Indiana has a rich presence of medical device, pharmaceutical, and other life science companies. There is also a surprising number of startups and entrepreneurs in this space. On April 25, 2013, Catherine Tanner, one of Indiana’s life science entrepreneurs, will share her story with INpact, a medical device networking group. Be sure to RSVP.
There is a great opportunity this Friday (3/22) to hear from Scott Durlacher of Anson Group on preparing for a FDA audit. If you are part of a medical device company, I highly recommend you participate. Having worked with and knowing Scott, he has a ton of experiences and suggestions to assist you in being prepared.
Here is a link to the INpact event page.
It’s refreshing to work with a medical device startup with a focus on getting products into the market as quickly as possible to help patients. This same approach will allow this startup to begin generating revenue from the sale of its own products. I say fresh because it is surprising how novel this concept seems to be.
Okay, of course every medical device startup I’ve worked with definitely wanted to get their devices cleared and sold as soon as possible. But this startup seems different.
- Initial capital equipment will not have lots of bells & whistles and will be similar to other products in this space.
- Realization that there are quite a few accessories, kits, etc. which could likely enter the market first and serve as a source of revenue to help offset product development expenses.
- Makes decisions with enough “facts” and without getting too bogged down with minutia.
- Trusts the resources hired to do the job. When it’s clear there is a mismatch in needs versus capabilities, makes tough decisions about next steps.
- Focused on the end-goal: get products cleared and ready for sale.
It’s still early. However, I think we are on the cusp of some exciting things with this startup, especially when it comes to the approach and their business model.
INpact is trying something new in February–an evening event at a cool space known as the Speak Easy. A local vascular surgeon, Dr. George Akingba will be speaking to the group, sharing some of his work and thoughts on healthcare.
Plenty of opportunities to network. Oh, and pizza and beer with your admission.
The medical device industry has several geographic pockets. Memphis, TN is one of these, especially in orthopedics.
I recently read about this medical device accelerator located in Memphis called ZeroTo510. They seem to have all the key pieces for a medical device concept to get off the starting blocks. Part incubator, part educator, part investor, part mentor. The program is geared towards helping medical device inventors and entrepreneurs get to a FDA 510(k) submission, while providing guidance and direction along the way
While I have no idea how successful this program has been, the model is very intriguing. So much so that I wonder if something like this could be piloted in central Indiana.
Okay, I can’t tell you just yet many details about this startup. But I can tell you that the medical device product development efforts are underway and off to a good start.
And a couple weeks ago, we concluded the Planning Phase of the project. During this phase, the deliverables included:
- Design & Development Plan
- Risk Management Plan
- Project Schedule
- Design Input Requirements
We also established the company’s Design & Development procedure, defining the project phases and minimum deliverables.
Yes, I’ve worked on medical device product development projects where the planning was so intricate and too detailed that all the project manager seemed to do throughout the project was update the Gantt chart. And yes, I’ve worked on projects where there was basically no documented plan at all because the project was a “slam dunk”. Any project that has a 100+ item Gantt scares me a bit. Any project professed to be a slam dunk makes me want to run far, far away.
Don’t misinterpret my words though. I do like project management and planning new medical device product development efforts very much. In fact, I just started a new product development project and am in the midst of planning now. I decided to share a few thoughts about the importance of the plan:
- Needs to be not too big, not too small, but just right.
- The plan will be wrong. Get over it.
- Product development projects represent uncertainties. Use experience to guide you and course adjust as necessary.
- The plan is a communication tool more than anything else. It explains what, by whom, and when.
- Keep it simple. Focus on the major milestones and deliverables. Don’t get into how these need to be done.
As planning efforts and the project continues, I’ll share more thoughts from the trenches of medical device product development.
This week, CQ is starting a new project–one that involves medical device product development. I’m not going to go into details at this time. However, the initiation of the project seems to be off to a very good start. The customer provided user needs, it seems as though there is a receptive market, and the project is funded.
I’m also excited about the opportunity to work again with Techshot. Techshot will be responsible for the product design. CQ will manage the project and assist with the quality system. The customer has hired an in-house resource to assist as well.
I’m just getting started with planning efforts, one of my favorite parts of medical device product development.
WellPlay Health, LLC, a start-up based in Bloomington (IN), seeking to change how patients and therapists work together during rehabilitation by providing a more engaging, collaborative, and user-centered solutions intended to maximize the patient’s recovery. The company is currently developing WellPlay: Rehab, an online platform featuring tele-health tools and games designed to achieve therapy outcomes for physical and cognitive functioning. This platform represents a significant innovation in tele-rehabilitation and the use of game technology.
While there are several health conditions that will ultimately benefit from WellPlay: Rehab, the initial application of this technology will be in brain injury rehabilitation (i.e., stroke and traumatic brain injury). This innovative platform utilizes expertise in game design, rehabilitation therapy, motion detection technologies, tele-health strategies, and social support tools to create a unique environment for supporting physical and occupational therapists in guiding and monitoring the patient.
Maximum recovery of daily activities and reducing re-admission rates for brain injury-related complications (including falling) is dependent on a longer-term, exercise-based therapy. That therapy begins while the patient is in the inpatient setting and usually continues after discharge where they will periodically meet with a therapist at either an outpatient clinic, skilled nursing facility, or in the patient’s home. In between these visits, the therapist will recommend or prescribe exercises to be performed by the patient on their own. Since a typical patient has limited health insurance coverage for rehabilitation services, therapists must rely on the patient complying with these exercises to assist in their recovery. Unfortunately, research data on compliance with these exercises indicate that most patients will not or cannot persist on their own. In fact, only 31 percent of patients actually perform these exercises as prescribed (Shaughnessy 2006). A large multi-state study in the Midwest identified the lack of patient compliance and limitations on outpatient clinic visits (and hence, monitoring) imposed by insurance policies as the top two challenges in stroke rehabilitation (GLRSN 2008).
WellPlay: Rehab platform provides both an entertaining context and an effective feedback mechanism to properly guide the patient through home-based exercises prescribed by his/her therapist. Meaningful data are captured from game play and shared with both patient and therapist to provide the necessary feedback on progress being made.
Rehabilitation games, designed in collaboration with physical and occupational therapists, will enable patients to achieve such outcomes as balance, coordination, endurance, strength, range of motion, and cognition. Progress toward these outcomes will lay the foundation enabling the patient to achieve functional and transitional goals identified by his/her therapist. As the patient works toward their goals, they will be guided from game-to-game through activities designed to incorporate the therapy necessary to achieve these goals.
A second key feature is WellPlay: Rehab’s ability to function as a tele-health platform. During game play, WellPlay: Rehab observes, measures, and evaluates specific motor movements within each game, as well as capture data such as frequency and duration of movement. The data captured during game play is made available to the patient’s therapist to allow for remote monitoring and communication with the patient. The therapists is then capable of evaluating progress, making necessary adjustments, and determining when they should next meet in person; thus, minimizing the frequency such visits must take place, enhancing access while adding convenience and lowering cost.
Finally, our solution will leverage multi-player game play to enhance the social support component of a patient’s rehabilitation. Existing game consoles enable multi-player, online game play. We will leverage these features so patients may socialize, compete, and/or rehabilitate together.
- Rehab Games. Suites of games designed to achieve functional outcomes for upper and lower extremities.
- Therapist Portal. The portal provides a toolset that enables access to and use of data collected during game play. Functionality includes:
- Patient Assessment Module
- Treatment Module
- Progress Module
- Reporting System
- Group Tele-Health. Game play is enhanced to provide the necessary social support structure during rehabilitation. Patients can play and/or compete with fellow patients, family members and friends while rehabilitating.
- Establishing Best Practices and Decision Support. Frequent game play from a large pool of patients will generate data that will be used to inform the therapist’s selection of games or combination of games that achieve the best outcomes.
- Secure Tele-Health within a Game Environment. Necessary security protocols and safeguards are in place to enable the secure transmission and storage of personal health information via online gaming sites.
- Pete Grogg, MHA – Chief Executive. Pete leads WellPlay Heath’s strategic direction and the development and management of company’s strategic partnerships. He brings 23 years of health care management experience in both inpatient and outpatient settings. His areas of expertise include health care delivery, consumer health technologies, health information technologies, and health information exchange.
- Hamid Ekbia, PhD – Chief Scientist. Hamid leads the development of research objectives supporting the strategic direction of our company, its products, and services. He also serves as the point of contact with all academic partnerships and initiatives intended to broaden our knowledge and talent base and future product development. Hamid’s background is in computer, cognitive, and information sciences. More recently, Hamid has applied his knowledge in human-computer interaction to the technical advances in health information technology as Associate Professor at Indiana University’s School of Library and Information Science and Director of the Center for Research on Mediated Interaction.
- Doug Bennett – President. Doug will be directing operations and business development activities while contributing significantly to the strategic direction of both product and company. He brings two decades of experience in financial management, strategy development, and business development to the WellPlay Health team.
- T.J. Deckard – Chief Architect. TJ has over 13 years experience of development experience in leading teams in the design, development, deployment of applications and technologies in the health care and financial industries.
For more information, please visit us at www.wellplayhealth.com
So if Lilly’s CEO John Lechleiter says Indiana needs to establish a world class research institute for life sciences, should resources in the state make it happen?
I’m still thinking about this, to be honest. Should Indiana play in the life science research space? Does the state have the right resources to make this successful?
You can read more of his comments at MedCity News.
Seems like a knee jerk reaction to me. But I’m just a medical device guy–not a pharma guy.
Back in 2006, a momentous event happened in Indiana’s medical device startup scene. Upstart Suros Surgical was acquired by Massachusetts-based Hologic for a ridiculous amount of money. Ever since then, Suros Surgical has served as a poster child for all other aspiring medical device startups in Indiana. And at the same time, many people also assumed that once acquired, the jobs established in Indianapolis around Suros would some day probably go away.
Fast forward six years later to present day. It was announced yesterday that Hologic will be closing its Indianapolis operations within the next 18 months. I have several friends who work at the Indy site–all great folks who I’m quite sure will land on their feet. But Suros / Hologic in central Indiana has been important to the “life science movement” in these parts. For years, it has represented the success story of entrepreneurs who literally started in a garage that eventually got acquired for hundreds of millions of dollars. And soon, Suros will fade off into the sunset.
For years, I’ve been wondering who the next Suros will be in Indiana. Or even if there will be a next Suros in Indiana.
Pete Yonkman of Cook Medical speaks about the impending 2.3% medical device tax and its impact on Cook. He also shares some thoughts about the potential affects of increased regulation.
UPDATE: I just came across another interview with Pete Yonkman on this topic and thought I’d share:
I’ve been reading quite a few blogs and articles about investment funding in the medical device industry. All reports seem to point to things being better than they’ve ever been–at least in recent years. And if I believe what I read, the Midwest, especially Indiana, is leading the pack. I plan to write more about this soon. I just have more research to do first.
Here’s what I do know:
- I’m not aware of any Indiana-based medical device startups who have received venture funding any time recently.
- Typical Indiana funding channels and resources for medical device seem to be very quiet and inactive.
What insights do you have on medical device venture funding?