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!

 

MedTech Vision 2011 Conference Friday AM October 2, 2011

Filed under: Debbie,Lisa,MedTech Women,Regulatory,Women consumers — Debbie Donovan @ 2:33 am

Name, Affiliation

Friday AM Sessions

Notes, Quotable Moment

Ellen Zane, president and CEO Tufts Medical Center, Boston MA Bringing it All Together: Clinical Practice, Industry, Research & Education Providers brand increases cost
Insurers need to be value-driven Employers’ fair share
Consumers need to become cost conscious and take responsibility Government pay fairly
Lisa Greenwald-Swire, JD – Principal, Fish & Richardson Emerging Markets Panel – New Frontier of Growth Moderator Expanding middle class Health care system consuming implants, disposables and diagnostic imaging
Nancy Travis – Vice President Global Strategy Advamed, former Deputy Director of US State Dept Office of Economic Policy in the Bureau of Easter Asia and Pacific Affairs Panelist In the next 5 years, China will export more med tech to the UYS/EU—current quality is low, counterfeit
Wendy X. Shao – Managing Director & Chairman of Board of R&D Systems China Co. Ltd. Panelist Healthcare identified as a key industry in the 12th 5-yr plan
Natasha Leskovesk, RN, JD – Partner, Cooley LLP, former researcher, NIH Regulatory Panel – Panels, Pivotals and Pain Moderator Data needed to satisfy agency is also needed to sell product to customers
Debra J. Rasmussen – Senior Director Regulatory Affairs, Companion Diagnostic CoE, Johnson & Johnson Panelist JNJ keeps submitting on schedule, focused on customer needs and wants
Jonette Foy, Ph.D. – Acting Deputy Director for Science & Regulatory Policy, Office of Device Evaluation, CDRH Panelist Communicate with agency early and often, flurry of draft guidance—please comment, improving transparency and predictability
Elaine Tseng, JD – Partner King & Spalding LLP, former FDA Counsel Panelist Draft guidance is making more clear the practice that has developed and is in use
Cindy Domecus, RAC (US & EU) – Principal, Domecus Consulting Services LLC Panelist “I no longer have the answer, just pray”
510(k): there’s a lower tolerance for the gap between base products and equivalents
trend toward de novo process
Tamara Fraizer, JD, PhD – Principal, Fish & Richardson Entrepreneurship Panel – Starting and Building Successful Companies in the New World Order Moderator Patent reform bill signed into law by Obama
Are leaders born or made?
Stacy Enxing Seng – President, ev3/Covidien Peripheral Vascular Panelist Born + rise to occasion Find the unmet and unfunded needs
Denise Zarins – Co-Founder, Ardian/Medtronic Panelist Born + education + luck (track record)
Karen Talmadge, PhD – Co-Founder of Kyphon and former start-up CEO Panelist Born (passion)
Prove the opportunity to yourself—be skeptical No short cuts, do each step
Erica Rogers – COO, Medicines360 and co-founder of Visiogen Panelist Born + big company experience See one; do one
Not all great ideas get enough funding to get to market

Related Links:

MedTech Women

MedTech Vision 2011 Conference

2011 (C) eGold Solutions and 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.

 

 
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