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Medical Device Startups – Keeping the Balance

March 26, 2013 By Leave a Comment

Medical device startups need balance. Specifically, keeping quality, regulatory, manufacturing, product development, and business in order and harmony with one another is a challenge and a must.

Which one rules the medical device startup?

Trick question. None of the functional areas rule. The trick is to keep quality, regulatory, manufacturing, product development, and business in balance. And yes, it’s always a trick. And always shifting and requires adjustment. One day quality might have the ball. Another might be regulatory. And yet another, all functions might share it.

As a startup, keeping the balance is a frequent, often daily, challenge. I don’t possess the magic formula. I don’t have all the answers. Helping startups with this balance is a large part of what CQ does.

Filed Under: All, Ask CQ, Medical Device - General, Product Development - General, Project Management, start-up Tagged With: , , , ,

Don’t Shoot! I’m Just the Messenger.

March 20, 2013 By Leave a Comment

A current product development project has me in a situation that is not very comfortable. A few weeks ago, the project needed to make a “pivot“. I was given the task of finding options. Meaning, I was tasked with finding product development resources who could assist with industrial design, mechanical engineering, electronics design, firmware, tooling, and manufacturing. As project manager for the startup medical device, this task was definitely within my scope. I tapped into my terrific network to try and figure out a path forward. The startup wanted a pretty quick turnaround for quotes. The startup was okay with having ballpark estimates to make a decision. But they wanted to make a decision as soon as possible; the project had already been delaued a few weeks.

I talked with probably a dozen resources. Some options were full turnkey. Others only addressed a particular functional area. I organized all into a matrix to ensure all areas of concern had been identified and to determine rough overall product development costs. I presented the options to the startup, who in turn asked me to provide and support my recommendations. Fine.

After making a decision, I then had the dubious responsibility of informing all the resource providers of the decisions. For most, this was a difficult message. I had to tell them that the startup chose to work with someone else.

And of course when these sources were told “no”, they wanted to know why. Was it cost? Was it schedule? Was it something else? Most took the decision pretty well–this is how the medical device product development business works. We have all been told that our firm was not selected. Others, though, got defensive and wanted detailed explanations. They wanted to schedule a meeting to better understand and have a chance to revise and so on.

I’ve been managing medical device product development projects for 15 years. I admit that delivering “bad news” is still tough for me. But it comes with the territory, like it or not. My job is to inform and communicate. Sometimes, I am just the messenger.

Filed Under: All, Product Development - General, Project Management, start-up Tagged With: , , , ,

INpact – Preparing for FDA Audit

March 18, 2013 By Leave a Comment

There is a great opportunity this Friday (3/22) to hear from Scott Durlacher of Anson Group on preparing for a FDA audit. If you are part of a medical device company, I highly recommend you participate. Having worked with and knowing Scott, he has a ton of experiences and suggestions to assist you in being prepared.

Here is a link to the INpact event page.

Filed Under: All, Events, Indiana Life Sciences, inpact, Medical Device - General Tagged With: , , ,

Where Does Your Real Meeting Happen?

March 14, 2013 By Leave a Comment

How many times have you been in a meeting when there was lots of discussion about the topic of hand only to have the real decisions happen in the hallway by a couple stakeholders minutes after the sit down? We’ve all been part of this. And it’s frustrating. Why assemble all these people to sit in a stuffy conference room for an hour or so if the two people who are going to make the real decisions are going to do so without everyone else?

It happens. It sucks. It’s the wrong approach too.

I didn’t realize how frustrating this past experiences were until I was part of the right way to do meetings. I have a startup client that has meetings the right way. Seldom does a meeting go over an hour. And during the meeting, there is an agenda. Topics are discussed. Decisions are made, if feasible. If not, action items with due dates are assigned. Once all topics have been discussed (or the hour is up), the meeting ends. When the door opens, everyone goes back to do their thing. No sidebar discussions outside the conference room to undermine the past 60 minutes. Stakeholders expect action items to be completed by due dates too.

I’ll just say it’s very refreshing.

Filed Under: All, Planning, Project Management, start-up Tagged With: , , , ,

Medical Device Startups Get to Revenue

March 12, 2013 By Leave a Comment

It’s refreshing to work with a medical device startup with a focus on getting products into the market as quickly as possible to help patients. This same approach will allow this startup to begin generating revenue from the sale of its own products. I say fresh because it is surprising how novel this concept seems to be.

Okay, of course every medical device startup I’ve worked with definitely wanted to get their devices cleared and sold as soon as possible. But this startup seems different.

  • Initial capital equipment will not have lots of bells & whistles and will be similar to other products in this space.
  • Realization that there are quite a few accessories, kits, etc. which could likely enter the market first and serve as a source of revenue to help offset product development expenses.
  • Makes decisions with enough “facts” and without getting too bogged down with minutia.
  • Trusts the resources hired to do the job. When it’s clear there is a mismatch in needs versus capabilities, makes tough decisions about next steps.
  • Focused on the end-goal: get products cleared and ready for sale.

It’s still early. However, I think we are on the cusp of some exciting things with this startup, especially when it comes to the approach and their business model.

Filed Under: All, Indiana Life Sciences, Medical Device - General, Project Management, start-up, Strategy vs. Tactics Tagged With: , , ,

New Product Development – Why Start with a Clean Slate?

March 11, 2013 By Leave a Comment

I’m currently providing project management services for a medical device startup. We recently encountered a “roadblock” requiring we find additional resources to move forward. I was able to reconnect with several capable options within my network for possible solutions. Nearly each resource I spoke with wanted to start at the beginning, basically with a clean slate and blank sheet of paper.

The thing is, this medical device project doesn’t need to start with a clean slate. In fact it should NOT for a couple reasons:

  • We’re developing a “me too” device. Yes, there are likely to be a few features and benefits which are unique to this product. But there is a ton of existing products in this space, including a couple identified as benchmarks.
  • The project actually started a few months ago. While we haven’t gotten too far, we have made progress. Let’s leverage and use as much as this progress as possible.
  • We have an aggressive yet realistic timeline to launch this device in 2013.

Thankfully, there were a couple potential resources who get it and want to minimize the research phase and get right into development. They realized and listened to what we were trying to say. We should make a final decision about the next resource(s) later this week. I assure you it will be those who we feel can pick up where we left off and help us get back on schedule as quickly as possible.

There are very few product development scenarios where you start with a clean slate and blank sheet of paper. Beg, borrow, and steal from other products and technologies. It’s very cliche, but don’t reinvent the wheel.

Filed Under: All, Ask CQ, Product Development - General, Project Management Tagged With: , , , , ,

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

March 7, 2013 By Leave a Comment

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.

 

Filed Under: All, Ask CQ, Medical Device - General Tagged With: , , ,

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

March 5, 2013 By Leave a Comment

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!

Filed Under: All, Ask CQ, Medical Device - General, Project Management Tagged With: , , ,

Garage Inventors Special Too

March 4, 2013 By Leave a Comment

I recently wrote about enjoying the opportunities to work with doctors on medical device ideas. There is another category of people I have enjoyed working with too. I call these people “garage inventors”.

I describe garage inventors as the people who are tinkering in their garages, basements, kitchens, coffee shops–wherever! These garage inventors are sometimes eccentric and eclectic but usually always passionate. Garage inventors are a special breed, believing their ideas and inventions will change the world and yield millions in revenue.

I recall several years ago when I was heavily into network, I was often asked who I wanted to meet. My answer was always garage inventors. And often times I was looked at strangely for suggesting this. Largely because the person asking was stumped. But I would add that we all know garage inventors. It might be that neighbor who has sparks flying out of his garage late at night. Or an uncle who is writing software. Or maybe a cousin who always seem to be patenting something new and crazy.

When I put it out there that I was interested in meeting garage inventors, a few of these people found their way to me.

Filed Under: All, CQ Story Tagged With: , , ,

6 Project Management Tips

February 28, 2013 By Leave a Comment

I recently read “Winning Project Management Practices for Medical Device Development” on the StarFish Medical blog. I’m sharing the 6 tips and practices and recommend you read their entire article.

  1. Under promise and over deliver
  2. Estimate, but remember they are just estimates
  3. Show transparency, provide weekly status reports
  4. Dare to discuss business questions
  5. Be sensitive to cultural difference
  6. Be available to discuss technical, resources, process issues and concerns
Filed Under: All, Project Management Tagged With: ,

Project Management No No

February 26, 2013 By Leave a Comment

I have a confession. On a recent engagement, where my role is the project manager, I got too complacent. I’m kind of the “go between” for the client and a design partner. I did follow-up with the design partner on a regular basis to monitor progress. A date was quickly approaching when the design partner was to present some ideas and concepts to the client. On the day of the reveal, I was seeing the ideas and concepts for the first time along with the client.

The ideas and concepts fell a little short of the client’s expectations. And I felt a queasy, uneasy feeling. I suddenly realize all too late that I should have intervened and pre-screened the ideas and concepts ahead of time. I trusted the design partner before trust had been earned. As an experienced project manager, I know better. It was a rookie mistake.

So now, my behavior with the design partner will be much different, maybe bordering a bit towards paranoia. I will not let the design partner nor myself be put in that kind of uncomfortable situation with the client again.

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FDA Expects Management to Be Engaged

February 25, 2013 By Leave a Comment

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.

Filed Under: All, Ask CQ, Medical Device - General, Quality System Tagged With: , ,

INpact Medical Device Network Meets February 21 at 5:30pm

February 20, 2013 By Leave a Comment

INpact is trying something new in February–an evening event at a cool space known as the Speak Easy. A local vascular surgeon, Dr. George Akingba will be speaking to the group, sharing some of his work and thoughts on healthcare.

Plenty of opportunities to network. Oh, and pizza and beer with your admission.

Check out the INpact Meetup page and RSVP.

Filed Under: All, Events, Indiana Life Sciences, inpact Tagged With: , , , , , ,

Opportunities to Work With Doctors and Medical Devices

February 19, 2013 By Leave a Comment

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.

Filed Under: All, CQ Story, Medical Device - General Tagged With: , , , , ,

Medical Device Companies – Get Ready for FDA

February 14, 2013 By Leave a Comment

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.

Filed Under: All, Ask CQ, Medical Device - General, Quality System Tagged With: , , , , ,
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