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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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.

 

Vanilla doesn’t sell unless it’s Ice Cream October 28, 2010

Vanilla ice cream has a rich taste and appealing aroma, making it the best selling ice cream flavor around. The Wikipedia page devoted to vanilla notes that it is the second most expensive spice after saffron, because of the labor required to grow the vanilla seed pods.Vanilla is used in foods, perfumes, aromatherapy, and apparently even as a bug repellant and a home remedy for minor burns. Clearly, it is very versatile.

Getting it right

However, when promoting a product, a ‘vanilla’ description is anything but appealing or versatile. Product descriptions are critical in product positioning.  Descriptions provide the basis for establishing a brand identity, a communication platform, a competitive edge, the value proposition and so much more. In the medical device space product descriptions are considered labeling. Significant effort and expense goes into securing medical device labeling.  Because medical device labeling is absolute and creative license is forbidden, getting it right is critical.

Connect the dots

To have the best possible chance at successful product adoption customers should readily recognize the value of the product through the labeling. Product descriptions should resonate intrinsically with the customer. Understanding customer needs is the core responsibility of marketing. Therefore, involvement by marketing in the product description is essential. It is senseless to disconnect the customer and patient advocate – marketing, from the customer and patient guardian – regulatory/clinical. 

Engagement at a higher level

Proactive interaction by marketing with the regulatory/clinical department early on in the clinical plan development provides the best possible outcome for labeling that will resonate with the physician customer.This is not about making it easy for marketing to promote a productNor is it about securing labeling that is loose, boastful or inaccurate in any way

Rather, this assertion that marketing participate in the discussion about the clinical plan and the desired outcome is because marketing should be leading the efforts to ensure that the product or service truly meets and exceeds customer expectations and is reflected clearly in product descriptions. The regulatory/ clinical expertise is most impactful by establishing strong and undisputed product labeling, that doesn’t need interpretation or lyrical descriptions for the product to be appreciated.

Untangle the tangle

Many marketers complain that they are hamstrung by the regulatory department when product promotion and communication plans and tactics are proposed. Many regulatory departments cringe at the creative approach marketers present to convey a product purpose, benefits and applications. 

It seems that the simplest and cleanest approach is to use the product labeling granted by the FDA,

based on evidence provided by the regulatory and clinical experts

that distinguishes the product precisely as it is intended to be used by customers,

through the distillation of customer needs by marketing. 

And while that seems a mouthful and a tall order, early collaboration between marketing and regulatory/clinical is the most likely path to labeling that is descriptive and telling. The kind of labeling where ‘creative marketing’ is about the many ways to communicate product availability and not about the many words required for product description. Product labeling typically happens only once. Getting it right so the right customer connects their needs with the value of the product will make the best use of all efforts to promote and protect.

(c) 2010 pH Consulting; all rights reserved.

 

Fish for Your Supper May 18, 2010

 

Fishing with nets, tacuinum sanitatis casanatensis (XIV century)

“Give a man a fish; you have fed him for today. 

Teach a man to fish; you have fed him for a lifetime.  

Teach a man to sell fish and he eats steak.”  Author unknown      

In a previous post I suggested that industry could play a role in physician practice marketing. To do so successfully defining a common purpose and identifying the intersection of that purpose is primary.  

Physicians and healthcare product companies have related interests, and very different roles and responsibilities. Because a patient exists, physicians and healthcare suppliers have purpose. The patient is at the very nexus of these interests, roles and responsibilities.   

If physicians desire greater demand for their special services and skills, saying so out loud, as discussed in prior posts Practice Marketing is Not Rocket Surgery and Make Some Noise, is essential.  Physicians are accustomed to communicating with patients through a one-on-one interaction.  While this is an effective means of communicating, it will take a bloody long time before this approach is impactful. A broader approach is needed and industry can provide effective lessons in marketing to a larger target audience.       

Essential Foundation   

 To effectively implement practice marketing programs a company must be committed to the following three fundamentals:   

  1. Focus on the patient as the primary reason for communications programs
  2. Grounding of all marketing activities around the needs of the physician/practice
  3. Establishment of professional marketing expertise before designing third party services

 Once these three fundamentals are well established, the tenets below will be useful in creating practice marketing programs for the physician.    

Program Framework   

Be a role model   

  • Develop, implement, measure, analyze, fail and refine all programs and processes first, before you ask your customers to do it.  If you haven’t tried it, why should your customer?

Identify common goals   

  • Clearly define the marketing goals and gain commitment by all participants of a practice marketing program in advance of implementation.  Hint:  The goal should be eerily similar to Fundamental #1 above…

 Start where they are   

  • Keep in mind that physicians’ expertise is in patient care, professional marketers excel in marketing.  Effective practice marketing starts the beginner at the beginning and advances them as tolerated.

 Respect boundaries   

  • At all times the doctor-patient relationship is a two person ‘only’ relationship.  Professional marketers can provide guidance, examples, recommendations, support and encouragement, but never patient care.

 Differentiate and collaborate   

  • The same methods and measurement models may be used in commercial and physician marketing programs; however, the objectives of the programs will differ based on the audience. Both parties will benefit by learning from each other.

 Teach and release   

  • When teaching and training the physician and staff on marketing practices take the opportunity to develop program champions and practice trainers. Success from doing/failing/learning/redoing will more likely encourage the practice to be self sustaining in their marketing efforts. 

 Applaud and move backstage   

  • Support the physician with information, analysis, recommendations and additional opportunities and then let the physician and practice staff take center stage with the program and the patients.

 Learn and adapt   

  • Each practice will experience their program differently than the next. Take notes, ask questions, and adapt the master program to incorporate the best and most innovative elements gleaned from the individual experiences.

 Healthcare companies can play a role in practice marketing by teaching the practice personnel new skills.  Teaching physicians to cast their net for a larger target audience will result in greater demand.   

Note:  There are defined regulations and restrictions that companies must adhere to with regard to practice marketing programs; the specifics of these are not covered in this post.  Y68BQHEBG7DJ

 (c) 2010 pH Consulting

 

 

  

 

It’s Not About What You Say April 8, 2010

The recent explosion at the Upper Big Branch coal mine in West Virginia is bringing renewed attention to the mine’s owner, Massey Energy.  Like most people, I realize that coal mining is an inherently dangerous job, and unfortunately, accidents happen.  If that were only the story here, it would be sad enough.

Instead much of the attention has focused on the 3,000 plus safety violations Massey has racked up since 1995. Yet, as of April 7, the home page on the company’s Web site still proudly proclaimed that 2009 was “another record-setting year for safety.”  Hard to believe. (As of today, they finally removed that article from the home page.)

In fact, the company’s statements declaring the importance of safety are in direct contrast to its record of egregious safety violations and the reports that Massey’s chairman and chief executive, Don Blankenship, allegedly told workers to ignore the orders of those who instructed them to construct support beams and ventilation shafts for safety purposes and just “run coal.” It is companies like this that give capitalism a bad name.

The Lesson To Learn

What can healthcare companies learn from this tragic incident?  It’s simple. Always remember that actions speak louder than words.

No matter how many times your top executives express concerns for patient safety or piously proclaim that their mission is finding better treatments or cures for disease, if the company is rushing a drug to market before its full side effects are known, it’s a lie. If they are pushing a device through trials and suppressing negative evidence that would keep it from FDA clearance, it’s a lie. If your hospital touts patient safety, but every staff member isn’t following strict protocols to combat healthcare acquired infections, it’s a lie.

Words vs. Action

Communicators use words.  Lots of words.  We draft mission statements, company vision statements, key messages and yes, even positioning statements.  But no amount of words can take the place of action.

Action is key to reputation.  Doing the right thing at the right time for the right reason—even at the expense of short-term profits—builds positive reputations.  And reputations are valuable.  A good reputation adds to the bottom line and helps companies weather the storms of crisis.  Just ask Massey Energy, whose stock has dropped nearly 12 percent and whose credit rating was downgraded below junk.  If that’s not enough to convince you, then just ask the families of those miners in West Virginia.

 

Expect the unexpected – what happens when the DTC campaign is launched February 3, 2010

Filed under: DTC,Lisa — Lisa Pohmajevich @ 11:28 pm
Tags: , , ,

You’ve launched your campaign and the phones are ringing – and among the many calls you’d hoped for are those you least expected.  Some reactions are anticipated, some will leave you gobsmacked!  These are a few that caused our heads to turn:

  • To capitalize on the DTC campaign, a physician invests in a local advertising to promote his practice and the new procedure; when interested patients with no contraindications or insurance issues contact the physician he convinces them to have an alternative procedure.
  • After being refused an elective procedure by a physician who promotes performing the procedure, consumers go to chat room sites and ‘teach’ each other the questions and responses to ensure getting what they want.
  • A non medical group successfully discourages physician adoption of new and safer techniques because of the implications to the group tenets and governance.
  • Advertising is dropped by a broadcaster because of one complaint received from a listener about the use of anatomically correct terms in the description of the procedure.
  • Competitors began advertising their unrelated products with our message.

Plan to be surprised from the most unexpected of experiences.  And remember to chuckle at the things you can’t control.   Comments welcome.

(c) 2010 pH Consulting

 

 
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