Blogs worth reading - creo Quality

creo Quality has a couple of excellent blog posts worth checking out, first off is Fast and Furious Medical Device Product Development: 

Ten months ago, I started a medical device product development project with an entrepreneur / CEO. The goal he made very clear was that before the end of 2013, he wanted to have the device on the market. The device is semi-complicated. It’s an electronic gadget driven by custom firmware. Plus, there are plastic parts and pieces, disposable components, and so on. Before kicking off the project, I had a few conversations with the CEO about project timeline. He reiterated time and again one year, one year, one year. I told him that while theoretically this schedule was possible, 18 months was more realistic–mostly because of FDA wildcard. So we talked about FDA and 510(k) process. After hearing about all of this, the CEO said he thought FDA would only take 90 days to provide clearance and that we should plan accordingly.

 Read the blog to see where they are now.

Second up is How DoYou Feel About FDA 510(k) Refuse to Accept?: 

In early July, I submitted a 510(k) for a fairly simple and straight forward disposable, single use device. The predicate was a very good match. Of course I followed FDA guidance documents, checklists, etc. for what to put into a 510(k). I also reviewed the RTA checklist as I compiled the 510(k) documents. Of course I felt the submission was complete. Why would I send it to FDA if otherwise? A couple weeks after submitting, I received a “refuse” response from FDA. The response included the RTA checklist with reviewer comments.

 I have never been part of a refuse to accept from the FDA, but this: 

In early August, the RTA response was submitted. A couple weeks later, I received a phone call from a FDA reviewer–someone different than the person who first reviewed the submission. He had a few questions, I had a few of my own. He said he would get back with me and did so the next day, this time with a few more questions. I was kind of confused at this point. Some of the things he asked about was marked as fine by the first reviewer. Other points of discussion pertained to how we addressed the issues identified by the first reviewer. Keep in mind, we discussed the specific action plan with the first reviewer who agreed with our plan. Any way, the second reviewer said he needed to discuss the issues with the branch chief and would get back with me.

 I have had happen, one reviewer at the FDA says do something this way, the next reviewer goes the opposite way.  In my case I was only involved in the second reviewer part, but we had conducted some biocompatibility testing based on the first reviewer's comments, the second reviewer didn't like the methodology.  We were able to back the testing up with other data, but it was not a sure thing we wouldn't have to repeat the testing entirely.  It was very frustrating for the entire team and the management.  However, there is not much you can do but suck it up. 

A similar situation happens from time to time in a company, say a new regulatory person on a project will have a new viewpoint, however, the good ones will generally only voice the opinion then not push it unless they absolutely think it is a show stopper.  They will stick with the old decision instead of refocusing the entire team to their whim.  Quite a few people are unable to distinguish between "Must Have", "Nice to Have", and personal preference.   Probably 90% of the comments I see are personal preferences that reviewers have.  Those are fine to have early in the process when many edits are being made, but a waste of time later on.  Think about it next time you are considering rejecting an ECO.

New Links

I've added Ford & Associates to the links on the side.  He has a blog covering mostly medical device quality and regulatory news, but the feed isn't working right for me at this time.

I've also added a link to Knobbe Medical's Blog.  All of Knobbe Medical bloggers are very well dressed so you know they're not wrong (feel free to use that quote on  your website guys).  I can assure you that I don't clean up so nice.  For some reason their feed doesn't seem to work either, maybe its Blogger's issue.

Just FYI, I signed up as an Amazon associate, if you buy anything through one of the Amazonlinks on this site, I get a small percentage at no additional cost to you.

How to efficiently follow your competition

Working in medical device R&D its important to keep an eye on your competitors.  Marketing is too busy working on presentation font size to be reliable on this.  The easiest way to do so is using Google Reader, you'll need a Google account to make it work.  From there just add Medgadget, your competitor's press release site (if any), and MassDevice to Google Reader.  If  your competitor launches a new device or has an idea it may be covered in Medgadget, more general news in MassDevice.  However, if your competitor has a poor marketing department or is small, some news may slip through the cracks.

To take your stalking to the next level, follow the company on LinkedIn, although this hasn't been that useful for me yet.  Then set up a search using your competitor's name in Google Blog Search.  Google blog search will pick up every little tidbit, but blogs are generally spammy, so you'll ignore a lot of things on there.  You can do the same thing with Google News and Google Patents.  From the FDA website, you can also follow recalls, reported complaints, 510k and PMA approvals, however, you'll probably have to do this manually or just read their monthly digests, the website isn't set up well for this.  For example, PMAs are set up one month per page, and every year has its own page, good luck getting that to work, they do have a feed for recalls though.  Short of actually talking to anyone, that is about as thorough as you can get.  You will obviously have a hard time following a start-up this way as there is usually no news.

While you're setting all of this up, you probably want to set it up for your company as well.  You can use other keywords like the type of device you're interested in instead of the competitor's name.  This blog can also be followed on Google Reader.  You don't have to use Google Reader for this, you can actually set up RSS feeds in outlook and it will email you items into a certain folder, but Google Reader you can log on anywhere with a web connection so I like it better.

2009 RAPS Horizons Conference & Exhibition

The 2009 RAPS Horizons Conference & Exhibition is April 1-3, I discussed last year's RAPS conference here. Unfortunately I will be unable to attend, we're moving some manufacturing to a contract manufacturer and keeping on top of it is taking a huge amount of time.

Medical Device Premarket Approval (PMA)

Advanced Medical Technologies (AMT) has an interesting post about the number of Premarket Approvals (PMAs) and Medtronic's dominance of the market. AMT created the graphic on the left using FDA data. Interesting that with health care approaching 20% of GDP, AMT notes that only one of the PMAs is original, the rest are supplemental information for PMAs filed in the past.

Medical Device Web News

Some medical device related news that caught my interest:

Nelson Laboratories to add 350 jobs- We use Nelson and have no complaints, I'm glad to see they're doing well. We also use pretty much everyone else though, it just depends on who is most responsive and seems like they can get the job done. I'm always glad to see anecdotal confirmation that the industry is not majorly affected by economic downturns. Although I would think device development may be, just because there would be less startups.

Top 10 medical device hazards of 2008- Its probably about the same every year, it is not like we've solved "Ineffective Alarms" lately. There hasn't been much movement on that front since blinking lights and a noise. The article is still interesting from a risk analysis standpoint.

Miraculous facial tumor surgery- With picture, Wow!

Best practices for part numbering- Keep it short and numerical for future barcode implementation is a good tip. Eventually it is going to get all screwed up (and this is actually a good thing, it means your company is growing and one person can't manage it all), having a good system at the start might give you an extra year or two before it does.

Medical device links

FuturePundit is one of my other favorite blogs, check out this post on Resveratrol and this one on an implanted device that tells you when you're full.

FDA CDRH may tell you about your 510(k) and PMA submission problems as they find them.

Stent startups are still popular among VCs. Why stents? There are a million stent companies out there.

Medical device industry, all boom, no bust.

University of Minnesota opens a medical device center, trying to keep Minneapolis/St. Paul as the place to be for cardiology devices.

New medical device discussion board links

I've added The Cove, ASQ Discussion Boards, and CR4 Forum: BioMech & BioMed to the links. I think reading them even counts as work!

UPDATE: I've also reorganized the links on the right side to incorporate some of Blogger's new features.

2008 RAPS Horizons Conference

The 2008 Regulatory Affairs Professionals Society (RAPS) Horizons Conference just concluded, I would have gone if I'd known about it, at least for the Navigating Product Development Process and Defining Research Ends and Design Control begins presentations. This link has many of their presentations available online, readers might find something interesting.

Medical device blog update

I added Navigating through R&D Projects to the links list, hopefully he doesn't mind the attention. I like his groupthink remedies. This brings the number of medical device blogs I know about to six or so.

Update: it is now apparently shut down.

Re: 10 Things You Need to Know About Medical Device Design

Connecting07 has a recent post, Medical Device Design: 10 Things You Need to Know. While I agree with most of it, a few things I didn't like:

#4 Biocompatibility. Any material used in a medical device has to pass a test before human use. Contact and duration. Must be aware from prototype through production. Material must be tested as used--processed and sterilized. Must be tested in final form. Sterilization affects various materials. There are pre-certified materials. This testing is expensive and time-consuming (8 weeks). There are different tests for different types of use depending on contact and duration.

I've posted on biocompatibility testing before, and as I stated then, the time required varies per device, don't assume 8 weeks is the longest it will take.

#5 Know manufacturing methods. Good Manufacturing Practices (GMP). QSR: Quality Systems Regulations. Lot traceabilty, sterilization methods, sterile packaging validation, specialized equipment, clean room manufacturing. Go to a medical device contractor manufacturer to do these things without the overhead.

Based on personal experience I don't agree with the last line, but some people may have had better luck. At one point in the distant past we were paying a contractor $50,000 a month to manufacture experimental devices for us, with the idea being we would have a "virtual" company and only worry about coming up with ideas and paid contractors to do the rest. After much complaining and pushing over a year we finally gave up on the contract manufacturer after their production reached a grand total of two devices a month. It was a complicated device, but after we brought it in-house with one production manager for paperwork and two assemblers, making two devices a day was fairly easy. The contract manufacturer's heart just wasn't in it.

I like the rest of the post, and think overall it is very good, but I will refrain from commenting on each point, just go over there and read it.

Validating the packaging process

Medical Device Technology has put "How to Validate a Packaging Process" online which contains pretty thorough information. I've discussed packaging a bit before here. Medium sized companies generally have a packaging engineer while small companies get whoever they can to design packaging and hope.

All sorts of design issues can show up unexpectedly in packaging, a small wrinkle in a bag or pouch seal can mean a complete redesign or worse. My boss's blood pressure skyrockets whenever someone mentions the dye penetration test (ASTM F1929) mentioned in the article. We received a bunch of failed test samples back from a testing lab that were solid coated with dye which supposedly showed how we failed the test, except after the test is over dye coats everything so you can't tell. Ever since then he's hated the test with a passion and if you want to avoid a 15 minute rant its better to stay off the subject.

I was part of a PMA that the FDA specifically required the dye penetration test for to move forward, so you'll likely have to get through it (although you can avoid packaging validation in the early stages of a PMA if you hand carry). The dye penetration test basically consists of pouring a dye solution into the packaging and then observing its progression through the package seal in a certain amount of time. The problem is that the test requires judgment calls regarding wrinkles and has a wide time range. A small wrinkle in the seal can allow the dye to penetrate quickly through the seal.

Dye Penetration Test Results

How do you avoid this problem? There are a couple ways to avoid it completely. If you gamma sterilize you don't need Tyvek breathers and the bags won't leak if you seal them properly in the first place. It is slightly harder to seal completely plastic bags, you can end up with ridiculously large amounts of air in the bag if you're not careful. There is also a company that makes Tyvek windows and you seal the plastic bag, since the Tyvek is not on the edge, you're much less likely to have a problem (I forget the name of the company offhand, but I'll update later). The sterilization degassing time may be longer however. The other packaging option is to use a more expensive tray type instead of a bag.

How do you minimize the problem? Don't handle the packaging bags. It makes me cringe when manufacturing or QA handles the bags roughly. The other thing you can do is properly design the box to limit the movement inside- this is difficult with the larger your product is however.

You mean we have to actually make this stuff?

Creo Quality asks When Should Design for Manufacturability be considered? and gives his current situation:

This time, the product development project is for a new start-up medical device company with no products on the market and none with FDA clearance. We are developing the first product for this company. As with many start-ups, funding presents issues and often influences decisions. For this project, there has been little to no effort with DFM. The product design is entering design verification and validation. A 510(k) submission is a few weeks away. Yet, manufacturing processes are ill-defined and the product design and components has hampered production of prototype and pilot units. The company has hired suppliers and contract manufacturers to assist with current, limited production units. It’s been a bit of a struggle. Product piece prices are ridiculously expensive–due in part to components selected during design, low volume, and lack of DFM.

We have the same issues, we have great financial backing for a start up company, so our investors are more far sighted than I think is typical, but the focus is still very much on product approval, then we'll think about how we make it profitably. The mood is without an approval you don't really have anything anyway, so get that as quickly as possible and grow from there. Although the engineers have already started to make some plans and changes, I'm positive there will be about 30 seconds between approval and management demands to get the product costs down, all part of the fun!

Project Management fun

Creo Quality's company is in about the stage my company is in:

It turns out that some of the disposable parts are not quite right. Tooling changes have been made, new, first articles were inspected, and more modifications are needed. Other disposable parts have been hard to acquire in a timely manner. Hardware testing has hit more snags. Hardware components require possible substitution. Others have ridiculous lead times. Critical project resources are torn between testing, further development, and other demands.

On my project someone (not me I promise) decided to add a component to the disposable design about one month before validation sterilization. It adds to the excitement, manufacturing is ready to kill though. The old revisions can be used for some testing if noted and justified, but not all testing, I managed to sort out what could be used for what, but thankfully it is not my job to now keep track of what IS what. That is left to QA/QC.

Delegating in a small medical device company

Creo Quality discusses delegating:

In my experience, engineers are typically poor at delegating tasks and activities. In fact, I often have heard engineers say they want something done a certain way and usually add “. . . if I want it done right, I’ll do it myself”.

This is largely how I feel (I'm an engineer), or perhaps it should be "if I want things done in a timely manner, I'll do it myself." Positions in small companies are not usually rigorously defined, people will have several roles. However, if you give out a task outside of their main one or two roles, it often gets put off while the person focuses on his or her primary roles. I do this too, at my company I'm in charge of the computer network, unless the P or VP of the company is asking, I'm not going to jump right on your computer problem until I feel I have nothing else important to do.

Creo then discusses another pitfall to watch out for:

Delegation is not always a good thing–especially with a small, growing company. I delegated some documentation tasks to a resource within the company. Perhaps this was my error. In hindsight, the resource probably does not have the skill set required to take on the type of task assigned.

This is true in my company too, I can generally recognize it when things are taking way too long to get done. If a task is dragging out weeks when it could have been finished in a day or something along those lines.

The difficult part is what to do about it. I or someone else could take the job over and do it, but you don't want to do that necessarily, everyone is already busy, so extra work isn't usually welcome, especially if it is something that does not require any special skills. How long do you let the person struggle at it? The best way is to find some middle ground, where you end up doing plenty of the work, but the person learns from it. But this only works if the person is interested in applying themselves.

You will have less problems if you make smart hiring decisions, I think small companies in particular shouldn't skimp on hiring experience, an extra $10k a year in salary can really be the difference between paying one person to do the job or having to get two to figure it all out. Don't go overboard, you don't need to hire engineers for assembly or anything like that, but for engineering, QA (maybe QC), and production management, experienced medical device people can save you a lot of trouble.

New Links

I'm adding some new links, thanks to Creo Quality for the ideas, MDeviceNow, AdvaMed, MDMA, and Medical Device Net. Add them all to your feeds!