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• anatomy

• physiology

• biology

• biochemistry

• biophysics

• bioengineering

• immunology

• mathematics

• statistics

• bioinformatics

• etc…

• Indentify a need

• devide design

• matrerials Synthesis

• Materials testing

• Fabrication

• Sterilizations and Packaging

• Device Testing

• REgulatory

• Clinical Use

• Explant Analysis

Identify a need

• Physician/Dentist

• Researcher

• Inventor

• Entrepreneur

  —> Treat a condition, Replace an organ, cosmetic

Materials Synthesis:

• CEramicist

• Mellaurgist

• Polymer Chemist

Materials testing:

• Bioengineer

• Mechanical engineer

• Biochemist

• Cell biologist

• Veterinary surgeron (Tierarzt)

  —> mechanical properties, Toxicology, Bioreaction to the material, Biostability

Device Testing:

• Bioengineer

• Veterinary surgeon

• Physician/Dentist

Regulatory:

• Regulatory specialist

• Regulatory agency

• Legislators

Explant Analysis

• Pathologist

• Bioengineer

  —> Explant registry, Phatalogical examination, Testing to understand the failure

—> angioplasty balloon catheter for expanding narrowed(verengt) arteries

—> intrasvascular Stent (no removemnt of the stent)

Surgergy —> Bypass surgery

—> active medical products : devices powered by an external source (pacemaker)

—> non-active medical products: acting by gravity or operated by muscle power (endoprothesis)

—> In-vitro diagnostics: devices with a measurement function that can be active ot non-active (bllod glucode mater)

• High Scientific/Technological level and Development Risk

• Significant Length of Time and Amount of Capital Required for Approval

• Understanding and Responding to Regulations Concerning to Medical Care, Pharmaceuticals, and Public Insurance

• Difficulty in Recruiting Highly Skilled Personnel

• Are the components and final product acceptably safe for the intended use?

• Is the manufacturing process capable of delivering a consistent product?

• Does the product perform in the manner intended by the manufacturer?

• Are the risks outweighed by the clinical benefit?

• Increase in public health awareness

• Ageing population

• Low cost alternatives

• Safer biomedical devices

• Life quality vs. life expectancy

• Non-invasive procedures

• What is the projected growth of the patient population?

• Current number of procedures / Number of units sold?

• Current solutions (use, outcome, reimbursed cost, required training and equipment)

• Is your solution incremental or a path-breaking replacement?

• Companies selling the existing solutions: Does your device complement their product or competes with it?

• The path of innovation: What will be the most likely new devices in one, five or ten years

• Number of patients who COULD BE and are LIKELY to be served by your solution

• The specialty that will use your solution, and whether this is a change from current practice

Innovation strategies:

• Customer-oriented

• Market-oriented

• Competition-oriented

• Technology-oriented

• Time-oriented

• Cooperation-oriented

Innocation structure:

• Who looks for ideas?

• Who decides whether to follow up these ideas?

• Who further develops the idea?

• How are the development teams put togheter?

• Which hierarchical levels need to be involved and at which level?

Innovation ressources:

• Provide teaching tools

• Establishing a creative working enviroment

• Establishing a flexible time-frame for innovation

• Provide access to information

Innovation process:

• The innovation process is a systematic process for sucessfully taking a product from bench to bedside —> Stage Gate Process

—>Stages break down the project into discrete, clearly differentiable segments

▪ Gathering of information in order to pass to the next decision step

▪ Interdisciplinary structure (functional project teams)

▪ Gathering of information so as to keep the risk of uncertainty low

Stages:

Needs, Ideas, Selection, Manufacture, Scale-up, Roll-Out

• Meeting of the entire project team

• Coordination via the department heads

• Compiling of all information

• Standarized structure of the gates: 1. Preliminary results (Review) 2. Evaluation criteria 3. Defined outputs

Gates: 1. concept choice, 2. project definition, 3. initial design, 4. final design, 5. product release