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 firstname.lastname@example.org.
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!
FDA 510(k) applicants should ensure that their submissions meet RTA screening criteria to avoid RTA letters that can delay their US market commercialization plans. Just have a look on the below five key reasons provided to avoid the RTA letter:
𝙁𝙞𝙫𝙚 𝙠𝙚𝙮 𝙧𝙚𝙖𝙨𝙤𝙣𝙨 𝙛𝙤𝙧 𝙧𝙚𝙘𝙚𝙞𝙫𝙞𝙣𝙜 𝙖𝙣 𝙁𝘿𝘼 𝙍𝙏𝘼 𝙡𝙚𝙩𝙩𝙚𝙧
1. Failure to comply with FDA guidance: Applicants should adhere to recommendations listed in the agency’s guidance documents on formatting Traditional, Special and Abbreviated 510(k) submissions. Some device sponsors may not understand how to compile and format their 510(k) submissions.
2. Failure to supply an eCopy: FDA 510(k) applicants must submit an electronic (eCopy) of their 510(k) applications to the agency.
3. Failure to understand the difference between different types of 510(k)s: There are three types of premarket notification submissions: Traditional (most common), Special (less common) and Abbreviated (rare). Some applicants do not understand the differences between these types of 510(k)s and submit the wrong type.
4. Failure to identify FDA guidance applicable to your device: In their submissions, 510(k) applicants should identify FDA guidance documents if applicable to their devices’ specific product code. If such information has not been included in a submission, FDA reviewers will deem your submission lacking.
5. Failure to provide test data applicable to your device: Virtually all 510(k) applications submitted for FDA review must include some type of test data (e.g., electromagnetic compatibility (EMC), electrical safety, sterilization, biocompatibility, shelf-life, mechanical performance, etc.)
"Why don't we see a more widespread use of virtual doctors? We see some here and there, but with the technology already available, why don't we see more?"
I put myself in the physicians shoes.
-Would I ADD computer screen virtual meetings with patients to my existing patient load? Where would I get the time to do that?
-Would I have to cut my existing patient load to add time for virtual meetings? If so, would I charge the same? Can I justify the same charge? Would the quality be the same?
Researchers have told us that over 90% of communication is non-verbal. This is why Webex meetings take longer than face to face meetings. It takes longer to understand something. in face to face encounters we capture feelings, perhaps see expressions that the camera would not catch, hear and feel things the microphone may not hear. We can sense despair, fear, and anxiety, which could lead us to better suited treatment paths.
Will quality of care go down with more virtual doctor visits, or up as some say? Or is it just about cost?
I would like to hear your thoughts.
Application-wise, right now I am looking for a material with similar strength and fatigue properties as titanium that may be easier to use in manufacturing, potentially injection molding.
Click on the following link to register for the webinar:
You will learn how the global technology leader in minimally invasive robotic-assisted surgery, Intuitive Surgical:
• Automated data integration processes, eliminating risk of manual errors
• Centralized label lifecycle management based on a single, compliance-ready platform for easy design, reliable production and cost effective dynamic change management in response to business needs
• Assured data integrity by sharing critical label data from core components of SAP ERP
• Centralized management and distributed production for labels
• Fully automated unattended label production from within SAP ERP
• Had support for changing labeling requirements driven by regulatory, supply chain, local language, postponement strategies and organizational profiles.
Register for this live webinar on 15th March. You can also watch the recording.
The webinar will be presented by Gyan Agarwal, Senior Program Manager, Digital Engagement at Intuitive Surgical and Chris Lentz - VP of SAP Business Development at PRISYM ID.
Please share the registration link with your colleagues http://bit.ly/2orIPKW.
Intuitive Surgical and PRISYM ID: Integrating Labeling with SAP for Label Content Integrity and Control
Date: 15 March | 8:30AM San Francisco/11:30AM New York/3:30PM LondonFor the label designer, creating the layout of a medical device or pharmaceutical label is just part of the story. The content required to populate the label including images, static
does anyone has insights into the interpretation of Article 45 of the MDR (Article 41 in the IVDR). It sais that as part of the market surveillance activities, there is a change that the competent auhorities will review the technical documentation of a product and that this may happen off- or on-site. I think this can be interpreted in two ways - either the CA will review the technical documentation during an audit of the NB or the CA audits the technical documentation during a NB audit of a manufacturer. Do manufacturers need to consider an authority sitting on the table during a NB-surveillance audit? Looking forward to see your thoughts on this.
All the Best
Dozens of U.S. patients may have to undergo surgery to replace their Medtronic heart defibrillators following the discovery of a manufacturing problem that could render the devices unable to provide life-saving electric shocks.
It's pretty amazing these long-existing medical device manufacturers keep releasing products before they're fully (creatively) tested - and the implications are severe: death.
Please feel free to read the article I posted, and tell me what you think.
Medical Device Recalls – Do You See the Pattern…?
Whenever I review the latest entries on the FDA Recall List , I’m still surprised when I see the Reason for Recall information. Especially since several device manufacturers appear on the list – repeatedly. “XYZ Medical” is recalling the “ABC” Product...
The huge advantage of a Special-type submission is that the FDA timeline for decision on your submission is 30 days instead of 90 days. However, you need to make sure that you are making a minor modification to the device. If there are multiple changes, and the changes require multiple functional specialties to review your submission, then your submission will be converted to a Traditional-type of submission and clearance will be delayed.
One strategy that has been used successfully is to submit a series of minor device modifications as a series of Special 510(k) submissions. This is especially useful for software feature additions.
However, most design processes and 510(k) templates that companies use are specific to Traditional-type 510(k) submissions. You need to modify your templates, your submission strategy and your overall design plan for a Special-type submission.
Next Thursday, March 8 @ 1pm EST, I will be hosting a webinar to show people how I modify 510(k) templates for a Special 510(k). I will also explain different strategies for Special 510(k) submissions. Finally, you will learn how to change your approach to design planning for these minor device modifications.
If you are interested in participating in the free webinar, please register on the following webpage: http://medicaldeviceacademy.com/special-510k-submission-webinar/.
Items in Your Cart
On Thursday, March 8, 2018 @ 1pm – 2pm (EST), Rob Packard is presenting a Special 510k Submission Webinar to explain how your design plan should be different for a Special 510k Submission.
With that, I would like to open up a discussion into this and see what group members, especially senior executives who have successfully navigated these waters, think. More specifically, what are the key components and actions needed to give your new medical device and start-up company the best chances of commercialization success.
If I were trying to establish a relationship with a new supplier, I might spend 15 minutes on introductions--or more. The purpose of a pre-sub meeting is to ask the FDA questions that will help you prepare your submission. You should focus as much time as possible on asking your most important questions.
Names and titles of all attendees can be communicated in advance of the meeting. Five minutes is more than enough for introductions. After introductions, you should only ask the most important questions, and you shouldn’t waste time arguing with the FDA.
The most important question is if your predicate is acceptable. If you select the wrong predicate, your entire submission may be jeopardized, or you may have to repeat comparative testing with a new predicate. The balance of your questions should focus on testing requirements. But not all tests are critical. The critical tests are the tests that take the longest, and the tests that cost the most money. If the test is quick and inexpensive, save those questions for last. You can also ask clarification questions in a supplement to the pre-submission.
You definitely should summarize action items, but this does not require 15 minutes. Typical actions items are: 1) submitting draft meeting minutes, and 2) providing additional data to the FDA in a supplement. The FDA might even be responsible for getting you additional information. Five minutes is probably all you need.
If you want to learn more about 510(k) pre-submission meetings, register for Thursday’s free webinar:
His father askes if I had any ideas - stem cell are the only thought I had or an external body robot that could be strapped on.
I wonder, do you know of any researchers who are in that area of research. If you do, I would appreciate their names so I can help him.
If any group of professionals can, I know they will be in this group who have dedicated their careers to alleviating human and animal suffering.
The FDA released two 510(k) guidance documents in 2016: 1) how to apply ISO 10993-1, and 2) applying human factors engineering. Those two guidance documents resulted in a large number of 510(k) deficiency letters. By 2017, I had completely changed my mind.
A pre-submission meeting should always be requested, even if there is a special controls guidance document. Now I start every new project with a 510(k) pre-submission request. In fact, I had three pre-submission meetings scheduled for the same week in January of this year.
On Thursday, February 22 I’m offering an updated live webinar on 510(k) pre-submissions (Free). Please visit the following webpage to register: http://medicaldeviceacademy.com/510k-pre-submission-webinar/.
In addition, we still have opening for our 2-day, 510(k) workshop in Las Vegas on March 21-22 ($995). To register, please visit the following webpage: http://medicaldeviceacademy.com/las-vegas-510k-workshop/.
Nelson Labs is offering a 1-day seminar the day before the 510(k) workshop on biocompatibility ($499): https://news.nelsonlabs.com/education/events/biocompatibility-testing-for-medical-devices-seminar.
Eisner Safety is also offering a half-day course on electrical safety ($200): https://www.eisnersafety.com/iec-60601-1-basics-workshop-las-vegas-20-mar-2018/.
Hey Joe, How's it goin'? Listen, me and the guys are gettin' together and makin' this thing. It's gonna be big. So if you know any big shots from one of your schools or businesses or anybody with a lot of money, tell them about us, okay? I'm tellin' you, you can get in on the ground floor of this thing and it's gonna be big. Call me, all right? We'll get a slice.This is no way to raise money, people. The message came from someone I hardly know who asked to connect with me here on LinkedIn. I did; he's in the industry, and we have 200 connections in common. I won't be sending him any leads. In fact, I'd delete it out of hand if it weren't so outrageous that it compelled me to stop what I was doing to write this piece. Giving him the benefit of the doubt, here's what he's saying.
Joe, you're a person of influence so I thought I'd write you. Please learn about my company, our strategy, our management, our intellectual property, our capitalization, and our likelihood of ever launching a product that will convince our target markets to switch their behaviors in favor of the behaviors that would enrich us.I suppose the next logical step would be:
I assume you know a lot of people with money. Please use your reputation and influence with them for my benefit? You might say, "Hello. It's been a while since we last spoke. Since you trust me, I'd like to tell you about someone I met. I did a deep dive into his company and while I've never spoken with him directly nor am I personally taking an equity stake, I think you should invest your money with him, or at least hear what he has to say. I wouldn't waste your time if I didn't believe in this. Good luck! And let me know what you end up doing!Sadly, that was the good scenario. The less generous interpretation is:
I'm looking for money and it would be great if you forwarded this message to anyone who might possibly invest in us.In that last one, my cash-poor friend didn't even stop long enough to consider how fast-and-loose he was playing with my reputation.
Moral of the storyDon't do that. Instead, consider what Mark Kraus, a member of the world's largest angel investor network, advised members of the Medical Devices Group back in 2015. He says: "When I am approached about a company, I generally ask for two pieces of information: • A one or two page summary of their business; and, • A short slide deck that the company uses in a 7- to 10-minute pitch for fundraising. The 1-2 page summary should include the following, each with a concise, single paragraph and/or bullet points. It's important to be concise – it's not a full business plan! Company Contact Info – name, address, url, key management, board, advisors, contact info for CEO Company Overview – elevator pitch summary of the company Market Problem – what problem / opportunity is the company trying to address? Solution – What product / service is the company developing to address that market problem? Market – Short description of overall market segment (overall size, revenue, segmentation and competition) Regulatory – What is the regulatory status or plans for the company’s product / service? Intellectual Property – Describe any patents granted, patents applied for, licenses, university/other commercialization agreements Business Model – How will your company make money? How will investors make money (exit, IPO, partnership, etc.)? Deal Terms – Prior funding summary, pre-money valuation, deal terms for current raise The slide deck needs to address the above points as well, albeit in a presentation format. Graphs, pictures, timelines, prototype examples, simple tables are often used. Generally a little more detail on financial than the above one pager allows, but important to keep it high level and not a detailed, complex spreadsheet. Overall, the presentation needs to tell a story that captures the essence of the company and why this is a great investment opportunity." Mark said if company executives can't provide the above, they probably aren't ready for his money.
For further reading, all these Medical Devices Group discussions:• Creative Funding in a Difficult Medical Device Environment http://medgroup.biz/creative-funding • How much money do you need to raise? http://bit.ly/how-much-raise • Why can't I get my start-up funded? http://bit.ly/why-not-funded • What 3 things must a startup do to get funding? http://bit.ly/get-medtech-funding • Is a prototype enough? http://bit.ly/ptotype • Medical Device Funding’s Dead Zone http://medgroup.biz/dead-zone • Got a $10-million idea? Who cares! http://bit.ly/10-mil-who-cares About the author: Joe Hage leads the world’s largest Medical Devices Group (350,000+ members), the industry’s only spam-free, curated forum for intelligent conversations with medical device thought leaders. Mr. Hage’s medical device marketing services help companies engage qualified prospects and his 10x Medical Device Conference (with MDTX) unites Medical Devices Group members in an fun and educational forum each year.
So if anyone can suggest suitable trade shows it would be greatly appreciated or companies that we should be talking to.
• SWOT “review your QMS to improve or verify compliance.” Back in my day, we called this an internal audit. How is the intent this example different from an internal audit?
• HACCP “an area of improvement in the QMS process then triggers use of a more detailed analysis.” So in the internal audit system, deficiencies and areas of improvement are identified in an audit report. Typically, each item is investigated in an audit response that involves a root cause investigation. Sounds like a “more detailed analysis” to me.
• Project Plan “create a strong project plan for improvement to address identified weaknesses.”Again, most audit response systems I have seen involve a corrective and preventive action plan coupled with effectiveness evaluation. How is a corrective or preventive action plan different from a “strong project plan for improvement”?
I fail to see why the Guide recommends creating a multi-layered risk-based analysis system when existing, long-standing systems within the QMS could be augmented with more risk-based concepts. The last thing small manufacturers need is to reinvent the wheel when existing systems can be utilized to fulfill the intent of the new risk-based approach requirement.
My last point of contention with the example is the number of layers and tools needed to conduct a comprehensive analysis of the QMS. Lets estimate the math.
• 1 SWOT x 5 major subsystems = at least 5 SWOT
• 5 SWOTS x identified 2 areas for improvement per system = 10 HACCP’s
• 10 HACCP’s x identified 3 areas in need of a project plan = 30 project plans
That’s a minimum of 45 new documents to effectively manage. This resource-intense example isn’t practical to small and mid sized manufacturers. And what does modeling a risk of not meeting a regulatory requirement look like? https://wp.me/p6wmF6-eG
Death by Risk-based Approach: The Practical Guide to the ISO 13485:2016 Practical Guide Part 3
This is the third post in the series “The Practical Guide to the ISO 13485:2016 Practical Guide”. (See the first installment and second installment.) This post explores examples and applicat…
In my experience, one unintended consequence is an undercapitalized startup, starved for cash and struggling to achieve milestones with inadequate resources. I own stock in one enterprise that has projected accomplishing its next important big step in six months for the last seven years. With the passage of time, the danger of another new market entrant eating their lunch grows. They could well save on their fare but miss the boat.
Other founders have told me that they loathe raising money, hustling to convince angel investors and or VCs to get attention to make a pitch, and facing serial rejections – even from people who stared at their mobile devices during the presentation. Worse yet, some potential investors do not respond definitively one way or the other. They seemed to endlessly discuss the idea with their partners, or ask for more information, or wait for another investor to move first. No wonder that so many entrepreneurs find the process highly frustrating, even when they are confident that they will eventually succeed at raising the next round.
The balance of risks is a difficult question. Whether it is more dangerous to raise money and risk control and share of the pie, or to shun new money and perhaps slow growth or even invite getting blind-sided by new competitors. Equity-stingy founders may fail to ask the question openly, or exert a genuine effort to answer it honestly, or to revisit the question at appropriate intervals. That kind of mistake could prove fatal.
How in the world can I get past the HR filtering nightmare... and how do I know If I did?
Key take-aways include:
• Justify all requirements or quality system elements deemed not appropriate with a written rationale. While a written justification is not required by the standard or Guide, having the rationale documented will help avoid discussions with an auditor debating the “appropriateness” of a particular requirement.
• Interpret “proportionate to the effects” to be synonymous with applying a risk-based approach.
• Apply a “risk-based approach” or justification to every QMS element.
Note these recommendations are based on my own conclusions after reading the ambiguous information available on risk-based approach. The take-aways are not meant to infer a requirement from the standard or guide but rather reflect my own ideas on implementation.
Take a look at the post and let me know your thoughts on risk-based approach and associated terminology.
Risk-based approach as clear as mud: The Practical Guide to the ISO 13485:2016 Practical Guide Post 2
This is the second post in the series “The Practical Guide to the ISO 13485:2016 Practical Guide.” If you missed the first installment, catch up by reading it here. This post explores how the Pract…
When I see bad numbers staying bad I suspect systemic flaws. So, I am starting a research campaign. I will be calling a select group of 100 industry practitioners to get their take on the problem and the pains it inflicts on them and their organizations.
You can jump ahead of the line and contact me directly to contribute your thoughts. Be prepared to take a quick 5 question problem survey. You can also volunteer for a deeper interview on where the industry should head. Feel free to reply to this post. Also, get more information and be proactive on my website www.menloparkassociates.com. I look forward the conversation we can have.
Eager to know, if there exist vendors/platform to connect multiple health parameters (BP, TP, Glucose, ECG & much more) from monitoring devices of the patient.
This is basically to monitor the patients remotely.