【製薬企業がクスリを売らなくなる日】
2018年、日経デジタルヘルスの連載で、アーサー・ディ・リトル・ジャパン社の増井 慶太氏が「製薬企業がクスリを売らなくなる日 ～Beyond the Pill～」というタイトルで記事を投稿している。
医薬品を取り巻く昨今の外部環境や企業内部の状況の変化から、製薬産業において大きなパラダイムシフトが起きているのだ。
“Beyond the Pills”（医薬品を越えて）の掛け声のもと、製薬企業が医薬品の創出・販売を越えた新たな事業モデルの構築や技術領域への投資を進めているという。
従前のように10数年、数百億円以上をかけて新薬を開発し、特許が切れる前にまた新薬を開発するといったビジネスモデルは、もはや成り立たなくなりつつある。これまでのやり方に固執している製薬企業は淘汰されかねないのである。
製薬業界では、競争の激化に加えて、医療財政悪化に伴う薬価の切り下げ、創薬ターゲット（タネ）の枯渇、収益性の悪化などにより、経営戦略を方針変換せざるを得ないのである。
【DTx（デジタル療法）】
近年、ソフトウェアが単体で医療機器として機能する「プログラム医療機器」（SaMD：Software as a Medical Device）が注目を集めている。いわゆるDTx（Digital Therapeutics：デジタル療法）としても知られている。
医療機器企業のみではなく、医薬品企業においてもDTxの分野に進出する動きがある。 DTxではスマートフォンのアプリなどを使用して、高血圧、糖尿病、精神神経疾患、不眠症、禁煙などへの治療介入に活用する。
2010年には、米国のWellDoc社が「Bluestar」という2型糖尿病患者向けの治療補助アプリで米国のFDAの認証を得た。
さらには人工知能（AI：artificial intelligence）や機械学習（ML：machine learning）が搭載されたプログラム医療機器の開発も進められている。
AI/MLを搭載したプログラム医療機器は、ユーザや患者が継続的に使用する間、データを収集・分析し、その結果をアップデートして機能に反映するというものである。
米国では、過去にSaMDの定義やクラス分類に関して二転三転した経緯がある。しかしながら、現在では積極的に産業界を支援し、早期に承認する制度（規制緩和）や体制を整えつつある。
FDAは2017年7 月に“Digital Health Innovation Action Plan” を発表し、世界に先駆けて新しい医療分野であるデジタルヘルスに対して積極的にコミットしていくことを表明した。
それに比べ、日本のプログラム医療機器に関する審査体制の確立や、規制要件の発出はかなり遅れていると言わざるを得ない。
【プログラム医療機器に関する規制】
DTxの研究開発においては、多額の資金調達や、臨床試験（治験）における有効性の証明など課題が多い。
加えて、プログラム医療機器は、医療機器承認（または認証）、販売、安全性監視などに関して規制がかかっている。
まず、プログラム医療機器を設計（ソフトウェアには製造工程はない）するためには、医療機器製造業の登録が必要だ。
また自社ブランドで国内市場に流通させるためには、医療機器製造販売業許可を受ける必要がある。医療機器製造販売業許可を受けるためには、体制省令やGVP省令に沿った人材要件を満たし、組織を構築し、手順書等を整備しておかなければならない。
さらにプログラム医療機器を販売（インターネット経由、メディア）する場合には販売業の許可または登録が必要である。
国内における医療機器ソフトウェアの承認（認証）申請においては、当該ソフトウェアがIEC-62304（JIS T 2304）に沿って設計・開発が実施されたことを証明しなければならない。
多くの場合、規制要件や国際規格を遵守した設計・開発が実施されておらず、仕様書等が適切に文書化されていないケースが多い。仕様書よりも先にプログラムが作成されている事案にしばしば遭遇する。
設計・開発と医療機器承認（認証）申請は、密接に関連している。医療機器ソフトウェアの設計・開発においては、申請書を作成することを前提に文書化を進める必要がある。
また、医療機器ソフトウェアが承認（認証）されるためには、その有効性と安全性が証明されなければならない。
医療機器には何らかのリスクが存在する。それらのリスクを回避するためには、ISO-14971などに沿ったリスクマネジメントが必要だ。 医療機器ソフトウェアに参入する多くの企業（スタートアップ、製薬企業など）は、有効性を追求することがもっぱらで、安全性に関しては疎いことが多い。
【MRJの失敗に学ぶ】
MRJ（三菱リージョナルジェット）は、2008年に事業化され、半世紀ぶりの国産旅客機の製造に挑戦したが、5回もの納入延期に追い込まれた。
当初、2013年に1号機をANAへ引き渡し予定であったが、未だに納入されていない。しかも、開発経費は当初の1500億円から4000億～5000億円へと膨れ上がってしまった。
現在では、生産拠点を日本から米国へ移し、名称もMRJからスペースジェットと変更された。（名称から三菱の名前が消えた。）
筆者は失敗の原因は、以下のとおりであると考えている。
１．旅客機開発の経験・ノウハウの乏しさ 旅客機部品の製造経験はあるものの、完成品の製造経験がなかった。 初期設計段階で必要な事項を十分検討、設計に反映できていなかった。
２．規制要件に関する知見の不足 規制当局からの「型式証明」を得るために必要な試験に関する開発陣の知見不足により、設計プロセスが振出しに戻った。 国交省による規制について、具体的に何をどうすればクリアできるのかをきちんと認識できていなかった。
３．人材不足 上記を回避するための経験・ノウハウ・知見・知識を有する人材が不足していた。
医療機器開発（プログラム医療機器を含む）においても同様のことが言える。経営者は新規ビジネスとして安易に医療機器に進出しようとする。
しかしながら、民生用の製品しか設計・製造した経験がない企業や、規制要件を理解していない企業が医療機器を開発した場合、そう容易いことではない。
ユーザ/患者の意図した利用に対して、適切に設計されていなければならない。
医療機器の事故は、ユーザの意図した利用と設計者の設計思想のギャップによって起きると言われている。
有効で安全な医療機器を設計開発するために、ISO、IECなどの国際規格や規制要件が存在する。 いわば、国際規格や規制要件は医療機器製品の品質を担保し、安全性を確保するためのベストプラクティスである。
それらを無視した設計開発では、承認が得られなかったり、査察で指摘を受けたり、市場で事故を起こしかねない。
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[blogcard url=”https://ecompliance.co.jp/SHOP/L_MDSW.html” title=”医療機器ソフトウェア規制（IEC-62304）への具体的な対応方法” content=”本邦において、2017年11月より、IEC 62304（医療機器ソフトウェア ‐ ソフトウェアライフサイクルプロセス）が実質的な規制要件となりました。
IEC 62304は、2006年5月に発行され、日本では2012年にJIS化（JIS T 2304）されました。2014年11月に施行された医薬品医療機器法第12条第2項において参照される「最新のライフサイクルモデル」です。
米国FDAにおいても2008年7月にRecognized Consensus Standardと認定されています。
IEC 62304は「医療機器ソフトウェア」の開発と保守に関するプロセスを規定しています。
日本以外でも欧州・北米・中国などにおいて医療機器申請時にIEC 62304に基づくソフトウェア開発の証拠が必要です。
つまりIEC 62304に従って「医療機器ソフトウェア」を開発しなければ、国内外においてソフトウェアを搭載した医療機器（単体プログラムを含む）を販売することができません。
しかしながら、IEC 62304は非常に難解です。具体的にどのような対応をとればよいのでしょうか。一般にプロセス規格は各社によってまちまちの解釈が行われ、手順書の内容が大きく異なってしまいます。
・IEC 62304を読んでも対応すべき内容や方法が分からない。
・IEC 62304を読んでもどこまでやるべきなのかの範囲が分からない。
・IEC 62304の詳細の内容が不明なまま文書構築を行っている。
などといった疑問点が多く寄せられます。
本セミナーでは、難解なIEC 62304を分かりやすく解説します。
またIEC 62304に準拠したSOPを配布し、皆様の企業内における手順書作成をご支援いたします。
【特典】
IEC 62304対応SOPのサンプルを電子ファイル（MS-Word）で配布します。
【対象者】
医療機器ソフトウェア設計者
医療機器ソフトウェア業界へ新規参入する企業担当者
医療機器製造業者へソフトウェアを供給するサプライヤ
認証機関担当者”]
[blogcard url=”https://ecompliance.co.jp/SHOP/O016.html” title=”DTx(デジタル医療)の最新の技術動向と知財戦略の新たな視点” content=”近年、デジタル・ネットワーク技術と医療技術との融合・連携による「デジタル医療」が注目されており、画期的な技術が次々に生まれています。第四次医療革命「Medicine 4.0」が進展する中、例えば、飲めるセンサーを内蔵した医薬品が開発され、手術空間をサイバー化した「スマート治療室」などが開発されています。また、アプリで病気の治療を支援する「治療用アプリ」も積極的に開発されています。人工知能を利用したＡＩ創薬も急速に進展しています。
このような新たな技術の開発に伴い、現在、特許出願も顕著に増加する傾向にあります。特許出願は、研究成果に基づいて利益を得るために必要不可欠であり、そのための特許戦略は、企業の将来性を左右する重要な課題です。とくに、広くて強い特許を取得することが重要であり、その結果、研究成果を事業活動に最大限に活かすことができます。
本講演では、このような観点から、「デジタル医療」に関する最新の技術動向と特許戦略の新たな視点について説明し、今後の課題と対応策について解説します。”]
[blogcard url=”https://ecompliance.co.jp/SHOP/EL-010.html” title=”【セミナービデオ】医療機器ソフトウェア規制（IEC-62304）への具体的な対応方法セミナー” content=”本邦において、2017年11月より、IEC 62304（医療機器ソフトウェア ‐ ソフトウェアライフサイクルプロセス）が実質的な規制要件となりました。
IEC 62304は、2006年5月に発行され、日本では2012年にJIS化（JIS T 2304）されました。2014年11月に施行された医薬品医療機器法第12条第2項において参照される「最新のライフサイクルモデル」です。
米国FDAにおいても2008年7月にRecognized Consensus Standardと認定されています。
IEC 62304は「医療機器ソフトウェア」の開発と保守に関するプロセスを規定しています。
日本以外でも欧州・北米・中国などにおいて医療機器申請時にIEC 62304に基づくソフトウェア開発の証拠が必要です。
つまりIEC 62304に従って「医療機器ソフトウェア」を開発しなければ、国内外においてソフトウェアを搭載した医療機器（単体プログラムを含む）を販売することができません。
しかしながら、IEC 62304は非常に難解です。具体的にどのような対応をとればよいのでしょうか。一般にプロセス規格は各社によってまちまちの解釈が行われ、手順書の内容が大きく異なってしまいます。
・IEC 62304を読んでも対応すべき内容や方法が分からない。
・IEC 62304を読んでもどこまでやるべきなのかの範囲が分からない。
・IEC 62304の詳細の内容が不明なまま文書構築を行っている。
などといった疑問点が多く寄せられます。
本セミナーでは、難解なIEC 62304を分かりやすく解説します。
またIEC 62304に準拠したSOPを配布し、皆様の企業内における手順書作成をご支援いたします。
【特典】
IEC 62304対応SOPのサンプルを電子ファイル（MS-Word）で配布します。
【対象者】
医療機器ソフトウェア設計者
医療機器ソフトウェア業界へ新規参入する企業担当者
医療機器製造業者へソフトウェアを供給するサプライヤ
認証機関担当者”]
[blogcard url=”https://ecompliance.co.jp/SHOP/MD-QMS-149.html” title=”【IEC-62304対応】ソフトウェア開発規程・手順書ひな形” content=”本邦において、2017年11月より、IEC 62304（医療機器ソフトウェア ‐ ソフトウェアライフサイクルプロセス）が、実質的な規制要件となりました。
IEC 62304は、2006年5月に発行され、日本では2012年にJIS化（JIS T 2304）されました。
2014年11月に施行された医薬品医療機器法第12条第2項において参照される「最新のライフサイクルモデル」です。
米国FDAにおいても、2008年7月にRecognized Consensus Standardと認定されています。
IEC 62304は「医療機器ソフトウェア」の開発と保守に関するプロセスを規定しています。
日本以外でも、欧州・北米・中国などにおいて、医療機器申請時にIEC 62304に基づくソフトウェア開発の証拠が必要です。
つまり、IEC 62304に従って、「医療機器ソフトウェア」を開発しなければ、国内外においてソフトウェアを搭載した
医療機器（単体プログラムを含む）を販売することができません。 しかしながら、 IEC 62304は非常に難解です。具体的に、どのような対応をとればよいのでしょうか。
一般にIEC 62304のようなプロセス規格は各社によってまちまちの解釈が行われ、手順書の
内容が大きく異なってしまいます。
・IEC 62304を読んでも、対応すべき内容や方法が分からない。
・IEC 62304を読んでも、どこまでやるべきなのかの範囲が分からない。
・IEC 62304の詳細の内容が、不明なまま文書構築を行っている。
などといった疑問点が多く寄せられます。
本「IEC 62304対応規程・手順書ひな形」を導入いただくことによってIEC 62304に準拠したQMSを効率的・効果的に作成することができます。”]
[blogcard url=https://xn--2lwu4a.jp/qms-md/ title=”QMS（手順書）ひな形 医療機器関連” ]
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