The Life Science Effect

EU MDR and FDA's Case for Quality are just two of the initiatives impacting medical devices in 2019. According to the new EU MDR (European Union Medical Device Regulation), combination products must meet medical device standards. This is new. Listen to Steve's advice on where to get more information.

Also: How do you go from managing projects in dirty chemical plants to Healthcare IT projects to Medical Devices and back to Pharma? What is the difference between medical devices and pharmaceuticals? What are FDA and European Union medical device regulators doing in 2019 that Medical Device and Pharma professionals need to know about?

Mentioned in this episode:

www.mgmt-ctrl.com

www.greenlight.guru

email Steve for more info at [email protected]

How do you create something that is greater than the sum of its parts? For decades, the foundries and steel mills of northwest Indiana, have melted and cast and forged metal into shape, creating something completely new from a few basic elements. At Purdue Foundry they bring together the basic elements of technology and talent and capital to bring innovations to life.

John Hanak and his colleagues created Purdue Foundry when Purdue's innovative President Mitch Daniels saw an opportunity for Indiana to capitalize the university's rich ecosystem of innovators. John is now the Managing Director of Purdue Ventures, a key component of Purdue Foundry.

The product of generations of steel workers, John was the first salaried steel worker in his family. He worked his way to the C-Suite at a major steel mill and then went on to lead high-tech startups before bringing his leadership to Purdue University.

Steve Vinson had the opportunity to hear John's story and to pick his brain to find out how Purdue Foundry, Purdue Ventures, and Now the Discovery Park District is launching technology into the marketplace.

Learn more about Discovery Park District at http://discoveryparkdistrict.com/

Connect with Purdue Foundry and Purdue Ventures at https://purduefoundry.com/

Thank for listening. Do not forget to subscribe and tell your colleagues about our show.

What is going on in the medical device industry right now that is driving companies and the FDA to address quality systems differently? What is the Quality Systems Management (QSM) Strategic Plan? How will it help organizations? How will it help patients?

Larry Mager is an experienced medical device quality executive with success in taking quality management systems to the next level at major global medical device companies.

He now is leveraging his decades of leadership and making his system available for any organization that wants or needs to improve.

Quality System(s) Management (QSM) = Measure | Manage | Improve

1. A Quality System(s) Management (QSM) plan is utilized to measure, manage, and improve the 'quality' of an organization's Quality Management System (QMS)

2. QSM measures what matters in regard to product and process quality, and does so in a manner that is actionable for Management

3. QSM enables the strategic understanding of product & process 'quality', as is expected of Management by the stakeholders

4. QSM targets issues of constraint, enabling the responsible and targeted improvement of the organization's constraints

5. Supports EU MDR and Case for Quality initiatives (see below)

EU MDR defines significant responsibilities associated with the verification of product & process 'quality' through the PMS & QMS surveillance activities utilized within a medical device company. The accountability for doing so resides within the designated role of Person Responsible for Regulatory Compliance (PRRC). The capability to satisfy the obligations of that role must be 'built' into the Quality Management System (QMS).

The Case for Quality is an FDA-driven initiative, coordinated in partnership with the Medical Device Innovation Consortium (MDIC) and in collaboration with the Medical Device Industry, focused on creating "sustained predictive practices that advance medical device quality and safety."

To connect with Larry: [email protected]

What is the latest in Biopharma? What is in store for this $300 billion industry in 2019? What if I told you the market is growing at more than 12% annually but that there is a global shortage of manufacturing capacity? What will it take to close the gap? Join me this week for a 1:1 conversation with you about the future of our industry.

Who else should be on the show? Drop me a line at [email protected]

Google and J&J have joined forces to create powerful, innovative surgical solutions. Rick Ditto and Matt Dressler have joined forces to create an exciting, inspirational episode this week. Open source seems to be winning in tech. Can it win in Life Science? What macro trends are shaping medical device careers and how can you be prepared? What will surgery look like in 30 years? Nobody knows the specific answers to these questions, but Rick and Matt are the right people to ask and folks are listening.

Thanks to IBRI and BPM Associates for sponsoring this week's episode: www.indianabiosciences.orgwww.bpm-associates.com

Research Fellow, VP of Digital Technology, and Director of the Applied Data Sciences Center

Daniel H. Robertson, a proven and experienced technical leader in information technology (IT), computational science and research, is focused on defining and developing the Institute's computational analytics, digital, and data science capabilities.

Dr. Robertson originally joined the IBRI in mid-2015 as part of a loaned executive program at Eli Lilly and Company, but in mid-2017 he accepted a permanent position at the IBRI due to the opportunity at the IBRI to drive innovative research among multiple life sciences companies, academic institutions, and technology companies to advance solutions to critical problems.

His most recent role at Eli Lilly and Company was Senior Director of Research IT where he led the IT team supporting discovery systems and processes across six global research sites and nine functional/therapeutic areas. During leadership role in IT at Lilly, Dr. Robertson restructured Research IT to become a leaner, more efficient organization, reset the Research IT strategy supporting the discovery functions, delivered emerging new technology and analyses through informatics, enhanced support for HPC, cloud, and internal big data storage and analysis. He also transformed the IT support for Open Innovation Drug Discovery program to be the first high-performing DevOps team, which was recognized with an InformationWeek 500 award. Throughout his 10 years in leadership roles at Lilly, Dr. Robertson developed several individuals within his organization to advance to higher level roles in other organizations within Lilly. He joined Lilly as a research scientist in Lilly Research Laboratories and performed numerous independent contributor and scientific leadership roles before transitioning to the IT organization in 2010.

Dr. Robertson earned his PhD in physical chemistry from Florida State University and his Bachelor of Science degree in chemistry, graduating Summa Cum Laude, from Florida Southern College. After earning his PhD., Dr. Robertson served as an NRC/NRL Postdoctoral Research Associate at the Naval Research Laboratory in Washington, D.C., and then held several positions at Indiana University-Purdue University Indianapolis (IUPUI) from 1993 through 2000. He last served as Associate Scientist and Director of Technical and Administrative Services and Manager of the Facility for Computational Molecular Science at IUPUI before joining Eli Lilly and Company in 2000.

Dr. Robertson has published 67 papers in refereed journals, authored three invited book chapters, and conducted more than 65 professional/technical presentations. He has been honored with multiple awards from Eli Lilly and Company and IUPUI, and is a member of the American Chemical Society, American Physical Society and physics and mathematics honoraries.

Chief Executive Officer, Chief Scientific and Innovation Officer

Rainer Fischer, PhD, joined the IBRI in April of 2017 as the Chief Scientific and Innovation Officer. In October that same year, he also was named Chief Executive Officer. Fischer spent 19 years building and leading the Fraunhofer Institute for Molecular Biology and Applied Ecology (IME) in Aachen, Schmallenberg, Muenster, Giessen, Frankfurt and Hamburg in Germany, and its subsidiaries in Newark, Delaware, USA and Santiago, Chile. The Fraunhofer-Gesellschaft is the largest applied science research organization in Europe, with applied research aimed at addressing issues of health, security, production technology, energy, materials, and the environment.

During his time at the Fraunhofer-Gesellschaft, Fischer grew the IME Institute from 40 to 680 employees, raised with his team almost one billion euro in extramural research funding, and established international collaborations with academia and industry in more than 25 countries. Those collaborations include many of the leading global companies in the biotechnology, pharmaceuticals, agriculture, food and chemical industries.

Fischer also served as Department Head of the Institute for Molecular Biotechnology at RWTH Aachen University where he was awarded a Distinguished Professorship in 2015. He created the department, co-establishing both undergraduate and graduate programs that have matriculated more than 500 students including 115 graduated PhD students. Fischer is a prolific presenter and has published more than 340 peer reviewed scientific papers that have been cited over 16,000 times. In addition to his academic and leadership experience, he co-founded five biotechnology startups, holds over 60 issued patents and has more than 120 patent applications pending. Fischer also holds a second Professorship at Maastricht University, Netherlands where he co-founded the Aachen-Maastricht-Institute-of-Biobased-Materials (AMIBM) in 2015.

Scott is the CEO of the Scottish Lifesciences Association. With a background in Pharma tech transfer and R&D, Scott has gone on to start and lead many life sciences companies. He is currently a Director of Benenox Ltd and Marine Biotech Ltd., in addition to giving back as the CEO of SLA.

From https://www.scottishlifesciencesassociation.org.uk

With over 130 member life sciences companies and organisations of all types and sizes, the Scottish Lifesciences Association is the voice of Scotland's vibrant life sciences industries to investors, NHSScotland, the Scottish and UK Governments, and the wider community. We are member driven through 14 Special Interest Groups and 4 sub-groups. We deliver on every aspect of members' businesses, helping each other to attract investment and increase business activity, and engaging with the NHS and Government to grow the life sciences sector in Scotland.

How do you start from scratch and build a multimillion dollar company? Stop. How do you do that two or three times? Check out my chat with Matt Wyatt. He is not just a successful startup leader. He is a dad and a great boss. Check out this episode to see what I mean...