HCP Guidance for Creation
of Collateral Material

• To provide guidance to HCPs in the creation of material which is intended to be delivered during a Stryker sponsored event.
• This document applies to material created by non-Stryker personnel which is intended to be used during an event which is sponsored by an entity within the Stryker EMEA sales division.
  

• HCPs who are not operating under control of Stryker QMS and are employed by organisations outside of Stryker, shall follow the applicable policies and procedures of that organisation relating to contracting with third parties
  • This may include the requirement that the organisation’s legal function perform review of documents for external use
• Ensure Data is accurately transcribed from the source documents
• HCPs are advised to complete the self verification checklist below

Ensure that supporting documents for claims are provided, this includes: 

• Source documents, example those used to substantiate claims
• Manufacturer supplied information
• Clinical Trial/Study reports
• Articles / journals

GDPR: Data Protection
Comply with data protection regulations concerning patient confidentiality

• Use of patient names should be avoided
• High level patient demographics may be used, providing that this does not use information which allows identification in any way, for example a smart code which encodes patient characteristics such as age, race, sex, domicile

Target Audience
The collateral material should be appropriate for the target audience and set objectives of the document. Consider level of expertise in the device and medical knowledge, especially when using technical language. Avoid the use of jargon when the audience includes those from outside the medical profession.  

The target audience for HCP presentation may include, but is not limited to: 

• Stryker personnel
• Sales or marketing personnel
• HCPs: surgeons, nurses, treating physicians, care workers, ambulance drivers, other healthcare workers
• HCPs: users or operators of a devices
• HCPs: purchasing and procurement, those responsible for, or who have an influence on, purchasing decisions
• Technicians: responsible for installation, service or maintenance of a device
• Patients:  
  • Note that there are strict regulations concerning the marketing/promotion of devices directly to patients
  • When there are patients or general public representation in the audience, the presentation should be focused on education and device usage

Consider the objectives and Purpose of the Document

Objectives may include:

• Provide information on device performance
• Provide information on device usage, servicing or installation
• Provide information on device characteristics
• Training on device usage

General

Third party speaker material concerning regulated products shall not: use text, names, trademarks, pictures, symbols or other signs that may mislead the user or the patient regarding the device's intended purpose, safety and performance.

Information provided within collateral material shall be:

• Accurate 
• Correct
  • Including information such as part numbers and product descriptions
• Complete

Include standard disclaimers: 

• If applicable: [Name] is a paid consultant of Stryker. The opinions expressed by [name] are those of [name] and not necessarily those of Stryker. Individual experiences may vary. 
• If applicable: The data included in this presentation was collected and owned by the surgeon author of this presentation. The data was not collected by Stryker.

Copyright

Material shall comply with applicable laws and regulations concerning copyright permissions. 

Where Stryker or the HCP does not own the copyright to use photographs, artwork or videos permission shall be obtained to use and reproduce the material concerned.

Claims

All claims shall be substantiated at the time of initiation:

• Do not ascribe functions or properties which the device does not have
• Statements must be factually accurate, balanced, fair, objective and supported by scientific evidence.
• Statements must be consistent with on-labeluse
• Statements must not mislead the intended audience directly or indirectly by implication, distortion, exaggeration or undue emphasis
• Do not create false impressions regarding treatment or diagnosis
• Evidence must be scientifically robust 
  • If specific statements are disputed among scientists, this should be made clear within the collateral material  
• The references and titles of supporting documentation which is used to substantiate claims shall be recorded
• Link each claim to the appropriate document which supports the claim
  

It is advised to avoid: 

• Efficacy claims, that can imply a promise of success if used as general statements
• Words such as effective, efficient, reliable, dependable, or precise 
  • Unless robust supporting data is used
• Safety claims
  • Unless the safety features that can be substantiated with objective evidence
• Superiority claims (superlatives) unless there is a clear fact about a device:
  • Best in-class, world class, unparalleled, optimal, maximum, minimum, exceptional, perfect, has set the standard

Device Usage and Labelling

Do not promote or suggest off label usage of a device, i.e. using a device outside of the intended purpose for which the conformity assessment process was carried out and approved.  

• The intended purpose of a device is documented within the labelling and IFU of the device
• A standard disclaimer may be added to the document which states that product should be used in compliance with the intended use, as documented within product labelling.
  • Stryker does not advocate off-label usage of devices

Product Performance

Statements about product performance shall be supported with factual evidence. Factual evidence may be:

• Documented within information supplied by the manufacturer, for example within labelling, IFU or service manuals
• Independent testing of a device
• Information from approved clinical trials or studies
• Patient case studies

Product Safety and Associated Risks

Verify that the document notifies readers of the risks associated with the use of the device, when it is used in line with its intended purpose, as documented within manufacturer supplied information. 

• Advised to refer directly to the IFU for information on associated risks and contra-indications

Product Comparisons 

Do not make negative or derogatory comments about other product.

Do be factual and objective:

• Results from the French clinical study, reference EU-2020-ABC, indicated that the Triple X hip system had a survival rate of 98% at 10 years compared to the industry average of 90%.  
  • Factual comparisons can be made to competitor product providing that available evidence supports the claims, example the competitor IFU for comparison devices

• If the objective is to encourage customers to upgrade to new generation product, ensure that comparisons do not suggest performance issues with the previous device, but are due product improvements, new technology for example:
  • The System 8X power tool uses new generation battery technology, which means a lighter and longer lasting battery than previous generation product
  • A matrix / table of product characteristics can be used to illustrate product characteristics and features, providing evidence supports the information provided within. See example below:

Documentation from Clinical Trials and Studies

Figures and statistics must be accurate, quoted verbatim and represented without opinion. 

Claims need to be supported by appropriate reference from a peer reviewed journal, presentation or poster.

Reference material must not reference off label use of products.

Referencing Style

All references should be in AMA format, see below for examples.

Print journal article with six or fewer authors: list all authors

Janda JM, Abbott SL. The genus Aeromonas: taxonomy, pathogenicity, and infection. Clin Microbiol Rev. 2010;23(1):35-73.

Kazerouni NN, Currier RJ, Hodgkinson C, Goldman S, Lorey F, Roberson M. Ancillary benefits of prenatal maternal serum screening achieved in the California program. Prenat Diagn. 2010;30 (10):981-987. 

Print journal article with more than six authors: acceptable to use ‘et al’

English PB, Sinclair AH, Ross Z, et al. Environmental health indicators of climate change for the United States: findings from the State Environmental Health Indicator Collaborative. Environ Health Perspect. 2009;117(11):1673-1681. 

Online journal article with six or fewer authors; article has a DOI:

Florez H, Martinez R, Chakra W, Strickman-Stein M, Levis S. Outdoor exercise reduces the risk of hypovitaminosis D in the obese. J Steroid Biochem Mol Bio. 2007;103(3-5):679-681. doi:10.1016 /j.jsbmb.2006.12.032. 

Online journal article with more than six authors; article does not have a DOI:

Siris ES, Miller PD, Barrett-Connor E, et al. Identification and fracture outcomes of undiagnosed low bone mineral density in postmenopausal women: results from the National Osteoporosis Risk Assessment. JAMA. 2001;286(22):2815-2822. http://jama.ama-assn.org/cgi/reprint/286/22 /2815. Accessed April 4, 2007. 

Journal article with no named author or group name: 

Centers for Disease Control and Prevention (CDC). Licensure of a meningococcal conjugate vaccine (Menveo) and guidance for use - Advisory Committee on Immunization Practices (ACIP), 2010. MMWR Morb Mortal Wkly Rep.2010;59(9):273. 

Conference poster: 

Smyth ME, Caurdy-Bess L. Legal aid for children: a medical-legal partnership supported by CATCH funding. Poster presented at: 2010 Medical-Legal Partnership Summit; March, 2010; Arlington, VA.

Conference presentation:

Smith J. The benefits and challenges of medical-legal partnerships. Oral presentation at: American Public Health Association Annual Meeting; June, 2011; Minneapolis, MN. 

Book: 

Brownson, RC. Evidence-based Public Health. 2nd ed. New York, N.Y.: Oxford University Press; 2011. 

Book Chapter:

Guyton JL, Crockarell JR. Fractures of acetabulum and pelvis. In: Canale ST, ed. Campbell's Operative Orthopaedics. 10th ed. Philadelphia, PA: Mosby, Inc; 2003:2939-2984. 

Online Book:

Rudolph CD, Rudolph AM. Rudolph's Pediatrics. 21st ed. New York, NY: McGraw-Hill Companies; 2002. http://online.statref.com/Document/Document.aspx?DocID=1&StartDoc=1&EndDoc=1882&FxID=13&offset=7&SessionId=A3F279FQVVFXFSXQ . Accessed August 22, 2007. 

Webpage:

Fast facts. National Osteoporosis Foundation website. http://www.nof.org/osteoporosis/diseasefacts.htm. Accessed August 27, 2007. 

Official organization report published on a webpage:

Office of Women's Health, California Department of Public Health. California Adolescent Health 2009. http://www.cdph.ca.gov/pubsforms/Pubs/OWH-AdolHealthReport09.pdf. Accessed January 5, 2011.