ITHS Tools
Login
Need Help? Have a Question?

Contact the Research Navigator

Connect with Us
Visit UW in a new window/tab
 

Technology Development Center

ITHS › Investigators › ITHS Research Services › Technology Development Center

Technology Development Center

The ITHS Technology Development Center is staffed with clinical, regulatory, and commercialization experts to assist academic and industry innovators through translation, startup formation, clinical study, regulatory clearance, fundraising, and market entry.

We welcome all for an initial consultation, in which we identify resources and define a scope of work optimized for the advancement of your small molecule, biologic, medical device, or digital health application. No matter where you are on your journey to commercialization, we can help you find the services, funding, and programs you need to move you forward. Explore what we have to offer below!

The Entrepreneur’s Journey

Technology Discovery

Services and support to help you get started on your journey: IP cultivation, customer discovery, fellowships, degrees, and academic programs for health science innovators.

 

[ultimate_modal btn_bg_color=”#002060″ btn_text=”Learn more” modal_size=”medium” overlay_bg_opacity=”80″ img_size=”80″ btn_txt_color=”#ffffff”]

Tech Development Mentorship, Strategic Guidance, Funding

 

*indicates ITHS services[/ultimate_modal]

Proof of Concept

Support to strengthen the spark of your idea: customer discovery, regulatory strategy, FDA law, and the funding to keep you forging ahead.

 

 

.

[ultimate_modal btn_bg_color=”#002060″ btn_text=”Learn more” modal_size=”medium” overlay_bg_opacity=”80″ img_size=”80″ btn_txt_color=”#ffffff”]

Support and Funding for Proof of Concept

*indicates ITHS services[/ultimate_modal]

Tech Development

Strategic advice and funding to aid you as you move toward commercialization: pre-clinical study, market research, business plan development, community engagement, mentorship for all sorts of entrepreneurs.
.

[ultimate_modal btn_bg_color=”#002060″ btn_text=”Learn more” modal_size=”medium” overlay_bg_opacity=”80″ img_size=”80″ btn_txt_color=”#ffffff”]

Tech Development Mentorship, Strategic Guidance, Funding

*indicates ITHS services[/ultimate_modal]

Final Steps to Startup

Support for human study, FDA clearance, and company formation: study design and coordination; assistance with equity, diversity and inclusion; legal counsel; grant writing; pitch practice; and investor connections.

[ultimate_modal btn_bg_color=”#002060″ btn_text=”Learn more” modal_size=”medium” overlay_bg_opacity=”80″ img_size=”80″ btn_txt_color=”#ffffff”]

Support for Human Study, FDA Clearance, and Company Formation

 

*indicates ITHS services[/ultimate_modal]

Our Services

We offer free initial consultations with the following services provided for a fee billable to your department or organization.

  • Team formation
  • Customer discovery
  • Market research, analysis, and strategy
  • Pricing research, analysis, and strategy
  • Business plan development
  • Links to Drug & Device Advisory Committee and other UW services for innovators

  • Regulatory strategy and application
  • Project management
  • Connection with mentors
  • Connection with investors
  • Pitch coaching
  • And more!

Sign up for our monthly newsletter to get training and funding opportunities sent directly to your inbox!

Biomedical Innovation Fireside Chat Series

We’re excited to host a new training series aimed at early-stage academic innovators who need to quickly learn the essentials of biomedical entrepreneurship. The Biomedical Innovation Fireside Chats is an annual series of free, virtual, hour-long talks held via Zoom. The first season was held January–May 2024 and a new series is being planned for 2025.

Additional Services

ddac thumb
Drug & Device Advisory Committee (DDAC)

DDAC reviews proposed innovations and provides free consultations to discuss specific pre-clinical development plans, focusing on tasks needed to efficiently move the drug to the clinic according to FDA guidelines.

inv-toolkit-thumb
Preclinical Researcher Toolkit
device-thumb
Device Development
ind-thumb
Drug Development

Have questions? Get answers! Click here to connect with us.

Meet The Team

Teddy Johnson red sq
Teddy Johnson, PE, MBA
Director

As director of the Technology Development Center, Teddy Johnson’s goal is to help entrepreneurs bring new health tech to market. His years of experience have given him the knowledge and connections to guide you on the path to success. Feel free to reach out to Teddy any time you have a question about your next steps.

[ultimate_modal modal_title=”Teddy Johnson Bio” modal_on=”text” modal_on_align=”right” read_text=”Learn more about Teddy” modal_size=”medium” overlay_bg_opacity=”80″ img_size=”80″ txt_color=”#4a66ac” trigger_text_font_style=”font-style:italic;”]Teddy joined the healthcare community over 25 years ago, after graduating from Stanford University’s mechanical engineering program. Since then, he has served start-up and Fortune 500 companies in research, design, clinical, marketing, and sales leadership roles; developing imaging, interventional, surgical, and pharmaceutical products. Along the way, Teddy earned his MBA from the University of Michigan’s Ross Business School. With hard work, good judgment, and a little luck, Teddy has celebrated 2 IPO’s and 4 acquisitions, while earning numerous patents and commercializing dozens of new products worldwide. As a way of fostering innovation, Teddy teaches in the STEM and Biomedical Regulatory Affairs Master of Science (BRAMS) Programs at the University of Washington, serves as Director of Technology Development for the Institute of Translational Health Sciences and WE-REACH, and mentors startup CEOs in Seattle and the Silicon Valley.[/ultimate_modal]
Dr. Terri Butler
Terri Butler, PhD

Dr. Terri Butler works with faculty and students at the University of Washington and collaborating Pacific Northwest research institutions advising on commercialization pathways for biomedical technologies. She is the primary contact for the ITHS Drug and Device Advisory Committee and manages the WE-REACH Biomedical Innovation Bootcamp.

[ultimate_modal modal_title=”Terri Butler Bio” modal_on=”text” modal_on_align=”right” read_text=”Learn more about Terri” modal_size=”medium” overlay_bg_opacity=”80″ img_size=”80″ txt_color=”#4a66ac” trigger_text_font_style=”font-style:italic;”]Terri Butler, PhD, draws on her industry experience to assist teams in vetting their ideas through a rigorous process of competitor analysis and market validation as well as laying out strategies for technical development. Prior to coming to the University Dr. Butler worked in key industry roles along the commercialization pathway, including invention, product development, FDA regulatory management, manufacturing scale-up, and sales and marketing.  She has worked at large and small companies, including 3M, Molecular Genetics, Bioenergy Life Sciences, and multiple university spin-out companies. Products she has commercialized include monoclonal antibodies, pharmaceutical release liner, nutritional formulations, and non-medical technologies in the high-tech materials field.  She is an inventor on 14 patents in coating processes, chemical formulations, and nutritional applications.

[/ultimate_modal]

Lynn_Rose sq
Lynn Rose, PhD
Regulatory Consultant & Advisor

Dr. Lynn Rose serves as a regulatory consultant and advisor for the ITHS Technology Development Center.  Her goal is to help investigators understand the regulatory basis for development of their medical product idea and to facilitate entry into the clinical phase as quickly as possible.  As a regulatory consultant for the ITHS, she primarily assists investigators with the development of a regulatory strategy, clinical protocols and the creation and submission of Investigational New Drug and Investigational Device Exemption applications to the FDA.

[ultimate_modal modal_title=”Lynn Rose Bio” modal_on=”text” modal_on_align=”right” read_text=”Learn more about Lynn” modal_size=”medium” overlay_bg_opacity=”80″ img_size=”80″ txt_color=”#4a66ac” trigger_text_font_style=”font-style:italic;”]Lynn Rose, PhD, is an affiliate Associate Professor in the University of Washington School of Pharmacy (SOP), where she maintains faculty positions with the SOP Master in Science in Biomedical Regulatory Affairs and the UW Institute of Translational Health Sciences (ITHS).  She has extensive experience in the development of biomedical products, gained in both industry and academic settings.  In previous positions she has had direct responsibility for preclinical, clinical, and regulatory programs across multiple therapeutic areas and product types.  This experience included participation on multiple drug development teams, four of which resulted in marketed products in the US and EU.  She is skilled at critical review of biomedical product concepts, clinical protocols, development of regulatory strategies, and the management of regulatory submissions to federal authorities.  In addition to sharing her regulatory experience with students of biomedical regulatory affairs,  Dr. Rose is also a founding member of the ITHS Drug and Device Advisory Committee (DDAC), which advises investigators on issues related to the regulatory requirements for product development.  This unique combination of experiences is the basis for her role within the ITHS Technology Development Service Center where she advises academic investigators on their regulatory options and strategy.

Dr. Rose’s primary basic and clinical research experience is in the field of immunology, with emphasis on autoimmunity, infectious disease and immune-oncology.[/ultimate_modal]

CJ_headshot2022
Cindy Jacobs, RN, JD
Regulatory Consultant & Advisor

Cindy Jacobs is a nurse-attorney who provides regulatory advice for the ITHS Technology Development Center.  She assists TDC teams with identifying and mapping the regulatory structure applicable to their innovations in order to help streamline the pathway to a marketable product. Her work with investigators is primarily centered around the FDA regulatory structure and process, but also includes peripheral regulatory issues that may be involved, such as telemedicine, scope of practice, and others.

[ultimate_modal modal_title=”Cindy Jacobs Bio” modal_on=”text” modal_on_align=”right” read_text=”Learn more about Cindy” modal_size=”medium” overlay_bg_opacity=”80″ img_size=”80″ txt_color=”#4a66ac” trigger_text_font_style=”font-style:italic;”]Cindy Jacobs, RN, JD, brings over 30 years of combined legal and health care experience to her role in the ITHS Technology Development Center. As a registered nurse before attending law school, she focused on the clinical specialty of neonatology, including 3 years in an advanced practice role. As an attorney, she has represented and advised health care clients regarding a variety of issues, including telemedicine and other health care technologies, FDA law, HIPAA, reimbursement and related compliance, health care contracting, risk management/professional liability, scope of practice/licensing, informed consent, and product liability. Cindy’s UW roles have included Assistant Attorney General in the UW Attorney General’s Office, Director of Clinical Risk Management for UW Medical Center, and Director of Clinical Projects for the UW School of Medicine.  She also continues to teach FDA Law at UW School of Law, which she has done since 2010, along with periodic law student seminars on telemedicine and healthcare clinical compliance. She is a member of the ITHS Drug and Device Advisory Committee.[/ultimate_modal]

Training Videos

Target Product Profile Video

GANTT Project Plan Video

Our Collaborators