https://www.mednest.com/blog daily 0.75 2019-01-01 https://www.mednest.com/blog/2018/12/27/tips-for-the-us-medtech-market-entry-26-27 monthly 0.5 2019-07-29 https://www.mednest.com/blog/2018/12/27/tips-for-the-us-medtech-market-entry-21-to-25 monthly 0.5 2019-07-29 https://www.mednest.com/blog/2018/12/27/tips-for-the-us-medtech-market-entry-6-to-10 monthly 0.5 2019-07-29 https://www.mednest.com/blog/2018/12/27/tips-for-the-us-medtech-market-entry-16-to-20 monthly 0.5 2019-02-27 https://www.mednest.com/blog/2018/12/27/market-access-for-health-technologies-in-the-united-states monthly 0.5 2019-02-26 https://www.mednest.com/blog/2019/2/25/what-are-ind-enabling-technologies-and-the-related-market-opportunities monthly 0.5 2019-02-25 https://www.mednest.com/blog/2018/12/27/tips-for-the-us-medtech-market-entry-11-to-15 monthly 0.5 2019-02-08 https://www.mednest.com/blog/2018/12/27/part-3-readiness-of-medical-technologies-for-the-us-markets-designing-for-cms monthly 0.5 2019-02-01 https://www.mednest.com/blog/2018/12/27/readiness-of-medical-technologies-for-the-us-markets-part-2-designing-for-fda monthly 0.5 2019-01-15 https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545922080394-E3CAQS6KBJY8RWYUQUSI/FDA+pic.png Blog - Part 2: Readiness of Medical Technologies for the U.S. Markets: Designing for FDA Fig. 2 https://www.mednest.com/blog/2019/1/8/what-is-clinical-utility-and-why-should-we-care monthly 0.5 2019-01-08 https://www.mednest.com/blog/2019/1/7/us-reimbursement-exploration-essential-activities monthly 0.5 2019-01-07 https://www.mednest.com/blog/2018/12/27/tips-for-the-us-medtech-market-entry-1-to-5 monthly 0.5 2019-01-05 https://www.mednest.com/blog/2018/12/27/readiness-of-medical-technologies-for-the-us-markets-part-1-designing-for-the-markets monthly 0.5 2019-01-04 https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545921974540-NVJ1O7O9O8DFSI46IL6I/Figure++1.+In+relatively+short+years%2C+the+dominants+claims+and+attributes+of+the+medical+technologies+that+are+in+demand+have+moved+from+mainly+clinical+outcomes+to+a+balanced+set+of+cost%2C+access+and+care+delivery+outcomes+%28including+all+aspects+of+patient+care%29. Blog - Part 1: Readiness of Medical Technologies for the U.S. Markets: Designing for the Markets Figure 1. In relatively short years, the dominants claims and attributes of the medical technologies that are in demand have moved from mainly clinical outcomes to a balanced set of cost, access and care delivery outcomes (including all aspects of patient care). https://www.mednest.com/blog/2019/1/1/new-year-new-website monthly 0.5 2019-01-01 https://www.mednest.com/blog/tag/PAYMENT monthly 0.5 https://www.mednest.com/blog/tag/FDA monthly 0.5 https://www.mednest.com/blog/tag/CLINICAL+TRIALS monthly 0.5 https://www.mednest.com/blog/tag/CPT monthly 0.5 https://www.mednest.com/blog/tag/HIPAA monthly 0.5 https://www.mednest.com/blog/tag/CMS monthly 0.5 https://www.mednest.com/blog/tag/MARKET+ACCESS monthly 0.5 https://www.mednest.com/blog/tag/UTILITY monthly 0.5 https://www.mednest.com/blog/tag/IND monthly 0.5 https://www.mednest.com/blog/tag/TIPS monthly 0.5 https://www.mednest.com/home daily 1.0 2019-07-29 https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545853793762-8ACA5NWWD78XP8G41B4Z/inco-REGULATORY.JPG What We Do REGULATORY PATHWAYS The pathway to approval for a medical device depends on its risk classification, and more specifically the balance between effectiveness and benefits vs risks. Because there is not much variation in the classification of devices, developers have a variety of options. The emergence of software, mobile applications and sophisticated cloud-based algorithms creates and additional level of sophistication in medical devices. MedNest will explore and optimize your regulatory pathways around the pivotal concept of Intended Use - tied to clinical utility and payment-, and often de-feature the technology platforms of its client to allow a multigenerational predicate-based regulatory pathway. If needed, MedNest will coach you to prepare register your company, list your product and prepare your FDA pre-market submissions Other regulatory requirements, such HIPAA can also be addressed. More … https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545853849277-LXOYKJ669WPXTSW3JC2Y/inco-OPERATIONS.JPG What We Do MARKET ACCESS With more than 5,000 hospitals of+30 different categories, a continuum of care with more than 15 different segments, +120 medical specialties, +19 categories of nurses, +1000 insurances companies and obviously 48 continental states, the U.S. is a very complex market place. The strategic segmentation of the U.S. Market opportunity is a critical step in of a market access plan. A focused and well funded market access plan will secure a competitive presence and/or attractive partnership proposal. Leveraging its experience over the past 10 years, MedNest will guide you trough this process and establish your multi-generational market access plan and mid-term financial pro-forma. More… https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545853665790-W6PLVQWEDU81C97IJP4D/Icon-PAYMENT.JPG What We Do PRICING, PAYMENT Understanding the Coding, Coverage and Payment options for your Medical Device, as well as the holistic Healthcare Economic benefits ( Including ICER models) of your solution are pre-requisite activities to your product design or your U.S. Market launch. MedNest will establish your Payment pathways and Pricing models and embed them in your clinical, regulatory and market access plans. More… https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545853608300-2UHF283DYGNJOLL8859B/Icon-CLINICAL.JPG What We Do CLINICAL UTILITY The relevance and usefulness of your medical solution in patient care is a pivotal concept to describe your “value proposition”. It has direct ties into the Intended Use of your Regulatory/FDA pre-marketing application as well as your reimbursement / economic model. When aligned with curent clinical guidelines and coverage decisions, your clinical utility will gain adoption speed. Evidence gathering plans, including clinical trials, must substantiate your clinical utility. More… https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545669471219-19M3H1LXIEDXBKO0VOEP/first%2Bpage%2Bbanner.jpg What We Do https://www.mednest.com/new-page daily 0.75 2019-07-02 https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1601645472317-GIQD40NG47I76ZTK7JSK/CR-SQ.jpg Track Record - Cardiorenal (2020) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1596469543910-NT61C4B7MRFNYFWWCEMI/cropped-Avatar-Medical_Logo_Shape-1.png Track Record - Avatar Medical (2020) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1583330012280-105QYP1QQSBDYF2F3MY9/Ganymed.png Track Record - Ganymed Robotics (2020) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1580250811136-4Z4C6MAIMKXLBCP78U32/0.png Track Record - Mdoloris (2020) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1580522683484-Q7Y53XPMNZICCGM8UPVV/SQR.jpg Track Record - NewClin (2020) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1562076731426-7IJNDNXQUU5GMPUA4V2M/0.png Track Record - SIL-Lab (2019) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1558645892952-YCB4R3A710210DWLMWS0/CR-SQ.jpg Track Record - Cardio-Renal (2019) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1554309920221-6XJOW4ELL8IZA0G36J3S/SYNAPSIS+SQ+LARGE.jpg Track Record - Synapsys (2019) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1550323065720-DRNUPIXH8FIOR19WPXSC/medicen+2018.png Track Record - Medicen (2019) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1562076927221-IG08KORBIN8ILPXZHYLC/Logo-Big-Bang-Factory.png Track Record - Big Bang Factory (2019) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1549307229843-UJ6L92S4DV3JPARVAG3Z/carenity.JPG Track Record - Carenity (2019) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545671683210-11DQB6EKZ2P1KV4HZOV6/Adscentiam.JPG Track Record - Adscentiam (2018) Multiple Sclerosis is a chronic autoimmune disease, which attacks myelin - the substance that surrounds and insulates the nerve fibers — as well as the nerve fibers themselves. MS impacts patients' motricity, balance, vision and evolves by relapses. In 85% of cases, patients develop handicaps and a loss of motricity. https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545671757829-0NCP4DWAHPYXOTPHGLC9/VitaDx.png Track Record - VitaDx (2018) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545671719353-O0XJJN4Z2UNNO62UQ1W0/Bewell.JPG Track Record - MyTens by BewellConnect (2018) BewellConnect’s smart TENS unit, MyTens, provides electrical muscle stimulation (EMS) and pain relief. Choose from 19 pre-set programs, or target based on your specific training and recovery needs. Use the MyTens app to sync data and review results. https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545865569804-RK06LBLZHXEGQUI7COG7/p2linkSQ+.png Track Record - P2Link (2018) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545911464219-9JE1YRF6QEIUPPY2R27R/SQ+logo+igetbetter+logo.png Track Record - iGetBetter (2018) iGetBetter (2018) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545866083224-KV3DMZ0BU8OIJRJW3BN6/SQ+-+FrenchTechHub_Logo_x900.jpg Track Record - French Tech Hub (2017-18) French Tech Hub (2018) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545866030846-TYH0LTOXBMLU7C3NY4X8/SQ+implicity.jpg Track Record - Implicity (2018) Implicity (2018) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545865424197-C8JLCU0AKCKYMGET7SAY/SUBLIMED.JPG Track Record - Sublimed (2018) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545866328392-K16NZLGG83O0RPRRI8O3/SQ-2-MEDICEN.jpg Track Record - Medicen-Paris (2018) Medicen-Paris (2018) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545865778230-H01ZWWUW83XWR2LZWU3J/SQ+novagray.png Track Record - NovaGray (2017) NovaGray (2017) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545671661784-PNL44NMVYCRM4YZ98Q77/Bewell+2017.JPG Track Record - BewellConnect (2015-17) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545866542785-9CUPSVUOW11DSBUE1ZJA/SQ-+genepred.jpg Track Record - BILHI Genetics (2017) BILHI Genetics (2017) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545910249124-7QA0T7TGQEDE3DAT57R7/SQ+-+quantificare.jpg Track Record - Quantificare (2017) Quantificare (2017) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545869175075-B9BBQZ6GKHGR0UPRFQF3/SQ+-+Synapsis.jpg Track Record - Synapsis (2017) Synapsis (2017) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545866802833-8VFAKNDNDTG72F1BGKIX/SQ-+DAMAE+MED.jpg Track Record - Damae Medical (2017) Damae Medical (2017) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545911101177-EV9SIME62I0NS72QFCGQ/SQ+-+medic+activ.jpg Track Record - MedicActiv (2017) MedicActiv (2017) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545918120608-3T6E9ILTTAZWK6EDH7PQ/GIS+Squared.JPG Track Record - Histoindex (2014-15) Histoindex (2014-15) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545869528696-FQNPYTXY9EH0R2YARV4L/SQ+-+dreem.jpg Track Record - Dreem (2017) Dreem (2017) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545910401058-R5NP4UKOQ0KE2XTYG4TG/SQ+-+neuralys.jpg Track Record - Neuralys (2017) Neuralys (2017) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545911677623-5TWEOS5R2GASHABSPX8Z/logo+voluntis.png Track Record - Voluntis / Oncology (2015-16) Voluntis / Oncology (2016) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545867508995-FVTICAL30AX4556JQPSW/ADV+-+Color+SQ.png Track Record - Advantage Austria (2013-16) Advantage Austria (2016) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545867264514-SD92IMTU8HXOV50UUTLR/SQ+-+curiox.jpg Track Record - Curiox (2015) Curiox (2015) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545867419519-7GNCCVVRGWBSOA79R3G7/SQ+-+brigth+cloud.jpg Track Record - Bright Cloud (2015) Bright Cloud (2015) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545910653695-68E6FAO4XBLFMO97MZBO/SQ+-+needle+concept.jpg Track Record - Needle Concept (2015) Needle Concept (2016) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545867040381-LYBS18626AZ3WO77U0RZ/SQ+-+cardiax.jpg Track Record - Cardiax (2014) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545867700717-FUBOOJ284HJFMMGYBIJ9/SQ+-+biobot.jpg Track Record - Biobot Surgicals (2014) Biobot Surgicals (2014) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545868968138-LBTOR5CNYWJJX6EQKTII/SQ+-+activa.jpg Track Record - Activa Laboratories (2013-14) Activa Laboratories (2014) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545869308188-C27QOM5WCBSZ6J1F49LD/S14.JPG Track Record - Biospine Implants (2014) Biospine Implants (2014) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545910849481-0W99GOZ2OS5SNIIW1CO9/SQ+-+kodro.png Track Record - Kodro (2014) Kodro (2014) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545911834096-UFEF04RT78BUIT46A8P9/diabeo.jpg Track Record - Voluntis / Diabeo (2014) Voluntis / Diabeo (2014) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545920176584-LDS9Q8I7AUN12R9IYIR1/spring+SG.png Track Record - SPRING Singapore (2014-15) SPRING Singapore (2014-15) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545912231312-CYTRM3KXR1XCPDKT6BVB/SQ+-+lltech.jpg Track Record - LLTech Imaging (2012-14) LLTech Imaging (2012-14) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545918824805-LZLY5GU72S46E30HAJFW/SQ+maia.jpg Track Record - MAIA Wound Care (2013) MAIA Wound Care (2013) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545919987900-816UHY8LXIY4275Q50II/SQ+Spectral+MD.jpg Track Record - SpectralMD (2013) SpectralMD (2013) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545920423161-RIW2EOQENK2H6ZP1TZYZ/cytoo.jpg Track Record - Cytoo / 2D+ (2011-13) Cytoo / 2D+ (2011-13) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545918618098-SP5X8D4HB4PJGJRAGPT1/SQ+-+intrasens.jpg Track Record - Intrasens (2012-13) Intrasens (2012-13) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545920562132-YL98JZDZ0GXOTZN1BR6Y/diasys.png Track Record - Diasys Diags (2012) Diasys Diags (2012) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545915825577-W1MT0ZO20EL5364JVMRK/SQ+-+bascom.jpg Track Record - Bsscom Research (2012) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545919064791-6ON1YB2PB8XPABOBIP92/SQ+-+rosa.jpg Track Record - MedTech Surgical / Rosa (2011-12) MedTech Surgical / Rosa (2011-12) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545916439395-W9QEO8JDHNMSTBU3TRFI/SQ+-+creapharm.jpg Track Record - Creapharm (2012) Creapharm (2012) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545916918874-0955JZ98GREMCXJLRDLD/SQ+-+Dynasil.jpg Track Record - Dynasil (2011) Dynasil (2011) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545916159063-LHUJKXD2NGRN9R4YB6HB/SQ+-+beep+track.jpg Track Record - Beep N Track (2010) Beep & Track (2010) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545916686815-CNZZA2WY1Y62JN988BQL/SQ+-+CCI+Bordeaux.jpg Track Record - CCI Bordeaux (2009-14) CCI Bordeaux (2009-14) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545917171412-T5Y0BQG94ELQS78LHX0U/SQebc.jpg Track Record - EBC Medical (2010) EBC Medical (2010) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545919869472-HBE0LGTG3UWSC4QI53E5/SQ+-+periop.jpg Track Record - PerioProtect (2010) PerioProtect (2010) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545917842048-LNBG1ARJRSSUATM2T7WE/SQ+-+echosens.png Track Record - Echosens (2009) Echosens (2009) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545918039606-2UFOZOTB862ERSINZW9E/SQ-+fluopharma.jpg Track Record - Fluopharma (2009) Fluopharma (2009) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545919600617-3M8N1XXV4J9ZJMN2NZOA/SQ+-+microTinitus.jpg Track Record - Microtransponder (2009) Microtransponder (2009) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545918445332-HZ3EKY2J87RZ54LA1BAI/SQ2-immt.jpg Track Record - IntimaMedia.Com (2009) IntimaMedia.Com (2009) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545915477098-5QT105SEPGEAI41IJYLW/SQ+-+biomod3d.jpg Track Record - Biomod 3D (2008) Biomod 3D (2008) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545919276278-Y15XPBPSI0H5U1DMD2I0/SQ+-+SmartTouch-AV-Proventil-300x300.jpg Track Record - SmartInhaler (2008-11) SmartInhaler (2008-11) https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545671378011-S5DX8DJGA9OEMJWV545J/med%2Bdevice%2Btrack%2Brecord.jpg Track Record https://www.mednest.com/new-page-1 daily 0.75 2019-07-29 https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545856287237-K61CYNBZFYFXG5AJ8AGR/Pic%2B-%2BB%2526W%2BSQ%2B-%2BLi%2BChen.jpg About Us https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1564434037203-QAKK30SM38P23RKD91YO/Brudi+SQR.jpg About Us https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545863526234-QKT90QAQ2EW7Q8GE3AEA/pic+-+B%26W+SQ+-Ken+Accardi+Head+Shot-1.PNG About Us https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545863663165-EFXDKFCV5DZJRJ83SKAO/pic%2B-%2BB%2526W%2BSQ%2B-%2BChristphe%2BA.jpg About Us https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545863769104-K1RLW0AN0G30HD5QU9SR/pic+-B%26W+SQ-+claudebenchimol.jpg About Us https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545864061015-4Z0SW9NLFG81FD5BZSES/pic+-+B%26W+SQ+-mathieu.jpg About Us https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545863893435-VUD5Z6HB4AVGVNMUFGZ1/Pic+-+B%26W+SQ+-++myles-1.jpg About Us https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545856192664-37G4LIS90DM14JI4PQME/PIC+-+B%26W+SQ-+Francois_Wilhelm.jpg About Us https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1546027868749-ZMTZWQGEZ1S8O56TUZ0T/Paul+B%26W+and+SQ.jpg About Us https://images.squarespace-cdn.com/content/v1/5c20f835f79392c86e19b9cc/1545672706328-IN4YY4DR4WBJX3YGEFUJ/team.jpg About Us https://www.mednest.com/legal daily 0.75 2019-06-01