medical device overview greg browne 2014

Product Development LeaderProgram Manager

15 years of Product Development Experience

7 Years in Consumer Product Development

8 Years in Human-Centered Medical Device Design

Manages multiple cross-functional design and engineering teams across N America

Expert in Design Management processes

Experienced system engineer

Expert in usability and user research

Expert in Agile development methodologies

Extensive knowledge of prototyping and production tech-nologies

Mentor

Multiple Issued Patents and Design Awards

Device Concept DevelopmentMedical Device R&D

Greg Browne Device R&D Manager/ Device Design Lead Experience

©2014 All Rights Reserved Gregory Browne. Not To Be Reproduced Without Written Permission.

Hands-on Knowledge Of The What It Takes To Get A Medical Device To MarketI have a good working knowledge of medical device regulatory and engineering standards and have helped formulate the product development strategies for many Class I and II devices. My project management experience includes leading several of these projects from conception through to transfer and ISO 13485 manufacture.

For products to be marketed in the US, it is imperative that one identify the reimbursement strategy and 510(k) predicates early. Regulatory Path decisions will impact greatly on the design, engineering and execution of a new medical product.

As a project manager I am adept at knitting regulatory needs with the design innovation and product development process..

IEC 60601 Edition 3

IEC 60601-1

IEC 60825

IEC 62366

IEC 62304

ISO 14971

ISO 13485

HEALTH CANADA

FDA FDA 510(k)

Device Development ProcessMedical Device R&D



A Broad Understanding Of The Clinical Workplace and End-User NeedsA human-centered approach to design and engineering development contributes greatly to the safety and success of a new device. FDA recall studies indicate that 44% of medical device recalls are a result of user error linked to the poor design of a product.

I have good working knowledge of users, protocols, equip-ment and environments and have logged hundreds of hours observing procedures, and working with physicians and providers at institutions across N America.

I am an advocate of the human-centered engineering processes and techniques described in IEC 62366:2007 and ANSI HE75 and have led qualitative and quantitative usability studies for many different types of devices.

Cardiothoracic Surgery

Perfusion

GI Surgery

POC IVD Devices

Interventional Cardiology

IVUS

Electrophysiology

Atrial Fibrillation

Bedside Ultrasound

ER (Trauma, Critical & Acute Care)

Orthopedic Surgery

Pediatric Oncology

Hospital Pharmacy

Civilian/ Military Tactical EMS

Tissue Pathology

IV & Intrathecal Drug Injectors

Flow Cytometry Laboratories

Dental Bridge Repair

Ophthalmic Devices

IMRT Treatment

Hospital Information Systems

Credentialling & Billing

PACS and DICOMM

Users & Usability ResearchMedical Device R&D



A Track Record Of Innovation And Generation Of New IP

I relish the challenge of taking multiple inputs and turning them into award-winning product offerings. I am a prolific inventor who relishes tackling mechanical and software design prob-lems. I am able to lead design teams through ideas and lines-of-thought quickly on paper using rough proof-of-principal prototyping methods as necessary to quickly establish the merit of ideas. I am experienced in a variety of different brainstorm techniques.

Elegant design thinking, innovative engineering and intuitive usability are the results a thorough idea development process and team effort. It is critical to get this right as it will define the character of the final device.

Issued device patents:

2010/0298831 A1 (United States )

8,292,891 (United States )

D633,199 (United States )

WO2013105986 A2 (United States )

13/083,360 (United States )

EP2355770 A1 (Europe)



D680652 S1 (United States )


2010/0025609 A1 (United States )

Device InnovationMedical Device R&D



Delivering Sophisticated Design Solutions Appropriate For Engineering DevelopmentAward-winning medical devices marry sophisticated technology platforms with great usability and influences from the consumer market. These products need to be well-considered from the inside and out, meet user needs, reduce user-error, provide reliable functionality and overall to contribute to improved patient outcomes and reduced costs.

As a design lead with a strong system engineering and process background I am able to blend technical engineering, innovation and human-factors inputs into compelling designs which are economical to engineer and manufacture.

Osseopulse Bone Regeneration System- Life Science & Medicine (Design Lead)

Red Dot Award (2010) Honourable Mention

Orga08 Modular Filing System- Offices Furniture (Design Team memeber)

Red Dot Award (2010)

Soundbug- Consumer Audio (Design Lead)

Red Dot Award (2003)- ‘Best of Best’ Product Design

Device Concept DevelopmentMedical Device R&D



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Proof-of-Principle PrototypingMedical Device R&D

Quick Exploration and Elimination of Ideas Using Rapid Prototyping Processes and TechniquesFast-track design and innovation requires that the design team is able to quickly work up paper ideas into physical proof-of-principle prototypes and fixtures which can be physically handled and tested. The processes can vary from foam and card, SLA and FDM to CNC machined and rapid-tooled parts. Whatever the process, the goal these techniques is the same - to ‘fail fast’, observe and gain expanded insights.

In past projects I have rapid prototyped everything from volumetric form-studies, precision metering mecha-nisms, micro-fluidic wells and chambers to injection portals and physical interfaces. Prototyping is an important part of my process.



Usability EngineeringMedical Device R&D

Integration Of Usability Within The Engineering Process To Meet Regulatory NeedsSince late 2013, the FDA requires conformity with 60601 3rd Edition as an input requirement for a 510(k) application. As such Usability Engineering processes now form a mandatory part of the device design development and Risk Management process.

Over the last three years I have developed multiple SOPs related making usability a trouble-free part of the Phase 1 process and ensuring conformity with IEC 62366 and the 3rd Edition Usability Checklist.

Usability sessions and focus groups are invaluable in growing engineers and designers who are sometimes inclined to have biases around the technology platform, and little awareness of the importance of user acceptance to the success and safety of the product.



Device Program ManagementMedical Device R&D

Maintaining The Vision From Phase 0 Through Engineering and ManufactureI lead cross-functional device engineering teams, ensuring that device projects stay on plan and that Critical Path milestones are met. Design issues which arise are documented and addressed in an ordered manner consistent with ISO 13485 device engineering standards. I maintain all Risk Management documenta-tion and the Technical File.

It is my responsibility to interface with Marketing and Sales and to ensure that the original product vision is sustained throughout the Phase 1 engineering process.

I have steered a number of products from design to market including single-use vascular-access devices, a point-of-care IVD instrument, imaging systems and other therapy devices.



Making Users Stakeholders In The Process To Improve The Chance Of Device SuccessResearch guide documents need to be created which are project-specific and contain all the necessary tools and methodologies to guide the activities. These include question guides, background information, data capture forms as well as other guidance.

The user sessions themselves can vary significantly - One-on-one interaction requires a more subtle approach compared to larger group sessions, multi-site and procedure observations. Information needed to be logged and captured in an ordered manner suitable for later filtering and processing. Not only are you trying to determine what users need but you are also building working relationships. This way the user can become a sounding board for ideas and prototypes through the development process.

Users & Usability Research 1.Medical Device R&D



Discrete procedure observation and documentation of workflow forms an integral part of the qualitative part of the research process. Often users do not realise what they do nor the habits that they follow when doing repetitive tasks or in stressful situations. These insights can become golden innovation opportunities.

Interviews and group workshop sessions provide a means of collecting quantitative inputs from larger groups of user-operators.

The outputs and insights attained are filtered and processed analytically using processing methodologies appropriate to complexity of the exercise and size of sample.

Understanding How People Do What They Do, When They Do it and Why




Deconstructing The Workspace and Auditing The Equipment That Operators UseMeasuring and digitising the working environment allows design-engineers to replicate scenarios back at the office in order role-play prototype usage scenarios.

LEAN design improvements can be discerned once the movement of participants during a procedure is understood. Small optimisations can make meaningful improvements in user comfort during long procedures.

While in the working environment one should spend time with users to audit the strengths and weaknesses of existing tools especially competitor products and devices. Where is it stored? How is it cleaned? Who will be respon-sible for servicing the device?

These inputs are invaluable to future Design Requirements documentation.




Translating Insights and Findings Into Practical Requirements and SpecificationsThe key is to ensure that the outputs from user research and usability studies are distilled into a clear set of Product Definition inputs and Design Requirements so that they might drive the engineering process. This way the user inputs become part of Risk Management File and findings can then be qualified during Verification and Validation.


