NEED FINDING

A thorough understanding of the problem you are trying to address, in other words the need, is essential to a great invention.

Taking the time to develop this understanding up front will set you up for success as an innovator. One of the best ways to accomplish this is through spending time in the environment and with the end user of your product. This end user could span the patient, caregivers, healthcare providers, and even insurance companies. By immersing yourself in the environment to experience the need first hand and keeping an open mind about potential solutions, you will put yourself in the best position to identify an unmet need.

While reading and interviewing can help, we recommend getting into the clinical setting to best understand and refine the problem and stakeholders. Penn Health-Tech can help Penn innovators to have clinical shadowing opportunities.

NEED SPECIFICATION

Creating a need specification is the second step after need statement development to create guardrails on the solutions you will create to address your unmet need.

Creating a need specification is the second step after need statement development to create guardrails on the solutions you will create to address your unmet need.

Check back soon to learn more.

 IDEATION & BRAINSTORMING

There is no one right way to go about brainstorming solution to unmet medical needs. However, there are a few core principles to keep in mind when going into a brainstorming session.

  1. Keep an open mind: there are no silly ideas
  2. The goal of this stage if to generate as many ideas as possible – build off of one another – you might be surprised what you learn and where you end up
  3. Leverage what you know: what exists within your current environment or tangential fields that could be applied in a new or novel way to your unmet need?

In addition to brainstorming on your own or with your team, Penn Health-Tech hosts monthly Meet-UPs where a clinician presents an unmet clinical need with the opportunity for groups to brainstorm and create teams to work on new projects. This is a great opportunity to jump-start your health-tech innovation process, and to experience brainstorming firsthand. Checkout the news and events tab to register for an upcoming Penn Health-Tech Meet-UP.

PROTOTYPING

Prototypes can take on a range of forms, from those that can be done rapidly at a low cost, to more complex, expensive prototypes. Prototyping is a process of iteration – where you want to build on top of lessons learned from earlier stages of prototypes while building your newest invention. Before you begin prototyping, you should have a sense of what endpoint you are trying to reach.

What do you need to prove about your device in order to increase the probability of adoption? What matters most to your stakeholders? The goal of prototyping is to answer questions. In order to successfully prototype, the Biodesign textbook (Zenios, Makower, Yock, Brinton, Kumar, Watkins, Denend, Krummel (2015). Biodesign: the process of innovating medical technologies, 2nd ed. Cambridge University Press.) recommends the following approach:

  1. Clearly identify the questions to be addressed focusing on the issues that will be answered with a prototype. These answers should mitigate significant risks.
  2. Recognize that different types of prototypes may be necessary to address different questions
  3. Isolate the most important functional blocks of a solution that need to be explored.
  4. Understand what is known about each functional block and what must be learned or proven.
  5. Use what is learned through prototyping to define more details design requirements and technical specifications.

There are different models of prototypes:

Works Like Model: demonstrate how the device works, even though it might not look like the end model

Looks Like Model: this is made of the end materials, but might not work. This is helpful in human factors testing.

Is Like Model: can be used in early testing, though it may not resemble the final form factor

And different types of testing to be performed:

User Testing: evaluating a concept by testing it with users to gather their input

Bench Testing/Simulation Testing: testing materials or device functionality in a lab controlled environment

Tissue Testing: evaluating initial anatomical or physiological properties

Penn Health-Tech can help connect you to a range of prototyping resources local to Philadelphia and externally. Get in touch to learn more.

On campus, The Penn EDS (Penn Electronic Design Shop) is a resource for the medical and research community at Penn and abroad, to provide of Electronic Design and Electronic expertise services. This includes, but not limited to: embedded design applications, Design for IoT (Internet of Things), electronic design, equipment troubleshooting and support, electronic design for manufacturing and lately hardware and sensor design for Artificial Intelligence applications. Please contact us at : ElectronicShop@psych.upenn.edu”. Our lab is on-campus and always available.

PRE-CLINICAL TESTING

The Institute for Medical Translation at Penn Vet is a phenomenal resource for Penn innovators to develop concept and feasibility as well as design validation and preclinical testing.

Institute for Medical Translation at Penn Vet

Our mission is to facilitate multi-disciplinary service, research, and education by supporting, enabling and bringing together scientists, engineers and clinicians for collaboration at the intersection of scientific discovery and medical product development in the non-clinical and veterinary clinical space.

School of Veterinary Medicine
New Bolton Center
Section of Surgery Department of Clinical Studies

Institute for Medical Translation
Translational Research in Orthopaedic Surgery
Preclinical Testing Facility for Drugs and Medical Devices (GLP)
Comparative Orthopaedic Research Laboratory (CORL)

Contacts:

Thomas P. Schaer, VMD
PENN VET New Bolton Center
382 West Street Rd
Kennett Square, PA 19348
610-925-6237
corl@vet.upenn.edu 

CLINICAL STUDIES

Across the Penn community, there are a wealth of resources to tap into for clinical studies.

Check back soon for more information.

REIMBURSEMENT STRATEGY

The majority of health technologies will fall under reimbursement by third party payers. There are two segments of payers within the United States who you should consider when evaluating your reimbursement strategy – private payers, which include commercial insurance companies, and managed care organizations, and government payers, the Centers for Medicare and Medicaid Services (CMS).

In order to receive reimbursement for your device, you will need both Coverage and a Reimbursement Code. Different codes are used depending where in the healthcare system your device will be used.

Coverage is determined by the individual third party payment agency, and can vary from payer to payer. Beyond the regulatory for your device, payers are looking for evidence that the new technology has a clinical or cost benefit versus existing available market technologies.

This is a constantly changing landscape, but there are many good resources to help you navigate the developments. A primer can be found in chapter 16 of the University of Minnesota Medical Device Innovation Handbook (Medical Device Innovation Handbook)

As you develop your product’s strategy, Penn Health-Tech can connect you to a number of resources within and beyond Penn. Get in touch to learn more.

INTELLECTUAL PROPERTY

The information in this section is intended to provide a general overview, and should not be interpreted as legal advice.

As a med tech entrepreneur, it is important to understand if your invention can be patented, what the patent landscape looks like, and who owns your idea.

Innovators at Penn are subject to the Penn patent policy, which can be found here: http://pci.upenn.edu/wp-content/uploads/2017/12/Patent-Policy-Most-Recent.pdf.

There are a number of resources at Penn to help you navigate the IP landscape for your med tech project. The Detkin IP and Technology Legal Clinic is run by the UPenn School of Law. It provides pro bono transactional patent, copyright, trademark and trade secret services to individuals, non-profit and for-profit clients with law students under the supervision of faculty. The program is led by Cynthia Dahl, J.D. It recently launched a “digital office hours” service which can provide short answers to general IP questions. It provides a great resource for students, staff and faculty as they explore IP aspects related to their medical innovation work. The link is:

https://upenn.co1.qualtrics.com/jfe/form/SV_5dTal1rpVjfQvPf

On the Detkin IP Clinic website, you can find answers to General IP FAQs:

https://www.law.upenn.edu/clinic/intellectualproperty/faqs.php#whatisip

The UMN book also has some great resources on patent basics that you can see in chapter 12 here: Medical Device Innovation Handbook

BUSINESS STRATEGY

There are a number of resources within the Penn community to help you get started on thinking through your Business Strategy.

PCI has created the attached commercialization guide:
https://www.pci.upenn.edu/commercialization-guide/

The Penn Wharton Entrepreneurship site has myriad resources across the Penn community to help you get started: https://entrepreneurship.wharton.upenn.edu/

REGULATORY STRATEGY

In the United States, Medical Devices are regulated by the Center for Devices and Radiological Health (CDRH).

According to FDA, there are three classes of medical devices categorized based on the level of risk:

  1. Class I General Controls
  • With Exemptions
  • Without Exemptions
  1. Class II General Controls and Special Controls
  • With Exemptions
  • Without Exemptions
  1. Class III General Controls and Premarket Approval

You can utilize the classification database to help determine the class for your device which will ultimately determine the regulatory pathway for your device.

For resources at Penn, checkout the Office of Clinical Research, or get in touch with Penn Health-Tech to connect to more resources.

For information on the Early Feasibility Study Pathway, checkout these resources from the Medical Device Innovation Consortium (MDIC).

EFS Patient Advocacy Tools/Resources:

GENERAL RESOURCES

The Penn Libraries have created resource guides that you can access here:

Health Care Industry Research Guide 

Pharmaceutical Industry Research Guide

Medical Device FAQ

PCI has created this Commercialization Guide