Convergent Medical Technology Part I - What Is It

Thinking about Life Sciences: Convergent Medical Technology: Part I - W...

1 of 3

http://blog.aesisgroup.com//2007/07/10/convergent-medical-technology-...

Thinking about Life Sciences http://blog.aesisgroup.com Tuesday, July 10, 2007 Convergent Medical Technology: Part I - What is it?

The medical concept of “diagnosis of exclusion” (per exclusionem) is defined as a diagnosis that is achieved by excluding all other, more defined possibilities. The Wikipedia definition (as of 7/10/07) states that a “diagnosis of exclusion … refers to a medical condition whose presence cannot be established with complete confidence from examination or testing.” That is actually not correct - perhaps I (or others) can get around to fixing that – because a diagnosis of exclusion can actually be quite precise and can represent a very distinct entity. Hence “diagnosis of exclusion” may represent a specific diagnostic entity (e.g. after eliminating all other possibilities) but it is more correct to define it as the process of obtaining that diagnosis rather than as a diagnostic entity on its own accord. For example, the clinical diagnosis of Alzheimer’s disease is one that is a diagnosis of exclusion. Namely, a physician has to make sure that the dementia is not due to a myriad of other causes such as vascular, other degenerative, post-trauma, toxic, infective, etc. conditions. Indeed, even depression - another classic “diagnosis of exclusion” – needs to be ruled out as well. On the other hand, a pathologic diagnosis of Alzheimer’s is accomplished either at autopsy or via a brain biopsy and since these two procedures (especially the former) are impractical for most clinical situations, the vast majority of Alzheimer’s sufferers have arrived at their diagnosis via this process of exclusion. In this regard, I suspect that Ronald Reagan’s terminal diagnosis was, in fact, a clinical diagnosis; yet his physicians were certainly confident enough in their diagnosis that the association between Reagan and Alzheimer’s has become an apolitical, hard fact for the history books. How is all this relevant to convergent medical technologies? Read on … Definition of Combination Medical Products It should first be pointed out that convergent medical technologies are also known as combination medical products though these two concepts are not exactly the same. The term "combination medical product" is used by the FDA; there is, in fact, at that agency a separate Office of Combination Products. Tthe FDA defines combination medical products as follows: As defined in 21 CFR § 3.2(e), the term combination product includes: 1. A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity; 2. Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products; 3. A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and where upon approval of the proposed product the labeling of the approved product would need to be changed, e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose; or 4. Any investigational drug, device, or biological product packaged separately that according to its proposed labeling

11/17/2008 12:43 AM

Thinking about Life Sciences: Convergent Medical Technology: Part I - W...

2 of 3

http://blog.aesisgroup.com//2007/07/10/convergent-medical-technology-...

is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect. The FDA definition is, in a way, a passive definition whereby a combination medical product is basically any combination of separately regulated products. Hence two drugs being combined together would be a combination product and likewise two biologics and so forth. While the FDA’s recognition of combination medical products and the establishment of the relatively new Office of Combination Products are certainly advances, it should be understood that this office and its work still functions within the conventional framework of separate drug and device tracks. While the FDA is certainly not ignorant of the unique and synergistic nature of true technology convergence, the combination medical product concept is more an adaptation of a bureaucratic mechanism rather than a truly new paradigm shift. Definition of Convergent Medical Technologies Convergent medical technologies, on the other hand, are not simply combinations of two separate products but can, indeed, be completely unique products in their own right. In addition, technology convergence does not encompass simple combinations of two drugs or two devices, for example. It’s not that convergence is necessarily better than combination but rather that true technology convergence carries with it unique challenges and opportunities which are not the case with simple combinations. Hence the way to define a convergent medical technology is via a “diagnosis of exclusion” process; hence the introductory discussion above. Convergent medical technologies (CMT) are those are technologies that cannot be defined purely as a drug, a device, or a software/IT product. As a picture is worth a thousand words (and we’ve expended already a number), the illustration below demonstrates this point. Essentially CMT are those technologies that fall within the intersections between these other, more defined sectors.

Hence we can categorize CMT along five lines (going counterclockwise around the diagram above starting at around 10 o’clock):

11/17/2008 12:43 AM

Thinking about Life Sciences: Convergent Medical Technology: Part I - W...

3 of 3

http://blog.aesisgroup.com//2007/07/10/convergent-medical-technology-...

Device-based drug delivery Nanobiotechnology Nanosensors and nanoelectronics Smart devices Bioinformatics There are obviously further subdivisions to this framework, but these five general categories should suffice to cover the broad universe of convergent medical technologies. Examples of each of these areas could be listed as follows: Device-based drug delivery - drug-eluting stents and implantable insulin pumps. Nanobiotechnology – devices with controlled-release or permanent nanotech coatings such as antibiotics, silver impregnation and so forth. Nanosensors and nanoelectronics – still quite early in development. Smart devices – implantable insulin pumps that have complex programs that coordinate with meals and blood glucose levels; microprocessor-controlled prosthetic limbs that execute finer-level movements and progressively improve functionality with use. Bioinformatics – the integration of devices and drugs with genomic and proteomic information to enable, for example, personalized medicine. Often a combined diagnostic/therapeutic or theranostics product is part of the system and thus even without the informatics component these are typically combination medical products.

After today’s basic definition piece, this blog will post two more articles discussing respectively the importance and implications of convergent medical technologies. Blogs are best if they are brief so we’ll leave these two other important topics for later. Does CMT have to be a Diagnosis of Exclusion? Being a blog, this venue allows for the audience to participate in the discussion. While Wikipedia has incorrectly defined a “diagnosis of exclusion” as being a diagnosis that is somewhat vague, that Wikipedia entry does capture the feeling of unease with a diagnosis that is obtained by excluding all others. Epistemologically, we would like something more concrete. The clinical diagnosis of Alzheimer’s is (with the exception of some new PET-based imaging techniques that are emerging) a diagnosis of exclusion yet the pathologic analysis (e.g. autopsy or biopsy) becomes definitive. Can we do the same with CMT? Your comments and suggestions are welcome and with the beauty of blogging technology can be posted here. What would be your definition for convergent medical technology? Ogan Gurel, MD MPhil [email protected] http://blog.aesisgroup.com/

Convergent Medical Technology Convergent Medical Technologies Combination Medical Products Drug-eluting stents CMT bioinformatics medical nanotechnology technology convergence Aesis Research Group Ogan Gurel MD

11/17/2008 12:43 AM