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Technology continues to play a big role in the life sciences industry as organizations seek new partnerships and opportunities for collaboration.
A recent article on the IndustryWeek website highlights five important technology trends that will influence the pharmaceutical industry andmedical device innovation?over the next five years.
A paradigm shift in the industry is reshaping the direction of medical device innovation. The industry is changing how it sells equipment to physicians and hospitals.
“We’re going to be judged based on value,” says Dr. Joseph Iannotti, chairman of the Orthopedic and Rheumatology Institute at the Cleveland Clinic.
An article on the Plastics News website explains that innovators of medical devices must answer complex questions concerning the value that the technology brings to the market.
It’s no longer just about getting market share. Now, it’s about value-based selling. The focus must be on where the technology fits in and how it will make a difference for patients.
The medical device tax now is in place, with a 2.3 percent excise tax on devices by manufacturers and importers, an article on the JD Supra website explains. As always, businesses impacted should look at ways to increase efficiencies and reduce costs. Investing in technology is one way to do that. Companies must find ways to do more with less.
We've been getting a lot of interest lately on our Life Sciences Partnering solution. If you have a need to improve your business development, alliance management and project/portfolio management for your pharmaceutical, biotechnology or medical device company, read on….
Partnerships and innovative collaboration will be the key to medical device sales growth this year, according to an article on the Medical Device and Diagnostic Industry website. It’s a great way to stretch investment dollars and reduce risk. Of course, it’s important to have a CRM system that can help track and manage these partnerships.
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 (http://i3.infinityinfo.com/blogs/tags/tag/sunshine-act).
Well, they finally made their decision today and released the details the life science industry has anxiously been awaiting – http://www.modernhealthcare.com/article/20130201/NEWS/302019903?AllowView=VW8xUmo5Q21TcWJOb1gzb0tNN3RLZ0h0MWg5SVgra3NZRzROR3l0WWRMWGJWdjBBRWxiNUtpQzMyWmVwNTMwWUpieWk=.
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 mhammons@infinityinfo.com.
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: http://i3.infinityinfo.com/blogs/entry/sunshine-act-compliance-deadlines-extended
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!
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: 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:
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:
Success in this new model requires:
Addressing the new commercial model, Liz described six tenets of the new commercial model
1. Fish where the fish are.
2. Shift personal selling to physician centric selling
3. Make it relevant to your audience
4. Facilitate patient and physician connectivity
5. Social is possible and without fear
6. Fully integrated multi channel marketing is now
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.
The FDA recently announced (some) updated social media guidelines for pharmaceutical and medical device firms. The actual title of these 
guidelines 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: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM285145.pdf
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.
V. RESPONDING TO NON-PUBLIC UNSOLICITED REQUESTS FOR OFF-LABEL INFORMATION DIRECTED TO DRUG OR MEDICAL DEVICE FIRMS
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:
7. A firm should maintain the following records:
VI. RESPONDING TO PUBLIC UNSOLICITED REQUESTS FOR OFF-LABEL INFORMATION, INCLUDING THOSE ENCOUNTERED THROUGH EMERGING ELECTRONIC MEDIA BY DRUG OR MEDICAL DEVICE FIRMS
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 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.