Human Factors Engineering For Medical Device Development
10th Global Drug Delivery& Formulation SummitMarch 12, 2019 - BERLINHuman FactorsEngineering for MedicalDevice DevelopmentR. Vomscheid, PhDDirector, Devices Development &Technologies - IPSEN
PRESENTATION AGENDA Human Factors Engineering: overview & regulatory frameworkPatient-centricity in Device Design and DevelopmentCase study: Development of a New Delivery System for Somatuline Autogel Conclusion10th Global Drug Delivery & Formulation Summit March 12, 2019 – BERLIN - External Ipsen
DISCLOSURE I am currently employed by Ipsen This study was sponsored by Ipsen10th Global Drug Delivery & Formulation Summit March 12, 2019 – BERLIN - External Ipsen
Human Factors Engineering:overview & regulatory framework410th Global Drug Delivery & Formulation Summit March 12, 2019 – BERLIN - External Ipsen
Usability Engineering Process Objectives“The aims of a usability engineering process are to deliver products that are easy to use and safein the intended context of use, and by intended users (whether by carers or patientsthemselves). Users should not have to read, understand and remember complex instructions foruse and adapt to the requirements of the device, or use it in an uncomfortable, incorrect andpossibly dangerous way: a well-designed product will be easy to use, and will have a user interfacethat is consistent with user experiences and expectations.In addition to safety considerations, products designed with human factors principles are morepleasing to use, and are therefore likely to lead to better adherence to correct use, at therequired frequency. Human factors principles are therefore employed by many companies indesign for customer loyalty and marketing purposes.”** MHRA Human Factors and Usability Engineering – Guidance for Medical Devices Including Drug-device CombinationProducts, v1.0, p.13 (2017)MHRA: Medicines and Healthcare products Regulatory Agency (UK)10th Global Drug Delivery & Formulation Summit March 12, 2019 – BERLIN - External Ipsen
Regulatory Landscape Medical Device Development / Human Factor StudiesEUROPEUSARegulation (EU) 2017/745 of the European Parliament andof the Council of 5 April 2017 on medical devices,amending Directive 2001/83/EC, Regulation (EC) No178/2002 and Regulation (EC) No 1223/2009 and repealingCouncil Directives 90/385/EEC and 93/42/EE21CFR820 Medical DeviceQuality System Regulation (and 21CFR part 4cGMP for combination products)ISO 13485:2016 requirements for a quality managementsystem specific to the medical devices industryAAMI/ANSI HE75:2009 Human factorsengineering - Design of medical devicesANSI/AAMI/IEC 62366-1:2015 Medical devices – Part 1: Application of usability engineering to medicaldevicesIEC/TR 62366-2:2016 Medical devices - Part 2: Guidance on the application of usability engineering tomedical devicesANSI/AAMI/ISO 14971:2007/(R)2016 Medical devices – Application of risk management to medical devices10th Global Drug Delivery & Formulation Summit March 12, 2019 – BERLIN - External Ipsen
Key guidances for Human Factor StudiesEUROPEUSAMHRA Human Factors and Usability Engineering – Guidancefor Medical Devices Including Drug-device CombinationProducts, v1.0 (2017)FDA Applying Human Factors and UsabilityEngineering to Medical Devices (2016)EMA PRAC* Good practice guide on riskminimisation and prevention of medicationerrors (2015)FDA Safety Considerations for Product Designto Minimize Medication Errors (2016)EC Guideline on the readability of the labelling and packageleaflet of medicinal products for human use (2009)FDA Human Factors Studies and RelatedClinical Study Considerations in CombinationProduct Design and Development (Draft, 2016)FDA Design Considerations for DevicesIntended for Home Use (2014)* The Pharmacovigilance Risk Assessment Committee (PRAC) is the European Medicines Agency's (EMA) committee responsible for assessing and monitoring thesafety of human h Global Drug Delivery & Formulation Summit March 12, 2019 – BERLIN - External Ipsen
Patient-centricity in Device Design and Development810th Global Drug Delivery & Formulation Summit March 12, 2019 – BERLIN - External Ipsen
DEVICESPATIENT-CENTRICDEVELOPMENTPROCESSUser / Patient testing(Usability/Human Factorstudies)Define & Design(3D modelling)Verification (benchtesting, mechanicalstability, drug/deviceinteractions )Prototyping (3D printing, soft& hard steel molds)Hard tools(steel molds)Soft tools(Alu molds)Designfreeze3D printingFormativeHF* studySummativeHF* studyFormativeHF* studyFormativeHF* studyUserfeedbackUsers &Patients* Human Factors
Review of useerror oncomparableproductsUser Insights(- User requirements)Risk Management ISO 14971Identification of use &environment(- Use specifications)Post-marketsurveillanceRisk assessment of useand use errorPrioritise tasks and user interfacecharacteristics related to safetyDevelop user interface specificationand HF validation planUSABILITYENGINEERINGPROCESSNew UseerroridentifiedFormative testing and design iterationDesign fixedSummative testing / design validationSummary human factors reportDevice LaunchAdapted from MHRA Human Factors and Usability Engineering – Guidance for Medical Devices Including Drug-device Combination Products, v1.0, p.14 (2017)
Risk Management ISO 14971e.g. Acromegaly patients hand size & fingerthickness dexterity & visione.g. use by HCPs or patients inclinical and home environments,deep subcutaneous injection,administered to the upper, outerquadrant of the buttock, or theupper, outer thigh.Review of use erroron comparablePost-marketproductssurveillanceUser Insights(- User requirements)Identification of use &environment(- Use specifications)USABILITYENGINEERINGPROCESSe.g. use the productLife cycle managementevenif Pre-FilledRiskassessment of useSyringe droppedand usebuterrore.g. trainingdoes not lookeffort,damaged, needlestickimprovablePrioritise tasks and user interfaceinjury, do not inject theergonomics, etc.characteristics related to safetycomplete dose, do notNew Useinject in the right site,errorDevelop useretc. interface specificationidentifiedand HF validation planFormative testing and design iterationDesign fixedSummative testing / design validationSummary human factors reportDevice Launch
Review of useerror oncomparableproductsUser Insights(- User requirements)Identification of use &environment(- Use specifications)Risk Management ISO 14971Potential Use Error (Failure Potential Use Error Effectsmode) for the new injection(Failure effects) for thesystemnew injection systemIn what ways can a useerror occur ?What is the impact of theuse error ?Risk assessment of useand use errorPotentialHarmSEVFailure effectoccurrenceRPN*NAHowSevereis theeffectto thepatient?How often doeseffect erroroccur? (quotedhere withouttaking accountany labelling /intuitive t-marketsurveillanceRecommended actionsSEVOCCRPN*Prioritise tasks and user interfacecharacteristics related to safetyNew Use AftermitigationerroridentifiedWhat are the recommended actions forreducing the occurrence of the use error ?Develop user interface specificationand HF validation planAftermitigationFormative testing and design iterationDesign fixedSummative testing / design validationSummary human factors reportDevice Launch* Risk Priority Number
Review of useerror oncomparableproductsUser Insights(- User requirements)Risk Management ISO 14971Identification of use &environment(- Use specifications)Post-marketsurveillanceRisk assessment of useand use errorPrioritise tasks and user interfacecharacteristics related to safetyDevelop user interface specificationand HF validation planUSABILITY N riskENGINEERINGxxPROCESSxxxxTaskNew UseerroridentifiedSuccess CriteriaParticipantselects superiorFormative testing and designiterationSelect injection siteexternal quadrants of thebuttockfixedPush theDesignplunger toParticipant depressesinjectplunger completelyParticipant engages theSummativetestingActivatessafety / design validationneedle safety mechanismmechanismwithout needlestick injurySummary human factors reportDevice Launch
Case study:Development of a New Delivery System forSomatuline Autogel 1410th Global Drug Delivery & Formulation Summit March 12, 2019 – BERLIN - External Ipsen
Ipsen vision & commitment in Acromegaly & NET*201620001995Somatuline LongActing 30 mg;(1/ 15 days)2010Somatuline autogel ready-touse with safety system(1/28 days)2019Somatuline autogel ready-touse, with safety system,new syringe (1/28 days)2001Somatuline autogel 60, 90, 120 mg,ready-to-use (1/ 28 days)2017Xermelo1996201620142018Ruszniewski, Gut 1996; Ducreux, AMGastroenterology 2000;Caplin, NEJM 2014; Vinik Endoc Practice 2016; Kulke, JCO 2016;Pavel et al. Endocrine-Related Cancer 2018*NeuroendocrineTumors
Somatuline Autogel indications(1) Treatment of acromegaly when circulating levels of growth hormone and/or IGF-1remain abnormal after surgery and/or radiotherapy or in patients who otherwise requiremedical treatment.(2) Treatment of G1 and a subset of G2 (Ki67 10%) gastroenteropancreatic neuroendocrinetumours (GEP-NETs) of midgut, pancreatic or unknown origin (where hindgut sites havebeen excluded) in adults with unresectable locally advanced or metastatic disease.(3) Treatment of symptoms associated with neuroendocrine (particularly carcinoid)tumours.Source: 64f3-f344-4821-b9a7-3750eb2a0c60.pdf16Subject - Internal Ipsen/ External Ipsen/ Confidential Ipsen/ Highly confidential Ipsen (delete unnecessarymentions)
Somatuline Autogel – Life cycle management1 delivery system for 3 Somatuline Autogel dosesAddition of a passive safety systemImproved ergonomics & user-friendliness(market user feedback)
218 users gave their feedback to develop the new delivery system 5 User studies for Regulatory submission in EU and USJun-Sep 15FormativeStudy 1Aim : Tounderstand users’experience withthe current onthe-market DS(1)and rank preferredfeatures of DSprototypes basedon users’expectationsAim : To gatherfeedback on aprototype of theDS(1) that had beendeveloped usingresults from thefirst formativestudy71 participants : Acro(3) NET’s (4) patients &Endocrine nurses5 participants whoparticipated to 1ststudyDelivery systemInstruction for Use(3) Acromegaly(4) Neuroendocrine Tumors(5) Healthcare Professionals(1)(2)Dec 15FormativeStudy 2Mar 16FormativeStudy 3Aim : To further testthe new DS(1) inorder to finalise itsdesign (e.g. rubbercoating, colour), andtest user’sunderstanding ofthe IFU(2)48 participants : Acro(3) NET’s (4) patients &Endocrine nursesSep 16FormativeStudy 4Aim : To maximisethe likelihoodthat the productis used safely andeffectively assess the usabilityof various plungerprotectors8 (US) 18 (EU)participants : 8 USHCPs(5), 2 Acro(3) patients,3 caregivers of NET(4)patients, 13 rep. ofpatients & caregiversMay-Jun 17Validation Study(Summative)Aim : To validatethat the productcan be usedsafely andeffectivelyby intended users,for intended uses,in the intendeduse environments68 participants : 35 HCPs(5),33 rep. of patients &caregivers
Somatuline Autogel – New Delivery SystemProtective plastic tray toensure no inadvertentdepression of the plungerwhilst within thepackagingA rigid plunger supportwith flat wide top toprovide stability fordepression with thumbWider & curved wingsto aid those withlimited dexterity(hand size, wearinggloves )What remains the same ?-The formulation and primary containerThe low injection volumeThe syringe body transparencyThe needle size designed for deep sub-cutAn automatic needle safety systemSafety and effectivenessRigid, large andgrippable syringe bodyto aid those withlimited dexterityEasy grip andremoval of the capto aid those withlimited dexterity
CONCLUSIONHuman Factors Engineering: Mandatory for device development. Detailed in US & UE regulations & guidance internationalstandards Patient-centric process by definition Essential for the development of a more ergonomic and user-friendly delivery system forSomatuline Autogel 10th Global Drug Delivery & Formulation Summit March 12, 2019 – BERLIN - External Ipsen
For their support, advice & information presented here, I would like to thank :Ali MajdiBéatrice HacherClémentine MégretCyril NinclausIpsen Publishing TeamLaurent BertocchiMarie GendillouNathalie AudonnetPauline EdmontPhilippe PitchenSolenne PiartXuan Mai Truong ThanhThe authors thank all patients involved in the study,as well as their caregivers and care team in participating institutions.remy.vomscheid@ipsen.com2110th Global Drug Delivery & Formulation Summit March 12, 2019 – BERLIN - External Ipsen
AAMI/ANSI HE75:2009 Human factors engineering - Design of medical devices ANSI/AAMI/IEC 62366-1:2015 Medical devices –Part 1: Application of usability engineering to medical devices IEC/TR 62366-2:2016 Medical devices - Part 2: Guidance on the application of usability engineering to medical devices
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ANSI/AAMI HE74 (2001-2010) “Human factors design process for medical devices” ANSI/AAMI HE75 (2009- ) “Human factors engineering - Design of medical devices” (a Tutorial to HE-74) 37 . US & FDA FDA Human Factors Draft Guidance Document: Agency Expectations for Human Factors Data in Premarket Submissions Applying Human Factors and Usability Engineering to Optimize .
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