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Medical Device Product Development Is A Linear Process

May 16, 2013 By Leave a Comment

If you believe this title, you have not worked on many medical device product development projects. But interestingly, FDA design control regulations and ISO 13485 design & development requirements convey the process as a linear progression. And most every product development and design control procedures I’ve read (and written) also lay out medical device product development in a very methodical, step-by-step fashion.

The trouble is no project ever follows a nice linear progression. Sometimes it seems as though everything is happening all at once. Sometimes it seems like manufacturing constraints dominate before the user needs are even defined.

And this is just the way it is.

With each medical device product development project I’m involved with, I grow more and more comfortable in the midst of the chaos. I also consider myself in a very auspicious and unique situation on these projects. I have an innate understanding and comprehension of the rules. And despite the muddy mess of a picture I might have just painted, there are several rules that must be followed. Having someone that knows how to navigate and apply the rules is important (if I do say so myself).

Please don’t misunderstand what I’m trying to convey. Yes, I definitely believe defining the process IS critical. Yes, you need to have a procedure that lays out the project phases and deliverables. And yes, this process should lay things out in a simple, linear fashion. Just don’t be so naive to think your medical device product development project is going to follow that process to the letter. If it does, you are not pushing hard enough. You have to figure out a way to get things done as quickly and thoroughly as possible. The process and the deliverables are reminders of what must be done.

Filed Under: All, Ask CQ, Design Control, Project Management, Project Phases, Strategy vs. Tactics Tagged With: , , , , , ,

Time to Play Design Control Catch Up

May 14, 2013 By Leave a Comment

I’ve written plenty of design control procedures. I understand FDA design control regulations very well. I’ve trained dozens of engineers and medical device professionals on the “rules” of design control. When to document, how to document, why to document.

And now I’m up to my eyeballs on a startup medical device product development project realizing I have to play catch up. Realizing that we are about to initiate tooling and that the design control documentation needs to get to a similar point in development.

The medical device design control purist will quickly tell you that keeping the design control documentation current and up to date with the state of the project is an absolute must. The medical device pragmatist will tell you to do the real development first and catch up the documentation later. I find myself stuck in between these two schools of thought. A few years ago, I would have been standing at the pulpit of design control advocating the need to keep documentation up to speed and current. Today, I have a very different point of view.

Don’t mishear me. I believe all the intent of design control regulations has been followed on this project. I believe there are documents, emails, notes, action items, etc. that adequately address everything that must be demonstrated with sound documentation and records. The challenge now, though, is to successfully extract this information buried deep in email messages, file folders on computer hard drives, and so on and to ensure it is placed in its proper home in the appropriate design control record.

I feel like now is the time to do so. Not to sound complacent, but I feel like I have time to take a few breaths before the strong push to the finish line. Just better make sure we have everything we need to win this race.

Filed Under: All, Ask CQ, Design Control, Project Management, Project Phases, start-up Tagged With: , , , , ,

A New Medical Device Startup in Indiana Completes Planning Phase

January 8, 2013 By Leave a Comment

Okay, I can’t tell you just yet many details about this startup. But I can tell you that the medical device product development efforts are underway and off to a good start.

The startup was very good about vetting out and defining user needs and building the business case before engaging Creo Quality and other product development resources.

And a couple weeks ago, we concluded the Planning Phase of the project. During this phase, the deliverables included:

  • Design & Development Plan
  • Risk Management Plan
  • Project Schedule
  • Design Input Requirements

We also established the company’s Design & Development procedure, defining the project phases and minimum deliverables.

Filed Under: All, Ask CQ, Design Control, Indiana Life Sciences, Planning, Project Phases, start-up Tagged With: , , , , ,

Medical Device Product Development in 12 Months

January 7, 2013 By Leave a Comment

Can it be done? I guess before you answer, it might be helpful for me to share a few more details.

  • Device is pretty clearly a class II with dozens of potential predicates.
  • This is essentially a “me too” product.
  • The project seems to be well-funded.
  • Product development has been outsourced to firms with expertise.

So do you think this medical device can be brought to market in 12 months time?

I believe so. Granted there isn’t much wiggle room in the schedule. And of course, there will be a FDA 510(k) submission involved. But getting this product ready for launch in a year seems feasible.

We had the project kickoff on November 26, 2012 and really got started the first part of December. So far, we have finished the planning phase, including definition of clear, objective design input requirements. The rest of the schedule is laid out. Yes, we all know that medical device product development is full of uncertainties and surprises.

I’ll keep you posted as to our progress along the way.

 

Filed Under: All, Design Control, Product Development - General, Project Phases, start-up Tagged With: , , , , , , , ,

Medical Device Project Management – The Phases

September 19, 2012 By Leave a Comment

Managing medical device product development projects requires a sound, defined process. We are currently working with several clients on defining and improving their medical device project management processes.

Here are the project phases we recommend:

  • Planning - To identify scope of the project; define user needs and corresponding design inputs
  • Design & Development - To establish product design and detailed specifications; to identify design outputs and verification methods
  • Design Verification - To demonstrate the product meets the design inputs
  • Design Validation - To demonstrate the product meets the user needs
  • Market Release - To launch product into manufacturing and marketplace

We developed a procedure / process that address FDA Design Controls and ISO 13485 Design & Development requirements and have been able to use this as a baseline that we are able to tweak for our clients.

Yes, we believe medical device project management to be our sweet spot. Yes, we believe we can help you with your medical device product development challenges.

Here are a couple other previous posts on medical device project management:

How to Succeed with Medical Device Product Devleopment

Rules for Medical Device Project Management

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

Failing Fast & Cheap During Product Development

August 27, 2012 By Leave a Comment

Several weeks ago, I suggested in a YouTube video that I was considering developing a new device for handling unruly nose hair. I spent less than $10 to come up with a couple “proof of concept” prototypes. A few weeks later, someone who watched the video created an animation of a 3D concept for a nose hair trimming device (I still haven’t met this person even via email, but I thank them for their interest). The other day while shopping for a few household items, I visited the personal grooming aisle. There are quite a few gadgets available claiming to be the best nose hair trimmers on the market. And maybe one actually is. I don’t plan to purchase each one by one to find out. But at the same time, noticing how many products are currently available has me a little concerned about the ability to penetrate the market.

The other day, I learned that people sometimes have nose hair removed via hot wax. And yes, there are plenty of YouTube videos on this as well. I decided to do a little research into this and found a local spa who is willing to rip my nose hairs out later today. Yes, I plan to have a video of this experience too.

Why am I sharing all this? Despite being a little bit of a cheesy example, I am actually traveling slowly down the path of medical device product development. It started with an idea and since, I’ve been in discovery mode–learning some about the market, competitors, etc. I have limited my expenses while trying to make progress. And depending on how the spa session goes later today, I might just kill the concept altogether.

This is an important point for product development of any kind. If you are going to fail, do it fast. Do it cheap. Then move on to the next idea. Product development is a process. There is (or at least should be) a method to the madness.

 

Filed Under: All, Create, Medical Device - General, Product Development - General, Project Phases Tagged With: , , , ,

Simplifying Medical Device Design Controls

April 20, 2011 By Leave a Comment

If you are like most medical device companies, the term “design control” is usually met with a cringe or two. I also suspect your product development process and design control deliverables might be more cumbersome and quirky than you’d like–especially since you are expected to complete your medical device product development efforts as quickly as possible.

And what happens once the product development project is complete? Do you file the design control records away in a design history file (DHF) and archive them in some file cabinet or electronic record system? How easy are these to retrieve and access for future projects? Do other groups, such as regulatory affairs have access to DHFs in order to compile regulatory submissions such as 510(k)s and technical files?

What if you had a software solution to document design controls as they happen? What if this same solution could be a living repository for all design control and product development activities? What if this same solution could also pre-populate regulatory submissions?

Don’t think this product exists? Think again. Creo Quality’s UniDoc software is the solution you need to streamline your medical device product development efforts.

UniDoc is developed from proprietary database platform software and be mapped to match your current product development and design control processes. The software is 21 CFR part 11 compliant and meets FDA, EU, and Canadian regulations for medical device design controls. UniDoc contains modules for key regulatory submissions, including FDA 510(k), FDA IDE, EU technical file, and Canadian submissions.

If you are interested in learning more about UniDoc and how you can get this product at your company, contact us: info@creoquality.com or 765 315 2736.

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Filed Under: All, Catalyst, Design Input Requirements, Product Development - General, Project Management, Project Phases, UniDoc Tagged With: , , , ,

Medical Startup Ideas – What do I do first?

November 6, 2009 By Leave a Comment

Small businesses are important to economic growth and have an incredible impact on economic growth. So, let’s say you are a small business and you have a medical device idea. What should you do first and where should you spend your money when building your idea?

Before you do anything, you need to prove that there is a market for your product or idea. Will people use / buy your product? At this stage, we recommend limiting the amount of dollars spent by determining your market through market research. Do not rush to build a prototype.

Yes, prototypes have value, but you must be sure that there is a need for the product and that the pricing to manufacture the product and sell it is such that your product price is justifiable and people will buy it.

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Filed Under: All, Indiana Life Sciences, Medical Device - General, Planning, Product Development - General, Project Phases, start-up Tagged With: , , , ,

What If The Start-Up Has No $? – part 2

July 26, 2009 By 1 Comment

Last month, we posted a blog about what entrepreneurs should do if funding is limited. We had a few comments on the post (thanks). The topic is extremely important for medical device entrepreneurs. We decided to discuss this during the July 17, 2009 INpact meeting. Here are some highlights from the INpact group discussion:

What is the first step? Find friends, family, and fools to invest. Build a prototype. Secure intellectual property. All of these steps should be considered in parallel rather than in series. Of course, the entrepreneur should have compelling marketing research to demonstrate there is a market and an unmet need.

Strategy is also very important. A sound business strategy and regulatory strategy are mission critical.

It’s also important to tell the entrepreneur what he/she needs to hear, rather than telling he/she what they want to hear. You can put lipstick on a pig, but it’s still a pig.

In my experience, one of the bigger obstacles for entrepreneurs is overcoming fear. An entrepreneur needs to trust others. An entrepreneur needs to establish relationships with service providers that have expertise and then trust them.

Filed Under: All, Product Development - General, Project Phases Tagged With: , , ,

What If The Start-Up Has No Money?

June 21, 2009 By 4 Comments

INpact has focused a great deal of effort building a product development roadmap. We all know that the phases and deliverables defined yield a formula for success. As we parted ways from the June INpact meeting, my friend and colleague, Pete Kissinger, posed an interesting question: “What happens when the entrepreneur doesn’t have funding to do all the things we’ve outlined in the roadmap?”

Great question. I wish I had a great answer. I’ll try my best.

The entrepreneur needs to constantly focus on value. What tasks, activities, and deliverables are most important? Who are they most important to? What are the risks of not doing some tasks defined in the roadmap? It obviously depends on the audience. For example, investors might care about something different than regulatory bodies (e.g. FDA).

I’ll take a stand and state that proving the concept is always most critical. Proving the concept is more than just having a widget that works. There has to be a receptive market too. The proof provided depends on the stage of development and the risks involved. For example, an entrepreneur shouldn’t focus on proving the widget works in man without first doing some benchtop testing and without demonstrating the product is safe. Every phase of develop requires reiterating the proof of concept. Of course the further along in development, proving the concept becomes more rigorous.

I guess I still haven’t answered what a cash-strapped entrepreneur should focus on very well.

Build prototypes.

This is the most tangible way entrepreneurs have to demonstrate to others their idea solves a problem. If the entrepreneur convinces others that the product is worthy, funding will come more easily. Funding may not always be in the form of cash. Sometimes others may be willing to “invest” their time and expertise to help the entrepreneur further the product development.

Filed Under: All, Product Development - General, Project Phases Tagged With: , , , ,

INpact – The Network Is Growing

June 21, 2009 By 3 Comments

We recently held the June INpact meeting. It’s been amazing to watch and be of part of this growing organization. I remember the first few meetings where we had a handful of people talking about this crazy idea. During the June meeting, we had nearly 50 people in attendance. But not just anyone.

Not that forming a networking group is easy, but if we just wanted to fill the seats, we could have done this long ago. INpact is very different. We are focused on medical device product development. The people that attend and the members of INpact have proven track records in medical device product development. We are working very hard to ensure that the integrity of this group stays top-notch.

Besides networking, what does INpact do? We are putting the finishing touches on the INpact Product Development Roadmap. We’ve identified product development project phases and key deliverables. Now we are matching up the INpact members to specific deliverables. In our experience, start-ups and entrepreneurs are constantly searching for the “best of breed” for specific deliverables. But there are not good resources currently defined to help these entrepreneurs find the best. Because of this, entrepreneurs sometimes ask vendors to do something that is not a fit with their core competencies and strengths. By mapping the process and identifying vendor strengths to product development deliverables, we are providing a qualified resource to the medical device community.

Filed Under: All, Indiana Life Sciences, Product Development - General, Project Phases Tagged With: , , ,

Design Transfer Is A Process

September 4, 2008 By Leave a Comment

There was a recent post at Medical Device Link about the importance of properly transferring technology and products from engineering to manufacturing. Absolutely! To me, “design transfer” is a critical part of the product development process. The product development process has several distinct phases and deliverables. Each phase requires different disciplines and activities. But before the job can be considered done, transfer from engineering to manufacturing must be successful. To quote the Medical Device Link post:

“Technology transfer needs to be a priority, or else you’ll have headaches,” DeCosta said. “It’s not just a technical process. It’s a process you need to monitor, track, and continuously improve.” 

Filed Under: All, Product Development - General, Project Phases

Imagination, Innovation, Realization: An Approach To Product Development

June 6, 2008 By Leave a Comment

Creo Quality has been hired by Priio to help them improve operational efficiency. Priio is a turnkey product development firm specializing in:

I’ve had the chance to work with Priio on two occasions and have been very impressed with their attention to detail, industrial design, and sound engineering approach. Priio has developed products ranging from paint ball guns to cardiovascular medical devices.

So why does Priio need help from Creo Quality? One primary area relates to project and program management. Priio definitely has the expertise and ability to deliver terrific solutions. The Priio “Path” is rooted in a systematic, methodical approach to projects. However, Priio wants to get better with resource allocation, managing multiple projects and programs, and the ability to efficiently move through the process. Plus, one of the issues Priio and firms like them deal with is managing customer expectations. Customers sometimes do not have the experience and knowledge regarding product development efforts, and often have unrealistic expectations.
Creo Quality is helping Priio firmly establish its product development “language” that will be communicated to their resources and customers. This will help inform and educate all involved regarding the mysterious product development world. The Priio “Path” includes three distinct phases:

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(images are trademarks of Priio)

Imagination, Innovation, and Realization define the core of any successful product development initiative. The managing partners of Priio certainly understand this. Creo Quality will just help ensure that everyone at Priio and their customers better understand this.

Creo Quality’s assistance in improving project and program efficiency will help Priio:

  • Navigate product development more smoothly.
  • Improve communication with internal resources.
  • Improve communication and relationships with customers.
  • Better manage their project pipeline.
  • Get a better handle on cash flow.
  • Continue to be a leader and innovator in turnkey product development services.

If you have a product development question or need, I encourage you to contact Priio. They just might turn your idea into a state of the art product!

And of course, if you need help improving your operational efficiency, Creo Quality might be able to help. Contact us.

Filed Under: All, Product Development - General, Project Phases, Strategy vs. Tactics

Product Development Project Phases Recap

September 9, 2007 By Leave a Comment

In case you missed the earlier posts on product development project phases, here is a recap with links to the original posts:

Defining a product development process and deliverables (in my opinion) is absolutely vital any product development entity–especially for early stage start-ups and entrepreneurs trying to advance a technology closer to market.

If you’d like more details, recommendations, suggestions, etc., let me know.

 

Filed Under: Project Phases

Phase 4: Verification & Validation

August 30, 2007 By Leave a Comment

Phase 4: Verification & Validation

  • V&V Planning
  • Design Verification
  • Design Validation
  • Process Validation Planning
  • Manufacturing Planning
  • Risk Control
  • Residual Risk Acceptance
Filed Under: All, Project Phases
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