selling.
Then Howard took us through a dozen questions to ask, ranging from clinical need to regulatory risk to sales and marketing.
As I said, a really worthwhile presentation. Replay, slides, and transcript athttps://medgroup.biz/Howard-Levin
+++Featured Medical Devices Group Job Board opportunities
See something you like? Click away!
Hiring managers and recruiters, let's get these nice people some jobs!
Please list your opportunities at https://medgroup.biz/jobs anytime this month for just $29 using code 29dollars.
Candidates, make yourselves at home. You can:
• Create a profile;
• Upload your resume;
• Run searches by keyword and location (city/state or ZIP); and,
• Sign up for job alerts (available at this time only in the US, Canada, UK, and Australia).
Good luck, and if there's additional functionality – like this resume review tool – you'd like to see on the job board, just reply to this email with your suggestions!
How familiar are you with risk analysis according to ISO 14971?If you have a few moments, would you take this short Jama Software survey? They basically wanna know how medical device manufacturers perform risk analysis. It's, like, six questions, the first of which is your level of familiarity: None | Somewhat | Mostly | Expert. So if you have the time, I'd appreciate it.
Discussions You May Have Missed
Yay! 🥂 I've wanted to restore this feature for three years now!
In this section, I highlight some of the recent contributions from group members because, hey, this is a community we have here! Please, add your questions right here.Kyle Vlasak, VP Sales and Marketing at Vonco Products, asks, "Why is PVC the go-to when developing liquid tight medical fluid bags in the US?" Saurabh Dubey, Junior Regulatory Affairs Manager at Syngene, asks for "Help with 510(k), GTIN, and GUDID." Christian Costantini, Regional Sales Manager Americas for Redax Spa/Maclin Power, asks, "Who provides market intelligence services for the medical device industry?"
Hello, is there a need to submit an annual safety reporting in medical devices, informing the progress of the investigation, in the pre-marketing phase?
If so, what´s it´s name? To whom should be submitted?
Polyolefins have been shown to be safe alternatives to PVC's widely reported risks.
However Polyolefin films make up only a small percentage of liquid tight medical bags in the US with shapes and fitments.
Is it because of the sizable investments already made, or not knowing how to make with Polyolefins in scale?
Group member Amy Baxter, MD, is furious.
"I just got back from #PAINWeek where supposedly doctors are learning about what works for their patients to manage pain. We brought our new DuoTherm low back pain thermal/vibration prototypes – almost all the doctors cared about was drugs!
Let me tell you a little about Dr. Baxter.
Amy Baxter MD is an inventor, innovator, and pediatric emergency physician. She made Buzzy, which, to date, has blocked pain from 31 million needle procedures.
And she's serious about drug-free pain relief. After Buzzy, she made VibraCool.
Then, in response to the repeated question, "When are you making one for the back?" she and her colleagues at PainCareLabs developed DuoTherm, now in the concept/prototyping stage and featured in an Indiegogo campaign through November 2018.
Why won't you believe me?
The history of devices is paved with skepticism. For your entertainment, a 1930 video entitled, "Fat Men Use Mueller Exerciser Belt." And, well, Theranos.
So you probably won't be shocked to learn, of the $60 billion spent on U.S. pain management each year, only two of it is on devices.
Devices are at such a disadvantage versus medication that – get this – the family behind OxyCotin is now looking to market a milder opioids to help wean addicts off, well, opioids.
Yet primary pain physicians aren't won over yet. "Only two of 126 #PAINWeek presentations were about consumer devices," Amy reported.
Turning the tide
"The first difficulty in turning the tide from pharma to device is, of course, reimbursement. Any prescription medication is fast tracked for coverage.
On the other hand, devices that work may not get paid for. Just last week, FDA announced a plan to give manufacturers clear guidance on what studies need to be done for payor reimbursement. This is extremely helpful, but underlies the huge hurdle of high quality studies."
"In general," Amy continued, "device research (especially for consumer devices) isn’t as rigorous as in pharma.
• Pharma has more cash to get top researchers;
• Evaluating drug studies is familiar to most physicians; and,
• Even "real-world" case studies can undermine the device industry."
Just one example, a device company study compared 800 compliant patients to 100 who self-selected out. They concluded those who stuck with the program, did better, evidence "the device works." Uh huh. 🙄
Audaciously, the QR code accompanying their "scientific poster" took you to a "Buy a Device" page. 😠
Fighting the good fight
Check out the IndieGogo campaign and, if you (or someone you love) is a back-pain sufferer, maybe get a unit at half price.
Thanks for reading and tell me what you think of this article, her concept, and the imbalance between device and pharma solutions in today's comments.
Jobs, Jobs, Medical Device Jobs!
Thank you for your warm response to the new Medical Devices Group Job Board last week.
Candidates can upload their resume and fill out a profile with links to sites of your choosing. And due to popular demand, medical device hiring managers can post a job for free through Thursday, September 13. Use code BETATEST at checkout.
I think it's gonna be big.
Also, we added a slick "Sharing" icon for each discussion. Use it to easily share items of interest over LinkedIn, Twitter, or email. I'm thrilled with the functionality.
Thank you for being part of our Medical Devices Group community.Make it a great week. Joe Hage Medical Devices Group Leader P.S. Four weeks to go, and the group rate at the beautiful Hyatt Regency Mission Bay Spa and Marina expires next week. So if you're flying in to San Diego for our 10x for ENGINEERS event, act today!
I'm based in India and would like to understand the overall regulatory workflow for medical device product development. What are the documents I need to create for entry into the US market?
I've started on our 510(k). Do I need to have GTIN and GUDID as well? How do I go about it?
Your assistance appreciated!
IS BLOOD PRESSURE READING JUST A NUMBER?
One of the most critical factors in patient assessment is the blood pressure reading. If the accuracy of the blood pressure reading is compromised then the ability for accurate assessment of the patient is also compromised.
For many years we were exposed to cross contamination due to microbe laden blood pressure cuffs. The medical industry has solved this dilemma through the use of cheap disposable blood pressure cuffs. New research questioning the accuracy of these cuffs is now available.
A major teaching hospital was concerned about the cross-contamination of their manufacturer-validated cuffs. They substituted a washable cuff. In their hypertensive unit they documented that 33% of their patients with poorly controlled hypertension were wrongly diagnosed as normotensive due to lack of accuracy of the washable cuffs. One third of the entire patients in this hypertensive unit would not be given the proper medication to control their hypertension had they not discovered the compromise in accuracy.1
The most comprehensive research to date on accuracy of various types of cuffs compared eight different types of cuffs made of coated woven and non-woven fabrics. There were variations of up to 27mmHg for systolic readings and 17mmHg for diastolic reading.2
Using the American Heart standards for blood pressure- a person with an accurate blood pressure reading of 113 systolic that had an erroneous 27mmHg systolic cuff could be diagnosed as Stage 2 hypertensive at 140.
This lack of accuracy should alarm every health care worker. The blood pressure measurement should be focused on accuracy, not the lowest cost of a cuff.
There is remedy for the compromise of accuracy by using a reliable well-made reusable cuff such as the W.A.Baum company makes and a low cost cover to protect the cuff, like Bowen Medical Cuff-Guard to prevent cross -contamination. Cleaning of the reusable cuffs between each patient is also an option-if it is thorough and documented.
The most basic of healthcare are the accurate evaluations of vital signs. The blood pressure reading should always be the most accurate we can strive to obtain.
“Since hypertension is a major world-wide problem affecting millions of people, its accurate estimation is imperative and needs further attention. The methods of measurement, equipment and the size of the cuffs have already been standardized but the cuff fabric construction and the material of the cuffs which are the cornerstone of accurate BP measurement have been neglected.”2.
1. Unsafe health and safety: sphygmomanometer cuffs are not interchangeable. By Shaw KC, McEniery CM, Wilkinson and Brown. Published in Journal of Hypertension 2013 July,27(7):434-36 2. Variation in BP values for different cuff types by Naqvi, Potluri, Mandal and Lewis published in Journal of Industrial Textiles 2018, Vol.47(7) 1478-1495.
Designing delightful and robust user experiences is not an art. It is science. And it is business.
These are the questions you should ask yourself - and the tools to get you started: http://bit.ly/product-love
Do you ask yourself these questions? If not, why? (I am genuinely interested in your perspective, so please comment)
All the best, Kasper
I've said for years, "The Medical Devices Group is the world's largest medical device community and the industry's only spam-free, curated forum for intelligent conversations with medical device thought leaders."
It was nice. But we've outgrown it.
We have an even bigger vision now.
and specifically MedicalDevicesGroup.net,
will be the world's most useful website
serving the medical device industry.
What do you think of our big, hairy, audacious goal?
I think we can do it. And it starts today!
Introducing the Medical Devices Group Job Board
I could tell you all about it. Or you could check it out now!
As of today, the job board lets:
- Candidates can post a resume.
- Candidates can create a profile.
- Candidates can search by keyword and location.
- Candidates can get job alerts.
- Employers can post jobs. (Today it's FREE! Ask me how.)
- Employers can highlight "urgent need" jobs and raise visibility with a "featured" job.
- Employers can sponsor a "featured employer" spot on the job portal.
I'm figuring it out as I go – today's job board is the minimally viable product – but I was too excited to wait another week to show you.
Please, try it out, and slam my inbox with feedback - good and bad (I can take it). I want to build the single most robust career platform available anywhere for the medical devices industry.
The Most Useful Medical Device Website:
What does that mean?
I know this is ambitious – it wouldn't be fun if it weren't. I'm setting a five-year horizon to build "every useful tool you can think of" to further your career and company success.
We have a strong head start, with:
• Years of completely searchable, archived questions and answers on the Community tab.
• 40+ archived webinars with replays, slides, and transcripts, all ready for your immediate download.
• The most comprehensive medical device events calendar available anywhere (also minimally viable, improvements underway).
• Legacy resources (we will build heavily here) and a blog (soon to be open for your contributions).
And with today's job board launch, we have the foundational elements in place.
SO WHAT ELSE?
My late mother-in-law would prompt me, “So what else?” right after I told her about something great that just happened.
So what else?
These are in the concept stage:
- Member reviews for events, books, content, etc.
- E-learning courses (for credit)
- Access to the Medical Devices Group Advisory Board
- Supplier directory
- Resources for distribution and inmport/export
- Research and tools you tell me you need
- Survey tools
And some nice-to-haves: Communication preferences (opt out of "this" but not "that"), a calendar of upcoming online events (webinars, etc.), nested comments, and more.
So what else? Well, that's up to you! What's on your wish list?
What do you wish "someone would just make because it would make your life so much easier?"
I may be that someone! Let's talk about it.
You can start by hitting the contact page today.
Big Things Ahead
I've never been more bullish on what our community can do together. Won't you tell your friends and colleagues about this site and our new job board?
I hope you will – and thank you in advance.
We're going to make something great together.
Thank you all so much!
Make it a great week.
Medical Devices Group Leader
P.S. Please come to 10x for ENGINEERS in San Diego if the agenda is remotely interesting for you. I want to meet (and serve) as many of you as I can. https://medgroup.biz/10x
We are an Italian medical device company promoting its products in the USA. Our products are related to post-op drain, chest tubes, and chest catheters. We seek an up-to-date information about prices, competitors' market share, SKUs and so on.
Which research companies provide that information? Recommendations welcomed.
PS: We seek local distributors too.
I'm trying to put together a very high level view of medical device development for novice (meaning no prior experience in the industry, not just this is their first invention) inventors.
I am interested to hear from others what (if any) role they have seen research play in the process of developing a new medical device, including at what point in the process the research occurred. Did most of the research occur pre-IP? Pre-POC? Did any occur after the design process (user requirements, design inputs, V&V plan, etc.) got underway?
P.S. Does anyone here has been involved in medical device development at a medical device company think that a data collection activity (bench testing, clinical trial) done to verify or validate the design could appropriately be described as "research?"
Group member Alma Denisse Martinez submitted a discussion that warrants a larger audience. She posted an article, "Mexico's new President-Elect Lopez Obrador and the future of NAFTA and Mexican Manufacturing."
Some excerpts (paraphrased for brevity):
- Leftist Andres Manuel Lopez Obrador (AMLO) won in a massive landslide... [in a] mandate to change the country. What does this mean for manufacturing in Mexico and the future of NAFTA?
- Rivals' propaganda and memes said AMLO would be disastrous for Mexican business.
- In his post-victory, AMLO said he'd sign NAFTA, affirmed practical economic policies, and the independence of the Bank of Mexico. (As former mayor, he had been a stauch NAFTA critic and has since adjusted his views, championing better wages and working conditions within existing trade agreements.)
- The US will resume NAFTA negotiations after the November elections, giving AMLO some time.
- Commentators suggest AMLO wants to put money into infrastructure, to be fiscally responsible, to gain investor confidence. They saw possible public-private investments, particularly in energy and power.
The unabridged article at https://medgroup.biz/AMLO.
For the group:
- Do you have experience manufacturing in Mexico?
- Do you believe NAFTA and/or the election will impact conditions materially?
- If you produce outside your country, was Mexico ever in your consideration set and rejected for some reason?
Agnitio’s take on an interesting BCG study at https://medgroup.biz/medtech-commercial-model. “Clinician-focused models generate revenues per sales rep 35% to 50% of those generated by companies targeting administrative decision makers.”
The demise of our LinkedIn group
The inside scuttlebutt among owners of big LinkedIn groups like mine say today (Tuesday, August 28, 2018) is the day LinkedIn starts the conversion to new groups.
This is the content of my last announcement to the group: "I SEE DEAD GROUPS."
And yes, I am quite pleased with my little meme here.
Thank you for being part of our Medical Devices Group community.Make it a great week. Joe Hage Medical Devices Group Leader
P.S. So you know how I say my 10x events are fun?
This is one of the between-session clips I played. Still makes me laugh.
I am doing a market study for a high performance coating and I seek your expert advice.
The technology allows the deposition of a very thin coating (between 200nm and 1,5 micron) on glass, stainless or ceramic. It brings anti-sticking, anti-corrosion, and hydrophobic properties to the surface. It can be deposited on and inside complex parts.
How often this type of problems are found in medical devices? Are they critical?
If they are, how are they generally solved?
I'm really interested by your feedback and advice on this topic. Many thanks in advance for your help.
Tanguy Van Regemorter
I am interested to learn about the fabric/textile products people are using in their medical-related work.
I am particularly interested to learn what problems could be helped with new or improved fabric/textile products. Thanks!
I am working with Live Life Personal Mobile Alarms in Canada to set up sales agents. Live life is a unique cell phone-based fall prevention alarm designed for seniors. Outstanding and innovative product with no monthly monitoring fees, extensive out of home coverage and a real benefit for seniors and their families. check it our and email me if you are interested. https://www.livelifealarms.ca
How gone are we?We're so gone that I changed the name of the LinkedIn group, From: Medical Devices Group To: MedicalDevicesGroup.net (we moved!)
Our progress so farI'm delighted with our first month of progress. We already have:
Full question-and-answer functionality along with the ability to be notified(!) when someone leaves a comment;
793 archived questions and 18,302 answers;
40 accessible webinars (replays, slides, transcripts);
Weekly announcements (opt-in required at https://medgroup.biz/stay); and,
NEW TODAY! A full calendar of 89 upcoming medical device events!
Coming attractionsVery soon, you'll also be able to:
Access our jobs board;
Search the entire database for questions and answers;
Share posts on LinkedIn, Twitter, and email;
Ask questions directly to our Medical Devices Group Advisors;
Consult a "promotions" tab for member offers;
Conduct a poll; and,
This is where you come inI grew up in Bay Ridge, Brooklyn, New York, where my 1978-1989 mayor Ed Koch asked his tagline, "How'm I doin'? If you have the time and inclination, tell me how I'm doin' with this group transition. I'm hosting an online "town hall" next week, Wednesday, August 29, where I can hear your real-time feedback and requests so we can build our new home into something really great. Here's the link to join us: Join the Town Hall.
Special Two-Day Offer: $250 offIn a cheeky farewell to the LinkedIn group, I'm running a 48-hour special on admission to 10x for ENGINEERS this October. Use promo code ByeLinkedIn to save $250 before Friday. It's the only time I'll have a promotion with this deep a discount. Take advantage of it today.
Thank you for being part of our Medical Devices Group community.Make it a great week. Joe Hage Medical Devices Group Leader P.S. Tick tock goes the clock! Just 48 hours to save $250 on your 10x for ENGINEERS admission.
- The rise of wearables and EHRs make precision medicine concepts possible.
- If medical device manufacturers are going to be successful with precision medicine, they’ll need to figure out how to navigate outcome-based compensation models for these therapies.
- Pharmaceutical companies work alongside medical device manufacturers for precision medicine. Pharma creates the targeted therapeutic; manufacturers design the diagnostics. There are 40,000+ different in vitro diagnostics (IVDs). The 2022 IVD market projection is $81.3 billion (a CAGR of 4.9%).
- 93% of drugs currently in phase III clinical trials are diagnostic-dependent.
- Multiple studies have shown that most traditional therapies in the US today are effective in fewer than 60 percent of treated patients, costing the healthcare system billions of unnecessary dollars.
- According to a National Academy of Medicine report, a precision-medicine innovation – one that more accurately identifies people who are at risk for a disease and is coupled to an intervention that reduces incidence even by as little as 10% – could generate hundreds of billions of dollars in value in the form of longer, healthier lives enjoyed by the US population.
FDA webinar in two days.Click here for the FDA content, courtesy of Jon Speer and Greenlight Guru. They will cover: • 'Critical To Quality' pilot program; • 'Manufacturing and Product Quality' pilot program; and, • Issues and concerns FDA is hearing from constituents. And you'll get access to the first FDA in the series where they covered what CfQ is and how FDA is engaging; summary detail on CDRH pilot programs; and, how FDA is rethinking regulations.
Members with questionsIf you've got the answers, please share with our community. Tautvydas Kazlauskas has a question on how to classify a fibrin-glue like medical device. Antonia Trevisan asks, "Are custom-made devices exempt from CE marking?" And I could really use help on Irina's question. So far no one has answered, "How to estimate safety BSE requirements?"
A whole new worldAs you can see, with our new home here in WordPress, I can add images and video each week. But even better, I have enough room to express myself and to highlight questions and contributions from group members like you! So here's your chance to ask a question and get a crowd-sourced answer from our members. Just go to https://medicaldevicesgroup.net/question/add/ to ask it. The page will look like this and there's even a way for you to get notified with each comment (just like the very old days):: I look forward to your participation!
Thank you for being part of our Medical Devices Group community.Make it a great week. Joe Hage Medical Devices Group Leader P.S. Meet me at ConX (Sep 17, South Carolina), the MedTech Regulatory Awards at RAPS (Oct 2, Vancouver, BC), and our group's 10x for Engineers (Oct 10-12, San Diego) – especially that last one! 😊
How would you classify fibrin-glue like medical device? The intended purpose of the device is management of bleeding in traumas or surgical procedures (i.e endoscopy) IIb or III and why?
I have a question on MDR implementation: Is it confirmed that custom-made devices are exempt from CE marking?
According to MDR art.20 par.1, and art.52 par.8, I believe that custom-made devices are exempt from CE marking.
Are there any conflicting interpretations or guidelines?
Kessler's RegretI was going to discuss the much-discussed Netflix documentary, "The Bleeding Edge" today. (Here is a direct link to the documentary for Netflix subscribers.) But the group could not wait until Tuesday! Three submitted discussions this week about it. I finally published Amy DeWinter's commentary and it racked up two dozen comments in no time. There is so much to unpack in "The Bleeding Edge." I'll likely return to it in the future. But they covered something so interesting about our 510(k) path to FDA clearance in the first 20 minutes, I couldn't get past it.
Direct excerpts from "The Bleeding Edge"These are intended for context for our discussion. Dr. Michael Carome, Director, Public Citizen Health Research Group [Carome]: Most people probably believe, when they get a medical device implanted, be it a pacemaker or a joint, that those medical devices have undergone appropriate testing to demonstrate that they are safe and effective before they came on the market and doctors started using them. But for most moderate and high-risk devices, that is not the case. William K. Hubbard, Former FDA Associate Commissioner: Originally, Congress intended that almost all new devices go through pre-market approval (PMA). A PMA is similar to a new drug application, in that a manufacturer must test it first in humans, compile all this data, and then present that to FDA scientists, who will approve the device if in fact it is safe and effective. Industry argues, "We're innovating, we're changing products every year and that costs a lot of money, to test each of those iterations in humans.” So Congress established the 510(K) process. Carome: For the 510(k) pathway, all the manufacturer needs to demonstrate is that their device is substantially equivalent, is the regulatory term, to another device that's already on the market. Dr. David Kessler, FDA Commissioner, 1990-1997: Dr. Adriane Fugh-Berman, Professor of Pharmacology & Physiology, Georgetown University: This really can cause problems when one medical device is approved on the basis of being substantially equivalent to a previous medical device that was approved because it was substantially equivalent to an earlier medical device than that. Dr. Deborah Cohen, Associate Editor, British Medical Journal: You end up with what we call a daisy chain. And then, quite often what you found is that some of these predicate devices, as they call them... have been recalled from the market because they've been failing. Jeanne Lenzer, Author, The Danger Within Us: I called the FDA and asked them, "How can you clear something based on a predicate device that's already been shown to be dangerous? And they said, "We don't judge what the prior device is." Dr. Rita Redberg, Editor, JAMA Internal Medicine: So even if the device was recalled because it was dangerous, you can still use it as a predicate and get your device cleared 'cause it's substantially equivalent. So there's a lot of problems with that 510(k) system.
Your TurnSo there we are, folks. The current state of the 510(k) pathway. Does it make you feel safe... especially that part about basing your device on a failed predicate?! Yikes! "The Bleeding Edge" documents a number of devices gone terribly, terribly wrong. What say you? Is 510(k) a pathway to close? Markedly reform? Leave alone? I can't wait to read your robust comments – which(!) – you can receive as alerts(!!) – when subsequent members leave their comments.
Access to the first two of four FDA’s Case for Quality webinars.Part 1 covered: • What CfQ is and how FDA is engaging; • Summary detail on CDRH pilot programs; and, • How FDA is rethinking regulations. Part 2 will cover the: • 'Critical To Quality' pilot program; • 'Manufacturing and Product Quality' pilot program; and, • Issues and concerns FDA is hearing from constituents. Guys, it doesn't get much better than this. Cisco Vicenty works at FDA right now as the FDA Case for Quality program manager. And you can ask direct questions during the live event, August 16 at 11:45 New York time. Come if you do QA, RA, Clinical Affairs, R&D, or any kind of medical device engineering. Click here for the FDA content, courtesy of Jon Speer and Greenlight Guru.
Want to meet in person?As leader of our Medical Devices Group, I host a few events annually to meet and help members in person. Here are my upcoming events:
- September 17-18, 2018 for ConX, the 31st operational excellence event hosted by the Institute for Process Excellence, in South Carolina (as keynote speaker).
- October 2, 2018 at RAPS; I'll participate in the MedTech Regulatory Awards (as master of ceremonies).
- October 10-12, 2018 for the 10x Medical Device Conference event, "10x for Engineers," in San Diego (as host).
Fast RoundAnother new feature, I'll close most weeks with short stories, links of interest, sponsored ads, and more. Is there something our community should know about? Contact me and tell me all about it. I'll reply as quickly as I can.
- Your Feedback. I'm acutely interested in your feedback about this email and the new site.If you have the time and inclination, I'd be ever so grateful if you hit "reply" to this email. It will come directly to me.
Thank you for being part of our Medical Devices Group community.Make it a great week. Joe Hage Medical Devices Group Leader P.S. 10x for ENGINEERS is two months away. We have a "Buy Two, Get Three" promotion: Send any two employees at regular price and send the third one, free!
I'm curious to hear what other industry professionals feel about the Netflix documentary "The Bleeding Edge" that recently debuted offering a scathing exposé of our industry. My thoughts: For sure there are companies that have not always held patients' best interests, as illustrated by the alarming number of adverse events reported with the Essure device in the film. That said, we rely on FDA to initiate investigations and recalls as a result of such reporting, and regulatory agencies SHOULD employ what is necessary to keep patients safe. Lastly, the argument that clinical trials are too short is unrealistic. For implants, post-market surveillance is key, and it appears FDA needs to do a better job.
It is extremely important for those involved to review and comment on the text, as this is the last chance for technical modifications to the project - if draft is accepted, technical requirements can no longer be modified until publication.
For each country, the availability of the document (which is copyrighted and not for open circulation) and means to comment depends on how the country deals with mirror groups to ISO TC 210 or ISO TC 210 JWG 1. Usually, there's a national mirror group that deals with the international work. Please inquiry at your National Committee organization.
In Brazil, the document is handled by WG 2 - Risk Management - from EC 26: 150.01 of ABNT CB 26. WG 2 members will receive and review the document.
The WG will also hold an open meeting for those interested to take note of the text and assist in creating the Brazilian comments. This meeting will be scheduled shortly.
Having no references to similar devices, I find it difficult to find the way to be able to license it when it is in the prototype phase.
First, where are other Healthcare Technology industry related discussions occurring in your life? I know some professional organizations may have forums on their websites, or during conferences, but I am asking to make sure I am aware of all resources.
Second, do you have any recommendations for transitioning into this industry? (medical device OEMs, contract medical device engineering firms, medical device consulting firms, etc.)
I have a Biomedical Engineering degree and an MBA, with much of my experience in clinical engineering within hospitals. While I have enjoyed my hospital time and may continue in that direction, I am exploring transitioning from the clinical setting towards industry to expand my experiences. There are many areas that peak my interest such as R&D, Quality, Manufacturing, Testing, Consulting, Auditing, Regulatory, etc., and I may be looking for a technical / hands-on role as an individual contributor. I’m pretty flexible on U.S. locations, and whether the roles are temporary or permanent, etc. (I have thought of performing or managing service for an OEM as a way to get my foot in the door, but I haven’t pursued that yet because it seems pretty close to what I’ve been involved in already.)
Difficulty seems to be convincing people my transferable skills allow me to take on new types of roles, kind of a chicken and egg scenario. I understand it is easiest in hiring to match jobs with candidates who perfectly match the stated position requirements. Have you ever had success in pivoting to new types of roles in this industry? If you have hired employees in this industry, have you been able to effectively source candidates with highly transferrable skills?
Thank you in advance for your insight!
Anyone here have answers for, or maybe just some thoughts on, any of these questions?
FDA updates Pre-Cert program as it begins to grapple with ‘hard questions’
New updates to the FDA's Software Pre-Cert working model shows the program is making significant gains, but FDA attorney Bradley Merrill Thompson tells FierceHealthcare the agency is starting to bump up against difficult legal and regulatory...
One of the themes I come across regularly with my medical product manufacturing clients is uneven skills in investigation and determining root cause through a rigorous and adequate Root Cause Analysis (RCA). In some cases, it is newer team members who have not yet been mentored or (preferably) fully trained. In other cases, it flows all the way to the senior staff and process owner levels (including CAPA procedures that only describe a single RCA tool like 5 Whys).
The investigation analysis tools used in RCA are not intended to be used in isolation; they are intended to sequence from one to another until RCA is completed and a plan is formed.
Recently, I came across this linked article. I think it does a nice, concise job of describing a typical RCA tool flow and how to apply that to corrective and preventive actions. Definitely not the deep dive, but an easy to apply and brief start to the topic.
What do you think?
#RCA #CAPA #investigation #processengineering
Root Cause Analysis, Ishikawa Diagrams and the 5 Whys
Root cause analysis (RCA) may be limited to brainstorming and not fully thought-through ideas. Incorporate Ishikawa diagrams along with the 5 Whys in order to maximize your RCA efforts.
"HeartSciences’ MyoVista® Wavelet ECG Device is breakthrough technology in electrocardiography designed to assist in the early detection of heart disease*. MyoVista wavECG Technology is focused on closing the diagnostic gap related to identifying patients having an elevated risk of a cardiac adverse event. Patented signal processing methods using wavelet mathematics provide new information related to energy in the acquired ECG signal.
As for me and my family, I don't want to waste my -or taxpayer money. But a simple, inexpensive ECG or EKG that provides early diagnosis makes sense.
Doctors Told Not to Order ECG's for Low-Risk Patients
Doctors shouldn’t routinely perform electrocardiograms on patients at low risk for heart disease, an influential federal panel is recommending. While an ECG test of the heart’s electrical activity is safe and inexpensive, the benefits for patients at...
A conversation with Crowdcube, Carbon Black System, and EnXray
Joe Hage: Hi, I'm Joe Hage. I lead the Medical Devices Group on LinkedIn with 350,000 members. I have the pleasure of being joined today by Patrick Ryan, Steve Ryan, and Ed Cappabianca to talk about Crowdcube and how they're using it to further their business. Welcome, gentlemen.
Three, overlapping: Thanks, Joe, good to be here. Thanks, Joe. It's nice to be here.
Joe Hage: Thank you all. Patrick, we'll start with you. Tell us your role at Crowdcube.
Patrick Ryan: So I'm an equity fundraising manager at Crowdcube. So that means I deal with businesses when they come in the door. I guide them through the process of fundraising, and help them achieve their funding targets.
Joe Hage: How long has crowdfunding been around in the UK, Patrick?
Patrick Ryan: Rewards-based crowdfunding, much like Kickstarter or Indiegogo in the US, has been around since about 2009, 2010. And equity crowdfunding has been around since 2011.
Joe Hage: All right, and Crowdcube joined the fray, when?
Patrick Ryan: Crowdcube joined the fray in 2011, and we were the first to market with equity crowdfunding. We were actually the first equity crowdfunding platform in the world.
Kickstarter and Indiegogo would be what we call rewards-based crowdfunding. So essentially, what they're offering is unsecured asset finance, right? You pitch your business idea and people pay in order to receive rewards in exchange – some products, access to a film, tickets to your show, whatever it is.
In equity crowdfunding, you're offering equity in the company in exchange for the investment.
Joe Hage: I see. Ed, we'll move to you. You are presently crowdfunding on Crowdcube. Tell us a little bit about your business, and why rewards-based crowdfunding program would not make sense for you?
[caption id="attachment_5995" align="alignright" width="300"] Click to read about local sterilization company EnXray, now fund-raising.[/caption]Ed Cappabianca: Well, my company is EnXray Limited. We're developing a technology for the healthcare and life sciences industries, specifically for sterilizing products using a form of ionizing radiation.
The reason a rewards-based crowdfunding system wouldn't work for a company like EnXray is, because we're developing an equipment-based technology, there isn't really much we can give to people who are interested to support the business. So it’s much more typical for us to raise equity capital from investors who understand our story and like the opportunity.
Joe Hage: How do you go about deciding what percent of equity you're giving away? And how, finally, can that be split up amongst shareholders? I mean, can I give as little as 10 pounds?
Ed Cappabianca: Actually, that's probably a good one for Patrick to field because it's a key part of their platform.
Joe Hage: Okay, Patrick, go ahead.
Patrick Ryan: Yes, you can invest from as little as 10 pounds, and it's open to all categories of investors. And the way that works typically is the investment is housed in a single-investment vehicle.
In a nominee structure, there's one business on the cap table and all the shareholders are beneficiaries of the shares owned by that business.
Ed Cappabianca: That system is actually one of the great appeals for us, because although we're attracting an awful lot – we've actually as of today have over 160 investors who contributed to our current campaign – we will only have to deal with Crowdcube as the nominee manager when we have to ask for votes or communicate things to shareholders, and they handle the rest of that distribution for us.
But what that also means for us is that as we move forward towards becoming a public company one day, we're already building a base of small, if you will, retail-type investors who are going to be well positioned to help us have liquidity in our shares later on.
Joe Hage: Ed, what percent of your equity raise is complete? How long have you been with Crowdcube?
Ed Cappabianca: We launched our offering with Crowdcube publicly just 12 days ago, and we'll run the campaign for 30 days, which we might be able to extend if there's additional interest and more investors want to come in.
So we set a target for how much we're looking to raise, and the pricing for that we set with some of our existing investors who are supporting the offering.
Joe Hage: 160 investors! Patrick, let me ask you, when Ed's program gets funded, will it be as though Crowdcube owns whatever percent is made available, and you'll take care of handling interactions with 160 investors?
Patrick Ryan: So there's a couple of ways of doing it. You can actually list the investors directly on your cap table, or yes, you can go buy this nominee. And in the case of the nominee, it's quite passive the way we operate it.
So when it comes to voting and preemption? Yes, you go to the nominee, and the nominee goes out to the investors.
In terms of day-to-day investor communications, or more like month-to-month or quarterly, we'd advise you to stay in touch with them. The point being, if you raise funds effectively from the right sorts of people, you'll want to keep engaged with them because they're going to add value and be collaborators in the business in some shape or form.
Joe Hage: Steve, if you would, what is your business? And I understand you've yet to list your business on Crowdcube, but you're considering it. So thank you for joining us.
Tell us about your funding options, how you came across Crowdcube. And are you ready to go or do you still have questions?
Steve Ryan: We're ready to go, hopefully within the next two weeks. We've done a fair bit of work towards putting our pitch together with a bit of assistance from Patrick and some other team members at Crowdcube.
Joe Hage: Tell us about your business.
Steve Ryan: Yes, Carbon Black System Limited, we've been on the go for a few years. We've got a fantastic product, which is a fantastic-looking carbon-fiber wheelchair that brings lots of benefits to users.
It was really well received a few years ago when we first brought it to the marketplace. We got rave reviews on the BBC and the trade press.
Unfortunately, our biggest challenge has been the chair was too expensive to really penetrate in the marketplace. So we spent the last six months really investing some time and effort to see how we can resolve that problem.
We've identified the resolution in terms of moving production elsewhere, changing some design features on the wheelchair to make it better.
We've made our first couple of wheelchairs under this process, and now we're looking for some funding to really roll out the manufacturing ability, the assembly facilities, and, more than anything, some marketing we need to do. That always seems to be the thing that costs the most money, unfortunately.
Joe Hage: You already have sales. Is that right, Steve?
Steve Ryan: Yes, we do. We've been selling the chair for a number of years, we just haven't generated the volumes we would like to purely because the chair price has been of our potential customer base.
Joe Hage: And may I ask what was that original price point?
Steve Ryan: The original price point when the company was launched was £14,500 for a manual wheelchair.
We've worked quite hard within certain confines to bring that price down to £10,000 about six months ago. In the UK, the premium wheelchair market tends to range between about £3,000 to £6,000. We are still well north of that position.
Our latest projected cost savings – and we've introduced a better redesign we've done – means we are now planning to retail at £3,995. Effectively, almost exactly the same-looking product with actually some additional benefits in there. So it’s a real game changer for us.
Joe Hage: If I understand you, you're lopping a full £10,000 off the price. Wow, that is game changing!
So, I wonder, do you anticipate either you're seeing among your present investors – or you anticipate among your crowdfunding investors – going back to the first point we talked about in terms of rewards?
I could foresee where somebody might contribute £4,000 to get his own chair. But that's not the way you chose to go, or is it something you can do in parallel? What are your thoughts about that?
And then I'll ask Patrick for his comments.
Steve Ryan: Yes, we had a conversation today with one of Patrick's colleagues and I had a discussion about some slightly different rewards we may offer, because it's not easy to offer a product as an award, even when the product is £4,000.
But the two slightly ingenious rewards we've come up with is, if you invest over a certain amount, you will come to a lunch that we're organizing with one of our ambassadors, Kadeena Cox, who's a double para-Olympic gold medalist.
Another thing that we're looking at is if you invest over a certain amount, we will donate a chair free of charge to a charity of your choice.
I'm actually in discussion with “Help for Heroes” just now to see if it would be something we could do in conjunction with them.
So I think we've tried to take a slightly different approach to the rewards than perhaps a more traditional raise might do. And Patrick, you probably have seen many different types of awards offered over the years, so we just thought this was something a little different.
Joe Hage: Yes, Patrick, talk to us about that. Do you have a couple of examples where it's a bit of a hybrid where you get equity, but there's also a reward kicker?
Do you find that they work better?
Patrick Ryan: Yeah, good question, Joe. I think Steve's hit the nail on the head. Yes, offering rewards is great. It's usually about offering rewards that are, in some way, exclusive or unavailable to other people who might be customers of the business. And, you know, it's about making your investors feel special and a part of the company where possible.
So things you quite often see if it's a consumer products or stuff like investor black cards that entitle you to – not always just discounts – but perhaps, for example, if you're running a brewery, it might be you become a member of a trialing tasting club for new product development, or a beta tester, that sort of thing.
And for other companies, it's dinner with founders and another interesting people connected to the business. But definitely, it's something that investors look at. It adds that little bit of "something special" to the fundraising.
Joe Hage: It sounds like an attractive marketing option. Patrick, how many potential investors do you currently have on Crowdcube?
Patrick Ryan: We have about 535,000 people registered on the platform.
Joe Hage: How many?!
Patrick Ryan: About 535,000 currently.
Joe Hage: Wow!
Patrick Ryan: So that means they've logged in on Facebook or LinkedIn, we've captured details and we're communicating with them by email.
Joe Hage: How many have ever made an investment?
Patrick Ryan: That's the key question. The number's now about 110,000.
Joe Hage: Wow!
And if I understand, it's all or nothing. Either you hit your goal or nobody contributes anything. Is that right?
Patrick Ryan: Yes, that's correct. So it's success only, essentially.
Typically, people have a minimum funding target, which is that sort of minimum capital requirement to execute the business plan, and then an over-funding target they'd stretch to, which will allow them to do points D, E, F, alongside points A, B, and C on their business plan, for example.
Joe Hage: Eddie, what are you finding with your program right now, in terms of the kind of interest that you're getting? Is it concentrated among a few large investors, and then everyone else is getting alerts?
Ed Cappabianca: There's quite a big spread.
There are a couple of big, chunky investors that you get, inevitably, but there’s a large number of very small investors who probably will distribute their investments across a wide number of different companies.
But one of the reasons that we're talking to you today, Joe, and one of the reasons that we're on Crowdcube and with crowdfunding now, is what we're perceiving – and it seems to be getting borne out by the fundraising that we're doing – is in the crowdfunding community, there's more of an interest for more sophisticated types of businesses.
We have seen a couple of quite technologically advanced companies come into the Crowdcube market and been successful in raising capital.
And one of the reasons we're talking to you is we're interested to make sure that people in the Medical Devices Group on LinkedIn can also be aware this is a way that companies like ours can get funded.
There may be people in your community who are thinking about raising money for a new business idea, and hadn't been aware that something like crowdfunding might even be possible for companies like ours.
Joe Hage: I wonder if this might be a question for Patrick or for you.
I'm here in America. I love your concept, Ed. I want to invest. How would I do that? Can I invest in dollars?
Maybe this is a Patrick question. So I'll switch to you, Patrick.
Patrick Ryan: The American equity crowdfunding landscape is a little bit complex.
There were a lot of regulations that came into place in the U.S. on small investments. To protect retail investors from penny stocks and early stage investments, in the U.S., you must be a registered investor with the SEC to invest in startups. That typically means, I think, you must have a net worth of over a million dollars, or an annual take home of over $150,000 or something like that. And that's changed recently.
So we're now partnering with a company called Seed Invest, which is an American equity crowdfunding platform, and we're looking, in some cases, at doing dual raises on both platforms.
So you can invest via an American vehicle into the British entity or via British vehicle into the British entity, if it's a British company we're raising for. And it's an American company, British investors can invest via Crowdcube into the American vehicle now.
Joe Hage: So it's important, then, where the crowdfunding funding platform is headquartered. Is that right?
Patrick Ryan: It's important where the entity is headquartered.
So if retail investors in the U.S. want to invest in a company, then the company has to be headquartered in the USA, typically Delaware.
And then they invest via a special regulatory framework they recently brought in the U.S., which is called a Reg CF.
Typically in the U.S., startups are raising money via a Reg D on Seed Invest, which is just a different regulatory framework. But that's only open to registered investors.
Joe Hage: Okay, Ed, let me ask you. So right now, I'd like to write a check. I'd like to participate.
Can I? And how I do that?
Ed Cappabianca: We, as a UK domiciled company, do have U.S. investors already.
As you can imagine, as an American, I have some good contacts over in the States. And we do have a number of US-based investors, all of whom have completed the same documentation that Patrick was describing to declare themselves as accredited investors.
So when it comes to our crowdfunding activity, it's a more complex process, but US-based investors can invest into EnXray, but they have to fulfill the additional paperwork to declare themselves as accredited investors.
Joe Hage: Right, and then they can use the Crowdcube platform?
Patrick Ryan: Yes.
Ed Cappabianca: And then they can use the Crowdcube platform but, like he said, there are more steps they have to go through.
Joe Hage: Patrick, will it make sense for you to have a competitor in each major country? Should there be one for Parisians, and one for Romans, etc?
Patrick Ryan: It varies by market. In the EU, different countries have different regulations around crowdfunding. It's very much an alternative finance space. And I'm speaking specifically about equity crowdfunding. And it's quite a recent development, so countries aren’t fully up to speed with the way this whole thing works.
Our vision as a company is very much to build a global marketplace for early-stage startup investments. We'd like to become the Amazon for early-stage finance, if you will. And the vision is really for that to be liquid as much as possible, very easy to do, and for people to be able to invest for as little as 10 pounds.
And some countries are more forward-thinking in those cases.
So we're working with a lot of Spanish companies, and quite a few Austrian and German companies, some Scandinavia companies, and in those countries, provided their lawyers are happy with things, we're able to proceed. The U.S. is a little bit more complex, so there we have a partnership with Seed Invest. Often we go via Seed Invest and we do a dual raise on both platforms. But yes, it depends.
Joe Hage: Patrick, a question for you. I understand that before you accept a company for investment, you go through a due-diligence process. I imagine it's much like any company would do before they choose to invest. Is there a difference?
Patrick Ryan: Yes, good question. So, the due-diligence process is fairly light compared to what you might experience with, say, a venture capital firm.
Our requirements are essentially to start with background checks on the directors and on the company, make sure there's nothing outstanding in terms of credit against the individuals running the company, and then it’s essentially ensuring any claims made in the body text of the pitch are verifiable.
In terms of detailed due diligence on the accounts of the company and that sort of thing, there's a light touch that is done, but we rely more on the view of the crowd on that.
So the intelligence of the crowd, in terms of where the valuations are, in terms of the company background, and the details about the founders and that sort of thing, we dig into things a little bit, and anything that's claimed is verified. But we're not auditing accounts or anything like that.
Joe Hage: Fair enough.
Steve, I understand that your participation in Crowdcube is all but certain, that Patrick's just doing his due diligence as he described.
Can you tell us how you chose crowdfunding as a viable financing alternative for you? And tell us: Is it an either/or? Or can you do all the things that people typically do, and you're just adding this as another way to reach a broader audience? Your thoughts on that?
Steve Ryan: Yes, I think in the first instance, it was clear to us that we needed to raise more money than we were able to raise from our existing shareholder group. We've already got a shareholder group, which is effectively a small venture capital group based up in the north of Scotland.
So it was obvious what we needed was beyond what they could raise and then we did look at alternatives. We did look to go to another venture capital group, and we did look at Crowdcube and other platforms as potential options.
The reason we chose Crowdcube was there is definitely a lighter touch on the due diligence. Not that we have anything to hide, but it just takes a little bit of the pain out of it.
I think also, certainly in this part of the world, there is limited access to venture capital, and it's very time-driven in terms of you get a one-hit chance when they have their next meeting, and it's either a yes or no, and then you move on.
Whereas with Crowdcube, you have the opportunity to get involved with a big network. So you've got a much bigger audience that may or may not be interested in your business, and then you also have the opportunity to keep that whole thing live.
It's not one hit and people either like it or they don't. You get the opportunity to run a campaign over 30 days. And if that can coincide with some really exciting activity in the business, then you get the chance to relay that as you go rather than just have that one-hit wonder that say yes or no.
So I think those are the things that did certainly attract us towards Crowdcube. I think the process itself has actually been quite an enlightening process as well. It does force you to think really carefully about how you're selling the product.
Joe Hage: What kind of marketing do you commit to, Patrick, on behalf of the companies on your platform?
So for example, I recently registered on your platform. When Steve's concept goes live, will I get an email saying, "Hey, everybody, there's a new investment for you to consider. And it's this. Go check out the page”?
Patrick Ryan: Sure. It's a good question. So, we do a few things, Joe. Email marketing is our main marketing channel. And there's a few ways that works.
We do a Monday mail-out that's quite general. You see new pitches that launched on the website and pitches that have recently hit their minimum funding target.
There's a Tuesday mail-out that's tailored, and we try to include all the companies that are currently live.
There's an algorithmic feature that goes on Thursdays. With that one, we hit investors who've previously invested in businesses similar to yours. Secondly, we target investors who've dwelled on your pitch page when they've been logged in.
So we try and be quite smart, the way we do things. We view the investment journey on an online marketplace as much like any e-commerce journey, and our job is very much to nudge investors along that journey from awareness in a company to decision to invest. It's much like any buying journey, the difference being that what you're purchasing is an investment product rather than a physical product.
Joe Hage: Why would anyone bother to invest just 10 pounds if I could get an alert anyhow? I mean, I doubled my money, I made 10 pounds, it seems like more effort than it's worth.
Patrick Ryan: Yes. So I think some people click and follow a pitch without investing just because they're curious, and they want to see how it goes.
And I think there's an element of behavioral economics here, right? People like to see social proof before they make a decision.
No one wants to eat in an empty restaurant. Momentum is very important to a crowdfunding pitch. What you'll notice is once you get closer to your funding targets, more and more investors come on board more organically. And that's often those people who followed; they're curious; they want to see others before they're willing to follow and make an investment themselves.
Joe Hage: It's kind of like, unless you're getting close to 75%, this probably isn't going to happen. So why bother?
Patrick Ryan: Yes, I think there's an element of that.
If you look at what happened with Bitcoin last year, any big surge in the stock price of a company, once people start buying, it starts a "snowball effect" where other people start buying.
It's just about the way people think. And I guess people like to think they're taking a risk with investments, but they're actually quite risk averse. So, they want to see other people taking a risk, and that makes it seem less risky to them.
Joe Hage: Okay, before we conclude, I have two business model questions for you, Patrick.
The first is, “when a company approaches you and you list them, they may not hit their target – so they raise zero funds. Are you paid nothing? Or do they owe you for having had the privilege of being on your platform?
Patrick Ryan: No. It's a success-only model. So we don't take any fees, unless the fund raise is successful.
Joe Hage: So you must be quite discerning, then, for you to let someone be on there. It would be a waste of your time and talent and your intellectual capital, reaching people and saying, “Go check out this and that,” if you don't think it's going to fund?
Patrick Ryan: Yes. We've looked at different approaches over the years, Joe. So for a while, we ran everything by an investment analyst team. And we were quite discerning about who we allowed on and who we didn't.
What we found was, in terms of percentages, that didn't really affect the success rate, because:
The fundamental thing that makes a difference to whether someone will succeed in equity crowdfunding is not just how good the underlying businesses is, but how will they understand how to market the opportunity to people. – Patrick Ryan, CrowdcubeI also think, when you get into the question of investment philosophies and stuff like that, if you look at stock markets, most brokers don't beat ETFs or index funds.
And so our position is, we're the marketplace. You can look at us like a NASDAQ or a FTSE 100.
We're happy for you to list. It's the decision of investors whether this is a good investment. We're not investing on balance sheet ourselves. And what that means for us as a business is we must be quite lean in the way we approach getting people to list on the platform.
A lot of the due diligence is carried out once the company hits 75% of their funding target, which we know is a tipping point for success.
The average investment on Crowdcube is about £1800 (mean). The median is about half of that: It's about 900 - 950 pounds.
This digs into the deeper question which is, “What's the point in crowdfunding as opposed to just raising from venture or angels, especially if you have a good business?”
I guess this would be our sales pitch. If you look at the way the Internet has changed us, we share everything, right? And there are different levels of collaboration, so it's on a very high level.
We share things on Instagram, Facebook, Twitter, that sort of thing. On a deeper level, we collaborate on things like open-source software. Bill Gates, famously lambasted Linux in its early days, in the early 90s, it now underpins most of the apps, mobile operating systems and internet web pages we use daily.
There's massive power in collaborative efforts. A business getting 300 or 400 investors on board isn't just about the money. It's about how can we leverage and work with this group to build something together. Now, this may sound to an American, like some sort, quasi-socialism. But I think what we're seeing with the Internet is – and there's a very good book called “The Inevitable,” written by one of the founders of Wired Magazine where he talks about this in quite a lot of detail – movement towards a sort of hybrid socialist/capitalist models of work that are working for everyone.
If you look at YouTube, they're competing with all the TV networks, but they don't create any of the content. There's some reason all these people want to create all this content for free and get it out there. It’s because it serves them some purpose alongside raising the money.
For Ed, he's interested in raising money from people in the medical field and, particularly, members of your group because they can contribute in ways alongside the capital, whether that's routes to market and new product development, and financials.
What we know is if you give people skin in the game, then they're way more motivated to do things for you. And it's quite fun to feel you're part of something, you've got a little stake in a business and you're helping them build it. And if they win, then you win.
Joe Hage: That makes a world of sense to me, Patrick. And I'll go further and say that I can't imagine that in 10, 20 years or perhaps much sooner than that, crowdfunding won’t very much be as accepted as any other way to finance a company.
Everything seems to be moving in that direction. It seems wonderfully on trend.
With that, Ed, would you summarize your experience with Crowdcube so far, and what you hope in these next couple of weeks on the platform? Perhaps some things other investors might consider when they're looking for financing options?
Ed Cappabianca: Sure. So the way we chose to go with Crowdcube, in the first instance, was we saw a number of companies in the science technology space, who were raising money this way. We were encouraged.
And we put together our campaign onto the platform privately, during which time we raised about 50% of the amount of money we were looking to raise, of that £400,000.
So we've been live for 12 days. And we're now already at 68% of our total. And we think that with the remaining 18 days to go, we're in a pretty good position to at least achieve our target.
Joe Hage: If you would summarize for us about your technology, what it can do, and what types of people you believe you'll reach using Crowdcube so that they can either be potentially new customers, for people who help you achieve your goals. Sure.
Ed Cappabianca: The EnXray technology is a platform technology that generates what's called low-energy X-ray. And it's this x-ray energy that can be used to sterilize or otherwise irradiate ATMPs, which are advanced therapeutic medical products.
One of the important things about sterilization, today, in advanced therapeutic products is that they are made in very small quantities. To be able to sterilize very small quantities efficiently, on site and on demand, is what our technology is all about.
One of the analogies that we talked to people about is the idea of when computing used to be done by mainframe computers, these were large remote facilities that had massive processing capacity. That's kind of what sterilization is like, today.
Our technology is going to be small, stand-alone machines that can sit in a laboratory or research and development facility and can be used to sterilize small quantities as and when needed.
What's also important about that is we think this technology will help to accelerate the development of other products and help other companies that might come to raise money on crowdfunding.
So that's one of the key reasons that we're talking to you to expose your network of contacts to what we're doing, and also what crowdfunding is about.
Joe Hage: I think you have a great concept, and I'm excited to share it with my network.
Steve, let's hear from you. Tell us again about your concept and why people who are involved in medical devices make for interesting prospects or potential collaborators for you.
Steve Ryan: Just looking at the UK alone, for example, there are around 800,000 wheelchair users in the UK alone.
So there is undoubtedly, even within the Crowdcube community, going to be some of that community for whom our product is very relevant. And an area in which they have some expertise.
Our concept, our product ticks all the boxes in terms of the medical benefits it brings to users. But more than that, I think it's such a fantastic-looking product, it's an immediate eye-catcher. And it's something that, down the years, has been so easy to get people engaged in the product because it looks so different than everything else that's out there on the marketplace.
It has many unique design features that actually getting people to the product in the first place is, we think, quite easy for us because of the way that it looks and the way that we've branded it.
Joe Hage: It sounds exciting. I wish you a lot of luck. You've got an innovation now available at a third of its previous price. Good luck to you, Steve Ryan.
And, Ed, I'll ask you the same question. Why, among all investments, should someone park some money with EnXray?
Ed Cappabianca: We think EnXray is a really interesting, exciting technology to bring to the life sciences industry, because there hasn't really been a logical change in the way that products can be sterilized.
And this is a really important aspect of how new products get developed.
Even very large companies like Johnson & Johnson or Medtronic, when they build and design a new product, they themselves start looking like a startup company.
So even the startup businesses and the really big companies would all benefit, and then everybody else can benefit from having these new technologies brought to the market more quickly.
So, our pitch is, by investing in EnXray, you're helping a much wider number of companies develop much more innovative products that can help society.
Joe Hage: Patrick, you're the one who brought us all together today, because yours is the platform these gentlemen are using to make their dreams a reality.
How would you let those on the call know about Crowdcube in a sentence or two and about why they should consider you for their alternate financing needs?
Patrick Ryan: Firstly, I'd say I think both Carbon Black and EnXray have really exciting products.
I think what Carbon Black is doing that's really interesting is looking at the fashion side of being a wheelchair user. Wheelchairs often seem quite functional. I think they are probably often designed by people who aren't actually wheelchair users themselves.
But when you're a wheelchair user, it's a part of your day-to-day life. And like an item of clothing, you want to make sure it looks good, and that's what they're offering. That’s quite an emotional driver. I think it will be a very successful product.
With EnXray, I think the opportunities it presents for companies to collaborate and innovate more quickly means – from an investment perspective – it’s one of those smart ones that's maybe the picks and shovels in a gold rush.
We're going to see a lot happening in med tech and a big acceleration in areas like stem cell research, and anyone who helps to facilitate that process is going to be a winner.
For Crowdcube, our mission is to democratize early-stage equity finance. We want to offer the opportunity to invest in the next unicorn company, the next Facebook or, in our case, companies we raised for, the next BrewDog or Revolut.
We want to offer people the opportunity to put some money in and see the same returns as a Marc Andreessen or a Peter Thiel sees. That's a really fun thing to be able to do. So yes, come along, check out the platform. There are always lots of cool businesses raising money. Invest aware, there is capital at risk, and have fun.
Joe Hage: What a great call. And a pleasure to see you all today: Patrick Ryan from Crowdcube, Steve Ryan – no relation – from Carbon Black System, Ed Cappabianca from EnXray.
I'm Joe Hage from the 350,000-member Medical Devices Group. Thank you.
It blamed manufacturer risk management for a 2014 peak in recalls: The culture, the shallow industry-wide understanding, the inability to tie risk management into quality management systems.
The authors quoted Francisco Poliodoro, "Safety-related behaviors fade over time and other motivating forces come to the fore, gradually launching the seeds of the next error,” adding, medical device manufacturers have an “inability to disengage from the reactive cycle” and calling them “the main impediments to the reduction of adverse events.”
Last year there was another peak and with it a challenging article: http://bit.ly/epidemic-rages-in-2017
Do you agree with either of the findings? I welcome your comments or questions here and at email@example.com.
My team is helping 3 companies with this problem. One company is very large, with thousands of employees and multiple sites. Another company is small and was recently acquired by a larger company, but their quality system has not yet been merged. The third company has less than 10 employees. Despite the differences, all 3 companies can simplify their quality systems using 3 strategies.
Consolidate your procedures. 28 procedures are required in ISO 13485:2016 and 25 procedures are required in 21 CFR 820. However, 2 companies have more than 70 procedures and the largest has more than 500. You don’t need a corrective action procedure and a preventive action procedure, when a CAPA procedure will do. You also don’t need a nonconforming materials procedure and a rework procedure. Those 2 procedures can be combined. Design controls requires 3 procedures, but you could easily consolidate that into 1 or 2.
Be and editor--not a writer. Every time a company receives a nonconformity or an FDA 483, the first approach is to add a reminder to a procedure. This seldom is effective. Better training and monitoring quality objectives are more effective. Therefore, delete the ineffective reminders and cut the procedure down to the minimum requirements so every procedure is as simple as it can be. Then implement quality objectives for tasks that are sometimes neglected. Your new lean procedures will be easier to remember too.
Don’t duplicate procedure content in your quality manual. Your manual explains how you meet requirements of each subsection in the standard, but if you have a procedure that meets the requirement--just reference the procedure. This strategy cuts down 28 subsections to a short sentence for each (e.g., This requirement is met by SOP 8.5.2).
Main possibilities from their perspective: 1) agency is taking a different, more cooperative or interactive approach to enforcement activities; 2) Med device co's are becoming more regulation savvy; 3) the Case for Quality Initiative is contributing to the drop
Agree? Disagree? Misses the mark, there are other factors?
Drop in Warning Letters for Medical Devices Raises Interesting Questions About the Industry
In 2017, FDA issued only 44 Warning Letters to medical device establishments. Of those, 11 were related to pre-market issues, which include investigational device exemption violations or lack of
I'm an investor in a medical device start up and our Team is seeking an experienced marketing consultant. The patented device has two major features:
1. Esophageal biopsy and, 2. Therapeutic drug delivery.
We are on track for FDA trial submission in June for the esophageal biopsy feature. The device is a balloon. The design is a single-application geographically oriented, four quadrant, circumferential esophageal biopsy. The balloon’s proprietary pleat system deflates after sampling to preserve cell density. In comparison, the current brush method accesses only a small area, requiring the use of multiple brushes and applications for wider sampling. The therapeutic drug delivery feature is still being tested and we believe it will significantly change the industry.
We have many marketing needs but initially we need assistance from an experienced medical device marketing consultant with development of messaging, product benefits over current methods, and marketing materials.
Referrals and recommendations are much appreciated!