Medical devices

Medical Devices

Allergic conditions

  • Focus groups assessing patient experience with nasal spray in allergic rhinitis, analysis of results and development of a report on concept elicitation and cognitive debriefing
  • Validation of the preference module of the Experience with Allergic Rhinitis Nasal Spray Questionnaire (EARNS-Q)
  • Manuscript on the development of the EARNS-Q
  • Regulatory support for the EARNS-Q
  • Preference questionnaire on allergic rhinitis spray devices

Cardiovascular disease

  • Demonstrating the value of a transcatheter heart valve in aortic stenosis
  • Gap analysis of PRO measures to substantiate labelling claims in angina trials of a drug-eluting stent (DES)
  • Development and validation of patient and clinician tools for myocardial infarction imaging
  • Analysis and reporting of myocardial infarction imaging validation study data
  • Clinician and patient satisfaction in an observational study in myocardial infarction SPECT imaging
  • Validation of clinician and patient questionnaires for myocardial infarction imaging
  • Demonstrating the value of a transcatheter heart valve in aortic stenosis
  • General consulting on a new stent device
  • Report on the cost of diagnosing vascular diseases with an MRA as the primary imaging modality

Central nervous system/neurology

  • Advisory board for a clinical screening tool for overactive bladder in multiple sclerosis (MS)
  • Development and validation of a clinical screening tool for overactive bladder in MS
  • Validation of a brief series of questions with a subgroup of MS patients

Dermatology

  • Testing PRO measures in electronic devices for rosacea

Endocrinology and metabolic diseases

  • Development of a manuscript on patient perceptions of prefilled insulin delivery devices
  • Consultation on a market research study on patient perceptions of pre-filled insulin pens
  • Injection Pen Assessment Questionnaire (IPAQ) field study in growth hormone deficiency
  • Establishing support of content validity for the modified Injection Pen Assessment Questionnaire (IPAQ) in growth hormone deficiency
  • Development of an instrument to assess subject perception of two gastric bands in obesity

Gastrointestinal diseases

  • Development of a global value dossier and budget impact model for capsule endoscopy for colonoscopy
  • Global value dossier for a therapy device in refractory ascites
  • Translation to support development of a value dossier and budget impact model in capsule endoscopy for colonoscopy
  • Patient Assessment of Constipation Symptoms (PAC-SYM) and analysis of a skin patch containing an opioid pain medication
  • Managing patients with stoma: Adaptation of a Quality of Life Index (QLI) questionnaire to current needs for colostomy patients

Haematology

  • Development and testing of a novel web-based tool to evaluate patient preference for a reconstitution device for haemophilia A in a real-world setting

Immunology

  • Strategic consultancy on physician attitudes and preferences regarding adult vaccinations
  • Demonstrating the value of antibiotic resistance testing software
  • Measurement strategy to demonstrate efficacy of medical devices in patients with pigmented villonodular synovitis (PVNS) or tenosynovial giant cell tumour (dTGCT)

Infectious diseases

  • Systematic literature review on the indirect protection from the HPV vaccination
  • Value demonstration and implementation plan for a new HPV test
  • Value pack for a HPV vaccine
  • Training sales reps on an interactive model for a HPV vaccine
  • Update of a budget impact model for a HPV vaccine
  • Cost-effectiveness analysis of a HPV vaccine for Spain
  • HTA submission for a HPV vaccine
  • Manuscripts on the German and Spanish cost-effectiveness analysis of a HPV vaccine
  • Analysis and reporting on the budget impact of a HPV vaccine
  • Two manuscripts on an influenza vaccine for patients at risk and patients over 65 years old in France
  • Conference poster on the cost effectiveness of adjuvant influenza vaccination in France
  • Update of a value dossier on an influenza vaccine
  • Cost-effectiveness analysis of an influenza vaccine
  • Review of influenza vaccine uptake data
  • Updating an economic model of influenza vaccination (phase 1) – update of a model in patients aged over 65 years in France and the UK
  • Communications package for an influenza vaccine
  • Economic value dossiers for influenza vaccines in a) an unprimed paediatric population and b) a primed school age population (intranasal delivery) including literature review, gap analysis and recommendations
  • Economic evaluation of a workplace influenza vaccination in Russia
  • Communication of the economics of an influenza vaccine
  • Manuscripts on the health economics of a pneumococcal vaccine
  • Brief adaptation of a Markov model for a HPV vaccine
  • Adaptation of a Markov model on a HPV vaccine to Belgium
  • Development of a rationale for the need for a HPV vaccine
  • Communications package for an influenza vaccine
  • Adaptation of an influenza vaccine model to Belgium
  • Regulatory support for the validation of a questionnaire for influenza vaccination

Oncology

  • Cognitive debriefing interviews to assess usability of an ePRO device for use in forthcoming clinical trials in ovarian cancer

Ophthalmology

  • Formal recommendations on a regulatory briefing document for intraocular cataract lenses
  • Development of a PRO questionnaire to assess implantation of an intraocular lens in cataract patients
  • Cognitive interviews for the development of a PRO to assess intraocular lenses in cataract patients
  • Scientific dissemination of the patient-reported intraocular lens questionnaire
  • Etiology and meta-analysis of posterior cacular opacification comparing two lens types
  • Support on the intraocular cataract lenses (IOL) Expert Focus Group
  • Manuscript on HRQoL trial results of a new lens

Respiratory system

  • Global value dossier update and e-v@luate upload for an asthma device
  • Value proposition for a new metered dose inhaler to treat chronic obstructive pulmonary disease (COPD)
  • Structured literature review and qualitative interviews with payers/HCPs on a device for COPD
  • Development of a mini global value dossier for an asthma device
  • Structured literature reviews for paediatric wheeze detection
  • Rapid structured literature review of nebulisation inhalation efficiency in paediatric asthma and other respiratory conditions
  • Validation of the preference module of the Experience with Allergic Rhinitis Nasal Spray Questionnaire (EARNS-Q)
  • Manuscript on the development of the EARNS-Q
  • Focus groups assessing patient experience with nasal spray in allergic rhinitis, analysis of results and development of a report on concept elicitation and cognitive debriefing
  • Regulatory support for the EARNS-Q
  • Preference questionnaire on allergic rhinitis spray devices
  • Update to the pilot inference model for an inhaler used in the treatment of asthma
  • PRO strategy support for an inhaler treatment for COPD
  • Exit interviews on a connected inhaler system for asthma

Surgery and wound care

  • Training in a manual compression device for surgery
  • Strategic review of European market access potential for a surgical device
  • Value demonstration on a new wound care technology and the cost of pain management, allowing data to be tailored for local markets and local payers
  • AMCP dossiers for several surgical products
  • Identification of data inputs for a Canadian budget impact model in surgery

Urology and urogenital diseases

  • Systematic review of lithotripters for ureterolithiasis

Women’s health

  • Manuscript publication on a monthly contraceptive device
  • Modification, development and validation of an existing tool in order to explore satisfaction and tolerability for an intrauterine device (IUD) versus oral contraceptives
  • Modification of the EVAPIL-R in order to explore tolerability for an intrauterine system (IUS) versus an implantable contraceptive

Other

  • Value strategy training on access to medical devices
  • Panel and presentation on PRO research on medical devices