In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clin­i­cal is the Aus­tralian CRO for in­ter­na­tion­al biotechs pro­vid­ing world-class clin­i­cal re­search ser­vices with FDA-ac­cept­ed da­ta across all phas­es. With Avance Clin­i­cal, biotech com­pa­nies can lever­age Aus­tralia’s sup­port­ive clin­i­cal tri­als en­vi­ron­ment which in­cludes no IND re­quire­ment plus a 43.5% Gov­ern­ment in­cen­tive re­bate on clin­i­cal spend. The CRO has been de­liv­er­ing clin­i­cal drug de­vel­op­ment ser­vices for in­ter­na­tion­al biotechs for FDA and EMA reg­u­la­to­ry ap­proval for the past 24 years. The com­pa­ny has been rec­og­nized for the past two con­sec­u­tive years with the pres­ti­gious Frost & Sul­li­van CRO Best Prac­tices Award and a fi­nal­ist in In­for­ma Phar­ma’s Best CRO award for 2022.

MedTech Op­por­tu­ni­ties for Re­mote Health Man­age­ment and Mon­i­tor­ing

As tech­nol­o­gy be­comes in­creas­ing­ly ubiq­ui­tous in our lives, the de­mand for re­mote or home-based MedTech for re­al-time con­di­tion de­tec­tion, mon­i­tor­ing or man­age­ment presents vast mar­ket op­por­tu­ni­ties. This par­a­digm shift is pre­cip­i­tat­ing the in­creased de­vel­op­ment of easy-to-use med­ical de­vices (in­clud­ing soft­ware as a med­ical de­vice), for the di­ag­no­sis, treat­ment and man­age­ment of lifestyle and chron­ic dis­eases.

In­no­v­a­tive MedTech cov­ers every­thing from phys­i­cal de­vices, ar­ti­fi­cial in­tel­li­gence (AI) and ma­chine learn­ing and dig­i­tal health­care, in­clud­ing biosen­sors in wear­ables like a watch, to a skin patch, or in­gest­ed or im­plant­ed de­vices. It in­cludes mon­i­tors that re­lease med­ica­tions, to more ad­vanced prod­ucts like im­plant­ed neu­rostim­u­la­tors, through mo­bile phone apps that can di­ag­nose a COVID cough or an­a­lyze speech to pre­dict neu­rode­gen­er­a­tive dis­eases.

It can al­so in­clude our every­day med­ical de­vices such as den­tures, sur­gi­cal equip­ment, 3D print­ing, ro­bot­ic surgery, laser surgery, ar­ti­fi­cial or­gans, pace­mak­ers, in­halers, and stents.

“The glob­al med­ical de­vices mar­ket size has been val­ued at USD 488.98 bil­lion in 2021 and is pro­ject­ed to grow to USD 718.92 bil­lion by 2029.” For­tune Busi­ness In­sights

Is This a MedTech Boom?

Avance Clin­i­cal is ex­pe­ri­enc­ing a sig­nif­i­cant in­crease in the num­ber of MedTech/med­ical de­vice com­pa­nies seek­ing to con­duct their tri­als in Aus­tralia. This is part­ly due to the eco­nom­ic pres­sures across the biotech sec­tor which is en­cour­ag­ing biotechs to look at more fi­nan­cial­ly at­trac­tive lo­ca­tions that still of­fer clin­i­cal and da­ta ex­cel­lence. In ad­di­tion, an ag­ing pop­u­la­tion and the COVID-19 re­mote liv­ing push has en­cour­aged dig­i­tal health in­no­va­tion, man­age­ment and care de­mand and ac­cep­tance that sup­ports MedTech ap­pli­ca­tions.

Avance Clin­i­cal is cur­rent­ly con­sid­er­ing sev­er­al pro­grams rang­ing from an in­jectable pro­tein-based bio­ma­trix to im­prove sur­gi­cal pro­ce­dures, to a wear­able bion­ic vi­sion de­vice with every­thing in be­tween from di­ag­nos­tic ma­chine learn­ing al­go­rithms to self-test in vit­ro de­vices for com­mu­ni­ca­ble dis­ease in­fec­tion de­tec­tion.

“Based on the lev­el of ac­tiv­i­ty we are see­ing it cer­tain­ly sug­gests we are in a MedTech growth pe­ri­od and that Aus­tralia is an at­trac­tive des­ti­na­tion for these biotechs. Im­por­tant­ly our MedTech reg­u­la­to­ry stan­dards are rec­og­nized in their en­tire­ty by the FDA and EMA and oth­er ma­jor ju­ris­dic­tions, pro­vid­ing con­fi­dence in the ac­cept­abil­i­ty of clin­i­cal tri­al da­ta ob­tained from med­ical de­vice tri­als con­duct­ed in Aus­tralia.” Avance Clin­i­cal CEO Yvonne Lunger­shausen

What Is MedTech?

1. Med­ical De­vices
2. In-Vit­ro Di­ag­nos­tics
3. Dig­i­tal Health

“An ar­ti­cle, in­stru­ment, ap­pa­ra­tus or ma­chine that is used in the pre­ven­tion, di­ag­no­sis or treat­ment of ill­ness or dis­ease, or for de­tect­ing, mea­sur­ing, restor­ing, cor­rect­ing or mod­i­fy­ing the struc­ture or func­tion of the body for some health pur­pose”. The World Health Or­ga­ni­za­tion

MedTech Reg­u­la­to­ry Process in Aus­tralia

The pro­ject­ed in­crease in the mar­ket size for med­ical de­vices is dri­ving con­sid­er­able re­search and de­vel­op­ment in­ter­est which is un­der­pinned by elec­tron­ic tech­nol­o­gy in­no­va­tion and in­creas­ing med­ical need.

Med­ical de­vice clin­i­cal tri­als are eval­u­a­tions or in­ves­ti­ga­tions un­der­tak­en to as­sess the per­for­mance and/or the safe­ty pa­ra­me­ters of a med­ical de­vice in re­la­tion to its pro­posed use for the treat­ment, pre­ven­tion or di­ag­no­sis of dis­eases. In Aus­tralia, the clin­i­cal tri­al de­vel­op­ment path­way, en­abling reg­u­la­to­ry ap­proval for med­ical de­vice prod­ucts, dif­fers com­pared to that of drug prod­ucts.

Med­ical de­vice clin­i­cal de­vel­op­ment to gain reg­u­la­to­ry ap­proval usu­al­ly com­pris­es two main stages:

1. Ex­plorato­ry/fea­si­bil­i­ty tri­als – con­duct­ed in the ear­ly stages of clin­i­cal de­vel­op­ment, aimed at demon­strat­ing pre­lim­i­nary safe­ty and ef­fec­tive­ness;
2. Piv­otal tri­als – their main ob­jec­tive is to demon­strate the safe­ty and ef­fec­tive­ness of the de­vice in re­la­tion to its spe­cif­ic use with­in the tar­get pa­tient pop­u­la­tion. The re­sults ob­tained from a piv­otal study are used to gain reg­u­la­to­ry ap­proval to mar­ket the de­vice.

“As soon as we get a re­quest from a MedTech or biotech com­pa­ny we bring in our sci­en­tif­ic and reg­u­la­to­ry team for a brief­ing ses­sion with the com­pa­ny on reg­u­la­to­ry process­es and how Aus­tralia is aligned with the US FDA. Fur­ther, we work to­geth­er to de­vel­op an ex­e­cu­tion strat­e­gy to en­sure the com­pa­ny’s clin­i­cal de­vel­op­ment mile­stones are met.” Avance Clin­i­cal’s Head of Busi­ness De­vel­op­ment, Li­ah­na Toy

                                                                                                                              Reg­u­la­to­ry En­vi­ron­ment and Glob­al Ac­cep­tance

Al­though the con­duct and gov­er­nance of med­ical de­vice clin­i­cal tri­als are not glob­al­ly har­mo­nized in the same way as clin­i­cal tri­als of small mol­e­cule and biotech­nol­o­gy-de­rived med­i­c­i­nal prod­ucts, there is a broad recog­ni­tion of In­ter­na­tion­al Or­ga­ni­za­tion for Stan­dard­iza­tion (ISO) stan­dards in most ju­ris­dic­tions.

“To­day, dig­i­tal health im­pacts more than a bil­lion lives, and es­ti­mates show that dig­i­tal health in Asia could col­lec­tive­ly cre­ate up to $100 bil­lion in val­ue by 2025.” McK­in­sey & Com­pa­ny

The gov­ern­ing body in Aus­tralia, the Ther­a­peu­tic Goods Ad­min­is­tra­tion (TGA) ad­min­is­trates the Aus­tralian reg­u­la­to­ry guide­lines for med­ical de­vices (ARGMD) which pro­vides in­for­ma­tion on im­port, ex­port, and sup­ply of med­ical de­vices in Aus­tralia and ex­plains the leg­isla­tive re­quire­ments that gov­ern med­ical de­vices.

Med­ical de­vice clin­i­cal in­ves­ti­ga­tions in Aus­tralia are re­quired to com­ply with the In­ter­na­tion­al Coun­cil for Har­mon­i­sa­tion (ICH) Guide­line for Good Clin­i­cal Prac­tice and ISO 14155:2020 Clin­i­cal In­ves­ti­ga­tion of Med­ical De­vices for Hu­man Sub­jects – Good clin­i­cal prac­tice.

The TGA al­so re­lies on oth­er sup­port­ing ISO stan­dards for the risk man­age­ment (ISO 14971:2019) and qual­i­ty man­age­ment (ISO 13485:2016) of med­ical de­vices.

These stan­dards are rec­og­nized in their en­tire­ty by the FDA and EMA and in oth­er ma­jor ju­ris­dic­tions, pro­vid­ing con­fi­dence in the util­i­ty of clin­i­cal tri­al da­ta ob­tained from med­ical de­vice tri­als con­duct­ed in Aus­tralia.