{"id":7238,"date":"2020-08-21T14:50:12","date_gmt":"2020-08-21T12:50:12","guid":{"rendered":"https:\/\/www.m3i-muenchen.de\/usability-schluessel-zum-erfolg\/"},"modified":"2021-02-02T09:40:09","modified_gmt":"2021-02-02T08:40:09","slug":"usability-schluessel-zum-erfolg","status":"publish","type":"post","link":"https:\/\/www.m3i-muenchen.de\/de\/usability-schluessel-zum-erfolg\/","title":{"rendered":"Usability in der Medizintechnik Entwicklung &#8211; Der Schl\u00fcssel zum Erfolg"},"content":{"rendered":"[vc_row type=&#8220;in_container&#8220; full_screen_row_position=&#8220;middle&#8220; column_margin=&#8220;default&#8220; column_direction=&#8220;default&#8220; column_direction_tablet=&#8220;default&#8220; column_direction_phone=&#8220;default&#8220; scene_position=&#8220;center&#8220; top_padding=&#8220;30&#8243; text_color=&#8220;dark&#8220; text_align=&#8220;left&#8220; row_border_radius=&#8220;none&#8220; row_border_radius_applies=&#8220;bg&#8220; overlay_strength=&#8220;0.3&#8243; gradient_direction=&#8220;left_to_right&#8220; shape_divider_position=&#8220;bottom&#8220; bg_image_animation=&#8220;none&#8220;][vc_column column_padding=&#8220;no-extra-padding&#8220; column_padding_tablet=&#8220;inherit&#8220; column_padding_phone=&#8220;inherit&#8220; column_padding_position=&#8220;all&#8220; background_color_opacity=&#8220;1&#8243; background_hover_color_opacity=&#8220;1&#8243; column_shadow=&#8220;none&#8220; column_border_radius=&#8220;none&#8220; column_link_target=&#8220;_self&#8220; gradient_direction=&#8220;left_to_right&#8220; overlay_strength=&#8220;0.3&#8243; width=&#8220;1\/6&#8243; tablet_width_inherit=&#8220;default&#8220; tablet_text_alignment=&#8220;default&#8220; phone_text_alignment=&#8220;default&#8220; column_border_width=&#8220;none&#8220; column_border_style=&#8220;solid&#8220; bg_image_animation=&#8220;none&#8220;][\/vc_column][vc_column column_padding=&#8220;no-extra-padding&#8220; column_padding_tablet=&#8220;inherit&#8220; column_padding_phone=&#8220;inherit&#8220; column_padding_position=&#8220;all&#8220; background_color_opacity=&#8220;1&#8243; background_hover_color_opacity=&#8220;1&#8243; column_shadow=&#8220;none&#8220; column_border_radius=&#8220;none&#8220; column_link_target=&#8220;_self&#8220; gradient_direction=&#8220;left_to_right&#8220; overlay_strength=&#8220;0.3&#8243; width=&#8220;2\/3&#8243; tablet_width_inherit=&#8220;default&#8220; tablet_text_alignment=&#8220;default&#8220; phone_text_alignment=&#8220;default&#8220; column_border_width=&#8220;none&#8220; column_border_style=&#8220;solid&#8220; bg_image_animation=&#8220;none&#8220;][vc_column_text]<span style=\"font-weight: 400;\"><span class=\"nectar-dropcap\" >D<\/span>ie Bedeutung der Usability in der Medizintechnik ist durch die neue Medizintechnik-Verordnung (MDR) stark gestiegen. Wir bei M3i sind davon \u00fcberzeugt, dass eine anwendernahe Produktentwicklung ein Kernfaktor f\u00fcr erfolgreiche Medizinprodukte in immer komplexer werdenden klinischen Prozessen und Abl\u00e4ufen ist. Deshalb sehen wir die Regularien als Gelegenheit Innovationsprozesse durch die strukturierte Einbindung von Nutzern marktgerecht zu gestalten. <\/span><\/p>\n<p><span style=\"font-weight: 400;\">In diesem Artikel erfahren Sie in K\u00fcrze:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\"><a href=\"#wasistusability\">was Usability ist<\/a> und <a href=\"#warumusabilitysowichtigist\">warum sie gerade in der Medizintechnik so wichtig ist<\/a><\/span><\/li>\n<li style=\"font-weight: 400;\"><a href=\"#wasgegenstandist\"><span style=\"font-weight: 400;\">was Gegenstand von Usability laut der Regularien ist<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><a href=\"#schl\u00fcsselzumerfolg\"><span style=\"font-weight: 400;\">warum Usability der Schl\u00fcssel f\u00fcr ein erfolgreiches Medizinprodukt ist<\/span><\/a><\/li>\n<\/ul>\n[\/vc_column_text][\/vc_column][vc_column column_padding=&#8220;no-extra-padding&#8220; column_padding_tablet=&#8220;inherit&#8220; 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scene_position=&#8220;center&#8220; top_padding=&#8220;2%&#8220; bottom_padding=&#8220;2%&#8220; left_padding_desktop=&#8220;5%&#8220; right_padding_desktop=&#8220;5%&#8220; text_color=&#8220;light&#8220; text_align=&#8220;left&#8220; row_border_radius=&#8220;none&#8220; row_border_radius_applies=&#8220;bg&#8220; overlay_strength=&#8220;0.3&#8243; gradient_direction=&#8220;left_to_right&#8220; shape_divider_position=&#8220;bottom&#8220; bg_image_animation=&#8220;none&#8220; shape_type=&#8220;&#8220;][vc_column column_padding=&#8220;no-extra-padding&#8220; column_padding_tablet=&#8220;inherit&#8220; column_padding_phone=&#8220;inherit&#8220; column_padding_position=&#8220;all&#8220; background_color_opacity=&#8220;1&#8243; background_hover_color_opacity=&#8220;1&#8243; column_shadow=&#8220;none&#8220; column_border_radius=&#8220;none&#8220; column_link_target=&#8220;_self&#8220; gradient_direction=&#8220;left_to_right&#8220; overlay_strength=&#8220;0.3&#8243; width=&#8220;1\/2&#8243; tablet_width_inherit=&#8220;default&#8220; tablet_text_alignment=&#8220;center&#8220; phone_text_alignment=&#8220;center&#8220; column_border_width=&#8220;none&#8220; column_border_style=&#8220;solid&#8220; bg_image_animation=&#8220;none&#8220;][vc_custom_heading text=&#8220;Von der MDR profitieren?&#8220; font_container=&#8220;tag:h2|font_size:52|text_align:left|line_height:56px&#8220; google_fonts=&#8220;font_family:Roboto%20Condensed%3A300%2C300italic%2Cregular%2Citalic%2C700%2C700italic|font_style:700%20bold%20regular%3A700%3Anormal&#8220;][vc_column_text css=&#8220;.vc_custom_1598605661619{margin-top: 15px !important;}&#8220;]5 Tipps wie Sie durch die Anforderungen der MDR erfolgreicher sein k\u00f6nnen[\/vc_column_text][\/vc_column][vc_column column_padding=&#8220;no-extra-padding&#8220; column_padding_tablet=&#8220;inherit&#8220; column_padding_phone=&#8220;inherit&#8220; column_padding_position=&#8220;all&#8220; background_color_opacity=&#8220;1&#8243; background_hover_color_opacity=&#8220;1&#8243; column_shadow=&#8220;none&#8220; column_border_radius=&#8220;none&#8220; column_link_target=&#8220;_self&#8220; gradient_direction=&#8220;left_to_right&#8220; overlay_strength=&#8220;0.3&#8243; width=&#8220;1\/2&#8243; tablet_width_inherit=&#8220;default&#8220; tablet_text_alignment=&#8220;center&#8220; phone_text_alignment=&#8220;center&#8220; column_border_width=&#8220;none&#8220; column_border_style=&#8220;solid&#8220; bg_image_animation=&#8220;none&#8220;][vc_row_inner column_margin=&#8220;default&#8220; column_direction=&#8220;default&#8220; column_direction_tablet=&#8220;default&#8220; column_direction_phone=&#8220;default&#8220; text_align=&#8220;right&#8220;][vc_column_inner column_padding=&#8220;no-extra-padding&#8220; column_padding_tablet=&#8220;inherit&#8220; column_padding_phone=&#8220;inherit&#8220; column_padding_position=&#8220;all&#8220; background_color_opacity=&#8220;1&#8243; background_hover_color_opacity=&#8220;1&#8243; column_shadow=&#8220;none&#8220; column_border_radius=&#8220;none&#8220; column_link_target=&#8220;_self&#8220; gradient_direction=&#8220;left_to_right&#8220; overlay_strength=&#8220;0.3&#8243; width=&#8220;1\/1&#8243; tablet_width_inherit=&#8220;default&#8220; column_border_width=&#8220;none&#8220; column_border_style=&#8220;solid&#8220; bg_image_animation=&#8220;none&#8220;][nectar_btn size=&#8220;large&#8220; button_style=&#8220;see-through-3d&#8220; color_override=&#8220;#ffffff&#8220; url=&#8220;https:\/\/www.m3i-muenchen.de\/de\/von-mdr-profitieren\/&#8220; text=&#8220;Mehr erfahren&#8220;][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row type=&#8220;in_container&#8220; full_screen_row_position=&#8220;middle&#8220; column_margin=&#8220;default&#8220; column_direction=&#8220;default&#8220; column_direction_tablet=&#8220;default&#8220; column_direction_phone=&#8220;default&#8220; scene_position=&#8220;center&#8220; top_padding=&#8220;30&#8243; text_color=&#8220;dark&#8220; text_align=&#8220;left&#8220; row_border_radius=&#8220;none&#8220; row_border_radius_applies=&#8220;bg&#8220; id=&#8220;wasistusability&#8220; overlay_strength=&#8220;0.3&#8243; gradient_direction=&#8220;left_to_right&#8220; shape_divider_position=&#8220;bottom&#8220; bg_image_animation=&#8220;none&#8220; shape_type=&#8220;&#8220;][vc_column column_padding=&#8220;no-extra-padding&#8220; column_padding_tablet=&#8220;inherit&#8220; column_padding_phone=&#8220;inherit&#8220; column_padding_position=&#8220;all&#8220; background_color_opacity=&#8220;1&#8243; background_hover_color_opacity=&#8220;1&#8243; column_shadow=&#8220;none&#8220; column_border_radius=&#8220;none&#8220; column_link_target=&#8220;_self&#8220; gradient_direction=&#8220;left_to_right&#8220; overlay_strength=&#8220;0.3&#8243; width=&#8220;1\/6&#8243; tablet_width_inherit=&#8220;default&#8220; tablet_text_alignment=&#8220;default&#8220; phone_text_alignment=&#8220;default&#8220; column_border_width=&#8220;none&#8220; column_border_style=&#8220;solid&#8220; bg_image_animation=&#8220;none&#8220;][\/vc_column][vc_column column_padding=&#8220;no-extra-padding&#8220; column_padding_tablet=&#8220;inherit&#8220; column_padding_phone=&#8220;inherit&#8220; column_padding_position=&#8220;all&#8220; background_color_opacity=&#8220;1&#8243; background_hover_color_opacity=&#8220;1&#8243; column_shadow=&#8220;none&#8220; column_border_radius=&#8220;none&#8220; column_link_target=&#8220;_self&#8220; gradient_direction=&#8220;left_to_right&#8220; overlay_strength=&#8220;0.3&#8243; width=&#8220;2\/3&#8243; tablet_width_inherit=&#8220;default&#8220; tablet_text_alignment=&#8220;default&#8220; phone_text_alignment=&#8220;default&#8220; column_border_width=&#8220;none&#8220; column_border_style=&#8220;solid&#8220; bg_image_animation=&#8220;none&#8220;][vc_column_text]\n<h3><span style=\"font-weight: 400;\">Was ist Usability?<\/span><\/h3>\n<p style=\"text-align: left;\"><span style=\"font-weight: 400;\">Das Usability-Engineering hat seinen Anfang in der Luft- und Raumfahrt genommen. Seither wurde dieses Prinzip in vielen weiteren Bereichen implementiert, auch in der Medizintechnik. Usability, oder auch Gebrauchstauglichkeit, beschreibt die Nutzungsqualit\u00e4t, die ein User bei der Interaktion mit technischen Systemen und Ger\u00e4ten oder Produkten erlebt.<\/span><\/p>\n[\/vc_column_text][\/vc_column][vc_column column_padding=&#8220;no-extra-padding&#8220; column_padding_tablet=&#8220;inherit&#8220; column_padding_phone=&#8220;inherit&#8220; column_padding_position=&#8220;all&#8220; background_color_opacity=&#8220;1&#8243; background_hover_color_opacity=&#8220;1&#8243; column_shadow=&#8220;none&#8220; column_border_radius=&#8220;none&#8220; column_link_target=&#8220;_self&#8220; gradient_direction=&#8220;left_to_right&#8220; overlay_strength=&#8220;0.3&#8243; width=&#8220;1\/6&#8243; tablet_width_inherit=&#8220;default&#8220; tablet_text_alignment=&#8220;default&#8220; phone_text_alignment=&#8220;default&#8220; column_border_width=&#8220;none&#8220; column_border_style=&#8220;solid&#8220; bg_image_animation=&#8220;none&#8220;][\/vc_column][\/vc_row][vc_row type=&#8220;in_container&#8220; full_screen_row_position=&#8220;middle&#8220; column_margin=&#8220;default&#8220; column_direction=&#8220;default&#8220; column_direction_tablet=&#8220;default&#8220; column_direction_phone=&#8220;default&#8220; scene_position=&#8220;center&#8220; top_padding=&#8220;50&#8243; bottom_padding=&#8220;50&#8243; text_color=&#8220;dark&#8220; text_align=&#8220;left&#8220; row_border_radius=&#8220;none&#8220; row_border_radius_applies=&#8220;bg&#8220; overlay_strength=&#8220;0.3&#8243; gradient_direction=&#8220;left_to_right&#8220; shape_divider_position=&#8220;bottom&#8220; bg_image_animation=&#8220;none&#8220; shape_type=&#8220;&#8220;][vc_column column_padding=&#8220;no-extra-padding&#8220; column_padding_tablet=&#8220;inherit&#8220; column_padding_phone=&#8220;inherit&#8220; column_padding_position=&#8220;all&#8220; background_color_opacity=&#8220;1&#8243; background_hover_color_opacity=&#8220;1&#8243; column_shadow=&#8220;none&#8220; column_border_radius=&#8220;none&#8220; column_link_target=&#8220;_self&#8220; gradient_direction=&#8220;left_to_right&#8220; overlay_strength=&#8220;0.3&#8243; width=&#8220;1\/6&#8243; tablet_width_inherit=&#8220;default&#8220; tablet_text_alignment=&#8220;default&#8220; phone_text_alignment=&#8220;default&#8220; column_border_width=&#8220;none&#8220; column_border_style=&#8220;solid&#8220; bg_image_animation=&#8220;none&#8220;][\/vc_column][vc_column column_padding=&#8220;no-extra-padding&#8220; column_padding_tablet=&#8220;inherit&#8220; column_padding_phone=&#8220;inherit&#8220; column_padding_position=&#8220;all&#8220; background_color_opacity=&#8220;1&#8243; background_hover_color_opacity=&#8220;1&#8243; column_shadow=&#8220;none&#8220; column_border_radius=&#8220;none&#8220; column_link_target=&#8220;_self&#8220; gradient_direction=&#8220;left_to_right&#8220; overlay_strength=&#8220;0.3&#8243; width=&#8220;2\/3&#8243; tablet_width_inherit=&#8220;default&#8220; tablet_text_alignment=&#8220;default&#8220; phone_text_alignment=&#8220;default&#8220; column_border_width=&#8220;none&#8220; column_border_style=&#8220;solid&#8220; bg_image_animation=&#8220;none&#8220;][nectar_single_testimonial testimonial_style=&#8220;bold&#8220; color=&#8220;Accent-Color&#8220; quote=&#8220;&#8230; die Eigenschaft der Benutzer-Produkt-Schnittstelle, die die Effektivit\u00e4t, Effizienz, Lernf\u00f6rderlichkeit und Zufriedenstellung des Benutzers umfasst. (IEC 62366-1)&#8220;][\/vc_column][vc_column column_padding=&#8220;no-extra-padding&#8220; column_padding_tablet=&#8220;inherit&#8220; column_padding_phone=&#8220;inherit&#8220; column_padding_position=&#8220;all&#8220; background_color_opacity=&#8220;1&#8243; background_hover_color_opacity=&#8220;1&#8243; column_shadow=&#8220;none&#8220; column_border_radius=&#8220;none&#8220; column_link_target=&#8220;_self&#8220; gradient_direction=&#8220;left_to_right&#8220; overlay_strength=&#8220;0.3&#8243; width=&#8220;1\/6&#8243; tablet_width_inherit=&#8220;default&#8220; tablet_text_alignment=&#8220;default&#8220; phone_text_alignment=&#8220;default&#8220; column_border_width=&#8220;none&#8220; column_border_style=&#8220;solid&#8220; bg_image_animation=&#8220;none&#8220;][\/vc_column][\/vc_row][vc_row type=&#8220;in_container&#8220; full_screen_row_position=&#8220;middle&#8220; column_margin=&#8220;default&#8220; column_direction=&#8220;default&#8220; column_direction_tablet=&#8220;default&#8220; column_direction_phone=&#8220;default&#8220; scene_position=&#8220;center&#8220; bottom_padding=&#8220;30&#8243; text_color=&#8220;dark&#8220; text_align=&#8220;left&#8220; row_border_radius=&#8220;none&#8220; row_border_radius_applies=&#8220;bg&#8220; id=&#8220;warumusabilitysowichtigist&#8220; overlay_strength=&#8220;0.3&#8243; gradient_direction=&#8220;left_to_right&#8220; shape_divider_position=&#8220;bottom&#8220; bg_image_animation=&#8220;none&#8220; shape_type=&#8220;&#8220;][vc_column column_padding=&#8220;no-extra-padding&#8220; column_padding_tablet=&#8220;inherit&#8220; column_padding_phone=&#8220;inherit&#8220; column_padding_position=&#8220;all&#8220; background_color_opacity=&#8220;1&#8243; background_hover_color_opacity=&#8220;1&#8243; column_shadow=&#8220;none&#8220; column_border_radius=&#8220;none&#8220; column_link_target=&#8220;_self&#8220; gradient_direction=&#8220;left_to_right&#8220; overlay_strength=&#8220;0.3&#8243; width=&#8220;1\/1&#8243; tablet_width_inherit=&#8220;default&#8220; tablet_text_alignment=&#8220;default&#8220; phone_text_alignment=&#8220;default&#8220; column_border_width=&#8220;none&#8220; column_border_style=&#8220;solid&#8220; bg_image_animation=&#8220;none&#8220;][vc_row_inner column_margin=&#8220;default&#8220; column_direction=&#8220;default&#8220; column_direction_tablet=&#8220;default&#8220; column_direction_phone=&#8220;default&#8220; text_align=&#8220;left&#8220;][vc_column_inner column_padding=&#8220;no-extra-padding&#8220; column_padding_tablet=&#8220;inherit&#8220; column_padding_phone=&#8220;inherit&#8220; column_padding_position=&#8220;all&#8220; background_color_opacity=&#8220;1&#8243; background_hover_color_opacity=&#8220;1&#8243; column_shadow=&#8220;none&#8220; column_border_radius=&#8220;none&#8220; column_link_target=&#8220;_self&#8220; gradient_direction=&#8220;left_to_right&#8220; overlay_strength=&#8220;0.3&#8243; width=&#8220;1\/6&#8243; tablet_width_inherit=&#8220;default&#8220; column_border_width=&#8220;none&#8220; column_border_style=&#8220;solid&#8220; bg_image_animation=&#8220;none&#8220;][\/vc_column_inner][vc_column_inner column_padding=&#8220;no-extra-padding&#8220; column_padding_tablet=&#8220;inherit&#8220; column_padding_phone=&#8220;inherit&#8220; column_padding_position=&#8220;all&#8220; background_color_opacity=&#8220;1&#8243; background_hover_color_opacity=&#8220;1&#8243; column_shadow=&#8220;none&#8220; column_border_radius=&#8220;none&#8220; column_link_target=&#8220;_self&#8220; gradient_direction=&#8220;left_to_right&#8220; overlay_strength=&#8220;0.3&#8243; width=&#8220;2\/3&#8243; tablet_width_inherit=&#8220;default&#8220; column_border_width=&#8220;none&#8220; column_border_style=&#8220;solid&#8220; bg_image_animation=&#8220;none&#8220;][vc_column_text]<span style=\"font-weight: 400;\">Die Gebrauchstauglichkeit stellt ein wichtiges Konzept f\u00fcr Wirksamkeit und Sicherheit der Produkte bei der Behandlung von Patienten dar. Je leichter die Nutzer eines Produktes ihre Ziele umsetzen k\u00f6nnen, desto h\u00f6her ist die Usability des Produktes und somit auch die Kundenzufriedenheit.<\/span>[\/vc_column_text][\/vc_column_inner][vc_column_inner column_padding=&#8220;no-extra-padding&#8220; column_padding_tablet=&#8220;inherit&#8220; column_padding_phone=&#8220;inherit&#8220; column_padding_position=&#8220;all&#8220; background_color_opacity=&#8220;1&#8243; background_hover_color_opacity=&#8220;1&#8243; column_shadow=&#8220;none&#8220; column_border_radius=&#8220;none&#8220; column_link_target=&#8220;_self&#8220; gradient_direction=&#8220;left_to_right&#8220; overlay_strength=&#8220;0.3&#8243; width=&#8220;1\/6&#8243; tablet_width_inherit=&#8220;default&#8220; column_border_width=&#8220;none&#8220; column_border_style=&#8220;solid&#8220; bg_image_animation=&#8220;none&#8220;][\/vc_column_inner][\/vc_row_inner][vc_row_inner column_margin=&#8220;default&#8220; column_direction=&#8220;default&#8220; column_direction_tablet=&#8220;default&#8220; column_direction_phone=&#8220;default&#8220; text_align=&#8220;left&#8220; el_id=&#8220;wasgegenstandist&#8220;][vc_column_inner column_padding=&#8220;no-extra-padding&#8220; column_padding_tablet=&#8220;inherit&#8220; column_padding_phone=&#8220;inherit&#8220; column_padding_position=&#8220;all&#8220; background_color_opacity=&#8220;1&#8243; background_hover_color_opacity=&#8220;1&#8243; column_shadow=&#8220;none&#8220; column_border_radius=&#8220;none&#8220; column_link_target=&#8220;_self&#8220; gradient_direction=&#8220;left_to_right&#8220; overlay_strength=&#8220;0.3&#8243; width=&#8220;1\/6&#8243; tablet_width_inherit=&#8220;default&#8220; column_border_width=&#8220;none&#8220; column_border_style=&#8220;solid&#8220; bg_image_animation=&#8220;none&#8220;][\/vc_column_inner][vc_column_inner column_padding=&#8220;no-extra-padding&#8220; column_padding_tablet=&#8220;inherit&#8220; column_padding_phone=&#8220;inherit&#8220; column_padding_position=&#8220;all&#8220; background_color_opacity=&#8220;1&#8243; background_hover_color_opacity=&#8220;1&#8243; column_shadow=&#8220;none&#8220; column_border_radius=&#8220;none&#8220; column_link_target=&#8220;_self&#8220; gradient_direction=&#8220;left_to_right&#8220; overlay_strength=&#8220;0.3&#8243; width=&#8220;2\/3&#8243; tablet_width_inherit=&#8220;default&#8220; column_border_width=&#8220;none&#8220; column_border_style=&#8220;solid&#8220; bg_image_animation=&#8220;none&#8220;][vc_column_text]\n<h2><span style=\"font-weight: 400;\">Warum Usability so wichtig ist<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Sp\u00e4testens seit Bekanntgabe der neuen MDR ist der Nachweis der Gebrauchstauglichkeit bei Herstellern von Medizintechnik in den Fokus ger\u00fcckt. Konnten zu Zeiten der MDD teilweise Studien noch vermieden oder in kleinerem Umfang durchgef\u00fchrt werden, werden in der MDR verst\u00e4rkt umfangreiche Studien zum Nachweis der Gebrauchstauglichkeit gefordert. Kurz: ohne eine gute und messbare Usability wird kaum mehr ein Produkt auf den Markt kommen k\u00f6nnen.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Im Folgenden hierzu einen kurzen \u00dcberblick \u00fcber die <\/span><span style=\"font-weight: 400;\">aktuellen Regularien,<\/span><span style=\"font-weight: 400;\"> welche ausdr\u00fccklich einen Nachweis der Gebrauchstauglichkeit fordern:\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Die bis Mai 2017 geltende Medical Device Directive (<\/span><b>MDD<\/b><span style=\"font-weight: 400;\">), oder Directive 93\/42\/EEC MDD hat Usability bereits im kleinen Umfang gefordert.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">In der neuen, europaweit geltenden Medical Device Regulation (<\/span><b>MDR<\/b><span style=\"font-weight: 400;\">) bzw. Medizinprodukte-Verordnung wird der Gebrauchstauglichkeit von Medizinprodukten eine h\u00f6here Bedeutung zugemessen. Demnach sollen Hersteller von Medizinprodukten u.a. Risiken verringern und die Produkte so auslegen, dass sie ergonomischen Grunds\u00e4tzen entsprechen.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Der Fokus der international anerkannten <\/span><b>IEC 62366<\/b><span style=\"font-weight: 400;\"> liegt auf der Minimierung des Risikos durch mangelnde Gebrauchstauglichkeit und fordert sowohl eine formative als auch eine summative Evaluation.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Dar\u00fcber hinaus befasst sich die <\/span><b>ISO 9241 <\/b><span style=\"font-weight: 400;\">speziell mit Software-Produkten und <\/span><b>IEC 60601<\/b><span style=\"font-weight: 400;\"> speziell mit medizinischen elektrischen Ger\u00e4ten.<\/span><\/li>\n<\/ul>\n[\/vc_column_text][\/vc_column_inner][vc_column_inner column_padding=&#8220;no-extra-padding&#8220; column_padding_tablet=&#8220;inherit&#8220; column_padding_phone=&#8220;inherit&#8220; column_padding_position=&#8220;all&#8220; background_color_opacity=&#8220;1&#8243; background_hover_color_opacity=&#8220;1&#8243; column_shadow=&#8220;none&#8220; column_border_radius=&#8220;none&#8220; column_link_target=&#8220;_self&#8220; gradient_direction=&#8220;left_to_right&#8220; overlay_strength=&#8220;0.3&#8243; width=&#8220;1\/6&#8243; tablet_width_inherit=&#8220;default&#8220; column_border_width=&#8220;none&#8220; column_border_style=&#8220;solid&#8220; bg_image_animation=&#8220;none&#8220;][\/vc_column_inner][\/vc_row_inner][vc_row_inner column_margin=&#8220;default&#8220; column_direction=&#8220;default&#8220; column_direction_tablet=&#8220;default&#8220; column_direction_phone=&#8220;default&#8220; text_align=&#8220;left&#8220; el_id=&#8220;wasgegenstandist&#8220;][vc_column_inner column_padding=&#8220;no-extra-padding&#8220; column_padding_tablet=&#8220;inherit&#8220; column_padding_phone=&#8220;inherit&#8220; column_padding_position=&#8220;all&#8220; background_color_opacity=&#8220;1&#8243; background_hover_color_opacity=&#8220;1&#8243; column_shadow=&#8220;none&#8220; column_border_radius=&#8220;none&#8220; column_link_target=&#8220;_self&#8220; gradient_direction=&#8220;left_to_right&#8220; overlay_strength=&#8220;0.3&#8243; width=&#8220;1\/6&#8243; tablet_width_inherit=&#8220;default&#8220; column_border_width=&#8220;none&#8220; column_border_style=&#8220;solid&#8220; bg_image_animation=&#8220;none&#8220;][divider line_type=&#8220;No Line&#8220;][\/vc_column_inner][vc_column_inner column_padding=&#8220;no-extra-padding&#8220; column_padding_tablet=&#8220;inherit&#8220; column_padding_phone=&#8220;inherit&#8220; column_padding_position=&#8220;all&#8220; background_color_opacity=&#8220;1&#8243; background_hover_color_opacity=&#8220;1&#8243; column_shadow=&#8220;none&#8220; column_border_radius=&#8220;none&#8220; column_link_target=&#8220;_self&#8220; gradient_direction=&#8220;left_to_right&#8220; overlay_strength=&#8220;0.3&#8243; width=&#8220;2\/3&#8243; tablet_width_inherit=&#8220;default&#8220; column_border_width=&#8220;none&#8220; column_border_style=&#8220;solid&#8220; bg_image_animation=&#8220;none&#8220;][vc_column_text]\n<h2><span style=\"font-weight: 400;\">Was Gegenstand von Usability laut der Regularien ist<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Im Laufe der Entwicklung eines medizintechnischen Produktes sind folgende zwei wesentliche Schritte verpflichtende Bestandteile f\u00fcr eine Zulassung:<\/span>[\/vc_column_text][\/vc_column_inner][vc_column_inner column_padding=&#8220;no-extra-padding&#8220; column_padding_tablet=&#8220;inherit&#8220; column_padding_phone=&#8220;inherit&#8220; column_padding_position=&#8220;all&#8220; background_color_opacity=&#8220;1&#8243; background_hover_color_opacity=&#8220;1&#8243; column_shadow=&#8220;none&#8220; column_border_radius=&#8220;none&#8220; column_link_target=&#8220;_self&#8220; gradient_direction=&#8220;left_to_right&#8220; overlay_strength=&#8220;0.3&#8243; width=&#8220;1\/6&#8243; tablet_width_inherit=&#8220;default&#8220; column_border_width=&#8220;none&#8220; column_border_style=&#8220;solid&#8220; bg_image_animation=&#8220;none&#8220;][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row type=&#8220;in_container&#8220; full_screen_row_position=&#8220;middle&#8220; column_margin=&#8220;default&#8220; column_direction=&#8220;default&#8220; column_direction_tablet=&#8220;default&#8220; column_direction_phone=&#8220;default&#8220; bg_image=&#8220;7295&#8243; bg_position=&#8220;center center&#8220; bg_repeat=&#8220;no-repeat&#8220; scene_position=&#8220;center&#8220; top_padding=&#8220;5%&#8220; bottom_padding=&#8220;5%&#8220; text_color=&#8220;dark&#8220; text_align=&#8220;left&#8220; row_border_radius=&#8220;none&#8220; row_border_radius_applies=&#8220;bg&#8220; overlay_strength=&#8220;0.3&#8243; gradient_direction=&#8220;left_to_right&#8220; shape_divider_position=&#8220;bottom&#8220; bg_image_animation=&#8220;none&#8220; shape_type=&#8220;&#8220;][vc_column column_padding=&#8220;no-extra-padding&#8220; column_padding_tablet=&#8220;inherit&#8220; column_padding_phone=&#8220;inherit&#8220; column_padding_position=&#8220;all&#8220; background_color_opacity=&#8220;1&#8243; background_hover_color_opacity=&#8220;1&#8243; column_shadow=&#8220;none&#8220; column_border_radius=&#8220;none&#8220; column_link_target=&#8220;_self&#8220; gradient_direction=&#8220;left_to_right&#8220; overlay_strength=&#8220;0.3&#8243; width=&#8220;1\/1&#8243; tablet_width_inherit=&#8220;default&#8220; tablet_text_alignment=&#8220;default&#8220; phone_text_alignment=&#8220;default&#8220; column_border_width=&#8220;none&#8220; column_border_style=&#8220;solid&#8220; bg_image_animation=&#8220;none&#8220;][divider line_type=&#8220;No Line&#8220; custom_height=&#8220;350&#8243;][\/vc_column][\/vc_row][vc_row type=&#8220;in_container&#8220; full_screen_row_position=&#8220;middle&#8220; column_margin=&#8220;default&#8220; column_direction=&#8220;default&#8220; column_direction_tablet=&#8220;default&#8220; column_direction_phone=&#8220;default&#8220; scene_position=&#8220;center&#8220; top_padding=&#8220;40&#8243; text_color=&#8220;dark&#8220; text_align=&#8220;left&#8220; row_border_radius=&#8220;none&#8220; row_border_radius_applies=&#8220;bg&#8220; overlay_strength=&#8220;0.3&#8243; gradient_direction=&#8220;left_to_right&#8220; shape_divider_position=&#8220;bottom&#8220; bg_image_animation=&#8220;none&#8220; shape_type=&#8220;&#8220;][vc_column column_padding=&#8220;no-extra-padding&#8220; column_padding_tablet=&#8220;inherit&#8220; column_padding_phone=&#8220;inherit&#8220; column_padding_position=&#8220;all&#8220; background_color_opacity=&#8220;1&#8243; background_hover_color_opacity=&#8220;1&#8243; column_shadow=&#8220;none&#8220; column_border_radius=&#8220;none&#8220; column_link_target=&#8220;_self&#8220; gradient_direction=&#8220;left_to_right&#8220; overlay_strength=&#8220;0.3&#8243; width=&#8220;1\/6&#8243; tablet_width_inherit=&#8220;default&#8220; tablet_text_alignment=&#8220;default&#8220; phone_text_alignment=&#8220;default&#8220; column_border_width=&#8220;none&#8220; column_border_style=&#8220;solid&#8220; bg_image_animation=&#8220;none&#8220;][\/vc_column][vc_column column_padding=&#8220;no-extra-padding&#8220; column_padding_tablet=&#8220;inherit&#8220; column_padding_phone=&#8220;inherit&#8220; column_padding_position=&#8220;all&#8220; background_color_opacity=&#8220;1&#8243; background_hover_color_opacity=&#8220;1&#8243; column_shadow=&#8220;none&#8220; column_border_radius=&#8220;none&#8220; column_link_target=&#8220;_self&#8220; gradient_direction=&#8220;left_to_right&#8220; overlay_strength=&#8220;0.3&#8243; width=&#8220;2\/3&#8243; tablet_width_inherit=&#8220;default&#8220; tablet_text_alignment=&#8220;default&#8220; phone_text_alignment=&#8220;default&#8220; column_border_width=&#8220;none&#8220; column_border_style=&#8220;solid&#8220; bg_image_animation=&#8220;none&#8220;][vc_column_text]<b>Formative Evaluation: <\/b> <span style=\"font-weight: 400;\">Eine Formative Evaluation liefert bereits w\u00e4hrend der Produktentwicklung m\u00f6gliche Verbesserungspotentiale des Produktes, die noch w\u00e4hrend des Entwicklungsprozesses umgesetzt werden k\u00f6nnen. Im Gegensatz zur Summativen Evaluation sind hier deutlich geringere regulatorische Anforderungen gefordert, was leider auch dazu f\u00fchrt, dass oft ausschlie\u00dflich firmeninterne Meetings oder \u00e4hnliches als Formative Evaluation festgehalten werden.\u00a0<\/span><\/p>\n<p><b>Summative Evaluation: <\/b><span style=\"font-weight: 400;\">Im Anschluss an die Fertigstellung des finalen Prototypen wird eine Summative Evaluation durchgef\u00fchrt. Hierbei werden durch die Einbindung potentieller zuk\u00fcnftiger Anwender alle (oder alle sicherheitsbezogenen) Nutzungsszenarien getestet und eine abschlie\u00dfende Bewertung durchgef\u00fchrt. Die Summative Evaluation ist mit hohen regulatorischen Anforderungen verkn\u00fcpft, was sie gleichzeitig aufwendig und teuer macht. Im Idealfall sollten deshalb eine gute Gebrauchstauglichkeit best\u00e4tigt und weitere \u00c4nderungen am Produkt vermieden werden.\u00a0<\/span>[\/vc_column_text][\/vc_column][vc_column column_padding=&#8220;no-extra-padding&#8220; column_padding_tablet=&#8220;inherit&#8220; column_padding_phone=&#8220;inherit&#8220; column_padding_position=&#8220;all&#8220; background_color_opacity=&#8220;1&#8243; background_hover_color_opacity=&#8220;1&#8243; column_shadow=&#8220;none&#8220; column_border_radius=&#8220;none&#8220; column_link_target=&#8220;_self&#8220; gradient_direction=&#8220;left_to_right&#8220; overlay_strength=&#8220;0.3&#8243; width=&#8220;1\/6&#8243; tablet_width_inherit=&#8220;default&#8220; tablet_text_alignment=&#8220;default&#8220; phone_text_alignment=&#8220;default&#8220; column_border_width=&#8220;none&#8220; column_border_style=&#8220;solid&#8220; bg_image_animation=&#8220;none&#8220;][\/vc_column][\/vc_row][vc_row type=&#8220;full_width_background&#8220; full_screen_row_position=&#8220;middle&#8220; column_margin=&#8220;default&#8220; equal_height=&#8220;yes&#8220; content_placement=&#8220;middle&#8220; column_direction=&#8220;default&#8220; column_direction_tablet=&#8220;default&#8220; column_direction_phone=&#8220;default&#8220; bg_color=&#8220;#134995&#8243; scene_position=&#8220;center&#8220; top_padding=&#8220;2%&#8220; bottom_padding=&#8220;2%&#8220; left_padding_desktop=&#8220;5%&#8220; right_padding_desktop=&#8220;5%&#8220; text_color=&#8220;light&#8220; text_align=&#8220;left&#8220; row_border_radius=&#8220;none&#8220; row_border_radius_applies=&#8220;bg&#8220; overlay_strength=&#8220;0.3&#8243; gradient_direction=&#8220;left_to_right&#8220; shape_divider_position=&#8220;bottom&#8220; bg_image_animation=&#8220;none&#8220; shape_type=&#8220;&#8220;][vc_column column_padding=&#8220;no-extra-padding&#8220; column_padding_tablet=&#8220;inherit&#8220; column_padding_phone=&#8220;inherit&#8220; column_padding_position=&#8220;all&#8220; background_color_opacity=&#8220;1&#8243; background_hover_color_opacity=&#8220;1&#8243; column_shadow=&#8220;none&#8220; column_border_radius=&#8220;none&#8220; column_link_target=&#8220;_self&#8220; gradient_direction=&#8220;left_to_right&#8220; overlay_strength=&#8220;0.3&#8243; width=&#8220;1\/2&#8243; tablet_width_inherit=&#8220;default&#8220; tablet_text_alignment=&#8220;center&#8220; phone_text_alignment=&#8220;center&#8220; column_border_width=&#8220;none&#8220; column_border_style=&#8220;solid&#8220; bg_image_animation=&#8220;none&#8220;][vc_custom_heading text=&#8220;Von der MDR profitieren?&#8220; font_container=&#8220;tag:h2|font_size:52|text_align:left|line_height:56px&#8220; google_fonts=&#8220;font_family:Roboto%20Condensed%3A300%2C300italic%2Cregular%2Citalic%2C700%2C700italic|font_style:700%20bold%20regular%3A700%3Anormal&#8220;][vc_column_text css=&#8220;.vc_custom_1598605661619{margin-top: 15px !important;}&#8220;]5 Tipps wie Sie durch die Anforderungen der MDR erfolgreicher sein k\u00f6nnen[\/vc_column_text][\/vc_column][vc_column column_padding=&#8220;no-extra-padding&#8220; column_padding_tablet=&#8220;inherit&#8220; column_padding_phone=&#8220;inherit&#8220; column_padding_position=&#8220;all&#8220; background_color_opacity=&#8220;1&#8243; background_hover_color_opacity=&#8220;1&#8243; column_shadow=&#8220;none&#8220; column_border_radius=&#8220;none&#8220; column_link_target=&#8220;_self&#8220; gradient_direction=&#8220;left_to_right&#8220; overlay_strength=&#8220;0.3&#8243; width=&#8220;1\/2&#8243; tablet_width_inherit=&#8220;default&#8220; tablet_text_alignment=&#8220;center&#8220; phone_text_alignment=&#8220;center&#8220; column_border_width=&#8220;none&#8220; column_border_style=&#8220;solid&#8220; bg_image_animation=&#8220;none&#8220;][vc_row_inner column_margin=&#8220;default&#8220; column_direction=&#8220;default&#8220; column_direction_tablet=&#8220;default&#8220; column_direction_phone=&#8220;default&#8220; text_align=&#8220;right&#8220;][vc_column_inner column_padding=&#8220;no-extra-padding&#8220; column_padding_tablet=&#8220;inherit&#8220; column_padding_phone=&#8220;inherit&#8220; column_padding_position=&#8220;all&#8220; background_color_opacity=&#8220;1&#8243; background_hover_color_opacity=&#8220;1&#8243; column_shadow=&#8220;none&#8220; column_border_radius=&#8220;none&#8220; column_link_target=&#8220;_self&#8220; gradient_direction=&#8220;left_to_right&#8220; overlay_strength=&#8220;0.3&#8243; width=&#8220;1\/1&#8243; tablet_width_inherit=&#8220;default&#8220; column_border_width=&#8220;none&#8220; column_border_style=&#8220;solid&#8220; bg_image_animation=&#8220;none&#8220;][nectar_btn size=&#8220;large&#8220; button_style=&#8220;see-through-3d&#8220; color_override=&#8220;#ffffff&#8220; url=&#8220;https:\/\/www.m3i-muenchen.de\/de\/von-mdr-profitieren\/&#8220; text=&#8220;Mehr erfahren&#8220;][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row type=&#8220;in_container&#8220; full_screen_row_position=&#8220;middle&#8220; column_margin=&#8220;default&#8220; column_direction=&#8220;default&#8220; column_direction_tablet=&#8220;default&#8220; column_direction_phone=&#8220;default&#8220; scene_position=&#8220;center&#8220; top_padding=&#8220;40&#8243; text_color=&#8220;dark&#8220; text_align=&#8220;left&#8220; row_border_radius=&#8220;none&#8220; row_border_radius_applies=&#8220;bg&#8220; id=&#8220;schl\u00fcsselzumerfolg&#8220; overlay_strength=&#8220;0.3&#8243; gradient_direction=&#8220;left_to_right&#8220; shape_divider_position=&#8220;bottom&#8220; bg_image_animation=&#8220;none&#8220; shape_type=&#8220;&#8220;][vc_column column_padding=&#8220;no-extra-padding&#8220; column_padding_tablet=&#8220;inherit&#8220; column_padding_phone=&#8220;inherit&#8220; column_padding_position=&#8220;all&#8220; background_color_opacity=&#8220;1&#8243; background_hover_color_opacity=&#8220;1&#8243; column_shadow=&#8220;none&#8220; column_border_radius=&#8220;none&#8220; column_link_target=&#8220;_self&#8220; gradient_direction=&#8220;left_to_right&#8220; overlay_strength=&#8220;0.3&#8243; width=&#8220;1\/6&#8243; tablet_width_inherit=&#8220;default&#8220; tablet_text_alignment=&#8220;default&#8220; phone_text_alignment=&#8220;default&#8220; column_border_width=&#8220;none&#8220; column_border_style=&#8220;solid&#8220; bg_image_animation=&#8220;none&#8220;][\/vc_column][vc_column column_padding=&#8220;no-extra-padding&#8220; column_padding_tablet=&#8220;inherit&#8220; column_padding_phone=&#8220;inherit&#8220; column_padding_position=&#8220;all&#8220; background_color_opacity=&#8220;1&#8243; background_hover_color_opacity=&#8220;1&#8243; column_shadow=&#8220;none&#8220; column_border_radius=&#8220;none&#8220; column_link_target=&#8220;_self&#8220; gradient_direction=&#8220;left_to_right&#8220; overlay_strength=&#8220;0.3&#8243; width=&#8220;2\/3&#8243; tablet_width_inherit=&#8220;default&#8220; tablet_text_alignment=&#8220;default&#8220; phone_text_alignment=&#8220;default&#8220; column_border_width=&#8220;none&#8220; column_border_style=&#8220;solid&#8220; bg_image_animation=&#8220;none&#8220;][vc_column_text]\n<h2><span style=\"font-weight: 400;\">Warum Usability der Schl\u00fcssel zum Erfolg ist<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Formative und besonders Summative Usability-Erprobungen sind zeitaufwendig und kostenintensiv. Die Einbeziehung geeigneter klinischer Endnutzer (\u00c4rzte, Pfleger, Reinigungspersonal, IT-Administratoren, Patienten usw.) ist wegen Zeitmangel des klinischen Personals, Compliance-Thematiken und der Suche nach dem richtigen Ansprechpartner in Kliniken eine echte Herausforderung f\u00fcr Hersteller von Medizintechnik. Gleichzeitig werden klinische Behandlungen und Eingriffe, sowie Innovationen in der Medizintechnik immer komplexer. Ein vermehrter Einbezug von Lead-Usern bei medizintechnischen Innovationen ist daher nicht nur regulatorisches Muss. Oft ist er auch der Schl\u00fcssel zu einem anwenderfreundlichen Produkt, welches den Praxisbedarf deckt und einen echten Mehrwert gegen\u00fcber Alternativprodukten darstellt. Der Nachweis der Gebrauchstauglichkeit bildet daher die Grundlage f\u00fcr einen effektiven, innovativen und erfolgversprechenden Entwicklungsprozess. Dar\u00fcber hinaus hilft die enge Zusammenarbeit mit einer Vielzahl an klinischen Experten dabei early Adopter zu finden und wichtige KOL\u2019s durch den Einbezug deren Meinungen und Vorschl\u00e4ge vom Produkt zu \u00fcberzeugen.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Durch Erweiterung des Usability-Prozesses um einige weitere Module kann so aus regulatorischer Notwendigkeit also ein ganzheitlicher und effektiver Innovationsprozess etabliert werden der nicht nur ein erfolgreiches Endprodukt garantiert, sondern auch die Bed\u00fcrfnisse vieler am Entwicklungsprozess beteiligter Mitarbeiter mit in den Fokus nimmt und so deren Effektivit\u00e4t steigert.\u00a0<\/span>[\/vc_column_text][\/vc_column][vc_column column_padding=&#8220;no-extra-padding&#8220; column_padding_tablet=&#8220;inherit&#8220; column_padding_phone=&#8220;inherit&#8220; column_padding_position=&#8220;all&#8220; background_color_opacity=&#8220;1&#8243; background_hover_color_opacity=&#8220;1&#8243; column_shadow=&#8220;none&#8220; column_border_radius=&#8220;none&#8220; column_link_target=&#8220;_self&#8220; gradient_direction=&#8220;left_to_right&#8220; overlay_strength=&#8220;0.3&#8243; width=&#8220;1\/6&#8243; tablet_width_inherit=&#8220;default&#8220; tablet_text_alignment=&#8220;default&#8220; phone_text_alignment=&#8220;default&#8220; column_border_width=&#8220;none&#8220; column_border_style=&#8220;solid&#8220; bg_image_animation=&#8220;none&#8220;][\/vc_column][\/vc_row][vc_row type=&#8220;in_container&#8220; full_screen_row_position=&#8220;middle&#8220; column_margin=&#8220;default&#8220; column_direction=&#8220;default&#8220; column_direction_tablet=&#8220;default&#8220; column_direction_phone=&#8220;default&#8220; bg_image=&#8220;7298&#8243; bg_position=&#8220;center center&#8220; bg_repeat=&#8220;no-repeat&#8220; scene_position=&#8220;center&#8220; top_padding=&#8220;5%&#8220; bottom_padding=&#8220;5%&#8220; text_color=&#8220;dark&#8220; text_align=&#8220;left&#8220; row_border_radius=&#8220;none&#8220; row_border_radius_applies=&#8220;bg&#8220; overlay_strength=&#8220;0.3&#8243; gradient_direction=&#8220;left_to_right&#8220; shape_divider_position=&#8220;bottom&#8220; bg_image_animation=&#8220;none&#8220; shape_type=&#8220;&#8220;][vc_column column_padding=&#8220;no-extra-padding&#8220; column_padding_tablet=&#8220;inherit&#8220; column_padding_phone=&#8220;inherit&#8220; column_padding_position=&#8220;all&#8220; background_color_opacity=&#8220;1&#8243; background_hover_color_opacity=&#8220;1&#8243; column_shadow=&#8220;none&#8220; column_border_radius=&#8220;none&#8220; column_link_target=&#8220;_self&#8220; gradient_direction=&#8220;left_to_right&#8220; overlay_strength=&#8220;0.3&#8243; width=&#8220;1\/1&#8243; tablet_width_inherit=&#8220;default&#8220; tablet_text_alignment=&#8220;default&#8220; phone_text_alignment=&#8220;default&#8220; column_border_width=&#8220;none&#8220; column_border_style=&#8220;solid&#8220; bg_image_animation=&#8220;none&#8220;][divider line_type=&#8220;No Line&#8220; custom_height=&#8220;350&#8243;][\/vc_column][\/vc_row][vc_row type=&#8220;in_container&#8220; full_screen_row_position=&#8220;middle&#8220; column_margin=&#8220;default&#8220; column_direction=&#8220;default&#8220; column_direction_tablet=&#8220;default&#8220; column_direction_phone=&#8220;default&#8220; scene_position=&#8220;center&#8220; top_padding=&#8220;40&#8243; text_color=&#8220;dark&#8220; text_align=&#8220;left&#8220; row_border_radius=&#8220;none&#8220; row_border_radius_applies=&#8220;bg&#8220; overlay_strength=&#8220;0.3&#8243; gradient_direction=&#8220;left_to_right&#8220; shape_divider_position=&#8220;bottom&#8220; bg_image_animation=&#8220;none&#8220; shape_type=&#8220;&#8220;][vc_column column_padding=&#8220;no-extra-padding&#8220; column_padding_tablet=&#8220;inherit&#8220; column_padding_phone=&#8220;inherit&#8220; column_padding_position=&#8220;all&#8220; background_color_opacity=&#8220;1&#8243; background_hover_color_opacity=&#8220;1&#8243; column_shadow=&#8220;none&#8220; column_border_radius=&#8220;none&#8220; column_link_target=&#8220;_self&#8220; gradient_direction=&#8220;left_to_right&#8220; overlay_strength=&#8220;0.3&#8243; width=&#8220;1\/6&#8243; tablet_width_inherit=&#8220;default&#8220; tablet_text_alignment=&#8220;default&#8220; phone_text_alignment=&#8220;default&#8220; column_border_width=&#8220;none&#8220; column_border_style=&#8220;solid&#8220; bg_image_animation=&#8220;none&#8220;][vc_row_inner column_margin=&#8220;default&#8220; column_direction=&#8220;default&#8220; column_direction_tablet=&#8220;default&#8220; column_direction_phone=&#8220;default&#8220; text_align=&#8220;left&#8220;][vc_column_inner column_padding=&#8220;no-extra-padding&#8220; column_padding_tablet=&#8220;inherit&#8220; column_padding_phone=&#8220;inherit&#8220; column_padding_position=&#8220;all&#8220; background_color_opacity=&#8220;1&#8243; background_hover_color_opacity=&#8220;1&#8243; column_shadow=&#8220;none&#8220; column_border_radius=&#8220;none&#8220; column_link_target=&#8220;_self&#8220; gradient_direction=&#8220;left_to_right&#8220; overlay_strength=&#8220;0.3&#8243; width=&#8220;1\/1&#8243; tablet_width_inherit=&#8220;default&#8220; column_border_width=&#8220;none&#8220; column_border_style=&#8220;solid&#8220; bg_image_animation=&#8220;none&#8220;][\/vc_column_inner][\/vc_row_inner][\/vc_column][vc_column column_padding=&#8220;no-extra-padding&#8220; column_padding_tablet=&#8220;inherit&#8220; column_padding_phone=&#8220;inherit&#8220; column_padding_position=&#8220;all&#8220; background_color_opacity=&#8220;1&#8243; background_hover_color_opacity=&#8220;1&#8243; column_shadow=&#8220;none&#8220; column_border_radius=&#8220;none&#8220; column_link_target=&#8220;_self&#8220; gradient_direction=&#8220;left_to_right&#8220; overlay_strength=&#8220;0.3&#8243; width=&#8220;2\/3&#8243; tablet_width_inherit=&#8220;default&#8220; tablet_text_alignment=&#8220;default&#8220; phone_text_alignment=&#8220;default&#8220; column_border_width=&#8220;none&#8220; column_border_style=&#8220;solid&#8220; bg_image_animation=&#8220;none&#8220;][vc_column_text]<b>Vorbereitende Arbeiten: <\/b><span style=\"font-weight: 400;\">Unsere Erfahrung aus enger Zusammenarbeit mit klinischen Experten ist: Einige \u00c4rzte sind richtige Innovations-Inkubatoren! Diese gilt es bereits gleich zu Beginn des Innovationsprozesses einzubinden. \u00c4rzte haben meist einen breiten \u00dcberblick \u00fcber Konkurrenzprodukte und dem clinical Need und haben so viele n\u00fctzliche Ideen und Meinungen die unbedingt in die Entwicklung einbezogen werden sollten. Dies kann beispielsweise im Rahmen eines Ideenworkshops mit Lead-Usern oder einzelnen Experteninterviews erfolgen.<\/span><\/p>\n<p><b>Formative Evaluation: <\/b>Immer wieder sehen wir, dass die Formative Evaluation leider vernachl\u00e4ssigt und sehr sp\u00e4rlich durchgef\u00fchrt wird, hat sie doch eigentlich am meisten Potenzial erheblichen Einfluss auf den Outcome der Entwicklung zu nehmen. Fr\u00fche Befragung von KOL\u2019s und Lead-Usern hat bei uns in der Praxis meist bereits fr\u00fch m\u00f6gliche Verbesserungspotenziale oder ungenutzte Marktpotenziale offenbart, welche so einfacher umgesetzt werden konnten als gegen Ende des Projekts. Ein iterativer Prozess sorgt hierbei mittels Experteninterviews, Workshops und Benutzertests f\u00fcr kontinuierlichen Einbezug der Endanwender und eine stetige Verbesserung des Produkts.<\/p>\n<p><b>Summative Evaluation: <\/b><span style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Durch eine starken Einbezug der Endanwender w\u00e4hrend der Formativen Evaluationen wird sichergestellt, dass w\u00e4hrend der Summativen Evaluationen eine gute Gebrauchstauglichkeit erfolgreich best\u00e4tigt wird. Dies ist wichtig um sp\u00e4te \u00c4nderungen am Produkt zu vermeiden, was erheblich Aufwand und Ressourcen spart. Neben dem geforderten Abschlussbericht f\u00fcr die Gebrauchstauglichkeitsakte k\u00f6nnen auch Schulungskonzepte f\u00fcr Endanwender abgeleitet werden.<\/span><\/span><\/p>\n<p><b>Benchmarking:<\/b><span style=\"font-weight: 400;\"> In einer sogenannten \u201eBenchmarking-Studie\u201c<\/span> <span style=\"font-weight: 400;\">kann das Produkt unmittelbar vor oder nach Markteinf\u00fchrung mit Konkurrenzprodukten im klinischen Einsatz verglichen werden, um die Leistungsl\u00fccke zwischen den einzelnen Produkten zu messen. Hierbei bewerten klinische Experten die Vor- und Nachteile der Vergleichsprodukte und erarbeiten starke \u201cMedical Claims\u201d, die durch reproduzierbare Messverfahren nachgewiesen werden und somit anschlie\u00dfend f\u00fcr Marketing-Zwecke verwendet werden k\u00f6nnen. Das Einholen von Testimonials von Endnutzern zum Produkt kann zus\u00e4tzlich f\u00fcr ein fundiertes Marketing n\u00fctzlich sein.\u00a0<\/span>[\/vc_column_text][vc_row_inner column_margin=&#8220;default&#8220; column_direction=&#8220;default&#8220; column_direction_tablet=&#8220;default&#8220; column_direction_phone=&#8220;default&#8220; text_align=&#8220;left&#8220;][vc_column_inner column_padding=&#8220;no-extra-padding&#8220; column_padding_tablet=&#8220;inherit&#8220; column_padding_phone=&#8220;inherit&#8220; column_padding_position=&#8220;all&#8220; background_color_opacity=&#8220;1&#8243; background_hover_color_opacity=&#8220;1&#8243; column_shadow=&#8220;none&#8220; column_border_radius=&#8220;none&#8220; column_link_target=&#8220;_self&#8220; gradient_direction=&#8220;left_to_right&#8220; overlay_strength=&#8220;0.3&#8243; width=&#8220;1\/1&#8243; tablet_width_inherit=&#8220;default&#8220; column_border_width=&#8220;none&#8220; column_border_style=&#8220;solid&#8220; bg_image_animation=&#8220;none&#8220;][divider line_type=&#8220;No Line&#8220;][vc_column_text]\n<h2><span style=\"font-weight: 400;\">Zusammenfassung: Vorteile eines guten Usability Prozesses<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Sieh die gestiegenen Anforderungen an den Nachweis der Gebrauchstauglichkeit also als Chance und profitiere von:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">hoher Praxisrelevanz der Innovation durch Einbezug von KOL\u2019s (Innovationsf\u00fchrerschaft)<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">einem effizienten Innovationsprozess mit geringem Fehlerpotential<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">sicherer und effizienter Zulassung und schnellem Markteintritt<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">schlagkr\u00e4ftigem und fundiertem Marketing<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Hervorhebung von Vorteilen beim direkten Vergleich gegen\u00fcber Konkurrenzprodukten<\/span><\/li>\n<\/ul>\n[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][vc_column column_padding=&#8220;no-extra-padding&#8220; column_padding_tablet=&#8220;inherit&#8220; column_padding_phone=&#8220;inherit&#8220; column_padding_position=&#8220;all&#8220; background_color_opacity=&#8220;1&#8243; background_hover_color_opacity=&#8220;1&#8243; column_shadow=&#8220;none&#8220; column_border_radius=&#8220;none&#8220; column_link_target=&#8220;_self&#8220; gradient_direction=&#8220;left_to_right&#8220; overlay_strength=&#8220;0.3&#8243; width=&#8220;1\/6&#8243; tablet_width_inherit=&#8220;default&#8220; tablet_text_alignment=&#8220;default&#8220; phone_text_alignment=&#8220;default&#8220; column_border_width=&#8220;none&#8220; column_border_style=&#8220;solid&#8220; bg_image_animation=&#8220;none&#8220;][\/vc_column][\/vc_row][vc_row type=&#8220;full_width_background&#8220; full_screen_row_position=&#8220;middle&#8220; column_margin=&#8220;default&#8220; equal_height=&#8220;yes&#8220; content_placement=&#8220;middle&#8220; column_direction=&#8220;default&#8220; column_direction_tablet=&#8220;default&#8220; column_direction_phone=&#8220;default&#8220; bg_color=&#8220;#ffffff&#8220; scene_position=&#8220;center&#8220; top_padding=&#8220;1%&#8220; bottom_padding=&#8220;1%&#8220; text_color=&#8220;dark&#8220; text_align=&#8220;left&#8220; row_border_radius=&#8220;none&#8220; row_border_radius_applies=&#8220;bg&#8220; overlay_strength=&#8220;0.3&#8243; gradient_direction=&#8220;left_to_right&#8220; shape_divider_position=&#8220;bottom&#8220; bg_image_animation=&#8220;none&#8220; shape_type=&#8220;&#8220;][vc_column column_padding=&#8220;no-extra-padding&#8220; column_padding_tablet=&#8220;inherit&#8220; column_padding_phone=&#8220;inherit&#8220; column_padding_position=&#8220;all&#8220; background_color_opacity=&#8220;1&#8243; background_hover_color_opacity=&#8220;1&#8243; column_shadow=&#8220;none&#8220; column_border_radius=&#8220;none&#8220; column_link_target=&#8220;_self&#8220; gradient_direction=&#8220;left_to_right&#8220; overlay_strength=&#8220;0.3&#8243; width=&#8220;1\/2&#8243; tablet_width_inherit=&#8220;default&#8220; tablet_text_alignment=&#8220;center&#8220; 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