The Four Most Common Reasons for Non-Conformities in Clinical Evaluations

The new MEDEV directive detailing the required contents of Clinical Evaluations has been out for several years now but there still seems to be some confusion about how to implement it.
As a freelance medical writer/regulatory consultant I have written more than 50 Clinical Evaluations over the past 5 years. In addition I have revised Clinical Evaluations that clients have written themselves, submitted to a notified body and received non-conformities. I’d like to share with you the 4 top reasons that I have seen for these non-conformities:
1) Failure to describe article search procedure – You must include your search strings, where you searched and how many hits you got for each search.
2) Unqualified person wrote the document – I have seen Clinical Evaluations where the director of marketing wrote the document. I’m sure that he/she is a very good director of marketing but in most cases that does not make them qualified to provide an analysis of the scientific literature and other required content.
3) Failure to grade the articles evaluated – You must explain your grading system and use it to justify inclusion/exclusion of articles.
4) Including only a literature review – A Clinical Evaluation is much more than just a literature review. Depending on where you device is in its life cycle, you may also need to include information such as post-marketing data, bench tests, unpublished clinical studies and comparisons with similar devices.
Some of you reading the above may be thinking: “we submitted a Clinical Evaluation with some or all of these defects and no non-conformities were generated”. This can definitely be the case because there is still a certain amount of inconsistencies between notified bodies and within the notified bodies themselves as to how Clinical Evaluations are to be reviewed. However, I can definitely say that over the past several years notified bodies have become much more strict in their reviews of Clinical Evaluations.

Working as a Completely Independent Contractor vs Working Through an Outsourcing Company Part 1

I have worked as project manager for three different outsourcing companies and have worked a s freelancer both directly with clients and through outsourcing companies.

The first company (Let’s call it Company X) that I worked for as project manager had an interesting business model whereby they worked only with freelancers so that the only people receiving a salary were the CEO and the office manager. The company had a marketing guy (also freelance) who would generate leads and pass them on to me. I would contact the lead, make my pitch and send a proposal. If the proposal was accepted I was given 70% of the amount and Company X kept 30%. I could then either do the project myself or find a freelance writer to do the project. In any case I was responsible for the quality of the output.

If I took an experienced writer to do the project I generally would give them 60% and keep 10% for myself.  If the writer was new and need more input from me it would be closer to 50% and 20%. My policy was to always tell the writers what percentage of the project they were getting and how much I was getting. I also offered to show them the proposal sent to the client so that they wouldn’t have any doubts. Interestingly no one asked to see the proposal and no one asked for a bigger percentage. In my experience one of the drawbacks to working through an outsourcing company is the feeling that you are being exploited. By being upfront with the writers we avoided this problem.

For my 10% I would review all material before it was sent to the client and resolve any problems.

Company X paid both the writer and me within 30 days of billing, regardless of if they had been paid by the client or not (as long as the client was satisfied with the work).

During the 10+ years I worked as project manager and my subsequent work as a freelance writer I gained a number of insights which I will share with you in my next entry.

Regulatory Writing/Consultation-A Career Upgrade for Technical Communicators–Part 1

I have been active in the technical writing field for more than 20 years and I have met more than a few writers who feel blocked in their career path both in terms of interest and money. One alternative that uses many of the same skill sets used in technical communication is the regulatory field.

My personal story is a good illustration of this. I was working a freelance technical writer for a start-up company that was developing a new type of imaging device to be used in the operating room. The device was quite large and complicated and required (to my delight)  a several hundred page manual. In addition, for the company to survive it needed to receive regulatory approval from the FDA to market its device. Due to the novel approach of this device the approval was far from automatic. Because it was kind of difficult to get clear explanations about the system from many of the engineers (sound familiar?) I began asking the VP of regulatory affairs. He was not a native English speaker and he then asked me to  go over some documents that he wrote to check the English. I asked him what each document was for and he provided me with good explanations of various aspects of the regulatory process and I spent more and more time helping him with the FDA submission. The company got the FDA approval, began marketing it device in the US and was eventually bought out by the multinational medical device company Medtronic. I leveraged my knowledge of preparation of regulatory documents to find more gigs and soon had enough experience to be able to honestly present myself as a regulatory consultant. I established my own company Carmel Scientific where I offer regulatory consulting and medical and technical writing services. The VP regulatory affairs left the company to set up his own consulting firm and I have been working with him as a subcontractor for the past 17 years.

In my next entry I’ll compare the two fields and offer advice on how to make the switch.

Writing Regulatory Compliant Medical Device Manuals-Part 1

Before a medical device can be legally marketed in most countries it must be approved by a regulatory body. In the US, marketing approval is granted by the FDA. According to the FDA, Medical devices are classified into Class I, II, and III. Regulatory control increases from Class I to Class III. The device classification regulation defines the regulatory requirements for a general device type. Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Premarket Notification 510(k); and most Class III devices require Premarket Approval. In the majority of cases devices are submitted via the 510(k) route.

In Europe the device must receive a CE mark before it can be marketed. The CE mark is granted by a Notified Body which grants its approval based on documents submitted and an inspection visit. As with the FDA process, devices are classified into different categories based mainly on the potential danger that they may pose to patients.

If you’d like a deeper explanation of regulatory processes there are several excellent sites on the web that describe both the European and American regulatory systems.

As a freelance technical writer you may be called upon to write a User Manual or Instructions for Use (IFU) for a medical device. As most of you are aware, there is regulatory aspect to the writing of a medical device manual. The manual must be filed together with many other documents to receive marketing approval in the US, Europe and many other countries. This series of posts will help you to work with regulatory experts in producing a regulatory-compliant manual and keeping it in compliance.

I’d like to stress that, as I wrote in the previous paragraph, the person who is ultimately responsible for ensuring that the manual is written correctly from a regulatory standpoint is the either the regulatory consultant hired by the company or the company’s in-house Regulatory Affairs Director.

The following posts will get into more specific details about how to write a regulatory compliant manual..

The Art of the Headline: “Voodoo sex ceremony starts fatal fire, officials say” –”

If the headline above won’t get you to read the story then you have a serious problem. In one short sentence it combines sex, religion, death and fire. What more can you ask for?
Let’s face it we all hope that someone will read, with interest, what we have wrote. Even if the audience is one person for say, regulatory documents or you’re going for a larger audience with marcom material, you don’t want to feel that you are completely wasting your time.
Headlines (or headings) should serve two purposes; convey what information is in the section and make the reader feel that it might interest them. Keep in mind however that the headline style must be appropriate to who the audience is. There are headlines that are appropriate for the New York Post and headlines for the New England Journal of Medicine.

Marketing Yourself As a Freelance Writer

Let’s face it if most of us freelancers really enjoyed marketing we’d be in Marketing not it in writing. Makes sense, no? But if we want to feed ourselves and our families we have to constantly be on the lookout for new clients. And here let me add that those of you who think that you are all set because you have one big client who keeps you busy all the time, may be in for a rude awakening. I would prefer to be making a little less money with several clients than more money with one big client. A freelance relationship by its very nature means that your big client can drop you tomorrow with no prior notice suddenly drying up your income and we all know that little Suzie isn’t interested in hearing that she has to stop her ballet lessons because Daddy’s (or Mommy’s) big client pulled the plug. The time between when you start to look for a new client and when actual money enters your bank account from this new client can be several months.
The only way to overcome our aversion to marketing is to set aside several hours per week for marketing and not compromising on this point.
What do I mean by marketing? I don’t mean cold-calling. I do mean setting up a web site if you don’t already have one, or maintaining one that you already have. If you are a writer it is a minimum that you have a web site. There is no excuse for not having one. I also mean doing web searches for likely clients or outsourcing companies and contacting them. I also mean considering setting up a professional blog, working on your CV, registering with LinkdIn and putting an ad in Google AdWords or similar services. If some of these things cost money, so be it. The amount of money that you can make from one serious client will pay all your marketing costs for several years.
Finally, if you’re looking for just one book to teach you about sales I recommend Soft Selling in a Hard World by Jerry Vaas. It deals with the types of clients who would be buying our services and also has lots of concrete examples.

Two Ways to Build Up Your Portfolio Without Feeling Exploited

As I discussed in a previous post to find work as a freelancer you need to have a portfolio. To have a portfolio you need to work. Kind of a problem. I gave several suggestions for building up your portfolio without having to work for internet companies that pay poorly and probably won’t contribute much useful material to your portfolio anyway. Here are two more:
Go to a site where you can download freeware or shareware (there are lots of them) and find a program that looks interesting. Check to see if they have any documentation. It is usually very weak or non-existent. Contact the developers and volunteer to document the product. I doubt if they will say no. You will then have a complete manual (or helpfile) for your portfolio. Believe me no one interviewing you for a job will ask you if you were paid to write the manual, and it doesn’t really matter.
The second option is site called Here you can help your fellowman by documenting a repair procedure and posting it. See the site for details.