Three Wise Dames

Marketing in the Life Science Industry

Simply Described: FDA Review of Medical Devices March 13, 2013

FDA Logo BetterWhen I learned about the regulatory process that a medical device goes through to get to market, I learned about it on-the-job from experienced medical device communications colleagues, clients and their regulatory counsel.  Since then, I’ve looked for resources to pass on to other teammates or students to explain the process, which can be complex. I’ve found some really good descriptions of the process a drug or biologic undergoes (one of my favorites is by my colleague Mark Senak), but nothing that really works for medical devices.  (If you have a resource, please share it!)

So, here’s what I’ve developed and shared (with the caveat that I am not a regulatory expert.  I have a lot of experience with FDA-regulated products, and I’m offering this from a communications perspective.)

Devices are can go through two different processes at the FDA: The 510(k) and the Premarket Approval (PMA). Every year the FDA reviews thousands of 510(k) submissions, which is about 10 times as many PMA applications.

510(k) Clearance

Approximately 90% of device applications that the FDA receives annually go through the 510(k) process. This is a premarketing submission made to the FDA to demonstrate that the device to be marketed is as safe and effective (substantially equivalent) as a device that is already being legally marketed. This process on average takes under five months, although it can range from three months to about a year. Because it usually requires no clinical trials or research it also requires less investment and presents less financial risk to investors.

However, changes are underway.  The FDA is now requiring some devices going through the 510(k) process to have supporting clinical data, requiring a trial. This is generally the case when there is a new technology or a request for a new indication for use. When a study is required, it is the same as an IDE study (explained below).

Premarket Approval

A PMA is an extensive application submitted to the FDA to request approval to market. Unlike a 510(k), a PMA is based on the FDA’s determination that “there is sufficient valid scientific evidence that provides reasonable assurance that the device is safe and effective for its intended use or uses.” (http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/default.htm)

This process generally takes at least five years, and often longer.  Here’s the process at a glance:

  • Feasibility studies are usually animal studies, and may include other kinds of economic and market research.
  • Investigational Device Exemption (IDE) approval is required from the FDA before in-human trials can begin.  An IDE trial can be a small, pilot or proof of concept study, or it could be a large pivotal trial.
  • In the medical device world, a pivotal trial is considered large when it includes several hundred patients, vs. the several thousand that may be included in a trial for a drug or biologic.
  • All PMAs for a first-of-its kind-device require an advisory committee review.  (I’ve never worked on a project going through the PMA process that didn’t have an advisory committee meeting.)
  • Of the three decisions the FDA can make, two are clear-cut: The device is approved or not approved. An approvable letter is a lot less clear-cut.  It means that the review is complete, but the FDA wants the company to address a few things, such as labeling, or setting up an inspection. When the issues are addressed to the FDA’s satisfaction, then the device may be approved.

Important Lingo

  • The FDA clears 510(k) submissions and products receive 510(k) clearance.
  • The FDA approves PMA applications and products receive FDA approval.

Other Good Resources

Mann Foundation

FDA PMA Overview

FDA 510(k) Overview

WSJ: Too Fast or Too Slow?

This information reflects my experience in working with FDA-regulated products.  Please only use this is a guide, and if you need the final word on matters, talk to your regulatory expert!

©2013 All rights reserved. This article may be shared in part or whole with credit given to author and link to Merryman Communications

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Do’s and Don’ts in Communicating about FDA-Regulated Products January 29, 2013

ImageIn response to a special request, this post provides some general guidelines on communicating about FDA-regulated products.  However, let me start by emphasizing that I am not a regulatory expert.  I have a lot of experience with FDA-regulated products, and I’m offering this from a communications perspective. So here are my product communications Do’s and Don’ts:

Do:

1. Work closely with regulatory counsel.  I’ve always valued a close and collaborative relationship with the folks in regulatory and I try to involve them in the planning process as well as the document review process.  Sitting across the table from them helps because when I understand why they say “No, you can’t do or say that,” I brainstorm with them to get to the “Yes, you can do or say that.”  I’ve also learned that, just like with doctors, lawyers and even marketing communications people, recommendations vary from expert to expert and client to client.  Often regulatory guidance comes down to a judgment call on the level of risk the client is or is not willing to bear.

2. Include risk information in appropriate materials.  The challenge surrounds what the appropriate materials are. Some are straightforward, such as advertisements and collateral and of course these must include fair balance.  I won’t tread into social media and the guidance (or lack thereof) as it’s a subject that’s been beaten to death. But how about press materials?

  • Press Releases:  One client’s regulatory counsel has advised that press releases remain one exception, and we still don’t include fair balance in our releases for that client.  A colleague who works for a large agency shared the opposite – that they include fair balance in all press releases they develop for pharma and med device clients.
  • Pitch letters:  This short, simple medium was never intended for the public.  Pitch letters are one-on-one communication directed at the media from a company or agency to interest them in your latest news and information. But a pitch letter recently received a red flag from the FDA, and now we’re all waiting with bated breath to see if we need to start including risk information in them.  Guess what?  So far it depends on which regulatory person you ask! (Read more about it here:  http://www.prweekus.com/pharma-communicators-keep-eye-on-fda-after-it-singles-out-product-pitch/article/270458/)

3. Present risk information in a balanced way. Including the fair balance information at the end isn’t enough.  You need to be sure that you (or your spokespeople, such as patients) tell your story in a evenhanded way.

  • Don’t let your spokespeople minimize the risk information. (One celebrity spokesperson declared during a national TV interview: “Oh, drug companies just have to say that…”  The drug company and agency had to work with the outlet to have it corrected immediately.)
  • Testimonials can’t overstate the product’s benefits. (For example, “Because of this product I improved my golf game” needs to be something more along the lines of: “Because I use this product, I feel better and because I feel better, I play golf better.”)

4. Ensure adverse event reporting processes are in place. As you all know, adverse event reporting has been a big reason some pharma or device companies have stayed away from product-oriented social media initiatives.  One client worked with her regulatory team to develop a weekly reporting process, and also relies on frequent check-ins with regulatory both at her business unit and at the corporate level. As we’re all learning, it can be done.

5. Understand the difference between the FDA and SEC. Regulations from each guide your communications recommendations for publicly traded companies and their products.  It’s important to understand whether your information is material and the level of flexibility you have in what to convey, timing your announcements or launches, etc.

Don’t:

1. Don’t provide information on off-label uses.  Controlling off-label statements presents a challenge in two-way social media channels, but now we have FDA draft guidance on this issue.  You can find a great at-a-glance diagram of this guidance here: http://www.doseofdigital.com/2012/01/translating-fda-social-media-guidance/.

2. Don’t overstate claims or claim superiority if you don’t have data to support it.

3. Don’t give medical advice. Instead we include a call-to-action that directs potential patients to speak to their doctors.

This is my general guide on communicating about FDA-regulated products. But please keep in mind:

This information reflects my experience in working with FDA-regulated products and teams on the client side.  It is based on a snapshot in time because policies at the FDA can (and do) change.  Please only use this is a guide, and if you need the final word on matters, talk to your regulatory expert!

Now let’s hear about your experience!

 

The Staircase to Nearly Nowhere March 23, 2012

Filed under: Lisa,Market Planning,Products — Lisa Pohmajevich @ 10:15 pm
Tags: , , , ,

Photo courtesy of Winchester Mystery House

Nowhere on my ‘bucket list’ is the must-do of building anything. However, I am hip deep in a construction project. This activity provided the opportunity to learn new things. Many of which I didn’t know I needed to learn, nor do I know at present, how to make all of the learning’s useful. I am sure it is simply a matter of time before it becomes clear.

Do it right the first time

My father is an engineer and from the school of ‘do it right the first time’ philosophy. ‘It’s all in the planning’ he told me. When repairing or constructing something at home, he spent more time thinking and calculating and planning and documenting than actually doing.  I’ve come to realize that approach saves countless mistakes while steering a direct course to a goal.

Step vs. Leap

Apparently the universe was keen on me taking this tenent to heart.  Recently, I received a call from my contractor about a staircase in my construction project. He asked about my height and athleticism, a curious question I thought. He wanted to confirm my ability to leap upwards and successfully reach the landing sixteen inches above the last step. I asked him why I would need to do that, never mind my abilities.

It happens that the plans included miscalculations resulting in a gap of approximately eleven inches from the top of the last step and the landing. This meant there was not enough space to add the two steps needed to reach the landing. Additionally, the gap provided a straight shot to the floor below – fourteen feet down! He assured me that as long as I could leap and make the landing above, he would continue building per the plan.

 Five steps of planning

This ‘do it right the first time’philosophy is particularly important when introducing a new product to the market, especially important if the product is the first for a company.  I’ve learned there are five key principles that must be included in the planning of new product development if success is the intended goal.  The five principles I’ve learned to include in development planning are:

  1. Economics are as indispensable as ergonomics.
  2. The payer is as essential as the provider.
  3. The patient is as influential as the physician.
  4. Integration is as important as ingenuity.
  5. Outcome is as significant as opportunity.

Using these principles as the guiding framework in the development of a new medical device can facilitate making the leap into the market, without missing a step. 

Stay tuned for more detail on the principles, in posts to follow.

(C) 2012 pH Consulting. All rights reserved.

 

3WD Interview–John Bashkin June 16, 2011

I met John Bashkin through our mutual membership in the Bio2Device Group. He asked me to co-author an article in MDDI based on a presentation I gave to the group in April. The article with side bar has been published–Medical Device Makers Can Learn Social Media Skills from Pharma + ShareThis Example. I’d like to introduce my collaborator.

John Bashkin

  • How did you arrive in your current role?

I began my career as a technologist and gradually became more interested in how technology and business map onto each other to create commercially successful innovation. That’s where I’ve been working for past decade or so, with particular interest in life science and medical device innovations.

  • What do you love most about the work you do?

Working across a wide variety of technologies and clinical needs pushes me to constantly learn, and that keeps the work stimulating.

  • Where is the most exotic place in the world that you’ve eaten?

In the heart of the Ranomafana National Park in Madagascar, where I was volunteering on a lemur conservation project. Exhausted, soaked to the bone, covered in mud, and flicking off leeches – a can of sardines never tasted so good!

Many colleagues know of my fascination for the medical use of leeches so I have to say that I am a little jealous of John’s experience.

(C) 2011 eGold Solutions; all rights reserved.

 

Using Social Capital December 15, 2010

As I was reading last week’s issue of People, I ran across this ad which is a collection of comments generated by a Sept 23rd prompt to fill in the blank: I think Biore pore strips are…

Sixty Biore Facebook Fans commented and a handful were selected and agreed to be featured on the print ad in People.

What a clever way to generate a plain folks, bandwagon testimonial ad for a national magazine.

When the art was put together they had 32,277 fans and as of today that has jumped to 45,094 (almost a 40% increase).

This idea has value in the life sciences corner of the marketing world. I can imagine a company with patient-facing messages using social capital to illustrate the patient value proposition to clinicians waiting for patients to ask for branded treatments.

Execution of this advertisement idea would be completely unexpected in a medical journal. I suspect would generate a fair amount of chatter–positive, negative and neutral; however there would be a conversation happening around THAT product.

I hope to be on the front lines of THAT product’s marketing very soon.

(C) 2010 eGold Solutions

 

May I have your attention, PLEEEAASSE?! September 30, 2010

If only we would stand still! Or

better yet – be consistently

predictable. So lamented my

client regarding their efforts to

sell products and services to

women. It seems that women

are everywhere – literally.

And yet, we ‘all’ are not in

everyplace. There is no one

place to find us. Therefore,

getting our attention, let

alone keeping it, is no small

challenge. Seth Godin posted

on the value of someone’s attention

(I’m paraphrasing here) under the

same post title. It is well worth

reading, as he describes how precious

a commodity is our individual

attention – making the compelling

point that it isn’t free. There is

a lot of competition for our attention.

As a mini experiment I tracked my

activities for one day to identify

how much of my time and attention

was available for promotional contacts of products and services. It turns out, not much. My day looked like the following:

  • Upright and dressed at 5:30a.m.
    • Note:  not particularly alert and NOT an early morning person
  • 30 minute walk – still dark outside
  • Breakfast at 6:30a.m., no background noise
  • Email at 7:00a.m.
    • Note: now alert, but quite yet at peak attention
  • Project work on computer 8:30a.m. – noon
    • attention at highest focus
    • some web searching, project related
    • Intermittent interruptions and phone calls
  • Stop  for lunch at  noon – radio in the background
  • Back to work on the computer 12:45p.m., no background noise
  • Client call at 2:30p.m.
  • Back to computer at 3:30p.m.
  • Errands to grocery store, bank and stop at neighbors’ at 5:45p.m.
  • Dinner preparation at 6:45p.m., dinner at 7:15p.m.
  • Clean kitchen, do laundry, read the paper, answer email at 8:00p.m.
  • Interact with family at 8:30p.m., watch 15 minutes of  Charlie Rose
  • ‘just-15-minutes-more-on-the-project-turned-hour’ on the computer at 9:15p.m.
  • Ready for bed at 10:15p.m.
  • Final chapter in the book of the week, month, who knows how long ago I started it…at 10:35p.m.
  • Asleep, probably at 10:40p.m.

When I looked at the places, activities, time frames and focus of one day, it became apparent, that unless a product/service was essential to me, and I knew about it, and it was in my path, it would go unknown. Therefore it would not be purchased or experienced.

This was one day, not all days are as well structured as that day was, some are more chaotic or disjointed. I don’t have children at home to further distract my attention, it can only be more of a challenge for women who do. I know through discussions with many a woman friend, colleague, relative and acquaintance, their days are similarly busy. As illustrated above, we have a lot of balls in the air, all the time. We rarely have free time where our attention is not otherwise diverted.

As noted in Seth’s post, our time is not free, as it turns out, in either of two dimensions.

A woman’s day is literally filled to the brink with activities and responsibilities. Precious little

time during a day is free from other thinking, doing or being activities.  Secondly, because

our days are not free filled, getting our attention – taking our time, will require

some effort and thus expense on the part of the pursuer.  Free time – NOT, times two.

Women are not going to readily deviate from a proven path or reliable schedule that gets us through a day, accomplishing the critical ‘must-do’ activities that facilitate our arrival at the desired finish line – our pillows. So what’s a marketer to do to get us to notice products and services? Where indeed can a marketer be that we will see their wares. [Rhythm and rhyme pure luck!]

I imagine such a place would resemble the image I have of an Egyptian bazaar. A place that has everything in a vast array of colors, sizes, styles, at every price point and in great abundance. However, no one location exists where all women visit and all marketers are present. Nor does it make sense that such place exist as women are not identical to one another.

It makes sense then to be ‘where’ we are, particularly when the introduction of new products and services are concerned.  We are at home, at work, preparing for presentations, in meetings, in our cars, on planes, at the store, bank, dry cleaners. We use computers and telephones.  We I listen to the radio, watch some network TV programs, read the paper and hard copy books.  And many of us also use new technologies – that allow us to eliminate the ‘noise’ of advertising.

Reaching us and getting our attention is not easy. There is not just one place. Our time is not free. And when we encounter and try new products and services, it will be because good marketers understand it is worth their effort and expense to be where we are.

Note:  If you know the illustrator to whom attribution can be assigned for the graphic in this post, please let me know.

(c) 2010 pH Consulting

 

Good products do not a business make August 3, 2010

I love Mexican wine. Yep, you read that correctly, especially Mexican wine from the small vineyards in the Valle de Guadalupe on the Ruta del Vino. If you like wine, and haven’t tasted wines from this region yet, you are seriously missing out. 

I have a goal to visit and taste wines from all the regions in the world, especially the little known regions. Unfortunately, Mexican wines still qualify as ‘little known’. While wine has been produced there since the 17th century, it was mostly for and by the Catholic Church, after a ban was imposed by the Spanish government preventing ‘New Spain’ from producing highly palatable wine, through a heavy-handed political power maneuver.  Bless the hearts of those defiant Jesuit and Dominican priests for keeping a good thing flowing! 

Fast forward and thanks to Russian immigrants fleeing the czar in the early 1900’s, replanting and winemaking revived many years after the Mexican Reform War.  During this period many church holdings were confiscated by the state, and wine making was abandoned.  

Mexican wines are relatively new again, having taken root, so to speak  in the 1980’s.  I traveled to the region a few years ago to seek out these wines. The wines and the region were more than worth the trouble to get to them.  However, even some twenty odd years later, the wineries were just beginning to develop businesses around the wine.

Wine clubs, restaurant wine lists, tasting rooms, wine events and out of state shipping were not part of the early product offering.  Nor were winery cave tours, branded websites, restaurant lists where wines were served, locations of wine stores where it could be purchased or wine stewards recommending pairings part of the winerys product offering.   Spanish wine was still served for official state dinners at the capitol in Mexico City until the early 2000’s!  Mexican wine, good as it is, was a product, not yet a business.  Each vintner and winery struggled to build businesses, even with a good product.

This situation repeats itself in many life science startup companies. New and innovative products are developed and then introduced to the market with the fundamental wrappings of sales brochures, 800 numbers, return policies and training materials. Companies pin their hopes and earnings projections on the basis of the product being novel, leapfrogging the competition, and winning awards for best in class. 

But it takes more, much more for a good product to be successful and a company to become a business. For a twist in thinking about successful businesses based only on the most innovative  and novel products, read the post by Greg Satell on Crappy Innovation.   Note in particular the references to Charles Schwab – not a crappy product. 

To turn a good, novel or even crappy product into a successful business requires servicing the customer beyond the product.  For life science technologies that includes advertising, PR, education, training, clinical data, publications, technical and reimbursement support, at a bare minimum. 

To develop a strong business the product offering must extend beyond the fundamentals and the traditional offerings.  Servicing the customer must meet their needs beyond the transaction. Providing new services like co-marketing, data sharing, virtual training, community building, cross technology development, and even competitive alliances that facilitate physicians’ abilities and enhance patient outcomes creates significant intrinsic value. If a company is to become a robust business, the product is not the be-all, end-all. Rather a good product must be the beginning of creating a robust business for the customer.

A few final words on Mexican wine – should you find a bottle of Mogor-Badan Chasselas or Casa de Piedra’s blend of Cabernet and Tempranillo, drink them to good health and think of me.

(c) 2010 pH Consulting

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