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Change is in the air on the design side of medical devices. Product design and development firm Continuum in Newton has done much of its work in the medical device field over the past 25 years. Two of its executives, vice president of program development Mark Hanks and vice president of production innovation Tom Merle, shared their thoughts on trends in the sector with Mass High Tech managing editor James M. Connolly.
MHT: What changes have you seen in medical devices?
Merle: One thing that‘s clearly a working dynamic is the regulatory oversight. It’s always been a dominant part of how you think about development, but it’s even more pronounced now — the strategy for submission, the time frame, the recognition of what a 510(k) will take for success, thinking about reimbursement models for insurance companies in the business-case side of things. Those are really becoming more and more dominant parts of the conversation early on.
Hanks: Plus, the pressure that clients have in time to market and the pressure that our clients have to get their ideas and products to market early.
MHT: Factoring in the FDA sounds like it’s crucial, in terms of planning.
Merle: In terms of planning, it is crucial. It affects us. As an example, if you are trying to get into an innovative space, you need to stay pretty close in line with what assessments have been made about things like predicate devices. So what are the things you have to be aware of and to leverage to make sure it’s part of the story that convinces the regulatory bodies that the changes are isolated, the innovation is isolated and there is a lot that is leveraged from existing solutions? The story of submission is one of managed risk.
Hanks: We say there is a foundation already there, here is our incremental. And that’s the part we are trying to deal with the submission on.
Merle: We’ve used this material before, so you don’t have to worry about that, we’ve used this software code before, so you don’t have to worry about that. It’s knowing that landscape, which is a little bit different from the IP landscape.
MHT: How much of this is your responsibility versus the client’s?
Merle: We make it very collaborative. … The regulatory work is fundamentally part of the strategy. It’s part of the strategy of the business success, and it works best when there is a partnership between the development team and the regulatory folks.
I would say the other thing that is a major challenge today in medical devices is in forming the design process. With consumer products, you have the ability go and in a fairly informal way gather information about people’s lives. Patient access, doctor access, experts in the field whom you need to learn from — it’s becoming harder and harder because of the fear of letting outsiders into situations and being quoted in certain areas. It’s gotten tighter to try to get the audience with the right people to form the process.
Hanks: Now there is HIPAA (Health Insurance Portability and Accountability Act). The patient in the operating room is protected from us being able to observe the operation.
MHT: Are you getting involved with the insurance companies earlier?
Merle: This comes up a lot when you get into very innovative, somewhat game-changing innovations. The current formulas for reimbursement or the current categories for reimbursement get either stretched or broken. We worked on a reimbursement model for the disposable insulin pump, which breaks the paradigm of the insulin pump being a durable good, a thing that gets used over and over again. That changed completely the way the insurance companies thought about reimbursing patient care, and that needed to be considered in order for the business case for the client to hold together.
Hanks: Our clients may deal directly with the insurance companies, but we need to understand what the reimbursement policy is going to be for that particular code.
MHT: Does this become a factor when designing, in terms of the cost to build a product?
Hanks: We use the word “constraint,” but sometimes people outside the industry look at the word a little differently. To us, it’s a guardrail; it’s understanding the space where we can play, and then working within those constraints.
MHT: What are some of the new foundation technologies you can use?
Merle: There’s been an awful lot in the category of what I call “delivering energy,” and that’s for diagnostic or therapeutic reasons. It’s delivering microwaves or infrared or ultrasonics — very, very innovative new discoveries in how that energy can be delivered to the body and make surgical changes, diagnostic changes or therapeutic changes. Another area is imaging systems: The ability to image and sense and provide three-dimensional information to doctors, which continues to move at a rapid pace.
Hanks: We’ve done a lot of work in the area of how to use light for therapeutic purposes. In the last two or three years, we’ve seen a surge there. Something else we’ve seen is a combination of devices and drugs. When we talk about reimbursement and regulation, there is a lot to be worked on in how to reimburse combinations. Another area that we’re seeing a lot of activity in is in the area of microfluidics for point-of-care products. A lot of emerging diagnostics companies are seeking to change the business model and provide testing at the point of care. So your doctor could provide diagnostics right on-site, rather than send a test to the lab and incur expense and time.
Merle: In the U.S. and western Europe, that’s a play to do more at the doctor’s office rather than a central lab. But in emerging markets that’s almost a necessity because the central lab model doesn’t really exist. Having this diagnostic tool that can go out into the field and is portable enough, small enough or flexible enough … there’s a lot going on with the classical lab-on-a-chip model.
MHT: How does globalization change your job?
Merle: It’s a new conversation about the launch and business intent for even startup companies. The day of everything “finding its way to the United States or it can’t succeed” isn’t necessarily true anymore. In order for us to be prepared to do this well, we need to have the right kind of guidance; we need to be working with our clients as partners to figure out what they need at whatever level to succeed. We have clients who are gravitating toward a European clinical approach and a launch in Europe followed by a move to the U.S. or perhaps a move to China or India. It definitely adds a level of complexity to the development process.
MHT: What do you see coming in a year or two?
Merle: There will come a day when a highly recognized medical device company comes to us and says, “We want you to build a solution only for the China market.” That will change a lot, in terms of how we approach a project like that. Also, sustainability — the concept of doing something that is good for people and good for the earth — is right on the doorstep of significantly influencing medical device companies. In the past, there has been an “efficacy rules” kind of model. If it works and provides the function, and it has more packaging material than it needs, therapy wins. The success of the treatment wins. But I think the knowledge base for patients, doctors, nurses, the idea that they want both, they want something that does work but doesn’t impact the earth. … It’s very, very prevalent in consumer discussions and it is going to be more prevalent among providers.
MHT: What makes engineering medical devices fun? Interesting?
Merle: A lot of the individuals who work in that space here really like the idea of influencing and saving people’s lives. There’s that soft element of really helping people. It’s a complex, technical challenge, but you are influencing people’s lives not just on a recreational or social level but in a much more meaningful way. People feel that sense of success, a real sense of professional satisfaction — they were able to create something that, yes it made money for the client, but to see the quality of somebody’s life improve is a big deal.
Hanks: Also, what’s interesting about medical devices as opposed to other industries we’re involved in is how many stakeholders there are — the doctors, the nurses who may be setting up the system or taking it down, the technicians who maintain the system, purchasing decision-makers, and don’t forget the patients. Think about all the stakeholders involved in the decisions, and it can be challenging.
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