Soft­ware development

Wheth­er embed­ded or stan­dalone soft­ware: the pur­pose determ­ines wheth­er soft­ware is to be clas­si­fied as an (inde­pend­ent) med­ic­al device.
We sup­port you from there onwards and accom­pany you through all the steps of devel­op­ment. You will be involved in our devel­op­ment pro­cess, which is prefer­ably agile. For us, agil means first of all: require­ments are always wel­come, at any time. And secondly, we deliv­er res­ults that you can check at any time — even dur­ing development.

In addi­tion, we devel­op test driv­en. Writ­ing many auto­mated tests serves the sta­bil­ity and good archi­tec­tur­al design that are essen­tial for a med­ic­al device.

The stand­ards rel­ev­ant for soft­ware devel­op­ment, such as IEC 62304, must be observed in every devel­op­ment pro­cess. For this reas­on, soft­ware devel­op­ment ends with doc­u­ment­a­tion that is com­pli­ant to stand­ards, which we pro­duce dur­ing development.

Devel­op­ment of electronics

Your com­pany wants to devel­op, approve or pro­duce a med­ic­al product? Thanks to our many years of exper­i­ence, we can sup­port you in ever phase of the devel­op­ment pro­cess. We find the right step in the pro­cess to accom­pany you from the idea to approv­al, if desired. Our com­pact mul­tidi­cip­lin­ary team sup­ports you find­ing a fast, cost-effi­ci­ant and high qual­ity solution.

Pro­to­typ­ing

Our large-volume gen­er­at­ive man­u­fac­tur­ing sys­tem from Ger­man Reprap and our 3‑axis CNC milling machine from Isel with mod­ern high-fre­quency spindle ensure the fast pro­duc­tion of high-qual­ity func­tion­al samples. Our net­work of part­ners in the region includes com­puter-aided met­al part machin­ing (CNC), prin­ted cir­cuit board man­u­fac­tur­ers and gen­er­at­ive man­u­fac­tur­ing tech­no­lo­gies com­pan­ies to pro­duce first-class pro­to­types for your product. The assembly of mech­an­ic­al assem­blies and elec­tron­ic cir­cuits can be car­ried out on site. We are look­ing for­ward to turn­ing your concept into reality.

Pro­ject coordin­a­tion and management

In addi­tion to the devel­op­ment of mech­an­ic­al and elec­tric­al com­pon­ents, soft­ware tech­no­logy in par­tic­u­lar has become increas­ingly import­ant in recent years. Due to the digit­iz­a­tion and net­work­ing of the dif­fer­ent sys­tems, a large num­ber of oth­er dis­cip­lines have been brought on the agenda, each of which can only be ful­filled by highly spe­cial­ized IT providers.

Due to the high degree of spe­cial­iz­a­tion of the devel­op­ment ser­vice pro­viders in their indi­vidu­al core com­pet­ences, how­ever, it is increas­ingly neces­sary that the devel­op­ment of com­plex med­ic­al tech­no­logy sys­tems can only be car­ried out in cooperation.

In addi­tion to tra­di­tion­al engin­eer­ing offices, this includes spe­cial­ized soft­ware pro­viders sup­por­ted by uni­ver­sity insti­tutes and clin­ic­al part­ners. Exper­i­enced pro­ject coordin­a­tion is cru­cial for these het­ero­gen­eous con­sor­tia to work togeth­er effect­ively. SurgiTAIX has 15 years of exper­i­ence in coordin­at­ing research pro­jects as well as indus­tri­al pro­jects and speaks the “lan­guages” of the vari­ous cooper­a­tion partners.

Integ­ra­tion services

SurgiTAIX AG has been involved in the open, cross-man­u­fac­turer net­work­ing of med­ic­al devices for almost 15 years. In the research pro­jects OrthoMIT and OR.NET, vari­ous stand­ards for the net­work­ing of med­ic­al devices were defined and trans­ferred to stand­ard­iz­a­tion. The res­ult was the IEEE 11073 SDC fam­ily of stand­ards, namely BICEPS, MDPWS and Archi­tec­ture Bind­ing. In the research pro­jects ZiMT, MoVE, MOMENTUM and PriMed, applic­a­tion scen­ari­os as well as approv­ab­il­ity and test pro­ced­ures were researched. The res­ults of these research pro­jects flow into the defin­i­tion of the so-called Par­ti­cipant Key Pur­poses, which are cur­rently in the bal­lot­ting phase of stand­ard­iz­a­tion. The PKPs define the require­ments for devices depend­ing on their func­tion, for example, for devices that can be con­trolled extern­ally or that issue or pro­cess alarms. Sim­il­arly, the so-called Device Spe­cial­iz­a­tions are cur­rently being derived, in which the require­ments for spe­cif­ic classes of devices such as RF devices, syr­inge pumps or oper­at­ing tables are col­lec­ted. The stand­ard­iz­a­tion was and is act­ively accom­pan­ied by SurgiTAIX AG.

sdcX — The com­mer­cial SDC library

In addi­tion, SurgiTAIX AG has been act­ive in the field of SDC lib­rar­ies and soft­ware stacks for years. Such a stack enables a med­ic­al device man­u­fac­turer without in-depth know­ledge of the stand­ards to net­work his device via SDC. The stack takes on the role of a com­mu­nic­a­tion lib­rary and ful­fills large parts of the require­ments of the IEEE 11073 SDC fam­ily of stand­ards. Pre­vi­ous, pub­licly avail­able SDC stacks such as the SDCLib / C developed by SurgiTAIX ( https://github.com/surgitaix/sdclib ) and SDCLib / J ( https://bitbucket.org/surgitaix/sdclib ) were primar­ily designed for use in demon­strat­ors and for tech­no­logy eval­u­ation. Use in com­mer­cial products was dif­fi­cult due to the lack of doc­u­ment­a­tion and risk assess­ment. The C ++ lib­rary sdcX, newly developed by SurgiTAIX, is the first stack that con­siders and ful­fills the require­ments for com­mer­cial oper­a­tion. sdcX imple­ments large parts of the three 11073 SDC core stand­ards as well as parts of the PKP sub­stand­ards that are cur­rently under development.

The use of cur­rent tech­no­lo­gies and pro­gram­ming meth­ods enables high per­form­ance with mod­er­ate memory and resource con­sump­tion at the same time. The lib­rary can be used regard­less of the mode of oper­a­tion of the device or value-added ser­vice, as it sup­ports dif­fer­ent pro­cess mod­els (call­backs, asyn­chron­ous pro­gram­ming, thread pool­ing).A focus dur­ing devel­op­ment was placed on the extens­ib­il­ity of the lib­rary — the X in the name stands for eXtens­ible. Through an extens­ible log­ger, logs gen­er­ated by the lib­rary can be integ­rated dir­ectly into the user’s own device-spe­cif­ic log­gers. Like­wise own eval­u­ations can take place by a mul­ti­pli­city of sub­scrib­able noti­fic­a­tions, for example with the entrance of a new mes­sage of a cer­tain type. This allows the lib­rary to be used in vari­ous use cases and fields.

The lib­rary sup­ports com­mon ARM and x86 sys­tems with Win­dows or Linux as oper­at­ing sys­tem. Cross com­pilers for Buil­d­root or Yocto Linux can be integ­rated par­tic­u­larly quickly due to the CMake-based build pro­cess used. A com­pre­hens­ive test suite is avail­able on request for test­ing the lib­rary on the tar­get plat­form. In this suite all parts of the stand­ards and the lib­rary are tested and evaluated.

In addi­tion to extens­ive doc­u­ment­a­tion, a com­pre­hens­ive risk ana­lys­is and IEC 62304-com­pli­ant devel­op­ment doc­u­ment­a­tion are also provided.
Already dur­ing devel­op­ment, IT secur­ity require­ments were determ­ined and con­sidered by a secur­ity pro­cess. This doc­u­ment­a­tion of the pro­cess as well as the con­sidered risks can be integ­rated into a doc­u­ment­a­tion for the cur­rently val­id “FDA Pre­market Sub­mis­sion for Man­age­ment of Cyber­se­cur­ity in Med­ic­al Devices”. The status of SOUP com­pon­ents will be con­tinu­ously reviewed.

The require­ments for med­ic­al devices are becom­ing more strin­gent, as are the demands of med­ic­al devices on the infra­struc­ture. Espe­cially miss­ing con­sid­er­a­tion of real-time require­ments as well as inter­fer­ing cables com­plic­ate or pre­vent innov­at­ive use cases. To this end, the 5G-FORUM research pro­ject will expand the lib­rary to include sup­port for real-time cap­able 5G net­work­ing with TSN. In the medi­um term, this will enable the lib­rary to be used in crit­ic­al areas such as the con­trol of con­trol elec­tron­ics, ima­ging or in robotics.

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