Medical engineering requires long-term approach

First there was Brex­it, trade wars and struc­tur­al change in key indus­tries, now it’s the coro­na pan­dem­ic. Up to now the machine tool man­u­fac­tur­ers have only been mar­gin­al­ly affect­ed by the eco­nom­ic set­backs, but they are now fac­ing increas­ing threats. Med­ical engi­neer­ing read­i­ly springs to mind when it comes to mar­kets that still hold growth poten­tial. But is there any point in even con­sid­er­ing mov­ing in this direc­tion in the short term? Niklas Kuczaty, Man­ag­ing Direc­tor of the VDMA’s Med­ical Tech­nol­o­gy Work­ing Group, is some­what scep­ti­cal: “Med­ical engi­neer­ing is a very com­plex indus­try. Those look­ing to gain a foothold need to show com­mit­ment and deter­mi­na­tion – and above all stay­ing pow­er – before any invest­ment will pay off.”

Machine tool man­u­fac­tur­ers need to plan care­ful­ly before enter­ing this com­plex Industry

At present, med­ical engi­neer­ing rep­re­sents some­thing of a uni­corn in the Ger­man indus­tri­al land­scape. It requires high inno­v­a­tiv­i­ty and invest­ment lev­els, but enjoys ris­ing demand that is not depen­dent on eco­nom­ic cycles, and remains steady and reli­able even in times of coro­na. But where there is light, there is inevitably also shade. Scarce­ly any oth­er indus­try is so heav­i­ly reg­u­lat­ed. The bar has been raised once again in the form of the new Euro­pean Med­ical Device Reg­u­la­tion (MDR). Machine tools used for the pro­duc­tion of implants and sur­gi­cal instru­ments or for micro-milled pros­the­sis geome­tries, for exam­ple, must offer max­i­mum pre­ci­sion and reli­a­bil­i­ty. Qual­i­ty assur­ance plays a deci­sive role here. When it comes to health, there is no room for com­pro­mise. “Any­one look­ing to enter the med­ical engi­neer­ing sec­tor needs to know what they’re get­ting into,” empha­sis­es Chris­t­ian Rotsch, Head of the Med­ical Engi­neer­ing Depart­ment at the Fraun­hofer Insti­tute for Machine Tools and Form­ing Tech­nol­o­gy (IWU), Dresden/Chemnitz. He regards ISO 9001 cer­ti­fi­ca­tion as a basic require­ment. Fraun­hofer IWU itself is ISO 9001-cer­ti­fied and it also holds ISO 13485 qual­i­ty man­age­ment cer­ti­fi­ca­tion for med­ical devices.

First there was Brex­it, trade wars and struc­tur­al change in key indus­tries, now it’s the coro­na pan­dem­ic. Up to now the machine tool man­u­fac­tur­ers have only been mar­gin­al­ly affect­ed by the eco­nom­ic set­backs, but they are now fac­ing increas­ing threats. Med­ical engi­neer­ing read­i­ly springs to mind when it comes to mar­kets that still hold growth poten­tial. But is there any point in even con­sid­er­ing mov­ing in this direc­tion in the short term? Niklas Kuczaty, Man­ag­ing Direc­tor of the VDMA’s Med­ical Tech­nol­o­gy Work­ing Group, is some­what scep­ti­cal: “Med­ical engi­neer­ing is a very com­plex indus­try. Those look­ing to gain a foothold need to show com­mit­ment and deter­mi­na­tion – and above all stay­ing pow­er – before any invest­ment will pay off.” .

Focus on man­u­fac­tur­ing process­es and materials

The Fraun­hofer IWU Insti­tute is involved in numer­ous med­ical engi­neer­ing projects. Its main empha­sis is on man­u­fac­tur­ing process­es and mate­ri­als, but also on bio­me­chan­ics and on trans­lat­ing project results into clin­i­cal treat­ments. Inter­dis­ci­pli­nary coop­er­a­tion is cru­cial. One of its key areas is the devel­op­ment of tech­nol­o­gy for cut­ting, ablat­ing and form­ing process­es in pre­ci­sion and micro man­u­fac­tur­ing. In addi­tion, it is car­ry­ing out research into bone-like struc­tures which can be pro­duced from cel­lu­lar struc­tures, for exam­ple from met­al foam or with the aid of gen­er­a­tive man­u­fac­tur­ing process­es. There are attempts to enhance mate­r­i­al prop­er­ties through sol­id form­ing. Addi­tive man­u­fac­tur­ing meth­ods are increas­ing­ly being deployed to cre­ate cus­tomised, patient-spe­cif­ic implants. Nev­er­the­less, Rotsch sees no threat here to the wide range of con­ven­tion­al meth­ods: “Machin­ing and the cor­re­spond­ing machine tools will still be need­ed in the future,” he points out.

The projects on which the Chem­nitz sci­en­tists are work­ing involve both medi­um-sized and large-scale machine tool man­u­fac­tur­ers. Chris­t­ian Rotsch sees very good prospects for SMEs to enjoy suc­cess with spe­cial solu­tions and machines, for exam­ple in the field of micro­pro­cess­ing and fin­ish­ing. Com­plete process chains are also in demand, espe­cial­ly involv­ing robot­ic sup­port, which Rotsch sees as a “lucra­tive field with great poten­tial in terms of demand”.

Max­i­mum qual­i­ty through reli­able processes

One such exam­ple is Exe­ron, based in Obern­dorf am Neckar – a sys­tem sup­pli­er of die-sink­ing EDM and high-speed milling machines. It joined forces with Erowa (Büren, Switzer­land) and Cer­ta Sys­tems (Nurem­berg, Ger­many), to devel­op a com­bined-process automa­tion cell for Aes­cu­lap (Tut­tlin­gen, Ger­many), a sub­sidiary of the B. Braun Group and man­u­fac­tur­er of sur­gi­cal, orthopaedic and inter­ven­tion­al vas­cu­lar med­ical prod­ucts. Aesculap’s chal­lenge is that the required com­po­nent geome­tries are some­times so small, com­plex and angled that they can no longer be milled and have to be sink erod­ed instead. In addi­tion, man­u­al retool­ing process­es always pose the risk of inac­cu­ra­cies creep­ing in. The desired accu­ra­cy was achieved through Exeron’s man­u­fac­tur­ing com­bi­na­tion of milling, die-sink­ing EDM, clean­ing and mea­sur­ing; Erowa’s zero-point clamp­ing sys­tem which increas­es pre­ci­sion and speed; and Cer­ta Sys­tems’ process con­trol sys­tem which pro­vides automa­tion with­in the man­u­fac­tur­ing network.

Accord­ing to Udo Baur, Sales Man­ag­er for Ger­many and Europe at Exe­ron, it is cru­cial to adapt to the spe­cial needs of this sen­si­tive indus­try and also to be pre­pared to offer unusu­al solu­tions or oth­er spe­cial ser­vices. This includes pro­vid­ing sup­port for prod­uct releas­es. The automa­tion cell was ini­tial­ly com­mis­sioned at Exe­ron but not hand­ed over to Aes­cu­lap until after the prod­uct release. “We know our cus­tomers and their strin­gent demands,” says Baur, “and we have the know-how and the machines to meet these.”

Spe­cial require­ments require tai­lor-made solutions

Chris­t­ian Thiele, Press Spokesman at Hart­met­all-Werkzeug­fab­rik Paul Horn, also reports on the high­ly spe­cialised require­ments for mate­ri­als, machin­ing sys­tems and tool solu­tions. “Expe­ri­ence from oth­er indus­tries is only trans­fer­able to a cer­tain extent,” he says. Horn is active in spe­cif­ic fields, offer­ing spe­cialised and unique tool solu­tions in the whirling of bone screws, for exam­ple. The pre­ci­sion tool man­u­fac­tur­er was able to sig­nif­i­cant­ly increase tool life by inter­nal­ly cool­ing the whirling tool while simul­ta­ne­ous­ly pre­vent­ing the risk of chip accu­mu­la­tion. Whirling is used in med­ical engi­neer­ing to pro­duce high-pre­ci­sion and dimen­sion­al­ly sta­ble bone screws made of tita­ni­um and stain­less steel. Horn also offers spe­cial solu­tions for sur­gi­cal instru­ment machin­ing in the form of spe­cial­ly ground milling tools or spe­cial milling cut­ters with a high milling depth and very nar­row cut­ting width for sur­gi­cal for­ceps. The com­pa­ny is also con­duct­ing research into cut­ter coat­ing solu­tions for med­ical engi­neer­ing mate­ri­als and into cut­ting con­di­tions for med­ical prod­ucts. Chris­t­ian Thiele also empha­sis­es the great impor­tance of qual­i­ty man­age­ment, which is essen­tial for the man­u­fac­ture of sophis­ti­cat­ed med­ical products.

Costs for med­ical devices con­tin­u­ing to rise

IWU expert Chris­t­ian Rotsch fears that the cost of new med­ical engi­neer­ing prod­ucts will increase dra­mat­i­cal­ly in the future. The Med­ical Device Reg­u­la­tion require­ments are a source of increas­ing eco­nom­ic pres­sure for the man­u­fac­tur­ers of med­ical devices, which they are pass­ing on to machine man­u­fac­tur­ers and sup­pli­ers. Nev­er­the­less, Rotsch is con­vinced that it will remain worth­while for machine tool man­u­fac­tur­ers and sup­pli­ers to enter the med­ical engi­neer­ing mar­ket. He believes that, if the post-pro­cess­ing stage can be auto­mat­ed, addi­tive process­es will give rise to new ideas through the inte­gra­tion of new func­tions and the trend away from mass-pro­duced towards cus­tomised prod­ucts. How­ev­er, the most impor­tant suc­cess fac­tor for com­pa­nies always remains their response to the reg­u­la­to­ry aspects and qual­i­ty assurance.

Paul Horn has been involved in med­ical engi­neer­ing for many years, and the sector’s share of total sales is like­ly to increase in the future. Auto­mo­tive and med­ical engi­neer­ing have tra­di­tion­al­ly been the strongest pil­lars of the com­pa­ny, but med­ical engi­neer­ing is cur­rent­ly prov­ing to be a sta­ble mar­ket for the met­al­work­ing com­pa­ny. The coro­na cri­sis has gen­er­at­ed a num­ber of short-term and urgent enquiries, such as the recent exam­ple of a cus­tomer who approached Paul Horn with machin­ing prob­lems in the pro­duc­tion of com­po­nents for a heart-lung machine. Paul Horn is main­tain­ing oper­a­tions in all areas, which will allow it to react quick­ly and effec­tive­ly. How­ev­er, it’s impor­tant to realise, says Thiele, that there is no decline in the demand for tools used in the man­u­fac­ture of implants and hip joints, for exam­ple; they are sim­ply out of the lime­light at the moment.

VDMA expert Niklas Kuczaty is also con­vinced of the strong growth prospects for med­ical engi­neer­ing, even if they are not expect­ed to reach the vol­ume of the auto­mo­tive indus­try. Fur­ther­more, the sec­tor is much less depen­dent on eco­nom­ic cycles. In any case, com­pa­nies that decide to enter the mar­ket have to realise that they will be invest­ing for at least two to three years before see­ing any suc­cess. Yet, as Kuczaty points out, tak­ing such a long-term approach will even­tu­al­ly pay off. Maybe not imme­di­ate­ly, but per­haps in time for the next crisis.

(Size: around 8,750 char­ac­ters incl. blanks)

Author: Cor­nelia Gewiehs, free­lance jour­nal­ist, Roten­burg (Wümme)