Funding For Medical Device Innovation Doesn?t Need To Come From Government

Why Funding For Medical Device Innovation Doesn?t Need To Come From Government

government-funding-medical-device-technology | Photo Courtesy of Depositphotos

While funding for medical device innovation is a good thing, it doesn?t necessarily need to come from government, whether that?s in the form of tax breaks or grants.

Robert Langer, an MIT professor and this year?s recipient of the Medical Design Excellence Awards (MDEA) Lifetime Achievement Award, said in a recent interview on the Medical Device and Diagnostic Industry website that a lack of funding is the biggest issue facing the medical device technology industry. He argued for incentives such as tax breaks for those investments.

However, that money should come from the private sector where it works much faster with far less waste. Our tax laws in particular are way too complex already, and all too often end up choosing winners and losers.

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Article originally posted on our CRM for Medical Device Organizations website.

Why Must Any Strong Medical Device Marketing Plan Use Key Opinion Leaders

Why Must Any Strong Medical Device Marketing Plan Use Key Opinion Leaders?

medical-device-marketing | Photo Courtesy of Depositphotos

The 2013 Deloitte annual survey of U.S. physicians reveals that they still believe doctors have the most influence in choosing equipment for patients and procedures. This news, highlighted in an article on the Becker?s ASC Review website, could have a big influence on the approach to medical device marketing moving forward.

The survey showed that about 70 percent of U.S. physicians believe that physician-led peer review of new medical technology is the top best practice when making purchasing decisions. It is incumbent upon medical device manufacturers to understand that physicians still rely on other physicians and peer reviews of medical device technologies. To put that knowledge into practice with a sound medical device marketing plan, it is critical for manufacturers to use key opinion leaders (KOLs) to help influence others.

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Article originally posted on our CRM for Medical Device Organizations website.

Why Are Pharma Companies Relying On Partnerships With Biotechs?

Pharma Companies Relying More On Partnerships With Biotechs
Pharmaceutical & Biotechnology Partnering

Facing a patent cliff and erosion from generic drugs, many pharmaceutical companies are relying on partnerships with biotech companies for innovation and development.

Shifting dynamics are now prompting some biotechs to seek more balanced deals than in the past, sharing rewards as well as risks, according to an article on the BioWorld Today website.

?Pharmas at the moment are cash-rich and molecule-poor,? says Nick Davies, co-author of a report on the pharmaceutical industry from global consulting firm PwC. That?s why they?re looking to biotechs as development engines.

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FDA/CMS Announce Long Delayed Ruling on Sunshine Act

As some of you may know, the FDA/CMS (Centers for Medicare and Medical Services) have been (very) late in issuing their final ruling as to when physician Sunshine Act reporting will begin. Those of you who follow me via Twitter and on the i3 Community site know that I’ve been posting updates about the Sunshine Act compliance deadlines and extensions communicated by the FDA and CMS since December of 2011 (

Well, they finally made their decision today and released the details the life science industry has anxiously been awaiting –

In a rare act of kindness, the CMS has provided manufacturers and GPO?s a bit of extra time to get things in order. By law, manufacturers and GPO’s were only required to provide a 3 month notification of when data collection should begin, however, they have now given 6 months notice.

Starting August 1, 2013, drug and device companies will be required to collect data about payments, gifts and other transfers of value given to physicians and teaching hospitals (greater than $10). This final ruling also requires manufacturers and GPOs to report the first round of data collection to the CMS by March 31, 2014. Data must be submitted annually by the 90th day of each calendar year thereafter.

What does this mean? Companies that have not yet implemented a solution for meeting the reporting requirements of the law now have a bit of breathing room, although not much. Microsoft Dynamics CRM provides an excellent platform for adding functionality that will allow companies to more easily meet these requirements – Infinity would love to show you how!

If you have any questions or would like to discuss further, please don’t hesitate to reach out to me at

Pharmaceutical/Biotech Mergers & Acquisitions Expected to Continue

I ran across this interesting article about a significant trend in the pharmaceutical and biotech industry.

Bloomberg Article

In a nutshell, drug makers are shifting their focus from cutting costs to filling pipelines through mergers and acquisitions. Next year could top the 2,076 deals worth $166 billion announced in the past 12 months. “What tends to drive that is the need. There’s clearly a need for larger companies who are facing patent cliffs and whose own R&D machines have not panned out, to find growth.?

The extremely high cost of bringing new drugs to market is one of the primary factors for this increase in partnerships, mergers and acquisitions in healthcare. The chart below shows the spending for top 10 firms and represents a whopping $66 Billion annual investment.

Research Spending Per New Drug

Company Ticker # of drugs approved R&D spending per drug ($M) Total R&D Spend 1997-2011 ($M)
AstraZeneca AZN 5 11,791 58,955
GlaxoSmithKline GSK 10 8,171 81,708
Sanofi SNY 8 7,909 63,274
Roche Holdings AG RHH 11 7,804 85,841
Pfizer, Inc. PFE 14 7,727 108,178
Johnson & Johnson JNJ 15 5,886 88,285
Eli Lilly & Co. LLY 11 4,577 50,347
Abbott Laboratories ABT 8 4,496 35,970
Merck & Co. Inc. MRK 16 4,210 67,360
Bristol-Myers Squibb Co. BMY 11 4,152 45,675

Sources: InnoThink Center For Research In Biomedical Innovation; Thomson Reuters Fundamentals via FactSet Research Systems

Cost cutting can only go so far before it negatively affects the growth of any company. Since 2000, the pharmaceutical industry has cut 297,650 jobs, according to consulting firm Challenger, Gray & Christmas. These companies are finding that a shift from cutting costs to making agreements can more effectively help build product lines.

Nearly half of today?s top-selling drugs are the result of partnerships. Companies that excel in business development and alliance management position themselves to win new deals. Those organizations that show a penchant for successful collaborations will attract other companies looking for strong allies ? in the process filling critical portfolio holes and penetrating exciting new markets.

A major challenge with business development and alliance management are the majority of pharmaceutical and biotechnology companies today have legacy CRM tools or home grown systems that have not been able to keep up with this rapid pace of change in the market. These traditional and legacy solutions have become much too inflexible and too costly to maintain, leaving pharmaceutical companies in the unenviable position of overspending every day on solutions that no longer meet their business requirements.

Infinity has developed the Infinity iPartner platform that is designed for the pharmaceutical and biotechnology partnering life cycle. Infinity iPartner puts everything in one place for your teams to track and coordinate the finding, partnering, deal management, obligations, payments, milestones and other key activities required for managing an increasingly complex network of partners. All on a modern and highly flexible platform that is easier to use and maintain than existing systems and processes.


To learn more about Infinity iPartner powered by Microsoft Dynamics CRM, contact us today.

Update on Sunshine Act Compliance Deadlines

Back in December I wrote a blog post about the Centers for Medicare & Medicaid Services (CMS) rule change for reporting on the Physicians Payment Sunshine Act. Original post here:

The CMS had decided to extend the data collection start date from January 1, 2012 to ?some later date?. A few days ago, on May 3, the CMS provided some updated information in their blog (The CMS Blog). During the extended comment period they received over 300 comments. that?s a good thing that people are voicing their concerns.

The CMS still hasn?t issued a final date but says in their blog ?CMS will not require data collection by applicable manufacturers and applicable group purchasing organizations before January 1, 2013? and ?CMS intends to release the final rule later this year?.

Some news is better than no news. The window is closing though for companies that will be required to report this information to the FDA. Time is ticking. We have helped a number of companies ensure their systems and processes are up date and compliant. If you are struggling with these rules, give us call, we are happy to help you too!

iPharma Connect Conference?The New Commercial Model

The 11th Annual iPharma Connect Conference was held last week in Philadelphia. This year?s theme was ?Digital Innovation for Marketing Decision Makers in the Life Sciences Industry?. I will share some notes on the conference and key trends and ideas that might provide you some value as well.

At its core, digital marketing is about making connections.  For Pharma, Bio and Device manufacturers, this is defined by connections with patients, physicians and payers. 

Hot Sessions for 2012 Include:

  • Keynote address by POZEN?s Chief Commercial Officer on the changing pharma commercial model
  • Regulatory update on the implications of FDA?s guidance for mobile medical applications
  • A physician?s perspective on preferred digital channels
  • Case study for online support systems and today?s patients
  • Industry panel on war stories and lessons learned from non-effective digital marketing campaigns
  • Best practices for implementation of multi-channel closed loop marketing capabilities

Keynote Address: The Old Model Just Won?t Cut It ? The Revolution of the Traditional Pharma Commercial Model

The Opening Keynote was kicked off with Liz Cermak, EVP and Chief Commercial Officer of Pozen, Inc., formerly WorldWide VP of Johnson & Johnson. The bottom line is the old model won?t cut it. The days of sample drops and focus on call volume are over or should be). We are now in the midst of the revolution of the traditional pharma commercial model. This echo?s what we have been hearing from the majority of our clients. Highlights include:

  • Rep access declining rapidly even when allowed office access, gets harder every day
  • 25 percent of physicians are inaccessible, and growing
  • Sales rep headcount down 26 percent from 2005 peak, today around 75,000
  • Physicians are now embracing digital
  • 9 of 10 feel one access improves quality care
  • 82% of physicians have smartphones
  • 64% own tablets
  • Physicians & Patients are seeking more information online

The patient shift has gone from getting information direct from the physician to participatory medicine and coupling your own information from online and community sources with the physician. This shift will continue as patients become more responsible for their own care. I can affirm this as I had a recent healthcare event (I?m fine now) where my physician directed us to online communities for more detailed information about the condition and even said to just ?Google it? one time.

The other major shift is on social. The healthcare industry has been reluctant to embrace it, largely due to regulatory uncertainty. The challenge is, social is happening with or without the industry, so it?s time to jump in. Sidenote: I blogged about the recent FDA Guidance on Social Media, click here. A little more on the social revolution in Healthcare:

  • It?s a Social world whether we like it or not.
  • Social accounts for 1 out of every 6 minutes sent online, and growing rapidly.
  • 61 million people use mobile phones for health info in the US.
  • More than 25 billion pieces of content (web links, news stories, blog posts, notes, photo albums, etc.) are shared each month.
  • There are currently over 133 Million blogs.
  • Over 50 Million tweets per day.
  • YouTube receives more than 2 Billion (with a B) viewers per day.
  • Digital is the audience connector.

Success in this new model requires:

  • Customer centric behavior
  • Consistent messaging and sharing
  • Audience engagement
  • Efficient organization workflow

Addressing the new commercial model, Liz described six tenets of the new commercial model

1. Fish where the fish are. 

  • The new model requires pharma to have customer centric behaviors.

2. Shift personal selling to physician centric selling

  • Expand and use digital sales toolkit.
  • Provide sources and access to digital and mobile medical information
  • Use eDetails and live chat.
  • Shift rep focus to services, right now services are only at 5 percent, must include multi-channel capabilities.

3. Make it relevant to your audience

  • 79 percent of physicians watch video clips on lectures and drug info.
  • Physicians are interested in connecting beyond the office visit, e.g. digitally, 1:1 presentations.
  • Pharma must be perceived as trusted partner along the patient health journey, nearly half of all Americans look up health info online, general health and social are high and growing, be part of those interactions.
  • Gamification is a trend and new behaviors, provides greater chance of improved patient adherence and disease management, makes it more engaging and fun.

4. Facilitate patient and physician connectivity

  • Previously was more about physician to pharma connectivity
  • Current use in digital communication is email, secure messaging, online video conferences
  • Patients are driving the physician relationship shift

5. Social is possible and without fear

  • The train has left the station.
  • Social Health issued by 30 percent of population.
  • Challenge is how to engage and be relevant.
  • Regulation has paralyzed the industry.
  • Must balance risk and benefit.
  • Resulted in >2 Million people screened for COPD, >60 Million impressions.

6. Fully integrated multi channel marketing is now

  • Communicate consistently and beyond the pill.
  • Digital marketing is growing rapidly, 2012 digital spend is forecast at 18.9% of major media spend, which is over $39 Billion.
  • Market research, planning, partnerships, advertising, direct response, CRM, social, mobile, must all be included.
  • E.g. Drive4COPD campaign, used social media channels (Facebook, Twitter, Email, Digg, etc.) and traditional marketing (magazine ads, banner ads, direct mail).

    I have to say, in my experience, Liz hit it out of the park with these tenets. The magic if the internet has empowered patients and physicians alike. The technology shift is happening rapidly. My grandmothers next phone will be a smartphone because she wants to ?surf the net?. Instant access to information is becoming the norm. Organizations and representatives both must adapt with these changing realities. The new commercial model must do all of the six tenets?and then some.

    FDA Updates Social Media Guidelines for Pharmaceutical and Medical Device Industry


    The FDA recently announced (some) updated social media guidelines for pharmaceutical and medical device firms. The actual title of these imageguidelines are ?Guidance for Industry: Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices?.

    This is still considered Draft Guidance and is an update to previously released guidance. This is, however, the first time the FDA mentions ?emerging electronic media? with specific examples related to YouTube and Twitter.

    The full FDA Draft Guidance can be downloaded here:

    The document is fairly short (12 pages), by government standards, and I highly recommend you read the whole thing if you are responsible for sales, marketing or customer service for pharmaceuticals or medical devices.

    I will point out some important bits below, particularly, related to responses as outlined in the FDA document. This is particularly important for maintaining compliance and is a great example of why CRM systems are very important for social media interactions and staying compliant with regulations.


    1. Information distributed in response to an unsolicited request should be provided only to the individual making the request directly to the firm as a private, one-on-one communication.

    2.  Information distributed in response to an unsolicited request should be tailored to answer only the specific question(s) asked.

    3.  Information distributed in response to an unsolicited request should be truthful, non-misleading, accurate, and balanced.

    4.  Information distributed in response to an unsolicited request should be scientific in nature.

    5.  Responses to unsolicited requests for information should be generated by medical or scientific personnel independent from sales or marketing departments.

    6.. Information distributed in response to an unsolicited request should be accompanied by the following:

    • A copy of the FDA-required labeling, if any, for the product (e.g., FDA-approved package insert and, if the response is for a consumer, FDA-approved patient labeling or, for new animal drugs, FDA-approved client information sheet)
    • A prominent statement notifying the recipient that FDA has not approved or cleared the product as safe and effective for the use addressed in the materials provided
    • A prominent statement disclosing the indication(s) for which FDA has approved or cleared the product
    • A prominent statement providing all important safety information including, if applicable, any boxed warning for the product
    • A complete list of references for all of the information disseminated in the response (e.g., a bibliography of publications in peer-reviewed medical journals or in medical or scientific texts; citations for data on file, for summary documents, or for abstracts)

    7. A firm should maintain the following records:

    • The nature of the request for information, including the name, address, and affiliation of the requestor
    • Records regarding the information provided to the requestor
    • Any follow-up inquiries or questions from the requestor


    1.  If a firm chooses to respond to public unsolicited requests for off-label information, the firm should respond only when the request pertains specifically to its own named product (and is not solely about a competitor?s product).

    2.  A firm?s public response to public unsolicited requests for off-label information about its named product should be limited to providing the firm?s contact information and should not include any off-label information.

    • The firm?s public response should convey that the question pertains to an unapproved or un-cleared use of the product and state that individuals can contact the medical/scientific representative or medical affairs department with the specific unsolicited request to obtain more information.
    • The firm?s public response should provide specific contact information for the medical or scientific personnel or department (e.g., e-mail address, telephone number, facsimile) so that individuals can follow up independently with the firm to obtain specific information about the off-label use of the product through a non-public, one-on-one communication.

    The customer service module within Dynamics CRM is particularly well suited to helping your team monitor, respond, and document social media interactions. We have a lot experience helping companies maintain compliance with regulations using CRM. If you need help, just call or fill out the request below and let us know.