Plastic examples in medical device competence

Dur­ing Com­pamed Spang & Brands , Friedrichs­dorf, Ger­many, will exhib­it a vari­ety of dif­fer­ent plas­tics engi­neer­ing solu­tions for appli­ca­tions in med­ical tech­nol­o­gy, such as con­nec­tors, caps and clo­sures with pierc­ing mem­branes, implant com­po­nents, and parts for min­i­mal­ly inva­sive med­i­cine, plus com­po­nents for infu­sions and blood reserves, as well as tran­si­tion and con­nec­tion sys­tems (for instance with pre­cise­ly defined pre­de­ter­mined break­ing points or link­ing points). Vis­i­tors can see assem­bled sys­tems and in-house pro­duced com­plete sys­tems with high-pre­ci­sion geome­tries and fea­tures ready-to-use.

Spang & Brands reacts con­sis­tent­ly and quick­ly to the cur­rent demands of the mar­ket. Com­pe­tence under one roof: Three years ago, med­ical device com­pe­tence was bun­dled in the tech­nol­o­gy cen­tre. Flat hier­ar­chy: it improves the inter­dis­ci­pli­nary com­mu­ni­ca­tion, trans­paren­cy, coop­er­a­tion and effi­cien­cy of the indi­vid­ual divi­sions, i.e. devel­op­ment, sales, order pro­cess­ing, con­struc­tion, mate­ri­als man­age­ment, qual­i­ty assurance/certification, tool­mak­ing, injec­tion mould­ing, assembly/clean room, dis­patch and after-sales ser­vice. This was accom­pa­nied by the restruc­tur­ing on the basis of three focal points: Strength­en­ing the range of mar­ket ser­vices from prod­uct devel­op­ment to val­i­da­tion, dri­ving for­ward the devel­op­ment of pro­pri­etary prod­ucts and expand­ing core com­pe­ten­cies. The fam­i­ly busi­ness in the third gen­er­a­tion builds its suc­cess on the advan­tage of medi­um-sized busi­ness­es and an organ­i­cal­ly grown net­work, in which part­ners in raw mate­r­i­al pro­duc­ing com­pa­nies, in spe­cial mechan­i­cal engi­neer­ing firms, in IMM man­u­fac­tur­ers’ and IT com­pa­nies play a tar­get-ori­ent­ed role in the exchange of com­ple­men­tary knowledge.

In view of high ini­tial costs of med­ical devices cus­tomers expect speedy prod­uct devel­op­ment from an all-inclu­sive provider in order to reach val­i­da­tion, clin­i­cal tri­als, and intro­duc­tion to mar­ket. Val­i­da­tion is one of the over­rid­ing top­ics in the med­ical device val­ue chain of a com­pa­ny such as Spang & Brands that is cer­ti­fied accord­ing to DIN ISO 13485. Mould mak­ing for med­ical devices in plas­tic dif­fers fun­da­men­tal­ly here from tool­mak­ing in auto­mo­tive and white goods sec­tors, for exam­ple. An injec­tion mould has to com­ply with typ­i­cal reg­u­la­tions that are com­mon in med­ical tech­nol­o­gy. “Process opti­mi­sa­tion and trace­abil­i­ty are essen­tial. Look­ing at the patient, it is impor­tant to be able to prove the ori­gin of the indi­vid­ual com­po­nents and the var­i­ous sta­ble process stages on the way to fault-free med­ical devices”, explains Friedrich Ech­ter­diek, CEO of Spang & Brands GmbH. It is for this pur­pose that Spang & Brands appoint­ed a val­i­da­tion offi­cer in 2016 to work seam­less­ly with qual­i­ty assur­ance and report direct­ly to the com­pa­ny man­age­ment. “Start­ing with the ini­tial 3‑D pro­to­type or 3‑D print­ed tri­al mould inserts, analy­sis of the pro­to­type sta­tus leads to quick­er and more flex­i­ble opti­mi­sa­tion of the indi­vid­ual parts, com­po­nents and assem­blies – in respect of design to val­ue and design for man­u­fac­tur­ing and assem­bly”, adds Friedrich Echterdiek.

Across the entire val­ue-added chain of a med­ical devices spe­cial­ist, Spang & Brands demon­strates ground-break­ing R&D tech­nol­o­gy and, sup­port­ed by a state-of-the-art tool­ing facil­i­ty and machine park, i.e. the entire diver­si­ty of opti­mized plas­tics tech­no­log­i­cal prod­uct ranges. Con­se­quent­ly, spe­cial plas­tics com­pounds, such as TPU, TPE, TPV, resomere mate­ri­als, and poly­lac­tides are used. ‘Employ­ing mul­ti-com­po­nent injec­tion mould­ing tech­nol­o­gy our start­ing point is to embrace increased com­fort enhanced with inno­v­a­tive func­tions and ben­e­fits based on the very lat­est mould­ing tech­nolo­gies’, empha­sizes the CEO of Spang & Brands.

Spang & Brands has spe­cialised in pre­ci­sion and clean­room injec­tion mould­ing tech­nol­o­gy for the med­ical and phar­ma­ceu­ti­cal indus­try for over 35 years. In addi­tion to its own prod­ucts, the com­pa­ny sees itself above all as a com­pe­tent con­tract part­ner for cus­tomer projects. Prod­uct inno­va­tions at Spang & Brands go through all process stages — from the idea to the fin­ished prod­uct, ready-to-use. The com­pa­ny ensures con­sis­ten­cy of CAD tool data and max­i­mum pre­ci­sion in CAM pro­duc­tion of moulds for med­ical and phar­ma­ceu­ti­cal devices in its own tech­nol­o­gy cen­tre. Spang & Brands has at its dis­pos­al lat­est equip­ment, as well as a team with a high lev­el of com­pe­tence and expe­ri­ence, which mas­ters the tech­nol­o­gy: part devel­op­ment, mould design and con­struc­tion, injec­tion mould­ing with 70 main­ly all-elec­tric sin­gle and mul­ti-com­po­nent IMM, as well as the impor­tance of clean­room pro­duc­tion. Ful­ly auto­mat­ic and man­u­al assem­bly and pack­ag­ing of parts and assem­blies are locat­ed in clean­rooms — from pre-series or just-in-time batch sizes, extreme­ly small series, and right up to full pro­duc­tion run­ning into mil­lions of prod­ucts. Strate­gi­cal­ly posi­tioned con­trol points and 3D mea­sur­ing tech­nol­o­gy sup­port qual­i­ty assur­ance. The com­pa­ny is cer­ti­fied e.g. accord­ing to DIN ISO 13.485.

Spang & Brands at the Com­pamed 2019: stand 8a M33