Shamelessly rumor-mongering ... By way of post
Post# of 8391
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Posted On: 02/09/2022 10:38:58 AM
Shamelessly rumor-mongering ...
By way of poster Zantt (mucho thx for this) our main man, Dr. Sree Koneru is now a Senior Program Manager @ Meraqi Medical (part of Viant Medical). Congrats and all that ... More on Viant later, but first ...
Another Piece of the Puzzle - 24 Jan 2022 // swordfish // #4784
The FDA requires those that are involved in the Manufacture, Import, or Repackaging of Medical Devices to register every year and pay a $5,600 fee. A search of the 'Establishment Registration & Device Listing' under the 'PQY' Product Code, all BIEL & affiliates, shows everyone is up to date with their 2022 Registration except BIEL's manufacturer, CICD. ... This could be related to BIEL's recent shake up with R&D, moving to expert Researchers in specific fields. Is the reason for the R&D changes the same reason BIEL's manufacturing may be moving way from CICD? ...
Viantmedical.com - They hired Dr. Sree b/c Viant is into Bioelectronics (the field of, not BIEL) medical devices and the good Dr. knows a boatload about bioelectronics. Viant also has 24 manufacturing locations globally in Europe, China, and the US.
Viant - Regulatory and Compliance - With 50+ years of medical device experience, we have developed a thorough understanding of the complex regulatory environment. Every product is manufactured to exact specification, in full compliance with FDA guidelines.
ISO 13485 Certified
FDA Registered and compliant with the Quality System Regulation cGMP
ISO 14971 Risk Management Certified
Class I, II, and III devices, including Premarket Approval (PMA) product support
ISO 7 and ISO 8 Certified Cleanroom Controlled Environments
Sooooooo ... what is the rumor I want to start? Buckle up ... might we, uh, have a relationship w/ Viant for manufacturing? Is Dr. Koneru part of a very large package deal? If (IF !!!) we have struck a deal w/ hospital groups in the US we will need lots and lots of devices, like 100 packs of RecoveryRx, manufactured in bulk (millions?). They, the hospital groups would demand one thing - reliable product delivery that absolutely meets FDA standards. If (IF !!!) we should garner additional clearances, the same thing applies for the new products.
And lookee here ... Viant employs Dr. Sree Koneru who, as it turns out, is intimately acquainted w/ PEMF products, is an expert in the field, and used to work for the company Bioelectronics (BIEL) where he designed the Actipatch which just so happens is selling like pancakes at a hobo convention. Go figure! Viant might be able to 'help' w/ the FDA when it comes to new clearances; yes, no, maybe??? Viant also does Packaging, Logistics and Supply Chain Management.
And, like a dog w/ a bone, can't leave it alone. Ever since the scamdemic, manufacturing has been a question mark. If (IF !!!) we landed a major (US, Eur, Asia) contract w/ RecoveryRx then reliability and volume is a must. So, the question is this. Is a deal involving RRx, expanded manufacturing w/ Viant, the employment of Dr. Koneru, and all the complexities contained therein, worth the 10+ months of mummified silence? I should think so.
So there you have it. If (IF !!!) you factor in any reimbursement scheme (CMMS or private) and lower shipping costs then the presumed additional manufacturing expense could be mitigated. I gave up not noticing coincidences long ago and this one was too good to pass up and/or speculate upon.
Be well, WBeacham
By way of poster Zantt (mucho thx for this) our main man, Dr. Sree Koneru is now a Senior Program Manager @ Meraqi Medical (part of Viant Medical). Congrats and all that ... More on Viant later, but first ...
Another Piece of the Puzzle - 24 Jan 2022 // swordfish // #4784
The FDA requires those that are involved in the Manufacture, Import, or Repackaging of Medical Devices to register every year and pay a $5,600 fee. A search of the 'Establishment Registration & Device Listing' under the 'PQY' Product Code, all BIEL & affiliates, shows everyone is up to date with their 2022 Registration except BIEL's manufacturer, CICD. ... This could be related to BIEL's recent shake up with R&D, moving to expert Researchers in specific fields. Is the reason for the R&D changes the same reason BIEL's manufacturing may be moving way from CICD? ...
Viantmedical.com - They hired Dr. Sree b/c Viant is into Bioelectronics (the field of, not BIEL) medical devices and the good Dr. knows a boatload about bioelectronics. Viant also has 24 manufacturing locations globally in Europe, China, and the US.
Viant - Regulatory and Compliance - With 50+ years of medical device experience, we have developed a thorough understanding of the complex regulatory environment. Every product is manufactured to exact specification, in full compliance with FDA guidelines.
ISO 13485 Certified
FDA Registered and compliant with the Quality System Regulation cGMP
ISO 14971 Risk Management Certified
Class I, II, and III devices, including Premarket Approval (PMA) product support
ISO 7 and ISO 8 Certified Cleanroom Controlled Environments
Sooooooo ... what is the rumor I want to start? Buckle up ... might we, uh, have a relationship w/ Viant for manufacturing? Is Dr. Koneru part of a very large package deal? If (IF !!!) we have struck a deal w/ hospital groups in the US we will need lots and lots of devices, like 100 packs of RecoveryRx, manufactured in bulk (millions?). They, the hospital groups would demand one thing - reliable product delivery that absolutely meets FDA standards. If (IF !!!) we should garner additional clearances, the same thing applies for the new products.
And lookee here ... Viant employs Dr. Sree Koneru who, as it turns out, is intimately acquainted w/ PEMF products, is an expert in the field, and used to work for the company Bioelectronics (BIEL) where he designed the Actipatch which just so happens is selling like pancakes at a hobo convention. Go figure! Viant might be able to 'help' w/ the FDA when it comes to new clearances; yes, no, maybe??? Viant also does Packaging, Logistics and Supply Chain Management.
And, like a dog w/ a bone, can't leave it alone. Ever since the scamdemic, manufacturing has been a question mark. If (IF !!!) we landed a major (US, Eur, Asia) contract w/ RecoveryRx then reliability and volume is a must. So, the question is this. Is a deal involving RRx, expanded manufacturing w/ Viant, the employment of Dr. Koneru, and all the complexities contained therein, worth the 10+ months of mummified silence? I should think so.
So there you have it. If (IF !!!) you factor in any reimbursement scheme (CMMS or private) and lower shipping costs then the presumed additional manufacturing expense could be mitigated. I gave up not noticing coincidences long ago and this one was too good to pass up and/or speculate upon.
Be well, WBeacham
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