V2

• diagnosis

• cure (Heilmittel)

• mitigation (linderung)

• treatment

• prevention of diseases or conditions

• pharmalogical

• immunological

• metabolic means

—> engineering-base physical objects:

• usually hava a localization treatment effect

• can become obsolete wthin months

• more frgamanted industry of midsize companies

• tend to require significant user interaction

—> chemistrs base compounds:

• often systematic application

• innovation cyclles 10-20 years

• small number of large companies

• shelf-life requirements play more significant role

1. Review of standard operating procedures (SOPs)

2. Identification of functional groups involved in device development

3. First round of interviews with focus on R&D: perspectives, activities, decisions…

4. Initital draft development modell

5. Second round of interviews: feedback, additons, changes 5 Distinct decline of proposals leads to convergence

6. Third round of interviews: accuracy assessment, no additonal adjustments

• internal R&D

• patiens

• physicians (Mediziner)

• competitors

• clinical literature

• direct observations

• Cooperation with universities, hospitals and other companies (—> becomes increasingly important): Consolidated collaboration (enge Zusammenarbeit), Establishment of a network of cooperations

• Most important cooperation partners: patients: Early involment of patients essential, win-win situation

• Identification of clinical needs

• Reductions of needs in funnelung (Trichter) process

• Selection of a need ans proposed concept

• How do phyicians/patients (miss)use the product?

• Which needs does the new product have to meet?

• What are unresolved issues using the current product for the patient?

• Which need is the most promising in terms of feasibility

• Which related concept should be pursued further?

• The potential product is evaluated in terms of the potential market.

• What are the strengths and weaknesses of the product and what does the product offer the customer as added value?

• What are possible competing products on the market and what is the "danger" of competitors?

• The selected concept is presented by the development team to the management. —> Management decides wheater to continue

—> At this point, decisions are often made in favor of the project and not looked at critically enough because the developers should still be given a chance for the project or because the original idea came from management.

• Market analysis /competitive assessment: market size ans groth potential, product positioning ans launch strategy without cannibalizing existing sales, SWOT analysis

• lega/IP analysis: Preliminary search of patents, Establisg design boundaries, Risk classification ans assessment based on IP landscape

• Risk classification of medical devices: class 1 (low risk), class 2a (low to moderate risk), class 2b (moderate to high risk), class3 high risk

• financial review: Calculating sales projections and projected gross margins, Time dependence of market introduction (e.g. pros and cons of first mover)

• Regulatory path: Identifying domestic regulatory path based on device and market entry point, EU: conformitee europeenne (CE) mark needed for market access

  -> Regulatory requirements play an important role in shaping activities and decisions in the process

  -> Non-adherence to regulatory can lead to significant delay or discontinuation of development

• Reimbursement (Entschädigung) path: Secure a payment strategy: the amount that insurers and users might be willing to pay for the proposed technology, Reimbursement: The payment of medical procedures with the aid of medical devices by the statutory health insurance.

SWOTS = Strehnghts, Weaknesses, Oppourtunities, Threats

Key deliverable: business plan • Critical to receive project approval from management • Critical to receiving resources for the project or capital from investors

• Project core team selection: Cross-functional project team consisting of members from different departments; Initiating design history file (DHF) according to DIN EN ISO 1345; General project plan and timeline

• Concepts and prototype analysis: Brainstorming sessions; Designs are frequently changed; Protypes are evaluated: Rapid prototyping, Computational fluid dynamics (CFD) ..

• Risk analysis (identification and quantification of risks) and risk management (mitigation of the identified risks) according to DIN EN ISO 14971: Failure mode and effects analysis (FMEA); Fault tree analysis (FTA)

• Technical risks

• Market risks (reimbursement)

• Regulatory risks

• Patent law obstacles

• External influences

• process design

• market analysis

• patent research

• regulatory path

• communication

• experiments

Product development is ready to begin:

• Product risk is acceptable

• Manufacturing has been assessed

• Technical feasibility is proven and optimized

Gate 3 is the most critical gate because the subsequent “Manufacture” section is very costly.

—> Probability of project termination is highest at this Gate

• Verification: : Establishing conformance of design outputs to design input

• Validation: : Establishing conformance that final product meets user needs

  -> Verification and validation (V&V) test matrix ist created by cross-functional team members

• Regulatory: Submitting design and test data to responsible agency for review and regulatory approval; Submitting an investigational device exemption (IDE) to allow the device to be used in a clinical study (if necessary)

• Process control: Initiation of process FMEA (pFMEA); Process validation plan for good manufacturing practices (part of QS regulation)

Commercialization readiness:

• Design output meets targets

• Risk mitigation confirmed

• Regulatory submisson testing complete

-> Design freeze

-> Ramp-up readiness

• Approval: Regulatory approval/clearance as a key requirement for medical device launch, Finalization of Reimbursement, Risk management, Establishing a quality system; Clinical validation continues before and after approval has been granted

• Process validation: Formal manufacturing prints for compontens and assembly-level drawing; Manufacturing efforts are often scaled-up in preparation for high-volume development, Final process validation is executed

• Sales launch preparation: Establish market launch plan/forecast (Choice of appropriate distribution channels , Identification of limited market release (LMR) sites for soft launch), Product branding (Determine an appropriate product name, Create a new logo for the device), Equip sales representatives (Surgical technique guide, Videos illustrating product use, Sample product kits for physicians)

Product release is prepared:

• Final validation

• Stable manufacturing process

• Sales representatives are equipped

—> Device is ready and cleared for launch, from an IP and regulatory perspective

Post launch activities:

• Continual improvements: product itself or the processes used to create the product: Label change when an aspect is not properly indicated on the instructions, Changes to satisfy the request of a specific customer, Total product redesign when there is a major flaw and/or recall by regulatory

• Implementation of post-market surveillance system

• Successfully proven in a limited number of facilities -> widespread distribution: Peer-to-peer physician education model is often used to promote rapid product adoption

• Trade shows: are one of the best ways to promote new products (especially in the B2B segment); Product demonstration possible; Exchange with other manufacturers/dealers and potential customers; Establish contacts, important for later e-mail marketing

• The stage-gate process is a linear model and therefore simplified -> Many processes within the model are likely to be iterative

• Because of iterations, some parts may already be in a more advanced phase than others -> Fuzzy boundaries between gates

• Iterations of high-cost activities (e.g. clinical trials) should be avoided

Late design freeze may reduce likelihood of subsequent iteration, but can lead to substantial delay in bringing the product to the market

• Applies to a broad range of medical technologies and innovation settings

• Strike a balance between sufficient process rigor and room for fexibility/creativity

  • Evolutionary product development: benefits from structure

  • Revolutionary product development: catalyzed by a less rigorous process environment