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ince 2005, Orfeo Nie­der­mann, Busi­ness Devel­op­ment Director at Ypsomed AG, has been working with part­ners from the phar­ma­ceu­tical and biotech­nology industry on the devel­op­ment of inno­v­a­tive injec­tion sys­tems for self-med­ica­tion. In an inter­view with HARRO, he talks about the trends in this field.

Mr. Nie­der­mann, how did the devel­op­ment of self-injec­tion sys­tems come about?

20 to 30 years ago, ther­a­pies that pro­vided for self-med­ica­tion by syringe were very com­plex and com­pli­cated for patients. More­over, mis­takes can happen when filling a syringe from a vial and deter­mining the cor­rect dose. Depending on the patient’s med­ical con­di­tion, the use of a syringe may no longer be pos­sible due to motor impair­ment, as occurs, for example, in rheuma­toid arthritis. Modern injec­tion sys­tems such as auto- and pen-injec­tors are much sim­pler, more com­fort­able and more reli­able to use.

Could you please describe the usage and oper­a­tion of an auto-injector.

Auto-injec­tors are injec­tion devices with a built-in inner syringe. By trig­gering a pre-loaded spring, the con­tents of the syringe are admin­is­tered within a few sec­onds. Our Ypso­Mate® auto-injector can be oper­ated in two simple steps. The patient removes the pro­tec­tive cap and presses the injector onto the skin. A click sig­nals the begin­ning of the almost pain­less injec­tion process via a short, thin needle into the sub­cu­ta­neous fat layer. The second click indi­cates the end of the injec­tion. Before, during and after med­icating, the auto-injector’s needle is shielded in order to pro­tect the user and third par­ties from unin­ten­tional injuries.

Which med­ica­tion can be administered?

Typ­i­cally, auto-injec­tors are used to admin­ister modern, biotech­no­log­i­cally pro­duced drugs – for example against inflam­ma­tory dis­eases such as rheuma­toid arthritis, mul­tiple scle­rosis or asthma. The most common self-injecting drug is insulin for dia­betes. Here, mostly pen-injec­tors with an adjustable dose are used. The active ingre­dient is stored in a car­tridge instead of a syringe, and can be used sev­eral times until the car­tridge is emp­tied completely.

“To equate needle-free with pain-free is a fal­lacy.“Orfeo Nie­der­mann, Busi­ness Devel­op­ment Director, Ypsomed AG

Can the regions of the world where pen- or auto-injec­tors are used be derived from this information?

In Asia, the number of dia­betic dis­eases is increasing as a result of changing lifestyles. Thus, the need for pen-injec­tors is increasing. In Europe and the US, the number of sig­nif­i­cantly more expen­sive and less fre­quently admin­is­tered biotech drugs is growing, and with that the demand for easy-to-use auto-injectors.

Could the needle be replaced sooner or later?

Needle-free appli­ca­tion sys­tems were already devel­oped 20 years ago. When patients are asked if they prefer drug admin­is­tra­tion with or without a needle, they will decide against the needle. At least until they have tried the needle­less injec­tion for the first time. “Needle-free” means that the liquid jet of the drug, that is admin­is­tered with high-pres­sure, pen­e­trates the skin and hits more nerve end­ings than a thin sharp needle. To equate needle-free with pain-free is there­fore a fal­lacy. For this reason, I do not see needle-based injec­tion sys­tems in jeop­ardy – on the con­trary, the demand is growing steadily. Fur­ther devel­op­ment trends appear to be directed towards smart injec­tion devices.

What does smart injec­tion device mean in con­crete terms?

Smart injec­tors are dig­i­tally net­worked. For example, they are capable of detecting whether they are cor­rectly used by the patient. They can record treat­ment-rel­e­vant data, such as admin­is­tered dose and injec­tion time, and make the infor­ma­tion acces­sible to a physi­cian through a con­nected smart­phone. The Ypsomed Smart­Pilot is an example of a smart injec­tion device. This reusable add-on for the Ypso­Mate® trans­forms the auto-injector into a device con­nected to the Internet, which offers numerous pos­si­bil­i­ties for fur­ther opti­miza­tion of the therapy.

Can you describe the devel­op­ment and pro­duc­tion of an injector? Which fac­tors play a role?

Prior to devel­op­ment, we clarify var­ious ques­tions regarding patient needs and cus­tomer require­ments, fol­lowed by the design and eval­u­a­tion of numerous tech­nical con­cepts. The most promising will ulti­mately become an actual product. A highly auto­mated pro­duc­tion process is taken into account from the outset, in order to ensure the desired func­tions and low product costs. Staff expe­ri­ence, opti­mized processes, and a modern infra­struc­ture are other key fac­tors. An auto-injector is made of plastic injec­tion-molded parts and springs, which are assem­bled at Ypsomed into two com­po­nents in a fully auto­matic process. The two com­po­nents are then deliv­ered to the phar­ma­ceu­tical com­pany or a con­tract man­u­fac­turer. The active ingre­dient con­taining syringe is inserted into the front injector unit and is con­nected to the rear injector unit con­taining the spring package.

What do your cus­tomers expect from the product they obtain from you?

The injec­tors must be pro­duced with con­sis­tently high quality and must operate absolutely reli­ably. It is also impor­tant for our cus­tomers to dis­tin­guish them­selves from their com­peti­tors. Our prod­ucts allow the phar­ma­ceu­tical com­pa­nies to indi­vid­u­ally design the external shape or color of an injector. The Ypsomed plat­form tech­nology remains the same, which ensures a short project dura­tion and low costs.

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Fotos: Ypsomed AG,Helmar Lünig