Providing biomedical product expertise and consulting to the legal community since 1993
Medical Devices | Biomedical Engineering | Product Design
I am confident that Mr. Simon's contribution was primary, if not pivotal, in forcing the Plaintiff to the table: I am of the opinion that after reading his Expert Report the Plaintiff was concerned that there was a real possibility their patent could be invalidated should the case to go to trial.
-- Patent infringement client
Your technical expertise and willingness to use creative thinking in approaching the design problem allowed me to get an excellent settlement for my client.
-- Product liability client
… his ability to test the product and show decisively that the failure was foreseeable was crucial. Also his rhetorical and writing skills were evident in assisting me with generating the affidavit. In short, Mr. Simon's contributions to the case were critical in allowing my client to obtain a fair and substantial settlement against a large, well-known, and well-defended consumer products company.
-- Product liability client
We have involved Dexterity Design in a couple of major products - one for our medical division and one for our aesthetics division. We have been very pleased with the results of both projects: Their designs are innovative, contemporary, and refreshing. Furthermore, the staff is professional and easy to work with. I recommend them without reservation.
-- Product design and development client
BIO - EXPERTISE IN ENGINEERING, CHEMISTRY, AND BIOLOGY
I am an experienced Biomedical Design Engineer specializing in product design and development for the medical device and biotechnology industries. My company, Dexterity Design, is a Utah-based product design consultancy offering conceptualization, design, development, ergonomics, testing, and pre-production assistance to a range of clients. I also provide project management, IP development, legal support, and bridge-to-manufacturing services. I am a Materials Scientist (B.S.) and Biomedical Engineer (M.Eng.) with over 35 years’ experience (mainly Medtech and Biotech products, as well as other product sectors, including recreational, consumer, and industrial goods). As a 25-year user of SolidWorks® CAD-ware, I am adept in the ideation, visualization, rapid prototyping (including 3D printing), and manufacturing processes of a wide variety of products, particularly those utilizing polymeric materials. I have designed and implemented durable instruments as well as disposables and consumables; my areas of product development include a wide array of therapeutic and diagnostic technologies. I am also the Managing Partner of Acme Biosystems LLC, a seed-stage biotech company in Salt Lake City developing advanced gas-permeable cell culture systems.
PRODUCT EXPERIENCE - BIOMEDICAL / BIOTECHNICAL DEVICES AND INSTRUMENTATION
Drug delivery including ports and blood access devices, wearables and implants,
Transdermal and percutaneous devices (diffusion and iontophoresis)
Stem cell culture and delivery
Cardiac devices / Vascular devices
Biosensors including PCR, SPR, and TIRF
Bone fixation / orthopedics
Dental devices and instruments
Ophthalmic devices / Ocular diagnostics / optical systems
Catheters and needle devices
Fluidics and microfluidics, cartridges & cassettes, pumping & actuation, test platforms, disposables
Cell & tissue cultureware / Cell growth surfaces / Tissue-Material interface
Device sensing including IV-based blood pressure monitoring
Surface treatment and modification, coatings
Laboratory devices, instrumentation, and consumables
Immunoassay and other in-vitro diagnostics
Dermal devices including phototherapy, dermabrasion, ultrasound, aesthetics, and ectoparasite (headlice) treatment
Incision closure / Wound healing
Handpiece and probe design / housing and enclosure design
Instrument housings & enclosures
Molded climbing walls
Design and failure of sunglasses and ski goggles including lenses and frames
Industrial products - traffic barriers, crowd control barriers, fluid connectors, and employment services (time-clocks)
Recreation and sport products - climbing, skiing, watersport, and performance apparel
Consumer goods - key accessories, fasteners, kitchen items, and apparel (softgoods)
CONSULTING FOR PLAINTIFF AND DEFENSE
> Successful resolutions for both plaintiff and defense
> Areas of litigation:
Breach of contract
> Skill set:
Technical analysis - medical devices and laboratory tools, biomaterials, engineered devices; materials testing and failure analysis, mechanical review
IP - patent search and review, claims construction, claim chart generation
Expert reports - history of the technology and technical tutorials (simple explanations of the technology), prior art, claim charts, expert opinion
Attorney support - assistance in construction of briefs, affidavits, and interrogatories
RANGE OF CASEWORK
consumer health products
BREACH OF CONTRACT
cell culture devices
Have a client who requires an independent technology assessment? My experience and knowledge of products, design, R&D, markets, and IP can assist you.
For more information about my skills and experience, please contact me using the email inquiry below.
GALLERY OF WORK
A range of product design expertise: Biomedical, Consumer, Recreational, and Industrial