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Medical Device Design and Product Development Engineering Whether you are a medical professional with a great idea for a new product or a medical device firm looking to outsource a project, MedSpark offers the ultimate platform to exponentially expand your product's intellectual property value. MedSpark offers a unique blend of product development expertise that ensures every step of the process, from concept through divestiture, is completely covered.

We have a passion for concurrently integrating Industrial Design techniques, Engineering fundamentals, IP Protection, and Manufacturability analysis - yielding products that incorporate aesthetically appealing form, ergonomics, and flawless function.

Product Development Engineering

Medical Device Design and Product Development Engineering The MedSpark team has tremendous experience engineering Medical Devices, Implants, Surgical Instruments, Durable Medical Equipment, and Capital Equipment. Although we strive to keep designs as simple as possible, frequently one or more specialties of engineering are required to create devices that function effectively and reliably. We can tackle any engineering hurdle from smoothly operating planetary gear systems to electronic systems for handheld wireless devices. Our Product Development Services Include:

  • Mechanical Engineering - Applied Mechanics, Kinematics
  • Biomedical Engineering - Biocompatibility, Biomechanics, Biomechatronics, Biotribology
  • Electrical Engineering - Mechantronics, Electronics
  • Manufacturing Engineering - DFM, DFA, MPM, MPP, MRP
  • Value Engineering
  • Computer Aided Engineering - FEA, CFD, CAA, Virtual Engineering
  • Reverse Engineering - Laser Scanning, CMM Arm, White Light, Computed Tomography
  • Risk Analysis
  • CAD Drawings - Manufacturing Prints, GD & T

Industrial Design

Industrial Design in Medical Devices and Products MedSpark integrates applied art and science into one through Industrial Design. Utilizing Industrial Design techniques helps develop products with improved aesthetics, optimized usability, marketability, and ergonomics. The marketability of new products can weigh heavily on aesthetics, therefore when suitable, we design products with organic, free-form surfacing.

We take functionality to the next level by communicating with you, and focus groups as needed, to optimize the users' modes and methods of interaction with the device. We design products that consider ergonomics to ensure that the user feels as connected and comfortable as possible when using the product. Our Industrial Design Services Include:

  • Ideation / Concept Development - Design Thinking, Lateral Thinking, Lead User
  • Human Factors Engineering
  • Ergonomics
  • Activity Centered Design
  • User Centered Design - Contextual Design
  • Usage Centered Design
  • Participatory Design (Cooperative Design)
  • Anthropometry
  • User Interface Design - HCI, IxD

Research

Medical Device Clinical Research and Trials One of the most important, yet many times under-utilized, aspects of product development is research. The MedSpark team performs several types of research throughout your product's development cycle to make sure your product will be on-track for success.

To ensure we maximize your product's market share, MedSpark conducts market research, technology assessment, and competition analysis to make sure your design is optimized to capitalize on your competitors' design weaknesses. Prospective, protocol-driven research speeds product development, decreases regulatory approval times, facilitates marketing efforts, and lowers product liability exposure.

Verifying your product's Freedom To Operate in the marketplace is one of the most important steps in the Product Development process. At MedSpark we thoroughly analyze the existing patent landscape to minimize the risk of Patent Infringement. Many times it is possible to design around your competitors' patent claims - Something that is only possible if we know they exist.

Assessing the needs of your product's users (Voice of the Customer, VoC) is another critical component of successful product development. MedSpark can focus in on your Target Market and determine what their needs are, such as improved mechanical function or enhanced ergonomics. Our Research Services Include:

  • Market Research - Target Market, User Input, Competitive Product Analysis, Market Intelligence
  • Patent Searches and Analysis
  • Freedom to Operate Analysis
  • Pre-clinical Research
  • Clinical Research

Prototyping and Manufacturing

Medical Device Prototyping and Manufacturing Once the product concept has evolved far enough, we will build prototypes to validate certain aspects of the design, such as ergonomics, mechanical function, user satisfaction, durability, and reliability.


Manufacturing Engineering is an integral part of our development process. Its fundamental role in the profitability of a product ensures that it remains an important consideration throughout the product evolution. At MedSpark we have extensive hands-on experience with nearly every commercially available manufacturing technique, which allows for a much more fluid transition between designs on paper and real product. Our Prototyping and Manufacturing Services Include:

  • Rapid Prototyping - FDM, SLA, DMLS, EBM, LOM, 3D Printing
  • Direct Machining - Milling, Turning, Grinding, EDM, Broaching, Water Jet
  • Welding - TIG, Electron Beam, Laser
  • Forming - Bending, Forging, Stamping, Extrusion, Spinning, Hydroforming, Rolling, Drawing, Superforming
  • Casting - Investment, Centrifugal, Shell Molding, Die, Vacuum
  • Molding - Plastic Injection, Overmolding, LIM, RTV, MIM, Blow, Rotational
  • Tooling - Injection Molds, Forging Dies, Stamping Dies, Bending Forms, Machining Fixtures
  • Textiles - Material Selection, Sewing, Harnesses
  • Surface Treatment - Anodization, CVD, PVD, Passivation
  • Heat Treating
  • Materials Selection - Metals, Plastics, Composites, Ceramics, Fabrics
  • Medical Device Packaging - Tyvek, Thermoformed PETG, HIPS, PETE, and RPET
  • Good Manufacturing Practice (GMP)

Intellectual Property

Your product is only as valuable as the patents protecting it. We work closely with you to develop and protect your intellectual property rights. Prior Art searches, Freedom-To-Operate Analyses, and Claims language development are performed in concert with experienced patent attorneys to maximize the value of your intellectual property. MedSpark can work with you to license your developed technologies to major manufacturers in exchange for a combination of cash, stock, and/or royalties. Our Intellectual Property Assistance Services Include:

Intellectual Property
  • Prior Art Patent Searches
  • Provisional Patent Applications
  • Regular Patent Applications - Utility and Design
  • USPTO Patent Filing and Prosecution
  • Intellectual Property Licensing

Regulatory

FDA Clearance, MDD, and CE Approval for Regulated Medical Devices Medical devices are highly regulated throughout the global economy. In the United States most medical devices require FDA approval prior to commercialization. The European Union requires devices to bear a CE mark provided by a company who has made an independent assessment of the manufacturing company's compliance with the quality system standard EN ISO 13485:2003. Other countries, like Japan, have their own regulatory requirements.

Wherever you plan to market your new product ideas, we can help you navigate the regulatory hurdles required to achieve your goals. Our Regulatory Assistance Services include:

  • 510(k) Development - Design History File
  • FDA Submissions - 510(k), PMA
  • Other Regulatory and Product Safety Submissions - CE, UL
  • Medical Coding and Reimbursement Analysis

Testing

Medical Device Testing During the design process testing can be used for proof of concept, design iteration, and specification validation. At the end of the design process, there are often mechanical and/or clinical tests required for regulatory submissions. Whatever stage of the design cycle, the MedSpark team can manage the testing you need to achieve your product design goals.

  • Prototype Testing - Ergonomics, Function, User Satisfaction
  • Mechanical Testing - Fatigue, Stress, Impact, Environmental, Durability, Reliability
  • Pre-Clinical Testing - Animal (In Vivo), Cadaver (In Vitro), Wet-Lab
  • Clinical Testing

Project Management and Business Support

Project Management, Business Planning and Divestiture If needed, we can also assist you with the business-related aspects of your project. We're not here just to design a product for you - We're here to increase patients' quality of life and to ensure you and your product achieve a high level of commercial success. Our Project Management and Business Support Services Include:

  • Business Planning - SWOT, TQM, TTM, Value Proposition
  • Capitalization
  • Divestiture

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