Europe
+33 (0)1 42 68 51 79
Japan
+81 (0)3 6260 6688
United States
+1 972 480 9554
Europe
+33 (0)1 42 68 51 79
Japan
+81 (0)3 6260 6688
United States
+1 972 480 9554
Ken Block Consulting (KBC) has achieved the impressive Breakthrough Device Designation (BDD) status for five (5) different novel and impactful medical devices, which are each described below. Our team would be happy to discuss your company's innovative new technology, whether your proposed device could be positioned appropriately for a Breakthrough Device Designation Request to the FDA, and how KBC can create the most appropriate BDD Q-Submission.
As background, FDA established the Breakthrough Devices Program to help fast-track the US market introduction of highly innovative medical device technologies still under development, which hold the promise to address life-threatening or permanently debilitating diseases and conditions. Candidate devices may be diagnostic-oriented or treatment-oriented, but companies must formally apply to the FDA and can only gain BDD status by meeting specific criteria. BDD advantages include close collaboration with an assigned FDA review group, agreement with FDA on the device validation data needed to enter the US market, frequent meetings with their FDA team, and prioritized FDA review of the eventual market authorization application: De Novo, “Breakthrough 510(k)” or PMA.
FLOXsp was developed by KBC startup client Neural Fiber Optic Systems, Inc. (NFOSYS) and is intended for short-term placement in the epidural space to monitor spinal cord blood flow and oxygenation before, during, and after surgical procedures where the spinal cord is at risk of injury due to ischemia. Spinal cord ischemia (SCI) can lead to paraparesis, paraplegia, tetraplegia, and other lifetime disabilities including chronic pain. Results of SCI are costly and can significantly reduce the length and quality of patient lives.
To help reduce the occurrence of SCI complications, NFOSYS President/CEO Thomas F. Floyd, MD, developed the FLOXsp device, which uses minimally invasive optical probes to measure acute changes in spinal cord blood flow and oxygenation as signs of impending SCI with an immediacy not possible with current electrophysiologic monitors. Dr. Floyd is a board-certified cardiac anesthesiologist and Professor of Anesthesiology and Pain Management at the University of Texas Southwestern Medical Center in Dallas. He emphasizes, “SCI is devastating. For decades, clinicians have searched for technology to reduce the risk of this complication. Our device may provide a much-needed solution designed to significantly improve patient outcomes.”
KBC successfully led NFOSYS through the appropriate Q-Submission process at FDA, resulting in the Breakthrough Device status for FLOXsp. Our team worked closely with our client and the FDA to achieve this valuable outcome. Breakthrough Device status will allow KBC and NFOSYS to meet frequently with the FDA, resulting in shorter time to market for the FLOXsp device.
Our press release for this first KBC Breakthrough Device success can be found here:
Ken Block Consulting helped our UK client Oxford Brain Diagnostics (OBD) gain Breakthrough Device status from the FDA for its Cortical Disarray Measurement (CDM) Software Device, which is intended for evaluating adults at risk of Alzheimer’s disease. Very different from the electro-mechanical software-driven technology of our NFOSYS client, the OBD device met both the FDA and the International Medical Device Regulators Forum (IMDRF) definition of Software as a Medical Device (SaMD).
More information about OBD and the CDM technology can be found on our client's website:
https://www.oxfordbraindiagnostics.com/
Applying the same principles of a successful Breakthrough Device application to this innovative and impactful SaMD, KBC worked closely with OBD to craft the appropriate Q-Submission to the FDA. After successfully achieving this important milestone, KBC was invited by the industry publication Med-Tech Innovation News to describe the process that we employed for gaining BDD status for the CDM device. The resulting published article by KBC can be read in its entirety here:
Given the KBC office in Paris and our two successes detailed above, the European industry magazine DeviceMed was interested in a French language article about this special FDA program. The resulting publication written by Ken Block (Programme Breakthrough Device : un raccourci vers le marché américain) provides a high-level view of the Breakthrough Device Program (and includes the two KBC clients above as examples of successful BDD applications):
Ken Block Consulting helped an orthopedic startup company from Switzerland achieve Breakthrough Device Designation in only 27 days (as compared to the standard 60-day FDA decision timeline). KBC client Kairos Medical AG has developed the innovative and proprietary orthopedic implant material TisMet™ from biologically friendly and specially engineered magnesium and calcium. Replacing the use of steel or titanium in certain orthopedic applications, TisMet™ has the significant advantage of completely dissolving after its medical intended purpose has been served. KBC helped Kairos Medical AG achieve BDD status for the KM Anchor One device, which uses TisMet™ and has a “Breakthrough 510(k)” pathway to the US market.
More information about Kairos Medical AG and the TisMet™ technology can be found on our client's website:
Working closely with a client who wishes to stay "under the radar" for now, Ken Block Consulting recently helped an organization achieve Breakthrough Device Designation for an innovative cancer treatment device using technology that is not yet part of the US Standard of Care (SOC).
Collaborating interactively with the FDA's Cancer Diagnosis and Treatment Devices Team, this is our first combination device to have achieved Breakthrough Device status. Our client is applying proprietary and novel technology to address life-threatening cancerous situations for populations who currently have no alternative treatments.
"Our team spent the prior year with another FDA consulting firm submitting 3 pre-subs and endless supporting material to the FDA with very limited success. We paused that work and engaged KBC for a second opinion. Within one review he identified areas we could revise in our approach to the FDA that led to a Breakthrough Device Designation in a matter of months. Our team witnessed Ken’s perfect execution of a Hail Mary. Needless to say, we would highly recommend his firm." – M.D. & Chief Scientific Officer
Assisting a new client who had made limited FDA progress over several years with a different consulting group, Ken Block Consulting (KBC) reoriented the company’s regulatory approach. We started with setting an important goal of gaining entry to one of FDA’s special “fast track” programs. Working under the updated Breakthrough Devices Program guidance document that now allows devices that target pain and reduction of opioid use, KBC achieved Breakthrough Device Designation for our client’s innovative implantable drug delivery device.
The FDA review team described this new technology as “exciting” and the device as “exactly what FDA is looking for” to raise the US Standard of Care (SOC) for the targeted patient populations. This success demonstrates an example of device technology that was previously eligible only for the FDA’s special Safer Technologies Program (STeP), but where that same technology can now qualify as a Breakthrough Device.
This achievement represents KBC’s fifth Breakthrough Device success. Given the excitement and interest of the FDA review team, the FDA decision arrived on day 30 of what is usually a 60-day process. Our client is now lining up additional investment funds, which will help accelerate the final device validation and eventual De Novo submission (which – under the Breakthrough Devices program – will receive priority review).
Please contact us (info@kenblockconsulting.com) to discuss your company's new and impactful medical device technologies, and how Ken Block Consulting can help you achieve FDA regulatory success!
