Getting Started In The Medical Device Industry- The Road Map

As we start to dip our toes into the sea of information that is the Medical Device Industry, I first must review what Medical Device Toolbox: IS NOT, to help everyone understand WHAT IT IS and how it will serve you if your just getting started in the industry or seasoned veteran.

First, This site will not be a collection of FDA regulations, collection of material specs, or a summary of the current market position of the major device manufactures, there are other places for that type of information. Those of you who have already waded into that pool, you realize it is deep and easy to find yourself washed out to sea.

So here is what I propose:

Medical Device Toolbox:

• Focused on Application: Medical Device Toolbox will focus on Application of information in the daily lives of engineers, scientist and other professionals in the device industry. We will bring in supporting resources as necessary but only as they provide Guidance to our daily activities.
• Focused on Changes and Evolution: In an attempt to help anticipate changes and identify opportunities we will also highlight significant shifts in industry trends. This might include patent trends, federal regulations or health care reform and reimbursement, just to highlight a few.
• Summarize Critical Information and Resources: In some instances, where appropriate, we will also collect useful information for easy access, this might include Terminology and Definitions, or other information that is useful and otherwise does not have an obvious home.

Now that we have laid that out in general terms, let's jump into the specifics:

Product Development Cycle- General

In very simple terms, this chart describes the product development cycle. Though they differ slightly from industry to industry, in general terms, this is a standard product life cycle for most commercial products. Notice these diagrams do not account for the length of steps, which is clear in that most ideas occur in an instant and move directly to an R&D/Development type phase. And in direct contrast to that, most testing or production activity can form a significant portion of the time necessary to bring something to the market.

Medical Device Development Cycle- General

It is clear that even from a high level perspective, the Medical Device Industry has a higher bar to market entry than your traditional commercial product, with the addition of the clinical and regulatory requirements.

This in a nut shell is the world of the medical device professional and hence the world of Medical Device Toolbox.

IDEAS

The concept of ideas in the medical device industry can take on several definitions in the device industry and we will deal with each in turn.

Ideas- Response to unfilled market need or gap, evolution due to new technology applied to a new application, response to improved quality of care and/or surgical technique. Ideas are truly the fuel of the device industry but as will soon become clear even fantastic ideas have a long journey to final product, which is filled with bumps and pot holes, which is where device professional enter the picture. It is our job to push-pull and plead with ideas to tease them into successful products that in the end, improve the quality of care, which is a fancy way of saying- that they help people!

R&D

This is where ideas take form, the conceptual become concrete. The astute reader will recognize that many if not most ideas actually come out of the R&D labs and research institutes a crossed the country and do not merely appear on the door step of the device company dropped by a silent messenger. I concede this point, however the activity I refer to when discussing R&D will be focused at the activity just beyond conception and just before implementation.

R&D- In the language of patents, R&D reduces to practice, which may mean just building the concept or potentially developing the technology necessary for the idea to become reality. A more artistic definition is that R&D is where the art and science of ideas and technology mingle and take final form, sometimes perfect, sometimes just possible (more on this comment in the Production section).

Patents- Another element of Ideas and R&D which is Key to the device industry is the concept of Intellectual Property, IP or Patents. This concept is the life blood of the industry and thus patents will form a major point of discussion as to how best to capture, protect and utilize the protection of patents in your daily work life.

Clinical

You will have to excuse the idiom but it fits too perfectly not to use it! If R&D is where concepts take form, then the clinical environment is where the RUBBER HITS THE ROAD (Sorry!). What I mean by this is that the clinical environment is where concepts and bench top test finally see the first taste of the real application, in the form of animal studies, and clinical trial on humans. This is where the real essence of the device industry lives and where many of the tools cannot be taught, but must be learned through experience (but I will share some of mine ;)).

Clinical- For our purposes the clinical discussions will focus on the processes, systems and alternatives available. Potentially reviewing existing data or alternatives but primarily relying of the FDA, guidance documents and experience to put this into context.

Production

This is where most of us live on a daily basis, this is a highly regulated portion of the device industry and as such spawns many question regarding design controls, validation processes, etc. To understand the role of production we might compare it to R&D. I would say that R&D is focus on whether something is possible (even just once!) and Productions' job or function is to determine if it is possible everyday, day in and day out, while ensuring its Quality and Safety.

Production- As we look at production it will be through the eyes again of the FDA and in the application of the various standards that control the various production activities, for example 21 CFR Part 820.

Quality- As a force of habit and for clarity I defined the function of production and did not highlight the quality element explicitly in the previous diagrams. Though some might argue that decision, I enter it here by way of clarifying, without production there is not need for quality. Needless to say, Quality and the Quality system plays an integral part of the device industry and as such will form a good part of the discussion.

Regulatory

If you had R&D/Production on one side of the scale, the other side would be balance by Quality and Regulatory. Quality and Regulatory form the checks and balances for the daily development and clinical activities described earlier.

Regulatory- The regulatory discussion will be woven through many, if not all, of the above topics due to it guiding influence and importance to the final stages of approval, and more specifically to sale of medical devices in the US.

Sales

Though this topic is included in the above diagram, it will not be a topic covered directly. The reason for this is intentional and based on the purpose for this site. This is not a site focused on Sales, nor on Marketing and in large part not of the business side in any considerable fashion. That being said however, we will discuss Business Development, which is a sales and marketing activity but more primarily focused on emerging technologies and is more in-line with the rest of the activities on this site.

Business Development- Here we will look at how these types of variables that factor into development activities, Ranging from the success of technologies, to missteps in handling the roll-out of new products.

In The END

I hope that as your review these topics and our approach that this information will serve you well in your career.

More specifically, it is my true intent that you personally have a picture of the success YOU would like to be within the Medical Device Industry- Your Dream. With Medical Device Toolbox providing you with the resources and the TOOLS, you will be able to create the Career you hoped for, and in The End find the Success you are looking for!

-dms