Top Pharma API and Finished Dosage Formulators

Quick visualization of US FDA audited companies have been captured in info-graphics GDUFAbelow. Regulatory data have been used as feed stock for these deductions.

Trailblazers across various areas have been highlighted in visualization. Some of the major observations have been outlined below:

  1.  Year 2016 witnessed dip in overall FDA audited facility counts.
  2. While Sanofi led the FDA approved facility count in API space, Mylan was forerunner in finished dosage segment.
  3. India witnessed highest facility count increase in API space, while Taiwan enjoyed  number 1 position in terms of increase in FDF approved facilities for the year trailing 2016-2017.

Note: Analysis was carried on data sets which was not very organized at company name level, hence some of the prominent entries might be missing from visualization.

 

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Medical device assembly service sees a major addition

We are referring to EmbedTek LLC’s recent entry into finished goods supply of medtech devices.

EmbedTek LLC has been for long delivering its services to medical device industry; however those service were limited to component level. Post getting FDA badge of contract manufacturer, it can now cater to finished good supply, which means, EmbedTek can now ship ready to use medical devices to OEMs doorstep.

EmbedTEK has shed its previous image of outsourcing partner working on client specs, and has become strategic CMO ready to take joint responsibility of product quality and delivery.

About Company:

EmbedTek designs and manufactures embedded computers and integrated display solutions for original equipment manufacturers and ISVs. We leverage our expertise in computing, displays, software, wireless, I/O and controls to provide solutions optimized for our customers. We collaborate with our customers early in the process to create solutions that make their end product better. We leverage open standards and augment with engineered hardware and software solutions that enhance the performance of our customers’ end product. We also provide ongoing supply chain management services; delivering the product to our customer throughout the lifecycle proactively managing component obsolescence and product quality. The team at EmbedTek is experienced, professional, agile and customer focused.

Is Innovating A Boon Or Bane In Disguise ?

Innovation

Is innovation a good thing ? Is being the first one to develop, advantageous? Do forerunners deserve royalty payments?

All these are the questions that are been raised by medtech innovators who according to recent Harvard study, do not get incentivised, but rather billed for the extra effort they  put in to develop innovative technologies.

Study from  Harvard Business School outlines that device that undergoes high risk PMA pathway are charged higher and take extra time in comparison to there follow on version. The delay cost is as high as USD 6.7 million ,a cost over USD 94 million that a company shells  out for high risk PMA approval , claims study results.

The research study was published in  Aug 2015 HBSWEEK copy.

According to study first high risk medical device which contains likes of stent , aortic heart valve as device types take 34% higher time in comparison to follow on versions. These stats demotivate players like Medtronic , BSC and others to innovate, as innovation bears no extra benefits for an organization which spends millions and billions to make a product patient ready, all for betterment of healthcare ecosystem.

Parallel pharma industry on other hand always favors innovators, with biopharma given a special privilege of bio-betters. Only in certain cases like para 4 innovators take a back stand , primarily because patients immediate need and affordability are made a priorities over rewards.

Regulatory authorities agree to the fallback, outlining they have been performing outstanding in protecting front but not in promoting. And hence they claim of adding on speedy checks & approvals across various regulatory amendments to address the need of the hour. Under recent regulatory introduction, namely 21st century cures act , speedy pathway clause is structured just to answer the same issue.

Innovation in healthcare are to address the unanswered questions of patients, and if they are getting impacted by some glitches at regulatory level, it’s an issue that needs to be looked into with shear priority.

All we can hope is that FDA lives up to its claims and provide patients world wide with better innovative devices. After all, we all want a better healthcare ecosystem that banks on preventing rather than curing.

Universal Companion Diagnostic

Covance
Image Source: Covance Website
Companion Diagnostic(http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm407297.htm) market is garnering much deserving attention in recent times on various factors ranging from  partnerships, M&As and Novel breakthroughs. The deal counts in companion diagnostics space were on record high in last couple of quarters. Lot of new trends were spoken around next generation sequencing and  universal companion diagnostics.