Video Recordings of Past Programs
1-14-21 Lunch and Learn – Best Practices in Medical Device Software and Firmware Design
Are you developing a medical device with software or firmware? If you plan on submitting your device to the FDA, there are specific regulatory requirements that must be met to ensure acceptance. In this webinar, you will learn the best practices for software and firmware development in a regulated field like medical devices. In the medical device industry, ISO 13485 defines requirements for a quality management system that demonstrates the ability to create medical devices that meet customer and regulatory requirements. Because of the inherent complexity of software systems, software development has become more tightly controlled than hardware in regulatory environments. Thus, standards have emerged to guide this process specifically for software. Under ISO 13485, medical devices containing software or firmware must be developed according to IEC 62304.
The processes put forth by IEC 62304 are established best practices in the software industry, most of which can be followed for both medical and non-medical projects. The activities described in the standard fit neatly into many phase-based product development approaches. This talk will focus on a phase-based product development approach that meets these standards through planning, risk management, architecture, detailed design, and verification.
Presenters: Katie Elliott and Dorota Shortell from Simplexity Product Development
12-9-20 Lunch and Learn – The 7 Habits of Highly Effective People in R&D
Here’s the question: Would you rather be like the Wright Brothers, who cracked the code of flight in three years for $3000, or Langley, head of the Smithsonian, who spent 25 times more and launched an airplane with great fanfare straight into the Potomac? Years ago I wanted to know what led the Wright Brothers to their success, and it turns out it’s not because they are geniuses, and not because it was inevitable with the advent of motors, but because they had developed a methodology that was a radical shift from what came before.
The 19th century method was to rely on the power of one’s mind to divine a solution. It is slow, expensive, and only sporadically yields results. The Wright methodology dependably, and in a finite amount of time for as little money as is possible, yields seemingly amazing results. Rather, the results are amazing, but it tends to appear that the inventor is amazing. The methodology allows results to emerge naturally. In its essence, the method presumes an answer exists, and serves as a navigational aide to get through the uncharted waters of from here to there.
In this talk I will outline the 7 habits that lead to solving big problems fast and cheap.
Presenter: Dan “Cosmo” Grupp, PhD
11-10-20 Lunch and Learn – Market Research Deep Dive
Who is your customer? We’ll explore why it’s so important to find out.
When we talk about market research, we seek to understand our customer’s needs or preferences to better frame our product or customer acquisition activities. In healthcare, however, the simple question “who’s your customer” is often times not as simple as it may seem. Is it the patient that received benefit from your product? The physician that prescribed or used your product? The payer that paid for your product?
In this session we’ll explore the complexities of selling into the US health system and discuss the role of a customer, a user and a buyer. One is not necessarily more important than the other, but it’s critical to understand the difference. Let’s do a deep dive to find out.
Presenter: Michael McGarry
10-6-20 Lunch and Learn – Cultivating High Performing Teams
Cultivating High-Performance Teams: Tips from Neuroscience
Today, in this era of the pandemic, we have been forced to rethink and make significant changes in how we live, work, play and learn. Work life for most is forever changed. We are having to learn new ways of getting work done, working collaboratively, and finding the energy to deal with working from home, schooling kids at home, social distancing, and so, so much more.
Many teams are struggling to stay engaged and enthusiastic about work. What can you do as a leader? As a member of a team?
This interactive program will identify 5 key characteristics of work that drive high performance for knowledge workers and teams. It is based on David Rock’s book, Your Brain At Work, and his SCARFⓇ Model. Lecture will be only 20-25 minutes, so you can talk with others in small groups and share ideas and Ah-ha’s for what you might do differently going forward to improve engagement and morale. We will then share best ideas with everyone.
Presenter: Pat Arcady, Ed.D
9-23-20 Lunch and Learn – Bioscience Career Panel
Interested in learning more about careers in the Bioscience industry? Please join Oregon Bioscience Incubator (OBI) and Oregon Health & Science University Knight Cancer Institute’s Cancer Early Detection Advanced Research Center (CEDAR) for an exciting panel featuring scientists employed in various Bioscience positions discussing their career paths and the skills required to be successful in their respective fields.
Our panelists are Kateri Spinelli, PhD, Elliott Parker, Holly Rockweiler, and Emmanuel Akporiaye, PhD. See bios below. The moderator is Andre Walcott from OHSU CEDAR.
8-11-20 Lunch and Learn – Valuation of Life Science Companies
Learn more about how life science companies are valued in this informative program!
Valuation of Life Science companies can be difficult. It requires a deep understanding of the industry and common valuation methodologies. Furthermore, based on the size, stage, and type of engagement, different approaches are needed.
Jameson Jenkins and David Hales from Scalar will discuss the importance of understanding the Scope of Work and the different valuation methodologies that can be used to value within this industry.
7-22-20 Lunch and Learn – They Said It Couldn’t Be Done! De-Risk Your Projects
“They said it couldn’t be done! Let’s talk about de-risking your projects.”
There are far more ways to fail than to succeed when developing new products. This presentation will provide three case studies illustrating how to increase the chances of getting medical devices to market. The talk will touch on four primary risk factors:
- Technical risks
- Execution risks
- Financial risks
- Market risks
We’ll also discuss ways to increase the chance of success. The presentation will conclude with “Pearls of Wisdom… and Lessons Learned.”
Presenter: Marc Fine
6-17-20 Lunch & Learn – Pivot with Purpose
Pivot with Purpose: Build Your Business Around Your Greatest Strength
Many companies fail by trying to outpace or outgun established competition. But what if you start playing a different game altogether?
Whether you are a multinational corporation or two nerds in a basement, you’re chasing goals, making moves, and looking to invest your energy where it counts. We’re here to tell you that the shortest path to success often only takes one single market differentiator — a unique value proposition, or what Rick Hou calls your “Secret Sauce.”
In the past 15 years, Rick has launched startups that have either become or have been purchased by fortune 500 companies. Rick has mastered the craft of pivoting with a rapidly changing market. Learn how to identify the value you pose to your audience, avoid the pitfalls most likely to cause you to fail, and leverage your greatest strengths to grow your company with lasting impact.
6-10-20 Lunch & Learn – How to Make Profitable Key Networking Connections
Are you looking for some easy ways to build key networking relationships in these uncertain times? Are you unsure about how to improve your networking skills and meet new power partners? How do you make those key connections efficiently and effectively in our virtual world? Many people think that because we can’t meet in person we don’t have to network. This is actually one of the best times to grow your network – strategically.
Join our Virtual Lunch & Learn with Portland’s networking expert Stephanie Arnheim. Stephanie will share with you her tips and strategies on how to make authentic connections in a virtual world and continue to grow your network. Learn about building relationships with power partners to grow your business and be a resource to your community. Please bring your networking challenges and questions.
6-9-20 Lunch & Learn – Maximize Your PPP Loan Forgiveness
Learn about maximizing your PPP loan forgiveness. The government’s Paycheck Protection Program loans have the potential for complete loan forgiveness provided it is used for the approved expenses. By tracking how you allocate your disbursement, you may be eligible for complete loan forgiveness on that Paycheck Protection Program loan. Hear about updates released by the SBA/Treasury recently on this topic. Formulas to calculate forgiveness will also be shared.
Presenter: Jessica Crannell-Menard
5-6-20 Lunch & Learn – Digital Health Early Stage Funding Panel
Digital health is the convergence of healthcare and technology to advance treatments, increase efficiency, and lower the cost of healthcare delivery. Oregon is a recognized global hub for the exact industry sectors that combine to create new companies and jobs focused on Smart Health and Smart Cities.
OBI has determined there are currently 130+ digital health companies in the State of Oregon, and this number continues to grow as adoption of connected devices and personalized medicine skyrockets.
As a digital health startup in Oregon, what are the best resources for Digital Health early stage funding? Hear from both the Funder, Angela Jackson, Co-Founder and Managing Director of Portland Seed Fund; and the Funded, Travis Rush, Founder and CEO of Sightbox.
4-21-20 Lunch & Learn – Financial Projections in the Time of Coronavirus
Learn about financial projections, especially in the time of crisis:
- An overview of SBA/Relief Bill/CARES/PPP information.
- Accounting strategies, such as cash flow management, budgeting, and modeling/scenario analysis, to confront and stay afloat during a crisis like this.
- Using your businesses’ accounting data to provide insight into what operational decisions to make next.
- Using accounting data to create a “road map” with more visibility into your business’ current state of affairs and its future.
Presenter: Jessica Crannell-Menard
4-14-20 Lunch and Learn – Negotiate Like a Boss by Being Yourself
Not knowing what to do, anxiety and even fear may confront us when we must negotiate. Often, the negotiator “type” is viewed as a haggler, a deceiver, even a manipulator. Decades of research show that effective negotiators do not exhibit these traits. What if there was a research-based process that lets you negotiate just by being yourself? And what if this approach is proven to get your needs met more often than not? Introduce yourself to the systems approach to negotiation from Martin Medeiros, who adopted this approach over 25 years of law practice.
Martin is a keynote speaker on negotiation, acts as a judge in the ABA Negotiation Competition, delivers the weekly “Persuasion Lab” podcast and authored 5 books on negotiation, persuasion, and influence. This interactive session delivers immediately actionable steps you can take.
3-10-20 Lunch and Learn – Aus-TRIAL-ia: Running Early Phase Clinical Trials in Australia
This talk will describe the speed, cost and quality considerations and advantages of conducting early phase clinical trials in Australia. Of particular note are the Clinical Trial Notification (CTN) program which allows for patients to be dosed within 8-10 weeks of document submission to the Ethics Committee (EHRC) for trial approval as well as the R&D tax rebate scheme from the Australian government.
There are several advantages to the CTN program, including reduced documentation requirements for study approval, fast review and approval, and reduced release testing requirements.
Trials conducted in Australia utilizing these more efficient processes meet international quality standards and are often the basis for IND and/or CTA fillings for Phase II trials in the US and EU.
Presenter: Jamie Weishaar
2-20-20 Lunch and Learn – Find and Equip Lab Space Quickly and Cost-Effectively
At some point every successful company faces the challenge of their physical working space no longer meeting their needs. Maybe the space isn’t large enough to meet demand, or perhaps business has evolved in a direction no longer served by the original facility. So how does one go about finding new space? Hire a broker? An architect? A contractor? All three? If so, then when? And how do you make sure your business needs are met quickly and cost effectively?
All of these questions follow the often overt realization that your space no longer works. The problem is that acquiring lab space is not simple. Most people who have been through the process will tell you it takes far more time than expected, and in the case of your company outgrowing its facility, that is time you can’t afford. The other challenge that is often underestimated at first is the complexity of fitting out that lab space.
At this program we will talk though the steps needed to find, acquire and fit-out lab space. We will discuss the role of brokers and their limitations; the timeline associated with finding and securing space; and the ins and outs of permitting and tenant improvement. We will touch on the complexities of developing lab space that make finding the raw shell area difficult, including zoning, mechanical systems, and occupancy types. We will talk about the time it typically takes from the decision to move or expand, to the new facility being fully operational. Finally, we will cover the management of tasks that are not typically handled by the broker, architect or contractor.
Presenters: Eric Myers, Sean Cole, and Mark Petchey
1-16-20 Lunch and Learn – OHSU’s Research and Innovation Landscape
OHSU has undergone significant changes at the leadership level in recent years. Among those changes, Peter Barr-Gillespie was named as OHSU’s chief research officer, and he has restructured his office, now named OHSU Research and Innovation. In addition, in response to an external review of the innovation landscape at OHSU, he launched a new office, OHSU Collaborations and Entrepreneurship, which is headed by Aditi Martin. One of Martin’s principal goal is to ensure that business development activities at OHSU, which occur in several offices in different units, are coordinated across the university. OHSU Technology Transfer, led by Andrew Watson, remains relatively unchanged from its structure within the former Technology Transfer and Businses Development (TTBD) office.
Barr-Gillespie will discuss these changes to OHSU’s research and innovation landscape, and review OHSU’s yearlong strategic planning process. He will be joined by Martin and Watson, who will elaborate on the new structure for technology transfer, collaborations, and entrepreneurship.
12-18-19 Lunch and Learn – Who’s on Your Board of Directors?
The people you allow to influence your business decisions will ultimately be the ones that help set your pace in life. If you choose wisely, the next time you face a major business decision, you can look confidently to your board for advice. Of course, each type of small business needs specific kinds of people to serve on its board of directors, but all businesses need individuals with integrity, commitment, and interest as board members.
Think of the board as an extension of “your team,” and they will simply fill gaps in your knowledge, skills, and/or network, while helping the company grow and prosper. Come hear about things you already know, didn’t know or just plain forgot.
Presenters: John Tortorici and Rose Marshall
10-22-19 Lunch and Learn – Pregame Your Business with Ciara Pressler
You have a business plan, but do you have a game plan? Find out how Pregame has reinvented business strategy for entrepreneurs, creators, and innovators. Founder and author Ciara Pressler will share the new best practices for growth in your business, marketing, and more. Pregame is the new HQ for entrepreneurs and experienced executives to accelerate their business growth. Like a gym for your goals, daily sessions in business strategy, marketing, sales, and more, give you unlimited opportunities to pump up your strategy and overcome your obstacles. Find out more at www.pregamehq.com.