When a Startup Says Design Isn’t Important, DO NOT Believe It!

On a recent medical device project, I worked with a startup and a couple third party resources on product development. The intended device was basically a “me too” product. Early on, the startup stressed the importance of an aggressive timeline. The actual design–the look and feel–was not formally discussed that often. The startup would sometimes, though, hold up his iPhone and comment about simple, yet elegant the design is. But then the discussion would shift back to technical details. A couple weeks later during a project team meeting, we began discussing detailed requirements and specifications. And again, the startup would casually mention a cool gadget he saw over the weekend, drawing extra attention to its buttons and display.

This sort of thing happened a few times. Sometimes there were emails with sketches. Other times comments like those described above. But for whatever reason, what was heard by the engineering firm was the focus needed to be 100% on the technical details, specifications, and product performance. And this all came to a screeching halt a few weeks later when the engineering firm presented the device concept at a design review. I knew the moment the device image was displayed on the screen during the presentation that the startup did not like what he was seeing. Yet he held his composure and gave me a bit of an earful afterward. I deserved it too. I ASSUMED that the engineering firm heard and understand that design was important. However, they had not.

My advice to you is realize that design is always important. How the product looks, how users will interact, how care givers interface are always aspects that must be considered with any product design.

 

Medical Device Project Management: Crash and Burn? Or Survive then Thrive?

I’ll admit this past weekend was a little hectic. A medical device product development project recently stalled. The summary is that the design direction we were pursuing needs to shift and take a new course to be successful. And I’m sure this project–like ALL other medical device product development projects I’ve ever been a part of–will have plenty more course adjustments in the months ahead.

But during the past couple weeks, it became apparent that choices made a couple months ago might not have been the best for the long term efforts of the project. As a project manager, I kicked myself in the ass a little about this. I played the “coulda, woulda, shoulda” game for a few days. Fortunately, I dried my tears and got over the pity party and rolled up my sleeves to take action. The medical device startup is counting on CQ to deliver, now more than ever.

Medical device product development projects always seems to have new twists and turns, resulting in a list of lessons learned. Here are a few from this latest saga:

  • Sometimes a project manager needs to micro-manage product development resources. It is wreckless to assume everyone is always on the same page.
  • Emails are okay. Phone calls are better. Face to face is best. Regardless, limited communication with critical project resources seldom works out well.
  • Remember your brand and reputation are almost always on the line. Clients understand there will be issues to deal with and do not expect everything to be smooth sailing. But a client also NEVER wants to be surprised.
  • As a project manager responsible for coordinating third party resources, ALWAYS insist on pre-screening everything before it is provided to the client.

As I mentioned, this project is about to head in a new direction. And thankfully, I have some fresh project management wounds to remind me of recent past issues and know what to do to mitigate.

This project will NOT crash and burn. We will find a way to survive and thrive!

FDA Expects Management to Be Engaged

FDA issued several 483 observations relating to Management Responsibility in 2012. Here is a list of some of these 483s as reported by enKap Community. Still think FDA can’t see your Management Review minutes?

The reality is that if during the course of a FDA inspection, all documentation and records could come into the scope of the inspection. If your company’s Management is engaged, and documentation and records are in good order, I would doubt that a FDA inspector would go fishing around too much without a reason to do so. However, if Management is not engaged, a FDA inspection could be a more painful than normal process.

Keep in mind too that today’s FDA inspections are a little more aggressive than from just a few years ago. As noted in a previous post, total number of inspections, 483 observations, and warning letters are higher now than ever. As such, FDA and regulators across the world EXPECT Management to be engaged and part of the overall decision making process, especially as it relates to compliance.

Opportunities to Work With Doctors and Medical Devices

One of the most rewarding aspects of my career has been working with the doctors and nurses who come up with novel medical technologies to help save patient lives. My first real experience of this occurred just a few months into my first job with Cook Medical.

I got to work with Dr. Dietmar Enk, an anesthesiologist from Germany. He had an idea for a medical device to help allow ventilation via high-pressure oxygen. He provided a prototype he had constructed from components and parts found. Like me, Dr. Enk was newer to medical device product development. And we seemed to learn the ropes together. His English was good but the time difference sometimes made communications a little difficult. But before long, I had a design and prototype that Dr. Enk was happy with and proceeded with the next steps to finalize Design Control documentation, work with production to manufacture, and eventually move the Enk Oxygen Flow Modulator to market.

Working with doctors and nurses directly and having opportunities to see devices that I helped design in use has been such a humbling and amazing experience. And I’d like to thank Dr. Enk for helping to establish this foundation for me. He was a great, patient mentor.

I had the opportunity to work with doctors on medical device ideas during the first few years of my career. But then I had a several year hiatus–still working in the medical device industry but not directly with physicians. This changed a few years ago when I started my own business, Creo Quality. Since doing so, I work first-hand with medical device inventors interested in commercializing their products and technologies. It continues to be a rewarding experience.

Medical Device Companies – Get Ready for FDA

Are we dealing with a new FDA? I posed this question last summer. In the past couple years, CQ has had quite a few engagements to help medical device companies during FDA inspections and to correct FDA 483 and warning letter observations. Data also supports my anecdotal experience as reported in a recent post on the AssurX blog:

  •  2005: FDA CDRH inspected 2,304.  2011: 3,369. I’m guessing the number was higher still in 2012
  • 2008: CDRH issued 152 warning letters. 2010: 200 issued.
  • 2008: CDRH issued ~4,000 483 observations. 2010: ~5,000.

Sometimes we have a chance to engage prior to a FDA inspection. In these situations, the process is usually a little smoother and calmer and a whole lot less stressful. These are the medical device companies who have enough clairvoyance to realize their shortcomings and are interested in developing an action plan to correct issues. These are the medical device companies who are doing their best to prepare for a visit by FDA.

And other times we don’t get involved until the FDA inspection is over and 483 observations (and sometimes a warning letter) have been issued. There has been a case or two when a medical device company has reacted with a bit of shock and awe after a FDA inspection. Reactions of real surprise. Sorry – but there really shouldn’t be that much of a surprise after a FDA inspection. Okay, the FDA quality system regulations are not entirely black and white. But the QSR is published–has been for quite some time. And a medical device company should have implemented policies and procedures to address the regulations and be active in keeping company procedures current. However, the companies which are suddenly surprised after the inspection did not do a good job of keeping policies and procedures up to date.

Has it been a while since your medical device company has had a FDA inspection? Don’t think FDA will come visit your company? You might be right. I suggest, though, that you get prepared–just in case.

CQ Pages Updated

Events

Tips for Startups

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Regulatory

Low-Cost Medical Device Design

There appears to be an interesting, albeit still somewhat small, movement happening in the medical device industry. There are a few organizations emerging focusing on simple medical device design to solve real problems in under-served markets. We wrote about Jose Gomez-Marquez and the Little Devices Group finding low-cost solutions leveraging existing products and technologies to solve real medical problems.

I recently discovered another similar group called Shift Labs. Their mission is to make low-cost medical devices to help improve healthcare in low resource settings. I was especially intrigued by the low-cost drip clip device designed and prototyped by the Shift Labs team.  I’m also intrigued by this project because it appears as though they leveraged crowdfunding to fund some of their product development efforts.

And I think the Little Devices Group and Shift Labs are onto something. Not only for medical device product development for low resource markets. But also right here in the United States. With all the recent developments in this country, including increased regulation, medical device taxes, increasing cost of healthcare, and tighter investment funding, I think we will begin to see other organizations emerge and mimic the low-cost device and product development approach. I think we’ll see other inventors and entrepreneurs of medical device technologies leverage crowdfunding models to fund their efforts.

INpact Is Kicking Off 2013 on January 23, 2013

INpact, an Indiana-based medical device network is kicking off 2013 on January 23 from 11:30 – 1:00 at the offices of Bingham Greenbaum Doll. We’re going to try a few new things this year, the first of which is creation of an INpact Meetup group.

Be sure to sign up to join us.

iPad Case – Almost the Idea I Had a Year Ago

Last January, I made a prediction that iPads would become more common in ORs. While I don’t this was a terribly bold prediction, I have been surprised that there haven’t been more stories about their usage during surgery. If you recall, within the same iPad prediction post from January 2012, I shared a product idea for an iPad cover to protect and provide a sterile barrier when used during surgery. I’m a little surprised there isn’t a product out there yet. Maybe the market is just too small.

Or maybe products like LifeProof are being used and sought after first.

Should a Medical Device Design History File Be “Living”?

I vote yes. Here’s why. I think it makes sense for a medical device design history file (DHF) to contain documentation and records that are a current depiction of the device.

I’ve heard others vote no, stating the DHF is a moment in time and should be treated as a historical reference.

I have some strong opinions about this and will offer them in an upcoming post. In the meantime, I hope you’ll share your opinions.

I also started a discussion on this topic on the LinkedIn Medical Devices: Design & Development subgroup. Not a member of this group? You should join.

Build Your Medical Device Quality System to Meet FDA and ISO 13485

CQ is currently assisting a few clients with quality system efforts. We also have a couple of proposals out to build a quality system for medical device companies. All of these projects requested their quality system be compliant to FDA 21 CFR 820 regulations. I asked about also being ISO 13485 compliant. The clients seemed perplexed. I think in part because there is a misconception that establishing a QS that is compliant with both FDA and ISO might be a difficult and more expensive endeavor.

I assure you, though, that a QS can be compliant with both with minimal extra effort. And knowing this in the beginning of QS efforts is easier to address than adding on at a later date. I encourage you to pursue a QS that is compliant with both FDA and ISO–even if you do not have immediate plans for EU market.

And if you want some tips for pursuing ISO 13485 registration, you should check out the blog post from Rob Packard on QC Is Dead.

Medical Device Tax Repeal? Obama Says No.

In an interview with a news reporter from Minnesota, President Obama said the medical device tax will not be repealed, citing there will be 30 million new patients for medical device companies because of healthcare reform.


Disappointing. It seems as though our elected leaders are not completely informed about the U.S. healthcare system.

Maybe there is still hope, at least for the tax to be delayed.

There are quite a few posts on the topic:

President Against Device Tax Delay (MPO Magazine)

Final IRS Device Tax Rules Changes Little from Draft as Industry Focuses on Repeal Effort (Medical Devices Today)

Medical Device Tax: Senators Call for Delay While Repeal Efforts Continue (MassDevice)

Medical Device Tax is Here to Stay, Says AdvaMed’s James Mazzo (MassDevice)

Democratic Senators Urge Tax Delay (MPO Magazine)

Med Devices Companies Across the US Are Bracing for the New Medical Device Tax (OrthoStreams)

Obamacare and Taxes: May Hike Your Pet’s Health Care Bills (The Foundry)

Support Appears To Be Growing To Delay the Medical Device Tax (FDA Law Blog)

Words of Caution for Device Tax Repeal Efforts (MassDevice)

5 Questions Regarding the Medical Device Tax (Medical Device CRO Blog)

 

Medical Device Product Development – The Importance of the Plan

Yes, I’ve worked on medical device product development projects where the planning was so intricate and too detailed that all the project manager seemed to do throughout the project was update the Gantt chart. And yes, I’ve worked on projects where there was basically no documented plan at all because the project was a “slam dunk”. Any project that has a 100+ item Gantt scares me a bit. Any project professed to be a slam dunk makes me want to run far, far away.

Don’t misinterpret my words though. I do like project management and planning new medical device product development efforts very much. In fact, I just started a new product development project and am in the midst of planning now. I decided to share a few thoughts about the importance of the plan:

  • Needs to be not too big, not too small, but just right.
  • The plan will be wrong. Get over it.
  • Product development projects represent uncertainties. Use experience to guide you and course adjust as necessary.
  • The plan is a communication tool more than anything else. It explains what, by whom, and when.
  • Keep it simple. Focus on the major milestones and deliverables. Don’t get into how these need to be done.

As planning efforts and the project continues, I’ll share more thoughts from the trenches of medical device product development.

WANTED: Medical Device Quality & Regulatory

Contact me if this is you. Specifically, I’m interested in connecting with you if you have 5+ years experience with quality systems, regulatory submissions (US and OUS), supplier audits, and internal auditing.

Plenty of Links on Medical Device Tax & IRS

I’m just playing the part of messenger and sharing the links I’ve seen. I haven’t had a chance to read all yet.

Medical Device Tax: IRS Shows (Some) Mercy to Medical Device Companies (MassDevice)

Rep. Paulsen: Device Tax Hurts the Medtech Success Story (MassDevice)

Cook Hopes Fiscal Cliff Talks Prompt Tax Delay (Inside Indiana Business)

Survey: How Optimistic Are You That Medical Device Tax Will Be Repealed? (MassDevice)

Medical Device Tax: IRS Makes Levy a Reality with Final Guidance Documents (MassDevice)

Flash: IRS Releases Final Guidance on the Medical Device Tax (MassDevice)

Medical Device Tax Winners and Losers – Reactions to the Long-Awaited IRS Medtech Tax Codes (MassDevice)